Healthcare Industry News: Silicone-Filled Breast Implant
News Release - October 10, 2013
VeriTeQ Partner Establishment Labs Receives CE Mark Approval to Market Motiva Implant Matrix Ergonomix Breast Implant with VeriTeQ’s Q Inside Safety TechnologyCE Mark Approval Permits the Sale of Motiva Implants with Q Inside Safety Technology to 28 countries in the European Union and fast track regulatory approvals in many countries in South America, the Middle East and Asia
DELRAY BEACH, Fla.--(Healthcare Sales & Marketing Network)--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”), announced today that its breast implant partner Establishment Labs, S.A. (“EL”) has received CE Mark approval for its Motiva Implant Matrix Ergonomix™ with VeriTeQ’s “Q Inside Safety Technology.” CE Mark approval enables EL to market its Motiva breast implants to patients in 28 countries in the European Union and fast track regulatory approvals in many countries in South America, Middle East and Asia. VeriTeQ and EL previously entered into a development and supply agreement to use VeriTeQ’s Q Inside Safety Technology in EL’s Motiva breast implant product line.
EL’s Motiva Implant Matrix Ergonomix™ with VeriTeQ’s Q Inside Safety Technology is the world’s first externally identifiable breast implant. By including VeriTeQ’s Q Inside Safety Technology, which is an FDA cleared radio frequency identification microchip that can be read safely from outside the body, in Motiva 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. The Ergonomix™ implant has unique technology to create the look and feel of a natural breast, a characteristic with strong cultural appeal for European consumers.
“We have fulfilled our promise to enhance through innovation the safety of silicone breast implants,” said Juan José Chacón-Quirós, CEO of Establishment Labs. “Q Inside Safety Technology in Motiva is about giving women the power of verification and control throughout the life of the device, if they choose to have breast implants. We are already in final talks with the biggest groups of clinics in Europe to provide the highest degree of safety, which patients have been rightly demanding after the recent breast implant scare in the EU."
Scott R. Silverman, Chairman and CEO of VeriTeQ, stated, “Our partner EL has proven to be not only an innovator in the breast implant industry that delivers a best-in-class device, but also a company that executes its business objectives expertly and swiftly as evidenced by this CE Mark clearance. We believe that medical professionals will quickly understand the benefits afforded to the healthcare system and to patients by including Q Inside Safety Technology in implantable and reusable medical devices for accurate device identification.”
According to the International Society of Aesthetic Plastic Surgery, the number of breast augmentation procedures performed worldwide in 2011 exceeded 1.2 million.
In September 2012, VeriTeQ entered into a development and supply agreement with EL, a global provider of breast implants under the Motiva Implant Matrix® brand name, to build next-generation breast implants that contain VeriTeQ’s Unique Device Identifier (“UDI”) called “Q Inside Safety Technology.” Under the terms of the agreement, VeriTeQ will receive payments from EL for the implantable microchips used in each implant, as well as external handheld readers.
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 Implants (www.motivaimplants.com) for breast 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 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 CE Mark approval enables EL to market its breast implants to patients in 28 countries in the European Union and fast track regulatory approvals in many countries in South America, Middle East and Asia; the likelihood that medical professionals will quickly understand the benefits afforded to the healthcare system and to patients by including Q Inside Safety Technology in implantable and reusable medical devices for accurate device identification; 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.
Source: Digital Angel
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