Fesarius Therapeutics
Fesarius Therapeutics is a New York–based regenerative medicine company that developed DermiSphere hDRT, the first FDA-cleared hydrogel dermal regeneration template for treating full-thickness skin loss. It sells directly to U.S. hospital systems and plastic/reconstructive surgeons under an exclusive manufacturing agreement with Regenity Biosciences.
- Company typePrivate
- Founded2015
- HeadquartersBrooklyn, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Fesarius Therapeutics does
Fesarius Therapeutics Inc. is a New York–based, commercial-stage regenerative medicine company founded in 2015 as a spin-out from the Laboratory for Bioregenerative Medicine and Surgery at Weill Cornell Medicine. The company's flagship product, DermiSphere hDRT, is a collagen-based hydrogel Dermal Regeneration Template that combines a less-dense collagen hydrogel with denser collagen microspheres to create differential resorption rates, enabling rapid vascularization (within 3 days in preclinical models), full wound bed incorporation, and stable neodermal tissue formation for the treatment of full-thickness skin loss. DermiSphere received FDA 510(k) clearance in January 2025, becoming the first and only hydrogel-class DRT available in the U.S. market, and the product is manufactured under an exclusive multi-year supply agreement with Regenity Biosciences.
The company monetizes DermiSphere through direct, quote-based sales to U.S. hospital systems, targeting plastic and reconstructive surgeons, wound care specialists, and burn/trauma centers. Its go-to-market is an enterprise field-sales motion supported by a customer service line (1-833-900-HDRT), medical affairs outreach, conference presence, and ASPS-channel relationships, with the American Society of Plastic Surgeons making its inaugural institutional investment in the company's June 2026 $20 million Series A alongside Jefferson Life Sciences, Johnson & Johnson Innovation – JJDC, and NY Ventures. Operating with a lean 1–10 employee footprint and using outsourced manufacturing, Fesarius is pursuing FDA Breakthrough Device Designation and a clinical-stage OneStep procedure that would combine DermiSphere with simultaneous split-thickness skin grafting, positioning the product to expand from a standalone DRT into a broader procedural platform.
Fesarius Therapeutics firmographics
Firmographics- Name
- Fesarius Therapeutics
- Legal name
- Fesarius Therapeutics Inc.
- Website
- https://fesariustherapeutics.com
- Company type
- Private
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Fesarius Therapeutics is a New York–based regenerative medicine company that developed DermiSphere hDRT, the first FDA-cleared hydrogel dermal regeneration template for treating full-thickness skin loss. It sells directly to U.S. hospital systems and plastic/reconstructive surgeons under an exclusive manufacturing agreement with Regenity Biosciences.
- Ownership category
- akta.pro rank
Fesarius Therapeutics industry classification
Industry- Product category
- Wound Care Medical Devices
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Scientific Research and Development Services (5417)
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Wound Healing & Skin Regeneration (advanced dressings, skin substitutes) (HLAAAGAG)
- akta.pro secondary industry
- Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts) (HLAHALAE)
Keywords
Where Fesarius Therapeutics is headquartered
LocationHeadquarters
- HQ city
- Brooklyn
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Fesarius Therapeutics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations
Revenue model
- DermiSphere hDRT Product Sales: Fesarius generates revenue through the commercial sale of its FDA 510(k)-cleared DermiSphere hDRT hydrogel dermal regeneration template to hospital systems and surgeons for the treatment of full-thickness skin loss. The company is currently commercially active across multiple U.S. hospital systems following FDA clearance in January 2025 and the completion of its manufacturing agreement with Regenity Biosciences.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Direct quotation-based pricing for healthcare providers |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels6 records
Fesarius Therapeutics product offering
Product offeringCore offering
Fesarius Therapeutics develops and commercializes DermiSphere hDRT, a proprietary collagen-based hydrogel Dermal Regeneration Template designed for the treatment of full-thickness skin loss. The product features a novel dual-density biphasic architecture combining a less-dense collagen hydrogel with denser collagen microspheres, enabling rapid vascularization and stable neodermal tissue formation. FDA 510(k) cleared in January 2025, DermiSphere is the first and only genuine hydrogel dermal regeneration template available on the U.S. market.
Product overview
Fesarius Therapeutics is a commercial-stage bioregenerative surgical company offering a single flagship product: DermiSphere™ hDRT (hydrogel Dermal Regeneration Template). This represents the first and only hydrogel-based dermal regeneration template available in the U.S. market, having received FDA 510(k) clearance in January 2025. The product uses a novel dual-density collagen hydrogel design with embedded collagen microspheres to accelerate wound healing for full-thickness skin loss by achieving rapid vascularization and complete cell invasion. The company became commercially active across multiple U.S. hospital systems following manufacturing agreement completion with Regenity Biosciences.
Differentiator
Problem solved
Functional benefit
Products and services
- DermiSphere hDRT (hydrogel Dermal Regeneration Template) The first and only hydrogel dermal regeneration template (hDRT) for treatment of full-thickness skin loss. Features a dual-density biphasic design combining a collagen-based hydrogel with denser collagen microspheres to facilitate rapid vascularization (within 3 days) and cellular invasion, enabling stable vascularized neodermal tissue formation. Used by plastic and reconstructive surgeons and wound care specialists in hospital systems.
Quantifiable outcome
- Achieves complete vascularization and cell invasion within 3 days in preclinical porcine model
- +3 more outcomes
Companies that use Fesarius Therapeutics
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles1 record
Fesarius Therapeutics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
Fesarius Therapeutics partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- Regenity BiosciencescoreExclusive multi-year manufacturing and supply agreement with Regenity Biosciences, the leading development and manufacturing partner of regenerative technologies for the medical device community. Fesarius contracted with Regenity in 2022 to establish transfer and development of commercial manufacture of DermiSphere hDRT. Regenity has exclusive manufacturing responsibility for the product. Regenity is headquartered in Paramus, New Jersey with manufacturing in New Jersey and Groningen, the Netherlands.
- Weill Cornell Medicine / Laboratory for Bioregenerative Medicine and SurgerycoreTechnology spin-out from the Laboratory for Bioregenerative Medicine and Surgery at Weill Cornell Medicine in New York City, led by Dr. Jason Spector. Fesarius was founded in 2015 based on technology developed at this lab, with Dr. Spector serving as Chief of the Division of Plastic and Reconstructive Surgery at Weill Cornell Medicine.
Scale indicators7 records
Recent moves6 records
Expansion highlights6 records
Fesarius Therapeutics competitors and assessment
Company assessmentBroad incumbents
- Integra LifeSciences: Integra LifeSciences is the dominant incumbent in dermal regeneration templates through its Integra Dermal Regeneration Template product line and broader wound care portfolio. Directly comparable to Fesarius because it sells competing collagen-based DRTs used for full-thickness skin loss in reconstructive surgery and burn care.
- Organogenesis: Organogenesis is a leading regenerative medicine company selling skin and wound care products (Apligraf, Dermagraft, PuraPly, Affinity) used for chronic wounds, burns, and surgical repair. Comparable to Fesarius because it competes in advanced wound care and skin substitutes with biologics and regenerative templates sold into hospital systems.
- Smith+Nephew: Smith+Nephew is a large medtech incumbent with an extensive advanced wound management portfolio (e.g., PICO single-use NPWT, skin substitutes and grafts) sold to hospitals and surgeons. Comparable to Fesarius as a broad wound care competitor that bundles products and competes for hospital formulary space.
- ConvaTec: ConvaTec is a global wound care and ostomy company selling advanced dressings, skin barriers, and regenerative products (e.g., InnovaMatrix) used in chronic and surgical wounds. Comparable to Fesarius because it competes in advanced wound care with biologic and matrix-based skin substitutes sold to hospitals.
- Solventum (3M Health Care spinoff): Solventum (spun off from 3M in 2024) is a large diversified medtech player with an advanced wound care and surgical solutions portfolio. Comparable to Fesarius as a broad incumbent selling into the same hospital procurement and wound care channels.
- Coloplast: Coloplast is a global medtech company with a sizable wound and skin care business (Biatain, Triademe) addressing chronic and surgical wounds. Comparable to Fesarius as an incumbent advanced wound care competitor pursuing similar hospital and specialty channel customers.
Direct peers
- MiMedx: MiMedx develops and commercializes regenerative skin and soft-tissue products (e.g., EpiFix, AmnioFix) used for wound healing and surgical reconstruction. Directly comparable to Fesarius because it serves the same plastic surgeon, wound care, and hospital customer base with tissue-based regenerative products for full-thickness and chronic wounds.
- ACell (Integra LifeSciences): ACell, acquired by Integra LifeSciences, sells MatriStem UBM-based wound management devices for wound healing and surgical repair. Directly comparable to Fesarius as a competing extracellular matrix/skin substitute product used by surgeons for full-thickness wounds.
- Vivex Biologics: Vivex Biologics markets tissue-based regenerative products (e.g., CYGNUS, AMNIOX) for wound healing, surgical repair, and orthopedic applications. Comparable to Fesarius because it sells amniotic and tissue-based skin substitutes and wound matrices into the same hospital and surgeon customer base.
Others
- Regenity Biosciences: Regenity Biosciences is Fesarius's exclusive contract manufacturer and a broader regenerative technology developer producing collagen and biologic scaffolds for medical devices. Comparable as an ecosystem participant that supplies competing regenerative matrix products to other medical device companies.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Fesarius Therapeutics social profiles
Digital presenceFesarius Therapeutics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Fesarius Therapeutics leadership team
Management profileNumber of profiles
Profiles9 records
Fesarius Therapeutics funding detail
Funding detailFunding overview
Funding rounds4 records
Investors6 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Fesarius Therapeutics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Fesarius Therapeutics
What does Fesarius Therapeutics do?
Fesarius Therapeutics develops and commercializes DermiSphere hDRT, a proprietary collagen-based hydrogel Dermal Regeneration Template designed for the treatment of full-thickness skin loss. The product features a novel dual-density biphasic architecture combining a less-dense collagen hydrogel with denser collagen microspheres, enabling rapid vascularization and stable neodermal tissue formation. FDA 510(k) cleared in January 2025, DermiSphere is the first and only genuine hydrogel dermal regeneration template available on the U.S. market.
Is Fesarius Therapeutics a public or private company?
Fesarius Therapeutics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Fesarius Therapeutics founded?
Fesarius Therapeutics was founded in 2015. It employs 1 to 10 people.
Where is Fesarius Therapeutics based?
Fesarius Therapeutics is headquartered in Brooklyn, United States, in the North America region.
How does Fesarius Therapeutics make money?
One revenue line is on record: dermiSphere hDRT Product Sales.
Who are Fesarius Therapeutics's main competitors?
Broad incumbents on record are Integra LifeSciences, Organogenesis, Smith+Nephew, ConvaTec, Solventum (3M Health Care spinoff) and Coloplast. Direct peers are MiMedx, ACell (Integra LifeSciences) and Vivex Biologics. Regenity Biosciences is listed as an others.
Does Fesarius Therapeutics have an API?
No public API is recorded for Fesarius Therapeutics.
What industry is Fesarius Therapeutics in?
Fesarius Therapeutics's product category is Wound Care Medical Devices. Its primary akta.pro industry code is HLAAAGAG, Wound Healing & Skin Regeneration (advanced dressings, skin substitutes), with a secondary code of HLAHALAE, Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts). Its NAICS code is 325414 and its SIC code is 2836.