Orthocell Ltd (ASX:OCC) enters 2022 with a strong balance sheet, a cash balance of A$13.6 million at the end of the December quarter and sufficient funds to support key regulatory approvals and commercialisation goals.
The company is focused on regenerating mobility for patients by developing innovative products for the repair of a variety of bone and soft tissue injuries.
It has a portfolio of products including CelGro®, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications and which has regulatory approval in the EU, Australia and the US for bone and soft tissue regeneration in dental procedures.
Other major products are personalised cell therapies Autologous Tenocyte Implantation (Ortho-ATI®) and Autologous Chondrocyte Implantation (Ortho-ACI®), which aim to regenerate damaged tendon and cartilage tissue.
Orthocell is moving forward with clinical studies for Ortho-ATI® designed to assist in the US (FDA) approval process and which is part of the company’s many quarterly highlights including:
- Phase 2a clinical study results show that OrthoATI™ is significantly more effective than steroid injection for treatment of rotator cuff tendon tears – further data pending on cross-over of steroid treated patients;
- OrthoATI™ US commercialisation plans accelerated with FDA engagement and commercial preparation activities being advanced to support a randomised controlled study;
- Significant progress made towards engagement of a US market distribution partner of Striate+ premium dental membrane with key opinion leader product use gathering momentum and product promotion events completed;
- Discussions with the Australian TGA regarding its application for approval to supply Remplir™ in the Australian market for peripheral nerve repair advanced. The company believes its application meets the requirements of the TGA and is on track for approval; and
- Commenced interactions with the US FDA regarding the US regulatory pathway for Remplir™, data to support expedited review and reimbursement positioning.
More effective than steroids
“Orthocell has achieved a significant clinical milestone with the OrthoATI™ study results clearly demonstrating that OrthoATI™ is more effective than steroid injection for treatment of rotator cuff tendinopathy,” Orthocell managing director Paul Anderson said.
“Our progress towards US and AUS market entry of Striate+ and the US regulatory program for Remplir™ is advancing rapidly and I look forward to what is shaping up to be a very exciting year ahead for the company.”
Product breakdown
OrthoATI™
OrthoATI™ is a world-leading cell therapy developed to treat chronic degenerative tendon injuries (tendinopathy/tendonitis) and can be used in both surgical and non-surgical applications.
It is at the forefront of a large and increasing market opportunity, estimated to be worth >US$7.7 billion and growing.
OCC is conducting two clinical trials - the first is focused on the rotator cuff and the second on tennis elbow tendon defects.
Just recently, the company received positive results from its OrthoATI™ trial, establishing the efficacy of the treatment for rotator cuff tendon injuries.
The final data from the Phase 2a study will be available this quarter and will include results from the treatment of the patients in the study that received steroids and after poor results – elected to 'cross-over' to be treated with OrthoATI™.
Success in this patient population will further confirm the efficacy of OrthoATI™ firmly placing Orthocell in a strong position to progress its US commercialisation strategy to deliver the first injectable cell therapy in orthopaedics for the treatment of chronic tendon injuries.
The tennis elbow study is fully recruited and last patient treatment is currently planned for Q1/Q2 CY2022.
CelGro™
CelGro™ is a biological collagen membrane manufactured by Orthocell to augment surgical repair of bone and soft tissue.
It represents a breakthrough in soft tissue reconstruction and offers significant commercial potential in existing addressable markets of bone, tendon, nerve and cartilage, and wider applications in general surgical and soft tissue reconstructive applications.
The global addressable market for CelGro™ is in excess of US$9.9 billion and growing.
Orthocell is looking to position CelGro™ as the best-in-class membrane for bone and soft tissue repair and to realise multiple commercial partnering opportunities.
Striate+™
Orthocell has successfully completed the regulatory phase for use of Striate+ (previously branded as CelGro® Dental) in dental bone and soft tissue repair procedures, successfully attaining AUS, US and EU approval.
It is seeking key market approvals and key opinion leader product and is well positioned to execute on its partnering and commercialisation strategy.
The company received FDA 510(k) clearance in 2021 to market and supply Striate+ for dental bone and tissue regeneration procedures in the US dental market, estimated at US$500 million per annum.
In Europe, Orthocell has been preparing for the anticipated return of demand for high quality products, such as Striate+, to facilitate rapid and high-quality dental procedures.
Remplir™
Orthocell is progressing discissions with the TGA regarding its application for approval to supply Remplir™ in the Australian market for peripheral nerve repair.
It also continued to work closely with US regulatory advisers Veranex (previously Experien Group), to evaluate opportunities for expedited approval of Remplir™ for nerve regeneration and commenced interactions with the US FDA regarding the appropriate US regulatory pathway, what data is needed to support expedited review and reimbursement positioning.
SmrtGraft™
A prospective study was published in the Journal of Orthopaedic Translation, evaluating the structural and biological properties of SmrtGraft™ (previously named CelGro™ tendon repair) and assessing the safety and effectiveness of its use in the augmentation of rotator cuff tendon surgical repairs.
The findings represent a substantial advance in improving patient outcomes by reducing rates of revision surgeries.
The publication follows a successful collaboration between Professor Allan Wang (University of Western Australia), Dr Will Haynes (Umhlanga Ridge Orthopaedic Centre, South Africa), Dr Bill Breidahl (Perth Radiological Clinic) and chief scientific officer, Professor Minghao Zheng at the Perron Institute and the University of Western Australia.
“This is exciting research that opens up potential for novel treatments addressing significant unmet medical needs and we will explore these development options alongside our nerve repair applications. SmrtGraft™ continues to be an impressive pipeline product and this further validates the very valuable CelGro™ platform technology addressing multiple medical needs,” Anderson said.