Soft-tissue regeneration company Aroa Biosurgery (ASX:ARX) says the Indian regulator has approved three of its products based on the ECM platform.
The company said the three products are Myriad, Endoform Natural and Endoform Antimicrobial have been approved under the ‘Medical Device Rules 2017’ administered by the Central Drugs Standard Control Organisation (CDSCO).
Aroa Biosurgery CEO Brian Ward said the regulatory approval is a milestone for the company, given the scale of patient need in India.
“With more than 1.35 billion people, there is a high and continuing level of patient need in India. It is estimated that 20 million patients in India suffer from chronic wounds, with about 11 million suffering from diabetic ulcers. Introduction of the three products we now have approved for use will give a large number of people access to advanced wound care in a market where traditional wound care has been the primary treatment approach,” said Mr Ward
The company said the advanced wound care market in India is currently valued in the range of US$225-485 million, with compounding growth between 5.5 and 8 per cent per year.
Aroa said it is targeting the distribution of its products in India in the second half of the 2021 calendar year. The company said it is currently in discussions to appoint an experienced Indian distributor to manage a network of sub-distributors across the subcontinent.
Endoform Natural and Endoform Antimicrobial provide a tissue matrix for treating chronic wounds (e.g. diabetic foot ulcers and venous leg ulcers) particularly during the inflammatory phase of healing. Myriad is a highly perforated, multi-layered extracellular matrix (ECM) graft engineered to have a high volume and surface area with interstitial spaces that are easily and rapidly accessible to cells.
Aroa has five commercial products approved for sale in the US based on its ECM technology, which has been used in more than four million procedures targeting chronic wounds, hernia and soft tissue. Aroa has regulatory market authorisation in more than 37 countries.