Orthocell Ltd (ASX:OCC) enjoyed a strong December quarter, receiving Australian TGA market approval to supply CelGro, a biological collagen membrane manufactured by Orthocell to augment surgical repair of bone and soft tissue, in dental bone and tissue regeneration procedures.
The inclusion of CelGro Dental in the Australian Register of Therapeutic Goods (ARTG) follows the company successfully demonstrating compliance with the requirements of the TGA’s Medical Device Regulations (Conformity Assessment) regarding the safety and performance of CelGro.
The company has now progressed its application to the Prostheses List Advisory Committee for inclusion on the Prostheses List (PL) which could be finalised by Q2 CY2021.
The company also received the first US FDA CelGro product approval in dental bone and tissue regeneration procedures subsequent to quarter end.
At the end of the quarter, Orthocell held a cash balance of A$17.56 million, a strong cash position which enables it to progress key regulatory approvals and its commercialisation strategy in 2021.
“Important milestone for CelGro”
Looking forwards, 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.
Orthocell managing director Paul Anderson said: “We are delighted to reach the important milestone and significant inflection point of gaining approval for CelGro in US and AUS for dental Guided Bone Repair indications.
“I am excited by these positive steps in our pathway to partnering Striate+, the first product from the CelGro platform technology.
“We are set to continue to grow the value of individual product segments within the significant bone, nerve and tendon markets.”
FDA market clearance
The FDA 510(k) clearance received subsequent to quarter end allows Orthocell to supply Striate+ (previously branded as CelGro Dental) in the US dental market, which is estimated at US$500 million per annum.
Striate+ has been approved for supply in dental bone and tissue regeneration procedures such as dental bone defect repair, augmentation around dental implants in immediate and delayed extraction sockets and guided tissue regeneration procedures in intra bone periodontal defects.
On the back of the recent FDA and TGA approvals, the company is now finalising plans for introduction to the Australian and US market to grow product awareness and use in key accounts.
UK and EU marketing
During the quarter, new strains of COVID-19 and subsequent social distancing restrictions in the EU and the UK prevented most dental practices from treating patients.
The company is utilising this period to prepare for the anticipated return of demand for high quality products (such as CelGro) to facilitate rapid and high-quality dental procedures by continuing to invest in its clinician advocacy program and a digital marketing campaign.
This includes release of the first of a series of webinars to grow product awareness and use in centres of excellence.
Video conferences in place of in person meetings proved effective in maintaining contact and continued development of strategic relationships with industry leading clinicians in the US, UK, Spain, France and Italy.
Recovery of Muscle Power in Patients with Quadriplegia
Positive clinical data
During the quarter Orthocell announced further positive long term clinical data showing nerve repair with CelGro results in predictable and consistent restoration of upper limb function in Quadriplegic patients.
The results from ten participants (involving 19 nerve repairs) 24 months after treatment with CelGro showing upper limb function was restored in 17 of 19 (89%) nerve repairs.
A review of the quadriplegic patient cohort contributing 12 and 24-month data after treatment, involving nine nerve transfers augmented with CelGro showed:
- Quadriplegic patients regained voluntary muscle movement of previously impaired or paralysed upper limbs within 12 months (MRC Grade 2 or better);
- Number of nerve repairs resulting in the best-case clinical outcome (MRC Grade 3 or 4) increased from 7 of 9 (78%) repairs at 12 months to 8 of 9 (89%) repairs at 24 months post treatment; and
- MRC Grade 3 or 4 means quadriplegic patients regain a level of independence enabling them to perform tasks such as brushing teeth, drinking from a cup, and transferring into and out of a wheelchair without assistance.
The clinical results have met the study objectives and the company has closed recruitment early.
Nerve repair market worth US$7.5 billion
The company believes CelGro to be an important step forward for improving nerve repair as its ease of use, consistent and predictable high-quality outcomes, achieved in a shorter time, when compared to other methods, will empower surgeons to improve the lives of patients with these complex injuries.
CelGro’s addressable market in nerve repair is estimated to be worth more than US$7.5 billion per annum.
Anderson, said “Following these positive results validating the interim data, our team is progressing regulatory applications in the Australia and will commence the US regulatory study shortly to make this treatment accessible to the millions of people who experience nerve damage annually.”
Tendon and ligament regeneration potential
During the quarter, the company also continued to progress the AUS and US product registration and commercialisation program for the CelGro tendon repair medical device.
Ortho-ATI is a novel cell therapy developed to treat chronic degenerative tendon injuries and the company is currently conducting two clinical trials; the first is focused on rotator cuff and the second on tennis elbow tendon defects.
The rotator cuff study is fully recruited and is on track to provide a final data read out in 3Q CY2021 with the tennis elbow study 70% recruited and expected to be fully recruited in CY 2021.
Ortho-ATI can be used in both surgical and non-surgical applications and is at the forefront of a large and increasing market opportunity, estimated to be worth more than US$7.7 billion and growing.