VeriTeQ Partner Establishment Labs Achieves CE Mark Approval to Market Motiva Implant Matrix Ergonomix Breast Implant with VeriTeQ's Q Inside Safety Technology
Digital Angel Corp., a provider of implantable medical device identification and radiation dose measurement technologies, following its recent share exchange with VeriTeQ Acquisition Corp. ("VeriTeQ"), announced 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.
According to a release, 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 an 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 technology to create the look and feel of a natural breast, a characteristic with cultural appeal for European consumers.
"We have fulfilled our promise to enhance through innovation the safety of silicone breast implants," said Juan Jose Chacon-Quiros, 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, noted, "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 a product portfolio consisting of advanced silicone-filled breast implants 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.
Digital Angel, through its VeriTeQ subsidiary, develops proprietary RFID technologies for implantable medical device identification, and dosimeter technologies for use in radiation therapy treatment.
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