BETA
New York-based medical-device company developing and commercializing collagen hydrogel scaffolds for wound management and dermal tissue repair.
Fesarius Therapeutics is a privately held medical-device company headquartered in New York, New York. Founded in 2015 around tissue-engineering technology developed at Weill Cornell Medicine, it focuses on wound management, dermal repair and reconstructive surgery. Its documented role includes bringing DermiSphere to market under its own brand while using a manufacturing partner.
Its flagship DermiSphere hDRT is a biodegradable wound dressing made from bovine collagen microspheres embedded in a collagen hydrogel matrix. FDA cleared the device in January 2025 for specified wound-management indications. Its biologically derived material and regenerative-medicine applications do not change that documented device classification.
Fesarius announced a multi-year manufacturing and supply agreement with Regenity Biosciences in April 2025 and a $20 million Series A financing in June 2026. The company reported commercial activity across U.S. hospital systems and plans to expand its field organization. These company-reported developments do not establish revenue, nationwide availability or comparative clinical benefit.
DermiSphere hDRT received FDA 510(k) clearance K241904 on January 6, 2025 for specified wound-management uses. FDA lists the product as an unclassified wound dressing with animal-derived materials and identifies it as not a combination product. The cleared material is a bovine collagen scaffold; it is a regulated medical device, rather than a BLA-licensed biologic. [5][2]
The completed named-company, DermiSphere and linked-identifier searches identified one 510(k) clearance and no matching De Novo grants, original PMAs or device recall events. [5][4][3][6]
Manufacturer-described rapid vascularization and tissue integration include preclinical evidence and should not be treated as proof of superior clinical outcomes. Current manufacturer information states that DermiSphere should not be used in patients with known sensitivity to bovine collagen and is not indicated for third-degree burns. [8][2]
Latest recorded source review: 2026-10-26.
Documented commercial product families.
Biodegradable scaffold comprising crosslinked bovine Type I collagen microspheres embedded in a bovine collagen hydrogel matrix. Designed to support host-cell ingrowth and capillary growth during wound management. [8][2][5][1]
FDA-clearedCommercially offered in the United States. Listed sizes: 4 × 5 cm and 10 × 12 cm.
Fesarius announced a manufacturing and supply agreement with Regenity in April 2025 and a $20 million Series A in June 2026. Its June announcement described plans for additional direct field representatives and clinical work on a OneStep procedure combining template placement and skin grafting. A future label expansion and pursuit of Breakthrough Device Designation were plans in that announcement; neither is represented here as a confirmed regulatory decision. [12][13]
Fesarius reported an oversubscribed $20 million financing led by Jefferson Life Sciences, with participation from JJDC, NY Ventures and ASPS Ventures. The company described plans to expand its direct field organization and advance clinical development. Financing is not revenue. [13]
Fesarius announced a multi-year agreement granting Regenity exclusive manufacturing responsibility for DermiSphere hDRT. This is a reported manufacturing and supply arrangement, not evidence of distributor exclusivity. [12]
Accessed 10/29/2026
Last substantive review: 10/26/2026