US approval for Orthocell regeneration product

Perth-based biotherapeutic company Orthocell has received US approval for the use of its CelGro regeneration platform.

Formerly known as CelGro Dental, the platform will be market globally as Striate+, and will use the CelGro platform for the regeneration of dental bone and tissue.

The approval from the US Food and Drug Administration comes eight months after Orthocell’s application was submitted and one month after it was approved by Australia’s Therapeutic Goods Administration.

The product has also received EU market approval.

Orthocell managing director Paul Anderson said that he was surprised by the speed of the approval and that the company was financially well positioned for this next stage of growth.

"I am excited by this strategic milestone and ... I look forward to working with our leading dental surgeons to introduce the new global brand, Striate+," he said.

Mr Anderson also told Business News that the product’s US rollout will start on a regional basis and has already been distributed to six key opinion leaders among US dental surgeons.

Orthocell will also hasten their ongoing negotiations with multi-national dental companies in the hopes of securing an exclusive international distribution partnership.

CelGro is a tissue and bone regeneration platform that Orthocell hopes can be applied to bone, nerve and tendon regeneration.

The company is currently trialling the use of the CelGro collagen medical device in nerve repair procedures.

Mr Anderson stated that US approval for Striate+ was a good sign for further product approvals in the future. 

“What we see here with these three major jurisdictions shows us that the manufacturing process is robust," he said.

“We will use the same manufacturing process for [nerve and tendon regeneration products]”.

Orthocell shares were trading at $0.58 at 3pm AEDT.