Transcription of Finance News Network interview with PolyNovo Limited (ASX:PNV) CEO Paul Brennan
Polynovo came out of the CSIRO in 2004. And they developed a platform technology of polyurethanes that could be made into various medical devices. We have spent the time since 2004 developing those products. The first of which is the BTM (Biodegradable Temporising Matrix), which is a temporising matrix and that regenerates the dermal layer of the skin, delivering outstanding results with minimal scarring to people that have been burned or had trauma, revision of surgery scars, wide excisions etc.
Further to that, we are now on sale in several markets around the world, including the US, New Zealand, Australia, South Africa, and soon through the Middle East and some markets in Southeast Asia.
BMT is fully developed and on sale. We are going through some clinical trials for regulatory purposes. They are divided into two sections. One is the for the CE Mark for Europe and Australia. That trial is in progress and we have just added Royal Brisbane Women's Hospital to the trial, along with Concord Hospital and the Royal North Shore Hospital here in Sydney. So with those combined with The Alfred, that should accelerate our recruitment of patients into the CE Mark trial.
Concurrent to that, we are also working with the TGA on our innovative technology pathway, to see if we can qualify for an earlier CE Mark approval, under the innovation technology platform.
We are also developing products in the breast field, which is a breast sling for reconstruction surgery and we are also looking at breast forms and breast coatings for implants. We are working with a US company on the development of that at this time.
We are also working on hernia products. And for that we developed three distinct prototypes. We are just going through our animal trials looking at the adhesion rates of those. And will progress those into more advanced progress towards ours 5.10.K filing for hernia products next year.
The BARDA program is split into two phases. We have the feasibility trial, which is in progress. We have had one patient recruited in Tampa Florida. We are running that through three sites which is Tampa, Memphis and Sacramento. When we conclude 10 patients we then go back to the FDA for approval for what is called the pivotal phase of the trial, which will be 100 patients in 20 burn centres. That’s progressing very well. It’s taken a long time to get started with patient enrolment and that’s just due to the complexity of the US systems of contracts and filings, BARDA’s internal mechanisms that we need to go through and the hospital sites and CRAS. But it’s progressing very well.
The highlights for the results in 2017 have been if you like ‘a steady as she goes cash burn’. We are offsetting our cash burn with revenue inflows which is a small amount from sales and also from recovery of costs in running those Barter trials through the US government funding that’s brought that trial program.
So, we’ve got a good runway going forward with enough money in the bank to be an ongoing concern to be a while yet.
As we move into developing new products, and moving them forward we will review the cash burn rate and investment requirements as phases go through. We are in a very healthy position at this stage.
We’re fully funded at the moment. What we are looking for now is AUS sales to come through. Those sales should augment our financial position and also fund the expansion within the US market.
The focus for the next six months is very much on the commercial returns out of our existing markets, opening new markets, for the BTM as I outlined earlier and advancing our partnerships with other companies in the development of other products, coatings and some other new things that we will announce at a later time.