The PolyNovo Ltd (ASX: PNV) share price is pushing higher in morning trade following the release of a trading update.
At the time of writing the medical device company’s shares are up 2% to $2.49.
What did PolyNovo announce?
PolyNovo has been a strong performer in FY 2020 despite the adverse impact of the pandemic on the industry.
According to the release, in June, PolyNovo had a record month of sales in the United States. This has been driven by the opening of seven new hospital accounts in the country since the start of April. Total accounts in the key market are now up 67% since the end of FY 2019.
Management advised that it has achieved this by using a number of tools to support surgeons where face to face meetings were not possible.
Over in the United Kingdom, the company has made its first sale since launch. A total of six operations have been made in the market, which management believes is a sign that additional sales will follow.
And finally, in Europe there have been numerous applications of the NovoSorb BTM in the DACH countries (Germany, Austria and Switzerland). Sales are growing accordingly as it gains traction across the region.
All in all, sales for the June quarter were 33% greater than the March quarter.
As a result of this solid finish to the year, management has reiterated its previous guidance that product sales will at least double in FY 2020.
Managing Director, Paul Brennan said: “These sales results for NovoSorb BTM are very strong given the difficulties faced with CoVid19. Our teams have maintained their engagement with customers, and we continue to see sales growth.”
Chairman, David Williams, added: “Sales are still lumpy but there is a strong upward trajectory as surgeons embrace our product and the patient results it gives. While FY20 sales will show impressive growth over FY19, the sales run-rate is more impressive and should be a better indicator of the near-term future.”
Pivotal trial protocol update.
In a separate announcement, PolyNovo revealed that it has received formal feedback from the U.S. FDA on its Pivotal trial protocol. This includes a request for some additional information including a formalisation of the review points through the trial.
While this may result in a delay to the commencement of its trial recruitment, Mr Brennan believes the FDA’s request is a positive.
He said: “The request for further information from the FDA is positive and will give the trial clarity and ensure robust outcome measurements. We have the ongoing support of our BARDA colleagues, and we will announce funding arrangements immediately the FDA approve the IDE.”
James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. owns shares of POLYNOVO FPO. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.