Regenative Labs
A New Era of Regenerative Medicine

In today’s ever-advancing field of regenerative medicine, birth tissue allografts have emerged as the leading sought-after option for tissue replacement and repair, offering advantages over traditional regenerative solutions. Administration of these allografts is non-invasive compared to treatment options such as PRP injections, stem cell treatment, Bone Marrow Aspirate Concentrate (BMAC), and prolotherapy. These characteristics position birth tissue allografts as the most effective option for a series of issues, including chronic wounds, orthopaedic injuries, and ocular repair.

Regenative Labs has taken application of birth tissue allografts to the next level of advancement with its proprietary 361 HCT/P products.

“Our mission is to provide the highest quality birth tissue allografts and analyse their effect on patients to help doctors explore more possibilities in homologous applications,” says Tyler Barrett, CEO of Regenative Labs.

Next-Gen Tissue Supplements

Its flagship offering, ProText^TM, is the first and only structural connective tissue allograft derived from the umbilical cord that has received government recognition to supplement missing or damaged tissue when applied at the site of structural defect. It preserves the structural integrity and original characteristics of Wharton’s jelly to repair damaged tissue and is intended for homologous use only.

Among Regenative’s other key offerings is its AmnioText^TM patch, a sterile, dehydrated dual-layer amniotic membrane allograft that can be applied on wound closure sites following a medical procedure, or directly onto an open wound. The allografts are minimally manipulated, per FDA guidelines, and processed to preserve their utility to serve as a covering or barrier.

The AmnioText^TM patches are produced and tested at Regenative’s state-of-the-art laboratories in Pensacola, Florida.

At the time of tissue collection, a mother’s blood sample is taken and sent for serological testing to rule out the possibility of spreading infectious diseases to the recipient. Following its clearance, Regenative aseptically processes the tissue in compliance with industry standards. Post-processing, tissues undergo sterility testing to ensure no fungal or bacterial growth. Donor and processing records are then sent to their Medical Director for approval prior to distribution.

Optimizing Patient Outcomes

Further distinguishing Regenative’s commitment to providing the highest quality human tissue allografts is its data repository for recording patient outcomes and analysis for statistical significance.

“We have established a retrospective data repository where we constantly monitor and analyse patient outcomes after connective tissue supplementation to discover new homologous applications,” says Barrett.

Regenative works closely with scientists, physicians, hospitals, and surgery centers that submit data pertaining to the effects on patients of its tissue allografts. The outcomes are tracked up to 120 days following an application of Regenative’s product. This data repository assists physicians in making more informed decisions for patient health while Regenative gains crucial insights from real-time patients to develop more advanced and effective products.

The data repository, designed to promote a value-based, outcome-focused practice, has inspired numerous case studies and peer-reviewed research.

It has enabled Regenative to publish several scientific articles, including one on the benefits of dehydrated amniotic membrane allografts in the closure of diabetic foot ulcers and chronic venous ulcers. The study program has collectively uncovered over 180 application sites, driving advancements in regenerative medicine.

Achieving Total Compliance

Aware of how compliance has always been a key criterion for upholding the credibility of regenerative medicine applications, Regenative ensures its products remain in compliance with all regulatory requirements.

Our Mission Is To Provide The Highest Quality Birth Tissue Allografts And Analyse Their Effect On Patients To Help Doctors Explore More Possibilities In Homologous Applications

According to FDA regulations, any new 361 product comprising human cells, tissues, and cellular products developed under 21 CFR Part 1271, must meet four crucial criteria to be classified under that particular code. Otherwise, the product is considered a drug or a 351 article.

The first and most important criterion is objective evidence of minimal manipulation, which many labs overlook. More often than not, a tissue-based product’s processing significantly impairs its biological functions and deems it incompatible for use. Regenative has published an extracellular matrix (ECM) study that provides objective evidence of minimal manipulation for homologous use before and after tissue processing. Regenative showcased how its allografts were indistinguishable in terms of the birth tissue’s structural properties and supplement similar recipient tissues.

The FDA mandate also states that the product should be used for homologous use only and cannot have a systemic effect or be dependent upon the metabolic activity of a living cell for its primary function.

Regenative has met all these criteria to strictly comply with all federal and state regulations. Its evidence-backed position in regenerative medicine makes Regenative Labs an FDAregistered and inspected HCT/Ps manufacturer maintaining compliance with regulatory bodies at all times.

In addition, it helps clients understand how to operate in the regenerative medicine space through impactful marketing training programs.

The Mark of Distinction

Among numerous instances that exemplify the excellence of Regenative’s products, one notable example is the application of ProText^TM on a patient who was struggling with dysregulation and postoperative wound dehiscence following a breast mammoplasty procedure.

Even after eight weeks of conservative management, the patient continued to suffer from a nearly 4cm open wound. It was imperative that her wound be closed as soon as possible to avoid further pain and infection.

A single dose of Regenative’s Wharton’s jelly flowable allograft was applied around and under the wound bed in conjunction with hyperbaric oxygen chamber treatments. The patient achieved 100 percent epithelialization and closure of the wound in just three weeks after the initial evaluation.

On another occasion, a 44-year-old male presented with a medical history of end-stage renal disease was also diagnosed with Type 2 diabetes mellitus. The patient developed an aggressive infection on his right foot and underwent a trans-metatarsal amputation. Post surgery, the patient had a large blister formed on the stump of his foot and reported numbness, tingling, and shooting sensations. The wound remained open despite the previous standard-of-care attempts, including using an off-loading pad in the shoe, dry sterile dressings, and sharp wound debridement with calcium alginate and betadine.

The patient then received weekly applications of Regenative’s dual-layer human amniotic membrane allografts directly on the wound over seven weeks. As the wound decreased in size, the grafts sizes were also decreased. Forty-nine days from the initial allograft application, the wound was completely closed. No adverse effects from the amniotic membrane allograft application were reported.

The Fountainhead of Success

Underpinning Regenative’s unparalleled competencies is its leadership team that brings a wide range of experience and industry application expertise.

Barrett, who has worked as an executive in several industries, brings an irrepressible entrepreneurial spirit that guides the company forward. Assembling an esteemed team of industry experts with illustrious careers in the regulatory field, stem cell programs, and corporate strategy space, he is determined to make Regenative Labs an emblem of innovation in regenerative medicine applications.

Having recently expanded its footprint in Taiwan, Regenative Labs is foraying into the Asia Pacific market, including Korea and Japan. It also plans to branch out into the South American and MENA regions.

Cutting-edge products, combined with its ability to deliver value-based care powered by data-driven clinical practices, make Regenative Labs the ultimate expert for advanced regenerative medicine, raising the bar for patient care worldwide.