The PolyNovo Ltd (ASX: PNV) share price has started the week with a bang.
In morning trade, the medical device company's shares are up 11% to $1.50.
Why is the PolyNovo share price storming higher?
Much to the dismay of short sellers, investors have been bidding the PolyNovo share price higher this morning following the release of an announcement.
According to the release, the company has received FDA 510(k) clearance for NovoSorb MTX, which it describes as a major new product innovation for soft tissue regeneration for the management of complex wounds.
The release notes that MTX leverages the technology platform underpinning the clinical success of BTM, but without a sealing membrane. It was developed in this way to satisfy clinician demand for a product for use in indications where the sealing membrane is not required.
BTM and MTX are complementary, and it is expected that clinicians will use both products for the treatment of soft tissue deficits.
Addressable market
The release reveals that MTX is indicated for use in partial and full thickness wounds, pressure ulcers, venous ulcers, chronic and vascular ulcers, diabetic ulcers, and surgical and trauma wounds. Management feels that this offers clinicians greater versatility in wound management.
Combined, the MTX product portfolio expands PolyNovo's addressable market in the U.S. by an estimated A$500 million.
PolyNovo's CEO, Swami Raote, was very pleased with the news. He said:
The creation of MTX is an exciting example of surgeon led product development that opens a significant new market for us. We are proud to bring MTX to U.S. surgeons and patients, and believe a product specifically designed for use in a single-stage procedure will leverage and expand our penetration of the advanced wound care space. We expect clinicians to carry BTM and MTX and provide them a richer tool kit for patient care. We aim to quickly put MTX in the hands of Key Opinion Leader surgeons.
