How to Choose the Right Regenerative Medicine Supplier

Regenerative medicine has many definitions which include a wide variety of products, services and treatments. Most regenerative medicine providers expand this area of their practice after researching a product that was introduced to them by a colleague, vendor or industry expert. Once they are satisfied that there is sufficient proof the product will work for their patients, their regenerative journey begins.

The challenge is that the industry is evolving and many of the products currently available are not approved or even designed for the treatment being considered. More troubling is the fact that some regenerative medicine companies are not FDA registered, inexperienced, underfunded and/or are noncompliant with all of the related federal and state regulations designed to protect providers and their patients.

Additionally, regenerative medicine is a comprehensive field of research, discovery, product development, testing, production and treatment all designed to provide patients a more successful, less invasive, faster and less expensive outcome.

Physicians considering using amniotic tissue, Wharton’s jelly or MSC derived exosome products, or any other regenerative tissue product(s), will want to investigate the viability, history and efficacy of the products they use. Most companies will have case studies, subject matter experts and sales collateral that supports the use of their products. As part of this evaluation, however, physicians should also carefully consider the viability and financial stability of the company that manufactures and sells these products. Physicians should consider the potential risk and liability of using tissue products sold by any start-up or undercapitalized regenerative medicine company.

While the FDA evaluates the future approval and classification of these tissue products, practices will want to align themselves with a company large enough to:

• Fund the FDA's new IND and/or BLA (biologic level application) research/clinical study studies; and

• Legally and financially stand behind any product issues that may be reported to the FDA.

Questions every MD should ask their biologics provider:

• Do they know where (hospital/city) their tissue is collected?

• What is the name of the lab / tissue bank that processes your product?

• Does your marketing company own the lab?

• Who can I talk to at the lab to discuss collection, processing and packaging of your products?

• Who does the screening of the mother - the hospital, company or a 3rd party?

• Who collects the tissue (hospital employee or 3rd party contractor)?

• How much time passes between birth and tissue arrival at tissue bank?

• Once the tissue arrives at the tissue bank, how is it handled/processed? (Aseptic clean room or laboratory?)

• How much time transpires between birth and product packaging / cryofreezing?

• "What is your company's annual revenue?

• Who carries your products liability insurance, the marketing company or the tissue bank?

• How much products liability insurance do you have?

• How long have you been in business?

• How many patients have been treated with your product?

• Have there been –ANY- adverse effects reported to the FDA?

Most regenerative medicine companies cannot or will not answer these questions. Some of these products are actually "private labeled" versions of an undisclosed tissue bank's tissue products. These unregistered marketing companies often disregard FDA regulations and make "stem cell" treatment claims that violate FDA regulations. The risk associated with using these products is unmeasurable.

Physicians using our products can communicate with and purchase products directly from the manufacturer. The production process is fully integrated. All aspects of their production, from pre-birth assessment of the mother, post-delivery “blunt dissection, packaging and transfer of the materials from the hospital to the lab, production, packaging, cryofreezing (when applicable) and product delivery.

GBV’s Goal

As the supplier of the leading regenerative medicine solutions, our goal is to offer physicians treatments that allow a patient’s body to heal itself, without surgery and with no medication.

GBV’s representatives receive complete product training and are contractually bound not to make any unapproved product claims. Our customers are able to communicate directly with each manufacturer's clinical and support team that can answer any product related questions.

GBV is the differentiator. We have fully vetted all of our suppliers, their intellectual property and history of success. This gives providers across the U.S. the assurance they need to treat their patients with the regenerative products we represent. GBV’s solution has no equal in the industry.