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.
Copyright Business Wire 2013