SpineGuard Announces ANVISA Clearance for its “DSG Connect” Products in Brazil
PARIS & BOULDER, Colo.--(BUSINESS WIRE)--Regulatory News:
SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that deploys its DSG® (Dynamic Surgical Guidance) sensing technology to secure and streamline the placement of bone implants, announces that it has received clearance from ANVISA (Agência Nacional de Vigilância Sanitária), the government regulatory authority, for authorization to sell its DSG Connect products in Brazil.
As announced in June, the obtention of ANVISA clearance was the last step in the registration process of SpineGuard’s DSG Connect platform in Brazil after obtaining ANATEL (Agência Nacional De Telecomunicações) certification in March and INMETRO (The National Institute of Metrology, Standardization, and Industrial Quality) certification in June.
“Having successfully finalized the registration process, we can now start selling DSG Connect in Brazil, the number one market for spinal devices in Latin America. Several distributors have been already appointed to cover the main Brazilian states with firm orders secured. The training of these distributors and their surgeon customers will be the next priority in the coming weeks,” said Patricia Lempereur, Sales & Marketing Director, International of SpineGuard.
Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard is an innovative company deploying its proprietary radiation-free real time sensing technology DSG® (Dynamic Surgical Guidance) to secure and streamline the placement of implants in the skeleton. SpineGuard designs, develops and markets medical devices that have been used in over 85,000 surgical procedures worldwide. Seventeen studies published in peer-reviewed scientific journals have demonstrated the multiple benefits DSG® offers to patients, surgeons, surgical staff and hospitals. Building on these solid fundamentals and several strategic partnerships, SpineGuard has expanded its technology platform in a disruptive innovation: the « smart » pedicle screw launched late 2017 and is broadening the scope of applications in dental implantology and surgical robotics. DSG® was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer.
For further information, visit www.spineguard.com
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.
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