While I wouldn’t hazard a guess as to the amount by which a PMA based on the burns trial might impact revenues, there are various reasons to believe the impact will be both positive and significant.
Firstly, there are statements that have been made by both the CEO and Chairman. They are more familiar than we are with the fine details of how the industry works behind the scenes. Swami Raote has expressed the opinion that, following the PMA, we’ll see the adoption curve of BTM in the United States move dramatically. David Williams has also said that PMA approval will change the trajectory of growth.
The second reason is reimbursement, something I’ve discussed before. From a post I wote approximately a year ago
One reason that Integra’s Bilayer Dermal Regeneration Template has remained the market leader in severe burns in the United States, despite its high cost, is that it has PMA regulatory approval.
The importance of PMA approval can be seen in health funds’ determination of whether products are medically necessary. In the example provided below, Blue Cross Blue Shield deems only four products to be “medically necessary” for the treatment of 3rd degree burns. Three of these are cell products - Epicel is a cultured epidermal autograft, Recell is a non-cultured, autologous, cell suspension system and TransCyte consists of a polymer membrane and newborn human fibroblast cells cultured on a porcine collagen coated nylon mesh. TransCyte is FDA approved for temporary coverage of deep burn wounds before grafting at a later date. As cell products, all three of these products had to obtain approval via the PMA pathway. The final product listed, Integra Dermal regeneration template, a “biosynthetic” product, received FDA PMA approval almost 30 years ago (1996) after more than two decades of research. The key patent covering this product was filed in 1981 and so would have expired two decades ago. Despite this, since its FDA approval in 1996, Integra’s dermal regeneration template has remained the only FDA-approved dermal template for the treatment of life-threatening burns.
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What is deemed to be a ‘medically necessary” product for a particular indication varies from one health fund to the next and is subject to change. In one health insurance policy I saw recently, Integra IDRT, despite PMA approval in 3rd degree burns, was only classified as medically necessary in 2nd degree burns and in other policies Recell, despite its PMA approval in burns, wasn't deemed to be medically necessary. What is clear is that, if it is even mentioned, Novosorb BTM is currently banished by every health insurance company to the long list of “experimental, investigational, or unproven” products that have “inadequate evidence in the peer-reviewed medical literature to support their clinical effectiveness.”
Having a PMA approval, I believe, will help shift that view, and being cheaper than currently "proven" products can only be a bonus. I believe that a PMA approval is also likely to positively impact the view of more conservative "slower adopter" surgeons.
Finally, BARDA’s interest in funding PMA approval has been driven by its desire to stockpile BTM for mass casualty events. PMA approval will allow it to do so. While this is an option and not guaranteed, I see it as a likelihood. In the case of Avita, receiving a PMA ultimately led to an order worth US$7.7m.
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