Monthly Archives: June 2022

Wilmington, Delaware, United States: According to Transparency Market Researchs latest report on the global regenerative medicine market for the historical period 20172018 and forecast period 20212028, increase in demand for customized regenerative medicine is projected to drive the global regenerative medicine market during the forecast period

Rise in Prevalence of Chronic Diseases, Genetic Disorders, and Cancer: Key Driver

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Key Players Increased Investment in Research & Development of Regenerative Medicine

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Costly Treatment Associated with Regenerative Medicine

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Regenerative Medicine Market: Competition Landscape

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Regenerative Medicine Market to Reach US$ 12.9 Bn by 2028, Increase in Demand for Customized Regenerative Medicine to Drive the Market - BioSpace

SOUTH SAN FRANCISCO, Calif., June 08, 2022 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in relapsed/refractory LBCL. The RMAT designation was based on the potential of ALLO-501A to address the unmet need for patients who have failed other therapies.

The designation for ALLO-501A supports the patient need for access to an off-the-shelf CAR T product that can be delivered faster, more reliably, and at greater scale, said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. Patients who are eligible for autologous CAR T therapy are often faced with treatment delays and manufacturing failures, placing them at risk for disease progression and disease-related complications. We look forward to initiating our pivotal trial on ALLO-501A and making this innovative product candidate readily available to patients.

Results from the ALPHA2 study were presented at an oral session of the American Society of Hematology (ASH) annual meeting in December 2021. Data support the potential of ALLO-501A to provide a safe and durable alternative to approved autologous CAR T therapies in CAR T nave patients.

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation. An investigational cell therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with FDA that may be used to discuss potential surrogate or intermediate endpoints and potential ways to satisfy post approval requirements.

About Allogene TherapeuticsAllogene Therapeutics, with headquarters inSouth San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visitwww.allogene.comand follow @AllogeneTx on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements for AllogeneThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as predicts, believes, potential, proposed, 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. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to progress the ALPHA2 trial of ALLO-501A, including initiating a pivotal clinical trial of ALLO-501A, which remains subject to further patient follow-up and discussions with the U.S. Food and Drug Administration; the ability to commercialize ALLO-501A; clinical outcomes, which may materially change as patient enrollment continues and more patient data become available; and the potential benefits of AlloCAR T. Various factors may cause differences between Allogenes expectations and actual results as discussed in greater detail in Allogenes filings with theSEC, including without limitation in its Form 10-Q for the quarter endedMarch 31, 2022. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

AlloCAR T is a trademark of Allogene Therapeutics, Inc.

Allogenes AlloCAR T programs utilize Cellectis technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S. while Servier retains exclusive rights for all other countries.

Allogene Media/Investor Contact:Christine CassianoChief Communications Officer(714) 552-0326Christine.Cassiano@allogene.com

Source: Allogene Therapeutics, Inc.

Read more from the original source:
Allogene Therapeutics Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) Designation to ALLO-501A for Large B Cell Lymphoma -...

China Regenerative Medicine International (HKG:8158) has had a rough three months with its share price down 12%. But if you pay close attention, you might gather that its strong financials could mean that the stock could potentially see an increase in value in the long-term, given how markets usually reward companies with good financial health. Specifically, we decided to study China Regenerative Medicine International's ROE in this article.

Return on equity or ROE is an important factor to be considered by a shareholder because it tells them how effectively their capital is being reinvested. Put another way, it reveals the company's success at turning shareholder investments into profits.

See our latest analysis for China Regenerative Medicine International

Return on equity can be calculated by using the formula:

Return on Equity = Net Profit (from continuing operations) Shareholders' Equity

So, based on the above formula, the ROE for China Regenerative Medicine International is:

44% = HK$49m HK$112m (Based on the trailing twelve months to March 2022).

The 'return' is the profit over the last twelve months. So, this means that for every HK$1 of its shareholder's investments, the company generates a profit of HK$0.44.

Thus far, we have learned that ROE measures how efficiently a company is generating its profits. We now need to evaluate how much profit the company reinvests or "retains" for future growth which then gives us an idea about the growth potential of the company. Assuming everything else remains unchanged, the higher the ROE and profit retention, the higher the growth rate of a company compared to companies that don't necessarily bear these characteristics.

First thing first, we like that China Regenerative Medicine International has an impressive ROE. Additionally, the company's ROE is higher compared to the industry average of 8.1% which is quite remarkable. This likely paved the way for the modest 17% net income growth seen by China Regenerative Medicine International over the past five years. growth

Next, on comparing with the industry net income growth, we found that China Regenerative Medicine International's growth is quite high when compared to the industry average growth of 12% in the same period, which is great to see.

Earnings growth is an important metric to consider when valuing a stock. The investor should try to establish if the expected growth or decline in earnings, whichever the case may be, is priced in. Doing so will help them establish if the stock's future looks promising or ominous. One good indicator of expected earnings growth is the P/E ratio which determines the price the market is willing to pay for a stock based on its earnings prospects. So, you may want to check if China Regenerative Medicine International is trading on a high P/E or a low P/E, relative to its industry.

China Regenerative Medicine International doesn't pay any dividend, meaning that all of its profits are being reinvested in the business, which explains the fair bit of earnings growth the company has seen.

In total, we are pretty happy with China Regenerative Medicine International's performance. Specifically, we like that the company is reinvesting a huge chunk of its profits at a high rate of return. This of course has caused the company to see substantial growth in its earnings. If the company continues to grow its earnings the way it has, that could have a positive impact on its share price given how earnings per share influence long-term share prices. Remember, the price of a stock is also dependent on the perceived risk. Therefore investors must keep themselves informed about the risks involved before investing in any company. Our risks dashboard would have the 2 risks we have identified for China Regenerative Medicine International.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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Declining Stock and Solid Fundamentals: Is The Market Wrong About China Regenerative Medicine International Limited (HKG:8158)? - Simply Wall St

DUBLIN, June 10, 2022 /PRNewswire/ -- The "Global Medical Collagen Market 2022-2028" report has been added to ResearchAndMarkets.com's offering.

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The global medical collagen market indicates that it would register growth at a CAGR of 6.57% in the projected years from 2022 to 2028.

The growing public awareness about the benefits of collagen is a key factor fuelling the growth of the market. Besides, the rising demand for collagen from the medical devices industry is also aiding the market's growth. However, certain health-related issues that may occur as a result of collagen usage and a section of the population restricting the use of animal-derived products pose a challenge to this growth.

On the other hand, there is still a large demand for collagen-rich food & beverages from people across the globe, which presents a growth opportunity for the market. Moreover, the growth of the cosmetics industry also indicates the vast potential for market growth as collagen is used substantially in many of these products.

The global market for medical collagen covers North America, Europe, the Middle East and Africa, Latin America, and the Asia-Pacific.

North America was the leading market globally in 2021, and is estimated to continue its reign until the end of the forecast period. It is known for being a developed region in all aspects. Further, the people here are also becoming significantly aware and conscious about their health. This has led to an increased demand for collagen-based products among people in the US and Canada. Consumers are including collagen in their diet in the form of food, drinks, and supplements. These factors are contributing to the growth of the regional market.

The noteworthy players profiled in the medical collagen market are Lapi Gelatine, Symatese, Integra Life Sciences, Collagen Matrix Inc, DSM, Nippi Inc, Connoils LLC, Gelita, Jellagen, Stryker, Italgel, Darling Ingredients Inc, Tessenderlo Group, Weishardt, and Nitta Gelatin Inc.

Integra Life Sciences is a renowned industry leader in the field of medical technology. Some of its famous brands include MatriStem UBMT, Integra, MediHoney, and ICP Express, among others. The US-based company was founded in 1989 and is headquartered in Princeton, New Jersey. In FY 2020, Integra's revenue and total assets increased in the fourth quarter. In Jan 2021, Integra Life Sciences acquired the regenerative medicine company Acell Inc. Post this acquisition, the company has been serving its customers more efficiently by offering them collagen-based wound management solutions.

Key Topics Covered:

1. Global Medical Collagen Market - Summary

2. Industry Outlook2.1. Impact of Covid-19 on the Medical Collagen Industry2.2. Key Insights2.2.1. Significant Investment in Research and Development Activities 2.2.2. Evolving Healthcare Industry2.2.3. Launch of New Products Due to Increased Research2.3. Porter's Five Forces Analysis2.3.1. Threat of New Entrants2.3.2. Threat of Substitutes2.3.3. Bargaining Power of Buyers2.3.4. Bargaining Power of Suppliers2.3.5. Threat of Competitive Rivalry2.4. Key Impact Analysis2.4.1. Quality2.4.2. Side-Effects2.4.3. Product Effectiveness2.4.4. Price2.5. Market Attractiveness Index2.6. Vendor Scorecard2.7. Industry Components2.8. Regulatory Framework2.9. Key Market Strategies2.9.1. Acquisitions2.9.2. Product Launches2.9.3. Partnerships2.9.4. Business Expansions2.10. Market Drivers2.10.1. Increasing Demand from the Medical Devices Industry2.10.2. Growing Public Awareness 2.11. Market Challenges2.11.1. Health-Related Issues2.11.2. Consumers Limiting the Use of Animal-Based Products 2.12. Market Opportunities2.12.1. Growth of the Cosmetics Industry2.12.2. Rising Demand for Collagen-Rich Food & Beverages

3. Global Medical Collagen Market Outlook - by Source3.1. Bovine3.2. Porcine3.3. Other Sources

4. Global Medical Collagen Market Outlook - by Product4.1. Gelatine4.2. Hydrolyzed Collagen4.3. Native Collagen4.4. Other Products

5. Global Medical Collagen Market Outlook - by Application5.1. Wound Care5.2. Bone Grafts5.3. Tissue Scaffolds5.4. Cartilage Repair5.5. Hemostats5.6. Diagnostics5.7. Vascular Grafts5.8. Other Applications

6. Global Medical Collagen Market - Regional Outlook

7. Competitive Landscape7.1. Gelita7.2. Nitta Gelatin Inc7.3. Nippi Inc7.4. Italgel7.5. Weishardt7.6. Darling Ingredients Inc7.7. Lapi Gelatine7.8. Tessenderlo Group7.9. Dsm7.10. Collagen Matrix Inc7.11. Connoils LLC7.12. Integra Life Sciences7.13. Symatese7.14. Stryker7.15. Jellagen

8. Research Methodology & Scope

For more information about this report visit https://www.researchandmarkets.com/r/10kuec

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Research and MarketsLaura Wood, Senior Managerpress@researchandmarkets.com

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Originally posted here:
Insights on the Medical Collagen Global Market to 2028 - Rising Demand for Collagen-Rich Food & Beverages Presents Opportunities - Yahoo Finance

Researchers from TU Wien have fabricated artificial human tissue on a chip using a multi-photon lithography technique which could eliminate the need for animal testing in the future.

The laser-based method enables the researchers to guide individual cells to specific locations within a hydrogel to form reproducible specialized tissue systems. These tissues can then be examined under precisely controlled conditions on a chip, holding promise for pharmaceutical research such as testing the efficacy of new drugs.

AM as an alternative to animal testing

In recent years, advances in bioprinting and tissue engineering technologies have offered increasingly viable alternatives to the use of animal models in experimental medical research. While viable patient-specific tissues for trialing the efficacy of drugs remain largely experimental for now, there is significant progress being made towards this goal.

For instance, bioprinter manufacturer CELLINK has pledged to advance its research into animal cruelty-free cellular testing models, while the University of Stuttgart is working on the development of microscale bioprinted skin models to trial the efficacy of cancer drugs.

Elsewhere, Fluicells Biopixlar platform is producing highly-complex neural models which could offer future applications for clinical drug screening, while UpNanos NanoOne Bio system is hoping to reduce the number of animal testing experiments with its 3D printed cell-culturing microstructures.

Most recently, the Institute of Bioengineering of Catalonia (IBEC) announced it was coordinating the EU-funded BRIGHTER project with the goal of developing new 3D bioprinting processes in order to reduce animal testing within the fields of tissue engineering and regenerative medicine.

Fabricating human tissue on a chip

Creating tissue structures in a lab often begins with living cells embedded in a hydrogel, usually a biocompatible material with properties very similar to those of biological tissue. Cells can migrate through the hydrogel and form a tissue, however the ability to precisely control this process and direct the cells towards a predetermined blueprint has so far been challenging.

By means of a laser, multi-photon lithography techniques can create intricate 3D microstructures with feature sizes as small as 100nm within photosensitive materials. The method has proven to be a suitable tool to precisely control the microenvironment of cells by altering the biochemical and biophysical properties of the hydrogel matrix they are encapsulated within.

According to Professor Aleksandr Ovsianikov, Head of the 3D Printing and Biofrabrication research group at TU Wien, the success of the teams technique is due to the addition of special molecules that change the physical properties of the hydrogel when activated by a laser.

At the precise point of contact with the laser, the hydrogel becomes softer and more permeable, enabling the creation of predetermined paths throughout the hydrogel along which cells can migrate.

The molecule couples to the network of the hydrogel, at this point the network becomes more hydrophilic, explained TU Wiens Simon Sayer. This changes the physical properties, and in this way it is possible to create a 3D pattern through which the cells can pass more easily than elsewhere.

As a result, the researchers were able to produce star-shaped or lattice-shaped cell structures within the hydrogel that mimic biological functions such as blood vessels. These tissues structures can then be placed on a chip of a few centimeters in size and be precisely supplied with specific nutrients or pharmaceutical compounds. How the tissues interact with each other can then be observed, allowing the team to gather important information about the effect of different drugs without the need for animal testing.

But this only works if we can precisely control the properties of these tissues, said Tommaso Zandrini, also of TU Wien. Firstly, these experiments need to be reproducible, so if you want several tissue samples with exactly the same microstructure, and secondly, you also need to be able to precisely connect the different samples for example, if youre studying the interaction between a small piece of heart muscle tissue and a small piece of liver tissue.

By leveraging their multi-photon lithography technique, the TU Wien team is able to accurately understand the interaction between different tissues as structures such as blood vessels can be printed in exactly the right place, while enabling the complexity of customized tissue samples to be significantly increased.

Further information on the study can be found in the paper titled: Guiding cell migration in 3D with high-resolution photografting, published in the Scientific Reports journal. The study is co-authored by S. Sayer, T. Zandrini, M. Markovic, J. Van Hoorick, S. Van Vlierberghe, S. Baudis, W. Holnthoner, and A. Ovsianikov.

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Featured image showsleveraging their multi-photon lithography process, the researchers created star shaped patterns (left), into which the cells can grow (right). Image via TU Wien.

See the article here:
TU Wien 3D prints human tissue on a chip in bid to eliminate animal testing - 3D Printing Industry

Injections of platelet-rich plasma (PRP) are commonly offered to men with erectile dysfunction (ED) by a variety of healthcare professionals at high cost, despite the lack of evidence-based guidelines to back its use or any standardized protocols or duration of treatment, according to a new study.

Investigators researched over 100 clinics in eight populous metropolitan areas of the United States and found that these injections were widely available. The mean cost of each injection was over $1500, and treatment ranged from one to an indefinite number of injections.

"The take-home message for patients is to approach purported 'miracle cures' with skepticism and realize that many cash-based treatments rely on salesmanship," senior author Sriram Eleswarapu, MD, PhD, assistant clinical professor of urology, University of California, Los Angeles, told theheart.org | Medscape Cardiology.

"Doctors and other healthcare workers should be mindful of the potential for medical harm and financial toxicity. Guidelines-conformant, evidence-based care should take precedence while investigational therapies like PRP are being studied in clinical trials," he said.

The study was published online May 26 in JAMA Network Open.

PRP, often called the "Priapus shot" or "P-shot," Eleswarapu said, "has emerged in a variety of medical and cosmetic applications, and there is some thought that PRP injections into the penis might be useful as a regenerative therapy of ED; however, there are no good data suggesting that PRP actually works for this purpose."

The American Urological Association (AUA) and the Sexual Medicine Society of North America have issued statements that PRP is an investigational treatment that should not be offered for payment, Eleswarapu points out. In fact, the AUA erectile dysfunction guideline states that men with ED "should undergo a thorough medical evaluation and offered a variety of proven treatment options, rather than investigational therapies."

Despite the absence of clinical trial data on PRP for ED, "many providers have begun to market this treatment and charge high fees, with no guarantee that it helps. Unfortunately, men are desperate for cures and are willing to pay for therapies with no proven benefit," he noted.

To "characterize the landscape" of PRP injection therapy for ED, the researchers used a "secret shopper" approach a market research method that involves using a script to inquire about products and pricing in service industries, they note.

Using an internet search, they identified 109 clinics that offered PRP for ED in eight major metropolitan areas (Atlanta, Boston, Dallas, Houston, Los Angeles, New York, Philadelphia, and Washington, DC). The researchers contacted the clinics via telephone and used a standardized script to request information about pricing, protocols, and clinician credentials.

Clinics that did not respond were excluded from the study, leaving 90 clinics for which data were available concerning pricing and treatment duration.

Of the providers, only 9% were urologists; 22% were not physicians and included chiropractors, integrative healthcare providers, naturopaths, nurse practitioners (NPs), and physician assistants (PAs). The most common providers were family medicine physicians (almost 14%), NPs (almost 14%), internal medicine practitioners (11%), and "unknown" or "other" providers (12%).

Other provider specialties included anesthesiology, emergency medicine, general surgery, obstetrics/gynecology, oncology, orthopedic surgery, plastic surgery, and physiatry.

Cost ranged from a mean price of $1367 (range, $350 $2500) in Los Angeles (n = 20 clinics) to $1580 ($1200 $1900) in Washington, DC (n = 5 clinics). Except for the clinics in Los Angeles, the mean price in all other areas was $1500.

The authors highlight the "substantial cost," lack of standardized protocol, and the high number of nonphysicians as well as physicians who had no training in male sexual dysfunction who administered these injections. The investigators state that the findings "suggest that guideline-nonconformant care has been driven by the consumerization of sexual health."

Commenting on the study for theheart.org | Medscape Cardiology, Ryan Terlecki, MD, professor and vice chair of urology, Wake Forest University School of Medicine, said it is "not surprising for those of us in practice to see what's taking place and that it is driven by financial benefit."

Many people in other areas of medicine have found that administering these injections is a "nice career change, and they can make a lot of money often cash-based with low stress and no insurance to file," said Terlecki, who was not involved with the study.

"The message for patients is 'buyer beware,' and for physicians, the message is that you can give these injections, and you can make a lot of money, but it doesn't appear necessarily to be ethical. Even when patients say that it worked, it might be a placebo response; but if you're going to get rich off a placebo response, is that ethical?"

He noted that there do not appear to be safety concerns regarding PRP injections for ED, since the cells being used are from the patient's own body.

"If you pay careful attention to skin preparation and how you handle the injections, there doesn't appear to be a huge risk to anything other than the wallet and perhaps faith in the medical community, in that the provider may potentially undermine legitimate attempts to determine whether something is of benefit scientifically."

No source of funding for the study was provided. Eleswarapu reports receiving personal fees from Metuchen Pharmaceuticals outside the submitted work. The other authors' disclosures are listed on the original article. Terlecki receives research funding from the Department of Defense and is a consultant for Boston Scientific; he also receives grant funding from Boston Scientific and is on its advisory board.

JAMA Netw Open. Published online May 26, 2022. Full text

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'P-Shot' for Erectile Dysfunction: Pricey and Without Proof - Medscape

BOSTON & ZUG, Switzerland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) announce presentation of new data on exa-cel, formerly known as CTX001, from CLIMB-111, CLIMB-121 and CLIMB-131 highlighting the potentially transformative profile of this investigational therapy for people with transfusion-dependent beta thalassemia (TDT) or severe sickle cell disease (SCD) and provided additional program updates.

New Data for exa-cel from CLIMB Clinical StudiesThe data presented at the European Hematology Association (EHA) Congress are from 75 patients (44 with TDT and 31 with SCD) with follow-up ranging from 1.2 to 37.2 months after exa-cel dosing.

Of the 44 patients with TDT, 26 had beta-zero/beta-zero or other beta-zero-like severe genotypes. Forty-two of 44 patients with TDT were transfusion-free with follow-up ranging from 1.2 to 37.2 months after exa-cel infusion. Two patients who were not yet transfusion-free had 75% and 89% reductions in transfusion volume. TDT patients had substantial mean increases in fetal hemoglobin (HbF) and corresponding increases in mean total hemoglobin (Hb) with mean total Hb levels increasing to >11 g/dL by Month 3 and maintained thereafter.

All 31 patients with severe SCD characterized by recurrent vaso-occlusive crises (VOCs) (mean of 3.9 VOCs per year over the prior two years) were free of VOCs after exa-cel infusion through duration of follow-up, with follow-up ranging from 2.0 to 32.3 months. SCD patients had mean HbF (as a proportion of total Hb) of approximately 40% by Month 4 and maintained thereafter.

The safety was generally consistent with myeloablative conditioning with busulfan and autologous stem cell transplant. All patients engrafted neutrophils and platelets after exa-cel infusion. Among the 44 patients with TDT, two patients had serious adverse events (SAEs) considered related to exa-cel. As previously reported, one patient had three SAEs considered related to exa-cel, hemophagocytic lymphohistiocytosis (HLH), acute respiratory distress syndrome and headache, and one SAE of idiopathic pneumonia syndrome that was considered related to both exa-cel and busulfan. All four SAEs occurred in the context of HLH and have resolved. One patient had SAEs of delayed neutrophil engraftment and thrombocytopenia, both of which were considered related to exa-cel and busulfan, and both SAEs have resolved. Among the 31 patients with SCD, there were no SAEs considered related to exa-cel.

Additional details were presented during the EHA media briefing and can be found in the published abstract and presentation.

Late-breaking abstract #LB2367 entitled Efficacy and Safety of a Single Dose of CTX001 For Transfusion-Dependent eta-Thalassemia and Severe Sickle Cell Disease, will be an oral presentation on Sunday, June 12 at 09:45-11:15 CEST.

These robust data from 75 patients, of which 33 have one year or more of follow-up after exa-cel infusion, further demonstrate the potential of this investigational therapy as a one-time functional cure for patients with transfusion-dependent beta thalassemia or severe sickle cell disease, said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex.

By reactivating a naturally occurring developmental process, exa-cel restores fetal hemoglobin production and thereby can ameliorate the course of these diseases, said Haydar Frangoul, M.D., Medical Director of Pediatric Hematology and Oncology at Sarah Cannon Research Institute, HCA Healthcares The Childrens Hospital at TriStar Centennial Medical Center. The remarkable results based on this approach give me great optimism and confidence in the potential of this treatment for patients.

I have seen first-hand the impact that this investigational therapy has had on patients in these clinical trials and continue to be impressed by the totality of the data, said Franco Locatelli, M.D., Ph.D., Professor of Pediatrics at the Sapienza University of Rome, Director of the Department of Pediatric Hematology and Oncology at Bambino Ges Childrens Hospital. Given the urgency for highly effective and curative therapies for patients with hemoglobinopathies, I am excited to be part of the team working towards the goal of addressing this unmet need.

Exa-cel Study UpdatesFollowing ongoing discussions with regulators, the clinical trial protocols for CLIMB-111 and CLIMB-121 were amended to incorporate feedback on the primary endpoints for regulatory submission. Specifically, the primary endpoint in CLIMB-111 for TDT has been amended from proportion of subjects achieving transfusion reduction after exa-cel infusion to proportion of subjects maintaining weighted average Hb 9 g/dL without red blood cell (RBC) transfusions for at least 12 consecutive months after exa-cel infusion.

The primary endpoint in CLIMB-121 for SCD has been updated from proportion of subjects with HbF 20% after exa-cel infusion, to proportion of subjects who have not experienced any severe VOCs for at least 12 consecutive months after exa-cel infusion.

Both clinical trials are now in Phase 3 and are fully enrolled. All patients will have the opportunity to join CLIMB-131, a long-term follow-up study, after completing participation in the initial studies.

Additional Pediatric StudiesIn line with the companys strategy of developing therapies for patients of all ages, two additional Phase 3 studies of exa-cel have begun. Earlier this year, the Independent Data Monitoring Committee (DMC) met to review the data in adults and adolescents and endorsed expanding into younger pediatric patients. CLIMB-141 and CLIMB-151 are Phase 3 open-label trials designed to assess the safety and efficacy of a single dose of exa-cel in patients ages 2 to 11 years with TDT or SCD, respectively. The trials are now open for enrollment and currently enrolling patients ages 5 to 11 years and will plan to extend to patients 2 to less than 5 years of age at a later date. Each trial will enroll approximately 12 patients. Patients will be followed for approximately two years after infusion. Each patient will be asked to participate in CLIMB-131, a long-term follow-up trial.

Vertex also presented three additional abstracts on the burden of disease in sickle cell disease and beta thalassemia at the EHA Congress.

About exagamglogene autotemcel (exa-cel)Exacel, formerly known as CTX001, is an investigational, autologous, ex vivo CRISPR/Cas9 geneedited therapy that is being evaluated for patients with TDT or SCD characterized by recurrent VOCs, in which a patients own hematopoietic stem cells are edited to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygencarrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. The elevation of HbF by exacel has the potential to alleviate transfusion requirements for patients with TDT and reduce painful and debilitating sickle crises for patients with SCD. Earlier results from these ongoing trials were published in The New England Journal of Medicine in January of 2021.

Based on progress in this program to date, exacel has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for both TDT and SCD. Exa-cel has also been granted Orphan Drug Designation from the European Commission, as well as Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), for both TDT and SCD.

Among geneediting approaches being evaluated for TDT and SCD, exacel is the furthest advanced in clinical development.

About CLIMB111 and CLIMB121The ongoing Phase 1/2/3 openlabel trials, CLIMB111 and CLIMB121, are designed to assess the safety and efficacy of a single dose of exacel in patients ages 12 to 35 years with TDT or with SCD, characterized by recurrent VOCs, respectively. The trials are now closed for enrollment. Patients will be followed for approximately two years after exacel infusion. Each patient will be asked to participate in CLIMB131, a longterm followup trial.

About CLIMB-131This is a longterm, openlabel trial to evaluate the safety and efficacy of exacel in patients who received exacel in CLIMB111, CLIMB121, CLIMB141 or CLIMB151. The trial is designed to follow participants for up to 15 years after exacel infusion.

About CLIMB141 and CLIMB151The ongoing Phase 3 open-label trials, CLIMB141 and CLIMB151, are designed to assess the safety and efficacy of a single dose of exacel in patients ages 2 to 11 years with TDT or with SCD, characterized by recurrent VOCs, respectively. The trials are now open for enrollment and currently enrolling patients ages 5 to 11 years of age and will plan to extend to patients 2 to less than 5 years of age at a later date. Each trial will enroll approximately 12 patients. Patients will be followed for approximately two years after infusion. Each patient will be asked to participate in CLIMB-131, a longterm followup trial.

About the GeneEditing Process in These TrialsPatients who enroll in these trials will have their own hematopoietic stem and progenitor cells collected from peripheral blood. The patients cells will be edited using the CRISPR/Cas9 technology. The edited cells, exacel, will then be infused back into the patient as part of an autologous hematopoietic stem cell transplant (HSCT), a process which involves a patient being treated with myeloablative busulfan conditioning. Patients undergoing HSCT may also encounter side effects (ranging from mild to severe) that are unrelated to the administration of exacel. Patients will initially be monitored to determine when the edited cells begin to produce mature blood cells, a process known as engraftment. After engraftment, patients will continue to be monitored to track the impact of exacel on multiple measures of disease and for safety.

About the VertexCRISPR CollaborationVertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. Exacel represents the first potential treatment to emerge from the joint research program. Under an amended collaboration agreement, Vertex now leads global development, manufacturing and commercialization of exacel and splits program costs and profits worldwide 60/40 with CRISPR Therapeutics.

About VertexVertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1mediated kidney disease, pain, type 1 diabetes, alpha1 antitrypsin deficiency and Duchenne muscular dystrophy.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 12 consecutive years on Science magazine's Top Employers list and one of the 2021 Seramount (formerly Working Mother Media) 100 Best Companies. For company updates and to learn more about Vertex's history of innovation, visit http://www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

(VRTX-GEN)

Vertex Special Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, (i) statements by Dr. Carmen Bozic, Dr. Haydar Frangoul, and Dr. Franco Locatelli in this press release, (ii) our plans and expectations to present clinical data from the ongoing exa-cel clinical trials during the EHA Congress, (iii) the progress of the ongoing exa-cel clinical trials, including expectations regarding the abstracts that will be made available on the virtual platform including anticipated projections and estimates related to the various economic impacts of SCD and TDT, (iv) the potential benefits, efficacy, and safety of exa-cel, including the potentially transformative nature of the therapy and the potential of the treatment for patients, (v) our plans and expectations for our clinical trials and pipeline products, and (vi) the status of our clinical trials of our product candidates under development by us and our collaborators, including activities at the clinical trial sites, patient enrollment, and expectations regarding clinical trial follow-up. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from a limited number of patients may not be indicative of final clinical trial results, that data from the company's development programs, including its programs with its collaborators, may not support registration or further development of its compounds due to safety and/or efficacy, or other reasons, that internal or external factors could delay, divert, or change our plans and objectives with respect to our research and development programs, that future competitive or other market factors may adversely affect the commercial potential for exa-cel, and other risks listed under the heading Risk Factors in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission (SEC) and available through the company's website at http://www.vrtx.com and on the SECs website at http://www.sec.gov. You should not place undue reliance on these statements or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(CRSP-GEN)

About CRISPR TherapeuticsCRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

CRISPR THERAPEUTICS word mark and design logo and CTX001 are trademarks and registered trademarks of CRISPR Therapeutics AG. All other trademarks and registered trademarks are the property of their respective owners.

CRISPR Therapeutics Forward-Looking StatementThis press release may contain a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, as well as statements made by Dr. Carmen Bozic, Dr. Haydar Frangoul, and Dr. Franco Locatelli in this press release, as well as statements regarding CRISPR Therapeutics expectations about any or all of the following: i) the safety, efficacy and clinical progress of the ongoing exa-cel clinical trials, including expectations regarding the abstracts that will be made available on the virtual platform and our plans and expectations to present and the clinical data that are being presented during the EHA Congress, as well as the potentially transformative nature of exa-cel and the potential of the treatment for patients; and (ii) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. Without limiting the foregoing, the words believes, anticipates, plans, expects and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, existing and prospective investors are cautioned that forward-looking statements are inherently uncertain, are neither promises nor guarantees and not to place undue reliance on such statements, which speak only as of the date they are made. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the potential for initial and preliminary data from any clinical trial and initial data from a limited number of patients (as is the case with exa-cel at this time) not to be indicative of final or future trial results; the potential that the exa-cel clinical trial results may not be favorable or may not support registration or further development; that future competitive or other market factors may adversely affect the commercial potential for exa-cel; CRISPR Therapeutics may not realize the potential benefits of its collaboration with Vertex; potential impacts due to the coronavirus pandemic, such as to the timing and progress of clinical trials; uncertainties regarding the intellectual property protection for CRISPR Therapeutics technology and intellectual property belonging to third parties; and those risks and uncertainties described under the heading Risk Factors in CRISPR Therapeutics most recent annual report on Form 10-K, quarterly report on Form 10-Q, and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC's website at http://www.sec.gov. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

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Vertex and CRISPR Therapeutics Present New Data on More Patients With Longer Follow-Up Treated With exagamglogene autotemcel (exa-cel) at the 2022...

When it comes to the different ways of exercising the human body, walking is about as accessible as they come, and new research suggests it could be a powerful way to tackle osteoarthritis in the knees. A study examined the benefits of a regular saunter in people aged over 50, and found not only can it reduce pain, but it may also slow the damage that takes place in the joint.

The research was carried out by scientists at the Baylor College of Medicine and draws on a multi-year observational study of more than 1,200 subjects aged 50 or older with knee osteoarthritis, the most common form of arthritis. The subjects self-reported their walking habits, including the time spent walking and frequency, enabling the researchers to classify 73 percent of the cohort as "walkers" and the remainder as "non-walkers."

Those who walked for exercise had a 40 percent decrease in the likelihood of experiencing frequent knee pain. X-ray images were also used to assess the progression and severity of osteoarthritis in the knees, with the walkers less likely to experience medial joint space narrowing, a measure of arthritis. This suggests that a regular stroll could not just limit the pain associated with the condition, but apply the brakes to osteoarthritis in the knees.

"These findings are particularly useful for people who have radiographic evidence of osteoarthritis but dont have pain every day in their knees, said first author of the paper Dr. Grace Hsiao-Wei Lo.This study supports the possibility that walking for exercise can help to prevent the onset of daily knee pain. It might also slow down the worsening of damage inside the joint from osteoarthritis.

There is no cure or way of reversing osteoarthritis, and although treatments are available these predominantly focus on relieving pain and improving mobility, such as through medication and physical therapy. Exciting advances are being made in regenerative medicine that could one day see grafts help reinforce troubled joints and reduce inflammation, but studies such as this one demonstrate there are already useful tools at our disposal.

People diagnosed with knee osteoarthritis should walk for exercise, particularly if they do not have daily knee pain, advised Lo. "If you already have daily knee pain, there still might be a benefit, especially if you have the kind of arthritis where your knees are bow-legged.

The research was published in the journal Arthritis & Rheumatology.

Source: Baylor College of Medicine

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Walking found to reduce pain and slow damage in arthritic knees - New Atlas

The new report by Expert Market Research titled, Global Live Cell Imaging Market Report and Forecast 2022-2027, gives an in-depth analysis of the global live cell imaging market, assessing the market based on its segments like product type, application, technology, and major regions. The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porters Five Forces models.

Request a free sample copy in PDF or view the report [emailprotected] https://bit.ly/3mtMGEU

The key highlights of the report include:

Market Overview (2017-2027)

As the number of stem cell research projects grows, so does the use of live cell imaging tools to analyse the location, purity, and amount of cells and their components, boosting market growth. The use of live cell imaging tools to precisely detect protein levels for optimal medication therapy is rising, as it is critical to determine the interaction between stem cells and tissues during stem cell research. The introduction of numerous government initiatives to support research and development (R&D) activities is fueling the live cell imaging industrys expansion. For example, in March 2020, the Canadian government announced a $6.9 million investment to promote stem cell research efforts in the country through the Stem Cell Networks research financing programme.

Furthermore, the increasing use of live cell imaging in the discovery of new medications is propelling the market forward. The development of new technologies that allow for the precise analysis of RNA, nucleic acid, proteins, and DNA, among other things, is driving demand for many diagnostic methods, moving the market forward. Furthermore, the rise in the prevalence of chronic diseases like cancer is driving up demand for live cell imaging in both diagnosis and treatment. The expanding research and development (R&D) activities to detect cancer cells in bone marrow while also allowing for the identification of specific cancer cells are likely to boost market growth.

Industry Definition and Major Segments

The study of living cells using microscope technology to obtain images of live cells and tissues is known as live cell imaging. It is essential in a variety of laboratory operations in biological and biomedical research because it gives real-time and reliable information on cells and tissues, making it suitable for stem cell research and regenerative medicine development.

Explore the full report with the table of [emailprotected] https://bit.ly/3tpEoSd

By technology, the market can be divided into:

The market can be categorised based on its applications into:

The major product types of live cell imaging are:

The regional markets include:

Market Trends

Artificial intelligence (AI), deep learning, and 3D printing are progressively being integrated into live cell imaging techniques, as technology improvements are a key antecedent of scientific research and development efforts. The expanding use of artificial intelligence (AI) allows for more precise, simpler, and time-efficient cell imaging. Furthermore, AI-based microscopy can recognise and analyse minor cell components like nuclei, allowing researchers to analyse data more quickly and effectively. AI-based microscopes also automate and optimise many functions for quantifying live cells, resulting in increased cell viability and faster image capture. This is fueling the expansion of the live cell imaging sector by increasing demand for such microscopes in research centres.

Furthermore, the increasing use of 3D printing in a variety of medical and biological applications is fueling market expansion. Because air bubbles are a common problem in perfusion chambers used in live cell imaging, the demand for fluidic devices made with 3D printing technology is increasing dramatically. Furthermore, the cost-effectiveness of 3D printing is increasing the affordability of live cell imaging research operations, which is propelling the market forward. In the forecast future, the development of portable and low-profile devices that can be directly installed on optical microscopes to improve cell imaging precision is expected to drive market expansion for live cell imaging.

Latest News on Global Live Cell Imaging [emailprotected] https://bit.ly/3HaaQ0z

Key Market Players

The major players in the market are Carl Zeiss AG, Leica Microsystems GmbH, Nikon Instruments Inc., Becton, Dickinson and Company, GE Healthcare and Others.

About Us:

Expert Market Research is a leading business intelligence firm, providing custom and syndicated market reports along with consultancy services for our clients. We serve a wide client base ranging from Fortune 1000 companies to small and medium enterprises. Our reports cover over 100 industries across established and emerging markets researched by our skilled analysts who track the latest economic, demographic, trade and market data globally.

At Expert Market Research, we tailor our approach according to our clients needs and preferences, providing them with valuable, actionable and up-to-date insights into the market, thus, helping them realize their optimum growth potential. We offer market intelligence across a range of industry verticals which include Pharmaceuticals, Food and Beverage, Technology, Retail, Chemical and Materials, Energy and Mining, Packaging and Agriculture.

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Global Live Cell Imaging Market to be Driven by Growing Stem Cell Research Market in the Forecast Period of 2022-2027 mbu timeline - mbu timeline