DUNDEE, Scotland--(BUSINESS WIRE)--3D, whose subsidiary, CarieScan Limited (“CarieScan”), is a leading producer of handheld devices for the early detection and monitoring of tooth decay, is pleased to announce that it has received 510(k) clearance from the Food & Drug Administration (“FDA”), allowing the CarieScan PROtm to be marketed in the United States of America (“US”).
This is a key milestone for CarieScan which opens up the major diagnostic market in the US to CarieScan PROtm,, providing a basis for securing a US distribution partner, giving the Company the opportunity to significantly increase product sales.
The CarieScan PROtm measures the presence of tooth decay earlier and more accurately than any other device on the market and is more than 90% accurate in detecting both sound and carious teeth, well ahead of other methods. It detects “hidden” decay, providing dental practitioners with the opportunity to arrest or even reverse decay, driving the trend towards preventative dental care.
The lightweight caries detection monitor not only offers best-in-class performance for decay detection but also allows easy monitoring of the effect of treatment regimes to show decay advancement or regression, thus enabling dentists to tailor treatment to the needs of the patient at a low cost. The CarieScan PROtm consists of a hand piece and a disposable sensor which is held against the tooth being examined in a process which takes approximately 4 seconds per tooth with the result displayed on the CarieScan PROtm .
James Noble, Non-executive Chairman of 3D Diagnostic Imaging said:
“The approval is the culmination of a very successful year for 3D in that we have successfully achieved a PLUS market listing, completed two significant fundraisings, and secured a UK distribution agreement. We now intend to begin discussions with potential distribution partners with the objective of securing agreements for the sale of CarieScan PROtm in the US during the coming months.”
The directors accept responsibility for the content of this announcement.
Contact:
3D Diagnostic Imaging Plc Graham Lay, CEO +44 (0) 138 2560 910 or St Helens Capital Partners LLP Oliver Cooke, Mark Anwyl +44 (0) 207 368 6959 or Buchanan Communications Diane Stewart, Jennie Spivey, Carrie Clement +44 (0) 207 466 5000
