Orthocell Managing Director, Paul Anderson, spoke with Jonathan Jackson at Proactive to provide an update on the Company’s market authorisation study for nerve repair device, Remplir™.
Orthocell Successfully Completes Surgeries for Remplir™ US Market Authorisation
Orthocell has announced that it has successfully completed the first stage of the Remplir™ US 510(k) market authorisation nerve repair study.
All surgical repairs of severed nerves were performed with no adverse events reported. This provides us with confidence that the final two stages, in which safety and effectiveness will be evaluated, will be consistent with the pilot study and positions the Company for US approval in 1Q CY25.
Top-line results from this study are expected in Q3 CY24, and Orthocell remains on schedule to submit its US 510(K) market authorisation application by the end of the year – with progression into sales soon thereafter.
Orthocell Managing Director, Paul Anderson, said:
“This study is an important next step in our international market access program with the potential to provide data demonstrating the impact and advantages of using Remplir over traditional nerve repair methods. We are excited to be at this important stage in the development of this product and remain committed to providing patients access to this life-changing treatment.”
The US addressable market in peripheral nerve repair is estimated to be worth more than US$1.1 billion annually, with an estimated 700,000 procedures where Remplir could be used, completed each year.
Proactive | Interview with CEO Paul Anderson
Orthocell CEO Paul Anderson spoke with Proactive about the Company’s recent strategic placement of $3.5 million, adding prominent investors to the share register.
The West Australian | Chris Ellison, Rod Jones and the McCuskers jump into Orthocell
Orthocell’s Company-led strategic placement has been reported in The West Australian newspaper, in an article by Senior Business Report Sean Smith titled “Chris Ellison, Rod Jones and the McCuskers jump into Orthocell”.
Orthocell Completes $3.5M Strategic Placement
Orthocell has today announced that it has completed a Company-led Strategic Placement to raise $3.5 million.
Orthocell submits Singapore Regulatory Application for Remplir™
Orthocell has today announced that the Company has submitted a regulatory application to the Health Services Authority of Singapore for approval to market and sell Remplir™ for use in peripheral nerve repair procedures
The Hon Kim Beazley AC Joins Orthocell Board
Orthocell has appointed Australia’s former US ambassador and Governor of Western Australia, The Hon Kim Beazley AC, as an Independent Non-Executive Director to the Board.
ABC News | Tennis elbow treatment trial successes offer hope for sufferers wary of surgery
Orthocell recently released compelling new data from our clinical trial comparing the effectiveness of our tendon cell therapy (OrthoATI™) to surgery, in the treatment of severe, chronic lateral epicondylitis – also known as tennis elbow.
This week, Orthocell was featured in a national news story (television, radio, online) by ABC News reporter, Erin Somerville, who shared the story of Annette Skirka – a patient whose debilitating experience with tennis elbow prevented her from pursuing her passion for mountaineering. This led her to explore a number of treatment options, before eventually participating in our clinical trial.
Click here to read Annette’s story.
Click here to watch the ABC News segment
Positive clinical results for OrthoATI™
Orthocell has today released positive results from our clinical study comparing OrthoATI™ to surgery for the treatment of severe chronic lateral epicondylitis (LE) – also known as tennis elbow.
Professor Fiona Wood AM joins Orthocell Board
Orthocell has today announced the appointment of one of Australia’s most innovative and respected plastic and reconstructive surgeons and researchers, Professor Fiona Wood AM, as an independent Non-Executive Director.