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The Markets
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Pharma & Biotech

Orthocell secures inclusion for Remplir™ on the prostheses list

“Inclusion of Remplir on the Prostheses List is the culmination of translational research and a regulatory program to bring this product to the Australian market,” said MD Orthocell

Orthocell Ltd (ASX:OCC) has secured inclusion for the use of Remplir™ on the Australian Prostheses list, enabling surgeons to receive reimbursement from private insurers for the use of the nerve repair device in peripheral nerve repair procedures, reducing costs to the patients.

The prostheses list defines the minimum value of benefit private insurers pay for Remplir used in approved peripheral nerve repair and reconstruction procedures.

Inclusion on the list follows Australian market approvals for Remplir™ medical device in March 2022, and the appointment of Device Technologies (DVT) as the exclusive distributor of Remplir™ across Australia and New Zealand in September 2022.

Looking ahead, Orthocell is well-positioned to gain traction in Australia and to expand into the US, the largest global healthcare market.

Culmination of translational research

Orthocell managing director Paul Anderson said: “Inclusion of Remplir on the Prostheses List is the culmination of translational research and a regulatory program to bring this product to the Australian market.

“I am delighted that patients now have access to a premium nerve repair device that has been designed, manufactured and now reimbursed in Australia.”

Australian market

The Australian addressable market for nerve repair and reconstruction is significant, with 11,7801 surgical repairs of peripheral nerves completed in public and private hospitals in the 2019/20 financial year.

The company believes Remplir will become the market-leading nerve repair device, with uptake driven by the surgeon’s preference for high-quality, easy-to-use devices that reduce the need for damaging sutures and facilitates better patient outcomes.

What’s more, Orthocell is well-positioned to achieve further international approvals for Remplir in nerve repair.

What is Remplir ?

Remplir™ is manufactured by Orthocell at its quality-controlled facility in WA, using the Company’s proprietary SMRTTM manufacturing technology, developed in conjunction with Professor Minghao Zheng and the University of Western Australia.

Clinical studies have shown nerve repair with Remplir™ consistently restores arm and hand function.

The final results of patients in Orthocell’s nerve repair clinical study showed 85% (23 of 27) of nerve repairs with Remplir™, at 24 months post-treatment, resulted in functional recovery of muscles controlled by the repaired nerve.

This is of significant interest to patients and clinicians due to potential improvement in the efficiency and efficacy of nerve repair procedures.

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