Orthocell Ltd's strong cash position of $21.7 million at the end of the March quarter has it well-positioned to progress regulatory approvals, establish commercial infrastructure and execute on its partnering strategy.
This prompted managing director Paul Anderson to state in the company's quarterly report: “The company is in a strong cash position of >$20 million and well-positioned to deliver US and AUS approval/s of CelGro and advance development and commercialisation of Ortho-ATI®.”
Progressing initiatives
The company remains focused on executing its partnering strategy for CelGro® in dental bone and soft tissue repair, which includes increasing international product awareness, growing product use in centres of excellence and growing base of brand ambassadors led by its key opinion leaders (KOLs), designed to optimise shareholder value.
Over the medium to long term, Orthocell intends to leverage the CE Mark to achieve AUS and US regulatory approvals and drive the introduction of the nerve and tendon indications, in parallel to the commercialisation of Ortho-ATI® and pipeline products.
Anderson said: “Orthocell has continued to progress key clinical, regulatory and commercial initiatives despite recent limitations on domestic and global business operations to contain the spread of COVID-19.
Partner discussions
Orthocell continues to advance discussions with potential global partners.
With EU approval achieved, 12 industry-leading KOLs appointed, including five based in the US, and a US market authorisation submission forthcoming, Orthocell is well-placed to execute on its commercial partnering strategy for the dental indication.
Increasing product awareness
During the quarter, the company continued its clinician advocacy program to expand the network of referring clinicians and product use in centres of excellence.
Orthocell sponsored six educational workshops undertaken by KOLs within the Association of Dental Implantology in the UK and Spain during the quarter.
Four workshops profiling the use of CelGro were held in the UK and two in Spain with topics including 'The Implant Occlusal Connection' and 'Guided Surgery, From Dental Reconstruction to Facial Reconstruction - The Lesson Learned'.
Video conferences were held in place of in-person meetings due to COVID-19 restrictions and were effective in maintaining contact and continued development of strategic relationships with industry-leading clinicians in the UK, Spain, Germany, Italy and the US.
CelGro® nerve regeneration trial
During the quarter, Orthocell progressed the CelGro® nerve regeneration trial and is in final stages of completing patient recruitment.
The company remains focused on completing this trial and leveraging the data for regulatory submissions in the US and Australia.
In December 2019, Orthocell received confirmation from the FDA that the proposed CelGro® nerve regeneration animal study protocol meets requirements to support a US 510(k) submission.
Orthocell is awaiting final approval from the ethics committee to begin the animal study.
Although final approval has been delayed due to COVID-19, Orthocell anticipates it will receive approval to begin shortly.
The company was on track to complete TGA (AUS) regulatory application by end of Q1 2020.
While COVID-19 has impacted this timeline, the company is rapidly finalising its documents and is targeting a submission by Q2 2020.
Progressing collaboration with Johnson & Johnson
The company is nearing completion of recruitment to the randomised controlled clinical trial (RCT) of Ortho-ATI® versus corticosteroid injection.
Due to the complexity of conducting a RCT, Orthocell has experienced some delays in recruitment; but it is not reflective of the significant patient population that is applicable for treatment with Ortho-ATI®.
The RCT is being undertaken in collaboration with DePuy Synthes Products, Inc., part of the Johnson & Johnson Medical Device Companies.
Orthocell is focussed on completing this trial and providing study outcomes to its collaboration partner.
US FDA regenerative medicine therapy designation
The company has continued working on submission documents required to support a Regenerative Medicine Advanced Therapy application (RMAT) to the US FDA. RMAT designation provides increased meeting opportunities with FDA and ongoing guidance and support with regards to market entry applications and approvals.
Orthocell remains focussed on submitting the RMAT applications and is finalising submission documents.