A few points of interest arising from the FY 24 Results and Presentation
PolyNovo should no longer be thought of as a Company that sells burns products into the US market.
- Swami Raote stated that burns used to account for 50% of BTM procedures in the US, but now accounts for just 20% of procedures.
- Europe now sells more units of BTM than the US.
- Ex-US markets now account for 25% of sales.
- BTM is now No. 1 by market share for dermal matrix in Australia and New Zealand, the UK and Germany. PolyNovo is now “the overwhelming market leader in difficult burns as well as soft tissue reconstruction procedures” in the UK and Germany. The Company is aiming to achieve market leader status in the remaining Top 5 EU markets within 18 months.
- In its first year of sales, BTM was used in 365 burns cases in India, all within the private system. This compares with use in 1100 burns cases in the US last year.
- There is a meeting with the Japanese regulatory authority next month and PNV will be submitting a marketing application using US data. Entry into the Japanese market, the third largest medical device market in the world, is expected in CY 25.
MTX was formally launched in the US in June and is gaining traction
- Swami Raote stated that US sales of MTX are already ~ $700,000.
- MTX will be expanded into new geographies.
- Additional sizes and a particulate version are to be added within the next 18 months
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Limb Salvage has replaced DFUs as Focus
It appears that PolyNovo will not persist with another DFU study to gain entry into the outpatient setting.
Swami Raote says the Company wants to focus on indications in which it can achieve meaningful differentiation and he doesn’t believe that will be best achieved in the treatment of DFUs outside of the hospital setting. He said that, to work optimally, BTM needs a “good healthy wound bed” and “hospitals do this better”. The focus has now shifted to the more challenging area of limb salvage, which is hospital-based.
PolyNovo has been conducting a randomised, controlled study, comparing the use of BTM combined with negative pressure wound therapy (NPWT) to the usual standard of care in neuroischemic diabetic foot wounds. Focus is on patients who need to undergo minor amputation of the foot. The study commenced in mid-2022 and is expected to complete recruitment later this year. The study will assess things like rates and time to complete wound healing and rates of infection as well as quality of life and health economics outcomes.
The study is being completed at Flinders Medical Centre in Adelaide and the BTM will be delivered via a surgeon. It is stated that NovoSorb BTM is already used at the Centre and all surgeons at the Centre have had training and experience in application of this treatment. (This was not the case in the abandoned US DFU study.)
Swami Raote said that data from the Flinders Medical Centre trial will provide additional clinical evidence for its broader use in patients with diabetic foot wounds complicated by vascular insufficiency.
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382672
Synthetic Allograft
As already discussed here, this seems to relate to the use of a BTM product as an alternative to the cadaver skin allograft which is often used as a “biological dressing” in the pre-grafting stage of extensive wounds.
Some might recall that, following the New Zealand Whakaari Island volcano eruption in 2019, 120 sq. metres of donor skin, worth millions of dollars, was needed to treat the extensively injured victims and had to be sourced from the United States.
Australia has also been caught short of banked donor skin during major bushfires and it has been recommended by the Royal Australian College of Surgeons that the Australian Federal Government should ensure adequate stockpiles of both allograft and BTM for mass burn casualty events.
As mentioned in a previous post, the US military treats half of 30-50% TBSA patients and 90+% of TBSA 50+% patients with allograft. Surely there could be interest by US military and others in stockpiling a synthetic allograft?
Swami Raote estimated that synthetic allograft might be a $125-130 m market but could well be higher.
https://hotcopper.com.au/threads/pnv-media-thread.4367012/page-911?post_id=46249286
https://www.utsouthwestern.edu/educ...ansplant-services-center/faqs/statistics.html
Suprathel and PolyMedics (PMI)
PolyNovo is now the Australian and UK distributor for Suprathel, a synthetic (polylactic acid) product for partial thickness burns, which is manufactured by German private company, PolyMedics. PolyMedics is the distributor for Novosorb BTM in Germany and multiple other European countries.
PolyNovo and Suprathel are said to be working together to build a product that is better than both Suprathel and Biobrane (Smith & Nephew), the SOC in these indications. It will be interesting to see how this product development partnership develops.
(20min delay)