Regenative Labs

What Regenative Labs does

Regenative Labs is a privately held, FDA-registered HCT/P manufacturer headquartered in Pensacola, Florida that produces cryopreserved Wharton's jelly allografts derived from donated human umbilical cord tissue, along with dehydrated amniotic membrane patches. The company processes birth tissue under Section 361 of the PHS Act and 21 CFR Part 1271 in ISO Class 5/7 cleanroom conditions, with structural integrity verified via electron microscopy and mass spectrometry in collaboration with Baylor College of Medicine. Its four core products — CryoText, SecreText, ProText (Q-Code Q4246), and AmnioText — are sold in coded variants eligible for insurance reimbursement and non-coded variants, targeting musculoskeletal applications (knee, shoulder, hip, spine, foot/ankle, hand/wrist), aesthetics, and wound care.

The company sells directly to healthcare providers (orthopedic surgeons, sports medicine physicians, podiatrists, and musculoskeletal specialists) through the MedNGINE provider portal on a unit-pricing, pay-as-you-go basis. Its go-to-market centers on a clinical site enrollment program that enrolls physician partners into IRB-approved outcomes data collection, providing clinical research coordinators, compliance-reviewed marketing materials, and a publication pathway. This model has accumulated over 20,000 patient outcomes submissions and produced 17 peer-reviewed publications across multiple anatomical applications, with reported zero adverse events and pain score improvements ranging from 32-50% across studies.

Regenative Labs is founder-led by CEO Tyler Barrett, with CFO Roger Liu (prior roles at HSBC, ABN AMRO, Ping An of China, and Transpac Asset Management), CSO Dr. John Shou (Baylor College of Medicine), and Medical Director Dr. Michael Bauer (Cedars-Sinai fellowship in transfusion medicine). The company holds ISO 13485:2016 certification and operates as a bootstrapped/private entity with no disclosed venture funding, though it has entered material strategic partnerships including a $5M veteran care initiative with Brothers in Arms in 2023. Distribution is domestic (United States) and revenue mechanics rely on physician-level repeat ordering rather than enterprise contracts.

Name

Regenative Labs

Legal name

Regenative Labs, Inc.

Website

https://regenativelabs.com

Company type

Private

Operating status

Operating

Headcount range

51–100 employees

Short description

Regenative Labs is an FDA-registered HCT/P manufacturer in Pensacola, Florida that produces cryopreserved Wharton's jelly and amniotic membrane allografts for orthopedic, sports medicine, podiatric, aesthetic, and wound care providers, sold directly through the MedNGINE provider portal.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Allografts

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cell & Tissue Banking (biobanking, cord blood/tissue) (HLAAAGAE)

akta.pro secondary industry

Bone Graft Substitutes & Orthobiologics (Synthetic/Allograft/DBM) (HLAHAEAG)

Keywords

• Regenerative medicine allografts
• Wharton's jelly tissue products
• Connective tissue supplementation
• Human umbilical cord allografts
• Amniotic membrane patches

Headquarters

HQ city

Pensacola

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Technology or R&D, Personnel, Marketing or Sales

Revenue model

1. HCT/P Allograft Product Sales: Regenative Labs generates revenue through the sale of cryopreserved Wharton’s jelly allografts and amniotic membrane products to healthcare providers. Products are sold in coded (ProText, AmnioText - billable to insurance with Q-codes) and non-coded (CryoText, SecreText) variants. Providers purchase through the MedNGINE portal after account creation.
2. Clinical Data Program Services: Revenue generated through clinical site enrollment program where physicians contribute patient outcomes data to the company’s repository, supporting publication pathway and evidence-based marketing.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels7 records

Core offering

Regenative Labs manufactures and distributes cryopreserved Wharton's jelly allografts (CryoText, SecreText, ProText) and dehydrated amniotic membrane patches (AmnioText) derived from donated human umbilical cord and amniotic tissue, sold to licensed healthcare providers for homologous use in connective tissue supplementation. Products are regulated as Section 361 HCT/Ps under FDA 21 CFR Part 1271, with select products carrying CMS Q-codes (Q4246) for insurance reimbursement.

Product overview

Regenative Labs is an FDA-registered HCT/P manufacturer offering birth tissue allografts derived from human umbilical cord (Wharton's Jelly) and amniotic membrane. Their product portfolio consists of four main products: CryoText™ and SecreText™ (non-coded Wharton’s Jelly products available in varying concentrations for structural support and aesthetic applications), and ProText™ and AmnioText™ (coded products with CMS Q-Codes for insurance billing). All products are derived from donated human umbilical cord tissue or amniotic membrane following full-term C-section deliveries, processed under Section 361 of the PHS Act for homologous use in connective tissue supplementation.

Differentiator

Problem solved

Functional benefit

Brands

• CryoText™: Most concentrated non-coded Wharton’s Jelly allograft product rich in cytokines, growth factors and scaffolding proteins. Used as replacement tissue for missing or damaged connective tissue.
• SecreText™
• ProText™
• AmnioText™

Products and services

• CryoText™ Non-coded cryopreserved Wharton's jelly allograft product rich in cytokines, growth factors, and scaffolding proteins. Used as replacement tissue to replace missing or damaged connective tissue in orthopedic, sports medicine, podiatric, and wound care applications. Sold to licensed healthcare providers via the MedNGINE portal.
• SecreText™ Non-coded cryopreserved Wharton's jelly allograft in lower concentrations (15mg/mL and 25mg/mL) intended for smaller defects and aesthetic applications such as facial volume restoration, treatment of facial lines and wrinkles. Sold to aesthetic and regenerative medicine providers.
• ProText™ Most concentrated cryopreserved Wharton's jelly connective tissue supplement intended for homologous use to replace or supplement missing or damaged tissue directly at the site of a structural defect. Coded product with Q-Code Q4246 enabling insurance billing. Available in 1mL (PT100-25) and 2mL (PT200-25) vials. Sold to healthcare providers via the MedNGINE portal.
• AmnioText™ Sterile, dehydrated human amniotic membrane allograft intended for homologous use to cover and protect the recipient's tissues. Dual-layer patch processed to preserve utility as a barrier in wound care and surgical applications. Coded product with Q-Code for insurance billing. Sold to wound care specialists and healthcare providers via the MedNGINE portal.

Quantifiable outcome

• 50% average reduction in pain scores (VAS 6.88 to 3.44) at 13-week follow-up for plantar fasciosis patients
• +7 more outcomes

Named customers7 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Baylor College of MedicinecoreStrategic or Co-development PartnerResearch collaboration to create mass spectrometry reports detailing structural components of Wharton’s jelly before and after processing. Dr. John Shou serves as Chief Scientist for the Department of Pharmacology and Chemical Biology at Baylor College of Medicine.
• Institute of Regenerative and Cellular Medicine (IRCM)coreStrategic or Co-development PartnerIRB approval for observational data collection studies. The institute provides oversight for clinical research protocols enabling physician partners to collect and publish patient outcomes data.
• University Foot & Ankle InstitutecoreStrategic or Co-development PartnerCollaboration on plantar fascia case series published in Biomedicines journal (September 2025), studying Wharton’s jelly connective tissue allografts in patients with plantar fasciopathy.
• Advanced Medicine of The OzarksminorStrategic or Co-development PartnerJoint publication of case series demonstrating utilization of Wharton’s Jelly allografts in supplementing connective tissue defects associated with Tarsal Tunnel Syndrome.
• Brothers in ArmsminorGTM or Marketing Partner$5 million partnership announced September 2023 for veteran care initiatives. Organization focused on supporting veterans through regenerative medicine treatment options.
• AAPCminorStrategic or Co-development PartnerHealthcare compliance collaboration announced August 2022 to further healthcare compliance education and resources for physician partners.
• MedNGINEcoreTechnology or IntegrationTechnology platform partner providing portal for provider account management, product ordering, and clinical data collection. MedNGINE serves as the e-commerce and data submission platform.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• MiMedx: MiMedx is the largest publicly traded birth-tissue allograft company, marketing dehydrated amniotic membrane and other placental-derived products for wound care, surgical recovery, and musculoskeletal applications. It is the most directly comparable competitor to Regenative Labs in Section 361 HCT/P birth-tissue products and competes for the same orthopedic and wound care physician customers.
• Organogenesis: Organogenesis is a regenerative medicine company offering wound care and surgical biologics including amniotic tissue products (e.g., Apligraf, Affinity, NuShield) under similar regulatory pathways. It directly competes with Regenative Labs in advanced wound care and is moving into orthopedic and sports medicine indications.
• Vivex Biomedical: Vivex Biomedical develops and markets regenerative therapies including birth-tissue allografts and amniotic products for orthopedic, wound care, and pain management applications. It directly overlaps with Regenative Labs' product portfolio (umbilical cord / amniotic tissue allografts) and serves the same specialty physician customer base.

Broad incumbents

• AlloSource: AlloSource is one of the largest nonprofit tissue banks in the U.S., providing cartilage, cellular, and bone allografts used in orthopedic and spine procedures. It competes with Regenative Labs across musculoskeletal applications, particularly in cartilage restoration and sports medicine.
• Arthrex: Arthrex is a global leader in orthopedics and sports medicine, with a regenerative medicine portfolio including autologous and allogeneic biologics. It is a broad incumbent competing with Regenative Labs in orthopedic applications via established surgeon relationships and extensive distribution.
• Integra LifeSciences: Integra LifeSciences is a large medical device and regenerative technologies company with orthobiologics and tissue regeneration offerings. It competes with Regenative Labs in orthopedic and wound care applications as part of a broader portfolio of neurosurgery, ENT, and reconstructive products.
• MTF Biologics: MTF Biologics is one of the largest tissue banks in the U.S., offering a broad portfolio of allografts including cartilage, tendon, bone, and birth-tissue products. It competes across the full spectrum of regenerative medicine applications where Regenative Labs operates and is a major source of allografts for hospital systems.
• Smith+Nephew (Osiris): Smith+Nephew acquired Osiris Therapeutics and markets regenerative medicine products including placental tissue allografts and skin substitutes. It is a large incumbent in sports medicine and orthopedics, with a sales force that overlaps significantly with Regenative Labs' physician targets.

Emerging players

• NuCel (NuTech Medical): NuTech Medical markets NuCel, an amniotic membrane and connective tissue allograft product for orthopedic and wound care applications. It is a smaller, niche competitor serving similar podiatric and orthopedic customers and represents an emerging alternative to Regenative Labs' portfolio.
• Surgenex: Surgenex markets cryopreserved birth-tissue allografts including umbilical cord and amniotic membrane products for orthopedic, wound care, and pain management applications. It is a smaller, emerging competitor with significant product overlap with Regenative Labs' Wharton's jelly and amniotic membrane portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/watch?v=oeLt-SKpsnc
• LinkedInlinkedin.com/company/regenative-labs
• Facebookfacebook.com/Regenative-Labs-111967610584305

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Regenative Labs