StemCell Therapy

Conference Call and Webcast Scheduled for 9:15 a.m. Eastern Time

BRISBANE, Calif., November 04, 2021--(BUSINESS WIRE)--Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today reported third quarter financial results and provided business and clinical highlights.

"We are delighted to share clinical data and business updates across several programs demonstrating that Sangamo has three important assets progressing toward late-stage development. Our gene therapy portfolio is advancing with accumulating safety and efficacy data in our Fabry and hemophilia A programs, and preliminary proof-of-concept data demonstrate the clinical potential of our zinc finger genome engineering technology in sickle cell disease. These data readouts show the progression of our first-generation genomic medicine pipeline and potentially pave the way for new treatments. Our next generation programs focus on genome regulation and allogeneic CAR-Treg cell therapy, where we have a robust preclinical pipeline in neurological and autoimmune diseases. We are energized by this momentum and look forward to continued execution of our corporate strategy," said Sandy Macrae, Chief Executive Officer of Sangamo.

Recent Clinical and Business Highlights

Fabry Disease First four patients dosed exhibited above normal -Gal A activity; Phase 3 planning initiated

Earlier today, we announced preliminary clinical data from the first four patients treated in our Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, or ST-920, our wholly owned Fabry disease gene therapy product candidate. Data as of the September 17, 2021 cutoff date from the four patients in the first two dose cohorts showed that isaralgagene civaparvovec was generally well tolerated. All four patients exhibited above normal alpha-galactosidase A (-Gal A) activity, which was maintained for up to one year for the first patient treated and through 14 weeks for the most recently treated patient. Activity of 2-fold to 15-fold above mean normal was observed at last measurement as of the cutoff date. Withdrawal from enzyme replacement therapy (ERT) has taken place for one patient and is planned for the other patient on ERT, based on the stability of their -Gal A activity following treatment.

The fifth patient in the STAAR study, who is the first patient in the third cohort (3e13vg/kg), was dosed after the cutoff date. The sixth patient is currently in screening also for the third dose cohort. We expect to provide updated data throughout 2022 and present these results at a medical meeting.

Based on the STAAR study results to date, we have initiated planning for a Phase 3 Fabry disease clinical trial.

Sickle Cell Disease Preliminary-proof-of-concept data will be presented at ASH as clinical program advances

Story continues

Preliminary proof-of-concept results from the Phase 1/2 PRECIZN-1 study investigating SAR445136, formerly BIVV003, an investigational zinc finger nuclease gene edited cell therapy, in patients with severe sickle cell disease (SCD) will be presented at the 63rd Annual Meeting of the American Society of Hematology (ASH) on December 12, 2021. Results as of the June 25, 2021 cutoff date show that all four treated patients did not require blood transfusions post engraftment and had no adverse or serious adverse events related to SAR445136 through 65 weeks of follow-up for the longest treated patient. The four treated patients all experienced increases in total hemoglobin, fetal hemoglobin and percent F cells.

We and Sanofi continue to advance the sickle cell disease program. We recently obtained manufacturing requirements guidance from FDA in preparation for further potential clinical studies. Separately, we and Sanofi made the business decision to cease development of the beta thalassemia indication in order to focus resources on the sickle cell disease program. ST-400 for beta thalassemia was developed with the support of a grant from the California Institute for Regenerative Medicine (CIRM).

Hemophilia A Four patients at highest dose experienced mean FVIII activity of 30.9% at week 104

Updated follow-up results from the Phase 1/2 Alta study of giroctocogene fitelparvovec gene therapy in patients with severe hemophilia A will be presented at ASH on December 12, 2021. For the four patients in the highest dose 3e13vg/kg cohort who have reached 104 weeks of follow-up as of the May 19, 2021 cutoff date, mean Factor VIII (FVIII) activity was 30.9% at week 104 as measured by chromogenic assay. In this cohort, the annualized bleeding rate was zero for the first year after treatment and 0.9 throughout total duration of follow-up. Giroctocogene fitelparvovec was generally well tolerated.

We and Pfizer also announced that some of the patients treated in the Phase 3 AFFINE trial of giroctocogene fitelparvovec experienced FVIII activity greater than 150% following treatment. None of these patients have experienced thrombotic events and some have been treated with direct oral anticoagulants to reduce thrombotic risk. Pfizer voluntarily paused screening and dosing of additional patients in the trial to implement a protocol amendment intending to provide guidance regarding the management of patients with FVIII levels that exceed 150%. On November 3, 2021, Pfizer was informed that the FDA has put this trial on clinical hold. The next step is to share the proposed protocol amendment with health authorities and respond to the clinical hold, after which the Companies will be able to provide updated timing for the trial.

Renal Transplant First patient enrolled, expect two patients to be dosed by mid-2022

The first patient has been enrolled in our Phase 1/2 STEADFAST study evaluating TX200, our wholly owned autologous HLA-A2 CAR Treg cell therapy product candidate treating patients receiving an HLA-A2 mismatched kidney from a living donor. We expect the first two patients in this study to be dosed by the middle of 2022 following kidney transplantation. We continue to open study sites and screen patients.

Research, Manufacturing, and Corporate Updates

Biogen announced type 1 myotonic dystrophy (DM1) as the previously undisclosed neuromuscular preclinical target in our collaboration.

We recently completed and brought online our in-house cell therapy manufacturing facility in our Brisbane, California headquarters and remain on track to complete our in-house cell therapy manufacturing facility in Valbonne, France by year-end.

We appointed D. Mark McClung as Chief Operating Officer, an important organizational step to support the multiple advancing wholly owned and partnered programs.

Third Quarter 2021 Financial Results

Consolidated net loss attributable to Sangamo for the third quarter ended September 30, 2021 was $47.7 million, or $0.33 per share, compared to a net loss attributable to Sangamo of $1.6 million, or $0.01 per share, for the same period in 2020.

Revenues

Revenues for the third quarter ended September 30, 2021, were $28.6 million, compared to $57.8 million for the same period in 2020, a decrease of $29.2 million.

The reduction in revenue was primarily due to a $39.3 million decrease related to our giroctocogene fitelparvovec and C9ORF72 collaboration agreements with Pfizer, resulting from the completion of our activities in 2020, and a $2.3 million decrease related to our collaboration agreement with Sanofi. These decreases were partially offset by higher revenues of $11.5 million and $1.3 million related to our collaboration agreements with Novartis and Biogen, respectively.

GAAP and Non-GAAP operating expenses

Three Months EndedSeptember 30,

Nine Months EndedSeptember 30,

(In millions)

2021

2020

2021

2020

Research and development

$

62.5

$

45.3

$

179.0

$

128.3

General and administrative

14.5

16.2

47.1

50.2

Total operating expenses

77.0

61.5

226.1

178.5

Stock-based compensation expense

(7.9

)

(6.7

)

(24.9

)

(19.1

)

Non-GAAP operating expenses

$

69.1

$

54.8

$

201.2

$

159.4

Total operating expenses on a GAAP basis for the third quarter ended September 30, 2021 were $77.0 million compared to $61.5 million for the same period in 2020. Non-GAAP operating expenses, which exclude stock-based compensation expense, for the third quarter ended September 30, 2021 were $69.1 million compared to $54.8 million for the same period in 2020.

The increase in total operating expenses on a GAAP basis was primarily driven by our higher clinical and manufacturing supply expenses along with our increased headcount to support the advancement of our clinical trials and our ongoing collaborations.

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of September 30, 2021 were $519.0 million compared to $692.0 million as of December 31, 2020.

Revised Financial Guidance for 2021

We are revising our full-year operating expense guidance initially provided on February 24, 2021 and reiterated most recently on August 5, 2021 as follows:

(in millions)

Initially Provided February 24, 2021;Reiterated May 4, 2021and August 5, 2021

Updated on November 4, 2021

Estimated GAAP Operating Expenses

$285 to $305

$300 to $310

Estimated Non-GAAP Operating Expenses

$255 to $275*

$265 to $275**

*excludes estimated stock-based compensation of $30 million

**excludes estimated stock-based compensation of $35 million

Conference Call

Sangamo will host a conference call today, November 4, 2021, at 9:15 a.m. Eastern Time, which will be open to the public. The call and live Q&A will be webcast.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 5178059. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. Call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 5178059.

About Sangamo Therapeutics

Sangamo Therapeutics is a clinical-stage biopharmaceutical company with a robust genomic medicines pipeline. Using ground-breaking science, including our proprietary zinc finger genome engineering technology and manufacturing expertise, Sangamo aims to create new genomic medicines for patients suffering from diseases for which existing treatment options are inadequate or currently dont exist. For more information about Sangamo, visit http://www.sangamo.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding our current expectations. These forward-looking statements include, without limitation, statements relating to the therapeutic and commercial potential of our product candidates, the anticipated plans and timelines of Sangamo and our collaborators for screening, enrolling and dosing patients in and conducting our ongoing and potential future clinical trials and presenting clinical data from our clinical trials, the anticipated advancement of our product candidates to late-stage development including potential future Phase 3 trials, anticipated implementation of a protocol amendment for the Phase 3 AFFINE clinical trial of giroctocogene fitelparvovec and the resumption of the dosing of additional patients in the trial; our revised 2021 financial guidance related to GAAP and non-GAAP total operating expenses and stock-based compensation; our continued execution of our corporate strategy; the anticipated completion of our in-house cell therapy manufacturing facility in Valbonne, France; and other statements that are not historical fact. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the effects of the evolving COVID-19 pandemic and the impacts of the pandemic on the global business environment, healthcare systems and business and operations of Sangamo and our collaborators, including the initiation and operation of clinical trials; the research and development process, including the enrollment, operation and results of clinical trials and the presentation of clinical data; the uncertain timing and unpredictable nature of clinical trials and clinical trial results, including the risk that any protocol amendment for the Phase 3 AFFINE trial of giroctocogene fitelparvovec may not be accepted by the relevant review bodies in a timely manner, or at all, or that the FDA may not lift its clinical hold on the Phase 3 AFFINE trial in a timely manner, or at all, each of which could further delay or preclude further patient dosing in the trial as well as the risks that therapeutic effects observed in clinical trial results will not be durable in patients and that final clinical trial data will not validate the safety and efficacy of our product candidates; reliance on results of early clinical trials, which results are not necessarily predictive of future clinical trial results; our limited experience manufacturing biopharmaceutical products, including the risks that we may be unable to maintain compliant manufacturing facilities, build additional facilities and manufacture our product candidates as intended; and our ability to achieve expected future financial performance.

There can be no assurance that we and our collaborators will be able to develop commercially viable products. Actual results may differ materially from those projected in these forward-looking statements due to the risks and uncertainties described above and other risks and uncertainties that exist in the operations and business environments of Sangamo and our collaborators. These risks and uncertainties are described more fully in our Securities and Exchange Commission filings and reports, including in our Annual Report on Form 10-K for the year ended December 31, 2020 as supplemented by our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. Forward-looking statements contained in this announcement are made as of this date, and we undertake no duty to update such information except as required under applicable law.

Non-GAAP Financial Measure

To supplement our financial results and guidance presented in accordance with GAAP, we present non-GAAP total operating expenses, which exclude stock-based compensation expense from GAAP total operating expenses. We believe that this non-GAAP financial measure, when considered together with our financial information prepared in accordance with GAAP, can enhance investors and analysts ability to meaningfully compare our results from period to period and to our forward-looking guidance, and to identify operating trends in our business. We have excluded stock-based compensation expense because it is a non-cash expense that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. This non-GAAP financial measure is in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. We encourage investors to carefully consider our results under GAAP, as well as our supplemental non-GAAP financial information, to more fully understand our business.

SELECTED CONSOLIDATED FINANCIAL DATA

(unaudited; in thousands, except per share data)

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Sangamo Therapeutics Reports Recent Business and Clinical Highlights and Third Quarter 2021 Financial Results - Yahoo Finance

NASHVILLE, Tenn., Nov. 4, 2021 /PRNewswire/ --Cryoport, Inc. (NASDAQ: CYRX) ("Cryoport" or the "Company"),a global leader in temperature-controlled supply chain solutions for the life sciences industry,today announced financial results for the three- and nine-month periods ended September 30,2021.

Jerrell Shelton, CEO of Cryoport, commented, "We delivered an outstanding third quarter and nine months of the year for the Company with strength across the board in all areas of our business. During the third quarter, our total revenue grew to a record $56.7 million driven by 38% organic growth year-over-year from Cryoport Systems and CRYOGENE and continuing strong revenue performance by MVE Biological Solutions and CRYOPDP. Our robust performance was driven by superlative execution by our global teams across all our business units. Our markets are strong and growing. Demand for MVE Biological Solutions' products remained at record highs, Cryoport Systems added 38 new customers during the quarter, and we successfully expanded the footprints for both CRYOPDP and CRYOGENE.

"Our Biopharma/Pharma revenue increased 371% year over year in the third quarter of 2021 or 41%, organically. But the story does not end there, we now support a record 582 clinical trials, compared with 561 at the end of the second quarter of 2021 and 517 at the end of the third quarter of 2020. We also support eight commercial therapies in regenerative medicine, including Novartis' KYMRIAH, Gilead/Kite's YESCARTAand TECARTUS, bluebird bio's ZYNTEGLO andSKYSONA, Bristol Myers Squibb's BREYANZI and ABECMA and Orchard Therapeutics' LIBMELDY. Additionally, four of the approved therapies received extended or supplemental approvals in the third quarter.

"Our revenue by market for the three- and nine-months ended September 30, 2021, as compared to the same periods in 2020 was asfollows:

Cryoport, Inc. and Subsidiaries

Total revenues by market

(unaudited)

Three Months Ended September 30,

Nine Months Ended September 30,

(in thousands)

2021

2020

% Change

2021

2020

% Change

Biopharma/Pharma

$ 46,001

$ 9,760

371%

$ 133,878

$ 27,120

394%

Animal Health

8,261

223

3598%

25,655

664

3762%

Reproductive Medicine

2,431

1,189

105%

6,635

2,551

160%

Total revenues

$ 56,693

$ 11,172

407%

$ 166,168

$ 30,335

448%

"Our solutions are experiencing accelerating global demand as a record number of cell and gene therapies are slated for commercialization in the coming months and years."

Mr. Shelton concluded, "We continue to set the pace and the standard for supply chain solutions for the regenerative medicine industry which continues to be in its very early stages of development. To support our continued global growth, we have expanded into 33 facilities in 16 countries and have initiated further expansion within the fast-growing Asia-Pacific (APAC) and EMEA (Europe, Middle East, and Africa) regions.We believe our strong momentum will continue to build through the remainder of the year and beyond as we realize the large commercial revenue potential of our vast pipeline of clinical trials supported. Our performance is a testament to the power of our strategy and our team's commitment to Cryoport and its mission, and, with that, we expect significant worldwide opportunities ahead to continue building sustainable, long-term value for shareholders."

Biopharma/Pharma

Our total Biopharma/Pharma revenue increased by $36.2 million, or 371%, to $46.0 million for the third quarter of 2021 compared to $9.8 million for the third quarter of 2020, driven by strong revenue contributions from all business units. For the third quarter of 2021, Biopharma/Pharma revenue grew organically by $4.0 million, or 41%, to $13.8 million compared to third quarter in the prior year.

As of the end of the third quarter, we supportedanettotalof582 clinical trials, compared with 561 at the end of the second quarter 2021 and 517 in third quarter 2020. The number of trials by phase and region are as follows:

Cryoport Supported Clinical Trials by Phase

Clinical Trials

September 30,

2021

2020

2019

Phase 1

240

207

180

Phase 2

272

244

191

Phase 3

70

66

54

Total

582

517

425

Cryoport Supported Clinical Trials by Region

Clinical Trials

September 30,

2021

2020

2019

Americas

459

411

360

EMEA

92

83

55

APAC

31

23

10

Total

582

517

425

A total of nine (9) Cryoport supported Biologic License Applications (BLAs) or Marketing Authorization Applications (MAAs) were filed in the nine months ended September 30, 2021, based on internal information and forecasts from the Alliance for Regenerative Medicine, of which three (3) were filed during the third quarter of 2021. Looking forward, we anticipate up to another four (4) BLA and MAA submissions for Cryoport-supported products during the remainder of 2021 and, at this time, an additional twenty-one (21) filings in 2022. Additionally, a total of four (4) Cryoport supported therapies received extended or supplemental approvals in the third quarter.

Animal Health

Our revenue from the Animal Health market increased by $8.0 million, or 3,598%, to $8.3 million for thethird quarter ended September 30, 2021,ascomparedtothesameperiodin2020 andwas primarily driven byouracquisitionofMVE Biological Solutions,whichhasastrongandlongstanding presenceinthismarket. Third quarter revenue grew organically by 31% over the prior year demonstrating successful execution of our engagement strategy within the animal health space.

Reproductive Medicine

Reproductive Medicine revenue more than doubled to $2.4 million for the third quarter of 2021 compared to $1.2 million for the third quarter of 2020, an increase of $1.2 million, or 105%. We see continuing strong demand for our CryoStork solutionprovided by Cryoport Systems driven by fertility clinic networks that are looking for global standardization on our best-in-class solution. MVE Biological Solutions also contributed revenue to our Reproductive Medicine market through its portfolio of cryogenic shipper and freezersolutions. We plan to continue to add agreements with new fertility clinics to our network globally during the remainder of 2021 and beyond to drive increased adoption of our services as well as expand our support efforts within this space to EMEA and APAC.

Financial Highlights

Note: All reconciliations of GAAP to adjusted (non-GAAP) figures above are detailed in the reconciliation tables included later in the press release.

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Cryoport Reports Record Third Quarter and Nine Months Revenue for 2021 - PRNewswire

SEAL BEACH, Calif. & SAN DIEGO--(BUSINESS WIRE)--Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of cellular immunotherapy, and Shoreline Biosciences, a biotechnology company developing allogeneic off-the-shelf, standardized, and targeted natural killer (NK) and macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer, today announced an alliance to advance the future of iPSC-derived cellular therapies.

The alliance leverages Dendreons extensive manufacturing, process development and end-to-end logistics expertise for the advancement of Shorelines pipeline of iPSC-derived cellular therapies. Dendreon is providing scalable cGMP manufacturing support for certain programs through clinical development and launch, enabling Shoreline to rapidly advance multiple products in parallel.

With more than a decade of proven expertise in cell therapy manufacturing and an established supply chain and logistics infrastructure, Dendreon is well positioned to support Shoreline in manufacturing from Phase I clinical trials through commercialization, said Maria Cho, Vice President of Business Development and Corporate Strategy. We are thrilled to partner with Shoreline to enable the future of cell therapy and change the way serious diseases are treated.

We are excited to partner with Dendreon, a leader in cell therapy, to manufacture cost-efficient, highly-scalable product candidates, said Mohammad El-Kalay, Ph.D., Senior VP & Head of CMC for Shoreline. Through our partnership with Dendreon, we are accelerating the commercialization of our next generation NK cell and macrophage products to bring scalable, allogeneic, off the shelf therapies to more patients in need.

About Dendreon

Dendreon is a commercial-stage biopharmaceutical company and end-to-end provider of manufacturing services for the cell therapy market. Dendreons flagship product, PROVENGE (sipuleucel-T), was the first FDA-approved immunotherapy made from a patients own immune cells and has been prescribed to over 40,000 men in the U.S. since 2010. Dendreon is headquartered in Seal Beach, Calif. For more information about Dendreons contract manufacturing services division, please visit https://www.dendreon.com/Partner-With-Us.

About Shorelines iPSC NK cell technology

Shoreline has developed a proprietary platform focused on iPSC-derived natural killer (NK) cells and macrophages that are optimized with precise and rational genetic reprogramming. The Shoreline NK cell and macrophage-based cell therapies are designed to provide an effective and efficient means for targeting and killing tumors as well as repairing tissue homeostasis. Shorelines approach, based on the advantage of its iPSC cell engineering and expansion, is being used to create a streamlined, affordable, and scalable manufacturing process that can deliver cell therapy treatments to patients in a more cost-effective, time-saving manner. Shorelines technology is at the forefront of regenerative medicine and is being used to develop potential therapies to treat a wide range of oncology indications.

About Shoreline Biosciences

Shoreline is dedicated to creating next-generation cellular immunotherapies for cancer that overcome the current limitations of first-generation cell therapy products. Shoreline is building a pipeline of natural killer (NK) cell and macrophage-cell therapy candidates derived from its deep expertise in iPSC differentiation methods and genetic reprogramming of disease relevant pathways. Shoreline has strategic partnerships with Kite, a Gilead Company, and BeiGene, a global biotechnology company, and is supported by high-quality institutional investors. Shoreline Biosciences is headquartered in San Diego, CA.

For more information, please visit https://shorelinebio.com/ and engage with us on LinkedIn.

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Dendreon Pharmaceuticals and Shoreline Biosciences Announce CMC and Manufacturing Alliance to Advance the Future of iPSC Cellular Therapy - Business...

TOKYO & MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--The SanBio Group (SanBio Co., Ltd. of Tokyo, Japan , SanBio, Inc. of Mountain View, California, US, and SanBio Asia Pte. Ltd. of Singapore) (TOKYO:4592), hereby announce that data comparing outcome measures for persons with traumatic brain injury (TBI) living with chronic motor deficits was published in Expert Review of Neurotherapeutics.

Success in clinical trials in chronic TBI is challenging to define and measure; therefore, this publication is an important advancement for the field of research as it relates to the assessment of persons with motor deficits resulting from a TBI, said Michael A. McCrea, Co-Director, Center For Neurotrauma Research; Professor, Department Of Neurosurgery, Medical College Of Wisconsin, Milwaukee, USA; and lead author for the publication. This study supports the use of Disability Rating Scale (DRS) and Fugl-Meyer Motor Scale (FMMS) in the evaluation of long-term functional outcomes and motor impairment in future clinical trials of persons with chronic motor deficits secondary to TBI.

While acute TBI is widely assessed using Extended Glasgow Outcome Scale (GOS-E), this scale is less well-defined for persons who have chronic, or long-term, motor deficits as a result of their injury. The publication, entitled, Determining minimally clinically important differences (MCIDs) for outcome measures in patients with chronic motor deficits secondary to traumatic brain injury, determined MCIDs for DRS and FMMS. MCID is defined as the smallest change on a measure that is reliably associated with a meaningful change in a patient's clinical status, function, or quality of life.

Establishing MCIDs for the DRS and FMMS in chronic TBI provides improved precision for assessing long-term functional outcomes and motor impairment, respectively, as compared to the widely used GOS-E Scale, which is most appropriate for use in acute TBI. The findings of this study support the use of DRS and Fugl-Meyer Scales in the evaluation of clinical outcomes, and define the amplitude of clinically meaningful improvement for future chronic TBI clinical trials.

At SanBio, we are passionate about improving the lives of persons living with long-term motor deficits as a result of a TBI or stroke. This publication will help to overcome one of the most challenging areas of clinical research: determining the minimal improvement that would be clinically meaningful in patients with chronic motor deficit. We would like to extend our gratitude to the physicians and rehabilitation specialists who supported this important work, added, Bijan Nejadnik, M.D., Corporate Officer, Chief Medical Officer and Head of Research.

This retrospective analysis is from SanBios 1-year, double-blind, randomized, surgical sham-controlled, Phase 2 STEM cell therapy for TRAumatic brain injury (STEMTRA) trial (NCT02416492), in which persons with chronic motor deficits secondary to TBI (n=61) underwent intracerebral stereotactic implantation of SB623 or sham surgery. MCIDs for DRS and FMMS were triangulated with anchor-based, distribution-based, and Delphi panel estimates. The published Delphi panel results are available here. The MCIDs for DRS and FMMS were: 1) 1.5 points for the Disability Rating Scale; 2) 6.2 points for the Fugl-Meyer Upper Extremity Subscale; 3) 3.2 points for the Fugl-Meyer Lower Extremity Subscale; and 4) 8.4 points for the Fugl-Meyer Motor Scale in persons with chronic motor deficits secondary to TBI.

The full publication can be accessed here.

About the STEM cell therapy for TRAumatic brain injury (STEMTRA) Trial

STEMTRA was a 12-month, Phase 2, randomized, double-blind, surgical sham-controlled, global trial evaluating the efficacy and safety of SB623 compared to sham surgery in patients with stable chronic neurological motor deficits secondary to TBI (https://clinicaltrials.gov identifier: NCT02416492). In this study, SB623 cells were implanted directly around the site of brain injury. The primary endpoint was mean change from baseline in FMMS score at six months to measure changes in motor impairment.

To be eligible for this trial, patients (ages 18-75) must have been at least 12 months post-TBI and had a Glasgow Outcome Scale extended (GOS-E) score of 3-6 (e.g., moderate or severe disability). The STEMTRA trial treated 61 patients from 27 sites in the U.S., Japan and Ukraine.

In this study, SB623 met its primary endpoint, with patients treated with SB623 achieving an average 8.3-point improvement from baseline in the FMMS, versus 2.3-points in the control group, at 6 months (p=0.040). No new safety signals were identified, and the most commonly reported adverse event was headaches. The Group, based on the study results, aims to apply for manufacture and marketing approval for SB623 as a regenerative medicine product by utilizing Japans conditional and time-limited approval system for regenerative medicine products.

About Traumatic Brain Injury

Traumatic brain injury (TBI) is one of the leading causes of death and disability worldwide. The estimated global incidence of acute TBI during 2016 was 27 million cases, and the estimated global prevalence of chronic impairment secondary to TBI was 55.5 million cases. Overall, TBI and long-term motor deficits secondary to TBI significantly impair persons self-care, employability, and quality of life, and are major burdens on healthcare systems worldwide. In the United States, approximately 43% of surviving hospitalized persons with TBI experience long-term motor deficits, with 5.3 million people estimated to live with long-term motor deficits secondary to TBI.

About SB623

SB623 is a proprietary, cell-based investigational product made from allogeneic modified and cultured adult bone marrow-derived mesenchymal stem cells (MSCs) that undergo temporary genetic modification. Implantation of SB623 cells into injured nerve tissue in the brain is expected to trigger the brains natural regenerative ability to recover lost motor functions. SanBio is preparing to file a Biologics License Application with the Pharmaceuticals and Medical Devices Agency in Japan for SB623 for the treatment of chronic motor deficits resulting from TBI with STEMTRA results.

About SanBio Group (SanBio Co., Ltd., SanBio, Inc. and SanBio Asia Pte. Ltd.)

SanBio Group is engaged in the regenerative cell medicine business, spanning research, development, manufacture, and sales of regenerative cell medicines. The Companys propriety regenerative cell medicine product, SB623, is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury and stroke. The Company is headquartered in Tokyo, Japan, Mountain View, California, US, and SanBio Asia Pte. Ltd. of Singapore), and additional information about SanBio Group is available at https://sanbio.com/en/

Sources:Alves, et al, Why Does Brain Trauma Research Fail? World Neurosurg. (2019) 130:115-121.Selassie AW, et al. Incidence of long-term disability following traumatic brain injury hospitalization, U.S., 2003. J Head Trauma Rehabil 2008;23:123-31.James SL, et al. Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2019;18:56-87.Walker WC & Pickett TC. Motor impairment after severe traumatic brain injury: a longitudinal multicenter study. J Rehabil Res Dev 2007;44:975-82.

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SanBio Announces Publication Comparing Outcome Measures for Persons With Chronic Traumatic Brain Injury in Expert Review of Neurotherapeutics -...

Findings led by experts in Seattle, San Francisco and Cincinnati suggest that some severe cases of heart failure have root causes surprisingly similar to neurodegenerative diseases like Alzheimers, Huntingtons and ALS.

CINCINNATI, Nov. 3, 2021 /PRNewswire/ -- One of the leading reasons why children and adults need heart transplants is a condition called dilated cardiomyopathy (DCM).

Model of mutant RBM20 differential splicing and P-body impacts in dilated cardiomyopathy. Proposed model for the impact of wild-type and mutant RBM20 on nuclear regulation of splicing based on RNA-Seq and eCLIP data as compared to cytoplasmic role of mutant RBM20 on P-body formation and 3UTR association with mRNAs implicated in granule formation.

Some cases of heart failure have root causes surprisingly similar to diseases like Alzheimers, Huntingtons and ALS.

Over time, sometimes quite rapidly, the heart's thick strong muscle tissue becomes thin and weak, causing the left ventricle to swell like a balloon. This makes the heart less able to squeeze efficiently, which can lead to blood clots, irregular heartbeats, and sometimes sudden death when the malfunctioning heart simply stops beating. The origins of cardiomyopathy are diverse, including viral infections, autoimmune diseases, toxic drug exposures, and dozens of gene mutations.

Now, a multi-disciplinary team of clinicians and researchers has deciphered the function of a specific genetic mutation that causes cardiomyopathy. Their findings, published Nov. 3, 2021, in Nature Communications, were made possible by growing gene-edited human heart tissue from induced pluripotent stem cells and measuring the activity, location and binding of this mutant protein.

The team was led by co-corresponding authors Charles Murry, MD, PhD, a regenerative medicine expert at the University of Washington; Bruce Conklin, MD, a genetic engineering expert with the Gladstone Institutes in California, and Nathan Salomonis, PhD, a computational genomics expert at Cincinnati Children's.

"We hope this study will lead to broader insights that could lead to improved heart failure therapies," Conklin says.

Cutting-edge experiments expose more of the heart's inner workings

Over the last several decades, the research community has made many discoveries that have led to improved medications and medical devices that can dramatically extend life by slowing down the progression of heart failure. However, we still lack proven cures.

Story continues

This study reveals a new mechanism of cardiomyopathy initiation by the RNA binding motif protein 20 (RBM20). This protein helps control RNA splicing in the heart, the process by which RNAs are sliced and diced to give rise to different proteins in different tissues. Normally, RBM20 splices RNAs to make proteins that enable the heart to adapt to stress and contract regularly throughout a person's entire life. But a class of mutations in RBM20 result in severe cardiomyopathy in adulthood.

"We and others had previously studied RBM20's function during heart development, but we had little to no clue of why it stops working in disease. We needed to step up our game if our research was to have a clinical impact," says Alessandro Bertero, PhD, who contributed to the work while at the University of Washington and now leads an Armenise-Harvard Laboratory at the University of Turin in Italy.

Discovering this protein's role was especially complex because knocking out this gene in animal models does not mimic the damaging effects seen in people. Instead, the work required editing the genome of healthy cells and engineering human heart tissue from these cells in a lab dish. Only by producing heart tissue similar to that found in humans could the authors understand the contractile defects and molecular mechanisms underlying this gene's function in a controlled manner.

"That was exactly what we intended when we started this project by genome-editing induced pluripotent stem cells," says co-leading author Yuichiro Miyaoka, PhD, of the Tokyo Metropolitan Institute of Medical Science.

First, the team observed that the engineered muscle tissue carrying the mutant form of RBM20 did not function like tissue engineered with normal RBM20 or lacking the protein all together. The mutated muscle fibers contracted with significantly less force and upstroke velocity, much like a heart affected by cardiomyopathy.

Then, at the single-cell level, the team detected another important clue. Normally, RBM20 is located exclusively within the cell nucleus. However, the mutated form localizes almost entirely out of the nucleus, in the cell's cytoplasm.

This, by itself, did not mean muchuntil the cell was exposed to heavy stress. When that occurred, the mutant protein was detected within tiny "stress granules" made of protein and RNA that cells rapidly produce as a reaction to stress. In contrast, RBM20 in healthy cells remained within the nucleus and distinct from stress granules. This suggests there are additional cellular mechanisms, along with changes in splice-activity, leading to RBM20 cardiomyopathy.

"When the RNA binding landscape of mutant RBM20 was revealed by a technology called enhanced CLIP, it mimicked the binding of other splicing factors that have been implicated in neurodegenerative diseases. These factors, when mutated, also change their activity from RNA splicing to RNA aggregation outside the nucleus," says co-author Gene Yeo, PhD, MBA, a member of the Department of Cellular and Molecular Medicine at the University of California San Diego.

"Over time, such aggregates play havoc with other cell functions, ultimately leading to the tissue-weakening of heart muscle during cardiomyopathy," Salomonis says.

"It is intriguing to note the parallels between our observations with RBM20 and recent findings in neuro-degeneration," the paper states. "Indeed, recent work has hypothesized cytoplasmic RBM20 may be similar to the cytoplasmic RNP granules associated with neurodegeneration (Schneider et al., 2020), such as TAU for Alzheimer s disease, Huntingtin for Huntington s disease, and FUS for amyotrophic lateral sclerosis (ALS)."

Next steps

Co-authors for this study also included scientists from the University of Cincinnati Department of Electrical Engineering and Computer Science, Sana Biotechnology, and the University of California San Francisco.

The co-authors say the 3D heart tissue model they've developed has the potential to be used to test new drugs to block the formation of cytoplasmic granules as a possible treatment for cardiomyopathy, even those without RBM20 mutations.

"RBM20 has been a frustrating protein to study, as animal models don't fully recapitulate human disease pathology," says lead author Aidan Fenix, PhD. "It's exciting to now have an in vitro human cell model of RBM20 cardiomyopathy that shows the major clinical feature of dilated cardiomyopathy--reduced contractile force. We hope these models will speed the discovery of therapies to treat RBM20 dilated cardiomyopathy."

About this study

This work was supported by grants from the National Heart, Lung, and Blood Institute (U01 HL099997, P01 HL089707, R01 HL130533, F32 HL156361-01, HL149734, R01 HL128362, R01 HL128368, R01 HL141570, R01 HL146868); the National Institute of Diabetes and Digestive and Kidney (U54DK107979-05S1); the National Science Foundation (NSF CMMI-1661730); a JSPS Grant-in-Aid for Young Scientists, and grants from NOVARTIS, the Mochida Memorial Foundation, SENSHIN Medical Research Foundation, Naito Foundation, Uehara Memorial Foundation, a Gladstone-CIRM Fellowship, and the A*STAR International Fellowship.

Cision

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SOURCE Cincinnati Children's Hospital Medical Center

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Heart Tissue in a Dish Reveals New Links Between Neurodegeneration and Heart Disease - Yahoo Finance

Supply chain woes are a headache for multiple industries, and the tech sector is no different amid semiconductor and component shortages and logistics disasters. The one exception may be 3D printing companies, which may actually benefit from supply chain challenges.

Stratasys' third-quarter earnings report hinted at an inflection point for 3D printing as supply chain issues are forcing manufacturers to rip up playbooks that have worked for decades. Offshore manufacturing doesn't look as good as it used to. Shipping costs are killing companies' margins, so you'll need more manufacturing closer to the customer. And inventory forecasting is a nightmare due to hoarding.

3D printing can alleviate a lot of these issues--as long as vendors can get enough inventory to make their own systems. Yoav Zeif, CEO of Stratasys, explained the supply chain challenges and opportunities well on the company's conference call.

We are one of those privileged industries there are not only suffering from the supply chain challenges, but also enjoying it long term because this is what brings to life the essence and the power of additive manufacturing. You want no more offshoring. You want to have digital inventory. You want to produce near the customer, and we see it every day in the level of engagement we have with the largest OEMs. We see that the world of manufacturing is going to change and be much more digitalized than what we see now.

Stratasys won't be the only one that may benefit from a shift from traditional supply chain practices to additive manufacturing.

Desktop Metal said it opened a new in-house manufacturing facility that will triple assembly space for its Production System platform. The upshot is that Desktop Metal is seeing pent-up demand for its Production System P-50 metal 3D printing platform.

3D Systems is also betting that additive manufacturing will see a demanding pop as enterprises look to make supply chains more flexible. 3D Systems has industrial use cases but has staked out healthcare and regenerative medicine as growth markets.

Lilach Payorski, CFO of Stratasys, said the third-quarter revenue growth of 24.3% was a sign of "the inflection point we are experiencing." "There was also strong performance from our manufacturing business, in particular, improvement from automotive and industrials in Europe," she said. Healthcare remains Stratasys' fastest growing business.

Stratasys reported revenue of $159 million with a net loss of $18.1 million, or 28 cents a share. Non-GAAP earnings were a penny a share. During the quarter, Stratasys landed a $20 million contract with the US Navy.

While in the long run, Stratasys can benefit from supply chain turmoil, Payorski said the company also has short-term issues like every other enterprise. She said:

We are carefully monitoring the ongoing macro issues of high global logistic costs and inflationary pricing of raw materials, which have pressured margins. Our top priority is to deliver our product in a timely manner. To help ensure this, we have increased production levels to offset sea and air delays in our planning process. We continue to evaluate a wide area of shipping options to ensure we can deliver goods with a minimal business impact.

Read more:
3D printing vendors poised to benefit long term from supply chain disruptions - ZDNet

DUBLIN--(BUSINESS WIRE)--The "Regenerative Medicine Market by Product, by Material, by Application - Global Opportunity Analysis and Industry Forecast, 2021 - 2030" report has been added to ResearchAndMarkets.com's offering.

The global regenerative medicine market is expected to reach USD 172.15 billion by 2030 from USD 13.96 billion in 2020, at a CAGR of 28.9%.

Companies Mentioned

Regenerative Medicine are used to regenerate, repair, replace or restore tissues and organs damaged by diseases or due to natural ageing. These medicines help in the restoration of normal cell functions and are widely used to treat various degenerative disorders such as cardiovascular disorders, orthopedic disorders and others.

The rising demand for organ transplantation and increasing awareness about the use of regenerative medicinal therapies in organ transplantation along with implementation of the 21st Century Cures Act, a U.S. law enacted by the 114th United States Congress in December 2016 are creating growth opportunities in the market. However, high cost of treatment and stringent government regulations are expected to hinder the market growth.

The global regenerative medicine market is segmented based on product type, material, application, and geography. Based on product type, the market is classified into cell therapy, gene therapy, tissue engineering, and small molecule & biologic. Depending on material, it is categorized into synthetic material, biologically derived material, genetically engineered material, and pharmaceutical. Synthetic material is further divided into biodegradable synthetic polymer, scaffold, artificial vascular graft material, and hydrogel material. Biologically derived material is further bifurcated into collagen and xenogenic material. Genetically engineered material is further segmented into deoxyribonucleic acid, transfection vector, genetically manipulated cell, three-dimensional polymer technology, transgenic, fibroblast, neural stem cell, and gene-activated matrices. Pharmaceutical is further divided into small molecule and biologic. By application, it is categorized into cardiovascular, oncology, dermatology, musculoskeletal, wound healing, ophthalmology, neurology, and others. Geographically, it is analyzed across four regions, i.e., North America, Europe, Asia-Pacific, and RoW.

Key Topics Covered:

1. Introduction

2. Regenerative Medicine Market - Executive Summary

3. Porter's Five Force Model Analysis

4. Market Overview

4.1. Market Definition and Scope

4.2. Market Dynamics

5. Global Regenerative Medicine Market, by Product Type

5.1. Overview

5.2. Cell Therapy

5.3. Gene Therapy

5.4. Tissue Engineering

5.5. Small Molecules & Biologics

6. Global Regenerative Medicine Market, by Material

6.1. Overview

6.2. Synthetic Materials

6.3. Biologically Derived Materials

6.4. Genetically Engineered Materials

6.5. Pharmaceuticals

7. Global Regenerative Medicine Market, by Application

7.1. Overview

7.2. Cardiovascular

7.3. Oncology

7.4. Dermatology

7.5. Musculoskeletal

7.6. Wound Healing

7.7. Opthalomolgy

7.8. Neurology

7.9. Others

8. Global Regenerative Medicine Market, by Region

8.1. Overview

8.2. North America

8.3. Europe

8.4. Asia-Pacific

8.5. Rest of World

9. Company Profile

9.1. Integra Lifesciences Corporation

9.2. Abbvie Inc.

9.3. Merck Kgaa

9.4. Medtronic plc

9.5. Thermo Fisher Scientific Inc.

9.6. Smith+Nephew

9.7. Becton, Dickinson and Company

9.8. Baxter International Inc

9.9. Cook Biotech

9.10. Organogenesis Inc

For more information about this report visit https://www.researchandmarkets.com/r/nzud5i

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Global Regenerative Medicine Market (2021 to 2030) - by Product, Material, Application and Region - ResearchAndMarkets.com - Business Wire

DUBLIN--(BUSINESS WIRE)--The "Cryopreservation Equipment Market Forecast to 2028 - COVID-19 Impact and Global Analysis by Type, Cryogen Type, Application, End User, and Geography" report has been added to ResearchAndMarkets.com's offering.

Freezers Segment to Contribute Major Share to Cryopreservation Equipment Market

Cryopreservation Equipment Market to reach US$ 11,255.02 million by 2028 from US$ 5,798.82 million in 2021; it is estimated to grow at a CAGR of 9.9%

The report highlights the trends prevailing in the market along with the market drivers and deterrents. The factors such as growing acceptance for regenerative medicine and increasing needs of biobanking practices drive the market growth. However, stringent regulatory requirements hinder the cryopreservation equipment market growth.

Cryopreservation plays an important part in the field of regenerative medicine as it facilitates stable and secure storage of cells and other related components for a prolonged time. Regenerative medicine enables replacing diseased or damaged cells, tissues, and organs by retrieving their normal function through stem cell therapy.

Owing to the advancements in the medical technology, stem cell therapy is now being considered as an alternative to traditional drug therapies in the treatment of a wide range of chronic diseases, including diabetes and neurodegenerative diseases.

Moreover, the US Food and Drug Administration (FDA) has approved blood-forming stem cells. The blood-forming stem cells are also known as hematopoietic progenitor cells that are derived from umbilical cord blood. The growing approvals for stem cell and gene therapies are eventually leading to the high demand for cryopreservation equipment. Following are a few instances of stem cell and gene therapies approved by the FDA and other regulatory bodies.

Based on type, the cryopreservation equipment market is segmented into freezers, sample preparation systems, and accessories. In 2020, the freezers segment held the largest share of the market, and it is expected to register the highest CAGR during 2021-2028. In ultracold freezers, liquid nitrogen is used for the successful preservation of more complex biological structures by virtually seizing all biological activities.

The COVID-19 pandemic has had a mixed impact on the cryopreservation equipment market. Restricted access to family planning services as well as diverted focus of people due to economic uncertainties and recession, and disturbed work-life balance have led to rise in egg and embryo freezing activities at fertility clinics during the pandemic.

As a result, the rising use of cryopreservation equipment is boosting the market growth. Furthermore, supply chain disruption caused due to congestion of ports and disturbances in other transport means has substantially affected the distribution of cryopreservation equipment and other accessories.

Market players are launching new and innovative products and services to maintain their position in the cryopreservation equipment market. In May 2021, Stirling Ultracold has been acquired by BioLife Solutions, Inc for cell and gene therapies and the broader biopharma market. In return for all of Stirling's outstanding shares, BioLife issued 6,646,870 shares of ordinary stock.

Key Market Dynamics

Market Drivers

Market Restraints

Market Opportunities

Future Trends

The report segments the global cryopreservation equipment market as follows:

By Type

By Cryogen Type

By Application

By End User

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/tjgti5

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Global Cryopreservation Equipment Market Report 2021-2028 - Growing Acceptance for Regenerative Medicine & Increasing Needs of Biobanking...

Regenerative medicine is a growing area of orthopedic treatment. Two orthopedic surgeons told Becker's what they found the most exciting about its development.

Ask Orthopedic Surgeons is a weekly series of questions posed to orthopedic surgeons around the country about clinical, business and policy issues affecting orthopedic care. We invite all orthopedic surgeon and specialist responses.

Next week's question: How will joint replacement surgical robots improve in the next 10 years?

Please send responses to Carly Behm at cbehm@beckershealthcare.com by 5 p.m. CDT Tuesday, Aug. 31.

Note: Responses were edited for style.

Question: What area of regenerative medicine holds the most promise for orthopedics?

Mihir Patel, MD. OrthoIndy (Indianapolis): Regenerative medicine is a truly exciting frontier in medicine. In orthopedics, bone graft implants and substitutes are helping patients return to normal activities. The implants can be used in index operations as well as revisions for a variety of orthopedic procedures including acute stress reactions, stress fractures not conducive to metal fixation, and subchondral procedures. The evolution of orthopedic implants from metal to plastic, and now bone is improving outcomes for patients and broadening our arsenal as surgeons to help patients heal. The bone graft substitutes are reducing comorbidities of graft harvesting. Additionally, they are adding to the value proposition for patients who may have difficulty healing bone defects, nonunions, and osteoporosis.

Much like advances in cancer therapies over the past decade, bone graft substitutes have the potential for personalized, targeted medicine for these diagnoses as biomarkers become more available to help clinicians really pinpoint at the molecular level why some heal more quickly than others. Finally, regenerative medicine includes mostly outpatient procedures with sterile kits that are easily transported, giving orthopedic surgeons the confidence in the manufacturing and sterilization process.

Jason Snibbe, MD. Snibbe Orthopedics (Los Angeles): I think the use of biologics from plasma and bone marrow have the most promise right now to help a variety of injuries in orthopedics. We are able to help people recover without surgery and use their own tissue to heal, specifically in labral tears of the hip and meniscus tears in the knee.

Read more from the original source:
2 surgeons weigh in on the most promising areas of regenerative medicine - Becker's Orthopedic & Spine

Dublin, Aug. 27, 2021 (GLOBE NEWSWIRE) -- The "Regenerative Medicine Market by Product, by Material, by Application - Global Opportunity Analysis and Industry Forecast, 2021 - 2030" report has been added to ResearchAndMarkets.com's offering.

The global regenerative medicine market is expected to reach USD 172.15 billion by 2030 from USD 13.96 billion in 2020, at a CAGR of 28.9%. Regenerative Medicine are used to regenerate, repair, replace or restore tissues and organs damaged by diseases or due to natural ageing. These medicines help in the restoration of normal cell functions and are widely used to treat various degenerative disorders such as cardiovascular disorders, orthopedic disorders and others.

The rising demand for organ transplantation and increasing awareness about the use of regenerative medicinal therapies in organ transplantation along with implementation of the 21st Century Cures Act, a U.S. law enacted by the 114th United States Congress in December 2016 are creating growth opportunities in the market. However, high cost of treatment and stringent government regulations are expected to hinder the market growth.

The global regenerative medicine market is segmented based on product type, material, application, and geography. Based on product type, the market is classified into cell therapy, gene therapy, tissue engineering, and small molecule & biologic. Depending on material, it is categorized into synthetic material, biologically derived material, genetically engineered material, and pharmaceutical. Synthetic material is further divided into biodegradable synthetic polymer, scaffold, artificial vascular graft material, and hydrogel material. Biologically derived material is further bifurcated into collagen and xenogenic material. Genetically engineered material is further segmented into deoxyribonucleic acid, transfection vector, genetically manipulated cell, three-dimensional polymer technology, transgenic, fibroblast, neural stem cell, and gene-activated matrices. Pharmaceutical is further divided into small molecule and biologic. By application, it is categorized into cardiovascular, oncology, dermatology, musculoskeletal, wound healing, ophthalmology, neurology, and others. Geographically, it is analyzed across four regions, i.e., North America, Europe, Asia-Pacific, and RoW.

The key players operating in the global regenerative medicine market include Integra Lifesciences Corporation, AbbVie Inc., Merck KGaA, Medtronic, Thermo Fisher Scientific Inc., Smith+Nephew, Becton, Dickinson and Company, Baxter International Inc, Cook Biotech, and Organogenesis Inc., among others.

Key Topics Covered:

1. Introduction

2. Regenerative Medicine Market - Executive Summary

3. Porter's Five Force Model Analysis

4. Market Overview4.1. Market Definition and Scope4.2. Market Dynamics

5. Global Regenerative Medicine Market, by Product Type5.1. Overview5.2. Cell Therapy5.3. Gene Therapy5.4. Tissue Engineering5.5. Small Molecules & Biologics

6. Global Regenerative Medicine Market, by Material6.1. Overview6.2. Synthetic Materials6.3. Biologically Derived Materials6.4. Genetically Engineered Materials6.5. Pharmaceuticals

7. Global Regenerative Medicine Market, by Application7.1. Overview7.2. Cardiovascular7.3. Oncology7.4. Dermatology7.5. Musculoskeletal7.6. Wound Healing7.7. Opthalomolgy7.8. Neurology7.9. Others

8. Global Regenerative Medicine Market, by Region8.1. Overview8.2. North America8.3. Europe8.4. Asia-Pacific8.5. Rest of World

9. Company Profile9.1. Integra Lifesciences Corporation9.2. Abbvie Inc.9.3. Merck Kgaa9.4. Medtronic plc9.5. Thermo Fisher Scientific Inc.9.6. Smith+Nephew9.7. Becton, Dickinson and Company9.8. Baxter International Inc9.9. Cook Biotech9.10. Organogenesis Inc

For more information about this report visit https://www.researchandmarkets.com/r/pl6r1p

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Worldwide Regenerative Medicine Industry to 2030 - Featuring AbbVie, Medtronic and Thermo Fisher Scientific Among Others - GlobeNewswire

The University of California, Davis, set a new record for external research funding, receiving $968 million in awards in the fiscal year 2020-21, up $27 million from the previous record set last year. A major reason for this years growth was increased funding related to medicine and public health.

Professors Diana Farmer and Aijun Wang are collaborating to develop a stem cell treatment for spina bifida. (2019)

The School of Medicine received the largest increase in funding, up $92 million from the previous year, for a total of $368 million. Funding related to COVID-19 research totaled $42 million for the year. Studies in this area are providing critical insight into testing, vaccines, treatments and social impacts.

We are very proud of our researchers at the School of Medicine who rose to the challenge and expanded their groundbreaking work in the face of the pandemic, said Allison Brashear, dean of the UC Davis School of Medicine. All our research teams have shown great agility and collaboration across disciplines, quickly responding to emerging needs to prevent transmission and find treatments and vaccines to combat COVID-19, while also offering patients life-saving clinical trials in areas involving stem cell treatments, cancer and neuroscience, among many others.

Brashear noted that the School of Medicines clinical trials grew by 63% in the last year to $98 million.

The College of Agricultural and Environmental Sciences ($153 million), School of Veterinary Medicine ($83 million), College of Engineering ($80 million) and College of Biological Sciences ($58 million) rounded out the top five recipients.

This achievement reflects the unwavering commitment of our research community and their passion to address important societal needs during a year when operations were constrained due to the COVID-19 pandemic, Chancellor Gary S. May said. The societal impact of UC Davis research is far-reaching, spanning geographical boundaries and catering to diverse populations and needs.

The awards enable a broad range of research on topics including advancing human and animal health, protecting our planet and food supply and enabling a more resilient society.

The largest award, $51 million from the Department of Health and Human Services Centers for Disease Control and Prevention, went to Marc Schenker, distinguished professor of Public Health Sciences, to improve public health outcomes for all Californians by providing proper disease surveillance and prevention.

The federal government remains the largest provider of funding at $514 million, up $37 million from last year. The second leading source came from the state of California at $164 million, up $32 million. Funding from industry made up the third highest source, totaling $116 million, up $31 million.

UC Davis researchers received a total of 18 NSF CAREER Awards, a record for the university. These prestigious grants are offered to early-career faculty who have the potential to serve as academic role models in research and education and to lead advances in the mission of their department or organization.

Collaborative research bringing experts together from different fields of study continues to attract significant funding. These joint efforts often focus on addressing complex, large-scale challenges that require expertise from many perspectives.

We continue to see how multidisciplinary research provides a distinct advantage in tackling multifaceted issues, said Prasant Mohapatra, vice chancellor for Research at UC Davis. As one of the most academically comprehensive universities in the world, UC Davis offers a unique environment to solve these complex issues by bringing together experts from across our campuses.

Notable multidisciplinary awards include a $16 million grant from the National Institute of Mental Health for the UC Davis Conte Center to explore how infections in pregnancy lead to disorders in offspring. Principal investigators on this grant are Kimberly McAllister and Cameron Carter.

The Interdisciplinary Research and Strategic Initiatives division within the Office of Research offers support and resources to help teams advance their programs. Some of the notable interdisciplinary research projects include the work of Sheryl Catz, professor at the UC Davis Betty Irene Moore School of Nursing. Catz received $225,000 from the NIH National Cancer Institute for a project to improve the reach and effectiveness of smoking cessation services targeted to veterans living with HIV.

Diana Farmer, professor and chair in the Department of Surgery at UC Davis Health, also received $9 million from the California Institute for Regenerative Medicine (CIRM). Farmer is the principal investigator of the clinical trial, known formally as The CuRe Trial a cellular therapyfor in utero repair of myelomeningocele which uses stem cells before birth to treat the most serious form of spina bifida.

This story was originally written by Neelanjana Gautam and published here.

Note: Where funds are awarded up-front to cover several years, the money is counted in the first year the award was received. Incrementally funded awards are counted as authorized in each year. Reports are based on the principal investigators home school or college.

See more here:
UC Davis and the School of Medicine set new records in research funding - UC Davis Health

We live in a unique time when for the first time in human history there is a real opportunity to extend our lives dramatically. Recent scientific discoveries and technological breakthroughs that soon will translate into affordable and accessible life-extending tools will let us break the sound barrier of the current known record of 122 years. I am talking about breakthroughs in genetic engineering, regenerative medicine, healthcare hardware, and health data.

Very soon, slowing, reversing, or even ending aging will become a universally accepted ambition within the healthcare community. Technology is converging to make this a certainty. Developments in the understanding and manipulation of our genes and cells, in the development of small-scale health diagnostics, and in the leveraging of data for everything from drug discovery to precision treatment of disease are radically changing how we think about healthcare and aging.

When I speak of the Longevity Revolution, what I really mean is the cumulative effect of multiple breakthroughs currently underway across several fields of science and technology. Together, these parallel developments are forming the beginning of a hockey-stick growth curve that will deliver world-changing outcomes.

Completed in 2003, the Human Genome Project successfully sequenced the entire human genomeall 3 billion nucleotide base pairs representing some 25,000 individual genes. The project, arguably one of the most ambitious scientific undertakings in history, cost billions of dollars and took 13 years to complete. Today, your own genome can be sequenced in as little time as a single afternoon, at a laboratory cost of as little as $200.

The consequences of this feat are nothing short of revolutionary. Gene sequencing allows us to predict many hereditary diseases and the probability of getting cancer. This early benefit of gene sequencing became widely known when Angelina Jolie famously had a preventative double mastectomy after her personal genome sequencing indicated a high vulnerability to breast cancer. Genome sequencing helps scientists and doctors understand and develop treatments for scores of common and rare diseases. Along with advances in artificial intelligence, it helps determine medical treatments precisely tailored to the individual patient.

Longevity scientists have even identified a number of so-called longevity genes that can promise long and healthy lives to those who possess them. Scientists now understand far better than ever before the relationship between genes and aging. And while our genes do not significantly change from birth to death, our epigenomethe system of chemical modifications around our genes that determine how our genes are expresseddoes. The date on your birth certificate, it turns out, is but a single way to determine age. The biological age of your epigenome, many longevity scientists now believe, is far more important.

Best of all, however, science is beginning to offer ways to alter both your genome and epigenome for a healthier, longer life. New technologies like CRISPR-Cas9 and other gene-editing tools are empowering doctors with the extraordinary ability to actually insert, delete, or alter an individuals genes. In the not terribly distant future, we will be able to remove or suppress genes responsible for diseases and insert or amplify genes responsible for long life and health.

Gene editing is just one of the emerging technologies of the genetic revolution: Gene therapy works by effectively providing cells with genes that produce necessary proteins in patients whose own genes cannot produce them. This process is already being applied to a few rare diseases, but it will soon become a common and incredibly effective medical approach. The FDA expects to approve 10 to 20 such therapies by the year 2025.

Another major transformation driving the Longevity Revolution is the field of regenerative medicine. During aging, the bodys systems and tissues break down, as does the bodys ability to repair and replenish itself. For that reason, even those who live very long and healthy lives ultimately succumb to heart failure, immune system decline, muscle atrophy, and other degenerative conditions. In order to achieve our ambition of living to 200, we need a way to restore the body in the same way we repair a car or refurbish a home.

Several promising technologies are now pointing the way to doing just that. While it is still quite early, there are already a few FDA-approved stem cell therapies in the United States targeting very specific conditions. Stem cellscells whose job it is to generate all the cells, tissues, and organs of your bodygradually lose their ability to create new cells as we age. But new therapies, using patients own stem cells, are working to extend the bodys ability to regenerate itself. These therapies hold promise for preserving our vision, cardiac function, joint flexibility, and kidney and liver health; they can also be used to repair spinal injuries and help treat a range of conditions from diabetes to Alzheimers disease. The FDA has approved 10 stem cell treatments, with more likely on the way.

Its one thing to replenish or restore existing tissues and organs using stem cells, but how about growing entirely new organs? As futuristic as that sounds, it is already beginning to happen. Millions of people around the world who are waiting for a new heart, kidney, lung, pancreas, or liver will soon have their own replacement organs made to order through 3D bio-printing, internal bioreactors, or new methods of xenotransplantation, such as using collagen scaffoldings from pig lungs and hearts that are populated with the recipients own human cells.

Even if this generation of new biological organs fails, mechanical solutions will not. Modern bioengineering has successfully restored lost vision and hearing in humans using computer sensors and electrode arrays that send visual and auditory information directly to the brain. A prosthetic arm developed at Johns Hopkins is one of a number of mechanical limbs that not only closely replicate the strength and dexterity of a real arm but also can be controlled directly by the wearers mindjust by thinking about the desired movement. Today, mechanical exoskeletons allow paraplegics to run marathons, while artificial kidneys and mechanical hearts let those with organ failure live on for years beyond what was ever previously thought possible!

The third development underpinning the Longevity Revolution will look more familiar to most: connected devices. You are perhaps already familiar with common wearable health-monitoring devices like the Fitbit, Apple Watch, and ura Ring. These devices empower users to quickly obtain data on ones own health. At the moment, most of these insights are relatively trivial. But the world of small-scale health diagnostics is advancing rapidly. Very soon, wearable, portable, and embeddable devices will radically reduce premature death from diseases like cancer and cardiovascular disease, and in doing so, add years, if not decades, to global life expectancy.

[Photo: BenBella Books]The key to this part of the revolution is early diagnosis. Of the nearly 60 million lives lost around the globe each year, more than 30 million are attributed to conditions that are reversible if caught early. Most of those are noncommunicable diseases like coronary heart disease, stroke, and chronic obstructive pulmonary disease (bronchitis and emphysema). At the moment, once you have gone for your yearly physical exams, stopped smoking, started eating healthy, and refrained from having unprotected sex, avoiding life-threatening disease is a matter that is largely out of your hands. We live in a world of reactive medicine. Most people do not have advanced batteries of diagnostic tests unless theyre experiencing problems. And for a large percentage of the worlds population, who live in poor, rural, and remote areas with little to no access to diagnostic resources, early diagnosis of medical conditions simply isnt an option.

But not for long. Soon, healthcare will move from being reactive to being proactive. The key to this shift will be low-cost, ubiquitous, connected devices that constantly monitor your health. While some of these devices will remain external or wearable, others will be embedded under your skin, swallowed with your breakfast, or remain swimming through your bloodstream at all times. They will constantly monitor your heart rate, your respiration, your temperature, your skin secretions, the contents of your urine and feces, free-floating DNA in your blood that may indicate cancer or other disease, and even the organic contents of your breath. These devices will be connected to each other, to apps that you and your healthcare provider can monitor, and to massive global databases of health knowledge. Before any type of disease has a chance to take a foothold within your body, this armory of diagnostic devices will identify exactly what is going on and provide a precise, custom-made remedy that is ideal just for you.

As a result, the chance of your disease being diagnosed early will become radically unshackled from the limitations of cost, convenience, and medical knowledge. The condition of your body will be maintained as immaculately as a five-star hotel, and almost nobody will die prematurely of preventable disease.

There is one final seismic shift underpinning the Longevity Revolution, and its a real game-changer. Pouring forth from all of these digital diagnostic devices, together with conventional medical records and digitized research results, is a torrent of data so large it is hard for the human mind to even fathom it. This data will soon become grist for the mill of powerful artificial intelligence that will radically reshape every aspect of healthcare as we know it.

Take drug discovery, for instance. In the present day, it takes about 12 years and $2 billion to develop a new pharmaceutical. Researchers must painstakingly test various organic and chemical substances, in myriad combinations, to try to determine the material candidates that have the best chance of executing the desired medical effect. The drugs must be considered for the widest range of possible disease presentations, genetic makeup, and diets of targeted patients, side effects, and drug interactions. There are so many variables that it is little short of miraculous that our scientists have done so much in the field of pharmaceutical development on their own. But developing drugs and obtaining regulatory approval is a long and cash-intensive process. The result is expensive drugs that largely ignore rarer conditions.

AI and data change that reality. Computer models now look at massive databases of patient genes, symptoms, disease species, and millions of eligible compounds to quickly determine which material candidates have the greatest chance of success, for which conditions, and according to what dose and administration. In addition to major investments by Big Pharma, there are currently hundreds of startups working to implement the use of AI to radically reshape drug discovery, just as we saw happen in the race to develop COVID-19 vaccines. The impact that this use of AI and data will have on treating or even eliminating life-threatening diseases cannot be overstated.

But that is not the only way that artificial intelligence is set to disrupt healthcare and help set the Longevity Revolution in motion. It will also form the foundation of precision medicinethe practice of custom-tailoring health treatments to the specific, personal characteristics of the individual.

Today, healthcare largely follows a one-size-fits-all practice. But each of us has a very unique set of personal characteristics, including our genes, microbiome, blood type, age, gender, size, and so on. AI will soon be able to access and analyze enormous aggregations of patient data pulled together from medical records, personal diagnostic devices, research studies, and other sources to deliver highly accurate predictions, diagnoses, and treatments, custom-tailored to the individual. As a result, healthcare will increasingly penetrate remote areas, becoming accessible to billions of people who today lack adequate access to medical care.

I predict that the development of AI in healthcare will change how we live longer, healthier lives as radically as the introduction of personal computers and the internet changed how we work, shop, and interact. Artificial intelligence will eliminate misdiagnosis; detect cancer, blood disease, diabetes, and other killers as early as possible; radically accelerate researchers understanding of aging and disease; and reestablish doctors as holistic care providers who actually have time for their patients. In as little as 10 years time, we will look back at the treatment of aging and disease today as quite naive.

The Longevity Revolution lives not in the realm of science fiction but in the reality of academic research laboratories and commercial technology R&D centers. The idea of aging as a fixed and immutable quality of life that we have no influence upon is ready to be tossed into the dustbin of history.

Sergey Young is a renowned VC, longevity visionary, and founder of the $100 million Longevity Vision Fund. This is an adapted excerpt from The Science and Technology of Growing Young, with permission by BenBella Books.

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These 4 tech breakthroughs could help end aging - Fast Company

The global Human Embryonic Stem Cells (HESC) Market has been comprehensively analyzed and the results are presented in the market report published. The market concentration that is currently occupied by the Human Embryonic Stem Cells (HESC) market and an overview of the Human Embryonic Stem Cells (HESC) manufacturing industry is extensively researched in the report. An analysis of the collected data is used to reveal the market revenue earned by the different companies operating in the Human Embryonic Stem Cells (HESC) industry.

The global Human Embryonic Stem Cells (HESC) market depends on different factors that can either be a positive influence on the global market or cause the market to decline. The factors are identified and are categorized based on the effect that they can have on the market. The various factors are identified across all market segments and the different regions that are mentioned in the report.

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The objective of the study is to define market sizes of different segments and countries in previous years and to forecast the values to the next Five years. The report is designed to incorporate both qualify qualitative and quantitative aspects of the industry with respect to each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as drivers and restraining factors which will define the future growth of the Human Embryonic Stem Cells (HESC) market.

Some of The Companies Competing in The Human Embryonic Stem Cells (HESC) Market are Astellas Institute of Regenerative Medicine, Asterias Biotherapeutics Inc., BD Biosciences, Cell Cure Neurosciences Ltd. (Israel),Cellular Dynamics International,GE Healthcare (UK), MilliporeSigma, PerkinElmer Inc., Reliance Life Sciences Ltd. (India),Research and Diagnostics Systems Inc., SABiosciences Corp.

It takes into account the CAGR, value, volume, revenue, production, consumption, sales, manufacturing cost, prices, and other key factors related to the global Human Embryonic Stem Cells (HESC) market. All findings and data on the global Human Embryonic Stem Cells (HESC) market provided in the report are calculated, gathered, and verified using advanced and reliable primary and secondary research sources. The regional analysis offered in the report will help you to identify key opportunities of the global Human Embryonic Stem Cells (HESC) market available in different regions and countries.

Market Analysis, Insights and Forecast By Type

Totipotent Stem Cell Pluripotent Stem Cell Unipotent Stem Cell

Market Analysis, Insights and Forecast By Application

Regenerative medicine Stem cell biology research Tissue engineering Toxicology testing

Do You Have Any Query Or Specific Requirement? Ask to Our IndustryExpert@ https://www.datalibraryresearch.com/enquiry/human-embryonic-stem-cells-hesc-market-2728?utm_source=unlvrebelyell&utm_medium=41

The study objectives of this report are:

To study and analyze the global Human Embryonic Stem Cells (HESC) consumption (value & volume) by key regions/countries, product type and application, history data from 2014 to 2018, and forecast to 2028.

To understand the structure of Human Embryonic Stem Cells (HESC) market by identifying its various subsegments.

Focuses on the key global Human Embryonic Stem Cells (HESC) manufacturers, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.

To analyze the Human Embryonic Stem Cells (HESC) with respect to individual growth trends, future prospects, and their contribution to the total market.

To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).

To project the consumption of Human Embryonic Stem Cells (HESC) submarkets, with respect to key regions (along with their respective key countries).

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.

To strategically profile the key players and comprehensively analyze their growth strategies.

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Human Embryonic Stem Cells (HESC) Market Updates to 2021: Brief, Trends, Applications, Types, Research, Forecast to 2028 UNLV The Rebel Yell - UNLV...

INTRODUCTION Given the consistent increase in number of cell therapies being developed and launched, this upcoming therapeutic segment is on its way to becoming one of the highest valued markets within the biopharmaceutical industry.

New York, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cell Therapy Manufacturing Market by Type of Cell Manufactured, Source of Cell, Scale of Operation, Purpose of Manufacturing and Key Geographical Regions - Industry Trends and Global Forecasts, 2021-2030" - https://www.reportlinker.com/p06130492/?utm_source=GNW In fact, in February 2021, the USFDA approved Breyanzi, a CAR-T cell-based therapy, developed by Bristol Myers Squibb, which is designed to treat relapsed or refractory large B-cell lymphoma. According to a recent report (published by The Alliance for Regenerative Medicine), over 1,200 clinical trials, focused on the evaluation of cell, gene and tissue-based therapies, are currently being conducted by over 1,000 organizations (including academic institutions), worldwide. Further growth of the market is primarily hindered by the limited availability of expertise, lack of specialized infrastructure to produce cell-based therapies, and several product development and manufacturing related challenges. With a sufficient body of evidence, validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, the focus of stakeholders in this industry segment has now shifted to optimizing the cell therapy manufacturing process. Moreover, as more big pharma players enter this field of research, there is likely to be a substantial rise in the cell therapy manufacturing demand, as the proprietary product candidates of these large companies mature and need to be mass produced. In order to address the concerns related to manufacturing, several cell therapy developers (including the larger companies) have turned to contract manufacturing organizations (CMOs).

The cell therapy manufacturing service landscape features a mix of industry players (including well-established companies, mid-sized firms and start-ups / small companies), as well as several academic institutes. It is worth highlighting that innovator companies that have the required capabilities and facilities to produce cell-based therapies for in-house requirements, also offer contract services (primarily to ensure the optimum use of their resources and open up additional revenue generation opportunities). Further, in order to make cell therapies more affordable, several stakeholders are integrating various degrees of automation to cut down on labor costs and also improve process scalability. This specialty services industry has witnessed significant partnership activity over the past few years, with several companies being acquired by the larger firms, in efforts to grow and consolidate their capabilities in this space. As stakeholders strive to mitigate existing challenges and focus on innovation to improve the cell production process, we believe that the market will witness significant growth in mid-long term.

SCOPE OF THE REPORT The Cell Therapy Manufacturing Market (4th Edition) by Type of Cell Manufactured (Immune Cells, Stem Cells and Others ), Source of Cell (Autologous and Allogeneic), Scale of Operation (Preclinical, Clinical and Commercial), Purpose of Manufacturing (In-house and Contract) and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America and MENA) - Industry Trends and Global Forecasts, 2021-2030 report features an extensive study of the current market landscape and future opportunities associated with cell therapy manufacturing, along with information on both contract manufacturers, as well as developers having in-house production capabilities, offering in-depth analyses of the various business entities engaged in this domain, across key global regions. Amongst other elements, the report includes: A detailed review of the overall landscape of players engaged in the manufacturing of cell-based therapies, along with information on type of cell manufactured (including immune cells (including T cells, dendritic cells, NK cells), stem cells (including adult stem cells, human embryonic stem cells and induced pluripotent stem cells) and others), source of cell (autologous and allogeneic), scale of operation (preclinical, clinical and commercial), purpose of production (fulfilling in-house requirements and contract services), manufacturing capabilities / services offered (including R&D, cell culture development, quality testing, packaging, cell banking, supply chain management services, and regulatory services), as well as location of headquarters and their respective manufacturing facilities. An analysis of the various expansion initiatives undertaken by service providers engaged in this domain in order to augment their respective cell therapy manufacturing capabilities, during the period 2016-2021, based on several relevant parameters, such as year of expansion, type of cell manufactured, scale of operation, purpose of expansion (facility expansion and new facility), location of expanded manufacturing facility, and most active players (in terms of number of expansion initiatives undertaken). An analysis of the recent partnerships focused on the manufacturing of cell-based therapies, which have been established during the period 2016-2021, based on several relevant parameters, such as the year of agreement, type of partnership model adopted, type of cell and scale of operation. A review of the various cell therapy manufacturing initiatives undertaken by big pharma players engaged in this domain, based on several relevant parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of cell manufactured. Informed estimates of the annual commercial and clinical demand for cell therapies (in terms of number of patients), based on type of cell therapy and key geographical regions. An estimate of the overall, installed capacity for the manufacturing of cell-based therapies, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity on the basis of scale of operation (clinical and commercial), company size (small, mid-sized and large firms) and key geographical regions (North America, Europe and Asia Pacific). An in-depth analysis of cell therapy manufacturers using three versatile representations, namely [A] a three dimensional grid analysis, presenting the distribution of companies on the basis of type of cell manufactured, scale of operation and purpose of production, [B] a logo landscape, based on the type of cell manufactured, geographical location of manufacturer (North America, Europe and Asia Pacific), and type and size of organization (non-industry players, and small, mid-sized and large companies), and [C] a schematic world map representation, highlighting the geographical location of cell therapy manufacturing facilities of both industry and non-industry stakeholders. A detailed analysis of various factors that are likely to influence the price of cell-based therapies, featuring different models / approaches adopted by manufacturers while determining the price of their proprietary offerings. An elaborate discussion on the role of automation technologies in improving the current manufacturing methods, along with a comparative (qualitive) analysis of cost differences between manual and automated processes. A qualitative analysis, highlighting the various factors that need to be taken into consideration by cell therapy developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO. A discussion on cell therapy manufacturing regulations across various geographies, including North America (focusing on the US), Europe and Asia (focusing on Japan and China), featuring an analysis of the diverse certifications / accreditations awarded to manufacturing facilities by important regulatory bodies across the globe. Elaborate profiles of key players (industry and non-industry) that offer contract manufacturing services for cell-based therapies; each profile includes an overview of the company / organization, information on its manufacturing facilities, service portfolio, recent partnerships and an informed future outlook. A discussion on affiliated trends, key drivers and challenges, which are likely to impact the industrys evolution, under an elaborate SWOT framework, along with a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall market dynamics. Insights generated in a market-wide survey, featuring inputs solicited from experts who are directly / indirectly involved in the development and / or manufacturing of cell-based therapies.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the cell therapy manufacturing market. Based on parameters, such as number of ongoing / planned clinical studies, cell therapy manufacturing costs, target patient population, and anticipated adoption of such products, we have provided informed estimates on the evolution of the market in the short to mid-term and mid to long term, for the period 2021-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] type of cell therapy (T cell therapies, dendritic and tumor cell therapies, NK cell therapies, stem cell therapies and others), [B] source of cell (autologous and allogeneic), [C] scale of operation (clinical and commercial), [D] purpose of manufacturing (in-house and contract), and [E] key geographical regions (North America, Europe, Asia Pacific, Latin America and MENA). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industrys growth.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals: Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics) Gilles Devillers (General Manager, Bio Elpida) Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies) Arik Hasson (Executive VP Research and Development, Kadimastem) Fiona Bellot (Business Development Manager, Roslin CT) David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota) Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR) Arnaud Deladeriere (Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy) Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, Yposkesi) Tim Oldham (Chief Executive Officer, Cell Therapies) Gerard MJ Bos (Chief Executive Officer, CiMaas)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

KEY QUESTIONS ANSWERED What is the current, annual, global demand for cell-based therapies? How is the demand for such products likely to evolve over the next decade? What is the current, installed contract manufacturing capacity for cell therapies? What are the key parameters governing the price of cell therapies? What are the key recent developments (such as partnerships and expansions) in this industry? What kind of partnership models are commonly adopted by stakeholders engaged in this domain? What are the different initiatives undertaken by big pharma players for the manufacturing of cell therapies in the recent past? What different types of automated technology platforms available for the development and manufacturing of cell therapies? Who are the key players (industry / non-industry) engaged in the manufacturing of cell-based therapies across the world? What are the key factors influencing the make (manufacture in-house) versus buy (outsource) decision related to cell therapies? How is the current and future market opportunity likely to be distributed across key market segments?

RESEARCH METHODOLOGY The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include Annual reports Investor presentations SEC filings Industry databases News releases from company websites Government policy documents Industry analysts views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various emerging trends in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market, gathered from various secondary and primary sources of information.

CHAPTER OUTLINES Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the cell-based therapy manufacturing market and its likely evolution in the short to mid-term, and long term.

Chapter 3 provides a general introduction to cell-based therapies and ATMPs. It further includes a detailed discussion on the manufacturing process of cell-based therapies, and associated challenges, along with highlighting the applications of currently approved products. Additionally, it highlights information on the different manufacturing models (centralized and decentralized) that are being used for the production of cell-based therapies, as well as their associated advantages and disadvantages. Furthermore, it features details related to the scalability of cell-based therapies. The chapter also includes a brief overview of the role of automation and the need for effective supply chain management for cell-based therapies.

Chapter 4 features a detailed list of all the industry, as well as non-industry players that are actively involved in the manufacturing of cell-based therapies. It provides information on the type of cell manufactured (including immune cells (including T cells, dendritic cells, NK cells), stem cells (including adult stem cells, human embryonic stem cells and induced pluripotent stem cells) and others), source of cell (autologous and allogeneic), scale of operation (preclinical, clinical and commercial), purpose of production (fulfilling in-house requirements and contract services), manufacturing capabilities / services offered (including R&D, cell culture development, quality testing, packaging, cell banking, supply chain management services, and regulatory services), as well as location of headquarters and their respective manufacturing facilities.

Chapter 5 features a detailed discussion on the regulatory landscape related to cell therapies across various geographies, such as the US, Europe, Japan and China. Further, it presents an analysis of the manufacturing facilities on basis of the certifications awarded (for manufacturing cell-based therapies) to individual sites by various regulatory bodies across the globe.

Chapter 6 describes the strategies that are likely to be adopted to accelerate the translation of cell-based therapies from laboratory to clinics. It provides details on roadmaps published by different organizations located across various geographies, specifically in the US.

Chapter 7 discusses the role of automation technologies in optimization of current manufacturing practices with the use of closed and single use systems. Further, it features a roadmap that provides information on the steps to develop automation devices, supported by two case studies. It also presents a qualitive analysis on the cost incurred while manufacturing cell-based therapies using manual versus automated manufacturing approaches. In addition, it features a list of organizations that offer automated technologies for manufacturing operations or provide services to therapy developers to automate their production processes.

Chapter 8 features detailed profiles of industry players that offer contract manufacturing services for cell therapies at the clinical and / or commercial scales. Each profile provides a brief overview of the company, details on its manufacturing capabilities and facilities, recent partnerships and an informed future outlook.

Chapter 9 features profiles of non-industry players that offer contract manufacturing services for cell therapies. Each profile provides a brief overview of the organization, and details on its service portfolio and manufacturing facilities.

Chapter 10 discusses the role of non-profit organizations in this domain. It provides a list of organizations that are actively involved in the development and production of cell-based therapies, across different global regions. Further, it includes profiles of organizations that provide financial and / or technological support to cell therapy manufacturers and developers. Additionally, the chapter provides information on various international / national societies that help in disseminating knowledge about the advancement of these therapies to the general community.

Chapter 11 features an analysis of the various partnerships and collaborations that have been inked amongst players engaged in this domain, between 2016-2021 (till February). It includes a brief description on the various types of partnership models that are employed by stakeholders in this market, and an analysis on the trend of partnerships. It also includes analyses based on year of agreement, type of partnership, scale of operation, type of cell manufactured and most active players. Moreover, it presents a schematic world map representation of the geographical distribution of this activity, highlighting inter- and intracontinental deals. Further, the chapter features an analysis of the various acquisitions that have taken place in this domain, highlighting geographical activity. The analysis also features an ownership change matrix, providing insights on the involvement of private and public sector entities in this domain.

Chapter 12 presents detailed analysis on the expansions that have taken place in the cell therapy manufacturing industry, since 2016. It includes information on expansions carried out for increasing existing capabilities, as well as those intended for setting-up of new facilities by manufacturers engaged in this domain. The expansion instances were analyzed based on various parameters, including year of expansion, type of cell manufactured, scale of operation, purpose of expansion (facility expansion and new facility), location of expanded manufacturing facility, and most active players (in terms of number of expansion initiatives undertaken).

Chapter 13 provides a detailed analysis of the various cell therapy manufacturing initiatives undertaken by big pharma players engaged in this domain, based on several relevant parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of cell manufactured.

Chapter 14 features a comprehensive analysis of the overall installed capacity of cell-based therapy manufacturers. The analysis is based on meticulous data collection of reported capacities, via both secondary and primary research, of various small, mid-sized and large companies, and non-industry players distributed across their respective facilities. The results of this analysis were used to establish an informed opinion on the cell-based therapy production capabilities of organizations across different types of organization (industry and non-industry), scale of operation (clinical and commercial), geographies (North America, Europe and Asia Pacific) and company size (small, mid-sized and large organizations).

Chapter 15 features a detailed analysis of the annual demand for cell therapies (in terms of number of patients), considering various relevant parameters, such as target patient population, dosing frequency and dose strength of the approved cell therapies, as well as those therapies that are currently being evaluated in clinical trials. The demand analysis has been segmented across different types of cell therapies (including CAR-T cells, TCR cells, TIL cells, NK cells, dendritic cells, tumor cells and stem cells), scale of operation (clinical and commercial) and regions (North America, Europe and Asia Pacific).

Chapter 16 highlights our views on various factors, including manufacturing costs, that may be taken into consideration while pricing cell-based therapies. It features discussions on different pricing models / approaches adopted by manufacturers to decide the price of its proprietary products.

Chapter 17 presents a qualitative analysis that highlights the various factors that need to be taken into consideration by cell therapy developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.

Chapter 18 presents an elaborate market forecast analysis, highlighting the future potential of the market till the year 2030. The chapter presents a detailed market segmentation on the basis of [A] type of cell therapy (T cell therapies, dendritic and tumor cell therapies, NK cell therapies, stem cell therapies and others), [B] source of cell (autologous and allogeneic), [C] scale of operation (clinical and commercial), [D] purpose of manufacturing (in-house and contract), and [E] key geographical regions (North America, Europe, Asia Pacific and Latin America and MENA).

Chapter 19 presents a collection of key insights derived from the study. It includes a grid analysis, highlighting the distribution of cell-based therapy manufacturers on the basis of type of cell manufactured, scale of operation and purpose of production (fulfilling in-house requirement / contract service provider). In addition, it consists of two logo landscapes, representing the distribution of cell-based therapy manufacturers based on the type of cell manufactured (immune cells and stem cells), geographical regions (North America, Europe and Asia Pacific) and the type / size of organization (non-industry, small, mid-sized and large companies). The chapter also comprises of two schematic world map representations to highlight the locations of various cell-based therapy manufacturing facilities across different continents.

Chapter 20 provides a discussion on affiliated trends, key drivers and challenges, under an elaborate SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall cell therapy manufacturing industry.

Chapter 21 summarizes the overall report, wherein we have mentioned all the key facts and figures described in the previous chapters. The chapter also highlights important evolutionary trends that were identified during the course of the study and are expected to influence the future of the cell therapy manufacturing market.

Chapter 22 presents insights from the survey conducted for this study. We invited over 100 stakeholders involved in the development and / or manufacturing of different types of cell therapies. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.

Chapter 23 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details of interviews held with Troels Jordansen (Chief Executive Officer, Glycostem Therapeutics), Gilles Devillers (General Manager, Bio Elpida), Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies), Arik Hasson (Executive VP Research and Development, Kadimastem), Fiona Bellot (Business Development Manager, Roslin CT), David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota), Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR), Arnaud Deladeriere (Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing), Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, Yposkesi), Tim Oldham (Chief Executive Officer, Cell Therapies) and Gerard MJ Bos (Chief Executive Officer, CiMaas).

Chapter 24 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 25 is an appendix, which contains a list of companies and organizations mentioned in this report.Read the full report: https://www.reportlinker.com/p06130492/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Cell Therapy Manufacturing Market by Type of Cell Manufactured, Source of Cell, Scale of Operation, Purpose of Manufacturing and Key Geographical...

NASHVILLE, Tenn., Aug. 25, 2021 /PRNewswire/ --Cryoport, Inc.(NASDAQ: CYRX) ("Cryoport" or the "Company"), a leading global provider of innovative temperature-controlled supply chain solutions to the life sciences including clinical research, pharmaceutical and cell and gene therapy markets, and Mitsubishi Logistics Corporation ("MLC"), Japan's leading pharma logistics company, today announced a multi-year strategic business alliance to create an integrated regenerative medicine supply chain partnership in Japan.

Cryoport and MLC will partner to create synergistic value by leveraging each other's global logistics networks. The partnership will provide integrated, end-to-end distribution solutions for specialty cell and gene therapies that demand stringent temperature control, track and trace systems and global distribution. MLC has chosen to adopt Cryoport's unique and proprietary temperature-controlled and traceability solutions to meet the increasing demand for cell and gene therapy supply chain solutions and to strengthen its logistics capabilities.

Mr. Masao Fujikura, President of MLC said, "This strategic alliance will strengthen our ultra-low temperature-logistics services for our valued customers both domestically and internationally, utilizing Cryoport's proprietary technologies for cell and gene materials."

Jerrell Shelton, CEO of Cryoport, said, "This strategic alliance furthers our expansion strategy in the Asia-Pacific ("APAC") region. MLC and Cryoport will encourage the use of each other's network, infrastructure, knowledge and resources to enhance each other's operational performance and to generate value for customers in Japan and overseas to meet demand from the increasing number of cell and gene therapies currently in development and expected to launch in coming years. Combining both companies' strengths is expected to realize reliable and seamless distribution services for biopharmaceutical and pharmaceutical companies in Japan and the APAC region."

As of June 30, 2021, Cryoport supported 561 clinical trials in regenerative medicine globally, 29 of which are in the APAC region. In addition, a number of therapies supported by Cryoport have recently been approved in the APAC region, including Novartis' commercial therapy KYMRIAH, which is approved in Japan, Singapore and Australia and Bristol Myers Squibb's commercial therapy BREYANZI, which was approved in Japan. Cryoport is continuing to build out its position to support the growing number of commercial therapies in anticipation of the next wave of expected commercial approvals in the APAC region.

About Cryoport, Inc.

Cryoport, Inc. (Nasdaq: CYRX) is redefining temperature-controlled supply chain support for the life sciences industry by continually broadening its platform of solutions and services, serving the Biopharma, Reproductive Medicine, and Animal Health markets. Through its family of companies, Cryoport Systems, MVE Biological Solutions, CRYOPDP and CRYOGENE, Cryoport provides strategic solutions that support the growing needs of these markets.

Cryoport's mission is to support life and health on earth through its advanced technologies, global supply chain network and dedicated scientists, technicians and supporting teams of professionals. Cryoport serves clients in life sciences research, clinical trials, and product commercialization. We support the creation of life, the sustaining of life and life-saving advanced cell and gene therapies in over 100 countries around the world. For more information, visit http://www.cryoport.com or follow @cryoport on Twitter at http://www.twitter.com/cryoport for live updates.

Forward-Looking Statements

Statements in this press release which are not purely historical, including statements regarding the Company's intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, those related to the Company's industry, business, plans, strategy, acquisitions, including CRYOPDP and MVE Biological Solutions, financial results and financial condition. It is important to note that the Company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties associated with the effect of changing economic conditions, trends in the products markets, variations in the Company's cash flow, market acceptance risks, and technical development risks. The Company's business could be affected by a number of other factors, including the risk factors discussed in the Company's Securities and Exchange Commission ("SEC") reports including, but not limited to, the Company's Annual Report on Form 10-K for the three and twelve months ended December 31, 2020 and any subsequent filings with the SEC. The forward-looking statements contained in this press release speak only as of the date hereof and the Company cautions investors not to place undue reliance on these forward-looking statements. Except as required by law, the Company disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

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Cryoport and Mitsubishi Logistics Corporation Partner to Bring Temperature-Controlled Supply Chain Solutions to Asia-Pacific - Gallatin News

WILLOWBROOK, Ill., April 14, 2021 /PRNewswire/ --Based in Willowbrook, Illinois, Russell Health is a national marketer and distributor of specialty medical products and services. Russell Health, Inc., was recently awarded as #2 in Global Business Leaders Magazine's "20 Leading Companies of the Year 2021." Based in Atlanta, Georgia, Global Business Leaders Magazine's mission 'focuses on exalting the contribution of leaders who have been the emissary for their respective industries.' Their 2021 Top 20 list features a collection of leaders across industries like medical technology, finance, marketing, blockchain solutions, industrial fabrication, and more. Read more here

Russell Health's full-page feature presents an article titled, "Russell Health: A Mini Amazon for Regenerative Medicine." It discusses the history of Russell Health Inc., ongoing research and benefits of Stem Cell Recruitment Therapy, and well-defined commentary about how Russell Health has redefined the medicine market, even during a global pandemic. Read Russell Health's featured article here

About Russell Health: Russell Health and its partners have distributed regenerative therapy products nationwide and achieved profound clinical outcomes in multiple therapeutic areas including cosmetics, wound care, pain management, podiatry, orthopedic, dentistry and gynecology. With their partners and suppliers, they work to provide innovative life-changing and sustaining products and therapies to patients and healthcare providers around the world.

Russell Health's Stem Cell Recruitment Therapyproducts are intended for homologous use to help repair, reconstruct or supplement the patient's joints or soft tissue as well as help to increase mobility while decreasing pain. These responsibly sourced acellular tissue allografts are helping people of all ages to recover from injuries and get their life back.

Pull Quotes:

"We have built a mini-Amazon for regenerative medicine." (Ryan Salvino, CEO of Russell Health)

"Our ultimate goal from the beginning has been to help people by providing safe alternatives to risky procedures and expensive treatments while offering an alternative to synthetic drugs and embracing more holistic and organic products. We want to continue to become the number one supplier of regenerative medicine in the U.S." (Jonathan Benstent, Vice President of Russell Health)

"While the pandemic caused major disruption throughout the industry, it managed to pivot patients and physicians toward alternative treatments such as Stem Cell Recruitment Therapy. This demand can help in further enhancing the discovery of new applications for Stem Cell Recruitment Therapy products. As a result, Russell Health is working with some of the top leaders in the regenerative medicine field to continue to grow and provide innovative products to customers and their patients." (Global Business Leaders Magazine)

Visit Russell Health online to learn more about Stem Cell Recruitment Therapy. For media inquiries or to contact the Russell Health team directly. Please visit http://www.russellhealth.comor email [emailprotected].

Contact: Veronica Bennett

Address & Phone: 621 Plainfield Rd., Willowbrook, IL 60527; 844-249-6200

Email: [emailprotected]

Online: http://www.russellhealth.com

Social Media: http://www.linkedin.com/company/russell-health:: https://www.facebook.com/russellhealthinc:: https://www.instagram.com/russellhealth:: https://twitter.com/health_russell

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Six decades ago, two researchers at the Ontario Cancer Institute at Princess Margaret Hospital made a startling discovery. James Till and Ernest McCulloch had found transplantable stem cells, special building block cells that have the ability to grow into any kind of human tissue.

Till and McCulloch were studying the effects of radiation at the time, but their work set off an explosion of research aimed at harnessing stem cells to treat all kinds of diseases and conditions. Subsequent breakthroughs in stem cell therapy have been used to treat more than 42,000 patients for hemophilia, restore sight to blind mice and even help a 78-year-old man regrow the end of a sliced-off fingertip. And researchers are still unlocking what might be possible.

The potential of regenerative medicine is astounding, says Michael May, president of the Centre for Commercialization of Regenerative Medicine (CCRM), a Toronto non-profit that helps bring new stem cell therapies and other regenerative medicine technologies to market. Researchers are harnessing stem cells to repair, replace or regenerate human cells, tissues and organs with the aim of improving treatments for conditions ranging from diabetes to blindness to heart failure and cancer.

More recent advances most notably Shinya Yamanakas Nobel Prize-winning 2012 discovery that regular adult tissue cells can be reprogrammed to become stem cells again, therefore endowing them with the ability to become any type of cell in the body have also ushered in a new wave of regenerative medicine research and what May calls a global race to bring newly possible cell therapies to market.

As president of CCRM, Mays job is to help move some of that research from the laboratory into the real world. Over the last decade, his organization has helped 11 companies come to market with regenerative medicine technologies, such as Montreals ExCellThera, which provides new therapeutic options for patients who suffer from myeloid leukemia and lack a traditional bone marrow donor.

While the last decade was defined by research and technological breakthroughs, May says the next decade will be all about lowering manufacturing costs and tackling patient access bottlenecks. Last November, CCRM announced that it would partner with McMaster Innovation Park in Hamilton to create Canadas first commercial-scale factory for making cells, which will be able to produce billions of cells enough to treat thousands of patients per week.

Weve just scratched the surface of whats possible in regenerative medicine, May says. He envisions a time when well eventually use these techniques not just to cure and fix human bodies, but also make them better. Now we can make cells, we can design them by genetically engineering them to do things that they naturally do, but that can be more than nature designed, says May. He says the editing of human traits in this way could eventually augment human abilities to such an extent that theyre unrecognizable.

Biomaterials are another technology that could transform regenerative medicine. Before joining CCRM, May himself helped found a Toronto biomaterials startup called Rimon Therapeutics, which developed a smart dressing for chronic wounds that used special polymers to support the bodys natural healing process. Similar advanced biomaterials could eventually be used in combination with cell therapies to not just fight aging and degeneration, but to also prevent it entirely, and even improve upon the human bodys natural baseline health.

Fifty years from now if theres some sort of blindness, well have a lens on the eye that will automatically focus and react or change as the eye ages, he says.

Nick Zarzycki is a freelancer who writes about technology for MaRS. Torstar, the parent company of the Toronto Star, has partnered with MaRS to highlight innovation in Canadian companies.

Disclaimer This content was produced as part of a partnership and therefore it may not meet the standards of impartial or independent journalism.

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Being bionic: the future of regenerative medicine - Toronto Star

In response to emailed questions, Cellino Biotech CEO and Co-founder Dr. Nabiha Saklayen, talked about the formation of the company and its goal to make stem cell therapies more accessible for patients.

Why did you start this company?

I see a huge need to develop a technology platform to enable the manufacture of cell therapies at scale. We recently closed a $16 million seed financing round led by Khosla Ventures and The Engine at MIT, with participation from Humboldt Fund. Cellino is on a mission to make personalized, autologous cell therapies accessible for patients. Stem cell-derived regenerative medicines are poised to cure some of the most challenging diseases within this decade, including Parkinsons, diabetes, and heart disease. Patient-specific cells provide the safest, most effective cures for these indications. However, current autologous processes are not scalable due to extensive manual handling, high variability, and expensive facility overhead. Cellinos vision is to make personalized regenerative medicines viable at large scale for the first time.

How did you meet your co-founders?

Nabiha Saklayen.

I met my co-founder Marinna Madrid in my Ph.D. research group. We had worked together for many years and had a fantastic working relationship. I then met our third co-founder Matthias Wagner through a friend. Matthias had built and run three optical technology companies in the Boston area and was looking to work with a new team. I was thrilled when we decided to launch the startup together at our second meeting. Matthias built the first Cellino hardware systems in what I like to call Matthias garage. In parallel, I was doing hundreds of expert interviews with biologists in academia and industry, and it started to narrow down our potential applications very quickly. Marinna was doing our first experiments with iPSCs. We iterated rapidly on building new versions of the hardware based on the features that were important to industry experts, such as single-cell precision and automation. Its incredible to witness our swift progress as a team.

What specific need or pain point are you seeking to address in healthcare/life sciences?

In general, autologous therapies are safer for patients because they do not require immunosuppression. The next iteration of cell therapies would use patient-specific stem cells banked ahead of time. Anytime a patient needs new cells, such as blood cells, neurons, or skin cells, we would generate them from a stem cell bank.

Today, patient-specific stem cell generation is a manual and artisanal process. A highly skilled scientist sits at a bench, looks at cells by eye, and removes unwanted cells with a pipette tip. Many upcoming clinical trials are using manual processes to produce stem cells for about ten to twenty patients.

At Cellino, we are converging different disciplines to automate this complex process. We use an AI-based laser system comes to remove any unwanted cells. By making stem cells for every human in an automated, scalable way, we are working towards our mission at Cellino to democratize personalized regenerative medicine.

What does your technology do? How does it work?

Cellinos platform combines label-free imaging and high-speed laser editing with machine learning to automate cell reprogramming, expansion, and differentiation in a closed cassette format, enabling thousands of patient samples to be processed in parallel in a single facility.

In general, autologous, patient-specific stem cell-derived therapies do not require immunosuppression and are safer for patients. Today, patient-specific stem cells are made manually, by hand. To scale the stem cell generation process, Cellino converges different disciplines to automate this complex process. We train machine learning algorithms to characterize cells before our AI-based laser system removes any unwanted cells. By making stem cells for every human in an automated, scalable way, our mission at Cellino is to democratize personalized regenerative medicine. Thats why our vision statement is Every human. Every cell.

Whats your background in healthcare? How did you get to where you are today?

When I arrived at Harvard University for my Ph.D. in physics, I wanted to be closer to real-world applications. Biology is inherently complex and beautiful, and I was interested in developing new physics-based tools to engineer cells with precision. During my Ph.D., I invented new ways to edit cells with laser-based nanomaterials. I collaborated with many brilliant biology groups at Harvard, including the Rossi, Scadden, and Church labs. Working closely with them convinced me that lasers offer a superior solution to editing cells with high precision. That realization compelled me to launch Cellino.

Do you have clinical validation for your product?

Our immediate goal for the next year is to show that our platform can produce personalized, high-quality, R&D-grade stem cells for different patients, which has not been established in an automated manner in the regenerative medicine industry so far. There is significant patient-to-patient variability in manual cell processing, which we eliminate with our platform.

Photo: Urupong, Getty Images

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Cellino Biotech developing tech to help scale stem cell therapies - MedCity News

Scribe and student: For the past five years, Brooke Ford has worked her way through college as an emergency room scribe at a few local hospitals. In her senior year at William & Mary, as the COVID-19 pandemic ravaged the nation, she managed medical scribes at two hospitals. Courtesy photo

by Adrienne Berard | April 16, 2021

For the better part of the past year, Brooke Fords return home from work has been an exercise in mitigating the spread of a potentially deadly pathogen.

She pulls off all her personal protective equipment, washes her hands, showers off, changes clothes, throws out any food or drink she may have touchedand greets her family.

I know a lot of people who were scared to even live with their families when they're working in a hospital room, because they didn't want to bring it home, said Ford, a William & Mary health sciences major who graduated in December.

For the past five years, Ford has worked her way through college as an emergency room scribe at a few local hospitals. In her senior year, as the COVID-19 pandemic ravaged the nation, she managed medical scribes at hospitals in Hampton and Newport News.

A scribe is responsible for recording the details of a patient's clinical history, current health issues, diagnoses and any medical procedures that are performed or prescribed, Ford explained. The scribe serves a vital role of being the ears and eyes in the room, so that a physician can focus squarely on treating the patient.

I lead teams at two hospitals, Ford said. During the pandemic, that has been really difficult because I had people that didn't want to come to work, which, I mean, it's scary. I dont blame them for that, but we had to learn to balance the fear and the need to do our jobs.

That balance between fear and the vital work ahead is one that has been familiar to healthcare professionals throughout the world this past year. For students graduating into the industry, the landscape has shifted dramatically, revealing fault lines in Americas healthcare system that these newest professionals are uniquely positioned to witness, study and address.

Matthew Tucker 22 started volunteering as an EMT with the Williamsburg Volunteer Fire Department his freshman year at William & Mary. Hes now the collegiate lieutenant, responsible for managing and training college students on the operations of emergency medical services provided by the local fire station.

I help train incoming college students on operations of the fire station, the ambulance, the equipment, all of those sorts of thing, he said.

This winter, as COVID-19 case numbers surged nationwide, Tucker was one of a handful of student volunteers who worked as first responders, supporting the career EMT staff at the fire station.

I know that the staff paramedics were especially burnt out. They couldnt trade shifts, they couldn't utilize their vacation time, so we were able to provide resources to support them in getting some relief, Tucker said. As students, we were able to see things that we haven't seen for 100 years. The amount of learning that can be done in that environment is astounding, and it has given me tremendous perspective on my future medical path.

Tucker said, as a student concentrating in public health, hes been particularly aware of the health disparities in the community he serves. It was immediately clear to him that the vast majority of emergency calls were coming from low-income neighborhoods.

I believe that we're often responding to places where the healthcare system has failed, where we are their primary care provider, a call to 911, taking them to the emergency room, he said. These disparities have always been there, but we're seeing them very plainly now, how socioeconomic status, job accessibility, food insecurity, all these different things affect someone's risk to COVID and ultimately affect people's health status. Weve not always been in tune to seeing that before the pandemic.

Sophie Kopec 21 spent this past summer analyzing data on experimental, early-stage clinical trials for the cell and gene medicine division of the non-profit Alliance for Regenerative Medicine. Explaining what she does is a key part of the job.

Its such an up-and-coming field that there are negative trigger words, all this stigma, especially around cell therapy, she said. So, part of my job was to look at data from all of these regenerative medicine clinical trials to identify the most promising ones. Then we translate that data into the commercial field to help show consumers that this is real, valid, verified science. Its not some kind of scam.

Kopec describes regenerative medicine as using the body's own functions to train it to fix itself.

For example, take gene therapy, in that case you have editing technology like CRISPR, where you can go in and actually edit the bodys genes and reprogram them to respond to the treatment and then body essentially heals itself, she said.

Kopec entered William & Mary with her sights hard-set on chemistry. It wasnt until her junior year, when she was working her way down the list of general education requirements, that she enrolled in a Foundations of Epidemiology course with Assistant Professor of Kinesiology and Health Sciences Carrie Dolan.

After taking that class, everything changed and I shifted my focus to public health, Kopec said. Ill always be grateful to William & Mary for that. I came into school with tunnel vision. I was going to go to med school and work in scrubs or in a lab, but my education broadened my perspective. Actually, it did more than that, it revealed my passion to me. Had I not been forced off track by the general education requirements, I would have never found this incredible spark and pursued this passion that I have now.

Graduation can be an anxiety-inducing milestone, even in the best of times. For those entering careers in the healthcare industry, the uncertainty of the pandemic has added another layer of stress and hope for overcoming the challenges of the past.

Next month, Kopec starts her new job as a clinical research coordinator at Children's National Hospital in D.C. Shell be serving in the neuro-oncology unit, working with children who have not responded to traditional therapy measures and providing experimental treatment that is often the last and only resort left. Her first in-person day at the hospital is scheduled for June 1.

Well be doing clinical trials that offer more therapeutic approaches to treating these late-stage tumors, she said. Even if the end result for some of these patients may be death, at least we know that we did everything in our power to help them and give them another chance to keep fighting and have another opportunity at life.

When Ford began her studies at William & Mary, she was interested in emergency medicine. She wanted to learn to respond in crisis to keep people alive. Now, after all she has witnessed in this year of pandemic, she hopes to study palliative care. She wants to learn how to help people live and die with dignity.

In medical school, they teach you how to save people, but what happens when you cant save them, when there is nothing else you can do? she said. Its not a conversation were often prepared for, but its so important. In a lot of ways, how can you know how you want to live if you don't know how you want to die?

So many families this year have had to make those choices for family members and they don't know what choices those family members would want to make for themselves, she added. Theyve had to make those choices, because those conversations haven't been had. I want to be there to help have those hard conversations.

After graduating from William & Mary, Tucker plans to go to medical school to obtain Master of Public Health and Medical Doctor degrees. He plans to work primarily with people experiencing homelessness and be able to treat them holistically.

If theres one main thing that I think that weve all learned this pandemic, its that health is incredibly complex, Tucker said. Truly, everything that we do impacts our health, every societal factor, institutional factor, personal factor that's put into place influences somebodys health.

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Lessons learned: W&M students working in healthcare reflect on a year of pandemic - William & Mary News

MIAMI--(BUSINESS WIRE)-- Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced that it has entered into an agreement with Oklahoma State University to evaluate Zofin for the treatment of respiratory diseases caused by virus infections of pandemic potential. This study site follows the Companys earlier announcement of the agreement reached with the Centers for Disease Control and Prevention (CDC) to conduct research to determine the anti-inflammatory and anti-infective effectiveness of Zofin in experimental models of influenza infection.

The ongoing COVID-19 pandemic has infected over 5 million people globally and caused over 300,000 case fatalities in 188 countries. Additionally, the CDC estimates between 39-55 million influenza related illnesses and more than 60,000 deaths due to influenza. The observed illnesses and case fatalities are primarily due to the lack of known effective antivirals and prophylactic vaccines to attenuate the viruses.

In this agreement, Organicell will supply Oklahoma State University with its lead compound, Zofin, which is an acellular material derived from human amniotic fluid. This extracellular vesicle-derived nanoparticle-based therapeutic will be assessed on its ability to induce antiviral and/or immunomodulatory activity against virus infections of pandemic potential as there is an unmet need for non-toxic and effective therapeutic approaches to deal with current and imminent pandemics.

Organicell is dedicated to continuing regenerative therapy research for diseases with unmet needs. We are thrilled to be partnering with Oklahoma State University and the CDC on the study of Zofin for viral infections of pandemic proportions. A year into the pandemic has shown us the importance of research aimed at the development of biologics, said Albert Mitrani, CEO of Organicell.

We are excited to partner with Oklahoma State University and the CDC to investigate how the extracellular vesicle-derived nanoparticles, in Zofin, will impact antiviral and/or immunomodulatory activity of viral infections with pandemic potential. Dr. Mari Mitrani, Chief Science Officer of Organicell.

About Zofin:

Zofin is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from perinatal tissues. Zofin is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin for the treatment of moderate to SARS related to COVID-19 infection vs placebo.

ABOUT ORGANICELL REGENERATIVE MEDICINE, INC.

Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR) is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative diseases. The Companys proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Mari Mitrani, Chief Scientific Officer. To learn more, please visit https://organicell.com/.

FORWARD-LOOKING STATEMENTS

Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the Securities Act), the Securities Exchange Act of 1934, as amended (the Exchange Act), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as will, believes, expects, potential or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties, including the risk factors discussed in the Companys periodic reports that are filed with the SEC and available on the SECs website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210414005207/en/

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Organicell and Oklahoma State University Enter Into Agreement To Study Zofin in Respiratory Diseases Caused By Virus Infections Of Pandemic Potential...