DELRAY BEACH, Fla.--(BUSINESS WIRE)--Digital Angel Corporation (“Digital Angel” or the “Company”) (OTC Markets: DIGA), a provider of implantable medical device identification and radiation dose measurement technologies following its recent share exchange with VeriTeQ Acquisition Corporation (“VeriTeQ”), announced that Establishment Labs, S.A. (“EL”), d/b/a Motiva, is now ready to market the world’s first traceable breast implant with Q Inside, enabling a manufacturer, physician or patient to access a secure online database and retrieve implant-specific data such as serial number, manufacturer name, date of manufacture, lot number, volume, size, and other data. In September 2012, VeriTeQ entered into a development and supply agreement with EL, a global provider of breast implants under the Motiva Implant Matrix® brand name, to build next-generation breast implants that contain VeriTeQ’s Unique Device Identifier (“UDI”) called “Q Inside.”
“With our FDA cleared Q Inside technology, we believe we offer the only solution of its kind that is currently available to meet the FDA’s Proposed Rule for the unique device identification of implantable medical devices,” stated Scott R. Silverman, Chairman and Chief Executive Officer of Digital Angel. “We are very pleased to work with EL, an innovative company with a forward-thinking management team on the cutting edge of healthcare technology.”
The FDA’s Proposed Rule for UDI reflects in § 801.50 a direct marking requirement recommended for implantable medical devices because these devices present unique risks that would be better controlled through such a 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 the final review is currently underway. It is anticipated that the final UDI Regulation will be released in the near future.
VeriTeQ’s Q Inside, a passive radio frequency identification (“RFID”) microchip, enables implantable medical devices to be quickly and safely identified from outside the body. Q Inside is a direct marking technology that provides Automatic Identification and Data Capture technology as required for implantable medical devices under the FDA’s Proposed Rule for UDI.
According to the International Society of Aesthetic Plastic Surgery, the number of breast augmentation procedures performed worldwide in 2011 exceeded 1.2 million.
About Digital Angel and VeriTeQ
Digital Angel, through its VeriTeQ wholly-owned subsidiary, develops innovative, proprietary RFID technologies for implantable medical device identification, and dosimeter technologies for use in radiation therapy treatment. VeriTeQ offers the world's first FDA cleared RFID microchip technology that can be used to identify implantable medical devices, in vivo, on demand, at the point of care. VeriTeQ's dosimeters provide patient safety mechanisms while measuring and recording the dose of radiation delivered to a patient in real time. For more information on VeriTeQ, please visit www.veriteqcorp.com.
Establishment Labs is a privately held, global breast, body and facial aesthetic company with offices in Florida, Costa Rica and Belgium, that designs, develops, manufactures and markets an innovative product portfolio consisting of advanced silicone-filled breast implants (www.motivaimplants.com) for breast and body shaping implants.
Utilizing only the highest quality of medical grade silicones, the CE-marked Motiva Implant Matrix® line is rigorously scrutinized by professional Quality Engineers throughout the entire manufacturing process. All its products are produced in full compliance with ISO and EU requirements, and are certified under the Medical Device Directive 93/42/EEC. For more information on EL, please visit www.establishmentlabs.com.
Statements in this press release about our future expectations, including without limitation, the likelihood that Motiva breast implants will have VeriTeQ’s heat-resistant microchip called “Q Inside” to enable the manufacturer, physician or patient to quickly and easily identify the implants from outside the body to comply with FDA’s Proposed Rule for Unique Device Identification; the likelihood that with its FDA cleared Q Inside technology, the Company offers the only solution of its kind that is currently available to meet the FDA’s Proposed Rule for the unique device identification of implantable medical devices; the likelihood that the final UDI Regulation will be released in the near future;; constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, the ability to promptly and effectively integrate the businesses of Digital Angel and VeriTeQ; VeriTeQ’s ability to target the UDI sector and implantable medical device manufacturers; VeriTeQ’s ability to raise capital; as well as other risks. The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.