OSspray Limited (“OSspray”), the emerging regenerative dentistry company based at King’s College London Dental Institute, is pleased to announce that it has received FDA 510(k) approval for its first product (working name: ‘OSspray cleaning compound’). This clearance to market facilitates the commercial launch of the product later in the year as a prophy powder for cleaning, whitening and desensitising applications.
OSspray is developing a range of innovative bioactive powders for use as teeth cutting, cleaning, desensitising, remineralising and whitening agents. The first OSspray powder will compete in the air polishing segment of the preventative dentistry market, a $70bn market growing at c10% per annum. The OSspray powders can be used in incumbent air polishing equipment and provide the dentist and hygienist with an innovative treatment that significantly improves tooth cleaning whilst also whitening and desensitising patients’ teeth. Additionally the treatment time is significantly reduced, thereby enabling greater patient throughput within dental practices.
FDA approval means the company is now able to proceed with a series of practitioner studies to gain additional comparative performance data and opinion leader endorsement prior to launch. These studies will be undertaken in tandem with product and packaging development and testing prior to formal launch later in 2007.
Commenting on the completion of US regulatory approval, Simon Cartmell, Chairman of OSspray, said:
“Having completed a funding round and secured the appointment of Michael Crane, a highly experienced dental executive as a non-executive Director in November 2006, FDA approval is further welcome news for OSspray, and another important achievement. 510k approval is a vital milestone that will enable us to generate the testimony that will inform and support our product launch later in 2007. This is an exciting time for OSspray and we look forward to executing further aspects of our commercialisation plan”.
Contact:
Simon Cartmell, Chairman +44 (0)796 645 3133
Piers Robinson, VP Commercial Operations +44 (0)794 112 5539
Website : www.osspray.com
