PARIS & BOULDER, Colo.--(BUSINESS WIRE)--Regulatory News:
SpineGuard (FR0011464452 – ALSGD), an innovative company that deploys its DSG (Dynamic Surgical Guidance) sensing technology to secure and streamline the insertion of bone implants, and XinRong Medical Group, a China leader in medical technology, announced today the placement of a large purchase order of PediGuard devices and the completion of a capital increase primarily intended to fund the registration of the whole SpineGuard product portfolio by the Chinese NMPA (National Medical Product Administration).
In line with the extended distribution agreement announced on May 16, XinRong Medical placed a purchase order for 448 Straight PediGuard units. In parallel, SpineGuard appointed a third-party regulatory agent, with XinRong’s input, to execute the Chinese registration of the other versions of PediGuard i.e. the Curved, the XS, the Canulated and the Threaded spinal drilling probes embedding SpineGuard’s DSG (Dynamic Surgical Guidance) technology.
XinRong’s equity contribution to SpineGuard has been made according to the terms announced on May 16 as follows:
- issuance of 500,000 new SpineGuard shares,
- at a price of €1.00 per share,
- equal to a €500K equity injection by XinRong Medical,
- representing 1.28% of current issued shares,
- with an 18-month lock-up period.
China’s spine market is the world’s second-largest market after the USA driven by an aging population, increasing disease prevalence and treatment rates, along with access to care growing affordability.
Pierre Jérôme, Chairman, CEO and Co-founder of SpineGuard, said: “I am delighted that our recently signed three-prong agreement with XinRong is swiftly materializing. This € 500,000 cash injection will finance the regulatory approval of the whole PediGuard product range in China. It confirms XinRong’s ambition and commitment to mobilize the necessary means for properly deploying SpineGuard’s DSG technology in the largest market for spinal surgical devices after the United States. This equity stake strengthens our collaboration and further aligns both companies’ interests which I believe is essential to make such partnership successful.”
Christine Zhang, CEO of XinRong Medical, added: “I am thrilled about our partnership with SpineGuard. Our investment in the company represents our shared commitment to innovation and advancing medical technology. We believe that SpineGuard's DSG technology will revolutionize spinal surgical devices and we are excited to be a part of that journey. The completion of this capital increase reinforces our dedication to bringing the latest medical advancements to patients in China and beyond. We look forward to working closely with SpineGuard over the coming years and are confident that our collaboration will yield significant results.”
“PediGuard increases safety for better screw placement, reduces surgical time, decreases X-ray exposure for patients, surgeons and staff and also helps train the young surgeons. It is a very useful and convenient device that is effective without any other supplementary equipment for complex spine surgery, especially for spinal deformity cases.” said Professor Yong Qiu, Chairman of Orthopedic Surgery of Nanjing Drum Tower Hospital and President of the Chinese Scoliosis Research Society.
Professor Weishi Li, Chief of Department of Orthopedics of Peking University Third Hospital (PKUTH), and Chairman of the AO Spine China Council, concluded: “As a medical expert, I would like to extend my heartfelt congratulations to SpineGuard and XinRong Medical Group on their new partnership. The placement of a large purchase order of PediGuard devices and the completion of a capital increase to fund the registration of the whole SpineGuard product portfolio by the Chinese NMPA is a significant achievement. I am excited about the potential impact that SpineGuard's DSG technology will have on spinal surgical devices in China, which is the world's second-largest market after the USA. The benefits of PediGuard in terms of increased safety, reduced surgical time, and decreased X-ray exposure are well-known, and I look forward to seeing this innovative technology being used to improve patient outcomes in China. Congratulations again to both companies on this exciting partnership.”
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 95,000 surgical procedures worldwide. Twenty-four studies published in peer-reviewed scientific journals have demonstrated the multiple benefits DSG® offers to patients, surgeons, surgical staff and hospitals. Building on these strong fundamentals and several strategic partnerships, SpineGuard has expanded the scope of its DSG® technology in innovative applications such as the « smart » pedicle screw, the DSG Connect visualization and registration interface, 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. SpineGuard has engaged in multiple ESG initiatives. For further information, visit www.spineguard.com
About XinRong Medical
XinRong Medical is a leading medical technology company in China that is dedicated to improving patient affordability and providing advanced solutions for surgeons to deliver the best possible patient care. With a focus on orthopaedic surgery, neurosurgery, and reconstructive surgery, XinRong Medical offers innovative solutions that utilize new materials, techniques, and minimally invasive therapies. Founded in 2000, XinRong Medical was one of the first companies in China to manufacture orthopaedic implants and has since grown to become a professional orthopaedic implants manufacturing enterprise. Backed by the world's leading investment institution, XinRong Medical is committed to constantly innovating and moving forward to meet the evolving needs of patients and surgeons alike. For more information, please visit our website at www.XRBest.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.