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 certification from the Brazilian National Institute of Metrology, Standardization, and Industrial Quality (INMETRO), for DSG Connect.
In Brazil, the registration of new medical devices featuring a wireless component like DSG Connect must follow a 3-steps process:
- Obtain ANATEL (Agência Nacional De Telecomunicações) certification to approve products embedding wireless technologies.
- Obtain INMETRO (The National Institute of Metrology, Standardization, and Industrial Quality) certification to attest that the concerned medical device complies with the Brazilian regulations and required safety standards.
- Obtain product registration from ANVISA (Agência Nacional de Vigilância Sanitária), the government regulatory authority, for authorization to sell the product on Brazilian territory.
“After obtaining the ANATEL certification in March 2021, and now the INMETRO certification, the next and final step for the commercialization of DSG Connect in Brazil is the ANVISA registration, expected before the end of the year. We are thrilled to soon start selling DSG Connect in Brazil, the largest spine market in Latin America, where it is expected by many spine surgeons. Our commercial strategy in this sizable market is to partner with several distributors to cover the different Brazilian states,” said Patricia Lempereur, Sales & Marketing Director, International.
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 80,000 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.