FDA Rule Mandating Unique Device Identification for Reusable Medical Devices Creates New Market Oppo
Sep 30th 2013 9:30AM
Updated Sep 30th 2013 9:32AM
FDA Rule Mandating Unique Device Identification for Reusable Medical Devices Creates New Market Opportunity for VeriTeQ in Breast Implant Sizers and Other Reprocessed Devices
Company estimates breast implant sizer market at approximately 600,000 devices annually
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"), discussed today a new market opportunity for identifying breast implant sizers, which was created, in part, by the U.S. Food and Drug Administration ("FDA") Final Rule for Unique Device Identification ("UDI"), announced on September 20, 2013. The Company estimates the breast implant sizer market at approximately 600,000 devices annually.
Breast implant sizers are used temporarily during breast augmentation surgery prior to the placement of the permanent breast implant to assist in determining the desired breast implant volume, and then re-sterilized for their next use. The Final Rule for UDI requires all medical devices distributed in the U.S. that are intended to be used more than once and intended to undergo any form of reprocessing before each use to carry a UDI with "direct part marking" of the device. VeriTeQ's Q Inside Safety Technology, a FDA cleared radio frequency identification ("RFID") microchip, can act as a direct part marking that can be included within a reusable, reprocessed, or implantable medical device and read with a handheld scanner.
Sizers, used by the world's leading manufacturers of breast implants, are similar to typical breast implants made of gel silicone and are intended for a maximum of ten additional reuses following sterilization after each use. The Company believes the Final Rule also may provide potential market opportunities to identify other reusable or reprocessed medical devices such as artificial joint sizers, heart valve sizers, surgical equipment, and endoscopy devices, among others.
"Over the past several months, in conjunction with a global breast implant manufacturer we are working with, we have successfully manufactured Q Inside Safety Technology into their breast implants, with the goal of providing manufacturers and patients a quality control and safety device to enhance their implants. With the recent FDA mandate to directly mark reusable devices with a UDI, we believe the use of Q Inside Safety Technology for breast implant sizers becomes more relevant," stated Scott R. Silverman, Chairman and Chief Executive Officer of VeriTeQ. "Like the opportunity in the breast implant sizer market, we also believe that there are undiscovered opportunities in other categories of the reusable medical device market that we intend to pursue diligently."
The FDA Rule was issued in response to the passage of the FDA Safety and Innovation Act, which directed the federal agency to develop regulations that would create a UDI system for medical devices.
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 breast implant sizer market is estimated at 600,000 devices annually; the likelihood that the Final Rule also may provide potential market opportunities to identify other reusable or reprocessed medical devices such as artificial joint sizers, heart valve sizers, surgical equipment, and endoscopy devices, among others; the likelihood that there are undiscovered opportunities in other categories of the reusable medical device market that the Company intends to pursue diligently; 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 medical device manufacturers; VeriTeQ's ability to raise capital; as well as other risks. Additional information about these and other factors may be described in future filings with the Securities and Exchange Commission 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.
Allison Tomek, 561-846-7003
KEYWORDS: United States North America Florida
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