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Merakris Announces Review in Biomedicines Medical Journal Highlighting Therapeutic Potential of Cell-Free Amniotic Fluid

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RESEARCH TRIANGLE PARK, N.C., Nov. 29, 2022 (GLOBE NEWSWIRE) — A review published recently in the international scientific journal Biomedicines highlights the therapeutic benefits of amniotic fluid in restoring, repairing and regenerating damaged tissue across a range of human diseases and disorders.

The article – Cell-Free Amniotic Fluid and Regenerative Medicine: Current Applications and Future Opportunities – evaluates a range of scientific studies focused on the use of full-term (harvested during Cesarean births) cell-free amniotic fluid (cfAF). And it addresses the questions and challenges around cfAF’s therapeutic potential.

The review, written by five regenerative medicine specialists, concludes that “these studies indicate that cfAF promotes wound healing, stem cell differentiation, cell growth, and has antimicrobial effects, each of which can contribute to its overall regenerative effects.”

The article notes that cfAF has been used successfully to treat complex wounds such as diabetic foot ulcers and burn injuries. The therapy can stimulate wound healing by promoting angiogenesis, the process of forming new blood vessels. This is achieved when targeted wound tissue absorbs soluble proangiogenic proteins and other biomolecules found in cfAF.

One of the studies highlighted in the article also demonstrates accelerated reepithelization (regeneration of the epidermis over a wound surface) of the cornea following cfAF treatment.

The article points out that, while additional pre-clinical research may be needed, promising results so far suggest that amniotic fluid can be used for challenging cases of nerve repair, or to prevent nerve degeneration. Studies also strongly suggest that cfAF can effectively stimulate cells to promote joint regeneration and reduce pain, promote joint health, and stimulate bone growth and healing.

Cell-free amniotic fluid may even be beneficial as a treatment for COVID-19. The article reports that a small number of severely ill COVID-19 patients treated with amniotic fluid showed rapid, significant improvement in organ failure assessment, hospital ICU status, and respiratory function.

W. Sam Fagg, MSc, Ph.D., assistant professor in the Department of Surgery at the University of Texas Medical Branch and an author of the review, had this to say about the findings: “My co-authors and I are thrilled to share this work with the research, clinical and regulatory communities, as there have been many recent advances in the study and use of cfAF, not to mention its dynamic regulatory status.”

Fagg also is lead scientist at Merakris Therapeutics in North Carolina’s highly acclaimed Research Triangle Park. Merakris pioneers the use of commercially scalable stem cell-derived biotherapeutic technologies, including cfAF, to promote the healing of damaged tissue. Fagg said studies examined for the Biomedicines article range from fundamental and translational investigations to clinical trials. “In the laboratory and the clinic, cfAF has been proven to be safe and shows efficacy in accelerating would healing, treating musculoskeletal defects, treating nerve defects or post-operative nerve damage, as well as treating certain congenital defects,” the review concludes.

The article points out that more study is needed – cfAF is still relatively under-researched compared to cell and stem cell-based regenerative therapies – and several obstacles remain. Included among them is the availability of an adequate supply of amniotic fluid to meet future demand. And questions persist around the basic mechanisms that produce cfAF’s beneficial therapeutic effects.

About Merakris Therapeutics

Merakris, founded in 2016, has as its mission to improve global patient care and outcomes through regenerative biotechnologies. The company’s products include:

  • Dermacyte® Amniotic Wound Care Liquid, a cell-free amniotic injection that is being developed under Merakris’ investigational New Drug (IND) approval for would healing.
  • Dermacyte® Matrix, a human amniotic membrane tissue graph that provides a protective covering for skin wounds and surgical sites.
  • Opticyte® Matrix, which creates an ophthalmic barrier to the corneal surface of the eye and can be used with various ocular procedures.

Merakris also is investigating other novel biotechnology solutions that promote wound healing and tissue regeneration.

The company will be one of the exhibitors at the upcoming Desert Foot Multi-Disciplinary Limb Salvage and Wound Care Conference The conference will be held in Phoenix, Arizona November 30 – December 3. It will bring together the federal service wound care and surgical community, along with hundreds of healthcare professionals in acute care, home care and the private sector.

Merakris also will present a poster on its adaptive design clinical trial for Dermacyte Amniotic Wound Care Liquid as a treatment for non-healing venous stasis ulcers.

Merakris Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris’ products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Merakris’ management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole.

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