PolyNovo Stock

PolyNovo Limited operates as a medical device company in Australia.

The company designs, develops, and manufactures dermal regeneration solutions using its patented NovoSorb biodegradable polymer technology. Its development program covers Breast Sling, Hernia, and Orthopedic applications.

The NovoSorb Biodegradable Temporising Matrix (BTM) is a tissue scaffold that facilitates the regeneration of the dermis when it has been lost or damaged through trauma, burns, surgery or wounding. The NovoSorb BTM has the U.S. FDA 510(k) approval for surgical wound application in the U.S., Australia, South Africa, and New Zealand.

The company’s principal activity is the development of medical devices for various medical applications. NovoSorb is a family of proprietary medical-grade polymers that could be utilized to manufacture novel medical devices designed to support tissue repair and which then degrade in a defined fashion in-situ to harmless by-products. The company is able to manufacture NovoSorb polymer devices with a range of mechanical properties that are suitable for different medical applications.

The company is selling NovoSorb BTM in the United States through its own directly employed sales team. PolyNovo NA LLC is the commercial entity charged with this function. In addition to the United States, the company has appointed distributors in South Africa, Australia and New Zealand to sell NovoSorb BTM. Further market entries would be announced in due course with its priorities being Israel, Hong Kong, and Singapore.

The company is planning for European market entry through a distributor model. The company anticipates this would be realized in 2018.

The company is also conducting a CE Mark clinical trial in burns with initial sites at St Anne’s Hospital, Toulon (France) and the Alfred Hospital, Melbourne (Australia). In addition to the clinical trials, the company would submit a Conformity Assessment application to the Australia Therapeutic Goods Administration (TGA) under the technologies pathway.

The company has a license agreement with Smith & Nephew for the use of NovoSorb’s two-part polymer for bone void filler in orthopaedic applications.

The company is collaborating with Beta Cell Technologies Pty Ltd from Adelaide on a research project exploring the potential of integrated NovoSorb BTM to host pancreatic islets in the skin.

History

The company was formerly known as Calzada Limited and changed its name to PolyNovo Limited in 2014.