The Polynovo Ltd (ASX: PNV) share price is in the red on Wednesday afternoon following an update from the company regarding its NovoSorb SynPath product.
During the opening bell, the medical device company's shares started the day at $2.11 before quickly sinking to $2.04 apiece.
However, a sharp recovery led the share price to climb into positive territory to $2.14. Since then, the share has retraced to $2.10, down 0.94%.
The broader S&P/ASX 200 Healthcare Index (ASX: XHJ) is also in the red at the time of writing. It's 1.35% lower.
Let's check the details of the company's latest update.
What did Polynovo announce?
In its announcement, Polynovo advised that it has enrolled its first patient in the clinical trial of NovoSorb SynPath.
The randomised controlled trial (RCT) is aimed at evaluating the safety and efficacy of the product for patients suffering from chronic diabetic foot ulcers (DFUs).
The trial is being conducted across eight sites in the United States. These include the centre for Clinical Research Inc. in San Francisco, California and Barry University in Miami, Florida.
Polynovo is hoping for SynPath to be used as a standard of care for people affected by DFUs.
Management is planning to recruit up to 138 people for the study. This is expected to be completed by April 2023.
The goal is to measure the percentage of ulcers that are fully healed at the end of a 12-week period.
The addressable market opportunity is massive for Polynovo as DFUs affect more than 300,000 people in the United States annually. This accounts for more than US$9 billion in annual expenditure.
Globally, the DFUs' addressable market was valued at $US7.03 billion in 2019 and is projected to reach $US11.05 billion by 2027.
What did management say?
Commenting on the update, Polynovo CEO Swami Raote said:
We are thrilled to have initiated our trial utilising NovoSorb SynPath for the treatment of chronic diabetic foot ulcers. This critical milestone has us on the road to help more patients with non-healing chronic wounds and to further investigate the benefits of our novel technology for these wound types.
SynPath is leveraging our successes in the acute care setting with NovoSorb BTM and allows us to expand our offering to the outpatient setting for clinicians dedicated to changing the lives of their patients.
Polynovo chair David Williams added:
Many surgeons are already successfully using BTM for the treatment of DFUs, but the time has come for a specific product to treat DFUs and venous leg ulcers. The trial will provide valuable data for surgeons and importantly, also put us on the path to reimbursement.
Polynovo share price summary
After hitting a multi-year low of 83.5 cents on 5 May, the Polynovo share price has rocketed by more than 150%.
The company's non-executive director David Williams notably took advantage of the share price weakness, loading up on his holdings.
In the past three months, Williams has bought more than $5.5 million of Polynovo shares.
It appears the spending spree has paid off with the company's shares hitting a year-to-date high of $2.14 today.
