Regenerative Labs

Regenative Labs is an FDA-registered manufacturer of human tissue allografts derived from birth tissues, specifically umbilical cord and placental membranes from healthy cesarean deliveries. The company's core mission centers on facilitating predictable patient outcomes by providing the highest-quality human tissue products for tissue supplementation and repair. Their flagship product, Wharton's jelly allograft, delivers tissue regeneration through homologous use, replacing or supplementing damaged cells with healthy tissue to address the root cause of patient conditions rather than symptoms.

The company operates under strict FDA and AATB compliance, manufacturing products in state-of-the-art ISO Class 7 cleanrooms with advanced quality control systems. Regenative Labs maintains a comprehensive retrospective repository of patient outcomes that enables predictive results and supports exploration of new tissue applications. Their evidence-backed regulatory position under 21 CFR 1271 (361 pathway) demonstrates structural property consistency before and after processing, with reported average functional improvement of 35 percent in transplant procedures.

Regenative Labs positions itself as a collaborative partner for healthcare providers, offering clinical support through dedicated Clinical Research Coordinators, educational programs on FDA regulations, and resources for data submission and publication. The company serves both providers and patients seeking minimally-invasive options for complex medical challenges, with a commitment to transparency through data collection and statistical analysis of patient outcomes.