PolyNovo may one day help mastectomy patients grow back their breasts
Health & Biotech
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A Melbourne medical device maker may one day allow women to grow back their own breasts after a mastectomy.
PolyNovo (ASX:PNV) yesterday signed a deal with an as-yet unnamed breast prosthesis manufacturer that will use Polynovo’s polymer technology to make a “breast sling” and a prosthesis.
The polymer is a biodegradable polyurethane that dissolves over time — but provides an initial scaffold into which the body can rebuild its own cells.
For example, where a severe burn has destroyed the layer under the skin — the dermis, or the part that contains nerve endings, sweat glands and blood vessels — the polymer can provide a structure onto which new cells can grow back and a layer which new skin can be grafted onto.
And because it’s a synthetic material it can be turned into any any kind of structure, from a foam to a more solid mesh.
Prosthesis allows tissue to grow around it
The PolyNovo version of a breast sling will be a support that goes under an implant (in the case of augmentation) or a prosthesis (in the case of a mastectomy) which creates a “hammock” to keep it in place and allow tissue to grow around it.
PolyNovo chief Paul Brennan says the sling helps relieve breast capsular contraction — a nasty side effect that 10-15 per cent of women endure after breast surgery where scar tissue forms around the implant and causes it to become misshapen and hard.
He told Stockhead the sling would likely be a woven mesh, whereas the prosthesis would be built out of a foam.
This is planned to be available commercially from 2019.
In the case of the prosthesis, which is number four in PolyNovo’s device development timeline, Mr Brennan says it will be a scaffold onto which fat and blood vessels can grow, creating a natural breast.
The details aren’t firm yet but the MoU will provide an upfront payment, milestone payments and ultimately a royalty stream from the commercial sale of a range of breast products.
Faster to market
Mr Brennan says PolyNovo is the first company to go through the Therapeutic Goods Administration’s (TGA) new priority review pathway.
The Biodegradable Temporising Matrix (BTM) is what is used for wound care, and it’s this product that PolyNovo is maneuvering into the Australian market.
It consists of an outer membrane used to close or cover a wound, a 2mm foam layer that creates a scaffold onto which the body can regrow its own tissues, and a middle layer to stick them both together.
BTM is eligible because it applies to serious conditions, provides a comparison against existing therapeutic goods, and is a major therapeutic advance.
PolyNovo will deliver the final documents by the end of the October and “hopefully” have an Australian Register of Therapeutic Goods (ARTG) listing by February next year.
Normally, Mr Brennan says, that could take about two and a half years.
BTM has been available on a restricted basis in Australia, and is being sold in the US, New Zealand, South Africa and, most recently, Israel, but the ARTG listing will mean they can actually start promoting it here.
“This is a radical change for the TGA,” he said.
PolyNovo’s shares were up 3 per cent on the news to 34.5c.