Ann: NovoSorb MTX product portfolio update, page-2

Wow! This seems to be 3 excellent announcements in 1?

ASX AnnouncementFDA 510k Clearance for NovoSorb MTX (up to 6 mm), TGA (Australia) and India CDSCO Clearance for NovoSorb MTX (2mm)

1) PolyNovo Limited (PolyNovo or the Company) is pleased to announce three key commercialmilestones for the NovoSorb MTX product portfolio.NovoSorb MTX (up to 6 mm) has received FDA 510k clearance with the addition of new indicationsfor tunneled/undermined wounds. This approval will offer healthcare professionals greater versatilityin management of deep soft tissue defects and expand the use of NovoSorb MTX into plastic andreconstructive surgery applications. The Company will work towards a market release to introduce theproduct to the U.S., leveraging the successful model first used for NovoSorb MTX (2 mm).

2) In addition, NovoSorb MTX with a 2 mm thickness has now been approved in Australia after inclusionin the Australian Register for Therapeutic Goods (ARTG) by the Therapeutic Goods Administration(TGA) and can now be marketed and sold in Australia.

3) Clearance for importation of NovoSorb MTX with a 2 mm thickness has also been received from theIndia CDSCO (Central Drugs Standard Control Organisation).NovoSorb MTX leverages the technology platform underpinning the clinical success of NovoSorbBTM, but without a sealing membrane. The product was developed to satisfy clinician demand for aproduct for use in indications where the sealing membrane is not required.Chairman, David Williams said: “The availability of the product in Australia and elsewhere will bewelcome news to Plastic Surgeons, amongst others.”This announcement has been authorised by PolyNovo

nice!