- PolyNovo (PNV) has received formal feedback from the U.S. Food and Drug Administration (FDA) on its Pivotal trial protocol
- Based on the protocol, the FDA has asked for more information and a formalisation of the trial’s review points
- Now, the company is working to provide a response, but trial recruitment could be delayed
- PolyNovo also announced it had achieved significant June sales in the United States and completed its first U.K. sale
- Further, the company believes that its FY20 sales are expected to be at least double those from FY19
- PolyNovo is down a slight 0.41 per cent on the market and shares are trading for $2.43 each
PolyNovo (PNV) has received formal feedback from the U.S. Food and Drug Administration (FDA) on its Pivotal trial protocol.
Based on the protocol, the FDA has asked for more information and a formalisation of the trial’s review points.
Now, the company’s clinical team and BARDA (Biomedical Advanced Research and Development Authority) are working together to provide a response. As a result, however, trial recruitment may be delayed.
The pivotal trial will support future submissions leading to pre-market approvals.
“The request for further information from the FDA is positive and will give trial clarity and ensure robust outcome measurements,” Managing Director Paul Brennan said.
“We have the ongoing support of our BARDA colleagues and will announce funding arrangements immediately when the FDA approves the investigational device exemption (IDE),” he added.
The company also announced it had achieved significant June sales in the United States and completed its first U.K. sale.
U.S.
On April 7, PolyNovo announced it had just had its best month of sales ever, recording a 173 per cent increase in sales compared to the same period last year.
It also recorded its best March quarter, experiencing a 166 per cent increase in sales.
Additionally, PolyNovo is one of the businesses who has actually benefitted from the COVID-19 pandemic, opening seven new hospital accounts.
From July 2019 to June 30 2020, the company experienced a 67 per cent increase in hospital account.
U.K.
In a milestone for the company, it achieved its first sale in the U.K. in January when its NovoSorb BTM was applied to the first patients in the country.
BTM is a synthetic dressing used to treat severe burns and wounds where there is a significant loss of flesh.
E.U.
In the European Union, there have been multiple applications of BTM in Germany, Austria and Switzerland, and sales are significantly growing across these regions.
“These sales results for NovoSorb BTM are very strong given the difficulties faced with COVID-19. Our teams have maintained their engagement with customers, and we continue to see sales growth,” Paul Brennan.
Trading update
Further, PolyNovo believes that its FY20 sales are expected to be at least double those from FY19.
“Sales are still lumpy, but there is a strong upward trajectory as surgeons embrace our product and the patient results it gives,” Chairman David Williams commented.
“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,” he added.
PolyNovo is down a slight 0.41 per cent on the market and shares are trading for $2.43 each at 1:28 pm AEST.