Orthocell’s easy cell into the US as it secures 12 distributors for nerve repair device Remplir

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Orthocell’s easy cell into the US as it secures 12 distributors for nerve repair device Remplir

Orthocell says it has moved at “warp speed” to secure US distributors for its nerve repair device, marking another milestone in the WA biotech’s commercialisation push into the world’s biggest healthcare market.

Fresh from winning US Food and Drug Administration approval for Remplir, ASX-listed regenerative medicine company Orthocell has now appointed 12 nerve specialists as distributors.

Collectively, they have operations spanning 21 States in the US and will be tasked with marketing and distributing Remplir — a collagen nerve wrap used in the repair of peripheral nerve injuries as a result of motor vehicle, sporting or work-related injuries — to surgeons.

“It’s nearly $80 million to get to this stage of research and development . . . it’s a lot of money and a lot of time in over a decade,” Orthocell chair John Van Der Wielen said.

“It’s been a rough long road but we’ve now got the road, I would say, tarmacked. We’re on smooth driving and now the revenue and profit will come next.”

The FDA nod in April for Remplir unlocks the door to a lucrative nerve repair market worth $US1.6 billion ($2.5b).

It adds to Remplir’s string of regulatory approvals, including most recently in Thailand, Canada and Singapore. Regulatory applications for the EU and the *** are set to be submitted in the next few months.

Having made its first shipment into the US, Orthocell chief Paul Anderson reiterated there was no need to move the company’s manufacturing base out of its facility in Murdoch, despite Donald Trump’s 10 per cent baseline tariff on *********** goods.

“The challenges and the excitement that lays in front of us is in the American market,” Mr Anderson said.

“We are sovereign partners with the United States and the US does need to have manufacturing security in allies like Australia. We hold no fears with regards to the tariffs.”

Mr Van Der Wielen added it was highly unlikely US tariffs were targeting complex medical devices that patients need.

“(As an example) high volume eye drops made by a US company . . . now being manufactured in India or China is more of the target, not a sophisticated medical device that changes people’s lives,” he said.

Orthocell’s other flagship product Striate+ — designed to protect the bone defect from ingrowth of gingival, or gum, tissue — is also approved in several markets, including in Australia, Singapore, the US, Canada and Brazil.

Mr Van Der Wielen said while biotech investors were “absolutely” aware of Orthocell’s success story, there was more to do.

“Do I think Western Australians per se recognises (Orthocell) as somewhere they can go and become employed as a young scientist? Yes, more than it used to be . . . but we’ve got to get that story out to people a little bit better,” he said.

The company already employs 55 staff across its operations in Australia and the US. It plans to grow that number to 100 in the near-term as manufacturing ramps up.

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