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Orthocell Ltd, an Australian-based biotech company, has raised A$17 million to fund the launch of its innovative nerve repair device, Remplir, in the lucrative U.S. market, valued at around US$1.6 billion. This financing, achieved through a share placement involving nearly 28.3 million shares, attracted strong interest from new and existing investors, including prominent Australian and international institutional backers and life science funds.
The capital raised is set to support Remplir's U.S. rollout, with Orthocell planning to submit for regulatory approval later this year through the FDA's 510(K) market authorisation pathway. The company is also seeing record revenue growth and expanding into other key markets, with recent regulatory approval for Remplir in Singapore and the first sales of its Striate product in Canada.
According to Orthocell's chairman, John Van Der Wielen, this latest investment will enable the company to ramp up U.S. market penetration, expand manufacturing capabilities, and accelerate the development of additional promising products in its pipeline. With these funds, Orthocell is on track for a major U.S. product launch for Remplir, expected by early 2025, alongside global expansion plans.