Both breast implants and dermal matrix used for reinforcement in breast reconstruction must be approved via the FDA’s PMA pathway (that is, extended clinical trials are required, such as BTM is undergoing with BARDA in full thickness burns for the US market).
Currently, there are no dermal matrix products cleared or approved by the FDA for use in breast reconstruction. Nonetheless, dermal matrix is widely (and lucratively) used for this purpose, albeit not as an approved indication. But manufacturers of dermal matrix are not allowed to advertise/promote their products in this indication.
The ADMs which are currently being used in breast reconstruction are the same as or based on those approved for hernia repair – such as Ovitex products. Hence PNV’s repeated reference to its hernia product being the building block for tissue reinforcement in applications such as breast reconstruction.
As to whether it would be possible to tie up with an approved breast implant manufacturer to create a “system” incorporating a non-approved dermal matrix sling, I think that might perhaps be fraught?
I’m not an expert, but perhaps building a reputation, a solid awareness and appreciation by plastic surgeons of the advantages of BTM in burns and wound reconstruction, could be successfully leveraged to accelerate market penetration of a breast reconstruction product?
PNV Price at posting:
$1.91 Sentiment: Hold Disclosure: Held
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