StemCell Therapy

WASHINGTON, Dec. 20, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- The Alliance for Regenerative Medicine (ARM), the international advocacy organization for the cell and gene therapy and broader regenerative medicine sector, today released the initial slate of presenting companies at the 2020 Cell & Gene Meeting on the Mediterranean. The event will be held April 15-17, 2020 in Barcelona, Spain.

The event, modeled after ARMs highly successful Cell & Gene Meeting on the Mesa, is expected to attract more than 500 attendees, including senior executives from leading cell therapy, gene therapy, and tissue engineering companies worldwide, large pharma and biotech representatives, institutional investors, academic research institutions, patient foundations, disease philanthropies, and members of the life science media community.

The second annual Cell & Gene Meeting on the Mediterranean will feature presentations by 50+ leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies.

The initial slate of 2020 presenting companies includes: Adaptimmune, AGTC, Ambys Medicines, American Gene Technologies, AskBio, Aspect Biosystems, Atara, Autolus Therapeutics, Avectas, AVROBIO, Axovant Gene Therapies, bluebird bio, Bone Therapeutics, Caribou Biosciences, Celavie Biosciences, Cellatoz Therapeutics, CEVEC, Cynata Therapeutics, Flexion Therapeutics, Fraunhofer IZI, GenSight Biologics, Healios, Iovance Biotherapeutics, Kiadis Pharma, Kytopen, LogicBio Therapeutics, MeiraGTx, Minerva Biotechnologies, MolMed, Novadip Biosciences, Orchard Therapeutics, Oxford Biomedica, PDC*line Pharma, Precision BioSciences, Promethera Biosciences, PTC Therapeutics, Recombinetics, REGENXBIO, ReNeuron, Rexgenero, Sangamo, SmartPharm Therapeutics, Standards Coordinating Body for Regenerative Medicine, Theradaptive, ThermoGenesis, Tmunity Therapeutics, Ultragenyx Pharmaceutical, VERIGRAFT, and Zelluna Immunotherapy.

Additional event details will be updated regularly on the conference website http://www.meetingonthemed.com.

Registration is complimentary for investors and credentialed members of the media. To learn more and to register, please visitwww.meetingonthemed.com. For members of the media interested in attending, please contact Kaitlyn Donaldson Dupont at kdonaldson@alliancerm.org.

For interested organizations looking to increase exposure to this fields top decision-makers via sponsorship, please contact Kelly McWhinney at kmcwhinney@alliancerm.org for additional information.

About The Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 350 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visithttp://www.alliancerm.org.

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The Alliance for Regenerative Medicine Releases Initial Slate of Presenting Companies at the 2020 Cell & Gene Meeting on the Mediterranean - Yahoo...

December 19, 2019 - SACRAMENTO, CA- Secretary of State Alex Padilla announced that the proponent of a new initiative was cleared to begin collecting petition signatures.

The Attorney General prepares the legal title and summary that is required to appear on initiative petitions. When the official language is complete, the Attorney General forwards it to the proponent and to the Secretary of State, and the initiative may be circulated for signatures. The Secretary of State then provides calendar deadlines to the proponent and to county elections officials. The Attorney Generals official title and summary for the measure is as follows:

AUTHORIZES BONDS TO CONTINUE FUNDING STEM CELL AND OTHER MEDICAL RESEARCH. INITIATIVE STATUTE.Authorizes $5.5 billion in state general obligation bonds to fund grants from the California Institute of Regenerative Medicine to educational, non-profit, and private entities for: (1) stem cell and other medical research, therapy development, and therapy delivery; (2) medical training; and (3) construction of research facilities. Dedicates $1.5 billion to fund research and therapy for Alzheimers, Parkinsons, stroke, epilepsy, and other brain and central nervous system diseases and conditions. Limits bond issuance to $540 million annually. Appropriates money from General Fund to repay bond debt, but postpones repayment for first five years. Summary of estimate by Legislative Analyst and Director of Finance of fiscal impact on state and local governments:State costs of $7.8 billion to pay off principal ($5.5 billion) and interest ($2.3 billion) on the bonds. Associated average annual debt payments of about $310 million for 25 years. The costs could be higher or lower than these estimates depending on factors such as the interest rate and the period of time over which the bonds are repaid. The state General Fund would pay most of the costs, with a relatively small amount of interest repaid by bond proceeds.(19-0022A1.)

The Secretary of States tracking number for this measure is 1880 and the Attorney General's tracking number is 19-0022.

The proponent of the measure, Robert N. Klein, must collect signatures of 623,212 registered voters (five percent of the total votes cast for Governor in the November 2018 general election) in order to qualify it for the ballot. The proponent has 180 days to circulate petitions for the measure, meaning the signatures must be submitted to county elections officials no later than June 15, 2020*. The proponent can be reached c/o James C. Harrison of Remcho, Johansen & Purcell, LLP at (510) 346-6203. The address for Remcho, Johansen & Purcell, LLP is 1901 Harrison Street, Suite 1550, Oakland, CA 94612.

*Date adjusted for official deadline, which falls on a Sunday (Elec. Code 15)Source: CA. SOS

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California Proposed Initiative Enters Circulation: Authorizes Bonds to Continue Funding Stem Cell and Other Medical Research - Sierra Sun Times

SmartTRAK recently redesigned SmartTRAK.com to prioritize key information for various functional groups as their customer base continues to expand

BioMedGPS, the developer of SmartTRAK Business Intelligence, is excited to announce the launch of their new website, Smarttrak.com. SmartTRAK offers a suite of advisory services for the life sciences industry including real-time online business intelligence and custom consulting.

The new SmartTRAK.com features a clean uncluttered design, improved functionality and enhanced custom content. It allows for medical device professionals to self-identify and learn how SmartTRAKs services, data, and industry insights help meet their specific professional needs. Visitors can learn how SmartTRAK can help streamline their workflow, saving them time while keeping them ahead of the market.

Marketing Technology News: Users Reveal Top Five SMM Vendors of 2019 for User Satisfaction Through SoftwareReviews

The newly launched site also spotlights our industry analysts all who are experts in their fields with years experience working for some of the biggest players in the industry. Visitors can sample articles, analyses and white papers put out by SmartTRAKs team.

Users can also view SmartTRAKs offering by market coverage including orthopedics, wound care, regenerative medicine and neuro therapies. Visitors can quickly pinpoint what coverage they would need and also quickly assess any future needs.

Marketing Technology News: MindTouch Enhances Salesforce Integration for an Improved Customer and Agent Experience

The new site, content and improved functionality speak directly to the needs of our customers. We believe that this new website will allow our visitors to have a very informative experience as we continue to grow, states Sharon OReilly, CEO, and President of BioMedGPS.

Medical device manufacturers who have business intelligence needs are encouraged to reach out to SmartTRAK to learn how SmartTRAK can support their teams.

Marketing Technology News: Ameriprise Financials New Customer Relationship Management System Helps Advisors Deliver Best-in-Class Service

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SmartTRAK Launches New Website that Speaks Directly to Customer Needs - MarTech Series

It has long been understood, and by cultures too various to list, that salamanders have something of the supernatural about them.

Their name is thought to derive from an ancient Persian vocable meaning 'fire within', and for at least 2,000 years they were believed to be impervious to flames, or even capable of extinguishing them on contact. Aristotle recorded this exceptional characteristic, as did Leonardo da Vinci. The Talmud advises that smearing salamander blood on your skin will confer inflammability. Not so. But the intuition that salamanders possess fantastical powers is not unfounded.

Like earthbound immortals, salamanders regenerate. If you cut off a salamander's tail, or its arm, or its leg, or portions of any of these, it will not form a stump or a scar but will instead replace the lost appendage with a perfect new one, an intricacy of muscle, nerve, bone and the rest. It will sprout like a sapling. Science has been chopping up salamanders for more than 200 years with the aim of simply understanding the mechanics of their marvels, but more recently with the additional aim of someday replicating those marvels in ourselves. Might salamanders be the great hope of regenerative medicine?

The salamander in which regeneration is most often studied is an odd and endearingly unattractive Mexican species known as the axolotl. In addition to its limbs and extremities, the axolotl is known to regrow its lower jaw, its retinae, ovaries, kidneys, heart, rudimentary lungs, spinal cord, and large chunks of its brain. It heals all sorts of wounds without scarring. The axolotl also integrates the body parts of its fellows as if they were its own, without the usual immune response, and this peculiar trait has facilitated some of the more grotesque disfigurements it's endured in the name of science. In experiments after the Second World War, East German scientists grafted small axolotls crosswise through the backs of larger ones. The animals' circulatory systems came to be linked, and the researchers hailed the conjoined mutants as triumphs of collectivism. While the axolotl can rebound from almost any bodily humiliation, it seems that humankind is proving too much for it: we have all but destroyed its natural habitat, and, outside of laboratory aquaria, it is nearly extinct.

In its most common form, which scientists call the white mutant, the axolotl resembles what the translucid foetus of a cross between an otter and a shortfin eel might look like. On the internet, it is celebrated for its anthropoid smile; in Mexico, where the Aztecs once hailed as it as a godly incarnation, it is an insult to say that someone looks like one. Behind its blunt and flattened head extends a distended torso resolving into a long, ichthyic tail. The axolotl can grow to nearly a foot in length; four tiny legs dangle off its body like evolutionary afterthoughts. It wears a collar of what seem to be red feathers behind each cheek, and these ciliated gill stalks float and tremble and gently splay in the water, like the plumage in a burlesque fan. They grow back if you cut them off, too. Precisely how the animal accomplishes this, or any of its feats of regrowth, is not well understood.

Like the axolotl, our evolutionary forebears seem to have been regenerators, and human children can in fact still regrow the tips of their fingers above the final joint, but that's the only complex regeneration we're known to do. We are, instead, a species that scars. Why our lineage lost its regenerative birthright is unclear. From our present evolutionary vantage point, however, it might be nice to get back what we lost. Amputees could recover their limbs; paralytics could walk; degeneration and decline of all sorts might be reversed.

Last year, after a long effort by an international consortium, the axolotl genome 10 times the length of the human genome was finally sequenced. In early 2019, it was mapped onto chromosomes by a team at the University of Kentucky. (It is, for the moment, the longest genome ever sequenced by far.) Jessica Whited, who heads an axolotl lab at Harvard Medical School, told me that, for those who hope to someday make regeneration available to human medicine, the axolotl is a perfect instruction manual. Its language simply needs decoding.

Regeneration is not, however, the axolotl's only biological extravagance, or prime mystery. Another puzzle of the axolotl concerned what it was. Most salamanders begin their lives as aquatic larvae, like tadpoles, before metamorphosing into terrestrial adults, but the axolotl seems to be a lifelong adolescent, the so-called 'Peter Pan of salamanders', remaining in its larval stage even as it arrives at sexual maturity. This retention of juvenile traits, a phenomenon known as neoteny, perplexed taxonomists, and for decades they debated whether it ought to be considered a species of its own or merely the larval form of the common tiger salamander. Confoundingly, on occasion the axolotl could be goaded (under what conditions remains unclear) into a final transformation, absorbing its gills and fins, and walking out of the water. In biological terms, the scale of this change is akin to a middle-aged human one day broadening her shoulders, lurching forward on her hands and loping off to the jungle to be a gorilla. In France, the Grand Dictionnaire Universel du XIXe sicle (1866) declared the axolotl 'the most imperfect, the most degraded of all the amphibians': a fallen creature, but also one that could accede, as if by grace, to a higher state of being.

Humans are attuned to this sort of qualified possibility. In 1920, the British biologist Julian Huxley found that he could cause axolotls to metamorphose by feeding them bits of sheep thyroid. The Daily Mail declared that Huxley had discovered 'The Elixir of Life'. Huxley's younger brother, the writer Aldous, adopted the axolotl as a metaphor for mankind, its peculiar neoteny an emblem of our incompletion, our frustrated potentiality. A number of his literary contemporaries became neoteny-boosters. Gerald Heard, the philosophising scholar, maintained in 1941 that the survival of mankind would depend upon individuals 'who manage to retain, with full mental stature, the radical originality and freshness of a vigorous child'; John Dewey and Timothy Leary held similar views. More recently, the Mexican sociologist Roger Bartra has proposed the axolotl, in its neotenous indeterminacy, as a symbol of his country's national character.

If the axolotl mirrors us so nicely, it's fitting that we, too, are neotenous. Our flat faces, small noses, hairless bodies and upright postures are all features of infancy in our evolutionary cousins and forebears. We also spend more of our lives in a juvenile state than any other primate. Our brains grow rapidly for a longer period, and are consequently larger; our childhoods are greatly extended, providing occasion for the lengthy training of those brains. We also maintain throughout our lives a 'remarkable persistent juvenile characteristic of investigative curiosity', in the words of the zoologist Konrad Lorenz. 'The constitutive character of man,' Lorenz wrote in 1971, 'is a neotenous phenomenon.'

Some affinity seems to have drawn us to the salamander since well before we fantasised in a serious way of regrowing our bodies how the salamander regrows its own. Perhaps this is what spurred the ancients and the Aztecs to ennoble the animals through mythology. Nowhere has the intuition of kinship been rendered more plainly, though, than in the Argentinian surrealist Julio Cortzar's short story 'Axolotl' (1952). Cortzar writes of one man's quiet obsession with the animals, whom he visits every day at an aquarium. 'After the first minute I knew that we were linked,' the man says, 'that something infinitely lost and distant kept pulling us together.' He watches through the glass tank until, one day, almost imperceptibly, he finds himself suspended in the water beside the creatures, transmuted into one of them, peering out at his former human soma peering in. 'Only one thing was strange: to go on thinking as usual,' the erstwhile man says, 'to know.'

This article was originally published at Aeon and has been republished under Creative Commons. Read the original article.

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Can the axolotl teach us to regenerate? - Big Think

NEWPORT NEWS, Va.,Dec. 18, 2019/PRNewswire/ Orthopaedic and Spine Center announced Dr.Jeffrey Carlson, Orthopaedic Spine Surgeon, became the first surgeon in Central andEastern Virginiaarea to implant the M6-Cartificial cervical disc. The outpatient surgery was performed on a 53 year old female at Bon Secours/Mercy Health Mary Immaculate Hospital inNewport News, VirginiaonNovember 20, 2019.

The patient reported symptoms of severe neck pain which radiated to both shoulders after a motor vehicle accident. After she failed to respond to conservative treatment, an MRI was ordered revealing severe spinal stenosis and spinal cord abutment at level C3-4 caused by a herniated disc. In consultation with Dr. Carlson, the patient made the decision to have cervical disc arthroplasty, using the Orthofix M6-C artificial cervical disc.

Ive been waiting for the right patient with the appropriate diagnosis to employ the M6-C disc, said Carlson. The technology used in this procedure facilitates a speedy recovery with minimal limitations and a great outcome, so that my patient can get back to her active life. She just had her two week post-surgical follow-up appointment her recovery is going very well and she feels much relief from the severe pain she once experienced.

The M6-C disc received U.S. Food and Drug Approval in February 2019.It was designed to closely mimic the anatomic structure of a natural disc as well as provide an effective alternative to a spinal fusion. By allowing the spine to move naturally, the M6-C artificial disc potentially minimizes stress to adjacent discs and other vertebral structures.

AboutJeffrey R. Carlson, M.D.Dr.Jeffrey Carlsonhas been a part of Orthopaedic & Spine Center since 1999 and serves as the President and Managing Partner. He is a board-certified, fellowship-trained orthopaedic surgeon who focuses on the treatment of injuries and disorders of the spine.

About Orthopaedic & Spine CenterOrthopaedic & Spine Center (OSC) is staffed by outstanding medical professionals who strive to provide the very best orthopaedic and interventional pain management care available anywhere. Our Center includes a comfortable, state-of-the-art medical facility, pleasant and well-trained personnel, physicians trained in the most advanced orthopaedic treatments, interventional pain management procedures, regenerative medicine, using stem cell and platelet therapies and a dedication to old-fashioned patient care.

SOURCE Orthopaedic & Spine Center

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Orthopaedic Surgeon, Dr. Jeffrey Carlson, first in Central and Eastern Virginia to implant the M6-C Artificial Cervical Disc - OrthoSpineNews

WASHINGTON, D.C., Dec. 11, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader regenerative medicine sector, announced its 2020 Cell & Gene Therapies State of the Industry briefing will take place January 13, 2020 in San Francisco, held in conjunction with Biotech Showcase 2020.

ARMs State of the Industry briefing is the largest cell and gene therapy-focused annual event taking place during the week of the 2020 J.P. Morgan Healthcare Conference. The briefing is expected to attract more than 500 of the fields leading executives, investors, life science media, patient advocates, and academic leaders.

This briefing offers a comprehensive industry overview, including insights into key sector trends and metrics, the financial and partnering outlook, recent advances, the clinical pipeline and potential product approvals, commercialization challenges, and a preview of the coming year.

Preliminary Agenda:

8:00 8:20am | Introduction & Industry UpdateJanet Lambert,CEO, Alliance for Regenerative Medicine

8:20am 9:05am | Emerging Cell Therapies for CancerPascal Touchon,CEO, Atara BiotherapeuticsMatthew Kane,Co-Founder and CEO, Precision BioSciencesSamarth Kulkarni,CEO, CRISPR Therapeutics

9:05am 9:50am | Next Generation Gene and Cell TechnologiesShelia Mikhail,CEO, AskBioLaurence Cooper,CEO, ZiopharmTimothy Miller,Co-Founder, President, & Chief Scientific Officer, Abeona Therapeutics

Registration is complimentary and open to the public; however,RSVP is required. The event will be broadcast live via streaming webcast,available on ARMs website.

The briefing will take place at the Parc 55 Hilton, 55 Cyril Magnin Street in San Francisco, California from 8:00 9:50am and is held in conjunction with Biotech Showcase, organized by EBD Group and Demy Colton. Please note that attendance at this briefing is separate from registering to attend the Biotech Showcase conference, which requires paid registration.

About The Alliance for Regenerative MedicineThe Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 350 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visithttp://www.alliancerm.org.

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The Alliance for Regenerative Medicine Announces 2020 Cell & Gene Therapies State of the Industry Briefing - GlobeNewswire

When embryonic Stem Cell therapy was first discovered in 1998, it changed the face of medicine. The idea of being able to regenerate and replace damaged cells seemed futuristic at the time, yet today such treatments are commonplace. Now, science has taken another quantum leap this time into the nano-sized world of exosomes, tiny bubbles that grow out of cell walls and contain much of the information contained within the cell including Growth factors, microRNA and messenger RNA. Mesenchymal stem cell (MSC) exosome therapy is currently one of the hottest trends in regenerative medicine, one that patients at AM Medical in Yelm can now experience.

Everyone has heard of stem cell therapy, but it turns out that its not the stem cells that are doing the work, says Dr. Ana Mihalcea, President of AM Medical. Its the exosomes that carry the information of regeneration. Infused stem cells, attach to blood vessel walls, and then give off exosomes.

Exosomes have several key differences from stem cells; they do not get removed from the circulation like stem cells, which are in the body for less than 72 hours before they get destroyed by the immune system; they do not produce a rejection reaction because they are not a cell and contain no DNA, and they pass the blood brain barrier, Mihalcea notes. In a study on stroke scientists fluorescently tagged exosomes, and the infused exosomes went exactly to the region where the stroke had occurred, she adds. The same was not true of stem cells as they do not cross the blood brain barrier.

As a result of their powerful cargo, exosomes can be used to address a multitude of conditions, including arthritis, autoimmune disorders, cardiovascular and neurogenerative diseases like Parkinsons and Alzheimers. Old cells can be reprogrammed by MSC exosomes as the target cells can transcribe the microRNA into functional proteins. Just like a virus, the exosome information of the young stem cells can infect the old cells with Youth, explains Mihalcea.

Spinal cord injuries are an area in which exosomes have produced dramatic results. Mihalcea cites the example of Dr. Douglas J. Spiels Interventional Pain Specialty Practice in NJ. Dr. Spiel has been able to rehabilitate spinal cord injuries with Exosome infusions into the spine and intravenously, she says. After several weeks, hes had patients regain muscle strength and sensation. These are prolonged, ongoing regenerative effects that continued to improve for months after the infusion.

When it comes to autoimmune diseases, inflammation plays a key role. Again, exosomes are able to reduce the problem by downregulating inflammation. TGF Beta 3 [Transforming growth factor beta-3] is the most important anti-inflammatory protein in the body and is abundant in MSC exosomes says Mihalcea. Many more Growth factors for blood vessel growth, neuronal and other tissue growth are present, allowing regenerative effects in all organ systems including skin wounds and burns.

The exosomes at AM Medical come from a laboratory in Florida that conducted pioneering research in the field. They come from perinatal mesenchymal stem cells and are scanned for any possible viruses to ensure their safety. Once harvested, the exosomes are concentrated so they can be infused in large doses.

For patients who qualify, the infusion process takes 10 to 15 minutes. Already, its been producing results for AM Medical patients. Weve had people with arthritis and chronic pain who had great responses, Mihalcea notes. There is an overall increase in wellbeing and sense of rejuvenation that is definitely noticeable.

Perhaps one of the largest sources of excitement over exosomes has to do with their anti-aging effects. Recently, ideas about the root causes of aging have been evolving, according to Mihalcea. Its been thought that aging occurs due to multiple different reasons like stem cell exhaustion, epigenetic changes, telomere shortening and others, she explains. It turns out that exosomes can modify almost all the hallmarks of aging. Theyre changing epigenetic expression to youthful function, and there are many potential applications. This is a new frontier in regenerative medicine that can help many people.

Learn more by watching Dr. Ana Mihalceas video on Exosomes The New Frontier Part 1: Longevity and Age reversal or reading further on the AM Medical website.

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Cutting Edge Exosome Regenerative Therapy Comes to Yelm's AM Medical - ThurstonTalk

WASHINGTON, Dec. 10, 2019 /PRNewswire/ -- A new report released by the independent, non-profit Alliance for Cell Therapy Now, highlights the need for a national effort to measure outcomes related to regenerative cell therapies, as well as increased federal funding for research at the National Institutes for Health (NIH) and expanded capacity at the Food and Drug Administration (FDA) to support this rapidly growing field. The report is based on insights shared by several leaders during a September 2019 event on Capitol Hill hosted by Alliance for Cell Therapy Now in collaboration with the Regenerative Medicine Foundation and the Cord Blood Association.

Regenerative cell therapies represent the next generation of treatments that are showing great promise in cardiology, neurology, oncology, orthopedics, osteoarthritis, and wound healing. Several well-designed clinical trials are now being conducted under FDA-approved investigational new drug protocols. At the same time, some clinics have caused patient harm or made questionable claims, taking advantage of vulnerable patients and casting a negative light on this promising field.

The 21st Century Cures Act contained several provisions to make safe and effective regenerative cellular therapies available to patients, and the FDA and the NIH have taken several steps to advance and support the field. However, additional actions are needed to help bring safe and effective therapies to patients.

Leaders representing FDA, NIH, the Duke University School of Medicine and Cord Blood Association, the Georgia Institute of Technology, the Marcus Foundation, the Regenerative Medicine Foundation, Sanford Health, the Wake Forest Institute of Regenerative Medicine, and Alliance for Cell Therapy Now, participated in the event.

To read the entire report, go to http://allianceforcelltherapynow.org/wp-content/uploads/2019/12/Regenerative-Cell-Therapies-Alliance-for-Cell-Therapy-Capitol-Hill-Briefing-Sept-2019-1.pdf

To view speaker slides and a webcast of the event, visit http://allianceforcelltherapynow.org/events/.

SOURCE Alliance for Cell Therapy Now

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New Report Calls for Measurement of Outcomes and Federal Funding for Research and Increased Capacity at FDA to Advance Safe and Effective Regenerative...

Based on promising results in an early clinical trial, Mayo Clinic has formed a new joint venture with materials engineering firm W.L. Gore & Associates to spearhead a new therapy using stem cells to repair a painful tissue problem stemming from Crohn's disease.

Mayo and Gore on Tuesday announced the formation of a for-profit company called Avobis Bio ("a vobis" is Latin for "by you"), based in Delaware, where Gore is also based. The privately held company will draw on the expertise of scientists at Mayo and Gore to launch a second-phase clinical trial in the hopes of eventually offering the treatment commercially.

A laboratory director at Mayo Clinic said Avobis Bio's therapy, if successful, may be a first-of-its-kind in health care, involving the delivery of a person's own mesenchymal stem cells on a synthetic "scaffold" that biodegrades over time, eventually leaving behind only native tissue sealing a wound. The first application of the technology is treatment of a health problem called perianal fistulae. But if successful, Avobis Bio may one day offer a variety of tissue and organ-repair therapies combining Mayo's stem cell expertise and Gore's medical materials.

"This is a completely new approach, where we are trying to leverage what the body can do for itself," said Allan Dietz, co-director of the Human Cell Therapy Lab in Mayo's Center for Regenerative Medicine.

Mesenchymal stem cells can naturally convert into other kinds of tissue, like muscle or bone. For the Avobis Bio therapy, the cells are harvested from a biopsy of a person's body fat and cultivated at a Mayo laboratory to high purity. No one knows whether the cells deposited into the wound directly convert into scar tissue, or if the stem cells trigger genetic signals that cause other cells in the surrounding tissue to begin the healing process.

"We provide stem cells in the right frame, at the right time, for the body to recognize the signals that it should begin the healing process," Dietz said. "I think in some ways, it was a required simple first step but it appears to be a major step."

Gore is perhaps best known to the public for its Gore-Tex outerwear, but the privately held $3.7 billion engineering and manufacturing firm sells products in an array of industries, including a line of medical devices designed to repair nonnatural holes in body organs. Mayo has used Gore-made devices for many years.

Several years ago, physician-researchers at the not-for-profit Mayo Clinic in Rochester grew keenly interested in a Gore device called the Bio-A Fistula Plug, a flexible bioabsorbable plug made from a material similar to dissolving stitches.

The plug can be used to repair unnatural canals that form between a person's anal canal and their outer skin, after Crohn's disease weakens surrounding tissues. These canals, also known as perianal fistulae, are painful, disruptive and difficult to treat, doctors said. For patients with Crohn's disease, lifetime incidence of perianal fistulae ranges between 23% and 38%, according to past studies.

In 2017, Mayo announced first-in-human results of their experimental therapy treating Crohn's patients' perianal fistulae using a Gore Bio-A Fistula Plug coated with the patient's own stem cells. The study, run in consultation with the Food and Drug Administration, provided the open-label treatment to a small group of patients whose fistulae had not responded to treatment for a median time of six years.

After initial results proved encouraging, the trial eventually enrolled 20 people. Of the 19 who remained in the trial for at least a year, 76% experienced healing of their fistulae, according to results announced by researchers but not yet published in a journal. If validated in a larger clinical trial, that rate of healing would be dramatically better than outcomes under existing treatments, the companies said.

"We have done work in the past looking at combining cells and materials. For us, the clinical trial results from Mayo were incredibly compelling," said Tiffany Brown, a Gore employee and general manager of Avobis Bio. "It is a challenge to translate how cells behave in the lab to how they will behave in patients. So having that proof in real patients really got the conversation going on how we could work together."

If the therapy is proved safe and effective in larger trials, Brown said about 50,000 Crohn's patients per year could be eligible to get it for perianal fistulae. Although Gore is phasing out general sales of its Bio-A Fistula Plug, the device will be supplied exclusively to Avobis Bio.

Mayo and Gore declined to reveal financial details for Avobis Bio, except to note that both parties are contributing to the limited-liability joint venture. The company has a five-member board of managers, with Mayo appointing two members and Gore appointing three.

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Mayo Clinic, maker of Gore-Tex outerwear are teaming up in Crohn's fight - Minneapolis Star Tribune

(Reuters) - Privately held drug developer Enzyvant said on Thursday the U.S. Food and Drug Administration declined to approve its regenerative tissue therapy for a rare immunodeficiency disorder and raised concerns about its manufacturing.

The company was hoping to win its first approval for the therapy, RVT-802, aimed at treating congenital athymia, a disorder affecting babies born without a small gland called thymus, which produces T-cells needed to regulate the immune system.

The health regulator in a letter to Enzyvant raised questions about the manufacturing process for the treatment as well other issues based on its inspection of the manufacturing site, the company said.

Many of these are topics that we are very aware of and we anticipated those to be post-marketing commitments, not approval requirements, Chief Executive Officer Rachelle Jacques told Reuters on a phone call.

The good news is theres no requirement for us to foresee any additional animal studies or any additional clinical trials.

The company said it had planned to manufacture its treatment through a third-party manufacturer.

If approved, RVT-802 would have been the first to win an FDA nod under the agencys Regenerative Medicine Advanced Therapy (RMAT) designation, granted to drug developers making regenerative therapies for conditions lacking treatment options.

Babies born with congenital athymia - about 17 to 24 cases in the United States every year - usually do not survive beyond the age of two.

RVT-802 is a tissue-based therapy, manufactured by sourcing thymus tissue from infants undergoing heart surgeries unrelated to congenital athymia, and administered only once.

Ten clinical studies spanning over two decades and 85 patients were conducted at North Carolinas Duke University, where the treatment was developed.

Enzyvant is currently owned and entirely funded by Swiss drug developer Roivant, but will become here a subsidiary of Japan-based Sumitomo Dainippon in a deal expected to close next year.

We would anticipate that the deal would close before we could fully address the issues in the (FDA letter), Jacques said.

Reporting by Vishwadha Chander and Tamara Mathias; Editing by Maju Samuel and Shinjini Ganguli

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FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns - Reuters

Policymakers around the world are determining how to apply existing regulations to 3D organ printing.

When Selena Gomez suffered from Lupus, her best friend Francia Raisa donated her kidney to her, saving Gomezs life. For decades, people just like Gomez have escaped death due to heroic organ donations, either from living or deceased donors.

Today, 3D printingalso referred to as 3DPmay revolutionize the practice of organ donation. Although 3D printing is currently used to make jewelry, food, and art, it may soon be used for medical solutions such as organ donations and bionic limbs.

As a result, policymakers around the world seek increased regulation of 3DP organs. Yet 3D bioprinting does not clearly fit into existing regulatory frameworks.

Since bioprinting generally falls within the regulatory domain of regenerative medicine, medical devices, and biologic drugs, regulators face the challenge of applying existing rules to this uncertain field. As of now, it is unclear whether policymakers can effectively regulate bioprinting under existing regulations, or if a new, specific regulatory process will be necessary.

In determining how to regulate 3D organ printing, policymakers must juggle many possible concerns. Since the technology is still developing, a lot of uncertainty remains about what the actual risks and ethical concerns are. For example, one ethical concern is that 3DP organs may be available to wealthy people only, while less affluent individuals will be blocked out from using these organs.

Another concern is safety. Since 3DP may require stem-cell technology, and the patients own cells may be used for replication, it is difficult to assess the safety risks. Stem-cell therapy cannot be tested on a large sample of healthy people, which limits effective clinical analysis. Also, 3DP biotechnology may open up new uses beyond 3DP organs, such as enhancement of human capacities for military use. Developers could use the technology to make military officers or even terrorists less vulnerable to injury in battle, but this would open up a whole new challenge for law enforcement and national security.

The U.S. Food and Drug Administration (FDA) focuses on the regulation of 3D printed organs. FDA so far has only released guidance on 3DP, and the recommendations do not cover bioprinting.

A significant concern in the United States is that 3D printed organs do not fit into any clear category of law. First, they are not organs because they are not born alive at any stage of development. Second, they are not drugs because drugs are used orally rather than through an invasive surgery, and drugs are primarily meant to relieve illness while donated organs may completely cure an illness.

Some policymakers in the United States propose regulating 3DP organs as a biological product, defined as a virus, therapeutic serum, toxinor analogous productapplicable to the prevention, treatment, or cure of a disease or condition of human beings.

Research company Biogelx suggests that biological products may be a promising category for printed organs. Within biological products, a 3DP organ is comparable to proteins because to print the organ, clinicians replicate healthy human cells, which include such proteins, says Biogelx. Although existing regulatory frameworks often compare 3DP organs to medical devices, Biogelx asserts that these organs should not be regulated as medical devices. Medical devices are not made of biological material and are often metal or plastic devices that help an individuals standard of life, but 3DP organs are different since they cause a chemical reaction in the body and have the purpose of wholly replacing an existing organ, says Biogelx.

International policymakers are also struggling to find a sufficient regulatory framework. In Canada, Health Canada released draft guidance last year to develop regulations for medical device manufacturers working towards bioprinting. Health Canada has several concerns about bioprinting, and it suggests that manufacturers looking for bioprinting licenses should be required to submit information regarding the use of additives in materials, the verification of the software for the bioprinting design, the method of sterilizing the machines, and the process of safe removal and reuse of bioprinting materials and residues.

Finally, Europes 3DP health technology is regulated by the European Medical Devices Directive, the Active Implantable Medical Devices Directive, and the Invitro Diagnostic Medical Devices Directive. The Medical Devices Directive categorizes bioprinting devices into several risk classes. Across the different classes, devices ranked as higher risk are subjected to third party assessment and more stringent requirements for clinical data. The highest risk class, implantable devices such as 3D organs, requires an independent design dossier review. A design dossier assesses risk, evaluates clinical data, and demonstrates the technologys compliance with regulations and requirements.

Although 3D printing of organs is right around the corner, policymakers around the world lack the information necessary to make regulatory decisions in this space. Different countries have different approaches, but many of the leading nations in 3DP share similar concerns. With more information, regulators will have to decide if existing regulatory frameworks can adequately address the safety concerns of 3D printed organs.

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The Uncertainty of Regulating 3D Organ Printing - The Regulatory Review

Circularity Healthcare, LLC Joins Forces with "Behind The Scenes" with Host Laurence Fishburne

MIAMI (PRWEB) December 11, 2019

Circularity is partnering with Telly Award-Winning "Behind the Scenes" to provide regular, ongoing, high-quality content from leading experts in a variety of fields with an initial focus on microcirculation science, regenerative medicine, and advanced wound healing and related symptoms.

"Behind The Scenes with Host Laurence Fishburne" is a public television series that has won numerous awards and delivers precision idea-telling at its best. Circularity is an innovative healthcare organization that is health-bent on their trademarked slogan: "Improving Lives by Improving Blood Flow." Their coming together to bring forward the ideas of modern health science on a stellar entertainment platform can only make for riveting content going forward. Viewers will find themselves in a win-win situation.

Watching informative content via this stylized venue will leave viewers feeling quite satisfied with their television watching experience. It is time well spent and information precisely delivered.

A Little More About Circularity

Circularity is concerned with bringing the very best in healthcare innovation to the public. In so doing, they have manufactured a product called D'OXYVA. This product has a two-pronged approach to health. First, it can be quite effective in reducing the debilitative effects of many of the diseases that are affecting the world today, such as COPD, diabetes, and cardiovascular illnesses. Secondly, Circularity's D'OXYVA can be used in a preventative capacity to improve microcirculation. The concept of microcirculation has far-reaching implications in neurology, oncology, endocrinology, cardiovascular health, respiratory health, dermatology, diabetic wound healing or diabetic wound care and other major fields.

Circularity Healthcare, LLC is the power behind D'OXYVA. This noninvasive trans-dermal and circulatory health technology is just the first product to be offered. Circularity is invested in revolutionizing the healthcare space. They plan to do this by creating cutting edge medical products and procedures that are both patient and physician friendly while being effective in minimizing and eradicating diseases.

What "Behind The Scenes with Host Laurence Fishburne" Will Bring to the Table

Behind The Scenes has been an innovator in bringing information to the forefront in the public television space. The award-winning series features segments on the newest technologies, as well as fresh takes on existing entities, phenomenon, and natural occurrences. The show's website boasts that the television series "highlights the evolution of education, medicine, science, technology and industry through inspiring stories."

Aside from the Emmy-winning and Academy Award nominated actor Lawrence Fishburne as host, the program has an award-winning creative development team. Viewers walk away with a rich knowledge of the subject. Viewers may have known about this subject their whole lives, or it may be about something completely new. Viewers learn an evolving aspect of the topic which keeps the perspective fresh.

The dawning of a new age has appeared with this collaboration. Individuals who want to know more about what the health science field is bringing into our hospitals and doctors' offices will not be disappointed. In today's world, it is imperative that we are advocates for our own health.

Coming Soon: Miami ReLife's Dr. Steven Gelbard

The first series is with Dr. Steven Gelbard, a nationally-famed authority with his ReLife Miami Institute on stem cells. Dr. Gelbard presents D'OXYVA's Nobel Prize-winning science as a regenerative medicine. Dr. Gelbard is involving his direct contacts with top NFL players and other top sports celebrities in the monthly series, along with 2540 top neurosurgeons and other experts working under ReLife.

Consumers might imagine having the ability to receive D'OXYVA and other innovative treatments and non-invasive procedures for chronic wound care amid the luxury of a five-star hotel. Behind The Scenes guest, Dr. Gelbard, a Tufts School of Medicine educated neurosurgeon, makes it happen right now. Medicine has left the hospital building and has become the proactive choice of the health conscious. Viewers can all look forward to learning more about how to live a healthier and more informed lifestyle from this awe-inspiring episode.

According to Norbert Kiss, President and CEO of Circularity Healthcare, this collaboration is door busting. Mr. Kiss tells us, "[We] can offer unprecedented access to this amazing Emmy-winning show called Behind the Scenes with very competitive terms due to our strategic involvement. We welcome any expert."

Don't miss the evolution. It's being televised. Circularity and Behind The Scenes viewers can stay tuned for a mind-fortifying experience!

Circularity Values:

Circularity believes in a long-sought-after goal in health care; people should have access to one health application that solves most of their short and long term health issues without compromising other aspects of their health while doing this quickly, affordably, and without pain.

Circularity develops, manufactures and markets advanced technologies that significantly improve quality of life by improving some of the most essential physiological functions in the body.

About Behind The Scenes With Laurence Fishburne

Behind The Scenes is an award-winning program that highlights new stories and innovative concepts through groundbreaking short-form and long-form documentary presentation. The program, which is anchored by a veteran production team with decades of industry experience, is able to effectively communicate the most critical stories to a wide and diverse audience.

Behind The Scenes with Laurence Fishburne, has established an impressive and heralded career, amassing over one-hundred credits across the varied platforms of stage, television and film. He's well known for major for roles in such films as; John Wick 2, Fantastic 4 Rise of the Silver Surfer, Mission Impossible III, Mystic River, Boyz n the Hood, What's Love Got to Do With It, and Apocalypse Now. On the small screen, the award-winning and versatile actor played compelling roles in shows such as CSI: Crime Scene Investigation, CSI: Miami, CSI: New York and Hannibal. The Behind The Scenes Actor currently stars as Pops on the hit TV comedy Black-ish.

About Circularity Healthcare, LLC

Circularity Healthcare, LLC, located in Los Angeles, CA is a private biotech and medtech products and services company that designs, makes, markets, sells, distributes and licenses its own patented and patent pending technologies, such as its flagship non-invasive deoxyhemoglobin vasodilator product line, D'OXYVA. One of the main mechanisms underlying D'OXYVA's science received the Nobel Prize for Medicine in 2019. Circularity enters into exclusive agreements with manufacturers to launch products and with large and small clinics and hospitals in order to help them enhance their profits and credit profiles with a wide variety of advanced products and services. In addition, Circularity Healthcare assists in the financing of equipment, working capital and also patient financing at industry-leading terms and speed.

For more information, please visit http://www.circularityhealthcare.com, or doctors (Rx only) visit http://wound.doxyva.com and send your general inquiries via the Contact Us page. For specific inquiries contact Circularity Customer Care by phone toll free at 1-855-5DOXYVA or at 1-626-240-0956.

Forward-Looking Information

This press release may contain forward-looking information. This includes, or may be based upon, estimates, forecasts and statements as to management's expectations with respect to, among other things, the quality of the products of Circularity Healthcare, LLC, its resources, progress in development, demand, and market outlook for non-invasive transdermal delivery medical devices. Forward-looking information is based on the opinions and estimates of management at the date the information is given and is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those initially projected. These factors include the inherent risks involved in the launch of a new medical device, innovation and market acceptance uncertainties, fluctuating components and other advanced material prices, new federal or state governmental regulations, the possibility of project cost overruns or unanticipated costs and expenses, uncertainties relating to the availability and costs of financing needed in the future and other factors. The forward-looking information contained herein is given as of the date hereof and Circularity Healthcare, LLC assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law. Circularity Healthcare, LLC makes no representations or warranties as to the accuracy or completeness of this press release and shall have no liability for any representations (expressed or implied) for any statement made herein, or for any omission from this press release.

For the original version on PRWeb visit: https://www.prweb.com/releases/innovative_collaboration_the_cutting_edge_of_medicine_goes_behind_the_scenes/prweb16783651.htm

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Innovative Collaboration: The Cutting Edge of Medicine Goes - Benzinga

Following in the very successful footsteps of its sister companies GE Additive, GE Aerospace, and GE Oil and Gas, now GE Healthcare is starting to seriously look at 3D printing. After signing with Formlabs to streamline 3D printing of anatomical models, the giant is now partnering with Advanced Solutions Life Sciences (ASLS) toadvance the field of 3D biofabrication.

And if GE Healthcare is moving fast, bioprinting is not going any slower. It may be the positive momentum from the latest Termis (the leading regenerative medicine event) in Orlando, or maybe 3dpbm is just in the right place at the right time, but 3D Bioprinting Solutions has also been making some giant leaps recently. Now Advanced Solutions Life Sciences, the company founded by Michal Golway, one of the first pioneers in bioprinting, is going to benefit from GEs powerful distribution and R&D means.

As per the agreement, GE Healthcare will distribute the worlds first integrated 3D bioprinter + confocal scanner (BioAssemblyBot + GE IN Cell Analyzer 6500HS) as part of a strategic R&D and distribution partnership that sets out to personalize tissue regeneration. The integration of IN Cell Analyzer and BioAssemblyBot systems technologies will embed cellular-level assessments into the 3D bioprinting workflow used to create human tissue models.

Bioprinted tissues are small in size and die quickly, due to an inability to engineer small blood vessels the bodys supply network. ASLS patented Angiomics technology enables bioprinted microvessels to self-assemble into functional capillary beds, which deliver nutrients, oxygen, and hormones to the 3D tissue model and remove waste. This partnership would allow life scientists and tissue engineers to quickly design, build and image living, vascularized 3D tissues in a single, agile process.

Printing multi-material 3D objects inside of microwell plates allows scientists to efficiently move away from traditional 2D monocultures on plastic, to 3D discovery and cytotoxicity models that more accurately reflect native biology and disease, said Emmanuel Abate, General Manager of Genomics & Cellular Research, GE Healthcare Life Sciences. By combining this flexibility and precision of the BioAssemblyBot with the image quality and speed of the IN Cell Analyzer 6500 HS confocal screening platform, the prospect of automating high content screening in 3D models can become a reality.

Currently, biopharmaceutical companies test their drugs in 2D models and animal models. Precise 3D models provide a more physiologically relevant environment for drug testing because they mimic human reactions. The power of both of these platforms brings a new level of efficiency, speed and quality with assay designs and 3D biofabrication, said Michael Golway, President & CEO of ASLS.

Traditional 3D bioprinters are not designed for quality or interoperability with the high-throughput screening methods that pharmaceutical developers use to identify drug candidates. This alliance will result in a new product to address this challenge: an integration of GE Healthcare Life Sciences IN Cell Analyzer confocal imaging platform with IN Carta cell analysis software, and ASLS BioAssemblyBot 3D bioprinter with TSIM design software.

For pharmaceutical companies, where the average time to develop a new drug candidate may take over seven years, moving from traditional stage-gate testing processes to a lean, agile workcell for 3D tissue fabrication and assessments will shorten development timelines. The integration between IN Cell Analyzer and BioAssemblyBot enables the automated inclusion of cellular imaging information into the tissue modeling process so that new therapies can be scaled more quickly and effectively.

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GE Healthcare pairs up with Advanced Solutions on regenerative tissue manufacturing - 3DPMN

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Creating an object from a scratch: not just an illusion, but a reality. Nowadays, there is a way to turn your ideas into three-dimensional objects and here, the magic word is 3D printing.

This technique, also called additive manufacturing, consistsofn successive layer-by-layer depositions of material which, all together, form the desired object. Contrary to conventional techniques, 3D printing allows the manufacturing of complex shapes using a small amount of material and reduced number of fabrication steps.

With the term 3D printing, we usually refer to technologies which use polymers, resins and molten metals as printing material to produce three-dimensional objects. However, over the last 30 years, this concept has developed toward new horizons, leading to the production of 3D artificial bio tissues which resemble the architecture and function of native ones. In this case, when used to deposit living cells layer-by-layer, we talk more specifically about 3D bioprinting.

Nowadays, the most common technologies for 3D bioprinting are based on approaches such as extrusion printing, stereolithography, laser-based methods, and melt electrowriting. These technologies have the ability to accurately control the spatial orchestration of multiple cell types and biomaterials in an automated patterning process. However, they also present some disadvantages, e.g., the difficulties in reproducing convoluted geometries, which in fact are typical of native tissues. Moreover, a severe restriction is represented by long printing times when large, physiological-sized constructs need to be fabricated. This characteristic also affects the large-scale production of artificial tissues, thus limiting the adoption of 3D bioprinting at an industrial level.

In order to overcome these limitations, Prof. Riccardo Levato of the University Medical Center Utrecht, the Netherlands, and Prof. Christophe Moser of cole Polytechnique Fdral Lausanne (EPFL), Switzerland, have proposed a new strategy for the 3D bioprinting. In their recently published article they present a Volumetric Bioprinting (VBP) approach to create any convoluted free-form geometry with unprecedented speed of fabrication.

This method takes inspiration from the principle of computed tomographycommonly used in medical imagingalthough in reverse. In VBP, a cell-friendly visible laser light is used to cast multiple tomographic projections onto a light-sensitive hydrogel embedding stem cells.Although the whole volume is photo-exposed, the composition of these projections creates a 3D light field that provides enough energy to crosslink the hydrogel only in correspondence to the desired design. This results in a 3D construct, floating in the host hydrogel, which can be realized in the time frame of a few tens of seconds.

Contrary to other bioprinting technologies, e.g., stereolithography, which works in the time scale of hours to produce clinically-relevant sized (> cm3) structures, VBP thus permits the fabrication of living tissue constructs with analogous dimensions and complex 3D architectures by strongly reducing the fabrication times. As a consequence, VBP not only leads to high mimicry of the architecture of human tissues, but it preserves cells by minimizing the time outside of their optimal culture environment.

Given the freedom to print any complex geometry, anatomical, patient-specific grafts with unprecedented precision and short fabrications times, VBP lends itself to be the new paradigm of regenerative medicine, also paving the way for the scaling-up of tissue production. Thanks to these characteristics, Prof. Levato and Prof. Moser expect this approach will find application in many fields also outside tissue engineering, even including soft robotics. As they claimed, We expect Volumetric Bioprinting technology to be part of the bioprinting toolkit that will one day create fully functional organs.

In the future, the authors aim to further improve VBP technology by addressing the structural function of load bearing tissues, developing new materials and fully matching the function between their biofabricated tissues and the native ones. This sounds promising to us: we are looking forward to seeing new developments!

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Volumetric Bioprinting: The New Paradigm in Regenerative Medicine - Advanced Science News

AVITA Medical (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, and scientists at the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine have announced a preclinical research collaboration to establish proof-of-concept and explore further development of a spray-on treatment of genetically modified cells for patients with epidermolysis bullosa (EB), with potential applicability to other genetic skin disorders.

The partnership will pair AVITA Medicals patented and proprietary Spray-On Skin Cells technology and expertise with the Gates Centers innovative, patent pending combined reprogramming and gene editing technology to allow cells to function properly. Under the terms of the Sponsored Research Agreement (SRA), AVITA Medical retains the option to exclusively license technologies emerging from the partnership for further development and commercialization. The Gates Center team is further supported by the EB Research Partnership in New York, the Los Angeles-based EB Medical Research Foundation, the London-based Cure EB Charity and government grants, in a collaborative effort to rapidly develop and translate this technology to the clinic for meaningful impact on patient lives.

The Gates Center is a leader in developing therapeutic approaches for genetic skin diseases. Researchers at the Gates Center have developed a powerful new approach for treating genetic skin disorders and improving the lives of patients with epidermolysis bullosa, said Mike Perry, PhD, chief executive officer of AVITA Medical and adjunct professor at the Gates Center for Regenerative Medicine. We look forward to collaborating with the team at the Gates Center on the expanded use of our technology. This agreement marks an important milestone in AVITAs mission to harness the potential of regenerative medicine to address unmet medical needs across a broad range of dermatological indications, including genetic disorders of the skin.

Epidermolysis bullosa is a group of rare and incurable skin disorders caused by mutations in genes encoding structural proteins resulting in skin fragility and blistering, leading to chronic wounds and, in some sub-types, an increased risk of squamous cell carcinoma or death. There are no approved curative therapies, and current treatment is palliative - focused primarily on pain and nutritional management, itching relief, wound care, and bandaging.

Its very exciting to partner with AVITA Medical to help advance our epidermolysis bullosa program, said Director of the Gates Center for Regenerative Medicine Dennis Roop, PhD. Were looking forward to exploring a novel approach to delivering gene-edited skin cells to patients that addresses current treatment challenges.

We believe that Spray-On Skin Cells technology combined with our genetically corrected cells has the potential to be game changing in the treatment of this disease. This combination could reduce time to treatment, lower manufacturing complexity, reduce costs and improve patient outcomes, said Ganna Bilousova, PhD, assistant professor of dermatology, who is a co-principal investigator on this research program.

ABOUT THE CHARLES C. GATES CENTER FOR REGENERATIVE MEDICINE

The Charles C. Gates Center for Regenerative Medicine was established in 2006 with a gift in memory of Denver industrialist and philanthropist, Charles C. Gates, who was captivated by the hope and benefit stem cell research promised for so many people in the world. The Gates Center aspires to honor what he envisionedby doing everything possible to support the collaboration between basic scientific researchers and clinical faculty to transition scientific breakthroughs into clinical practice as quickly as possible.

Led by Founding Director Dennis Roop, PhD, the Gates Center is located at the University of Colorados Anschutz Medical Campus, the largest new biomedical and clinical campus in the United States. Operating as the only comprehensive Stem Cell Center within a 500-mile radius, the Gates Center shares its services and resources with an ever-enlarging membership of researchers and clinicians at the Anschutz Medical Campus, which includes University of Colorado Hospital, Childrens Hospital Colorado and the Veterans Administration Medical Center, as well as the Boulder campus, Colorado State University, the Colorado School of Mines, and business startups. This collaboration is designed to draw on the widest possible array of scientific exploration relevant to stem cell technology focused on the delivery of innovative therapies in Colorado and beyond.

ABOUT THE UNIVERSITY OF COLORADO SCHOOL OF MEDICINE

Faculty at the University of Colorado School of Medicine work to advance science and improve care. These faculty members include physicians, educators and scientists at University of Colorado Hospital, Childrens Hospital Colorado, Denver Health, National Jewish Health, and the Denver Veterans Affairs Medical Center. The school is located on the CU Anschutz Medical Campus, one of four campuses in the University of Colorado system. To learn more about the medical schools care, education, research and community engagement, visit its web site.

ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medicals patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patients own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES), an autologous suspension comprised of the patients skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patients own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. Burn Centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit http://www.avitamedical.com.

Photo at top: From left, Igor Kogut, PhD, Ganna Bilousova, PhD, and Dennis Roop, PhD.

Guest contributor: Gates Center for Regenerative Medicine/ASX

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AVITA Medical Teams With Gates Center to Advance Therapeutic Skin Restoration - CU Anschutz Today

No longer just for professional athletes, these are the stem cell and regenerative medicine options DCs need to know about

The health care landscape continues to evolve at a dizzying pace. Insurance deductibles are increasing, and this has placed a financial burden on patients who are required to self-pay for necessary and yet uncovered services.

The opioid crisis has left physicians with limited clinical options to treat chronic pain and dysfunction. At the same time, pressure has been placed on health care providers to provide affordable alternatives to invasive procedures that provide limited clinical options with high failure rates. This confluence of supply and demand has resulted in the growth of emerging therapies in the field of stem cell and regenerative medicine. These therapies are bringing hope to patients and new opportunities to health care providers who deliver them.

Regenerative medicine is the process of replacing or regenerating cells and tissues to restore normal function. Initially popularized by professional athletes, these therapies have become mainstream. More than 27 million Americans suffer from osteoarthritis today, and in 2030 25% of U.S. adults will be diagnosed with osteoarthritis. The global regenerative medicine market is predicted to reach more than $100 billion by 2022.

These moderately-invasive regenerative procedures are eclipsing traditional highly-invasive procedures, such as hip and knee implantation, which will have a global market of $35 million over the same period.

There are four primary regenerative medicine options:

Irritant therapies include prolotherapy, ozone and prolozone. Theyincludeadding multipleirritatingsubstances along with numbing agents into degenerated or injured joints, and areas of pain.

These therapies cause inflammation to kick-start regeneration by stimulating the body to send in macrophages, which are cells that ingest and destroy theirritantsolution and trigger the healing response. Irritant therapies are an excellenttreatmentfor all forms of musculoskeletal and joint pain includingchronic neck and back pain, and rotator cuff injuries.

The effect of irritant therapies is analogous to jump-starting the battery in a tractor to get the engine to turn over.

Protease inhibition therapy eliminates the factors causing cartilage degradation, tissue breakdown, inflammation and pain. It cleans and protects joints. It is most commonly used for patients with osteoarthritis (OA) and degenerative disc disease (DDD).

It includes therapies such as alpha-2-macroglobulin (A2M) and interleukin-1 receptor antagonist protein (IRAP). A2M and IRAP are proteins found naturally in our blood. They act as protease inhibitors by binding to and inactivating damaging proteases in the body. Proteases are catabolic enzymes that break larger molecules into smaller units. Proteases trapped in the joints catabolize cartilage and break it down, causing arthritis. A2M is a large protein made in the liver. It blocks activity for all known molecules that cause cartilage breakdown. It works like a Venus flytrap by having a bait-and-trap mechanism on two sides.

Once the proteases are bound on both sides, the molecule initiates a suicide cascade and dies, allowing it to be flushed out of the area by the body.

The binding effect of protease inhibition therapy is analogous to de-weeding a garden and tilling the soil before planting.

A fibronectin-aggrecan complex test (FACT) may be used to determine the presence of FAC, which is a biomarker or indicator of cartilage breakdown caused by proteases. FAC is a unique molecular complex that is specific for painful inflammation of the spine and cartilage.

A small sample of fluid is taken from the joint or disc and sent to a lab for testing. The test looks for the presence of FAC in the fluid sample and determines where you are: FAC+ or FAC-. FAC+ patients are identified as ideal candidates for A2M injections and have a 90% rate of responding to the A2M therapy.

Stem cell therapy is focused on concentrating the workhorses of regeneration and restoration of tissues: stem cells. This results in greater cell signaling and cell recruitment than other regenerative therapies. Stem cells are known as mesenchymal signaling cells. They are considered pluripotent, which means they are undifferentiated and can replicate into various cell and tissue types.

Stem cells are found in bone marrow, the soft spongy tissue found at the center of large bones. Introducing stem cells into an injured area initiates the healing response, repairing damaged tissue by growing new, healthy tissue. The most common stem cell therapies include bone marrow aspirate concentrate (BMA), nanofat and stromal vascular fraction.

Injecting stem cells into an injured area is analogous to planting seeds in a garden.

Growth factor therapies are focused on cell signaling and cell recruitment. Blood is made up of white blood cells, red blood cells, and platelets that are suspended in plasma. Platelets are most widely known for their ability to clot blood. Platelets are also highly rich in growth factors that are proteins that stimulate healing. When an injury occurs, platelets become activated, migrate to the site of injury and release growth factors.

Growth factor therapies are the most popular provider choice for the low-cost regeneration of tissues and include platelet-rich plasma (PRP) and platelet-rich fibrin matrix (PRFM). The therapy includes drawing the patients blood followed by centrifugation to concentrate the platelets and exclude other unwanted blood products.

Another type of growth factor therapy is amniotic fluid growth factor (GF) injection therapy. Amniotic fluid surrounds the fetus during pregnancy and provides protection and nourishment. Human amniotic fluid is sourced from consenting mothers during full-term C-sections. It contains over 200 growth factors, cytokines and proteins. The therapeutic use of amniotic fluid is regulated by the FDA. It must be tested for disease and may not include any viable cells. Amniotic fluid GF therapy has both anti-inflammatory and anti-microbial properties and includes naturally-occurring hyaluronic acid for lubrication. It is most commonly used to promote the repair and reconstruction of soft tissues including cartilage and tendons.

Exosomes are being heralded as the next frontier of growth factor therapies. While they are not cells, exosomes play a vital role in the communication and rejuvenation of all the cells in the body. Exosomes are extracellular vesicles, or small bubbles, released from cells, especially from stem cells. These culture-expanded cell secretions are derived from human placental tissue. They allow for cell-to-cell communication, transporting molecules that are important regulators of intracellular information. Exosomes act as a food source for stem cells and prolong their activity. Exosomes are anti-inflammatory and include more than 300 growth factors, cytokines and proteins.

Patients with Lyme disease, burns, chronic inflammation, autoimmune disease and other chronic degenerative diseases may benefit from including exosomes in their treatment regimen. The application of growth factor therapies is analogous to applying fertilizer to a garden to help the crop grow and flourish.

Moving stem cell and regenerative medicine forward in the treatment algorithm may eliminate the need for other ineffective or potentially harmful therapies. These therapies provide new hope for patients whose only alternatives have been long-term medication, steroid injections, and costly and time-consuming surgery and rehab.

Stem cell and regenerative medicine therapies may only be provided by licensed medical professionals following all appropriate rules and regulations. An understanding of these emerging therapies and the benefits they may provide is essential as the collaboration between doctors of medicine and chiropractic increases and we join forces to combat chronic pain, dysfunction and disease.

MARK SANNA, DC, ACRB LEVEL II, FICC, is a member of the Chiropractic Summit and a board member of the Foundation for Chiropractic Progress. He is the president and CEO of BreakthroughCoaching, and can be reached at mybreakthrough.com or800-723-8423.

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A primer: stem cell and regenerative medicine as 'the' emerging therapy - Chiropractic Economics

SAN CARLOS, Calif., Dec. 02, 2019 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc., (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that the company plans to present at the following conferences in December:

Live and archived webcasts of the presentations will be available in the Investors section of the Iovance website at http://ir.iovance.com.

AboutIovance Biotherapeutics, Inc.

Iovance Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patients own immune cells to attack cancer. TIL cells are extracted from a patients own tumor tissue, expanded through a proprietary process, and infused back into the patient. After infusion, TIL reach tumor tissue, where they attack tumor cells. The company is currently conducting pivotal studies in patients with metastatic melanoma and advanced cervical cancer. In addition, the companys TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. A clinical study to investigate Iovances T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is being initiated. For more information, please visit http://www.iovance.com.

Forward-Looking Statements

Certain matters discussed in this press release are forward-looking statements of Iovance Biotherapeutics, Inc. (hereinafter referred to as the Company, we, us, or our). We may, in some cases, use terms such as predicts, believes, potential, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. The forward-looking statements include, but are not limited to, risks and uncertainties relating to the success, timing, projected enrollment, manufacturing and production capabilities, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates (including both Company-sponsored and collaborator-sponsored trials in both the U.S. and Europe), such as statements regarding the timing of initiation and completion of these trials; the timing of and our ability to successfully submit, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, our product candidates, including those product candidates that have been granted breakthrough therapy designation (BTD) or regenerative medicine advanced therapy designation (RMAT) by the FDA and new product candidates in both solid tumor and blood cancers; the strength of the Companys product pipeline; the successful implementation of the Companys research and development programs and collaborations; the Companys ability to obtain tax incentives and credits; the guidance provided for the Companys future cash, cash equivalent, and short term investment positions; the success of the Companys manufacturing, license or development agreements; the acceptance by the market of the Companys product candidates, if approved; and other factors, including general economic conditions and regulatory developments, not within the Companys control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Companys business, including, without limitation: the preliminary clinical results, which may include efficacy and safety results, from ongoing Phase 2 studies may not be reflected in the final analyses of these trials or subgroups within these trials; a slower rate of enrollment may impact the Companys clinical trial timelines; enrollment may need to be adjusted for the Companys trials and cohorts within those trials based on FDA and other regulatory agency input; the new version of the protocol which further defines the patient population to include more advanced patients in the Companys cervical cancer trial may have an adverse effect on the results reported to date; the data within these trials may not be supportive of product approval; changes in patient populations may result in changes in preliminary clinical results; the Companys ability or inability to address FDA or other regulatory authority requirements relating to its clinical programs and registrational plans, such requirements including, but not limited to, clinical, safety, manufacturing and control requirements; the Companys interpretation of communications with the FDA may differ from the interpretation of such communications by the FDA; risks related to the Companys ability to maintain and benefit from accelerated FDA review designations, including BTD and RMAT, which may not result in a faster development process or review of the Companys product candidates (and which may later be rescinded by the FDA), and does not assure approval of such product candidates by the FDA or the ability of the Company to obtain FDA approval in time to benefit from commercial opportunities; the ability or inability of the Company to manufacture its therapies using third party manufacturers or its own facility may adversely affect the Companys potential commercial launch; and additional expenses may decrease our estimated cash balances and increase our estimated capital requirements. A further list and description of the Companys risks, uncertainties and other factors can be found in the Companys most recent Annual Report on Form 10-K and the Companys subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov or http://www.iovance.com. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investor Relations Contacts:Annie ChangSolebury Trout646-378-2972achang@troutgroup.com

Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com

Media Relations Contact: Rich AllanSolebury Trout646-378-2958rallan@troutgroup.com

Excerpt from:
Iovance Biotherapeutics to Present at Upcoming Investor Conferences in December - BioSpace

I recently had an experience that highlights, for me, some of what is wrong with our medical insurance system.

I love playing tennis, but my knees have been deteriorating. The cushioning material is wearing away, and there is arthritis. The increasing pain and swelling I was experiencing led me to consider knee replacement surgery, or the end of my tennis career. Neither choice was appealing.

My naturopathic doctor suggested I consider PRP therapy. Platelet-rich plasma treatment has been growing in popularity because it often provides an alternative to knee- and hip-replacement surgery. It can also help tennis tendinitis and rotator cuff injuries. Professional athletes, including Tiger Woods, use PRP therapy. Despite its successful track record, it is not covered by insurance, Medicare or otherwise.

PRP therapy involves removing a small amount of ones blood and separating out its components in a centrifuge. The concentrate is then injected into the area that needs help. The platelet-rich blood attracts stem cells, the bodys repairmen, to the area to rebuild tissue, muscles and tendons.

I love this concept because it uses the bodys own healing ability to rebuild worn-out parts. As a lifelong proponent of homeopathy and other natural healing modalities, I decided to give PRP a try. On Sept. 10, I drove to the office of Dr. John Herzog in Falmouth, Maine, to check it out, despite the fact that Medicare would not cover the cost.

Dr. Herzog is an osteopathic orthopedic surgeon who has performed thousands of surgeries to replace knees and hips over his 30-year career. In 2009 he decided to stop doing surgery and focus on PRP, after finding how much it helped his own knee condition. He has treated more than 3,000 patients since then, with an 80% success rate.

After a basic physical exam to see how well my knees flexed, we looked at them with ultrasound. It was fascinating to watch as Dr. Herzog explained the state of each knee cavity. Fortunately, I was not in a complete bone-on-bone condition; both knees were good candidates for PRP treatment.

I initially thought I would test the treatment on one knee, but opted to have both done. The cost was $600 for one knee, $1,000 for both. Despite paying for this out-of-pocket, it seemed a reasonable cost given the much more expensive alternatives. Knee and hip replacements average $30,000.

Dr. Herzog drew a cup of blood from my arm, put it in a centrifuge and injected the platelet-rich concentrate into both knees. I was out of the office on my way home in a little over an hour. I was told results were normally felt within 4 to 6 weeks, and could last up to a year or more. Every person responds differently, some return for tune-ups after a year.

The following day both knees were quite sore and swollen as blood and oxygen rushed to the area. The next day the swelling began to subside, and five days after the treatment I played tennis. Now, some two months later, the results have been remarkable. Both knees are stronger. Recovery after tennis is greatly reduced. I stopped wearing knee braces, and my movement on the court is now the best its been in years. Im considering playing three times a week instead of two. I feel a little bit like Forrest Gump!

Given the significant success rate of this treatment, the low cost, low risk and absence of side effects, why is it not covered by medical insurance? When I posed this question to a spokesperson at Concord Orthopedics, where one doctor now offers the treatment, their guess was the lack of clinical data on PRP therapy. Its clear this therapy is rapidly gaining in popularity because it is effective and inexpensive.

Dartmouth-Hitchcock offers PRP treatments. Vermont Regenerative Medicine, located in Burlington, recently ran a series of full-page ads in the Monitor advertising their services.

You would think insurance companies and the medical establishment would jump on embracing such benign treatment. I was able to afford the $1,000 fee to have both knees treated, but how about all the people who cannot?

For many years, acupuncture and chiropractic care were not covered by medical insurance. Now they are. Similar to PRP therapy, they are effective, non-invasive and low cost. All therapies that employ our bodys healing ability to recover from injury should be put at the top of the list of treatments covered by insurance. Especially when they offer a true alternative option to more expensive and invasive surgery.

(Sol Solomon lives in Sutton.)

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My Turn: The malaise of medical care - Concord Monitor

Ever since we began covering them as the first Russian bioprinting company,3D Bioprinting Solutions, or 3dbio for short, came across as more focused on raising awareness on bioprinting by conducting high profile experiments than on exploring commercial applications for the future of bioprinting. Visiting the companys lab in Moscow, and speaking with Co-founder Yusef Khesuani, we learned that it may be exactly the opposite: maybe we are not talking about 3dbio nearly as much as we should.

In fact, that may all be changing now with some more announcements coming up in the next few weeks. One of the main issues limiting 3dbios visibility in Western Europe and North America may be related to the fact that they are based in Russia. Due to generalized lack of awareness of Russian matters in the West, the way for 3dbio to get some well-deserved recognition has been to do things that are quite literally out of this world: building Russias first bioprinter (Fabion) in 2014, bioprinting and implanting a rodent thyroid gland in 2015, developing a bioprinter based on magnetic levitation and finally sending (not once but twice) said bioprinter, aptly named Organ.aut, to print in space on the ISS. That was in 2018.

Now the time has come for the bioprinting company to come back down to Earth and leverage its space-faring experience to venture into more short-term commercially viable businesses, such as bioprinting meat or in-situ bioprinting of tissue grafts. We spoke about these and the bioprinting markets status in general with Dr. Khesuani.

3D Bioprinting Solutions was founded by INVITRO, the largest private medical company in Russia, which is why the laboratory is located on one floor of the INVITRO facility in Moscow. The companys other Co-founders include INVITRO founder Alexander Ostrovsky and VIVAX BIO CEO & CFO (also INVITRO Advisory Committee Member) Yakov Balakhovsky. New York-based VIVAX BIO is actually 3D Bioprinting Solutions mother company through a complex structure that sees 3dbio as the core research lab used to fuel ideas for new, bioprinting based, commercial startups.

We hope that our R&D efforts will serve to create new spinoffs that will work as business startups, Dr. Khesuani begins. 3dbio is not a classical startup. We are here to set the foundations for science and give direction. Now we are going to launch a new startup next January, focusing on bioprinting artificial (bioficial) meat and based on the successful experiment we conducted printing meat on the ISS, together with Aleph Farms. In this case, we used the muscle cell sources supplied by Aleph Farms and combined them with our bioprinting technologies.

While artificial (or bioficial) meat may be closer to commercialization, the ultimate goal of 3dbio has been to produce human organs from the very beginning. Khesuani points out how bioprinters today are made primarily to print scientific papers rather than organs or implantable tissues. They basically combine different cells, different hydrogels and different geometries. Every different combination of one of these three factors is a basis for a new scientific paper, he says. Bioprinters are also used for drug discovery by companies like Organovo, another firm that started with the goal to print organs then moved to drug research. Khesuani believes that the drug discovery analysis process for bioprinted tissues is still too incomplete to attract big pharma companies.

One key difference between 3dbio and other bioprinting companies is that, after the Fabion and Fabion 2 systems, which are based on different types of extrusion, deposition and curing processes, they have now been working on a morevolumetric approach for bioprinting in spaces microgravity environment. While extrusion and deposition systems are considered ideal for flat, layered organs, such as cartilage and skin, more complex, tubular organs, such as, for example, a urethra, need a more tridimensional approach.

Using the Organ.aut magnetic system and further developing new acoustic means of controlling cellular materials in microgravity, 3dbios volumetric technique is able to produce more complex constructs without requiring a scaffold. The bioprinter now on the ISS uses magnetic fields to control the cellular materials. Using microgravity as a co-factor, it implements a scaffold-free, nozzle-free and label-free (no magnetic nanoparticles involved) formative approach. 3dbio researchers also showed off an early version of the acoustic system (in the video above). In theory, one could be used to distribute the material on the X and Y axes while the other could be used to control them along the Z-axis.

What feels particularly amazing is that, while visiting the 3dbio lab and speaking with Dr. Khesuani, Earths orbit, all of a sudden, seems a lot closer. Supplies from 3dbio regularly go up to (and down from) the ISS, in special containers that even have a stamp showing they transited on the ISS (seen in the photo above). In general, all of Moscow seems to have a particularly close relationship with space. When 3dbio approached Roscosmos about bioprinting in space in 2014 their proposal was met with enthusiasm. The project was conducted very rapidly, in spite of the first launch failing. Now laughing about it, Khesuani revealed that the bioprinter that fell back to Earth from a height of about 80,000 meters was actually still functional and will be exhibited at the Space Museum in Moscow in March.

Another approach to bioprinting that 3dbio is exploring is that of using a multi-axis robot for in-situ contour 3D bioprinting also considered a type of volumetric 3D printing. We have also been working with Kuka on using one of their robots to 3D printing tissue grafts directly on the body and we are soon going to announce another startup focusing on this technique, Khesuani reveals. We implemented our nozzles on the robotic arm to print directly on skin defects. One key issue that we are approaching is that our system will be able to use computer vision and machine learning algorithms in order to compensate for a living organisms body movements while breathing.

Along with the software, 3dbio developed a number of innovations for material handling in order to make the skin graft truly effective These will be officially presented next December 6th, in a joint release with Kuka. The first experiments will be conducted on small size pigs. Some experiments were already successfully conducted on rats, however, Khesuani explained that there is a significant gap between experimenting on small and large animals and an even bigger gap between large animals and humans. We expect to have the results of the tests for in-situ bioprinting on the pigs sometime next year, he said.

If bioprinting may still take years to bring real commercial applications, is bioprinted meat any closer? The answer lies in what we mean by meat. Just like industrial applications, to fully leverage the benefits of digital, additive manufacturing we need to completely reinvent food products. Thats one of the reasons why there is so much interest for bioprinting in space, where astronauts and cosmonauts already need to eat very different paste-like food products.

A lot of people think the goal is to bioprint a steak, Khesuani explains. If that is the final objective, then regenerative medicine may actually be closer. What we need to do is imagine new food products based on cellular agriculture. Even snacks such as Mars or Snickers were invented for military purposes in the 50s and 60s. We need to think of food products that do not exist today.

One of the biggest limits, in food as in medical bioprinting, is the lack of adequate cellular materials. Its almost like having Google without having the Internet, Khesuani says. We have the bioprinters to surf but we lack the materials to surf on. For in-situ medical applications, 3dbio developed the Viscoll line of collagen materials, which are suitable for any 3D bioprinter. It is aconcentrated sterile solution of highly purified Type 1 collagen which can be used to print three-dimensional scaffolds directly, or blended with cell suspensions to print cell-laden hydrogels. It was designed for the engineering of biocompatible and non-toxic, three-dimensional tissue constructs ideal for tissue engineering and regenerative medicine. A unique feature of the Viscoll hydrogel range is the use of a viscous solution of collagen with a physiological pH value, enabling the addition of living cells or spheroids without neutralization prior to 3D bioprinting. This significantly reduces the time and effort spent on conducting experiments and increases the viability of biological material.

The wide range of collagen concentration allows researches to produce designs with different mechanical densities and rates of bioresorption, depending on their biomedical purpose and the type of cells being used fibroblasts, multipotent mesenchymal stromal cells, pancreatic islet cells, and so on. The presence of any collagen Types I-V or other ECM proteins (Vitronectin, Fibronectin, Laminin) in the hydrogel determines the specific tissue type of the constructs: skin, bone or cartilage tissue, blood vessels, and parenchyma of internal organs.

Selling bioprinters is also a possible commercial business, and several FABION systems are now installed worldwide. Khesuani does not expect this to ever become a core business for 3dbio as operating these machines require engineering experience that is not often found in a scientific laboratory. The systems are generally installed in institutes that partner directly with 3dbio on developing new applications.

We have to be optimistic Khesuani says -. When we started there were maybe six bioprinting companies all over the world, now there are over 80 including companies, like CELLINK that have a great business model, although different from ours. Our goal was always to print human organs. We need to focus on that, rather than on selling more machines. He believes that other possible areas of expansion could be the development of medical devices and a new B2S business to science segment, where 3dbio could provide scientific results from experiments and help to commercialize them, as they are doing with the bioprinter in space.

One such result, also achieved in space, was growing of protein crystals, another was the development of new materials in space to use in regenerative medicine. Yet another was the production of 3D structures using bacteria, also in space, to study antibiotic resistance. 3dbio continuous to build networks with some of the most prestigious universities in the world and is entering talks with other space agencies such as ESA and JAXA. Next up will be the next generation of magnetic and acoustic bioprinters for volumetric bioassembly, as 3dbio continues to go where no other bioprinting company has ever gone before while building the bioprinting application market here on Earth.

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The future of bioprinting is out of this world at 3D Bioprinting Solutions in Moscow - 3DPMN

Hitachi, Ltd. headquartered in Tokyo, Japan, is focusing on Social Innovation Business combining its operational technology, information technology and products, has developed a new automation technology of 3D culture, solving problems of the previous 3D culture using Hitachi's Automated Cell Culture Equipment for iPS cells.

Automation of both 2D culture and 3D culture using this equipment makes it possible to automatic massive manufacture a variety of cell types such as cardiomyocytes, meeting customer needs. The automation technology was developed by collaborative research with Myoridge Co. Ltd. which has culture technology of iPS cell-derived cardiomyocytes by the protein-free method.

Furthermore the support service to establish an automatic manufacturing process for customers who are considering automation of manufacturing regenerative medicine products will be started on December 1st, 2019. As for the service, Hitachi will examine customers' manual manufacturing process to find out the important parameters, and suggest how to optimize them by the development knowledge of automation technology of 3D culture.

Expanding the market of regenerative medicine to recover the functions of tissues and organs is expected in recent years. A large number of cells are required for regenerative medicine but it is difficult to manufacture an enough amount of cells manually. So the automation technology of mass cell culture is necessary to expand the market of regenerative medicine.

Hitachi had been developing automation technology of mass iPS cell culture, and developed the automated cell culture equipment for iPS cells for research use in June 2017. Adopting the closed flow channel for the connection of the culture vessels and the medium bottles, the equipment is capable of cell seeding, culturing, and monitoring in sterile environment and offers stable supply of high-quality mass cells. Hitachi commercialized the automated cell mass culture equipment which has the necessary functions to comply with the Japanese regulation, GCTP for the first time in Japan in March 2019.

Hitachi automated the new 3D culture (low medium cost, low shear stress, and simple medium change process) by collaborating with Myoridge, solving problems of the previous 3D culture. The previous 3D culture has problems such as using a large amount of medium because of the height of the culture reactor, the shear stress to cells from the agitating medium, and the complex process of medium change. Hitachi started the collaborative research with Myoridge in October 2018 and developed the automation technology of the new 3D culture by distributing spheroids both uniformly and densely on the cell culture vessel for 2D culture. Furthermore, Hitachi manufactured cardiomyocytes by the automation technology more effectively than by manual. The technology is probably able to be applied to a variety of cell types and make them be manufactured automatically.

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Hitachi develops automation technology of 3D culture - BSA bureau