Orthocell Limited (ASX: OCC) helps in the restoration of mobility and formation of soft tissue. The company also focuses on providing different new approaches to the formation of tendon, cartilage and the repair of soft tissue injuries.
The company today, on 1st May 2019, announced it has submitted an application to achieve Therapeutic Goods Administration approval of CelGro® collagen medical device, for introduction into the substantial Australian commercial market.
The application of OCC for TGA approval of CelGro® in Australia follows its recent approval in Europe, where the company is gaining significant market traction in key markets, including the UK and Italy. The company is well placed to secure approval in Australia, enabling the marketing and sale of CelGro® in various dental guided bone and tissue regeneration procedures in 2019.
The company estimates that the current market for dental barrier membranes used along with the bone graft substitutes is approximately 1,500,000 units per year, with a total value of the addressable markets to be greater than US$600 million globally.
The company believes that the introduction of CelGro® into strategic markets will benefit from the product’s distinct advantages and the existing reimbursement environment, which covers applicable dental surgical procedures and resorbable barrier membrane materials.
The company has a clear commercialisation strategy to drive product adoption and sales of CelGro® in Europe, Australia and the US. With key opinion leaders and distributors engaged, Orthocell is well positioned to gain traction in the key markets and establish CelGro® as the highest quality, best-in-class medical device for oral bone and soft tissue regeneration procedures.
The company recently released its quarterly report for the quarter ended 31 March 2019. The year-to-date total product revenues for the nine months to 31st March 2019, was up 80% when compared to the prior corresponding period of nine months to 31st March 2018. Further, the group expects to release top line results in the second quarter of CY2019.
The company successfully progressed studies required by the FDA for CelGro® to receive 510(k) clearance in the US. The annual quality study exhibited 82% success rate using Ortho-ATI® stem cell therapy for the treatment of chronic tendon injuries to the shoulder, elbow, hip, knee and ankle tendons. The clinical trial comparing Orthocell’s tendon regeneration therapy to corticosteroids is on track for recruitment completion by the second quarter of CY2019.
During March 2019, the company attended the biennial International Dental Show held in Cologne, Germany. IDS is the leading global trade fair for the dental community, showcasing innovations and new products, where the major international dental companies and global Key Opinion Leaders remain present.
On the price-performance front, at market close on 1st May 2019, the stock of Orthocell Limited was trading at $0.120, an increase of 4.348% during the day’s trade with a market capitalisation of $13.9 million. The stock has a negative YTD return of 25.81%, with negative returns of 51.06%, 11.54% and 17.86% over the past six months, three months and one-month period, respectively. Its 52-week high price stands at $0.380 and a 52-week low price at $0.105, with an average trading volume of 70,600.