StemCell Therapy

Theres a lot to like about growth stocks. They can provide a healthy shot in the arm to an otherwise flat portfolio. Which makes sense. When a company is growing faster than the market average, the stock price usually isnt far behind. But to really reap the benefits, high-growth stocks offer the most potential bang for the buck.

So whats the difference between a regular growth stock and a high-growth stock? The answer is maturity.

Now, there are a lot of ways to pinpoint a growth stock. The classic metric is finding one with a high price-to-earnings (P/E) ratio. But most high-growth stocks are still flying under the radar of the average investor. Thats because theyve got a lot of growing left to do.

Finding a stock that has yet to hit its growth spurt can be like looking for a needle in a haystack. Theyre not quite the talk of Wall Street yet. But theyve got all of the characteristics in place to dominate their respective industry.

Lets start with a classic. Amazon (Nasdaq: AMZN) has been considered a growth stock for most of its existence. The e-commerce giant started off by going years without turning a profit. Instead of taking the opportunity to excite investors with booming profits, CEO Jeff Bezos reinvested nearly every dime the company made back into itself.

It proved to be a fruitful move. These days, Amazon controls nearly50% of all e-commerce. And it got there by focusing on growth. In the meantime, investors that stuck with the company through its heady adolescence have been handsomely rewarded.

Amazons P/Estayed above 70 from 2019 to 2020. So investors still believe it will have high earnings growth. But beyond world domination, it cant possibly maintain the growth trajectory its already undergone.

Despite the fact that Amazon is an extremely large blue chip stock, its EPS growth expectations over the next five years sit around 30%. So its still a solid investment If you can afford to get in. Heck, even if you cant afford a full share, theres a solid case to be made for investing in Amazon.

But for our purposes, were looking for a stock thats not just in a position to outpace the greater markets But one thats positioned to blow the doors off the market average.

And one thats in a perfect position to do so is Digital Turbine (Nasdaq: APPS).

As the companys ticker suggests, this potential high-growth stock is in the mobile app business. But its positioned in a rather unique way. Digital Turbine acts as a third party that works with wireless carriers to preinstall apps on new cell phones. It then sells available slots to companies like Uber, Spotify and Amazon that want their apps on phones. And business is going well.

Digital Turbine has also developed a strategic partnership with Samsung, the largest cellphone manufacturer in the world. This arms the company with a potent ally in the world of mobile advertising. Digital Turbine also boasts an impressive 92 P/E ratio that could signal significant future growth At least until the whole cell phone fad dies out. But until that happens, Digital Turbine could be just the propellant a sluggish portfolio needs.

The second potential high-growth stock is BioLife Solutions (Nasdaq: BLFS). This companys been around for a little longer than Digital Turbine. But that just means its had more time to perfect what it does.

BioLife is a leader in the medical instrument and supply industry Thanks in no small part to some state-of-the-art developments its spearheaded.

Sorry in advance for the 10-dollar words, but BioLife develops, manufactures and supplies:

While this might not sound all that important to the average investor, these two developments are huge. This biobanking technology is used in regenerative medicine Its essential for medical research And it plays an essential, supporting role in drug and therapy development.

In other words, when theres a medical breakthrough, theres a decent chance that BioLife played a role. And in an age when nobody knows when the next disease will pop up, BioLife Solutions has positioned itself to play a vital role treating it.

BioLife also boasts strong, innovative leadership in its CEO, Michael Rice, and a high P/E ratio over 170 Making this an enticing high-growth stock.

Cybersecurity is big business. But its a pretty crowded field. Which is why a company like FireEye (Nasdaq: FEYE) can easily get looked over by investors. There are, however, plenty of reasons to give this potential high-growth stock a second look.

Year-over-year sales growth of just 6% seemingly hit a bit of a snag this year. But whats not accounted for was the companys massive (and expensive) shift to cloud-based services.

By jumping into the subscription-based model, FireEye has set itself up with a strong baseline of future revenue And it still has plenty of time to put the pedal to the metal as cybersecurity demands increase.

With a broad array of cybersecurity products for healthcare, government, financial services and personal cloud computing, FireEyes seasoned leadership is proving to be guiding the company in all of the right directions.

A company on the rise can make a huge difference in any investors portfolio. But like all investments, they come with some inherent risk. And because most high-growth stocks dont offer dividends (but there are exceptions like these dividend growth stocks) the only way to make money off them is by selling them in the future.

But thats not the only risk. When it comes to young companies, missing expectations can cause a lot more tumult both for the business and stock price than it would for a blue chip stock. So before you take the plunge on any investment, its important to first come to grips with your risk tolerance.

If you decide that high-growth stocks are right for you, we wish you good investing. If however, you dont have the stomach for it, there are plenty of other investment opportunities out there.

And if youd like to have up-to-the-minute market analysis delivered to your inbox every day, be sure to sign up for the Investment U e-letter below.

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3 High-Growth Stocks to Watch in 2020 - Investment U

Global 3D Printed Implants Market: An Overview

The global 3D printed implants market is an important part of the growing larger trend, the 3D printing in medical applications.

The global 3D printed implants market players are serving a crucial need of the medical sector. Medical processes can be enhanced with training on artificial models before surgeries. Additionally, the products in the global 3D printed implants market are helping reconstruction of entire facial features, limbs and tissue lost during serious illnesses such as Arthritis and much more.

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Moreover, due to growing advancements in technologies such as nano-materials, today physicians can recreate exact replicas of individual anatomy and extend their services naturally. Moreover, critical surgeries like heart replacement and total joint replacement have also become feasible, thanks to virtual planning and guidance provided by 3D printed technology.

Currently new material advances such as polymer based hearts and other organs are making their ways into the medical field. Orthopedic implants like the ones made up of metals are also on the rise. This new material promotes osseointegration and increase the ability of surface bearing load capabilities. Today, many healthcare institutions, especially hospitals are introducing 3D printed machinery in their operations through radiology departments.

Additionally, the devices created using 3D printed technology are superior to conventional ones. For example, printed casts for fractured bones can be open and custom-fitted. These enable wearers to scratch, ventilate, and wash the damaged area. Additionally, these can also be recycled.

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The growing advancements in materials, supporting technology, and increasing medical applications are expected to drive significant growth for the printed implants market in the near future.

Global 3D Printed Implants Market: Notable Developments

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Global 3D Printed Implants Market: Key Trends

The global 3D printed implants market is witnessing positive developments such as identical bone customized implants, CT-bone, and zygoma augmentation process. The additional control over medical processes provided by the 3D printed implant technology is expected to create many opportunities for various players in the market. Moreover, rising R&D development, increase in medical surgeries, and growing biomedical applications of 3D technology are also expected to boost the 3D printed implants market.

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However, high initial investments in the technology, lack of skilled technician, and longer production queues are expected to limit growth of the 3D printed implants market. However, the growth in cranial as well as orthopedic implants are likely to offset the setbacks in favor of the 3D printed implants market. The growth in the orthopedic segment reached an all-time high in 2018. It is expected to drive more tumor surgeries to create robust new opportunities.

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3D Printed Implants Market: Growing Biomedical Applications of 3D Technology is Expected to Boost the Market - BioSpace

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Int J Stem Cells. 2020 Aug 31. doi: 10.15283/ijsc20076. Online ahead of print.

ABSTRACT

COVID-19 pandemic has brought the whole world stand still, locked down in their homes, infecting more than 8 million people, and many thousands (449,182) -have lost their lives across the globe. Due to lack of any definitive medicine or vaccine, treatment options are supportive of oxygenation, antiviral, antiretroviral drugs, antibiotics, fluid/ electrolyte, mechanical ventilation with ICU (Intensive Care Unit) support, and chloroquine/hydroxychloroquine have been tried to fight this infection. However, mortality due to severe pneumonia, ARDS (Acute Respiratory Distress Syndrome), and multiorgan failure arising from the overactive immune response (storm) mediated by cytokines remains a treatment challenge in elderly and patients with severe medical comorbidities. Recently, anti-inflammatory, angiogenic, immune-modular, and healing properties of intravenous injections of culture derived stem cells have been proposed and shown to benefits in a small number of patients with severe COVID-19 infections. Based on previous experience with other viral infections, convalescent plasma, and serum transfusion are being used as a source of neutralizing antibody/factors to minimize the effects of inflammatory cytokines in this infection. Immunotherapy with purified monoclonal antibodies and conditioned serum with a mixture of unique cytokines are also being developed. Regenerative Medicine has emerged as a crucial adjuvant tool in promoting healing and early recovery in severe COVID-19 infections and other supportive treatments.

PMID:32840231 | DOI:10.15283/ijsc20076

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Emerging Treatment Options of Regenerative Medicine in Severe Corona Virus/COVID 19 Infections - DocWire News

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Stem Cells Transl Med. 2020 Aug 27. doi: 10.1002/sctm.20-0245. Online ahead of print.

ABSTRACT

This perspective from a Regenerative Medicine Manufacturing Society working group highlights regenerative medicine therapeutic opportunities for fighting COVID-19. This article addresses why SARS-CoV-2 is so different from other viruses and how regenerative medicine is poised to deliver new therapeutic opportunities to battle COVID-19. We describe animal models that depict the mechanism of action for COVID-19 and that may help identify new treatments. Additionally, organoid platforms that can recapitulate some of the physiological properties of human organ systems, such as the lungs and the heart, are discussed as potential platforms that may prove useful in rapidly screening new drugs and identifying at-risk patients. This article critically evaluates some of the promising regenerative medicine-based therapies for treating COVID-19 and presents some of the collective technologies and resources that the scientific community currently has available to confront this pandemic.

PMID:32856432 | DOI:10.1002/sctm.20-0245

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Regen med therapeutic opportunities for fighting COVID-19 - DocWire News

Reports Web presents the intelligent report title as Regenerative Medicine Market Covid-19 Impact Global Analysis and Forecasts by product, application and end user. Market is expected to provide several growth opportunities across the globe. The global market for asset performance management, on the basis of architecture, has been segmented into software and services.

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Key Players:

Allergan plc, Integra lifesciences, Mimedx Group, Inc., Medtronic plc, Organogenesis Inc., Zimmer Biomet, Acelity L.P. Inc., Nuvasive, Inc., Stryker Corporation, Japan Tissue Engineering Co., Ltd. (Fujifilm Holdings Corporation subsidiary), Osiris Therapeutics, Inc., Vericel Corporation and other predominate and niche players.

The target audience for the report on the market include, Manufactures, Market analysts, Senior executives, Business development managers, Technologists, R&D staff, Distributors, Investors, Governments, Equity research firms, Consultants.

The report provides complete details about the usage and adoption rate of regenerative medicine in various therapeutic verticals and regions. With that, key stakeholders can know about the major trends, drivers, investments, and vertical players initiatives. Moreover, the report provides details about the major challenges that are going to impact on the market growth.

The market report provides a detailed overview of the industry including both qualitative and quantitative information. It provides overview and forecast of the global market based on type, and end user. It also provides market size and forecast till 2026 for overall Regenerative Medicine market globally.

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Report Overview:

Section 1 Regenerative Medicine Product Definition

Section 2 Global Regenerative Medicine Market Manufacturer Share and Market Overview

2.1 Global Manufacturer Regenerative Medicine Shipments

2.2 Global Manufacturer Regenerative Medicine Business Revenue

2.3 Global Regenerative Medicine Market Overview

2.4 COVID-19 Impact on Regenerative Medicine Industry

Section 3 Manufacturer Regenerative Medicine Business Introduction

Section 4 Global Regenerative Medicine Market Segmentation (Region Level)

Section 5 Global Regenerative Medicine Market Segmentation (Product Type Level)

Section 6 Global Regenerative Medicine Market Segmentation (Industry Level)

Section 7 Global Regenerative Medicine Market Segmentation (Channel Level)

Section 8 Regenerative Medicine Market Forecast 2020-2025

Section 9 Regenerative Medicine Segmentation Product Type

Section 10 Regenerative Medicine Segmentation Industry

Section 11 Regenerative Medicine Cost of Production Analysis

Section 12 Conclusion

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Regenerative Medicine Market | Leading industry players, products and services, Market Size and Trends 2020-2026 - The News Brok

CAMBRIDGE, Mass.--(BUSINESS WIRE)--ElevateBio, LLC, a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies, announced that the company will present at the virtual Morgan Stanley 18th Annual Global Healthcare Conference on September 16, 2020 at 5:00 p.m. ET.

About ElevateBio

ElevateBio, LLC, is a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies. It begins with an environment where scientific inventors can transform their visions for cell and gene therapies into reality for patients with devastating and life-threatening diseases. Working with leading academic researchers, medical centers, and corporate partners, ElevateBios team of scientists, drug developers, and company builders are creating a portfolio of therapeutics companies that are changing the face of cell and gene therapy and regenerative medicine. Core to ElevateBios vision is BaseCamp, a centralized state-of-the-art innovation and manufacturing center, providing fully integrated capabilities, including basic and transitional research, process development, clinical development, cGMP manufacturing, and regulatory affairs across multiple cell and gene therapy and regenerative medicine technology platforms. ElevateBio portfolio companies, as well as select strategic partners are supported by ElevateBio BaseCamp in the advancement of novel cell and gene therapies.

ElevateBios investors include F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, Samsara BioCapital, The Invus Group, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures HC.

ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass. For more information, please visit http://www.elevate.bio.

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ElevateBio to Present at the Morgan Stanley 18th Annual Global Healthcare Conference - Business Wire

The Global Video collaboration as a Service (VCaaS) Market was valued at USD 4 Billion in the year 2018. The market is expected to grow at a CAGR of 4.38% during 2019-2024, owing to increase in applications of video conferencing solutions among end users such as healthcare organizations, educational institutions and public sectors. Video conferencing has gained huge popularity and adoption among enterprises as a form of business communication.

Thevideo conferencing solutionshelp organizations to achieve desired goals by discussing the strategies and providing trainings over video conferences to enhance the business output. Introduction of web-based technology with fewer complications by the IT sector is further anticipated to propel the market significantly in near future. Further, surging investment towards innovative products, rising consumer demand, declining manufacturing cost, growing number of outlets and increasing research & development by leading service providers is also expected to augment the market growth.

The Final Report will cover the impact analysis of COVID-19 on this industry:

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A comprehensive research report published by Azoth Analytics in August 2019 aims to present the analysis of Global Video collaboration as a Service (VCaaS) Market. The report presents the analysis of Video collaboration as a Service (VCaaS) Market by Technology Type (Cloud Conferencing, On Premise Conferencing) and by Usage Type (Meetings, Webinars, Trainings). The Global Video collaboration as a Service (VCaaS) Market has been analysed By Region (North America, Europe, Asia Pacific, LAMEA) and By Country (United States, Germany, China, India) for the historical period of 2017-2018 and the forecast period of 2019-2024.

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Video Collaboration As A Service (VCaaS) MarketCryptocurrency MarketCash Logistics MarketCar Rental MarketRegenerative Medicine Market Online Food Delivery And Takeaway MarketShea Butter MarketCT Scanner MarketVinyl Flooring MarketHigh Temperature Refractory Insulation Material MarketFloating Production System MarketCompounding Pharmacies MarketVascular Stent MarketRobotic Surgery MarketSalmon Market

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Global Video Collaboration as a Service (VCaaS) Market (Actual Period: 2017-2018, Forecast Period: 2019-2024) Market Sizing, Growth, Forecast Analysis by Technology Type -Cloud Conferencing, On Premise Conferencing Analysis by Usage Type -Meetings, Webinars, Trainings Competitive Landscape Market Share Analysis

Regional Video Collaboration as a Service (VCaaS) Market North America, Europe, Asia Pacific, ROW (Actual Period: 2017-2018, Forecast Period: 2019-2024) Market Sizing, Growth, Forecast Analysis by Technology Type -Cloud Conferencing, On Premise Conferencing Analysis by Usage Type -Meetings, Webinars, Trainings

Country Analysis Video Collaboration as a Service (VCaaS) Market by Value United States, Germany, China, India (Actual Period: 2017-2018, Forecast Period: 2019-2024) Market Sizing, Growth, Forecast Analysis by Technology Type -Cloud Conferencing, On Premise Conferencing Analysis by Usage Type -Meetings, Webinars, Trainings

Other Report Highlights Strategic Recommendations Market Dynamics Trends, Drivers, Challenges Company Analysis Zoom Video Communications, Inc, Cisco WebEx, LogMein, Inc, BlueJeans Network, Intercall

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The report could be customized according to the clients specific research requirements. No additional cost will be required to pay for limited additional research.

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Video Collaboration As A Service (VCaaS) Market Share, Trend, Opportunity, Affect On Demand By COVID-19 Pandemic And Forecast 2020-2024 - The Daily...

Post COVID-19 Impact on 3D Cell Culture Market

With the emergence of the COVID-19 crisis, the world is fighting a health pandemic as well as an economic emergency, almost impacting trillions of dollars of revenues. Research Dive group of skilled analysts provide a solution to help the companies to survive and sustain in this economic crisis. We support companies to make informed decisions based on our findings resulting from the comprehensive study by our qualified team of experts.

Our study helps to acquire the following: Long-term and short-term impact of Covid-19 on the market Cascading impact of Covid-19 on 3D Cell Culture Market, due to the impact on its extended ecosystem Understanding the market behavior Pre- and Post-COVID-19 pandemic Strategy suggestions to overcome the negative impact or turn the positive impact into an opportunity Well help you fight this crisis through our business intelligence solutions.

Pre COVID-19 Analysis of 3D Cell Culture Market

According to a study of Research Dive, global 3D Cell Culture market forecast shall cross $12,638.8 million by 2026, growing at a CAGR of 29.4 during forecast period.

3D Cell culture is an essential tool in clinical analysis and biological science. It has multiple applications such as in biosensors, drug screening and others. Many improvements have been made in automated high-throughput cell culture systems. Increasing demand for regenerative medicine and economic drug discovery is expected to drive the demand for the 3D cell culture market. 3D cell cultures are primarily used to observe the abnormal behavior of cells and the cell-cell interaction. Furthermore, 3D cell culture systems play a significant role in the development of precision medicine and personalized medicine. For instance, as per study of cancer researchers (University of Michigan) newly invented 3D structure could enable physicians to test medications on model tumors grown from a patients own cells. These advances are projected to boost the growth of global cell culture market. However, more complex culture system, added expenses and threats from substitutes like 2D cell cultures are projected to limit the 3D cell culture market growth.

With new advances, 3D composite scaffolds have many versatile properties. It will be tremendously useful to develop treatments for nerve disorders and spinal cord injury (SCI) by taking help of cell transplantation methodologies and biomaterials. The most remarkable advantage of 3D cell culture is, their properties can be easily adapted by modifying the structure and composition. These key factors of 3D cell culture are projected to create enormous opportunities for the growth of 3D cell culture industry.

According to Analyst Evaluation, Microchips market shall register a revenue of $2,515.5 million by the end of 2026, growing at a CAGR of 30.1% during the forecast period; this is significantly due to new advances in 3D culture organs-on-chips. Organs-on-chips allow study of human physiology and also reveal development of novel in vitro disease models. It could provide potential replacements for animals used in toxin testing and drug development. These advancements are anticipated to grow the demand of microchips in global market, and are projected to boost the global market. Scaffold-based platforms have the largest market share and this segment will register a revenue of $3,425.1 million by the end of 2026, growing at a CAGR of 28.4%. Scaffolds can be significantly used in drug development therapeutic or specialty areas; which is anticipated to fuel the of global market growth.

Based on applications, the market is segmented into Stem Cell research, drug discovery, cancer research, and regenerative medicine. 3D cell culture market size for cancer research will generate a revenue of $4,057.1 million by 2026, growing at a CAGR of 28.5% throughout the forecast period; this is majorly due to various types of cancers such as breast cancer, lung cancer and others being dominant among the population. Cancer has a pervasive prevalence across the globe, which has led to rise in demand for cancer research, which is further attributed to boost the demand for 3D cell culture market. 3D cell culture market for regenerative medicine will register a revenue of $3,690.5 million by 2026, growing at a CAGR of 30.1%. Many developed and developing countries such as Japan is focusing more on contract manufacturing tie-ups, and continues to be a lucrative place for biotech ventures to do business. Japan is the world leader in regenerative medical products; these key strategies of the government are anticipated to spur the growth of 3D cell culture market.

3D cell culture market for biotechnology & pharmaceutical companies will register a revenue of $5,184.4 million by 2026, growing at a CAGR of 28.9% during the forecast period; this is majorly due to huge developments in the laboratory, technology and operations. Furthermore, rising pressure on sales of established treatments, rapid growth of cell therapies and focus on advanced manufacturing and technologies are the factors expected to grow the market.

North America 3D Cell Culture market size will cross $4,019.1 million by 2026, increasing at a healthy CAGR of 28.1%.

Heavy investments in research & development, high healthcare expenditure, and extensively increasing number of cancer cases are considered to be one of the driving factors that are booming the growth of North American market.

3D Cell Culture market share for Asia-Pacific region is expected to rise at a CAGR of 30.7% by generating a revenue of $3,020.7 million by 2026. The market growth in the region is increasing drug discovery initiatives among pharmaceuticals and biotechnology companies in the region. Major economies such as India, Singapore, Japan and South Korea are emphasizing more on public sector openness to partnership with established companies. For instance, leading market players such as Bayer, GlaxoSmithKline and AstraZeneca are collaborating with Singapore partners across drug discovery.

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The major 3D Cell Culture manufacturers includeQGel SA, Hrel Corporation, SynVivo, Greiner Bio-One International, Advanced BioMatrix, Lonza, Corning Incorporated, Thermo Fisher Scientific, TissUse GmbH, 3D Biotek. Players using updated technologies for their 3D Cell Culture will have good probability of having success in the rapidly blooming market. For example, Lonza has innovated the RAFT 3D Culture System that produces hepatocytes with increased stability and stronger cytochrome responses.

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How COVID-19 Pandemic Will Impact on 3D Cell Culture Market Growth and Demand in 2020 and Coming Future? - The Daily Chronicle

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Researchers have found a way, in mice and human tissue, to regenerate the cartilage that eases movement between bones.

Loss of this slippery and shock-absorbing tissue layer, called articular cartilage, is responsible for many cases of joint pain and arthritis, which afflicts more than 55 million Americans.

The researchers can envision a time when people are able to avoid getting arthritis in the first place by rejuvenating their cartilage before it is badly degraded.

Nearly 1 in 4 adult Americans suffer from arthritis, and far more are burdened by joint pain and inflammation generally.

The researchers figured out how to regrow articular cartilage by first causing slight injury to the joint tissue, then using chemical signals to steer the growth of skeletal stem cells as the injuries heal.

Cartilage has practically zero regenerative potential in adulthood, so once its injured or gone, what we can do for patients has been very limited, says co-senior author Charles K.F. Chan, assistant professor of surgery at Stanford Universitys School of Medicine.

Its extremely gratifying to find a way to help the body regrow this important tissue, Chan says.

The work builds on previous research that resulted in isolation of the skeletal stem cell, a self-renewing cell that is also responsible for the production of bone, cartilage and a special type of cell that helps blood cells develop in bone marrow.

Articular cartilage is a complex and specialized tissue that provides a slick and bouncy cushion between bones at the joints. When this cartilage is damaged by trauma, disease, or simply thins with age, bones can rub directly against each other, causing pain and inflammation, which can eventually result in arthritis.

Damaged cartilage can be treated through a technique called microfracture, in which tiny holes are drilled in the surface of a joint. The microfracture technique prompts the body to create new tissue in the joint, but the new tissue is not much like cartilage.

I realized the only way to understand the process was to look at what stem cells are doing after microfracture.

Microfracture results in what is called fibrocartilage, which is really more like scar tissue than natural cartilage, says Chan. It covers the bone and is better than nothing, but it doesnt have the bounce and elasticity of natural cartilage, and it tends to degrade relatively quickly.

The most recent research arose, in part, through the work of surgeon and lead author Matthew Murphy, a visiting researcher at Stanford who is now at the University of Manchester.

I never felt anyone really understood how microfracture really worked, Murphy says. I realized the only way to understand the process was to look at what stem cells are doing after microfracture.

For a long time, Chan says, people assumed that adult cartilage did not regenerate after injury because the tissue did not have many skeletal stem cells that could be activated. Working in a mouse model, the team documented that microfracture did activate skeletal stem cells. Left to their own devices, however, those activated skeletal stem cells regenerated fibrocartilage in the joint.

But what if the healing process after microfracture could be steered toward development of cartilage and away from fibrocartilage?

The researchers knew that as bone develops, cells must first go through a cartilage stage before turning into bone. They had the idea that they might encourage the skeletal stem cells in the joint to start along a path toward becoming bone, but stop the process at the cartilage stage.

The researchers used a powerful molecule called bone morphogenetic protein 2 (BMP2) to initiate bone formation after microfracture, but then stopped the process midway with a molecule that blocked another signaling molecule important in bone formation, called vascular endothelial growth factor (VEGF).

What we ended up with was cartilage that is made of the same sort of cells as natural cartilage with comparable mechanical properties, unlike the fibrocartilage that we usually get, Chan says. It also restored mobility to osteoarthritic mice and significantly reduced their pain.

As a proof of principle that this might also work in humans, the researchers transferred human tissue into mice that were bred to not reject the tissue, and were able to show that human skeletal stem cells could be steered toward bone development but stopped at the cartilage stage.

The next stage of research is to conduct similar experiments in larger animals before starting human clinical trials. Murphy points out that because of the difficulty in working with very small mouse joints, there might be some improvements to the system they could make as they move into relatively larger joints.

The first human clinical trials might be for people who have arthritis in their fingers and toes. We might start with small joints, and if that works we would move up to larger joints like knees, Murphy says.

Right now, one of the most common surgeries for arthritis in the fingers is to have the bone at the base of the thumb taken out. In such cases we might try this to save the joint, and if it doesnt work we just take out the bone as we would have anyway. Theres a big potential for improvement, and the downside is that we would be back to where we were before.

One advantage of their discovery is that the main components of a potential therapy are approved as safe and effective by the FDA, says co-senior author Michael Longaker, professor of surgery.

BMP2 has already been approved for helping bone heal, and VEGF inhibitors are already used as anti-cancer therapies, he says. This would help speed the approval of any therapy we develop.

Joint replacement surgery has revolutionized how doctors treat arthritis and is very common: By age 80, 1 in 10 people will have a hip replacement and 1 in 20 will have a knee replaced. But such joint replacement is extremely invasive, has a limited lifespan and is performed only after arthritis hits and patients endure lasting pain.

The researchers say they can envision a time when people are able to avoid getting arthritis in the first place by rejuvenating their cartilage in their joints before it is badly degraded.

One idea is to follow a Jiffy Lube model of cartilage replenishment, Longaker says. You dont wait for damage to accumulateyou go in periodically and use this technique to boost your articular cartilage before you have a problem.

The work appears in the journal Nature Medicine.

Support for the research came from the National Institutes of Health, the California Institute for Regenerative Medicine, the Oak Foundation, the Pitch Johnson Fund, the Gunn/Olivier Research Fund, the Stinehart/Reed Foundation, The Siebel Foundation, the Howard Hughes Medical Institute, the German Research Foundation, the PSRF National Endowment, National Center for Research Resources, the Prostate Cancer Research Foundation, the American Federation of Aging Research, and the Arthritis National Research Foundation.

Source: Stanford University

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Method regrows cartilage to cushion bones - Futurity: Research News

More than 500 clinical trials are under way world-wide in the race to find an effective treatment for Covid-19. Everybody wants it; nobody has ityet. But one of the most promising therapies for Covid-19 patients uses medicinal signaling cells, or MSCs, which are found on blood vessels throughout the body.

In preliminary studies, these cells cut the death rate significantly, particularly in the sickest patients. With a powerful 1-2-3 punch, these cells eliminate the virus, calm the immune overreaction known as a cytokine storm, and repair damaged lung tissuea combination offered by no other drug. This type of regenerative medicine could be as revolutionary as Jonas Salks polio vaccine.

In one pilot study in March, doctors at Mount Sinai Hospital in New York treated a dozen severely ill Covid-19 patients on ventilators with MSCs. Two infusions modulated their hyperactive immune systems, and 83% of those patients survived. With such promising results, the team at Mount Sinai and the supplier of the cells, Mesoblast Ltd., won Food and Drug Administration clearance and National Institutes of Health funding to conduct a randomized trial on 300 patients. The first patients in the trial received the treatment in early May.

A July 10 article in the Lancet reported on 13 critically ill Covid-19 patients also treated with MSCs. Eleven of the 13 patients livedan 85% survival rate, which mirrors the results from Mount Sinai. The number of virus-fighting T-cells rose even as inflammation fell, suggesting that these cells can control the immune response as needed. In addition, chest X-rays showed that the drug repaired lung tissue, in some cases within 48 hours.

Healing tissue is essential because the cytokine battle with the Covid-19 virus is so vicious that it punches holes in the delicate lung membranes, allowing the virus to flood into the bloodstream and body cavities. These holes must be repaired, as virus leaks create some of the complications not usually associated with respiratory infectionsblood clotting, heart attacks, stroke and multiple organ failure, which cause about 40% of Covid-19-related deaths. Blood-vessel density, and thereby the number of MSCs, decreases as we age, gain weight or develop diseases, which may explain why the elderly and those with chronic health conditions are faring worst.

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The Treatment That Could Crush Covid - The Wall Street Journal

The global stem cell and regenerative medicines market should grow from $21.8 billion in 2019 to reach $55.0 billion by 2024 at a compound annual growth rate (CAGR) of 20.4% for the period of 2019-2024.

Report Scope:

The scope of this report is broad and covers various type of product available in the stem cell and regenerative medicines market and potential application sectors across various industries. The current report offers a detailed analysis of the stem cell and regenerative medicines market.

The report highlights the current and future market potential of stem cell and regenerative medicines and provides a detailed analysis of the competitive environment, recent development, merger and acquisition, drivers, restraints, and technology background in the market. The report also covers market projections through 2024.

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The report details market shares of stem cell and regenerative medicines based on products, application, and geography. Based on product the market is segmented into therapeutic products, cell banking, tools and reagents. The therapeutics products segments include cell therapy, tissue engineering and gene therapy. By application, the market is segmented into oncology, cardiovascular disorders, dermatology, orthopedic applications, central nervous system disorders, diabetes, others

The market is segmented by geography into the following regions: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The report presents detailed analyses of major countries such as the U.S., Canada, Mexico, Germany, the U.K. France, Japan, China and India. For market estimates, data is provided for 2018 as the base year, with forecasts for 2019 through 2024. Estimated values are based on product manufacturers total revenues. Projected and forecasted revenue values are in constant U.S. dollars, unadjusted for inflation.

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Report Includes:

28 data tables An overview of global markets for stem cell and regenerative medicines Analyses of global market trends, with data from 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024 Details of historic background and description of embryonic and adult stem cells Information on stem cell banking and stem cell research A look at the growing research & development activities in regenerative medicine Coverage of ethical issues in stem cell research & regulatory constraints on biopharmaceuticals Comprehensive company profiles of key players in the market, including Aldagen Inc., Caladrius Biosciences Inc., Daiichi Sankyo Co. Ltd., Gamida Cell Ltd. and Novartis AG

Summary

The global market for stem cell and regenerative medicines was valued at REDACTED billion in 2018. The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED to reach approximately REDACTED billion by 2024. Growth of the global market is attributed to the factors such as growingprevalence of cancer, technological advancement in product, growing adoption of novel therapeuticssuch as cell therapy, gene therapy in treatment of chronic diseases and increasing investment fromprivate players in cell-based therapies.

In the global market, North America held the highest market share in 2018. The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period. The growing government funding for regenerative medicines in research institutes along with the growing number of clinical trials based on cell-based therapy and investment in R&D activities is expected to supplement the growth of the stem cell and regenerative market in Asia-Pacific region during the forecast period.

Reasons for Doing This Study

Global stem cell and regenerative medicines market comprises of various products for novel therapeutics that are adopted across various applications. New advancement and product launches have influenced the stem cell and regenerative medicines market and it is expected to grow in the near future. The biopharmaceutical companies are investing significantly in cell-based therapeutics. The government organizations are funding research and development activities related to stem cell research. These factors are impacting the stem cell and regenerative medicines market positively and augmenting the demand of stem cell and regenerative therapy among different application segments. The market is impacted through adoption of stem cell therapy. The key players in the market are investing in development of innovative products. The stem cell therapy market is likely to grow during the forecast period owing to growing investment from private companies, increasing in regulatory approval of stem cell-based therapeutics for treatment of chronic diseases and growth in commercial applications of regenerative medicine.

Products based on stem cells do not yet form an established market, but unlike some other potential applications of bioscience, stem cell technology has already produced many significant products in important therapeutic areas. The potential scope of the stem cell market is now becoming clear, and it is appropriate to review the technology, see its current practical applications, evaluate the participating companies and look to its future.

The report provides the reader with a background on stem cell and regenerative therapy, analyzes the current factors influencing the market, provides decision-makers the tools that inform decisions about expansion and penetration in this market.

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Stem Cell And Regenerative Therapy Market Industry Outlook, Growth Prospects and Key Opportunities - Kentucky Journal 24

MIRAMAR, Fla., Aug. 13, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) is pleased to announce that physicians at Yale University School of Medicine and the VA Connecticut Healthcare System have published a paper in the Journal of Vascular Surgery Cases and Innovative Techniques describing the use of Excellagen wound conforming collagen matrix as part of a hybrid surgical protocol to repair a femoral artery pseudoaneurysm. Femoral artery pseudoaneurysms are the most common complication following cardiac and peripheral angiographic procedures, with an incidence ranging from 2-6% following interventional procedures. Apseudoaneurysm occurs when a blood vessel wall is injured and the leaking blood collects in the surrounding tissue. While small pseudoaneurysms (< 2 cm) often thrombose (clot) spontaneously, larger pseudoaneurysms involving blood sac expansion, vascular symptoms, and surrounding hematoma confer a risk of rupture and warrant surgical intervention to prevent serious complications including death.

Naiem Nassiri, MD of Yale University School of Medicine commented, Excellagens purity, versatility, and user-friendly application render it ideal for a diverse array of indications for collagen delivery in vascular surgery. For us to date, these have included, but are not limited to re-explored wounds; topical hemostatic agent by virtue of dead space elimination and granulation tissue formation; a regular adjunct to negative pressure dressings; a precursor to skin grafting; and topical applications in cosmetically sensitive areas following embolotherapeutic procedures.

Rapid healing of the vascular surgical repair site is needed to prevent recurrence or progression of the pseudoaneurysm. Using Excellagen from Generexs subsidiary, Olaregen Therapeutix, the surgeons at Yale and the Connecticut VA demonstrated a simple, safe and effective approach to pseudoaneurysm repair. The novel hybrid technique avoided surgical exploration in the face of active hemorrhage, expedited culprit vessel identification, avoided the need for remote percutaneous arterial puncture, reduced blood loss, and minimized overall operative time.

Excellagen is a ready to use 3-dimensional wound conforming matrix that supports a favorable wound healing environment. It is designed to activate collagen, accelerate granulation, and promote new tissue growth by providing a structural scaffold for cellular migration and proliferation. Excellagen has been shown to trigger the localized release of endogenous growth factors including Platelet-Derived Growth Factor (PDGF), a key biological mediator of wound healing.

Anthony Dolisi, CEO of Olaregen commented, We have been working closely with the VA system using case studies to evaluate the use of Excellagen in numerous wound management applications, including diabetic foot ulcers and vascular surgery procedures. As this peer-reviewed publication demonstrates, Excellagen can be used successfully in complex vascular surgeries like pseudoaneurysm repair to promote healing that lead to better patient outcomes. We look forward to engaging with the VA and the vascular surgery community to introduce our FDA-cleared cellular tissue product Excellagen into their surgical protocols for the benefit of patients with life-threatening conditions.

About Generex Biotechnology Corp. Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

In addition to advancing a legacy portfolio of immune-oncology assets, medical devices, and diagnostics, the Company is focused on an acquisition strategy of strategic businesses that complement existing assets and provide immediate sources of revenue and working capital.

About Olaregen Therapeutics

Olaregen Therapeutix, Inc. is a regenerative medicine company focused on the development, manufacturing and commercialization of products that fill unmet needs in the current wound care market. The company aims to provide advanced healing solutions that substantially improve medical outcomes while lowering the overall cost of care. Olaregen's first product introduction, Excellagen (flowable dermal matrix) is a topically applied product for dermal wounds and other indications. Excellagen is a FDA 510K cleared device for a broad array of dermal wounds, including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/ grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds, enabling Olaregen to market Excellagen in multiple vertical markets. in bone and joint regeneration comprise the current pipeline. The company's mission is to become a significant force in regenerative medicine and advance the science of healing.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato 646-599-6222

Todd Falls 1-800-391-6755 Extension 222 investor@generex.com

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Generex Biotechnology Subsidiary Olaregen Therapeutix Announces Publication on the Use of Excellagen for Vascular Repair - GlobeNewswire

New Jersey, United States,- Verified Market Researchhas recently published an extensive report on the Regenerative Medicine Market to its ever-expanding research database. The report provides an in-depth analysis of the market size, growth, and share of the Regenerative Medicine Market and the leading companies associated with it. The report also discusses technologies, product developments, key trends, market drivers and restraints, challenges, and opportunities. It provides an accurate forecast until 2027. The research report is examined and validated by industry professionals and experts.

The report also explores the impact of the COVID-19 pandemic on the segments of the Regenerative Medicine market and its global scenario. The report analyzes the changing dynamics of the market owing to the pandemic and subsequent regulatory policies and social restrictions. The report also analyses the present and future impact of the pandemic and provides an insight into the post-COVID-19 scenario of the market.

Global Regenerative Medicine Market was valued at USD 24.96 billion in 2019 and is projected to reach USD 121.01 billion by 2027, growing at a CAGR of 23.54% from 2020 to 2027.

The report further studies potential alliances such as mergers, acquisitions, joint ventures, product launches, collaborations, and partnerships of the key players and new entrants. The report also studies any development in products, R&D advancements, manufacturing updates, and product research undertaken by the companies.

Leading Key players of Regenerative Medicine Market are:

Competitive Landscape of the Regenerative Medicine Market:

The market for the Regenerative Medicine industry is extremely competitive, with several major players and small scale industries. Adoption of advanced technology and development in production are expected to play a vital role in the growth of the industry. The report also covers their mergers and acquisitions, collaborations, joint ventures, partnerships, product launches, and agreements undertaken in order to gain a substantial market size and a global position.

Regenerative Medicine Market, By Product:

1.1 Overview1.2 Cell-Based Products1.2.1 Allogeneic Products1.2.2 Autologous Products1.3 Acellular Products

Regenerative Medicine Market, By Therapy:

2.1 Overview2.2 Tissue Engineering2.3 Immunotherapy2.4 Gene Therapy2.5 Cell Therapy2.6 Others

Regenerative Medicine Market, By Application:

3.1 Overview3.2 Central Nervous System Diseases3.3 Oncology3.4 Diabetes3.5 Orthopedic & Musculoskeletal Disorders3.6 Dermatology3.7 Cardiology3.8 Others

Regional Analysis of Regenerative Medicine Market:

A brief overview of the regional landscape:

From a geographical perspective, the Regenerative Medicine Market is partitioned into

North Americao U.S.o Canadao MexicoEuropeo Germanyo UKo Franceo Rest of EuropeAsia Pacifico Chinao Japano Indiao Rest of Asia PacificRest of the World

Key coverage of the report:

Other important inclusions in Regenerative Medicine Market:

About us:

Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

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Regenerative Medicine Market Size by Top Companies, Regions, Types and Application, End Users and Forecast to 2027 - Bulletin Line

HONG KONG Singapore-based Tessa Therapeutics Pte. Ltd. released the results of two investigator-initiated phase I/II trials that found its autologous CD30 CAR T-cell therapy TT-11 showed a high rate of durable complete responses and a favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma.

The studies, funded by Tessa, were led by researchers at the Baylor College of Medicine and the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center.

The trials enrolled 41 adult patients who received CD30 CAR T-cell therapy following lymphodepletion with chemotherapy. The overall response rate in the 32 patients with active disease who received fludarabine-based lymphodepletion was 72%, including 19 patients (59%) with complete responses.

Among those who participated in the studies, 94% were still alive a year after treatment and 61% of those who had a complete response also reported no evidence of recurrence a year later.

None of the patients experienced complications that have been seen with several CD19 CAR T cell trials. The results have been published in the Journal of Clinical Oncology.

These data are significant, as they demonstrate that CAR T-cell therapy may be a safe and effective treatment option for patients with Hodgkin lymphoma and potentially other lymphomas expressing the CD30 antigen, said Natalie Grover, study co-first author, assistant professor in the UNC Department of Medicine and a UNC Lineberger member.

The highest dose treatment led to the complete disappearance of tumors in the majority of patients, and almost all subjects had clinical benefit. As such, we believe further study of this treatment approach is warranted, said Carlos Ramos, study co-first author, professor at the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston Methodist Hospital and Texas Childrens Hospital.

Expanded testing to come

Ivan Horak, Tessas president of R&D, told BioWorld that the company plans to further explore the results in a Tessa-sponsored regulatory phase II trial, which it aims to initiate this year. The TT-11 trial would be conducted out of 22-plus sites in U.S. and Europe, he said.

The companys clinical trial partners include institutions in the U.S. such as MD Anderson, Baylor College of Medicine, Stanford Cancer Institute, City of Hope National Medical Center, UCSF Medical Center and Baylor Scott & White Health, as well as other centers in Massachusetts, Texas and California.

The University of North Carolina has granted Tessa an exclusive license to its patents, data and know-how, while Baylor College of Medicine has granted Tessa the rights to use its data and know-how, for the further development and commercialization of this therapy. Tessa declined to speak on the financial arrangements given confidentiality considerations.

Tessa's pipeline currently has four IND-approved clinical trials, covering the evaluation of TT-11 in Hodgkins lymphoma the companys lead program, which has a regenerative medicine advanced therapy designation and non-Hodgkin lymphomas, as well as trials for TT-11X and TT-16. It also has one preclinical program for a candidate known as TT-20X, which will explore allogeneic dual CAR Epstein-Bar virus-specific T cells in solid tumors. The company also plans to test TT-11 (HL) in pediatric patients, Horak said.

TT-11X, the companys allogeneic candidate, combines the properties of CD30-CAR and virus specific T-cells (VSTs) in an allogeneic setting. VSTs can be used for allogeneic application without T-cell antigen receptor (TCR) deletion or other genetic modifications, with a minimal risk of graft rejection, Horak said. CD30-CAR as a target has shown strong efficacy in Hodgkin lymphoma and further increases the persistence and expansion of VST cells, he said.

TT-16 is in an upcoming investigator-initiated phase I trial in HER2-positive solid tumors. The FDA has approved the trial to commence at Baylor College of Medicine.

Tessa also is building an in-house 90,000-square-foot GMP facility, which will be one of the companys commercial-scale cell therapy manufacturing facilities in Asia.

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Tessa enjoys positive results from two phase I/II trials of CD30 CAR T-cell therapy - BioWorld Online

With this research service, our Transformational Health team provides critical insights into the global biologics industry highlighting the growth opportunities, market revenue segmentation, and technology trends influencing its growth.

New York, Aug. 11, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Curative Oncology and Rare Disease Therapies Transforming the Global Biologics Market, 20202024" - https://www.reportlinker.com/p05950884/?utm_source=GNW The global biologics market covered in this study includes 4 major segments antibody therapies, recombinant proteins, vaccines, and regenerative medicine.

The forecast for the global biologics market till 2024 reveals interesting trend and paradigm shifts that are set to take place in the industry. Importantly, the study also identifies actionable growth opportunities for industry participants to profit upon.This research service identifies the largest revenue-generating segments and key therapeutic areas for the global biologics industry. Accelerated regulatory approvals for biologic products and the emergence of next-generation technologies are highlighted, in addition to their influence on market trends during the forecast period. The study highlights the dynamics of the biologics industry and the sub-segments of the biologics market. Growth opportunities in antibody-drug conjugate (ADC), RNA therapy, and gene therapy platforms are also explored. Further, the study discusses the impact (such as the accelerated development of vaccines) of the COVID-19 pandemic on the biologics industry and the market. Current challenges facing the biologics industry such as the sluggish growth rate of vaccines, and recombinant proteins are discussed. Most importantly, this research service discusses possible future market trends such as the accelerated development of mRNA-based vaccines and the increasing importance of specialty bio-CDMOs for the development and commercialization of regenerative medicine. Based on the market trends and revenue forecasts, our group of analysts highlight key growth opportunities in ADC, RNA, and gene therapy platforms through successful drug launches such as Belantamab Malfodotin, Inclisiran, and Zolgensma.Read the full report: https://www.reportlinker.com/p05950884/?utm_source=GNW

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

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Curative Oncology and Rare Disease Therapies Transforming the Global Biologics Market, 20202024 - Yahoo Finance

DUBLIN, Aug. 11, 2020 /PRNewswire/ -- The "Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report" report has been added to ResearchAndMarkets.com's offering.

Since the discovery of induced pluripotent stem cells (iPSCs) a large and thriving research product market has grown into existence, largely because the cells are non-controversial and can be generated directly from adult cells. It is clear that iPSCs represent a lucrative market segment because methods for commercializing this cell type are expanding every year and clinical studies investigating iPSCs are swelling in number.

Therapeutic applications of iPSCs have surged in recent years. 2013 was a landmark year in Japan because it saw the first cellular therapy involving the transplant of iPSCs into humans initiated at the RIKEN Center in Kobe, Japan. Led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB), it investigated the safety of iPSC-derived cell sheets in patients with macular degeneration. In another world-first, Cynata Therapeutics received approval in 2016 to launch the world's first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD. Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its off-the-shelf iPSC-derived CAR-T cell product candidate. Numerous physician-led studies using iPSCs are also underway in Japan, a leading country for basic and applied iPSC applications.

iPS Cell Commercialization

Methods of commercializing induced pluripotent stem cells (iPSCs) are diverse and continue to expand. iPSC cell applications include, but are not limited to:

Since the discovery of iPSC technology in 2006, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified and explained, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated. The main objectives of this report are to describe the current status of iPSC research, patents, funding events, industry partnerships, biomedical applications, technologies, and clinical trials for the development of iPSC-based therapeutics.

Key Topics Covered:

1. Report Overview

2. Introduction

3. History of Induced Pluripotent Stem Cells (IPSCS)

4. Research Publications on IPSCS

5. IPSCS: Patent Landscape

6. Clinical Trials Involving IPSCS

7. Funding for IPSC

8. Generation of Induced Pluripotent Stem Cells: An Overview

9. Human IPSC Banking

10. Biomedical Applications of IPSCS

11. Other Novel Applications of IPSCS

12. Deals in the IPSCS Sector

13. Market Overview

14. Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/kpc95y

About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Opportunities in the Global Induced Pluripotent Stem Cell (iPS Cell) Industry - PRNewswire

- StrataGraft Skin Tissue, If Approved, Could Reduce or Eliminate the Need for Autografting of Healthy Skin to Treat Burn Wounds -

STAINES-UPON-THAMES, United Kingdom, Aug. 10, 2020 /PRNewswire/ --Mallinckrodt plc(NYSE: MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Stratatech Biologics License Application (BLA) for StrataGraft, an investigational regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The FDA granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) target date ofFebruary 2, 2021.

Autograft, the current standard of care for deep partial-thickness thermal burns, involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, leaving the patient with more wounded areas requiring care. Each year, approximately 40,000 patients in the U.S. require hospitalization for the treatment of severe burns.1 The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), expressed interest in StrataGraft skin tissue asa medical countermeasure in response to large-scale burn incidents, and provided funding and technical support for the continued development of StrataGraft skin tissue.

"Treatment advances are needed that can help minimize or eliminate the need for autografting. The FDA's acceptance of the BLA submission for StrataGraft skin tissue for review takes us one step closer to providing adult burn patients in the United States with a potential new treatment option for deep partial-thickness thermal burns," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We are focused on delivering solutions to patients with severe and critical conditions, and look forward to working with the FDA during the regulatory review process for StrataGraft skin tissue."

The StrataGraft skin tissue BLA is based on data from the pivotal Phase 3 STRATA2016clinical trial, previously publishedas an abstract in the Journal of Burn Care & Research and presented via a prerecorded video at the virtual American Burn Association 52nd Annual Meeting, with support from the STRATA2011clinical trial, previously published in Burns. Top-line results from the Phase 3 trial of StrataGraft skin tissue, which met both primary endpoints in adults with deep partial-thickness thermal burns, including autograft sparing and durable wound closure, were announcedin September 2019.

The completion of the BLA rolling submission was announcedon June 9, 2020. The FDA granted StrataGraft skintissue orphan drug designation, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act.

About StrataGraft StrataGraft regenerative skin tissue is an investigational treatment being developed to reduce autograft in patients with severe thermal burns. An engineered, bilayer tissue, StrataGraft skin tissue is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. StrataGraft skin tissue can be sutured, stapled or secured with an adhesive. StrataGraft skin tissue is cryopreserved in order to deliver viable cells upon application.

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Mallinckrodt is currently conducting a StrataGraft skin tissue continued access clinical trial (StrataCAT, NCT04123548) under an Expanded Access Program (EAP). The trial sites involved in the pivotal Phase 3 trial (STRATA2016, NCT03005106) have the opportunity to participate in this multicenter, open-label study. The company is planning to evaluate StrataGraftskintissue for the treatment of adults with full-thickness burns (also referred to as third-degree burns). Additionally, Mallinckrodt plans to conduct a study evaluating StrataGraft skin tissue in treatment of pediatric populations.

StrataGraft skintissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.

The continued development of StrataGraft skin tissue, including the pivotal Phase 3 clinical study (STRATA2016) and the BLA process for StrataGraft skin tissue in the United States, is being supported through a partnership with BARDA, under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under Project BioShield Contract No. HHSO100201500027C. These efforts are part of BARDA's strategy to build emergency preparedness in response to mass casualty events involving trauma and thermal burns by developing novel medical countermeasures for adult and at-risk populations. In the case of a mass casualty thermal burn event, the Government Accountability Office estimates that more than 10,000 patients might require thermal burn care.2The limited number of specialized burn centers and related medical infrastructure in the United States creates a public health need for therapies that could be deployed quickly for use in these and other care sites.

About Deep Partial-Thickness Thermal BurnsDeep partial-thickness thermal burns are complex skin injuries in which the damage extends through the entire epidermis (outermost layer of skin) and into the lower part of the dermis (innermost layer of skin).

Autograft is considered to be a standard of care by many for deep partial-thickness thermal burns. It involves the surgical harvesting of healthy skin tissue from an uninjured site on the patient and transplanting the skin graft to the injury. While this process can be effective in providing closure of the original wound, it has significant limitations related to the donor site wounds created during surgical removal of the skin tissue for grafting. Donor site wounds are painful and can create risks of additional scarring and infection. In addition, the amount of healthy skin available for harvesting is frequently limited in those patients with large burns, necessitating sequential re-harvesting of available donor sites. As a result, there is a need for alternatives to donor site harvesting for the treatment of severe burns.

About Mallinckrodt Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit http://www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

Cautionary Statements Related to Forward-Looking StatementsThis release includes forward-looking statements concerning StrataGraft regenerative skin tissue, including the anticipated regulatory review process, its potential impact on patients, and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACTS

For Trade Media InquiriesSheryl SeapyW2O 213-262-9390sseapy@w2ogroup.com

For Financial/Dailies Media InquiriesRon BartlettH+K Strategies Senior Vice President813 545 2399ron.bartlett@hkstrategies.com

Investor Relations Daniel J. SpecialeVice President, Investor Relations and IRO314-654-3638daniel.speciale@mnk.com

Government AffairsMark TyndallSenior Vice President, Government Affairs & Chief Counsel, Litigation202-459-4141mark.tyndall@mnk.com

Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.

2020 Mallinckrodt. US-2001226 07/20.

________________________1 American Burn Association. Burn Incidence Fact Sheet. http://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/. Accessed May 15, 2020.2 United States Government Accountability Office. National Preparedness: Countermeasures for Thermal Burns. https://www.gao.gov/assets/590/588738.pdf. Accessed February 12, 2020.

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SOURCE Mallinckrodt plc

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Mallinckrodt Announces U.S. FDA Filing Acceptance of Biologics License Application for StrataGraft Regenerative Skin Tissue for Treatment of Adults...

The U.S. government bought 100 million doses of mRNA-1273 from Moderna Inc., of Cambridge, Mass., with a new award worth up to $1.525 billion. The deal, part of Operation Warp Speed, also brings a U.S. government option to buy up to an additional 400 million doses from Moderna. The implied price per dose is about $15.25, below SVB Leerinks $22 price per dose model from previous Moderna-Operation Warp Speed deals. On July 27, Moderna dosed the first of what could be as many as 30,000 healthy volunteers as it began its phase III COVID-19 vaccine trial. Those volunteers at increased risk of contracting COVID-19, with a large percentage being elderly or people with co-morbidities those most at risk for life-threatening COVID-19 infections are receiving placebo or mRNA-1273.

Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the infections themselves, theres one point of agreement: the pandemic has been a painful experience that everyone needs to learn from. Im hoping that memory is not short, Mike Piccarreta, a partner at global consulting firm Kearney, told BioWorld. Clearly we were not prepared for this type of pandemic in terms of government response and manufacturing capacity, he added. Had the U.S. and other countries acted on lessons that should have been learned in the past, they would have been better prepared for COVID. And if they allow the current lessons to fade with time, they will not be ready for the next pandemic.

LONDON Antifungal specialist F2G Ltd. has closed a $60.8 million round, providing the means to complete phase III development of the lead product olorofim, a treatment for life-threatening invasive infections, and to scale up in preparation for commercialization. Olorofim is the first of a new class of drugs called orotomides, discovered and developed to phase IIb by F2G. If approved, it will be the first new antifungal based on a novel mechanism in nearly 20 years.

A bid by top shareholders and managers of the U.S.-China cell therapy developer Cellular Biomedicine Group Inc. to take the company private pushed shares (NASDAQ:CBMG) 35% higher Wednesday, just shy of the offering price. "As a private company, we will have access to the resources and long-term commitment needed to better pursue new capital investment in existing assets and targeted acquisition opportunities as our sector continues to evolve, including further geographic and product diversification," CBMG's CEO Tony Liu told employees.

As part of its earnings report earlier this week, Reata Pharmaceuticals Inc. provided a regulatory update that caused some chagrin among investors. The company said the FDA is not convinced that the Moxie Part 2 results will support a single study approval without additional evidence that lends persuasiveness to the results. A phase II study with omaveloxolone for Friedreichs ataxia, Moxie Part 2 had gained the agencys sign-off regarding its primary endpoint; improvement on the modified Friedreich Ataxia Rating Scale. Reata said an NDA submission is now targeted for the first quarter of next year, assuming regulators accept the trial design of the companys planned crossover study. The company provided more encouraging news about the progress of bardoxolone in Alport syndrome. Shares (NASDAQ:RETA) took a hit Monday, dropping from $156.20 to $105.40, and were trading midday at $103.09.

Newly founded Lianbio, with offices in Shanghai and San Francisco, aims to quickly establish a presence in China and Asia with late-stage assets in-licensed from Bridgebio Pharma Inc. and Myokardia Inc. in two deals amounting to $531.5 million and $187.5 million, respectively. Launched on Aug. 11, Lianbio was founded, seeded and incubated by hedge fund Perceptive Advisors with the aim of bringing in first-in-class drugs. Perceptive will help the startup pick assets that have a good chance of becoming clinically successful.

PERTH, Australia Aussie regenerative medicine company Regeneus Ltd. has out-licensed its lead mesenchymal stem cell and secretome therapy, Progenza, to Japans Kyocera Corp. for osteoarthritis of the knee for the Japan market. Under the terms of the deal, Regeneus will receive $19 million in up-front and milestone payments, consisting of $9 million up front and $10 million in regulatory and development milestones. Regeneus will also receive double-digit royalties on sales. The company retains rights to negotiate licenses with other partners for additional indications inside and outside of Japan.

HONG KONG Singapore-based Tessa Therapeutics Pte Ltd. released the results of two independent phase I/II trials led by Baylor College of Medicine and the University of North Carolina Lineberger Comprehensive Cancer Center. It was found that Tessas autologous CD30 CAR T-cell therapy (TT-11) showed a high rate of durable complete responses and a very favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma.

Adverum, Akari, Arca, Ascendis, Azurrx, Beroni, Blade, Boehringer Ingelheim,Botanix, Cellular Biomedicine, Cytovia, Eli Lilly, Eloxx, Epirium, Eyegate, Genscript, Helix, Hepion, Horizon, Ikena Oncology, India Globalization Capital, Inhibrx, Innovent, Kahr Medical, Kineta, Monopar, Nektar, Nicox, Nymox, Omeros, PDL, Pliant, Redhill, Regeneron, Sapience, Seattle Genetics, Seres, Theranexus, Therapeutic Solutions, Trevena, Vaccibody, VBL

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Moderna receives $1.525B more in COVID-19 funding from Operation Warp Speed - BioWorld Online

A new intelligence report Advanced Wound Management Technologies Market has been recently added to Adroit Market Research collection of top-line market research reports. Global Advanced Wound Management Technologies Market report is a meticulous all-inclusive analysis of the market that offers access to direct first-hand insights on the growth trail of market in near term and long term. On the basis of factual information sourced from authentic industry experts and extensive primary industry research, the report offers insights on the historic growth pattern of Advanced Wound Management Technologies Market and current market scenario. It then provides short- and long-term market growth projections.

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Some of the major companies operating in the global advanced wound management technologies market are 3M, Bard Medical Division, Coloplast A/S, Derma Sciences Inc., Hartmann Group, Shire Regenerative Medicine and Baxter International Inc. In addition, some other companies operating in global advanced wound management technologies market are Ethicon Inc., Smith & Nephew Plc, Convatec Inc. and Genzyme Corporation, a Sanofi company.

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Advanced Wound Management Technologies Market Table of Contents

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Advanced Wound Management Technologies Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2015 2021 - Jewish Life News

A recent stem cell study has shown that SARS-CoV-2, the novel coronavirus, can infect heart cells via the same receptor present in the lungs. This may be responsible for the cardiac complications associated with COVID-19.

Experts initially thought that COVID-19 was a respiratory disease, with symptoms including cough, shortness of breath, and pneumonia. However, more recent evidence into COVID-19 shows that the disease can also cause neurological and cardiac symptoms.

Physicians have reported changes to the circulatory system in people with COVID-19, sometimes leading to blood clots, as well as cardiac complications, such as changes to the heart rhythm, damage to heart tissue, and heart attacks.

Although there is widespread agreement that COVID-19 is a risk to the heart, whether these symptoms are due to the virus directly or a consequence of other disease processes, such as inflammation, has been unclear.

Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.

In a new study appearing in the journal Cell Reports Medicine, scientists have helped resolve this mystery by showing that SARS-CoV-2 can infect heart cells and change their function.

Their findings, from experiments in human stem cells, suggest that the cardiac symptoms of COVID-19 may be the direct result of the infection of heart tissue.

The scientists used a type of stem cell called induced pluripotent stem cells (iPSCs) to generate heart cells.

Scientists can create iPSCs from a persons skin cells and then reprogram them to become any cell type in the body. They provide a useful tool for research into human disease and a way to test new treatments.

In this study, the team programmed the iPSCs to become heart cells and later incubated them with SARS-CoV-2. Using microscopes and genetic sequencing techniques, the researchers found that SARS-CoV-2 could directly infect the heart cells.

They also showed that the virus can rapidly divide inside heart cells, which caused changes to the hearts ability to beat after a period of under 3 days.

We not only uncovered that these stem cell-derived heart cells are susceptible to infection by [the] novel coronavirus, but that the virus can also quickly divide within the heart muscle cells, explains first study author Dr. Arun Sharma, a research fellow at the Regenerative Medicine Institute of Cedars-Sinai Medical Center in Los Angeles, CA.

Additional experiments focused on the different genes expressed by heart cells before and after the virus infected them. These studies showed activation of the innate immune response and antiviral clearance pathways to help fight the virus.

However, how does the virus get into the heart in the first place? The researchers suggest that one way in which it gains access may be by using angiotensin-converting enzyme 2 (ACE2). This is the same receptor the virus uses to infect cells in the lungs.

Importantly, studies have shown that treatment with an ACE2 antibody can help stop SARS-CoV-2 from replicating and save cells in the heart.

By blocking the ACE2 protein with an antibody, the virus is not as easily able to bind to the ACE2 protein, and thus cannot easily enter the cell. This not only helps us understand the mechanisms of how this virus functions, but also suggests therapeutic approaches that could be used as a potential treatment for SARS-CoV-2 infection.

Dr. Arun Sharma

The researchers suggest that scientists could use stem cell-derived heart cells to screen new drugs and find compounds able to stop the infection of heart cells.

This key experimental system could be useful to understand the differences in disease processes of related coronaviral pathogens SARS and MERS, adds study author Dr. Vaithilingaraja Arumugaswami, an associate professor at the University of California, Los Angeles.

There are some limitations to this approach, however. These include the fact that stem cell-derived heart cells are not exactly the same as the real thing.

The researchers also studied the cells in a dish, an isolated system lacking the immune interactions that would occur in the human body.

Nevertheless, the experiments clearly showed that the cells became infected with SARS-CoV-2, which is in line with some clinical data showing the virus in the hearts of people who died from COVID-19.

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

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COVID-19 could directly affect the heart - Medical News Today