Regenerative medicine company Orthocell Ltd has set the stage for a swift entry into the US market, appointing its first four US distributors of flagship nerve repair product Remplir™.
FDA clearance anticipated
Remplir received US FDA 510(k) approval on April 3, which cleared the way for its immediate commercial distribution into the US.
Orthocell CEO and MD Paul Anderson said: “We have been working closely with a number of distributors in the United States in advance of our recently received FDA 510(k) clearance and welcome them on board as our first partners in the US.
“We are looking forward to our distributor network helping us to drive Remplir sales, and as a company, we are primed and ready to deliver Remplir into the US.
The company’s sales and marketing executives were well prepared – they moved quickly to capitalise on the US approval and kick off first sales into the world’s biggest nerve repair market, which is worth an estimated US$1.6 billion.
The distributor model is a direct and efficient path to market in the US, and it also provides a cost-effective operating structure for Orthocell.
US distributors generally focus on specialist product lines within a given medical field in local geographic regions where they hold trusted relationships with surgeons and hospitals.
The first four distributors Orthocell has signed up specialise in nerve repair and have relationships in Michigan, Virginia, Colorado and Indiana.
These distributors will market and distribute Remplir for use in the surgical repair of peripheral nerves across their respective geographic regions.
The will conduct medical education, target promotion activities and initiate sales, as well as expanding the network of referring plastic and orthopaedic surgeons.
These distributors will operate on a commission basis, which is typical of US medical product distributor relationships.
Targeting more distributors
To accelerate the US Remplir rollout and grow sales, Orthocell hopes to appoint in the vicinity of 10 US distributors by the end of this financial year in select regions.
These appointments would account for representation in close to 25 states.
The distributor network will be managed by an in-house team of sales directors, led by the US vice president of sales, with a further four territory managers to support sales activities.
Orthocell is well positioned to achieve firstsales of Remplir into this US$1.6 billion nerve repair market, having already conducted extensive pre-launch activities in anticipation that FDA 510(k) clearance would be secured.
The company has all its manufacturing and logistics ducks in a row, and has sufficient Remplir inventory built up to meet US sales requirements.
“The distributor model is an excellent fit for us in the US,” Anderson said.
“It allows us to partner with distributors that have existing strong relationships and established sales channels with both surgeons and hospitals which means we only need a small, but experienced, on-the-ground team of in-house employees.”
About Remplir
Remplir is a collagen wrap used in nerve repair surgery to assist surgeons to improve outcomes in the repair and regeneration of damaged nerves.
Remplir is currently approved for sale in Australia, New Zealand and Singapore, with pending approvals in Canada and Thailand within the next six months.
Regulatory applications for the EU and UK are on track to be submitted in the next 6-12 months.
Orthocell is targeting a large global addressable nerve repair market estimated to be worth in excess of US$3.5 billion with an estimated two million peripheral nerve repairs performed across Australia/New Zealand, Singapore, USA, EU/UK, Canada, Brazil, Japan and Thailand.
The company has a strong balance sheet with A$31.7 million cash at bank as at March 31 and no debt, and is very well funded to continue to broaden its commercial footprint and grow revenues in existing and new markets.