With around $33 million in cash and no debt, regenerative medicine company Orthocell (ASX:OCC) says it is well-positioned to successfully launch Remplir in Singapore and other key markets including US, South East Asia, Canada and the EU/UK.
Importantly, the company remains on schedule to submit its Remplir US application in Q4 CY24, with progression into US FDA clearance and commercial distribution soon thereafter.
The company has successfully completed its Remplir nerve repair study, validating the candidate as safe and effective for use in the surgical repair of peripheral nerves. The US Regulatory Study is a key component of the FDA submission to gain U.S. marketing clearance and the company remains on schedule to submit its 510(k) application in December CY24, with U.S. FDA clearance expected in Q1 CY25 and commercial distribution soon thereafter.
The study was undertaken in collaboration with highly regarded research scientist Professor Bill Walsh, Director of Surgical and Orthopaedic Research Laboratories at the Prince of Wales Hospital in Sydney and the University of New South Wales, and Professor Minghao Zheng Winthrop Professor of Orthopaedic Research at University of Western Australia. The study met all required endpoints and outcomes.
The study outcomes reinforce the clinical results, indicating consistent and predictable return of upper arm and hand function following nerve repair with Remplir. The clinical results, published in peer-reviewed Journal of Reconstructive Microsurgery Open, showed 85% (23 of 27) of nerve repairs with Remplir, at 24 months post treatment, achieved functional recovery of muscles controlled by the repaired nerve.
Collectively, the positive outcomes from the US Regulatory Study and clinical studies will assist the Company in driving into the US market, estimated to be worth in excess of U.S. $1.6 billion per annum and growing, and strengthens the sompany’s position to successfully execute its proven strategy to engage high quality distribution partners.
US 510(k) Study Overview
The primary objective of the Study was to generate critical data to demonstrate safety and performance outcomes equivalent to an FDA-cleared product, in support of an application to the FDA to gain US market clearance. The study was conducted using an established rat sciatic nerve injury model. Repair of surgically transected (severed) nerves was evaluated in 72 rats across three treatment groups: repair using suture only (control group), repair with Remplir, and repair with the predicate product (comparator). Nerve regeneration was measured at 4, 12 and 24 weeks post-treatment. The key outcome measures included restoration of motor and sensory function and the performance of Remplir in facilitating high quality nerve regeneration.
“Use of Remplir did not induce inflammation or scarring, which are known to impede nerve regeneration. This outstanding local tissue response, combined with its optimal handling qualities, will be a key advantage for Remplir in nerve repair surgery,” Orthocell CSO, Professor Minghao Zheng, said.
“Use of Remplir will help surgeons to simplify the repair process, facilitate high quality nerve regeneration, and ultimately provide consistent and predictable outcomes to patients and support their return of function goals.”
Next Steps
With circa $33 million in cash and no debt, Orthocell is well-positioned to successfully launch Remplir in Singapore and other key markets including United States, South East Asia, Canada and the EU/UK. Importantly, the company remains on schedule to submit its Remplir US 510(K) application in Q4 CY24, with progression into U.S. FDA clearance and commercial distribution soon thereafter.
