RegenLab USA
RegenLab USA LLC manufactures and distributes FDA-cleared medical device kits for autologous platelet-rich plasma (PRP) preparation, serving wound care specialists, orthopedic surgeons, and dermatologists in the United States via proprietary thixotropic gel separation technology.
- Company typePrivate
- Founded2003
- HeadquartersBrooklyn, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What RegenLab USA does
RegenLab USA LLC is the U.S. operating subsidiary of Swiss-founded Regen Lab SA (est. 2003) and manufactures/distributes medical devices for autologous platelet-rich plasma (PRP) preparation under FDA 510(k) clearance, with operational headquarters in Jersey City, NJ. The company's core product line comprises single-use evacuated borosilicate tube kits (RegenKit BCT, THT, Wound Gel, Enhanced HA) and the Regen ATS autologous thrombin serum device, all built on a proprietary thixotropic gel separation technology protected by granted U.S., European, and Swiss patents. Centrifugation at 1500 g causes the thixotropic gel to form a stable physical barrier isolating platelets and plasma from erythrocytes and granulocytes, yielding standardized PRP with >80% platelet recovery and >99.7% RBC elimination. The technology supports multiple cellular selectivity profiles (RegenPlasma leukocyte-poor vs. RegenCell mononuclear-selective) and concentration flexibility (1.6x to 6.9x baseline).
Revenue is generated primarily through one-time sales of single-use medical device kits to healthcare professionals across three primary segments: wound care specialists (CMS-reimbursed under HCPCS G0465 via MiMedx Group exclusive U.S. distribution); orthopedic surgeons and sports medicine physicians (RegenKit-THT/BCT for knee OA, tendinopathy, bone graft augmentation); and dermatologists/aesthetic practitioners (Enhanced HA for hair loss and skin rejuvenation). Pricing is not publicly disclosed; orders are placed through Account Support ([email protected]) and online account portals, with enterprise-level Doctor-to-Doctor Sales Advisors targeting hospitals and wound care centers. Sales reps carry monthly targets of $100K with commission of 5% on new clients and 4% on recurring/dormant accounts. An additional revenue stream comes through proprietary technology licensing via Regen Lab SA's global patent portfolio. Across the parent group, Regen Lab operates ~145 employees (30 US, 75 Switzerland HQ, 40 France), sells in 160+ countries, and has treated over 2 million patients with RegenLab technology.
RegenLab USA firmographics
Firmographics- Name
- RegenLab USA
- Legal name
- Regenlab USA LLC
- Website
- https://regenlabusa.com
- Company type
- Private
- Founded year
- 2003
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- RegenLab USA LLC manufactures and distributes FDA-cleared medical device kits for autologous platelet-rich plasma (PRP) preparation, serving wound care specialists, orthopedic surgeons, and dermatologists in the United States via proprietary thixotropic gel separation technology.
- Ownership category
- akta.pro rank
RegenLab USA industry classification
Industry- Product category
- Regenerative Medicine Medical Devices
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)
- akta.pro primary industry
- Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts) (HLAHALAE)
- akta.pro secondary industries
- Wound Healing & Skin Regeneration (advanced dressings, skin substitutes) (HLAAAGAG), Fibrin Sealants & Plasma-Derived Surgical Hemostats (Fibrinogen/Thrombin) (HLAIAHAG)
Keywords
Where RegenLab USA is headquartered
LocationHeadquarters
- HQ city
- Brooklyn
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
RegenLab USA business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Operations, Supply Chain, Personnel, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- RegenKit® Medical Device Sales: RegenLab USA sells single-use medical device kits (RegenKit® BCT, THT, Wound Gel, Enhanced HA, ATS) and supplemental devices (centrifuges, applicators, blood draw accessories) to healthcare professionals. Products are sold directly via sales team and through the MiMedx distribution partnership for Wound Gel. Revenue is generated per kit/unit sold.
- Proprietary Technology Licensing: RegenLab licenses its patented thixotropic gel technology and A-PRP® preparation methods globally through sister company Regen Lab SA. The company holds an extensive portfolio of U.S., European, and Swiss patents covering PRP preparation, BMC gel devices, ATS, PRP+HA combinations (Cellular Matrix®), and associated technologies.
- Supplemental Devices and Accessories: Sale of complementary devices including the Horizon 6FA Centrifuge, Regen® Spray Applicator, Neo Oxus Trocar, and blood draw accessory sets (Safety-Lok™ Butterfly needles, collection holders, transfer devices, syringes) compatible with RegenKit® products.
Go-to-market motion4 records
Distribution channels4 records
Marketing channels7 records
RegenLab USA product offering
Product offeringCore offering
RegenLab USA LLC manufactures and distributes single-use medical device kits and laboratory products that enable healthcare professionals to prepare autologous platelet-rich plasma (PRP) at the point of care. Its portfolio includes the RegenKit family (BCT, THT, Wound Gel), Regen ATS for autologous thrombin serum, Enhanced HA combining PRP with hyaluronic acid, and supplemental devices (centrifuge, spray applicator, blood draw accessories) used in wound care, orthopedics, dermatology, and aesthetic applications.
Product overview
RegenLab USA LLC offers a comprehensive portfolio of medical devices for autologous regenerative medicine, centered on their proprietary thixotropic gel technology for platelet-rich plasma (PRP) preparation. The core product line includes RegenPRP™ treatment combined with RegenKit® medical device kits (BCT, THT®, Wound Gel) and Regen® ATS for coagulation activation. Additional offerings include Enhanced HA combining PRP with hyaluronic acid, and supplemental devices such as the Horizon 6FA Centrifuge, Spray Applicator, and Blood Draw Accessories. The portfolio provides concentration flexibility through different cellular selectivity models (RegenPlasma® leukocyte-poor and RegenCell® monocyte-selective), enabling individualized therapeutic approaches for wound care, orthopedics, dermatology, and aesthetic applications. Distribution is handled through exclusive partnerships including MiMedx for the FDA-approved RegenKit-Wound Gel.
Differentiator
Problem solved
Functional benefit
Brands
- RegenPRP™: Medical treatment using platelet-rich plasma from the patient's own blood to enhance tissue regeneration.
- RegenKit® BCT
- RegenKit® Wound Gel
- RegenKit® THT®
- Regen® ATS
- Enhanced HA
- A-PRP® Cellular Selectivity
- RegenWound® Gel
- Cellular Matrix™
- BioBridge®
Products and services
- RegenKit BCT Single-use medical device kit for preparing leukocyte-poor autologous platelet-rich plasma (PRP) at point of care. Achieves >80% platelet recovery and >99.7% RBC elimination. Available in 10 mL and 20 mL configurations for orthopedic, wound care, dermatology, and aesthetic applications.
- RegenKit THT Single-use medical device kit for preparing monocyte-selective autologous PRP, designed for mixing with autograft/allograft bone in orthopedic surgical applications. Achieves >95% platelet recovery and 70-80% mononuclear cell recovery. Available in 10 mL and 20 mL configurations.
- RegenKit Wound Gel Single-use medical device kit for preparing autologous PRP wound gel at point of care. Produces ~6.5 mL (Wound Gel-1) or ~13 mL (Wound Gel-2) of gel from patient blood. Achieves 99.7% RBC elimination and >80% platelet recovery. Indicated for chronic diabetic ulcers, pressure ulcers, leg ulcers, and debrided wounds.
- Regen ATS (Autologous Thrombin Serum) Single-use medical device kit for preparing autologous thrombin serum that activates PRP coagulation via the physiological coagulation cascade. Produces a 3D fibrin matrix enabling sustained growth factor delivery for tissue repair applications.
- Enhanced HA Single-use medical device kit combining platelet-rich plasma with hyaluronic acid in a single tube for skin and joint rejuvenation. Yields ~4 mL of PRP/HA 1:1 mixture per tube with >70% platelet recovery and high purity standards.
- Horizon 6FA Centrifuge Fixed-angle centrifuge designed to complement RegenKit medical devices. Accommodates tubes up to 125 mm including 8 mL, 10 mL, and 20 mL variations with pre-programmed settings for consistent PRP preparation.
- Regen Spray Applicator Class 2 medical device for efficient application of non-homogeneous fluid mixtures such as PRP directly to treatment sites. Designed for evenly dispersing mixtures across larger surface areas for wound healing applications.
- Regen Blood Draw Accessories Blood draw accessory set including Safety-Lok Butterfly needles, collection holders, transfer devices, and syringes designed for efficient and reliable blood collection when used with RegenKit medical devices.
- Neo Oxus Trocar
Quantifiable outcome
- Platelet recovery >80% (BCT) and >95% (THT); RBC elimination >99.7% (BCT) and >99% (THT); Granulocyte removal ~96.5% (BCT) and 85-90% (THT)
- +4 more outcomes
Companies that use RegenLab USA
Customer profileNamed customers3 records
Segments5 records
Ideal customer profiles4 records
RegenLab USA technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature9 records
RegenLab USA partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- MiMedx Group, Inc.coreMiMedx Group, Inc. signed an exclusive U.S. distribution agreement with Regen Lab USA LLC to market RegenKit-Wound Gel, an FDA-approved autologous platelet-rich plasma wound gel cleared in 2022 for treating diabetic chronic wounds. The product is nationally covered by CMS and LCD under HCPCS code G0465 and will complement MiMedx's existing Advanced Wound Care portfolio. The agreement, combined with the upcoming Local Coverage Determination implementation on January 1, 2026, strengthens MiMedx's competitive position heading into the new year. MiMedx also reported strong Q3 2025 earnings (EPS $0.15 vs. $0.06 forecast, revenue $113.7M vs. $94.73M expected), indicating financial strength as a distribution partner.
Scale indicators7 records
Recent moves9 records
Expansion highlights6 records
RegenLab USA competitors and assessment
Company assessmentBroad incumbents
- Arthrex: Arthrex is a leading orthopedic medical device company that offers autologous conditioned plasma (ACP) and other PRP systems for orthopedic and sports medicine applications, directly competing with RegenKit BCT and THT in the same physician-channel market.
- Terumo BCT: Terumo BCT (a Terumo group company) is a global leader in blood component separation technology, offering centrifugal apheresis and PRP collection systems that compete at the higher-volume hospital and blood bank end of RegenLab's market.
- Zimmer Biomet: Zimmer Biomet is a global orthopedic device incumbent that has invested in PRP/orthobiologics (e.g., BioCUE) and competes in musculoskeletal applications where RegenKit THT is used for bone graft and sports medicine.
- Stryker: Stryker is a broad medical device incumbent with orthopedic, wound care, and surgical portfolios that compete at the hospital system level where RegenLab's RegenKit products are deployed via MiMedx and direct sales.
Direct peers
- EmCyte Corporation: EmCyte is a direct competitor in PRP and platelet-rich fibrin preparation kits for orthopedic and aesthetic use, with overlapping product lines (Concentrating Systems, kits) and similar point-of-care preparation approach to RegenLab.
- MiMedx Group: MiMedx is RegenLab's exclusive U.S. distribution partner for RegenKit-Wound Gel and also a peer in advanced wound care (placental tissue allografts), competing in the same HCPCS-coded wound care segment while serving as channel partner.
- Royal Biologics: Royal Biologics offers autologous regenerative medicine products including PRP kits and amniotic fluid products for orthopedics and wound care, directly competing with RegenLab's kit-based portfolio for physician offices.
- Celling Biosciences: Celling Biosciences is a regenerative medicine company specializing in autologous cellular therapies and point-of-care preparation devices, overlapping with RegenLab's bone marrow concentrate (BMC) and PRP preparation positioning in orthopedics.
Emerging players
- STRATA Skin Sciences: STRATA Skin Sciences operates in dermatology/aesthetic device space and overlaps with RegenLab's dermatology and PRP-for-hair-loss segments, including similar physician-channel customer bases.
- Collagen Solutions: Collagen Solutions develops biologic medical devices and tissue-based products for wound care and orthopedics, partially overlapping with RegenKit-Wound Gel and orthobiologics applications.
Market position
Strengths5 records
Weaknesses3 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
RegenLab USA social profiles
Digital presenceRegenLab USA compliance and trust
Trust signalCompliance7 records
RegenLab USA financial estimates
Financial estimateRevenue estimate
Valuation estimate
RegenLab USA leadership team
Management profileNumber of profiles
Profiles2 records
RegenLab USA subsidiaries and ownership
Company hierarchySubsidiaries3 records
RegenLab USA funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
RegenLab USA 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 RegenLab USA
What does RegenLab USA do?
RegenLab USA LLC manufactures and distributes single-use medical device kits and laboratory products that enable healthcare professionals to prepare autologous platelet-rich plasma (PRP) at the point of care. Its portfolio includes the RegenKit family (BCT, THT, Wound Gel), Regen ATS for autologous thrombin serum, Enhanced HA combining PRP with hyaluronic acid, and supplemental devices (centrifuge, spray applicator, blood draw accessories) used in wound care, orthopedics, dermatology, and aesthetic applications.
Is RegenLab USA a public or private company?
RegenLab USA is a private company. It is classified as corporate owned and is currently operating.
When was RegenLab USA founded?
RegenLab USA was founded in 2003. It employs 51 to 100 people.
Where is RegenLab USA based?
RegenLab USA is headquartered in Brooklyn, United States, in the North America region.
How does RegenLab USA make money?
Three revenue lines are on record. RegenKit® Medical Device Sales are the primary driver. The others are proprietary Technology Licensing and supplemental Devices and Accessories.
Who are RegenLab USA's main competitors?
Broad incumbents on record are Arthrex, Terumo BCT, Zimmer Biomet and Stryker. Direct peers are EmCyte Corporation, MiMedx Group, Royal Biologics and Celling Biosciences. Emerging players are STRATA Skin Sciences and Collagen Solutions.
Does RegenLab USA have an API?
No public API is recorded for RegenLab USA.
What industry is RegenLab USA in?
RegenLab USA's product category is Regenerative Medicine Medical Devices. Its primary akta.pro industry code is HLAHALAE, Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts), with a secondary code of HLAAAGAG, Wound Healing & Skin Regeneration (advanced dressings, skin substitutes). Its NAICS code is 325414 and its SIC code is 3841.