EthOss® Regeneration Ltd has announced the latest stage of it rapid global growth after receiving regulatory approval for its primary product to be sold in Australia.
The company has obtained approval for its primary product, EthOss®, an innovative synthetic bone graft solution for dental implants, from the Therapeutic Goods Administration (TGA) – the regulatory body for medical products in Australia.
The approval means that EthOss® is now freely available to dentists and patients across Australia.
In conjunction with TGA approval, EthOss® Regeneration has also signed up an exclusive Australian distributor, W9 Pty Ltd. W9 will be distributing EthOss® through its network of dealers across Australia, with the launch taking place at ADX18 – Australia’s biggest dental exhibition – held in Sydney (23 – 25 March).
Further to TGA approval, EthOss® has also just gained regulatory approval in New Zealand with Medsafe, the New Zealand Medicines and Medical Devices Safety Authority. The distributor for EthOss® in New Zealand is Healthcare Essentials.
EthOss® has proved hugely popular with dentists across the world due to a number of benefits to both end-user and patient.
The unique composition of EthOss®, which has a built-in cell-occlusive barrier, removing the need for a separate collagen membrane, provides a highly stable graft and typically produces 50 per cent new bone after 12 weeks.
EthOss® is a bi-phasic synthetic material made from a mixture of beta tri calcium phosphate and calcium sulphate and is completely free from animal or human content.
The built-in membrane function prevents soft tissue ingress and helps to dramatically speed up healing times, by allowing the periosteum (and the related blood supply) direct contact with the graft site. This means surgical procedures can be completed much more quickly and reliably, benefitting both patient and dentist.
Dr Paul Harrison, Managing Director of EthOss® Regeneration Ltd: “This is another milestone in the growth of EthOss® as a company and product. We are delighted to have achieved regulatory approval whilst simultaneously signing up a partner with substantial experience in selling in to the dental market.
“From end-users to distributors, we had consistent feedback about the benefits of being able to use an ethical synthetic material, as well the advantages EthOss® provides with regards to reported healing times.
“We have already agreed distribution partnerships covering several international markets and we’re now looking forward to satisfying the growing demand for EthOss® across the Australasian region.”