Regenerative medicine company Orthocell Ltd (ASX:OCC, OTC:ORHHF) had a 2023 characterised by some key developments on the clinical and commercial fronts.
The company hopes the year will prove to be pivotal in laying the groundwork for global growth, with a particular focus on the US market.
Expansion with new facility
A major milestone was the opening of a new bio-manufacturing facility at Orthocell's headquarters in Perth.
This facility is designed to increase the production capacity for the Striate+™ dental membrane, aiming to produce more than 100,000 units annually.
In Europe, Striate+™ received regulatory approval under the new European Medical Device Regulations, paving the way for its entry into the European market.
In the realm of nerve repair and regeneration, Orthocell commenced a comparator study for its Remplir™ collagen scaffold.
Since its Australian launch, Remplir™ has been adopted by some 90 surgeons in Australia and New Zealand for peripheral nerve repair surgeries.
Orthocell also released the final results of a clinical study comparing its OrthoATI™ cell therapy to surgical treatments for severe, chronic tennis elbow.
The study found OrthoATI™ to be an effective alternative to surgery.
People power
The year has also ushered in big changes in Orthocell's leadership.
“Orthocell has strategically refreshed its board of directors this year, to support good governance principles, robust leadership and high-level networking to support its clinical and commercial ambitions – at home and abroad,” said managing director Paul Anderson.
John Van Der Wielen was appointed as independent non-executive chair, bringing a wealth of experience in global healthcare.
“A seasoned executive with extensive experience in global healthcare and life sciences, John's dynamic leadership style has already made a profound impact, and he will be instrumental in guiding Orthocell through its next phase of growth,” said Anderson.
The board was further strengthened by the addition of Professor Fiona Wood AM and Ravi I. Thadhani, MD, MPH, who joined as independent non-executive directors.
“We have welcomed some of Australia’s brightest and most respected professionals to our board,” Anderson said.
Professor Fiona Wood AM, who joined the board in November is celebrated for her pioneering work in burns and reconstructive surgery, and the company says her expertise will be invaluable as it expands its product portfolio.
The company also expects to draw on Thadhani’s expert knowledge in US healthcare markets and regulatory landscapes.
Two internationally recognised orthopaedic surgeons were also appointed to OCC’s Medical Scientific Advisory Board.
Professor Christopher Dy and Professor David Brogan from the Washington University and Barnes-Jewish Orthopedic Center in the US are expected to be instrumental in Orthocell’s expansion, especially into the US market.
In the news
Orthocell's advancements in 2023 received media coverage from various outlets, including ABC News, the Australian Financial Review and The West Australian, as well as strong coverage by Proactive.
Proactive covered the launch of Orthocell’s expanded manufacturing HQ, following a $23.1 million global exclusive marketing and distribution deal with global leader in dental implants, BioHorizons, as did The West Australian.
Orthocell is firmly focused on the US market in 2024, with a view to the commercialisation of Remplir™.
The company plans to engage with the FDA and is looking to appoint a US-based corporate adviser to aid in the commercialisation process.
“Our main priority in the year ahead will be to progress our US commercialisation plan including technology scale-up, FDA engagement and commercial preparation activities to support the launch of Remplir™ in this market,” Anderson said.
“The company will also look to appoint a US-based corporate adviser to assist in securing a strategic partner to progress commercialisation of OrthoATI™.”