• Polynovo recorded first $7m+ monthly sales
  • Pacific Edge slumped 67% after the US Medicare ended coverage for its product
  • The US FDA has approved Acrux’s fourth ANDA


Medical devices company Polynovo (ASX:PNV) came out of trading halt swinging this morning, up by 10% after announcing its first ever $7m sales month.

May’s sales of $7.2m were driven by a strong showing in the US, where it had a record monthly sales (unaudited) of $5.2m, up 97.3% on the pcp.

The rest of the world also had record monthly sales (unaudited) of $1.9m, up 189.3% on the pcp, including encouragingly strong sales in Canada, Hong Kong, and India and a first-time order from the Middle East.

“While lumpy, the results demonstrate our ability to quickly gain traction in new markets and to grow existing markets,” said Polynovo CEO, Swami Raote.

Polynovo is focused on wound care and develops solutions (NovoSorb BTM, NovoSorb MTX) using its patented NovoSorb biodegradable polymer technology.

NovoSorb BTM is a dermal scaffold for the regeneration of the dermis when lost through extensive surgery, trauma or burn.

The product uses a novel range of bio-resorbable polymers that can be produced in many formats including film, fibre, foam, and coatings.


Pacific Edge crashes over 60pc

Cancer diagnostics company Pacific Edge (ASX:PEB) plunged 67% this morning after announcing the Medicare coverage of Cxbladder tests in the US market is expected to cease from 17 July 2023.

The decision came as US regulators determined that Cxbladder, and tests provided by other companies, as ‘not considered medically reasonable and necessary’.

This means Cxbladder has failed to satisfy the minimum threshold required for coverage under the US Social Security Act. A number of other companies are also affected by the decision.

As a direct result of this, Pacific Edge’s revenue is expected to reduce substantially from current levels until Cxbladder tests regain coverage.

In FY23, tests for Medicare and Medicare Advantage made up around 60% of US commercial tests, or ~13,800 tests, and generated ~$15.3 million, or 77.3%, of the company’s operating revenue.

Post 17 July, all of these tests and revenues are expected to be impacted.

The company said it was planning legal appeals.


FDA approves Acrux’s gel

Acrux (ASX:ACR) announced that the US FDA has approved its fourth ANDA (abbreviated new drug application), Dapsone.

Dapsone a generic version of Aczone Gel, 5% (Dapsone Gel, 5%), and is a topical treatment of acne vulgaris in patients aged 12 years and older.

Based on recent data, sales generated by the product in the US with which Acrux’s generic will compete exceeded USD$17.5 million.

This marks Acrux’s fourth ANDA to be approved by the FDA.


Share prices today: