New Breast Implant Recall in the EU Prompts Need for VeriTeQ’s Device Traceability Technology
February 24 2014 - 8:30AM
Business Wire
VeriTeQ’s Q Inside Safety Technology is
Currently Being Used in the EU and UK with its Partner’s Motiva
Implant Matrix® Breast Implants
VeriTeQ Corporation (“VeriTeQ” or “Company”) (OTC Markets:VTEQ),
a provider of implantable medical device identification and
radiation dose measurement technologies, today commented on the
latest breast implant recall in the European Union. Breast implants
manufactured by French company Cereplas are being recalled by The
National Security Agency of Medicines and Health Products (“ANSM”)
due to concerns regarding sterilization and equipment used in
production of the implants.
The ANSM in the EU has suspended the marketing, distribution and
use of breast implants and sizers from Cereplas until the company
achieves compliance with regulations, which include control of the
process of sterilization and qualification of equipment used in
production. Cereplas’ CE marking Certificates for its breast
implants have also been suspended.
“This new recall of breast implants is the latest example of
regulators pushing for higher standards for medical devices
following the PIP scare in the EU,” said Scott R. Silverman,
Chairman and CEO of VeriTeQ. “Furthermore, it serves as another
reminder for manufacturers, physicians and patients of the need for
advanced device traceability technologies like VeriTeQ’s Q Inside
Safety Technology, that can externally retrieve the device
information without the stress and risk of a re-operation.”
VeriTeQ’s Q Inside Safety Technology acts as an electronic
serial number in breast implants and other implantable and reusable
medical devices to identify them during a recall or adverse event
to help ensure patient safety.
VeriTeQ is currently working with breast implant manufacturer
Establishment Labs, S.A. (“EL”), which markets its Motiva Implant
Matrix® breast implants with VeriTeQ’s Q Inside Safety Technology
in the EU. EL’s CE cleared Motiva Implant Matrix® product line with
VeriTeQ’s Q Inside Safety Technology offers the world’s first
externally identifiable breast implant.
By including VeriTeQ’s FDA cleared Q Inside Safety Technology in
breast implants and other medical devices, manufacturers,
physicians and patients will have access to a secure online
database to retrieve device-specific data such as serial number,
manufacturer name, date of manufacture, lot number, volume, size,
and other data from the medical device manufacturer. Q Inside
Safety Technology also provides an extra level of protection to the
patient in the event of a recall or other safety event as it
provides accurate and immediate confirmation of the origin of a
patient’s medical device.
About EL
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 (www.motivaimplants.com) 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.
About VeriTeQ
VeriTeQ 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 by including
VeriTeQ’s FDA cleared Q Inside Safety Technology in breast implants
and other medical devices, manufacturers, physicians and patients
will have access to a secure online database to retrieve
device-specific data such as serial number, manufacturer name, date
of manufacture, lot number, volume, size, and other data from the
medical device manufacturer; 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, VeriTeQ’s ability to
commercially launch its Q Inside Safety Technology in the EU and UK
in 2014; VeriTeQ’s ability to raise capital; as well as other
risks. Additional information about these and other factors may be
described in VeriTeQ’s Forms 10-Q, filed on August 9, 2013 and
November 14, 2013, and 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.
VeriTeQ CorporationAllison Tomek,
561-846-7003atomek@veriteqcorp.comorRedChip CompaniesBrendan
Hopkins, 1-800-RED-CHIP (733-2447), ext.
134Bhopkins@redchip.com
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