Orthocell Ltd (ASX:OCC) made strong operational progress during the half-year ended December 31, 2021, advancing the development and commercialisation of collagen medical devices and cell therapies for the repair and regeneration of human tendons, bone, nerve and cartilage defects.
During the period, the company achieved key milestones on its path to securing distribution partners for Striate+™ in dental bone and tissue repair procedures, clinical development milestones in nerve and tendon repair and development objectives of its key pipeline products.
Looking ahead, the company remains focused on executing its distribution partnering strategy for Striate+™, accelerating the most appropriate regulatory programs for the introduction of the nerve indications, in parallel with the commercialisation of OrthoATI® and pipeline products.
Manufacturing and logistics
During the half-year, Orthocell made significant progress towards US market entry with preparations to scale-up manufacture completed, the incorporation of Orthocell’s wholly-owned Delaware LLC to enable product supply and the set-up of a high-quality US warehouse and logistics solution.
The company also completed its international logistics solution for the EU/UK with the engagement of Expeditors International to manage logistics, warehousing and distribution requirements.
Clinical advocacy program
Orthocell has a highly desired KOL network now in place with 18 industry-leading clinicians (KOLs) based in the EU, UK, US and Australia actively representing the company at industry conferences as product ambassadors and using Striate+™ in their dental surgeries, implant procedures and education workshops.
The KOL network has assisted the company in expanding the network of referring clinicians and supported ongoing discussions with potential distribution partners.
Increasing product awareness
During the period, the company completed product awareness initiatives in the US including the Sunrise Dental Solutions Group launch showcasing Striate+ at the Sunrise Summit in October 2021.
In Australia, the company attended the Australian and New Zealand Association of Oral and Maxillofacial Surgeons (ANZAOMS) annual conference in November 2021.
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 by continuing to invest in its clinician advocacy program and targeted digital marketing program in the UK and the EU.
Positive nerve generation results
In August 2021, Orthocell announced successful pre-clinical and clinical Remplir™ (formerly named CelGro™ nerve repair) study results showing superior nerve regeneration and consistent restoration of upper limb function in people with tetraplegia and these were presented at the 50th West Australian Branch Australian Orthopaedic Association (AOA) annual scientific meeting.
Australian orthopaedic nerve specialist and clinical trial lead, Dr Alex O’Beirne presented the results of two successful Remplir™ nerve repair studies titled: 'Development of an epineurial substitute for nerve repair in patients with tetraplegia: proof of concept pre-clinical and clinical studies'.
During the half, the company progressed discussions with the TGA regarding its application for approval to supply Remplir™ in the Australian market for peripheral nerve repair
CelGro pipeline
Orthocell has initiated a prospective study 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.
Orthocell has progressed its regulatory strategy to achieve the US and AUS approval to market SmrtGraft™ for tendon repair procedures and continues to work towards the completion of a clinical trial relating to the positive performance of SmrtGraft™ in augmenting tendon repair.
OrthoATI™ pipeline
Also in the half, the company delivered the first statistically significant results from its Phase 2a randomised, multicentre, controlled rotator cuff tendon clinical study (‘RC Study’).
The data confirmed that the study achieved its goals, demonstrating that OrthoATI™ is a safe and effective treatment for patients suffering from rotator cuff tendinopathy with intrasubstance tendon tear compared directly to the standard of care (steroid injections).
In light of the initial study results, Orthocell is accelerating its US commercialisation plans with technology scale-up, FDA engagement and commercial preparation activities being advanced to support a Phase 2b randomized controlled study to support eventual FDA submission.