Regenative Labs
Pioneering Regenerative Medicine for Safer Tissue Supplementation

With its demonstrated wound-healing capabilities, birth tissue is revolutionizing regenerative medicine as Regenative Labs uncovers a new dimension of treatment methodologies. Today, many research studies highlight the pivotal role birth-tissue-driven therapies play in enhancing the outcomes of traditional treatment procedures, such as surgical intervention, historically riddled with complications.

At the forefront of this research is Regenative Labs. The FDA-registered manufacturer produces and delivers high-quality allografts for tissue supplementation aimed at improving patient outcomes by targeting the source of their pain.

Regenative Labs’ mission is to provide the highest-quality human tissue. Its portfolio of products is comprised of two categories. These products use birth tissue extracted from umbilical cords and placental membranes from healthy C-sections. Its placental membrane product is a dehydrated or desiccated patch for barrier or covering functions, while the umbilical cord-derived products are built for tissue supplementation. The lab’s flagship product is its Wharton’s jelly allograft, which delivers predictable patient outcomes by replacing or supplementing damaged cells with new healthy tissue through homologous use.

Its retrospective repository containing numerous patient outcomes (recorded after connective tissue supplementation) also enables Regenative to facilitate predictive results and empower clients to explore new homologous tissue applications.

Organizations seeking to enter the regenerative medicine domain typically follow one of two regulatory pathways (351 or 361) to bring their products to market.

This is a highly regulated process for organizations providing allogenic cell-based therapies, as they must meet four-part criteria before gaining 361 HCT/P approval. According to the mandate, products must be minimally manipulated, not create any health or safety concerns for patients, and have no systemic effect or be dependent upon the metabolic activity of a living cell for their primary function.

Regenative meets these 361 criteria, publishing objective evidence of how its tissue products were indistinguishable in structural property before and after processing. This evidence-backed position in the regenerative medicine space makes it a unique partner for diverse clinical applications.

Additionally,, Regenative assists its clients in overcoming regulatory hurdles through educational programs designed to support them in adapting to ever-changing FDA regulations. Beyond compliance, the firm also boosts extracellular matrix (ECM) studies by ensuring the timely sharing of samples for electron microscopy, known to uncover analogous tissue functions. This helps them understand how to operate in the regenerative medicine space through impactful marketing training programs.

“We undertake research to produce offerings that follow FDA regulations and create 361 HCT/P-approved products that deliver an average functional improvement of 35 percent when used in transplant procedures,” says Tyler Barrett, CEO of Regenative Labs.

Regenative produces 361 products under 21 CFR 1271, which include human cells, tissues, and cellular and tissue-based products. Concurrently, by partnering with the American Academy of Professional Coders (AAPC), Regenative has produced a list of ICD 10 codes that match homologous use applications.

An excellent success story exemplifying Regenative’s impact is when its Wharton’s jelly product was applied to a patient struggling with dysregulation and scarring after a breast mammoplasty procedure. Within three weeks of incorporating the product into their treatment regime, the patient made a full recovery. This success drove the company to outperform existing research efforts, resulting in eight new publications and over 180 documented application sites.

Regenative’s cutting-edge services, combined with its ability to deliver value-based care, good clinical practices, and impactful education on achieving better patient outcomes, poises it to continue bringing new healthcare breakthroughs to light.