Orthocell receives regulatory approval for Striate+ in Singapore

PERTH: Orthocell Limited, a regenerative medicine company, announced on March 18, 2025, that it has received regulatory approval from Singapore’s Health Sciences Authority (HSA) for its dental membrane product, Striate+.

This approval allows the company to begin sales in Singapore, a key market known for its advanced medical treatments and as a gateway to other major ASEAN markets.

Striate+ is a sterile, resorbable collagen membrane used in dental bone and tissue regeneration, including dental implant procedures. The product is designed to protect bone defects from gingival tissue ingrowth, promote osteogenesis, and ensure reliable formation of high-quality bone. It has already received approvals in the U.S., Europe/UK, Australia, New Zealand, and Canada.

Paul Anderson, Orthocell’s CEO and Managing Director, expressed enthusiasm about the approval, stating, “We are delighted to receive Singaporean regulatory approval for Striate+ in this important regional gateway market. This approval provides additional validation of Orthocell’s high-quality products, manufacturing processes, and quality systems.”

Orthocell’s global marketing and distribution partner, BioHorizons, is already established in Singapore, which is expected to facilitate a quick transition to first sales and revenue generation in the region. Striate+ has been experiencing strong sales growth in existing markets, driven by positive feedback from dental surgeons and an impressive 98.6% success rate from post-market clinical studies.

Singapore’s approval is seen as a strategic step for Orthocell, as the country is recognized for its efficiency, high standards, and state-of-the-art medical facilities. The company is also working on expanding into other large markets, including Brazil, where regulatory clearance is expected within the next 3-6 months.

Orthocell has a strong financial position, with approximately AU$33 million in cash reserves, positioning it well to continue broadening its commercial footprint and growing revenues in both existing and new markets. The global market opportunity for Striate+ is estimated to be around AU$1 billion, with Orthocell targeting a 20% market share.

Orthocell is a regenerative medicine company focused on developing products for the repair of bone and soft tissue injuries. Its product portfolio includes the CelGro™ platform of collagen medical devices, which facilitate tissue reconstruction and healing in various dental and orthopedic applications.