() is in the final stages of recruiting an experienced in-country (EU/UK) dental production distribution management expert to engage higher-quality distributors and assist servicing key opinion leaders to grow product use of CelGro®.
In its June quarterly update, the company confirmed it continues to supply CelGro® to KOL’s in the Australian market through the Special Access Theme (SAS) governed by the Therapeutic Goods Administration (TGA).
CelGro® is a biological collagen membrane manufactured by Orthocell to augment surgical repair of bone and soft tissue.
Platform medical device
The product 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 more than US$4.4 billion and growing.
Orthocell 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.
Continuing to grow product value
Managing director Paul Anderson said: “Orthocell is progressing towards regulatory approvals for CelGro in the major global jurisdictions and is well on the way to having a formidable portfolio of CelGro products within the bone tendon and nerve space.
“This is a unique position internationally and sets a perfect platform for us to continue to grow the value of as individual product segments but importantly grow the value of the company.”
Engaging partners
The company remains committed to engaging strategic partners to manage the distribution and marketing of CelGro® for dental bone and soft tissue repair procedures.
With scalable manufacturing in place, EU regulatory approval, AUS and US submissions in progress, and industry-leading brand ambassadors using the product, Orthocell is well-positioned to execute on its partnering strategy and to generate revenue.
Regulatory approvals
During the quarter, Orthocell announced submission to the US Food and Drug Administration (FDA) seeking 510(k) clearance for marketing its CelGro® product for dental guided bone and soft tissue regeneration applications.
The US 510(k) submission follows positive results from its US regulatory study showing CelGro® is effective in facilitating bone regeneration when used in conjunction with bone substitute and a dental implant.
The US FDA provides 90-180 days of their resources and time to evaluate each submission.
Orthocell is working towards US 510(k) clearance by the second quarter of 2021 to allow time for interactions with the FDA regarding the submission, which complements its current “in progress” regulatory submission to the TGA in Australia for approval to market CelGro® for dental bone and soft tissue regeneration applications.
The company held progress discussions with the TGA regarding its submission during the quarter and remains on track for Australian market approval in 2020.
Orthocell is now finalising plans for introduction to the Australian market and to grow product awareness and use in key accounts.
Increasing product awareness
The company has confirmed that dental surgeons commenced the return to work in the EU and the UK in mid to late June following a period of COVID-19 restrictions which prevented dental procedures.
During the quarter, Orthocell continued its clinician advocacy program to grow product awareness and to use in centres of excellence through the delivery and sponsorship of dental implant and guided bone regeneration webinars, in place of in-person workshops and symposia attendance.
In particular, the company sponsored a dental industry webinar, attended by 2,100 physicians and industry personnel in the EU/UK on 'The New Normal - Dental Response to COVID-19'.
Orthocell also presented at The City of London Dental School webinar on 'Osteoconductive Collagen Membrane for Guided Bone Regeneration'.
Surgical procedures to begin
Orthocell was advised during the quarter that restrictions on undertaking research have been lifted at the University of Western Sydney, where it is conducting the US regulatory study and that surgical procedures can begin in early September.
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