Category Archives: Regenerative Medicine

MCLEAN, Va.--(BUSINESS WIRE)--The Thought Leadership & Innovation Foundation (TLI) announces today plans to build on its existing Regenerative Medicine Program through a research collaboration with cellular therapy industry leader RenovaCare. As part of TLIs efforts to conduct vital research in regenerative medicine and chronic disease, this initiative aims to innovate methods for reducing complications from burn and diabetic wounds across large populations.

Our research base, collaborative institutions and long history of innovation align with RenovaCares commitment to breakthrough biomedical technologies, says Bill Oldham, founder and chairman of the Board, TLI. The patented RenovaCare SkinGun technology and its ability to ultra-gently spray stem cells could present a special opportunity for investigations and applications in a wide range of regenerative therapies. Working together, our overall goal is to improve the quality, efficiency and effectiveness of patient care by not only developing new treatment methods, but also by making thoughtful and systematic changes to healthcare and health systems.

TLIs Regenerative Medicine program seeks to adapt new strategies based upon sound scientific evidence, utilizing its infrastructure to support the continuation of scientific and medical work, as well as the development of grant-funded research and other initiatives.

Dr. Robin A. Robinson, who is a TLI Fellow, Vice President of Scientific Affairs, RenovaCare, and named one of the top 100 innovators in medicine by Medicine Maker in 2018, states, This exciting collaboration between RenovaCare and TLIs Regenerative Medicine Program is the first step toward the development of meaningful and quality therapeutic treatments that will benefit patients around the world.

About TLI Foundation:

TLI Foundation is a nonprofit foundation focused on driving innovative thinking and action on global issues relating to health, education and economic empowerment. The organization is committed to fostering transformative change and improving the health and well-being outcomes of communities around the world. Visit https://www.thoughtfoundation.org/

About RenovaCare:

RenovaCare, Inc. is a biotechnology company focused on developing first-of-their-kind autologous (self-donated) stem cell therapies for the regeneration of human organs. Initial products under development target the bodys largest organ, the skin. Investigative clinical use of their flagship technology has shown to be promising new alternatives for patients suffering from burns, and chronic and acute wounds. https://www.renovacareinc.com.

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Thought Leadership & Innovation Foundation to Expand Its Regenerative Medicine Program Through New Collaboration with RenovaCare - Business Wire

Global Sausage Stuffers Market Report 2019 Market Size, Share, Price, Trend and Forecast is a professional and in-depth study on the current state of the global Sausage Stuffers industry.

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Regenerative Medicine Market 2019 overview, segmentation, top key companies, market size and trends by 2025 - Health News Office

The company is an Australian clinical-stage stem cell and regenerative medicine corporation focused on the development of therapies based on Cymerus a therapeutic stem cell platform technology.

() has been awarded a Federal GovernmentInnovations Connections grant to advance development of therapies based on itsCymerus technology platform for the treatment of coronary artery disease (CAD).

CAD, which is the narrowing or blockage of the arteries in the heart, causes the majority of heart attacks and about one-third of all deaths in people over the age of 35 in developed countries.

The Innovations Connections grant of $50,000 is supported by the Australian Governments Department of Industry Innovation and Science.

These funds will be used to support the continuation of research at the University of NSW in Sydney under the leadership of Associate Professor Kristopher Kilian, ARC future fellow at the UNSW School of Chemistry and School of Materials Science and Engineering.

Cynata's chief operating officer Dr Kilian Kelly said: We are very pleased to receive this non-dilutive funding which enables us to further our research into the development of customised MSCs that address CAD before a heart attack occurs.

Associate Professor Kristopher Kilian and his team have already demonstrated the potential value of this approach and we now look forward to generating further data in support of a future clinical trial.

Thisfurther research leads on from a collaborative project with this group which started in 2018 and identified optimal cell culture matrices to stimulate the growth of new blood vessels.

These positive effects were demonstrated in a well-established in vitro assay and were maintained after the cells were frozen and then thawed, which is important from a commercialisation perspective.

The additional project, which is expected to complete by the end of 2020, seeks to build on the previous findings by profiling the pro-angiogenic factors released from the primed MSCs, establish the ability of primed cells to promote new blood vessel formation in vivo, followed by in vivo safety and efficacy in a preclinical model.

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Cynata Therapeutics awarded grant to progress stem cell therapies for coronary artery disease - Proactive Investors Australia

The Global Medical Waste Managementmarket research report added by Report Ocean, is an in-depth analysis of the latest trends, market size, status, upcoming technologies, industry drivers, challenges, regulatory policies, with key company profiles and strategies of players. The research study provides market introduction, Medical Waste Management market definition, regional market scope, sales and revenue by region, manufacturing cost analysis, Industrial Chain, market effect factors analysis, Medical Waste Management market size forecast, 100+ market data, Tables, Pie Chart, Graphs and Figures, and many more for business intelligence.

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Awareness among people regarding the disposal of medical waste, and taking care of their safety from harmful medical waste are the major trend currently driving the market growth. Regulated waste disposal generally costs more than unregulated waste disposal. Growth of the overall medical and healthcare industry is driving the demand for medical waste management systems. In the U.S. and European countries, due to strict regulations, most medical waste management service providers require government permits, approvals, certificates from all jurisdictions in which they operate. In India, the Ministry of Environment and Forests (MoEF), Government of India, declare the Medical waste management and Handling Rules, 1998 and the Bio-Medical Waste (Management and Handling) (Amendment) Rules, 2003, to provide legal and mandatory guidelines for healthcare and medical waste management industry

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Regenerative Medicine Market Industry Outlook, Growth Prospects and Key Opportunities - Health News Office

"Our mission has always been to meet the diverse and unique health needs of all women, and this approval of LILETTA for up to six years means women have even greater flexibility and choice when it comes to their reproductive health," said Jessica Grossman, M.D., CEO of Medicines360. "Studying our products in robust clinical trials, like ACCESS IUS, ensures we can provide quality birth control that works for a broad range of women in the U.S., something we take pride in for leading the way."

The FDA approval was based on a review of additional efficacy and safety data from the largest ongoing Phase 3 clinical trial of an intrauterine system in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), with 1,751 U.S. women receiving LILETTA. LILETTA proved to be more than 99 percent effective in preventing pregnancy for up to 6 years in a diverse population of women. The study population in the ACCESS IUS trial included women of various ages, races, and body mass index (BMI).

"I hear all the time from women that they want a reliable and long-term option for birth control that is reversible," said Carolyn Westhoff, M.D., MSC, chief of the Division of Family Planning, Sarah Billinghurst Solomon Professor of Reproductive Health, Department of Obstetrics and Gynecology, Professor of Population and Family Health and Epidemiology, Columbia University, and investigator in the ACCESS IUS study. "This groundbreaking trial has given healthcare providers the ability to confidently offer women the option of pregnancy prevention for up to six years."

LILETTA is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to six years. The system should be replaced after six years if continued use is desired. Medicines360 received initial approval of LILETTA in February 2015. Since then, Medicines360 and Allergan have continued to invest in the product, which has led to the introduction of the single-handed inserter and, now, the extended duration of use for up to six years.

LILETTA is commercially available in the U.S., and through Medicines360's unique mission-driven model, LILETTA is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.

"Our partnership with Medicines360 helps to ensure that women can obtain an effective, long-term birth control option," said David Nicholson, Ph.D., Allergan's Executive Vice President and Chief Research and Development Officer. "Our goal is to provide a variety of contraceptive options for women so they and their healthcare providers can choose what is best for them. We are proud to deliver a product that now provides women with an even longer duration of pregnancy prevention."

ABOUT LILETTA

Indication

LILETTA (levonorgestrel-releasing intrauterine system) 52mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 6 years.

Important Risk Information About LILETTA

LILETTA does not protect against HIV or STDs.

Available by prescription only.

Please see full Prescribing Information for LILETTA.

About Medicines360

Medicines360, located in San Francisco, California, is a nonprofit global women's health pharmaceutical company with a mission to remove cost as a barrier to health by developing and providing affordable Women's Health products. Medicines360 is committed to working with healthcare providers, advocacy groups and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit http://www.medicines360.org

About Allergan Women's Healthcare

Allergan is a leader in women's healthcare that is dedicated to developing and commercializing best-in-class pharmaceuticals to improve the health and wellness of women. Allergan takes a holistic and a best-in-class approach to women's healthcare as it prioritizes educational partnerships with OB/GYNs. The mission of Allergan Women's HealthCare extends beyond its pharmaceutical products to ensure that all women can make informed decisions about their health and have access to high-quality medications. Allergan is committed to investing in programs that support the education and well-being of all women.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website atwww.Allergan.com.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

SOURCE Medicines360

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FDA Approves Medicines360's LILETTA (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Six Years, the Longest...

As we head into the fresh weekof trading, note the action on Friday in shares of Predictive Technology Group Inc (OTCMKTS:PRED). The rally looks tobe related to news of an uplist onto the OTCQX tier of the OTC market. But wewould also point out the companys announcement that a team mostly from PRED(including Kenneth Ward, M.D., laboratory director of Predictive Laboratoriesand chief executive officer of Juneau Biosciences; Rakesh Chettier M.S.,director of biostatistics of Predictive Laboratories; and Hans Albertsen,Ph.D., chief scientific officer of Juneau Biosciences) has received the 2019Endometriosis Special Interest Group (EndoSIG) Prize Paper in the Best inClinical/Population Science category.

According to the release, Dr. Albertsens presentation entitled Cytoskeletal and extracellular matrix genes are key contributors in the pathogenesis of endometriosis was delivered at the American Society for Reproductive Medicine (ASRM) 2019 Scientific Congress & Expo in Philadelphia on October 16. EndoSIG is a member group of ASRM aimed at fostering increased interest in the biology, pathophysiology and clinical management of endometriosis.

Predictive Technology Group Inc (OTCMKTS:PRED) promulgates itself as a company that, together with its subsidiaries, develops and commercializes discoveries and technologies involved in novel molecular diagnostic and pharmaceutical therapeutic/human cells, tissues, and human cellular and tissue-based products (HCT/Ps).

The company operates through two segments, Regenerative Medicine Products and HCT/Ps, and Diagnostics and Therapeutics. It offers ARTguide, a genetic diagnostic and prognostic test for women experiencing infertility as a result of endometriosis and other health concerns; and regenerative medicine products, including AmnioCyteT, AmnioCyte PlusT, PolyCyteT, and CoreCyteT.

The company was formerly knownas Global Enterprises Group, Inc. and changed its name to Predictive TechnologyGroup, Inc. in July 2015. Predictive Technology Group, Inc. was founded in 2005and is headquartered in Salt Lake City, Utah.

According to companymaterials, Predictive Technology Group aims to revolutionize patient carethrough predictive data analytics, novel gene-based diagnostics and companiontherapeutics through its subsidiaries Predictive Therapeutics, PredictiveBiotech, and Predictive Laboratories. These subsidiaries are focused onendometriosis, scoliosis, degenerative disc disease and human cell and tissueproducts. The subsidiaries use genetic and other information as cornerstones inthe development of new diagnostics that assess a persons risk of illness andtherapeutic products designed to identify, prevent and treat diseases moreeffectively.

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As noted above, PRED just announced that a team mostly from the company has received the 2019 Endometriosis Special Interest Group (EndoSIG) Prize Paper in the Best in Clinical/Population Science category.

Weve witnessed 28% tacked on to share pricing for the name in the past week. In addition, the stock has witnessed a pop in interest, as transaction volume levels have recently pushed topping 120% over what the stock has registered over the longer term.

We are honored to receive this prestigious award from the ASRM Research Committee, said Dr. Albertsen. As endometriosis is generally characterized as a hormonal and inflammatory disease, current therapies often come with significant debilitating side effects. The scientific breakthroughs reported in these award-winning discoveries provide Predictive with insights into new non-hormonal therapies.

At this time, carrying acapital value in the market of $475M, PREDhas a bankroll ($1.8M) of cash on the books, which is balanced by about $14.1Min total current liabilities. One should also note that debt has been growingover recent quarters. PRED is pulling in trailing 12-month revenues of $43.5M.In addition, the company is seeing major top-line growth, with y/y quarterlyrevenues growing at 88%. You can bet we will update this one again as newinformation comes into view. Sign-up forcontinuing coverage on shares of $PRED stock, as well as other hot stock picks,get our free newsletter today and get our next breakout pick!

Disclosure: we hold no position in $PRED, either long orshort, and we have not been compensated for this article.

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The Bounce is On in Predictive Technology Group Inc (OTCMKTS:PRED) - The Oracle Dispatch

Regenerative medicinewhich involves regrowing damaged or dysfunctional cells, tissues, and organs, in order to treat and cure human diseaseholds great promise. Discoveries in stem cell research and tissue engineering as well as advances in regulatory and industry support have brought regenerative medicine treatments closer than ever to the clinic. Two areas showing particular potential are diabetes and vascular disease. Whether acquired or congenital, diabetes afflicts millions of people worldwide and presents a tremendous burden both in terms of physical deterioration and loss of economic capacity. Current treatments rely mainly on lifetime injections of exogenous hormones and palliative treatments with pharmaceuticals, neither of which can address the lack of properly functioning beta cells in the pancreas. Similarly, vascular diseases are among the leading causes of mortality and morbidity. The ability to generate new, clinical-grade vascular tissue is critical to the long-term treatment of complications arising from ischemic injury, stroke, aneurisms, retinopathy, and other acute and chronic vascular conditions; significant progress has been made in using stem cell sources to produce this tissue. But what is needed to get such potentially transformative treatments over the finish line?

During this webinar, the speakers will:

This webinar will last for approximately 60 minutes.

University of Miami Miller School of MedicineMiami, FL

Juan Domnguez-Bendala, Ph.D., is director of the Stem Cell Development for Translational Research and research associate professor of surgery at the Diabetes Research Institute (DRI), University of Miami Miller School of Medicine. Before joining the DRI faculty, he worked at the Roslin Institute (Scotland, United Kingdom) under the supervision of one of the creators of Dolly the sheep. He obtained his Ph.D. there and acquired considerable experience in embryonic stem cell research and state-of-the-art genetic engineering techniques. Working with other DRI faculty and international collaborators, Dr. Domnguez-Bendala is currently involved in several projects that focus on the use of stem cells to obtain pancreatic islets that could be safely and efficiently transplanted into patients with type 1 diabetes. He is also working on new methods for the endogenous regeneration of pancreatic beta cells.

Mayo ClinicRochester, MN

As deputy director of Translation for the Center for Regenerative Medicine, medical director of the Advanced Product Incubator, and director of the Van Cleve Cardiac Regenerative Medicine Program at the Mayo Clinic in Rochester, Minnesota, Dr. Behfar has worked to establish off-the-shelf good manufacturing practice (GMP)-grade regenerative technologies. Over the last two decades, his program has engaged in evaluating cell-based technologies for restoration of skeletal and cardiac muscle function. During this time, he initiated clinical trials in heart failure along with Dr. Andre Terzic, using stem cells to restore cardiac function and treating over 400 patients. Through that experience, it was discovered that exosome secretion was the primary driver of the regenerative action of stem cells. More specifically, an exosome product was purified (termed purified exosome product, or PEP) from our regenerative platform that revealed massive biopotency in activating regeneration through mitogenic, antioxidant, anti-inflammatory and provasculogenic influence. This discovery now serves as the basis for many preclinical and clinical efforts at Mayo Clinic.

Science/AAASWashington, D.C.

Dr. Oberst did her undergraduate training at the University of Maryland, College Park, and her Ph.D. in Tumor Biology at Georgetown University, Washington D.C. She combined her interests in science and writing by pursuing an M.A. in Journalism from the Philip Merrill College of Journalism at the University of Maryland, College Park. Dr. Oberst joined Science/AAAS in 2016 as the Assistant Editor for Custom Publishing. Before then she worked at Nature magazine, the Howard Hughes Medical Institute, The Endocrine Society, and the National Institutes of Mental Health.

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Regenerative medicine today: Are diabetes and vascular disease treatments ready for the clinic? - Science Magazine

Learning how everyday things work in space, such as how to effectively brush teeth or how hair grows, is intriguing, but knowledge of how medical research translates from Earth's surface to above its atmosphere is limited.

A new alliance between the McGowan Institute for Regenerative Medicine at the University of Pittsburgh and the International Space Station (ISS) U.S. National Laboratory aims to drive the progress of regenerative medicine research in microgravity environments specifically, aboard the ISS.

The questionis What can we do in space that we can't do on Earth that makes a difference?" said William Wagner, director of the McGowan Institute. "That's a pretty exciting question, because it's currently unanswered; we don't know what the key value of microgravity is. I think when we find that, we can attract investment, we're going to begin to identify what the most promising technology is."

The ISS National Laboratory and the McGowan Institute will collaborate with partners from industry as well as other academic research centers and government agencies to drive the progress of regenerative medicine research aboard the ISS. As part of this alliance, Pitt will develop facilities on campus to advance research and meet with potential partners, while working in coordination with the ISS National Laboratory on flight opportunities to the orbiting laboratory. The program will focus on microgravity life sciences research and development, with a line of sight toward products and services for clinical application on Earth.

"What has to happen now is knowing how we can leverage research into a treatment or technology that someone will invest in because it will replace the current way we do things here on Earth," Wagner said. "We are very enthusiastic about this, because we believe the time is right to move from the observational to the more practical, moving things toward commercialization. One of the things we're going to try to do is give industry the best and brightest research in our country, not just at Pitt, but other universities as well, to pitch different concepts and partner with those concepts to help develop them."

An example of this research in action could include exploiting the unique behavior of stem cells in microgravity in order to improve cell-based therapies for a variety of diseases and impairments, such as traumatic brain injury and type I diabetes. Similarly, microgravity could allow 3D printers to create complex tissue structures that are difficult to achieve in the presence of full gravity.

This alliance a core element of the ISS National Laboratory Industrial Biomedicine Program was unveiled at the 8th annual ISS Research and Development Conference held in Atlanta earlier this year.

University leaders are optimistic this alliance will be the next big step in space research and commercialization.

The McGowan Institute has built on its deep history advancing the development of artificial organs to establish a position of internationally recognized leadership in regenerative medicine, said Rob A. Rutenbar, senior vice chancellor for research at Pitt. The ISS National Laboratory will benefit from that deep expertise, as well as our commitment to rapid clinical translation.

The products of the Industrial Biomedicine Program will help build the fundamental business case for the industrialization of crewed platforms in low Earth orbit. In future alliances, the ISS National Laboratory will work with companies and research partners who seek to find solutions to common problems on Earth through space-based experimentation on the ISS National Laboratory.

The ISS National Laboratory is proud to announce this alliance with Pitt and McGowan in order to develop biomedical products in space that could benefit human health on Earth, said ISS National Laboratory Chief Strategy Officer Richard Leach. Part of the role of the ISS National Laboratory is to create and implement innovative strategies to enhance the research capacity of the orbiting laboratory, and we believe alliances like this will pave the way for future collaborations to advance the discoveries of space-based science.

More details about the alliance are available on the ISS National Laboratorys website.

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Exploring Regenerative Medicine in Microgravity Aboard the International Space Station - UPJ Athletics

IRVINE, Calif., Oct. 1, 2019 /PRNewswire/ -- AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, today announced that it will be presenting at the following investor, oncology and regenerative medicine conferences in October:

Cell & Gene Meeting on the Mesa Company Presentation Time: October 2, 11:00 AM PST Location: Park Hyatt Aviara Resort Golf Club & Spa, Cognate in the Bioservices Ballroom, Carlsbad, CA

World Immunotherapy Congress Keynote Title: Enhancing patient responses with autologous cancer stem cell vaccine in combination with checkpoint inhibitors Time: October 16, 9:25 AM CET Location: Congress Centre Basel, Basel, Switzerland

BIO Investor Forum Company Presentation Time: October 23, 10:15 AM PST Location: Elizabethan A, The Westin St. Francis,San Francisco, CA

World Vaccine Congress Talk Title:Autologous Cancer Stem Cell Vaccines for Solid Tumor Cancers When: October 29, 3:45 PM CET Location: Palau de Congressos de Catalunya, Barcelona, Spain

About AIVITA Biomedical AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITA's skin care products support the treatment of women with ovarian cancer.

SOURCE AIVITA Biomedical, Inc.

http://aivitabiomedical.com

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AIVITA Biomedical to Present at Meeting on the Mesa and Other Investor, Oncology and Regenerative Medicine Conferences in October - PRNewswire

NEW YORK, Oct. 07, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc.(NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for BrainStorm's new US Patent Application, number: 15/113,105, titled: Method of Qualifying Cells'.

The allowed claims cover a pharmaceutical composition for MSC-NTF cells secreting neurotrophic factors (NurOwn) comprising a culture medium as a carrier and an isolated population of differentiated bone marrow-derived MSCs that secrete neurotrophic factors.

Patent families protecting NurOwn have previously issued in the United States, Japan, Europe, Hong-Kong and Israel.

"This allowance further expands the patent protection of the NurOwn Cellular Therapeutic Technology Platform and enables us to accelerate clinical development for new neurodegenerative indications, commented BrainStorm President and CEO,Chaim Lebovits.

About NurOwn

NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com

Safe-Harbor Statements

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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