Orthocell earns CE Mark approval for CelGro collagen medical device

Regenerative medicine company Orthocell Limited is pleased to announce receipt of European regulatory approval (CE Mark) for its CelGro^® collagen medical device. CelGro^®, for a range of dental bone and soft tissue regeneration procedures, can now be marketed and sold within the European Union (EU).

"European regulatory approval for CelGro^® marks a major milestone for Orthocell as it enables commercial rollout in the lucrative dental bone and soft tissue regeneration market, where there is a significant and growing demand and market opportunity. This provides a strong foundation for Orthocell to progress additional dental regulatory applications in key markets, such as the US, Japan and Australia," Orthocell Managing Director Paul Anderson said.

"The CE Mark also validates the potential of the entire technology platform by endorsing CelGro^®'s clinical performance and quality manufacturing. In addition, the achievement of this CE Mark supports regulatory applications for additional indications."

CE Mark approval for dental bone and soft tissue regeneration

Orthocell has received market authorisation (CE Mark) of CelGro^® collagen scaffold medical device in the EU for dental bone and soft tissue applications. The CE Mark allows CelGro^® to be sold within EU countries, validates CelGro^®'s quality manufacturing and product performance, and provides a strong foundation for indication expansion and regulatory approvals.

Orthocell has a clear commercialisation strategy in place to drive initial sales of CelGro^® and the Company is in discussion with strategic commercial partners for product distribution in Europe and other key regions. Orthocell is also currently in discussions with selected Key Opinion Leaders in the dental and bone regeneration fields, who play an important role in driving broader market adoption.

CelGro^® is manufactured by Orthocell at its quality controlled Good Manufacturing Practices (GMP) licensed facility in WA, using the Company's proprietary SMRT^TM tissue engineering process, developed in conjunction with Professor Minghao Zheng and the University of Western Australia. CelGro® plays a critical role in dental bone and soft tissue regeneration therapy as it offers superior functionality over existing products for improved tissue repair.

Key Opinion Leader, Dr Brent Allan (oral & maxillofacial surgeon) commented, "CelGro^® is an exciting new product with clear advantages over the available alternatives. I prefer to use CelGro^® over existing scaffolds. It is easy to handle and enables a high quality tissue repair."

CelGro^®'s dental addressable market is estimated to be worth more than US$600 million per annum, with approximately 1.5m procedures that utilize these types of scaffolds being completed each year. Market growth is expected to be underpinned by an aging population, significant growing demand for dental therapies and the surgeons' preference for quality and functional bio-absorbable membranes. With the CE Mark achieved, Orthocell is well positioned to capture a significant share of a large and growing market given CelGro® has demonstrated in clinical studies, superior bone regeneration.

Expanding CelGro^® indications

Securing the CE Mark approval for the dental and soft tissue application of CelGro^® is a critical milestone for Orthocell. The CE Mark regulatory approval further validates the CelGro^® technology platform and can be leveraged across a range of additional applications including:

• neurological: peripheral nerve repair;
• orthopaedic: tendon, ligaments, cartilage and bone; and
• other: general surgery (including hernia repair) and urogynaelogical.

CelGro^® is targeted to a variety of orthopedic, reconstructive and surgical applications. The company believes it represents a breakthrough in soft tissue reconstruction and offers significant global commercial potential in its existing addressable markets of bone, tendon, nerve and cartilage as well as much wider applications in general surgical and soft tissue reconstructive applications.