VeriTeQ Partner Establishment Labs Receives Additional CE Mark Approvals to Market Breast Implants with Q Inside Safety Techn...
February 18 2014 - 8:30AM
Business Wire
New CE Mark Approvals Permit the Sale of Motiva
Implants with Q Inside Safety Technology to 28 Countries in the
European Union
VeriTeQ Corporation (“VeriTeQ” or “Company”) (OTC Markets:
VTEQ), a provider of implantable medical device identification and
radiation dose measurement technologies, announced today that its
breast implant partner Establishment Labs, S.A. (“EL”) has received
additional CE Mark approvals for its Motiva Implant Matrix®
VelvetSurface PLUS with Q Inside Safety Technology and Motiva
Implant Matrix® SilkSurface PLUS with Q Inside Safety Technology.
EL’s Motiva Implant Matrix product line with VeriTeQ’s Q Inside
Safety Technology offers the world’s first externally identifiable
breast implant.
VeriTeQ’s FDA cleared Q Inside Safety Technology acts as an
electronic serial number in breast implants and other implantable
and reusable medical devices. By including VeriTeQ’s Q Inside
Safety Technology in Motiva Implant Matrix® implants,
manufacturers, physicians and patients will have access to a secure
online database to retrieve implant-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.
Motiva’s SilkSurface PLUS implants provide a soft, gliding
printed nano-surface that reduces complications related to
traditional textures while reducing capsular contracture rates.
Motiva’s VelvetSurface PLUS implants provide a printed
micro-surface that promotes a more secure fit in the breast
pocket.
“We continue to advance the safety and exclusivity of our entire
breast implant portfolio to answer the demands from both physicians
and patients alike,” said Juan José Chacón-Quirós, CEO of
Establishment Labs. “Including VeriTeQ’s Q Inside Safety Technology
in Motiva’s SilkSurface PLUS and VelvetSurface PLUS implants
emphasizes our primary focus of providing best-in-class products
for the protection of the patient.”
Scott R. Silverman, Chairman and CEO of VeriTeQ, stated, “We
believe these new CE Mark approvals will provide continued momentum
for EL’s product launch in the EU. Giving physicians and patients
the power to identify their breast implants in a healthcare setting
is the next generation of technology and security, and we believe
both groups will ultimately demand this level of safety from their
implants.”
According to the International Society of Aesthetic Plastic
Surgery, the number of breast augmentation procedures performed
worldwide in 2011 exceeded 1.2 million.
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 Q Inside Safety Technology in Motiva Implant Matrix®
breast implants, manufacturers, physicians and patients will have
access a secure online database to retrieve implant-specific data
such as serial number, manufacturer name, date of manufacture, lot
number, volume, size, and other data from the medical device
manufacturer; the likelihood that textured breast implants may help
reduce the risk of capsular contracture; the likelihood that these
new CE Mark approvals will provide continued momentum for EL’s
product launch in the EU; the likelihood that physicians and
patients will demand the ability to identify their breast implants
in a healthcare setting; 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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