Fesarius Therapeutics receives NIH Commercial Readiness grant for DermiSphere™ dermal regeneration template in preparation for market release

Fesarius Therapeutics receives NIH Commercial Readiness grant for DermiSphere™ dermal regeneration template in preparation for market release

BROOKLYN, N.Y., Aug. 16, 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 an $800,000 SBIR CRP grant to advance the development of their novel DermiSphere™ dermal regenerative template to treat full thickness skin loss. The Small Business Innovation Research (SBIR) Commercialization Readiness Pilot (CRP) grant is targeted to the manufacturing and testing required for regulatory approval and to support highly promising medical solutions in their final stage before entering the US market.

The technology behind DermiSphere™ is designed to address the unmet need for effective, rapid, 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 these shortcomings by providing a dermal template that can be applied simultaneously with a split thickness skin graft while eliminating the need for a second surgery, reducing the pain, morbidity and cost of current approaches. The company estimates that over 500,000 split thickness grafting procedures performed annually would significantly benefit from incorporating the DermiSphere dermal template.  And as surgeons and wound care providers experience the compelling and cost-effective advantages of DermiSphere in treating full thickness skin loss, this number will further expand each year, bringing significant benefit to patients suffering with today's limitations.

"It is a testament to our team, our compelling innovations and the recognition by expert review at the NIH, that Fesarius has benefited in over $4.6 million in non-dilutive funding for our work to date", said Tom Roueche, President and CEO. "This most recent CRP funding will support work with our Contract Manufacturing Partner as we complete the final steps in bringing the important and life changing benefits of DermiSphere to patients across this country."

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 SB1AR076301. 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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