Australian regenerative medicine company Orthocell has received US 510k clearance to market and supply its collagen medical device, Striate+, in the country.
The device is approved for use in dental bone and tissue regeneration procedures such as dental bone defect repair, augmentation around dental implants in immediate and delayed extraction sockets, and guided tissue regeneration processes in intrabony periodontal defects.
The clearance enables Orthocell to deliver Striate+ in the US dental bone and tissue regeneration market.
Furthermore, the company will negotiate with global dental companies for US marketing and distribution rights while retaining the manufacturing of the finished product.
Orthocell MD Paul Anderson said: “US approval is a significant inflection point for our company and we are now primed to partner and distribute this product.
“I look forward to working with our leading dental surgeons to introduce the new global brand, Striate+, previously branded as CelGro dental, to make a meaningful impact in the US market.”
The latest development follows the company’s application submitted to the Food and Drug Administration (FDA) last May.
US dental surgeon Dr Pamela Ray said: “Striate+ has exceptional handling qualities – when manipulating, it remains dimensionally stable and unrolls easily back to the original size.
“It has great tensile strength and does not deform when hydrated.”
According to the surgeon feedback, Striate+ has various benefits and could help surgeons to offer enhanced patient outcomes through optimal handling characteristics, tissue integration qualities, and improved bone healing.
In 2017, Orthocell obtained CE-Mark for its CelGro medical device, enabling marketing within the EU countries.