PARIS & SAN FRANCISCO--(BUSINESS WIRE)--Regulatory News:
SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today during the North American Spine Society (NASS) annual meeting being held in Orlando, Florida from October 25-27, the commercial release in the USA of the DSG enabled Z-Direct Pedicle Screw system from Zavation.
This launch at NASS marks the first commercially available pedicle screw in the USA using the one-step-insertion of pedicle “smart screws” guided by DSG™ (Dynamic Surgical Guidance) technology and follows the successful early results from first cases announced in March, 2017.
The DSG enabled Z-Direct Pedicle Screw System may be used in open or minimally invasive approaches. It incorporates a single-use SpineGuard DSG pin embedded with a bipolar sensor that is inserted into the cannula of the Zavation Screwdriver/Pedicle Screw and connected to the electronic processor inside the single-use SpineGuard DSG handle. The distal awl-like tip of the DSG pin facilitates entry into the pedicle and the bipolar sensor continuously checks for the proximity of the cortical walls of the pedicle and alerts the surgeon of the potential for cortical breach. The design of the Z-Direct screw tip allows for redirection during insertion until the screw is past the pedicle isthmus.
Steve McAdoo, US General Manager of SpineGuard said: “SpineGuard continues to enhance the value offered to surgeons and hospitals with the US launch of the DSG enabled Z-Direct Pedicle Screw System by Zavation. This key achievement further demonstrates how our DSG technology can be integrated within pedicle screw instrumentation for additional clinical benefits and efficiencies.”
Dee Hillhouse, National Sales Manager for Zavation, added: "Zavation and its distributors are very excited about the advancement of the DSG technology with the Z-Direct screw. The added benefit of accurate screw placement within the highest quality bone is unparalleled. Additionally, the surgeons and the Hospitals staff will be exposed to less radiation. SpineGuard’s vision and the hard work of Zavation’s engineers have changed the way pedicle screws are implanted.”
More information on the DSG™ technology, its new applications and surgeons’ testimonials here.
More information on the Zavation products that incorporate DSG™ technology click here.
Next financial press release: 2017 full year revenue, January 4, 2018
Founded in 2009 in France and the USA, by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 55,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. 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.