Orthocell Ltd’s (ASX:OCC) strong cash position of $17.77 million at the end of the March quarter will enable the company to progress key regulatory approvals and its commercialisation strategy.
The company is well-positioned to establish CelGro® as the best-in-class membrane for bone and soft tissue repair and to realise multiple commercial partnering opportunities.
CelGro®'s global addressable market is more than US$9.9 billion and growing.
Achieved milestones
Orthocell managing director Paul Anderson said: “This has been a tremendous quarter for the company.
“We have achieved significant milestones in the commercialisation of Striate+, the first on-market product from our CelGro® platform technology.
“I am excited by the potential of our Australian invented and manufactured product, and the progress of our broader team in preparing for entry into the Australian and significant US market.”
Striate+ for dental bone and tissue repair
Orthocell has successfully completed the regulatory phase for use of Striate+™ in dental bone and soft tissue repair procedures, successfully attaining Australian, US, and EU approval.
With scalable manufacturing and an increasing number of industry-leading dental surgeons advocating on its behalf, Orthocell is well-positioned to execute on its partnering and commercialisation strategy.
In the quarter, Orthocell received US Food and Drug Administration (FDA) 510(k) clearance to market and supply Striate+ for dental bone and tissue regeneration procedures, estimated at US$500 million per annum.
The company is focused on preparing for market entry, including the incorporation of a Delaware limited liability company to supply product in the US, evaluating high-quality warehouse and logistics providers, establishing a US-focused website and the engagement of Seattle Study Club as a key global Striate+ education and promotion partner.
In Australia, CelGro® Dental has been included on the Australian Prostheses List and the company has been actively preparing for WA market entry, establishing key opinion leader accounts, engaging public/teaching hospitals, private hospitals and corporatised dental practices and evaluating potential distributors.
In the UK and EU markets, new strains of COVID-19 and subsequent social distancing restrictions prevented most dental practices from treating patients.
In preparation for the expected return of demand for high-quality products, such as Striate+, to facilitate rapid and high-quality dental procedures, Orthocell continued to invest in its clinician advocacy program and targeted digital marketing program, including sponsoring surgical workshops in Spain, Greece and Poland, and released a series of webinars by Dr Nick Fahey and Prof Massimo Simion.
CelGro® nerve regeneration
Following positive results from the US 510(k) animal pilot study, the company is evaluating opportunities for expedited approval of CelGro®.
Following the finalisation of the CelGro® nerve regeneration human clinical study in the second quarter of 2021, the company will engage with the FDA to determine whether an expedited regulatory approval is possible and what this will mean for reimbursement value for the product.
Ortho-ATI®
Its Ortho-ATI® - a world-leading breakthrough in regenerative medicine to treat chronic degenerative tendon injuries is under two clinical trials.
The first focused on rotator cuff is fully recruited and is on track to provide a final data readout in the third quarter of 2021.
The second study on tennis elbow tendon is 80% recruited and plans to be fully recruited in 2021.
Intellectual property
During the quarter, the company was granted a new US divisional patent for CelGro®, further protecting and strengthening the IP position.
Orthocell has secured 11 patent families covering its portfolio of breakthrough regenerative medicine products, comprising 110 separate patents/applications, of which 75 are granted.