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Regenative Labs

Pensacola, Florida, United Statesregenativelabs.com ↗

Ownership: Private
Employees: ~57
Development stage: Commercial

Overview

Regenative Labs manufactures human birth tissue-derived allograft products—primarily from umbilical cord and amniotic membrane—for use in orthopedic, sports medicine, and wound care. Their main marketed products include ProText™, CoreText™, CryoText™ Pro/Plus, SecreText™/Pro. The company operates an FDA-inspected facility with ISO Class cleanrooms in Pensacola, Florida. In June 2023 the FDA issued a warning letter stating that several of their cellular/tissue-based products are considered drugs or biologicals requiring premarket approval rather than being solely regulated as HCT/Ps under Section 361 of the PHS Act.

Therapeutic areas: DermatologyRheumatology
Modalities: Cell therapy (birth tissue-derived allografts)Biologic (human tissue allografts)Cellular therapy (umbilical cord/Wharton’s jelly products)
Industry: Biotech

Drug pipeline

1 asset

ReGen5

Preclinical

Partnerships

Collaborations with universities including Baylor College of Medicine for research validation; no major pharma partnerships disclosed.

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