Category Archives: Regenerative Medicine

Enlivex Therapeutics Ltd

Nes-Ziona, Israel, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the Company), a clinical-stage macrophage reprogramming immunotherapy company, today announced that company management will participate in, and present at, the 4th Macrophage-directed Therapies Summit, which is taking place in Boston, Massachusetts from October 4-6, 2022.

Enlivexs presentation will take place at 2:30 PM ET on October 06, 2022. During the presentation, company management will provide an overview of Enlviex's clinical programs in sepsis and solid cancers, and review previously presented data supporting these programs. Those interested in registering for the summit can do so here.

ABOUT THE 4th MACROPHAGE-DIRECTED THERAPIES SUMMIT

The 4th Macrophage-directed Therapies Summit will include presentations regarding approaches to target dont eat me signal, strategies to reprogram tumor-associated macrophages, and techniques to discover next-generation targeting methods to develop highly effective and controlled therapies. The program will delve into clinical translatability, novel targets beyond CD47, combination strategies vs. monotherapy approaches, and lean on the lessons learned in oncology to bridge the gap between diseases in autoimmunity, inflammation, and regenerative medicine.

ABOUT ENLIVEX

Enlivex is a clinical stage immunotherapy company developing Allocetra, a universal, off-the-shelf cell therapy designed toreprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visithttp://www.enlivex.com.

Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as expects, plans, projects, will, may, anticipates, believes, should, would, could, intends, estimates, suggests, has the potential to and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATMprograms. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivexs business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATMproduct line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivexs filings with the Securities and Exchange Commission, including in the Companys most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

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ENLIVEX CONTACTShachar Shlosberger, CFOEnlivex Therapeutics, Ltd.shachar@enlivexpharm.com

INVESTOR RELATIONS CONTACTEric RibnerLifeSci Advisorseric@lifesciadvisors.com

Excerpt from:
Enlivex to Present at the 4th Macrophage-Directed Therapies Summit - Yahoo Finance

BLA Includes Substantial Body of Data from Pivotal Phase 3 and Ongoing Phase 1/2 Studies

If Approved, Would Be 1st Gene Therapy in U.S. for Treatment of Severe Hemophilia A

SAN RAFAEL, Calif., Sept. 29, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the Company resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A. The resubmission incorporates the Company's response to the FDA Complete Response (CR) Letter for valoctocogene roxaparvovec gene therapy issued on August 18, 2020, and subsequent feedback, including two-year outcomes from the global GENEr8-1 Phase 3 study and supportive data from five years of follow-up from the ongoing Phase 1/2 dose escalation study.

BioMarin anticipates an FDA response by the end of October on whether the BLA resubmission is complete and acceptable for review. Typically, BLA resubmissions are followed by a six-month review procedure. However, the Company anticipates three additional months of review may be necessary based on the number of data read-outs that will emerge during the procedure. If approved, valoctocogene roxaparvovec would be the first commercially-available gene therapy in the U.S. for the treatment of severe hemophilia A.

The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to valoctocogene roxaparvovec in March 2021. RMAT is an expedited program intended to facilitate development and review of regenerative medicine therapies, such as valoctocogene roxaparvovec, that are expected to address an unmet medical need in patients with serious conditions. The RMAT designation is complementary to Breakthrough Therapy Designation, which the Company received for valoctocogene roxaparvovec in 2017.

In addition to the RMAT Designation and Breakthrough Therapy Designation, BioMarin's valoctocogene roxaparvovec also received orphan drug designation from the EMA and FDA for the treatment of severe hemophilia A. Orphan drug designation is reserved for medicines treating rare, life-threatening or chronically debilitating diseases. The European Commission (EC) granted conditional marketing authorization to valoctocogene roxaparvovec gene therapy under the brand name ROCTAVIAN on August 24, 2022 and endorsed the recommendation from the European Medicines Agency (EMA) to maintain orphan drug designation, thereby granting a 10-year period of market exclusivity in the European Union.

"We are pleased to reach this point in the development program for valoctocogene roxaparvovec and look forward to working with the FDA with the goal of bringing a potentially transformative therapy to people with severe hemophilia A in the United States," said Hank Fuchs, M.D., President of Worldwide Research and Development at BioMarin. "This large and robust data set provided in this BLA resubmission shows an encouraging efficacy profile. We remain committed to sharing these data with the public, along with even longer-term data generated through our ongoing clinical trials and any post-approval studies, to further our understanding of AAV gene therapy in severe hemophilia A and of gene therapies more broadly."

The resubmission includes a substantial body of data from the valoctocogene roxaparvovec clinical development program, the most extensively studied gene therapy for severe hemophilia A, including two-year outcomes from the global GENEr8-1 Phase 3 study. The GENEr8-1 Phase 3 study demonstrated stable and durable bleed control, including a reduction in the mean annualized bleeding rate (ABR) and the mean annualized Factor VIII infusion rate. In addition, the data package included supportive evidence from five years of follow-up from the 6e13 vg/kg dose cohort in the ongoing Phase 1/2 dose escalation study. The resubmission alsoincludesaproposedlong-term extension studyfollowingall clinicaltrialparticipantsfor up to 15years, as well astwo post-approval registry studies.

Robust Clinical Program

BioMarin has multiple clinical studies underway in its comprehensive gene therapy program for the treatment of severe hemophilia A. In addition to the global Phase 3 study GENEr8-1 and the ongoing Phase 1/2 dose escalation study, the Company is also conducting a Phase 3, single arm, open-label study to evaluate the efficacy and safety of valoctocogene roxaparvovec at a dose of 6e13 vg/kg with prophylactic corticosteroids in people with severe hemophilia A (Study 270-303). Also ongoing are a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with pre-existing AAV5 antibodies (Study 270-203) and a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with severe hemophilia A with active or prior Factor VIII inhibitors (Study 270-205).

Safety Summary

Overall, to date, a single 6e13 vg/kg dose of valoctocogene roxaparvovec has been well tolerated with no delayed-onset treatment related adverse events. The most common adverse events (AE) associated with valoctocogene roxaparvovec have occurred early and included transient infusion associated reactions and mild to moderate rise in liver enzymes with no long-lasting clinical sequelae. Alanine aminotransferase (ALT) elevation, a laboratory test of liver function, has remained the most common adverse drug reaction. Other adverse reactions have included aspartate aminotransferase (AST) elevation (101 participants, 63%), nausea (55 participants, 34%), headache (54 participants, 34%), and fatigue (44 participants, 28%). No participants have developed inhibitors to Factor VIII, thromboembolic events or malignancy associated with valoctocogene roxaparvovec.

About Hemophilia A

People living with hemophilia A lack sufficient functioning Factor VIII protein to help their blood clot and are at risk for painful and/or potentially life-threatening bleeds from even modest injuries. Additionally, people with the most severe form of hemophilia A (Factor VIII levels <1%) often experience painful, spontaneous bleeds into their muscles or joints. Individuals with the most severe form of hemophilia A make up approximately 50 percent of the hemophilia A population. People with hemophilia A with moderate (Factor VIII 1-5%) or mild (Factor VIII 5-40%) disease show a much-reduced propensity to bleed. Individuals with severe hemophilia A are treated with a prophylactic regimen of intravenous Factor VIII infusions administered 2-3 times per week (100-150 infusions per year) or a bispecific monoclonal antibody that mimics the activity of Factor VIII administered 1-4 times per month (12-48 injections or shots per year). Despite these regimens, many people continue to experience breakthrough bleeds, resulting in progressive and debilitating joint damage, which can have a major impact on their quality of life.

Hemophilia A, also called Factor VIII deficiency or classic hemophilia, is an X-linked genetic disorder caused by missing or defective Factor VIII, a clotting protein. Although it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous mutation, a new mutation that was not inherited. Approximately 1 in 10,000 people have hemophilia A.

About BioMarin

BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening genetic diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company's portfolio consists of eight commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases. For additional information, please visitwww.biomarin.com.

Forward-Looking Statements

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about: BioMarin anticipating an FDA response by the end of October on whether the BLA resubmission is complete and acceptable for review, BioMarin's expectations regarding the duration of the review procedure, valoctocogene roxaparvovec being the first commercially-available gene therapy in the U.S. for the treatment of severe hemophilia A, if approved, BioMarin's commitment to sharing longer-term data generated through its ongoing clinical trials and any post-approval studies. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: the results and timing of current and planned preclinical studies and clinical trials of valoctocogene roxaparvovec; additional data from the continuation of the clinical trials of valoctocogene roxaparvovec, any potential adverse events observed in the continuing monitoring of the participants in the clinical trials; the content and timing of decisions by the FDA and other regulatory authorities, including decisions to grant additional marketing registrations based on an EMA license; the content and timing of decisions by local and central ethics committees regarding the clinical trials; our ability to successfully manufacture valoctocogene roxaparvovec for the clinical trials and commercially; and those and those factors detailed in BioMarin's filings with the Securities and Exchange Commission (SEC), including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.

BioMarin is a registered trademark of BioMarin Pharmaceutical Inc and ROCTAVIAN is a trademark of BioMarin Pharmaceutical Inc.

Contacts:

Investors

Media

Traci McCarty

Debra Charlesworth

BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc.

(415) 455-7558

415) 455-7451

SOURCE BioMarin Pharmaceutical Inc.

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BioMarin Resubmits Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Severe Hemophilia A to the FDA - PR...

ReportLinker

INTRODUCTION It is a well-known fact that almost 90% of the therapeutic interventions fail in clinical trials, resulting in significant economic losses to the pharmaceutical industry.

New York, Sept. 30, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Organ on a Chip Market - Focus on Products and Technologies - Distribution by Type of Product, Application Area, Purpose, and Key Geographical Regions : Industry Trends and Global Forecasts, 2022-2035" - https://www.reportlinker.com/p06323408/?utm_source=GNW The lack of effective preclinical prediction of drug responses in humans is one of the various reasons for drugs failure to get approved. Animal testing for preclinical evaluation of drugs sometimes fails to identify toxicity signs caused by a drug in humans. Moreover, these studies are quite expensive, time-consuming and are associated with several ethical concerns. In order to reform the drug approval process and use non-animal testing models for preclinical evaluations, the US democrats and republicans introduced the FDA Modernization Act in 2021. The U.S. Environmental Protection Agency (EPA) has also declared the termination of the funds granted for the studies on mammals by 2035. As a result, several stakeholders have opted to modernize their conventional testing methods in order to cope up with the increasing limitations associated with animal models. One such innovative technology, organ-on-chip has the potential to transform the drug discovery process by simulating the human physiological and functional environment on a microfluidic system. The use of such novel testing models in drug discovery and toxicity testing has been steadily increasing. Up till now, several pharmaceutical manufacturers and research institutions have embraced the use of these in vivo like in vitro models; however, a remarkable rise in the adoption rate of these models has been observed since the FDA changed its laws towards putting an end on the animal testing models. , The novel organ-on-chip models have various advantages over the traditional animal-based models, including fine control over microenvironment, lower cost, lesser time, easy to use and portable. , Given the inherent benefits of organ-on-chip technology, a number of players have launched their proprietary products in order to expedite preclinical studies of novel drug interventions across a wide array of disease indications. There are several organ-on-chip models, including lung-on-chip, liver-on-chip, heart-on-chip, brain-on-chip and multiple organ models, which are being offered by various players. Apart from offering efficient user-friendly organ-on-chip models, some developers also offer customization of these models as per the client requests. It is worth mentioning that various developers have made significant efforts in developing organ-on-chip technologies, paving the way for new innovations, primarily integrating artificial intelligence driven technology for early detection of pharmaceuticals and toxicity risks, along with detection of unknown mutations. Driven by promising benefits over animal testing, increasing R&D activity and financial support from investors, the organ-on-chip market is anticipated to grow at a commendable pace in the mid to long term.

SCOPE OF THE REPORTThe Organ-on-Chip Market, 2022-2035: Focus on Products and Technologies - Distribution by Type of Product (Organ(s) based Models and Disease(s) based Models), Application Area (Cancer Research, Drug Discovery and Toxicity Testing, Stem Cell Research and Tissue Engineering and Regenerative Medicine), Purpose (Research and Therapeutic Production), and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of organ-on-chip products and technologies, over the next decade. The report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. In addition to other elements, the study includes:A general introduction of organ-on-chip, including history and development, classification, advantages and limitations and applications and future perspectives of organ-on-chip.A detailed assessment of the current market landscape of organ-on-chips based on a number of relevant parameters, such as type of offering(s) (chip, plate / system, and technology), type of model (organ(s) based and disease(s) based), status of development (commercialized, developed, and under development), type of technology / platform, number of chips in a plate, material used for construction of chip / plate (polymer, glass and silicon), type of polymer (polydimethylsiloxane, cyclic olefin polymer, cyclic olefin copolymer, elastomer, polycarbonate, polypropylene, polystyrene, polyester, tygon, and styrene TEP), compatible tissue / organ, and application area (cancer research, drug discovery and toxicity testing, stem cell research, and tissue engineering and regenerative medicine). In addition, the chapter provides details on the companies engaged in the development of organ-on-chip products and technologies, along with information on their year of establishment, company size and location of headquarters.Elaborate profiles of the key players developing organ-on-chips (which are presently commercialized), which are headquartered in North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, its financial information (if available), organ-on-chip product portfolio, recent developments, and an informed future outlook.An in-depth analysis of various patents that have been filed / granted for organ-on-chip, till 2022, based on various relevant parameters, such as type of patent, publication year, application year, issuing authorities involved, type of organizations, emerging focus area, patent age, CPC symbols, leading patent assignees (in terms of number of patents granted / filed), patent characteristics and geography. It also includes an insightful patent valuation analysis.A detailed brand positioning analysis of the key industry players, highlighting the current perceptions regarding their proprietary products by taking into consideration several relevant aspects, such as experience of the manufacturer, number of products and technologies offered, product diversity, and number of patents published.A study of the various grants that have been awarded to research institutes engaged in projects related to organ-on-chip, between 2017 and 2022, based on parameters, such as year of award, support period, amount awarded, funding institute center, grant type, emerging focus area, type of recipient organization, key regions, and leading recipient organizations.An analysis of the partnerships that have been established since 2017, covering various types of partnerships, such as research and development agreements, clinical trial agreements, product development and commercialization agreements, technology integration agreements, and product development and manufacturing agreements of the companies focused on developing organ-on-chip products and technologies.An analysis of the investments made, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in start-ups / small companies (with less than 50 employees) and mid-sized companies (with 51-200 employees) that are focused on developing organ-on-chip products and technologies.A case study on scaffold-free 3D cell culture products, including hanging drop plate, 3D petri dish, and ultra-low attachment plate, featuring a list of more than 60 products that are being used for research and pharmaceutical testing, based on a number of relevant parameters, such as status of development (commercialized and developed, not commercialized), type of system (suspension system, attachment resistant and microfluidic system), type of product (ultra-low attachment plate, plate, hanging drop plate, chips and dish) and material used for fabrication (chemical / polymer based, human based and plant based).

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of organ-on-chip market. Based on multiple parameters, such as overall 3D cell culture market, and share of organ-on-chip, we have provided informed estimates of the evolution of the market for the period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of type of product (organ(s) based models and disease(s) based models), application area (cancer research, drug discovery and toxicity testing, stem cell research and tissue engineering and regenerative medicine), purpose (research and therapeutic production), key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industrys growth.

The opinions and insights presented in this study were also influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of discussions held with the following individuals (in alphabetical order of company / organization names):Pierre Gaudriault, (Chief Business Development Officer, Cherry Biotech)Matt Dong-Heon Ha (Chief Executive Officer, EDmicBio)Michael Shuler (President, Hesperos)Jelena Vukasinovic (Chief Executive Officer, Lena Biosciences)Maurizio Aiello (Chief Executive Officer, react4life)Michele Zagnoni (Chief Executive Officer, ScreenIn3D)

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

The secondary sources of information include:Annual reportsInvestor presentationsSEC filingsIndustry databasesPress releases from company websitesGovernment policy documentsIndustry analysts views

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

KEY QUESTIONS ANSWEREDWho are the leading players engaged in the development of organ-on-chip products and technologies?What are the different application areas where organ-on-chip can be used?Primarily in which geographical regions, are the organ-on-chip developers located?How has the intellectual property landscape of organ-on-chip, evolved over the years?Which partnership models are commonly adopted by stakeholders in the organ-on-chip domain?What are the investment trends and who are the key investors actively engaged in the research and development of organ-on-chip systems?How is the current and future opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES

Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the organ-on-chip market and its likely evolution in the short to mid-term and long term.

Chapter 3 provides a general introduction to organ-on-chip, covering details on the background of organ-on-chips along with their classification. In addition, it also provides information on various advantages and limitations of such products. It also discusses the various application areas and future perspectives of organ-on-chips market.

Chapter 4 provides a detailed analysis of the current market landscape of organ-on-chips based on a number of relevant parameters, such as type of offering(s) (chip, plate / system, and technology), type of model (organ(s) based and disease(s) based), status of development (commercialized, developed, and under development), type of technology / platform, number of chips in a plate, material used for construction (polymer, glass and silicon), type of polymer (polydimethylsiloxane, cyclo olefin polymer, cyclic olefin copolymer, elastomer, polycarbonate, polypropylene, polysterene, polyester, tygon, and styrene TEP), compatible tissue / organ, and application area (cancer research, drug discovery and toxicity testing, stem cell research, and tissue engineering and regenerative medicine). In addition, the chapter provides details on the companies engaged in the development of organ-on-chip products and technologies, along with information on their year of establishment, company size and location of headquarters.

Chapter 5 features elaborate profiles of the key players engaged in development of organ-on-chip (which are presently commercialized), which are headquartered in North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, its financial information (if available), organ-on-chip product portfolio, recent developments, and an informed future outlook.

Chapter 6 features in-depth analysis of various patents that have been filed / granted for organ-on-chip, till July 2022, highlighting key trends associated with these patents, across type of patents, publication year, application year, issuing authorities involved, type of organizations, emerging focus area, patent age, CPC symbols, leading patent assignees (in terms of number of patents granted / filed), patent characteristics and geography. It also includes an insightful patent valuation analysis.

Chapter 7 features brand positioning analysis of the key industry players, highlighting the current perceptions regarding their proprietary products by taking into consideration several relevant aspects, such as experience of the manufacturer, number of products and technologies offered, product diversity, and number of patents published.

Chapter 8 features study of the various grants that have been awarded to research institutes engaged in projects related to organ-on-chip, between 2017 and 2022, highlighting various important parameters, such as year of grant award, amount awarded, funding institute, support period, type of grant application, purpose of grant, activity code, emerging focus area, study section involved, type of recipient organization, key project leaders, key regions, and leading recipient organizations.

Chapter 9 features analysis of the partnerships that have been established since 2017, covering various parameters such as, research and development, clinical trial agreement, product development and commercialization agreement, technology integration agreement, and product development and manufacturing agreement of the companies focused on developing organ-on-chip products and technologies.

Chapter 10 features analysis of the investments made, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in start-ups / small-sized companies (with less than 50 employees) that are focused on developing organ-on-chip products and technologies.

Chapter 11 is a case study featuring scaffold-free 3D cell culture products, including hanging drop plate, 3D petri dish, and ultra-low attachment plate, featuring a list of more than 60 products that are being used for research and pharmaceutical testing, based on a number of relevant parameters, such as status of development (commercialized and developed, not commercialized), type of system (suspension system, attachment resistant and microfluidic system), type of product (ultra-low attachment plate, plate, hanging drop plate, chips and dish) and material used for fabrication (chemical / polymer based, human based and plant based).

Chapter 12 features an insightful market forecast analysis, highlighting the future potential of the market till 2035. The current and future opportunity has further been segmented on the basis of type of product (organ(s) based models and disease(s) based models), application area (cancer research, drug discovery and toxicity testing, stem cell research and tissue engineering and regenerative medicine), purpose (research and therapeutic production), key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). It is worth mentioning that we adopted a top-down approach for this analysis, backing our claims with relevant datapoints and credible inputs from primary research.

Chapter 13 is the summary of the overall report, which presents insights on the contemporary market trends and the likely evolution of the organ-on-chip market.

Chapter 14 is a collection of interview transcripts of discussions held with various key stakeholders in this market. The chapter provides a brief overview of the company and details of the interview held with Pierre Gaudriault (Chief Business Development Officer, Cherry Biotech), Matt Dong-Heon Ha (Chief Executive Officer, EdmicBio), Michael Shuler (President, Hesperos), Jelena Vukasinovic (Chief Executive Officer, Lena Biosciences), Maurizio Aiello (Chief Executive Officer, react4life) and Michele Zagnoni (Chief Executive Officer, ScreenIn3D).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 16 is an appendix, which contains the list of companies and organizations mentioned in the report.Read the full report: https://www.reportlinker.com/p06323408/?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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Organ on a Chip Market - Focus on Products and Technologies - Distribution by Type of Product, Application Area, Purpose, and Key Geographical Regions...

October 3, 2022

When most people think of civil engineering, images of construction sites, bridges and tunnels will likely come to mind. However, a recent collaboration between Arizona State University and Mayo Clinic is placing civil engineers in a new light.

There is a huge world out there where engineers can use their skills in areas that are traditionally not associated with civil engineering, says Subramaniam Subby Rajan, a civil engineering professor in the Ira A. Fulton Schools of Engineering at ASU.

Putting that concept to the test, Rajan has spearheaded a number of projects in the School of Sustainable Engineering and the Built Environment, part of the Fulton Schools, with private companies such as Honeywell and Raytheon and government organizations such as the Federal Aviation Administration and NASA. He has aided in the materials testing of everything from jet engines to bulletproof vests efforts that have not only expanded his knowledge of civil engineering, but also that of his students and research assistants who get to participate in the studies as well.

If you ask a person on the street or even a practicing civil engineer whether civil engineering skills can be used in answering questions dealing with bone fractures, the answer will inevitably be 'no'; there is not a connection between the two. However, there are a lot of connections, Rajan says.

In his latest research project, Rajan is using his civil engineering expertise to help forensic researchers draw more accurate conclusions about the impact of trauma made on the human body.

Video by Steve Filmer/ASU Media Relations

Subramaniam Subby Rajan

With a long track record of applying civil engineering mechanics to diverse research projects, Rajan was contacted by researchers at Mayo Clinic in Arizona. The team is actively working on a project that could redefine the process for identifying trauma made to human remains. More specifically, the research could allow forensic anthropologists to determine the time at which blunt-force trauma may have occurred to a human body with greater precision and, ultimately, if the trauma played a role in a person's death.

This work is important to forensic scientists because knowing whether a fracture occurred perimortem at or around the time of death versus postmortem can give us important information about the cause and manner of death with crime scene investigations, says Natalie Langley, a consultant in the Department of Laboratory Medicine and Pathology at Mayo Clinic in Arizona and president of the American Board of Forensic Anthropology.

The collaborative team at Mayo Clinic also includes researchers from the Center for Regenerative Medicine in Arizona, the Biomaterials and Histomorphometry Core Laboratory at Mayo Clinic Rochester, Mayo Clinic postdoctoral research fellow Jessica Skinner and ASU's Barrett, The Honors College graduate intern Yuktha Shanavas.

Langley explains that femur bones are sourced from males between the ages of 50 and 80 who donated their bodies to scientific research. Those demographic variables were chosen to control for sex- and age-related compositional differences in bone. The bones are then heated at controlled temperature and humidity for varying amounts of time to simulate the loss of elasticity that bones experience during the postmortem interval.

Bone is an elastic material, and it maintains elasticity for some time after death, Langley says. By heating the bone, we are able to replicate longer periods of time after death that commonly lead to a bone losing some elasticity, leaving different fracture patterns than if it were broken while still elastic.

A layer of spray paint is also applied to the surface of the bones so high-speed cameras can detect deformation and surface strain that occur during the impact testing.

Donated femur bones are coated in a black-and-white speckled spray paint that allows high-speed cameras to capture the deformations on the surface of the sample during fracture testing. Photo by Monica Williams/ASU

Langley says her team needed help minimizing the unknowns in their research.

I contacted ASU initially because we needed an impact tester to induce fractures in a controlled manner, she says.

Rajans team and Mayo Clinic researchers created a special apparatus to hold a fragment of femur bone to allow for an impactor to drop at a controlled and monitored rate.

These are impacts that are strong enough to break a bone, but they are not as high velocity as a gunshot wound, Langley says. We even take it one step further and use high-speed photography to measure, or track, the movement of the bone during the fracture process.

This allows her team to consider what forces are being distributed across the bone.

Once the bone is fractured, it is handed back over to Langley and her team for a thorough review and documentation of the fracture characteristics.

One of the things we look at is the pattern of the fracture, Langley says. Fractures that occur at or around the time of death have a certain appearance; and those that occur much longer after death, when the bone is not as elastic, have a different appearance.

We captured 5,000 frames per second and were able to tell where the weight struck the bone and where the cracks were propagating in the bone, says Ashutosh Maurya, a graduate research associate who volunteered to participate in the bone testing.

Maurya is completing his doctorate in civil, sustainable and environmental engineering in the Fulton Schools. Despite the bone testing research having a different focus from his dissertation work, he felt it was a great opportunity to expand his skills as he explores impact dynamics problems connected to aircraft structures.

If you look at almost any research, you will see people from different areas working together, Maurya says. This will definitely help me in my future career as I collaborate with non-engineering background professionals and manage projects across disciplines.

Ashutosh Maurya, a doctoral student of civil, sustainable and environmental engineering, volunteered to participate in the collaboration with Mayo Clinic in hopes of expanding his experience working with individuals in different research fields. Photo by Monica Williams/ASU

It is a philosophy Mauryas mentor Rajan has tried to instill in all of the students that pass through his classroom.

It's only when you start looking at the fundamental tools that are used across all these different problems, that you find there are a lot of commonalities, Rajan says. For this specific project, we are able to make an impact beyond what is commonly expected of civil engineers.

In the coming months, Langley and her team will be compiling data from the fracture testing, tracking formations and markings left in the bones at different intervals of drying. The results will then be used to create a new standard for determining when trauma was inflicted on a crime victim.

Working with Rajan and his team allowed us to think outside of the box of our own work, Langley says. Their knowledge in controlling the variables with forcefully creating fractures gives validity to our work, ultimately changing the process for solving crimes and giving closure to families.

Top photo:Natalie Langley, a consultant in the Department of Laboratory Medicine and Pathology at Mayo Clinic in Arizona, applies fingerprint powder to a fractured bone to help see fracture surface markings left by an impact. These markings are then documented to help create a new set of criteria for determining the timing of fracture events (e.g., perimortem versus postmortem). Photo by Monica Williams/ASU

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Tulsa, OK - (NewMediaWire) - September 23, 2022 - via QC Kinetix - QC Kinetix (Riverside Parkway) provides customized treatment plans to treat pain and injuries naturally and offers free consultations.

Pain from injuries, accidents, and diseases is unpleasant and potentially destructive to one's personal and professional life. Physicians often recommend surgeries and prescribe addictive pain medications when patients' pains persist. While these interventions are helpful, technological advancement and research have provided more efficient and less invasive ways of treating pain and injuries. One of the modern solutions is the use of regenerative medicine, which has a broad spectrum of minimally invasive procedures to treat mild and severe body pain.

QC Kinetix (Riverside Parkway) uses regenerative medicine to treat pain and injuries naturally. The biologic therapies help the body heal faster than normal by stimulating its natural healing abilities. In addition, the therapies strengthen the tendons, ligaments, and cartilage to avoid re-injury. These treatments are minimally invasive yet have long-lasting results to improve function and quality of life. They treat many conditions, including pain in the knee, wrists, shoulder, back, hip, and other body parts, QC Kinetix (Riverside Parkway) also has solutions for pain caused by degenerative conditions like arthritis to relieve pain and inflammation in large and smaller joints.

The pain control clinic's therapies address symptoms like limited joint mobility, stiffness, swelling, redness and warmth, knee cracking, popping, and grinding, among others. The treatments have long-lasting results and may be an alternative for knee repair and knee replacement surgeries. QC Kinetix (Riverside Parkway) offers free consultation services with one of their physicians. The consultations help patients to know whether they are eligible for regenerative medicine and inform them on the most useful therapies for their condition. During the session, the physicians investigate patients' medical history and may require additional tests to diagnose.

The treatments barely have any downtime once the healing process begins, which allows patients to get back to their normal lives faster than they would have if they had surgery. The pain control clinic provides personalized concierge-level service for logistical support for patients when receiving treatments at the facility. The physicians provide follow-up services to ensure treatments work as expected and make any necessary adjustments promptly. They keep patients informed at every step of the process, eliminating ambiguity.

QC Kinetix (Riverside Parkway) has an entire department dedicated to sports medicine to treat sports injuries like golfer's elbow, torn meniscus, torn rotator cuff, torn ACL and MCL, among others. Their sports medicine therapies are ideal when the common advice of rest, ice, compression, and elevation has failed. The clinic combines traditional sports injury treatment, rest, and bracing with regenerative medicine for optimal results. They have partnered with sports athletes like Elliot Smith, who are among the hundreds of patients that have benefited from their therapies.

The clinic has a team of board-certified physicians with extensive experience in regenerative medicine. They use advanced technologies like laser therapy and modern equipment and tools to improve the accuracy of their diagnoses and treatments. The regenerative medicine industry is among the most rapidly growing industries, and the pain control clinic has adopted a continuous learning policy that allows them to keep up to date and adapt new, evidenced techniques that can improve their patient outcomes.

The clinic representative had this to say regarding their services, "At QC Kinetix in Tulsa, OK, we are proud to offer a vast selection of regenerative treatments, helping patients of all ages avoid expensive surgeries and invasive methods. Whether your pain is due to degenerative conditions, poor body posture, repetitive movement, or a sports injury, we will find a way to relieve your symptoms and restore your movement."

The regenerative medicine provider does not believe in a one-size-fits-all approach and instead develops customized treatment plans for each patient based on their health needs. They incorporate patient values and feedback into these treatment plans and maintain a high level of engagement between them and their patients. Patients can avoid the long recovery periods and high costs commonly associated with invasive procedures through their treatments.

QC Kinetix (Riverside Parkway) is located at 9716 Riverside Pkwy, Suite 101, Tulsa, OK, 74137, US. For consultation and booking, contact their staff by calling (918) 990-9200. Visit the company website to learn more about their Tulsa office and for more information on their regenerative medicine treatments that naturally heal damaged tissues resulting in pain relief.

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Company Name: QC Kinetix (Riverside Parkway)

Contact Person: Scott Hoots

Phone: (918) 990-9200

Address: 9716 Riverside Pkwy, Suite 101

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State: OK

Postal Code: 74137

Country: US

Website: https://qckinetix.com/tulsa/riverside-pkwy/

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A new approach is paving the way for improved stem cell therapies and regenerative applications using cells from pigs. Led by Wan-Ju Li, a SCRMC researcher and associate professor in the Department of Orthopedics and Rehabilitation and the Department of Biomedical Engineering, this new study published in Scientific Reports offers a viable strategy to enhance the generation of induced pluripotent stem cellsfrom large animal cells and provides researchers with insight into the underlying mechanism controlling the reprogramming efficiency of cells. In turn, this approach will allow researchers to reprogram cells more efficiently into iPSCs which can be used to study regenerative therapies aimed at treating everything from osteoarthritis to heart disease.

While this approach can be applied to regenerative therapies targeting any organ or tissue, Li and his Musculoskeletal Biology and Regenerative Medicine Laboratory study cartilage, so he developed the model by deriving iPSCs from the fibroblast cells of three different breeds of miniature pigs including Wisconsin miniature swine, Yucatan miniature swineand Gttingen minipigs. Fibroblast cells are easily obtained for cellular reprogramming and Li is interested in using these cells to efficiently develop cartilage cells that can be used to help patients experiencing osteoarthritis. But, while his goal for the study was specific, the model has wide-reaching implications.

"This model we created can be used for many applications," says Li. "In successfully developing iPSCs from three different breeds of minipigs, we learned we can take somatic skin cells from these pigs that we programmed ourselves into iPSCs and then inject them back into the same animal to treat the disease. Or we can take the cell that carried the disease gene and put that into the culture dish and use that as a disease model to study disease formation."

Li explained that iPSCs can be created from nearly any type of somatic cell, such as skin or blood cells, that are reprogrammed back into an embryonic-like pluripotent cells. These pluripotent stem cells are the bodys master cells and are, therefore, able to become nearly any cell in the body. Harnessing the power of such a cell and being able to grow these versatile cells in the lab is invaluable to medicine as these cells can be used for the regeneration or repair of damaged tissue and in drug testing to see how medication will impact heart, liver, or other cells within the body.

Through this research, Li and his lab have provided researchers with insight into the underlying mechanism controlling the reprogramming efficiency of iPSCs, allowing researchers to harness to power of iPSCs and develop them more efficiently. Specifically, he discovered that the expression level of the switch/sucrose nonfermentable component BAF60A, which is essentially a protein that can remodel the way DNA is packaged, helps to determine the efficiency of iPSC generation. He also noted that the BAF60A is regulated by STAT3, a transcription factor protein that plays a role in cell growth and death. Through this, Li discovered that the efficiency of iPSC generation is based on the expression level of these proteins and that the expression levels vary among pig breeds.

"While we successfully developed iPSCs and programmed iPSCs from the three different strains of pig, we noticed that some pigs had a higher reprogramming efficiency,"says Li. "So, the second part of our findings, which is significant in biology, is understanding how these differences occur and why."

Li shared that understanding why different pig breeds have varying levels of reprogramming efficiency will directly translate to understanding differences in the effectiveness of iPSC generation between individual humans. In fact, a previous study by Mackey et al., has shown that a person's ethnicity may impact their cell's reprogramming efficiency. So, understanding what mechanisms control cellular reprogramming will be crucial to developing effective protocols of iPSC generation for individualized therapies.

"With this model, we can study musculoskeletal regeneration particularly cartilage regeneration for osteoarthritis patient,"says Li. "But we think the impact is way beyond the application of orthopedics because from now on, anybody on campus who is interested in using the technology we have developed for a minipig model, can reprogram their cells into iPSCs and then these cells and the animal can be used to investigate heart disease, kidney disease, neuronal diseaseor any type of a disease."

Translating this research to improve human health, is deeply important to Li. He has spent much of his career studying novel approaches to regenerate cartilage and bone for orthopedic applications and developing a translational model like this means that science is one step closer to healing more patients using stem cells.

"I feel really touched by the stories people share. You cannot imagine how many emails come in asking me if they can become the first human patient in our future clinical trial,"Li says. "People are in desperate need for something, especially when those people feel the current surgical procedure or intervention is not suitable for them. I have to keep saying, 'wait for another two, three years, maybe we'll be ready for a clinical trial,'but for me, it's time to move on and really do our larger animal studies to fulfill our promise. At least that way, I can fill the gap between the lab and clinical trials as the larger animals must be studied before you go into a clinical trial."

Li's development of a reliable and translational model for the generation of iPSCs in a large animal is critical as it has been a challenge to generate pig iPSCs with efficiency. The reprogramming efficiency of pig cells is relatively low compared to that of human or mouse cells, but large animal studies remain a crucial step in bringing treatments to clinical trials.

Interest in moving these treatments forward has grown and while this study was funded in part by NIH, Li also received support from the Plunkett Family Foundation in Milwaukee through their donation to the UW Stem Cell and Regenerative Medicine Center. After hearing of Li's research, Gwen Plunkett and her daughter Karen visited Li and his lab in 2019 to learn more and were inspired to support research into stem cells for cartilage regeneration.

"Innovation in medicine sparks critical change, for the world and the survival of our species and the Plunkett Family mission is to be a catalyst in stem cell and regenerative medicine research,"says Karen Plunkett. "We supported Jamie Thomson's lab in the early days when federal funding for human stem cell research was restricted. More recently, we continued our commitment to this research by supporting Dr. Wan-Ju Li's stem-cell based approaches for regenerating skeletal tissues, cartilageand bone for orthopedic applications. Additionally, it is personally gratifying to be able to support the SCRMC while my son completes his senior year studying neurobiology at UWMadison.We are happy to be part of the University of Wisconsin family."

Li shared that the donation was profoundly impactful and allowed him to further his goal of using stem cells to help patients struggling with osteoarthritis as well as other joint diseases.

"I want to make sure that our findings in stem cell research can be used to help people,"says Li. "I just feel this internal drive to study this area and I feel good knowing this model carries significant weight in terms of its potential for translational stem cell research and the development of therapeutic treatments."

This research was supported by grants from the National Institutes of Health (R01 AR064803) and the Plunkett Family Foundation. The UW Department of Pathology and Laboratory Medicine and UWCCC (P30 CA014520) and the Small Animal Imaging andRadiotherapy Facility and Flow Cytometry Laboratory, supported by UWCCC (P30 CA014520) also provided facilities and services.

Source: University of Wisconsin-Madison, whichis solely responsible for the information provided, and wholly owns the information. Informa Business Media and all its subsidiaries are not responsiblefor any of the contentcontained in this information asset.

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Reprogramming pig cells leads way for new regenerative therapies - National Hog Farmer

This week, researchers delivered insights and breakthroughs in regenerative medicine, Long COVID, immuno-oncology and inflammatory diseases.

Epigenetic Treatment Shows Potential in Spinal Cord Regeneration

Researchers reported that activation of the CBP/p300 protein family led to increased axon growth, regenerative signaling and synaptic plasticity in the spinal cord after injury in mice.

The study, led by Imperial College London,used a molecule called TTK21 to activate the genetic program to induce axon regeneration in neurons. During this process, TTK21 changes the epigenetic state by activating the CBP/p300 family of co-activator proteins, effectively leading to increased axon regeneration.

In the study, researchers began treating the mice 12 weeks after severe spinal cord injury and continued for 10 weeks. They found axon sprouting in the spinal cord and retraction of motor neurons above the injury. These changes are believed to have been spurred by increased gene expression related to regeneration, which the researchers attributed to the TTK21 treatment.

The results, while early and limited, are a step toward potential treatments for spinal cord injury.

The next steps will be to enhance the effects of the treatments and trigger the regenerated axons to connect to the rest of the nervous system. The ultimate goal is to enable animals, and eventually people, to regain movement lost from their injuries.

Neurological Consequences Evident in Long-Term COVID Study

In a recent attempt to decode the long-term impacts of COVID-19, researchers built a dataset fromthe national healthcare databases of the US Department of Veterans Affairs.

The study,led by the Clinical Epidemiology Center, Research and Development Service at VA St. Louis Health Care System,included154,068 individuals with COVID-19, 5,638,795 contemporary controls and 5,859,621 historical controls.

Results were published Thursday in Nature Medicine.

Upon examination of the data sets, the researchers noted an increased risk in a series of neurological consequences. These included: ischemic and hemorrhagic strokes, episodic disorders, extrapyramidal and movement disorders, mental health disorders, musculoskeletal disorders, sensory disorders, Guillain-Barr syndrome and encephalitis or encephalopathy.

They estimated a hazard ratio of 1.42 neurological sequelae per thousand COVID-19 cases, and 70.69 burdens per 1,000 cases.

These numbers were not impacted by the severity of the infection or the need for hospitalization. The researchers note the sample set comprised a majority of white men, so further exploration into other demographic groups may be necessary for future studies.

Novo Nordisk and Octagon Unite on Inflammatory R&D

Octagon Therapeutics, a pre-clinical biopharmaceutical focused on autoimmune disease, announced the initiation of a multi-year research collaboration with Novo Nordiskto studypotential treatments for inflammatory diseases.

Octagon will bring its functional target discovery approach and novel chemistry approach, while Novo will contribute its specific disease expertise.

Uli Stilz, vice president of the Bio-Innovation Hub at Novo Nordisk, commented on the synergies.

Combined with our disease understanding in the cardiometabolic space and Octagons approach in targeting specific lymphocyte populations that drive disease progression, it will be exciting to see what therapeutic discoveries the collaboration can lead to, he said.

Regen's RNA/DNA-Based Cancer Immunotherapy

Regen BioPharmaannounced the filing of a provisional patent application for its RNA/DNA-based approach to cancer immunotherapy.

The patent pertains to what Regen believes is the first combination of an immunotherapy and a gene silencing agent in a single drug.

The novel composition acts as a checkpoint inhibitor drug that also silences the genes that regulate T-cells and cancer cells such as NR2F6 and Survivin.

The new drug takes advantage of aptamers - a short RNA or DNA sequence that can also function as an antibody, recognizing specific proteins and binding to them. The proprietary sequence codes for inhibitory RNA, while keeping the aptamer intact on the other side. When it binds to a checkpoint such as PD-1, that RNA is converted within the cell, thus killing it.

Used to target cancer cells, this could lead to better disease control and treatment. There is also hope that this process could be used to activate T cells, improving their immunotherapeutic potential.

Toronto-Based Researchers Uncover Potential Solve for CAR T Toxicities

Allogeneic double-negative (DN) chimeric antigen receptor (CAR)-T cells inhibit tumor growth without off-tumor toxicities, a new study found.

Current CAR-T therapies approved by the FDA in treating blood cancers are limited by their level of toxicity and cost of production. Researchers from the Toronto General Hospital Research Institute, University Health Network, reported a new version of these therapies that did not have these drawbacks.

The researchers found healthy donor-derived allogeneic DNTs as a CAR-T cell therapy platform had high levels of efficacy in both the human and mouse models.

The researchers found the DN CAR-T cells were as effective as previously studied CAR-T cells but did not have the associated toxicity levels. They also come with the advantage of being made from mixed donors and remained effective even after being frozen for long periods of time. This feature could potentially overcome manufacturing challenges in the space.

The authors noted these features make DN CAR-T cellsan attractive off-the-shelf CAR-T cell therapy option.

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Wellness and Esthetics Expert, Dr. Giselle M. Batcheller, In #1 Selling Medical Book Worldwide

Park City, Utah local and owner of Wellness and Esthetics and CARE Esthetics Utah, Dr. Giselle M. Batcheller, is featured in Quintessences 2022 #1 Selling Book Worldwide, CARE Esthetics.

Although the book was just published earlier this year, the new book written about the latest technologies in dermatology, orthopedics, regenerative medicine, and facial esthetics quickly catapulted to the number one selling spot for Quintessence.

Dr. Batcheller explains, CARE Esthetics outlines the latest technologies in regenerative medicine and facial esthetics. Quintessence historically publishes texts for doctors, yet because of the vast interest, CARE Esthetics was published for the clients of the esthetics community. That shows how highly sought after this information is.

Dr. Batcheller believes this trend will continue. Natural solutions and regenerative medicine and esthetics is a hot topic. Everyonenot just the clinicianwants to know about it. This is the future of medicine and aesthetics, and it is a very exciting future!

Dr. Batcheller provides a variety of services at Wellness and Esthetics in Park City with the most cutting edge technologies and world class equipment.

Wellness and Esthetics menu includes a variety of treatments for both health and aesthetics including PRF injections, full body (and localized) light therapy called photobiomodulation, strength-based body contouring that reduces both visceral and subcutaneous fat naturally. In addition, there are wellness enhancing laser treatments of the airway for athletic performance and Obstructive Sleep Apnea, non-surgical cavitation treatments, scar revisions, regenerative joint injections, natural treatments for non-invasive pelvic floor strengthening, and more.

Dr. Giselle M. Batcheller (DDS, NMD) and her clients are putting Park Citys Wellness and Esthetics community on the global map for advanced regenerative medicine in 2022. Dr. Batchellers passion is helping her clients look and feel their best in the most healthy and natural ways possible.

Dr. Batcheller was the first doctor in Utah to use these advanced protocols discussed in CARE Esthetics. Dr. Batcheller has been working in natural and holistic medicine since 2011. She started performing regenerative medicine and all-natural esthetics procedures with lasers and smart blood concentrate technologies in 2018. Since then, Dr. Batcheller has taught these sought after methods to dozens of prestigious doctors and providers from across the United States as well as locally throughout Utah as theyve been advancing. Dr. Batcheller has received accolades from world experts in her industry. She has been widely recognized and sought after to teach and to perform her services. She has called Park City home since 2016, and after providing these services throughout Utah and on the East Coast, shes delighted to bring her gifts to her Wellness and Esthetics office in Park City.

CARE is the acronym for the Center for Advanced Rejuvenation and Esthetics, and the book is written about a the technologies offered in CARE Esthetics centers.

Quintessence International Publishing Group is a scientific and clinical publishing company with publishing houses in 14 countries. Theyve produced more than 1,500 books from more than 3,000 authors.

Media ContactCompany Name: Wellness and Esthetics + CARE EstheticsContact Person: Dr. Giselle M. BatchellerEmail: Send EmailPhone: 833.411.4PRF (833.411.4773)Country: United StatesWebsite: https://wellnessandesthetics.com/

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MIAMI, FL / ACCESSWIRE / September 20, 2022 / Organicell Regenerative Medicine, Inc. (OTCQB:OCEL), a clinical-stage biopharmaceutical company focused on the development of innovative biological therapeutics and regenerative medicine, announced that the Company has recruited a new Chief Operating Officer, Chief Information Officer, and Director of Finance.

Organicell's new Chief Operating Officer, Ryan Likes, has previously served as Co-Chief Operating Officer of Super Deluxe, a division of Turner Broadcasting, and Chief of Operations and Business Affairs of Televisa USA, the English language division of Grupo Televisa. Ryan has a juris doctorate from the Yale Law School and started his career as a corporate attorney in the Century City office of O'Melveny and Myers specializing in Mergers & Acquisitions and Finance.

Organicell's new Chief Information Officer, David Aciego, formerly served as Chief Information Officer of HTCS Corp, a managed source provider for technical services. Throughout his career,

Mr. Aciego has designed multiple systems including proprietary Enterprise Resource Planning (ERP) and Customer Relationship Management (CRP) solutions which enabled the streamlining of ordering deficiencies between different organizations and third-party distributors. Mr. Aciego has been programming since the age of seventeen and has worked with Cisco, IBM, Dell, Microsoft, Fortinet, and Meraki. Mr. Aciego served in the United States Marine Corps where he worked as an engineer on the implementation of network technologies.

Jacqueline (Jackie) Domenech, Director of Finance for Organicell, has over 10 years of Controllership experience in various healthcare and technology companies - including a recent Controller role at MD LIVE. She has successfully led transitions from outsourced accounting providers and implemented ERP systems.

Matt Sinnreich, who joined Organicell in August of 2022 as Chief Operating Officer and Acting Chief Executive Officer, will continue as President and Acting Chief Executive Officer.

Story continues

Mr. Sinnreich said, "At this stage of growth it is necessary to invest in people that can handle specific tasks and responsibilities. I am a believer in creating systems for every facet of a business that can be taught, duplicated, and scaled. I made these strategic hires to surround myself with talent with specific core-competencies in the areas of the company that needed enhancement.

Over the past few months, we have consulted with our department heads and long-term employees to identify where we as a company can improve efficiency, cut costs, and manage risk."

Sinnreich continued, "The first thing we needed was someone to help centrally manage operations and interface with our legal team. Hence, our COO hire had to be not only an experienced COO in large companies, but also a lawyer by trade. Ryan Likes has the skill sets to assist in creating processes throughout the organization and provide a completely different perspective on deal making. The deals we are working on in business development and recruiting other key additions to our team are similar in structure and milestones to talent and entertainment deals, so Ryan's experience and education will be a tremendous asset.

Next, we needed a robust Enterprise Resource Planning (ERP) system and Customer Relationship Management (CRM) system that can handle our current needs and scale with the Company's growth plan. David Aciego is running point on the development of a fully integrated, HIPAA compliant, ERP + CRM system that is currently being built on the Microsoft Dynamics platform. Data collection and management, coupled with the ability to automate Organicell's forecasting, inventory management, and staff needs, is essential in helping our company scale."

Sinnreich concluded, "Finally, our CFO needed support to better service our staff's budgetary needs to focus on the high-level compliance work and financial reporting that comes along with a publicly traded company. The Company needed systems and regulations put in place to manage and track expenses. Companies at this growth-stage rely on active and accurate cash management to expand and thrive. Jackie is highly experienced in this department with a proven track record and we believe that she will be an incredible asset to this Company."

Future Press Releases and Updates

Investors interested in receiving periodic press releases and updates are encouraged to

send an e-mail to ir@organicell.com

About Organicell Regenerative Medicines, Inc.

Organicell Regenerative Medicine, Inc. (OTCQB:OCEL) is a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics for the treatment of degenerative diseases and the provision of other related services. The Company's proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. To learn more, please visit https://organicell.com/.

Forward-Looking Statements

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

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Organicell Investor Relations1-888-963-7881 Ext.701IR@organicell.com

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Organicell Regenerative Medicine, Inc. Announces Expansion of Management Team - Yahoo Finance

Clinical assessments three-months post-treatment report no serious adverse events and reduced seizure frequency to date in first trial participant

Data Safety Monitoring Board clears advancement of trial to continue enrollment

Pioneering cell therapy approach could provide a disease-modifying treatment for drug-resistant focal epilepsy

Data presented at ISSCR-ASGCT Conference: Emerging Therapies at the Intersection of Genetic and Cellular Technologies

SAN FRANCISCO, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapies for the treatment of neurological disorders, today announced the presentation of a clinical case study from the initial dose cohort of the Phase 1/2 first-in-human epilepsy clinical trial of its lead program, NRTX-1001. The data from three months post-cell therapy administration to the first patient in this study show that there were no serious adverse events associated with NRTX-1001 treatment and that the patient has thus far experienced reduced seizure frequency from an average prior history of 30+ seizures per month to four seizures in total during three months of follow-up to date. The data are being presented by Catherine Priest, Ph.D., Neuronas chief development officer at the ISSCR-ASGCT Conference: Emerging Therapies at the Intersection of Genetic and Cellular Technologies being held in Madison, WI, September 21 -23, 2022.

The reduced number of seizures reported by the first person to receive NRTX-1001 is very encouraging, and we remain cautiously optimistic that this reduction in seizure frequency will continue and extend to others entering this cell therapy trial. NRTX-1001 administration has been well tolerated thus far in the clinic, which is in line with the extensive preclinical safety data collected by the Neurona team, said Cory R. Nicholas, Ph.D. Neuronas president and chief executive officer. With recent clearance from the Data Safety Monitoring Board we are excited to continue patient enrollment. We are very grateful to these first participants, and thank the clinical teams for the careful execution of this pioneering study.

In addition to the preclinical data supporting the clinical program, the presentation highlights initial data from the first patient treated in Neuronas clinical trial who received a starting dose of NRTX-1001. The patient is a young adult male with a 9-year history of seizures and was diagnosed with unilateral mesial temporal lobe epilepsy (MTLE). In the six months prior to the administration of NRTX-1001, the patient experienced an average of 32 seizures per month, despite being on several antiepileptic medications. The patient received NRTX-1001, and the treatment was well tolerated; there have been no serious adverse events to date. The patient has reported having four seizures during the first three months since receiving NRTX-1001.

The clinical trial is funded in part by the California Institute for Regenerative Medicine (DISC2-10525; TRAN1-11611; CLIN2-13355).

About Neuronas Clinical Trial of NRTX-1001 for Mesial Temporal Lobe Epilepsy (MTLE)Neuronas multicenter, Phase 1/2 clinical trial is designed to evaluate the safety and efficacy of a single administration of NRTX-1001 for drug-resistant MTLE. The first stage of the trial is an open-label dose-escalation study in up to 10 people with MTLE, with five patients to be treated at a starting dose and five at a higher dose. Patients treated with a single infusion of NRTX-1001 cells will be monitored for safety, tolerability, and effects on their epilepsy disease symptoms. Patient recruitment is underway at epilepsy centers across the United States. For more information, please visit http://www.clinicaltrials.gov (NCT05135091). The first part of the clinical trial is supported by a recently announced $8.0 million grant from the California Institute for Regenerative Medicine (CIRM; CLIN2-13355).

About NRTX-1001NRTX-1001 is a regenerative neural cell therapy candidate derived from human pluripotent stem cells. The fully-differentiated neural cells, called interneurons, secrete the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Delivered as a one-time dose, the human interneurons are intended to integrate and innervate on-target, providing long-term GABAergic inhibition to repair hyper-excitable neural networks.

About Mesial Temporal Lobe Epilepsy (MTLE)An estimated three million Americans have epilepsy, and 25 to 35 percent live with ongoing seizures despite treatment with approved drugs, which means that there is a huge unmet medical need in this community. MTLE is the most common type of focal epilepsy in adults and primarily affects the internal structures of the temporal lobe, where seizures often begin in a structure called the hippocampus. For people with seizures that are resistant to anti-seizure drugs, epilepsy surgery, where the damaged temporal lobe is surgically removed or ablated by laser, can be an option. However, the current surgical options are not available or effective for all, are tissue-destructive, and can have significant adverse effects.

About NeuronaNeuronas regenerative cell therapy candidates have single-dose curative potential. Neurona is developing off-the-shelf, allogeneic neuronal, glial, and gene-edited cell therapy candidates that are designed to provide long-term repair of dysfunctional neural networks for multiple neurological disorders. For more information about Neurona, visit http://www.neuronatherapeutics.com

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Neurona Therapeutics Presents Clinical Case Study from First Human Trial of Regenerative Cell Therapy, NRTX-1001, in Adults with Drug-Resistant Focal...