It is estimated that by the end of 2019 the total market capitalization for biologic products, including HCTPs (human cells, tissues and tissue based products), will reach 23 Billion. Many of our customers are already seeing an impact as it relates to new product approval requests from vendors and how this affects their bottom line.
At Synergy Biologics, we combine decades of experience in human tissue processing with accomplished track records in surgical product development and regulatory compliance. More specifically, we are a vertically integrated tissue biologics company that specializes in the recovery, processing and distribution of amniotic tissue allografts. This means that we control the quality of each tissue allograft throughout the entire continuum (tissue recovery, processing and distribution) as well as the costs associated.
Ultimately, our focus is to provide a suite of amniotic tissue based allografts in the most cost effective manner so that more patients have the ability to receive these therapeutic allografts.
Interestingly, there are many tissue products (HCTPs) on the market with varying commercial names but they are all considered "birth tissue" and are regulated under 21 CFR 1271 via PHS 361 by the FDA. These HCTP products do not require "FDA Approval" but do however have to comply with certain regulations in order to be considered a "361" i.e., that they must be for "homologous use" only and should only be "minimally manipulated".
With that, all of the amniotic tissue products that are seen marketed are essentially the same in that they cannot be more than minimally manipulated. This has been a source of confusion for many purchasers in that they are told by certain companies that their product is somehow clinically superior and that they have a special proprietary process that ensures this claim.
In reality, all amniotic tissue based products are supposed to be minimally manipulated per the FDA and thus should not require a "special process" that in turn increases overall cost.
In light of these facts, we have been able to drastically reduce the bottom line cost for these amniotic tissue allograft products with our partner hospitals and ASCs, while providing the very same therapeutic benefits for their patients.