ASX Health Stocks: TGA gives Orthocell green light for its nerve repair device Remplir
Health & Biotech
Health & Biotech
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The ASX 200 Health Index (XHJ) is trading lower by 0.50% at the time of writing, compared to the broader index which is up by 0.30%.
Orthocell (ASX:OCC) lifted 15pc this morning after announcing that its Remplir device has been approved for inclusion on the Australian Register of Therapeutic Goods (ARTG).
It’s a major development for Remplir, a nerve repair device that facilitates the regeneration of damaged peripheral nerves.
There is a significant addressable market for the device, with 11,7801 surgical repairs of peripheral nerves completed in public and private hospitals in the 2019/20 financial year alone.
“Remplir is the first-of-its-kind biological scaffold designed by an Australian team of researchers to mimic the outer layer of the peripheral nerve and facilitate high quality nerve repair,” said Orthocell CEO, Paul Anderson.
“It’s the only Australian manufactured medical device for nerve repair to gain Australian regulatory approval, and is a significant inflection point for our company,” he added.
Inclusion of Remplir on the ARTG follows the successful assessment by the TGA, with Orthocell now also planning a submission for inclusion in the Prostheses List in Q2 of this year.
The Prostheses List is a list of medical devices for which insurers are required to pay a benefit when a member has the relevant coverage.
Remplir is manufactured by Orthocell at its GMP facility in WA, using the company’s proprietary SMRTTM manufacturing technology.
This technology was developed in conjunction with Professor Minghao Zheng, the University of Western Australia and the Perron Institute.
Argenica Therapeutics’ (ASX:AGN) Chief Scientific Officer, Prof Bruno Meloni, has published a study in the Journal of Thrombosis and Thrombolysis on Argenica’s lead asset, ARG-007.
The publication confirms the superior proteolytic stability of the ARG-007 peptide, which was previously reported in Argenica’s ASX announcement in July last year.
The findings suggest that R18D (ARG-007), when co-administered with the thrombolytic inducing agents alteplase (tPA) and tenecteplase (TNK), do not degrade ARG-007 nor have a negative impact on ARG-007’s efficacy, when used clinically during clot thrombolysis.
ARG-007 has also been previously demonstrated to improve outcomes in pre-clinical stroke models, and is currently in the process of being verified for its safety and toxicity before commencing Phase 1 clinical trials in humans.
“We are delighted that this research has been recognised by the Journal of Thrombosis and Thrombolysis. It is a testament to the scientific rigour employed by Professor Meloni and his team of collaborators,” commented Argenica CEO, Dr Liz Dallimore.