|By Business Wire||
|September 9, 2013 08:32 AM EDT||
Digital Angel Corporation ("Digital Angel" or the "Company"), also known as VeriTeQ (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 today that it has hired Caryn Mills as its Director of Strategic Alliances for its Unique Device Identification ("UDI") business. Mills will be responsible for identifying and advancing new partnerships with implantable medical device manufacturers to help them meet federal regulations requiring unique device identification by using the Company's FDA cleared radio frequency identification microchip, "Q Inside," within their devices.
Mills has over 15 years of successful sales, marketing and customer relations expertise, most of which comes from the medical device and pharmaceutical industries, including companies such as Covidien Surgical Solutions and Schering Plough Corporation.
"The FDA's Proposed Rule requiring the UDI of all implantable medical devices makes this is an opportune time to join VeriTeQ," said Mills. "I am eager to utilize my industry experience to advance the use of VeriTeQ's innovative and first-of-its-kind Q Inside technology, which enables the safe and accurate identification of implantable medical devices from outside of the body."
"Caryn's solid background and relationships in the medical device industry make her a valuable addition to our team," said Scott R. Silverman, Chairman and Chief Executive Officer of VeriTeQ. "We believe Caryn's expertise will enable her to take advantage of the substantial opportunities in the industry due to the FDA's Proposed Rule for UDI of implantable medical devices."
Q Inside provides a proven way for implantable medical device manufacturers to comply with the FDA's direct marking requirement of the Proposed Rule for UDI. 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.
On July 9, 2012, the FDA Safety and Innovation Act was signed into law. In conjunction with that legislation, the FDA proposed a new rule for a UDI System, which would, among other things, allow more accurate reporting of adverse event reports so that problem devices can be identified and corrected more quickly; reduce medical errors by enabling health care professionals to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device; provide a consistent way to enter information about devices in electronic health records and clinical information systems; provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls; and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
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.
Statements in this press release about our future expectations, including without limitation, the likelihood that the FDA’s Proposed Rule requiring the UDI of all implantable medical devices makes this is an opportune time for Mills to join VeriTeQ; the likelihood that Mills’ expertise will enable her to take advantage of the substantial opportunities in the industry due to the FDA’s Proposed Rule for UDI 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.