Fesarius Therapeutics receives prestigious NIH SBIR research grant for DermiSphere™ hydrogel technology to treat full thickness skin loss

Fesarius Therapeutics receives prestigious NIH SBIR research grant for DermiSphere™ hydrogel technology to treat full thickness skin loss

BROOKLYN, N.Y., Aug. 8, 2023 /PRNewswire/ -- FesariusTherapeutics, Inc., an emerging bioregenerative technology company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care markets, today announced they have been awarded $1.83 Million from the National Institutes of Health (NIH) to further fund development of their Advanced Dermal Regeneration Scaffold for Reconstructive Surgery. Fesarius applied for this research funding in the January 2023 review cycle to support next generation dermal repair products beyond the company's flagship DermiSphere dermal template. The rapid review and award of this major research grant will further accelerate the development of the company's suite of next generation product offerings.

The technology behind DermiSphere™ is designed to address the unmet need for effective and affordable treatment of full thickness skin loss, which can result from burns, trauma, surgery, or chronic wounds. The current standard of care involves either a split thickness skin graft alone, which often results in debilitating contracture and scarring, or a two-stage procedure that requires one surgery to place a dermal substitute, then a second surgery 2-4 weeks later to place the skin graft. Each of these approaches have significant shortcomings, not the least of which is significant pain, morbidity, scarring, and cost.

DermiSphere™ aims to simplify and vastly improve this process by providing a dermal template that can be applied simultaneously with a split thickness skin graft, thus restoring the dermal layer of skin, while eliminating the need for a second surgery. DermiSphere™ is composed of a novel biodegradable collagen microarchitecture that promotes native collagen deposition and rapid, robust vascularization to enable the viability of the skin graft.

"We are honored and excited to receive this prestigious grant from the NIH, which further validates our innovative technology and supports our mission to bring DermiSphere™ to the market," said Yulia Sapir-Lekhovitser, Chief Scientific Officer of FesariusTherapeutics. "We believe that DermiSphere™ has the potential to revolutionize the treatment of full thickness skin loss and improve the quality of life for millions of patients worldwide."

Tom Roueche, President, CEO of Fesarius, commented, "This is the third NIH research award Fesarius has received to date and represents nearly $4 Million of non-dilutive grant funding for the company and its novel technology. It is very rewarding to see the tremendous work our team has conducted continue to receive peer recognition from such a prestigious institute as the NIH."

Fesarius Therapeutics initial DermiSphere™ template is currently undergoing biocompatibility studies needed in support of their FDA 510K submission this year.  Accordingly, the company is on track to begin early commercialization of this novel wound care technology in 2024, while this grant award will concurrently support the development of alternate formulations of DermiSphere™ to enable this novel technology to be deployed in adjacent advanced wound care indications and other soft tissue regeneration applications.

FesariusTherapeutics, Inc. was formed in 2015 to leverage the unique technology developed by Jason A. Spector, MD, at the Laboratory of Bioregenerative Medicine and Surgery at Weill Cornell Medicine in NYC where he also serves as Chief of the Division of Plastic and Reconstructive Surgery. Dr. Spector was inspired to develop DermiSphere™ after experiencing the limitations of products currently available for treating full thickness skin loss and the negative impact they had on his patients. Fesarius is currently pursuing FDA clearance for DermiSphere™.

This award is support from the National Institute of Arthritis And Musculoskeletal And Skin Diseases of the National Institutes of Health under Award Number R44AR082787. The research conducted is solely the responsibility of FesariusTherapeutics and does not necessarily represent the official views of the National Institutes of Health."


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