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Orthocell receives A$3.17 million refund to help with development and commercialisation milestones

Published 21/06/2023, 10:27 am
© Reuters.  Orthocell receives A$3.17 million refund to help with development and commercialisation milestones

Orthocell Ltd (ASX:OCC, OTC:ORHHF) has received a Research and Development (R&D) Tax Incentive refund of A$3.17 million for the financial year 2021/2022, which gives it a 14.5% boost to cash reserves.

The Australian-based regenerative medicine company will use the money to achieve several milestones including:

  • scale up Striate+™ and Remplir™ manufacturing capacity and distribution partnering programs;
  • progression of Remplir™ US regulatory studies;
  • advancing the development and commercialisation of OrthoATI™.
Orthocell is positioning itself to deliver regenerative medicine products to the world’s largest healthcare markets including US, EU and AUS.

Orthocell managing director Paul Anderson said: “Orthocell holds a strong cash position with A$24.99 million cash at bank following receipt of a A$3.17 million R&D tax incentive refund.

"This will support the scale-up of Striate+™ and Remplir™ manufacturing capacity and distribution partnering programs, our Remplir™ nerve repair US regulatory approvals, as well as development and commercialisation of OrthoATI™ in the USA.”

Work in regenerative medicine

The R&D Tax Incentive is a program initiated by the Australian Government aimed at encouraging Australian businesses to conduct research and development (R&D) activities domestically. Under this initiative, qualifying companies can receive cash rebates that account for up to 48.5% of their eligible R&D expenditure.

The money will help Orthocell, a company operating at the forefront of regenerative medicine, with its focus on restoring mobility for patients by developing innovative products designed to repair a variety of bone and soft tissue injuries.

At the core of Orthocell's product portfolio is the CelGro™ platform, a range of collagen medical devices aimed at facilitating tissue reconstruction and healing in a wide array of dental and orthopaedic reconstructive applications.

Striate+™, the first product approved for dental GBR applications, has gained regulatory approval for dental GBR applications in various markets, including the US (FDA 510k), Australia (ARTG), and Europe (CE Mark). It is being distributed worldwide by BioHorizons Implant Systems Inc.

Remplir™ is designed for peripheral nerve reconstruction. It recently received approval and reimbursement in Australia and is being exclusively distributed by Device Technologies in the Australian market.

SmrtGraft™, Orthocell's product for tendon repair, is available in Australia either under the Special Access Scheme or through participation in a clinical trial.

Orthocell's other products include autologous cell therapies, designed to regenerate damaged tendon and cartilage tissue. The company is ramping up the development of its tendon cell therapy in the US, with technology transfer, manufacturing scale-up, and engagement with the FDA preceding a randomised controlled study under the agency's supervision.

Read more on Proactive Investors AU

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