Digital Angel Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, following its recent share exchange with VeriTeQ Acquisition Corporation (“VeriTeQ”), announced today that VeriTeQ has enhanced its patent portfolio by filing two new patents with the U.S. Patent and Trademark Office in order to protect its position as a leader in breast implant identification and safety technologies.
The first patent is for VeriTeQ’s temperature-resistant microchip, designed specifically to withstand high temperatures during sterilization in the manufacturing of breast implants and other implantable medical devices. The second patent covers the process of using the Company’s temperature-resistant microchip in the manufacturing of a breast implant.
VeriTeQ is working with implantable medical device manufacturers in the U.S. and abroad to incorporate its FDA cleared passive radio frequency identification (“RFID”) microchip, referred to as “Q Inside Safety Technology,” within breast implants and other medical devices to enable the devices to be quickly and safely identified from outside the body. VeriTeQ’s Q Inside Safety Technology enables implantable medical device manufacturers to comply with the FDA’s Proposed Rule for Unique Device Identification (“UDI”), which contains a direct marking requirement recommended for implantable medical devices because these devices present unique risks that would be better controlled through direct marking (versus simple labeling on the outside of the medical device packaging). The UDI Regulation has been released from the FDA to the White House Office of Management and Budget, and it is anticipated that the UDI Final Regulation will be released in the near future.
“We have chosen to focus initially on the UDI of breast implants due to the global demand for the safe and accurate identification of these devices once inside the body. This demand stems from past recalls of breast implants, particularly the scandal involving Poly Implant Prothese’s implants in the European Union,” stated Scott R. Silverman, Chairman and Chief Executive Officer of VeriTeQ. “We believe our innovative technology and intellectual property, which we continue to improve upon and protect, puts us in a strong position to help supply safer implantable medical devices for patients.” According to the International Society of Aesthetic Plastic Surgery, the number of breast augmentation procedures performed worldwide in 2011 exceeded 1.2 million.