Orthocell Ltd (ASX:OCC, OTC:ORHHF) is gearing up to launch its nerve repair product Remplir™ to the US market, with the final regulatory approval from the US Federal Drug Administration (FDA) expected in the first quarter of 2025.
The company has appointed two US-based highly experienced sales and medical affairs executives, John Walker and Phillip Edmondson, to drive the marketing and commercialisation of its product.
Collectively, Walker and Edmondson bring more than 19 years of experience specifically in the US nerve repair sector and Orthocell expects to leverage their experience, specifically with respected medical device company Axogen.
Walker and Edmondson will target the US$1.6 billion market, leading medical affairs, sales strategies and account management.
Plans for rapid expansion and uptake
“The Remplir launch in Australia has proven to be a great success, with over 150 surgeons now using the product and rapidly growing sales,” Orthocell CEO and managing director Paul Anderson said.
“The US provides a significant opportunity for our company as a circa US$1.6 billion market and our belief is that it will quickly become our single largest market.
“Over the last two years, we have been working closely with US surgeons, Centres of Excellence and leading research institutes to prepare for US FDA approval and market launch.
“We are delighted to have John and Phillip join us to lead the US launch and are excited about the next phase of growth.
“With all the preparation we’ve been conducting in the background, we expect revenue growth and surgeon adoption of Remplir to accelerate from market clearance.”
Nerve repair experience
Walker is a highly experienced sales executive, who has successfully led global product launches and sales strategies, most notably helping to lead the growth of nerve repair device sales at Axogen.
Edmondson is an award-winning medical affairs professional, who excels in creating product awareness, building advocacy and implementing successful medical education programs, that contribute to sales growth.
OCC is well funded for its US Remplir launch with A$35 million in the bank – the revenue and exposure gained from its US launch will also drive expansion into other targeted markets, including Singapore, Southeast Asia, Canada, and Europe.
Read more: Orthocell lifts revenues as it continues to improve quality of life for patients
The company is preparing to release its top-line results from the US market authorisation study in the fourth quarter of this year, which will open the door to a 510(K) application.
Orthocell expects to secure the final FDA approval and begin sales into the lucrative market soon after.