FDA Approves Collagen-Based DermiSphere Hydrogel

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Fesarius Therapeutics Inc. announced today that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its DermiSphere hydrogel Dermal Regeneration Template (DermiSphere hDRT). This product represents a new class of collagen-based dermal matrices designed to support tissue integration, revascularization, and wound healing, targeting applications in Advanced Wound Care, Reconstructive Surgery, and Regenerative Medicine.¹

Tom Roueche, CEO of Fesarius Therapeutics Inc., commented on the FDA clearance, “We are thrilled to receive FDA clearance for DermiSphere hDRT. This clearance marks a significant milestone in our mission to develop advanced regenerative solutions that improve patient outcomes. DermiSphere hDRT offers a truly novel approach to dermal regeneration, and we are excited about its potential to transform wound care.”

Full-thickness wounds, which involve the complete loss of the dermal and epidermal layers of the skin, present significant challenges to healing. Unlike superficial or partial-thickness wounds, these injuries lack the cellular and structural components necessary for natural tissue regeneration. If not addressed through surgical interventions, patients may face risks of delayed healing, infection, and severe scarring. Standard treatment typically includes 2 surgical steps: generating new dermal tissue using dermal matrices and performing split-thickness skin grafting.²

The company described DermiSphere hDRT as a hydrogel-based dermal regeneration template, differing from conventional fibrillar collagen products. Its collagen composition is intended to mimic the natural extracellular matrix, providing a scaffold for cellular infiltration and tissue regeneration. Preclinical models have suggested that this design may support faster and more effective dermal wound healing.

With FDA clearance, Fesarius Therapeutics plans to market and distribute DermiSphere hDRT in the United States. The product launch is expected in the coming months, with a focus on providing surgeons and healthcare professionals with tools to address full-thickness wounds. The company aims to improve wound care practices and patient outcomes.

Fesarius Therapeutics was established in 2015, informed by research from Jason A. Spector, MD, FACS, at Weill Cornell Medicine’s Laboratory of Bioregenerative Medicine and Surgery. As Chief of the Division of Plastic and Reconstructive Surgery, Spector recognized limitations in existing treatments for full-thickness skin loss and the negative impact they had on his patients, and developed DermiSphere hDRT as a potential solution.

In 2023, the company was awarded $1.83 million to further fund the research and development of products beyond DermiSphere hDRT. The company stated the award, from the National Institutes of Heath (NIH), will support further development of alternate formulations of DermiSphere, allowing the technology to be used in adjacent advanced wound care and other soft tissue regeneration applications.

"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," Roueche said at the time of the award.

References

1. Fesarius Therapeutics inc announces FDA 510(k) clearance for dermisphere hydrogel dermal regeneration template. News Release. PR Newswire. Published January 8, 2025. Accessed January 8, 2025. https://www.prnewswire.com/news-releases/fesariustherapeutics-inc-announces-fda-510k-clearance-for-dermisphere-hydrogel-dermal-regeneration-template-302346137.html
2. Takeo M, Lee W, Ito M. Wound healing and skin regeneration. Cold Spring Harb Perspect Med. 2015 Jan 5;5(1):a023267. doi: 10.1101/cshperspect.a023267.