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(Incorporated in Delaware)
We develop and manufacture medical devices for tissue repair and other healing situations. Our two major products are RegenKit, a PRP preparation kit, and Cellular Matrix, a PRP-HA combination for knee osteoarthritis.
Most of our products have received the CE mark in Europe Our wound gel is covered by Medicare. Many of our products are approved by the FDA in the United States. Cellular Matrix has not been approved yet in the U.S.; it is still in the PMA process.
We sell our products in about 90 countries.
RegenLab is a science-driven regenerative medicine company originally founded in Switzerland in 2003 and now structured under RegenLab USA, Inc., our U.S.-based holding entity. We operate through a fully integrated platform with three manufacturing sites and dedicated R&D and clinical teams based in New Jersey (USA), Paris (France), and Monthey (Switzerland). Across these sites, we maintain full control of the development and industrialization cycle, including GMP manufacturing, clinical and regulatory affairs, and global IP management. RegenLab is the holder of over 70 granted patents, covering proprietary blood-processing devices (Platelet Rich Plasma, or “PRP”), crosslinked scaffolds, combination products (PRP with Hyaluronic Acid (“HA”)), bone marrow–derived solutions, and bioengineered matrices designed for point-of-care preparation and safe, reproducible use across outpatient and surgical settings.
With a growing body of clinical and economic evidence, our products have been evaluated in approximately 300 clinical studies supporting joint preservation, soft tissue healing, dermal rejuvenation, and urogenital regeneration.
RegenLab has built a modular regenerative product platform that enables tailored solutions across multiple therapeutic areas, notably:
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A stratified osteoarthritis platform designed to address all Kellgren–Lawrence (“KL”) grades (II to IV) with standardized offerings, including:
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Arthrovisc, our CE-MDR product utilizing HA-alone syringes for Grade II KL;
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Regenkit, our CE-MDR and FDA cleared product utilizing PRP-only solutions for Grade II KL;
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Cellular Matrix, our CE-MDR product, with a PMA in process, integrating PRP with linear HA for Grade III KL; and
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RegenMatrix, our pipeline product, integrating PRP with crosslinked HA.
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An expanding wound care platform, anchored by RegenWound, our gel-based autologous product currently reimbursed by CMS in the U.S. for chronic wound management and under commercialization through key partnerships, as well as our newly EU-MDR certified Cellular Membrane product (also referred to herein as CellularWound).
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Emerging platforms targeting tissue repair and regenerative surgery, including bioresorbable electrospun implants, PRP-enhanced matrices, and next-generation gelation systems integrating calcium gluconate or tranexamic acid for hemostatic and anti-inflammatory applications.
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Through this vertically integrated model, RegenLab has achieved direct control over all critical functions — from core IP ownership, to R&D, device design, engineering & manufacturing, clinical validation, and regulatory execution — enabling us to deliver compliant, clinically validated, and scalable regenerative products in a rapidly evolving global market.
RegenLab’s medical device products are commercialized through a mix of direct sales forces in key markets, including the United States, Switzerland, France, Germany and Spain and distribution partnerships.
Our Products
RegenLab is a global leader in autologous regenerative medicine, offering a fully integrated portfolio of standardized PRP, PRP-HA, and tissue engineering technologies across four major therapeutic domains: (1) Musculoskeletal (MSK) Regeneration; (2) Advanced Wound Care; (3) Medical Aesthetics/Dermatology and (4) Women’s Health/ Urogynecology
RegenLab’s vertically integrated model extends beyond PRP to include crosslinked HA gels, nanofiber scaffolds, bioresorbable implants, and fibrin-based biomaterials, enabling a convergence of cell-based therapy and tissue engineering. Each of the four therapeutic platforms is built on a scalable, modular product suite, addressing disease severity and clinical workflow, which we believe opens up a combined global market opportunity exceeding $30 billion.
Note: Net loss and revenue are in U.S. dollars for the 12 months that ended on June 30, 2026.
(Note: RegenLab USA filed its S-1 on Sept. 25, 2026, and outlined its plans for its small IPO without disclosing the terms. Estimated proceeds are $35 million.)
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