VeriTeQ Partner Establishment Labs Receives Additional CE Mark Approvals to Market Breast Implants with Q Inside Safety Technology
New CE Mark Approvals Permit the Sale of Motiva Implants with Q Inside Safety Technology to 28 Countries in the European Union
DELRAY BEACH, Fla.--(BUSINESS WIRE)--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.
“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.”
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.
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.
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.