VeriTeQ Corp., a provider of implantable medical device identification and radiation dose measurement technologies, said that it expects to commercially launch its Q Inside Safety Technology through partners in the European Union ("EU") in the first quarter of 2014.
In a release, the Company said that it is working with Establishment Labs, S.A. ("EL"), its distributors, and other groups in the EU to launch EL's Motiva Implant Matrix Ergonomix breast implant with Q Inside Safety Technology as early as January.
VeriTeQ said that Q Inside Safety Technology is an FDA cleared radio frequency identification ("RFID") micro-transponder that serves as a device identifier, or UDI, that can be read safely from outside the body to identify an implantable medical device in vivo or embedded in reusable medical devices for proper sterilization and use verification.
In the case of breast implants, VeriTeQ said that its Q Inside Safety Technology is being used in EL's CE-marked Motiva Implant Matrix Ergonomix implants to enable physicians and patients to access a secure online database to retrieve implant-specific data, such as serial number, manufacturer name, date of manufacture, lot number, volume, size, and other data. Q Inside Safety Technology also provides an extra level of protection to the patient in the event of a recall or other safety event, since Q Inside Safety Technology provides accurate device identification that cannot be lost or entered incorrectly into a patient's electronic health record. Q Inside Safety Technology has attracted interest from insurers and others based on this first-of-a kind advanced safety technology for patients who choose to get breast implants.
"We are eager to make this technology available to physicians and their patients in early 2014 to offer them peace of mind, particularly in light of the PIP breast implant scandal that occurred across the EU in 2010 and 2011," said Scott R. Silverman, VeriTeQ's Chairman and Chief Executive Officer. "We look forward to providing additional information about the customers we have procured in the EU and the product launch in the coming weeks."
The Company previously announced that it delivered its first order of 2,000 Q Inside Safety Technology RFID micro-transponders to breast implant partner Establishment Labs, S.A. ("EL") in October of this year.
According to the International Society of Aesthetic Plastic Surgery, the number of breast augmentation procedures performed worldwide in 2011 exceeded 1.2 million.
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