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SpineGuard and XinRong Medical Expand Their Collaboration to Deploy DSG® Technology in China
Rhea-AI Impact
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Rhea-AI Sentiment
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Rhea-AI Summary
SpineGuard and XinRong Medical Group have expanded their collaboration with the signing of three agreements. This includes an exclusive distribution extension for SpineGuard products in China, funding for the registration process of new products, and potential co-development of a Smart Screw system for the Chinese spinal surgery market. The expansion will allow XinRong Medical to sell a wider range of SpineGuard's DSG spinal drilling probes in China. The NMPA registration for these devices will be funded by XinRong Medical. SpineGuard will issue new shares priced at €1.00 per share to fund the registration process. The companies are also considering the co-development of a DSG enabled single step pedicle screw system. China's spine market is the second-largest in the world.
Positive
SpineGuard and XinRong Medical have expanded their collaboration, which could lead to increased sales in China for SpineGuard products. The NMPA registration for new devices will be funded by XinRong Medical, providing a cash injection of €500K into SpineGuard's capital. SpineGuard will issue new shares priced at €1.00 per share to fund the registration process, representing 1.28% of current issued shares. The potential co-development of a Smart Screw system for the Chinese spinal surgery market could open up new opportunities for SpineGuard.
Negative
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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 placement of bone implants, and XinRong Medical Group, a China leader in medical technology, announced today that they expanded their collaboration with the signature of three concomitant agreements:
China exclusive distribution extension to the whole SpineGuard product portfolio
Funding of the NMPA (National Medical Product Administration) registration process for SpineGuard new products via a cash injection of €500K by XinRong Medical in SpineGuard capital
Potential co-development of a Smart Screw system for the Chinese spinal surgery market
Until today, XinRong Medical was only selling the SpineGuard’s Classic PediGuard products in China, this new distribution agreement will enable them to commercialize the Curved, the XS, the Canulated and the Threaded versions of SpineGuard’s DSG (Dynamic Surgical Guidance) spinal drilling probes.
The NMPA registration of these new devices for the Chinese market will be funded via a €500K equity injection by XinRong Medical. SpineGuard will issue 500,000 new shares priced at €1.00 per share representing 1.28% of current issued shares with a 18-month lock-up period. SpineGuard will own all product registrations that will be executed through a third-party regulatory agent jointly appointed by both companies.
XinRong Medical and SpineGuard also decided to envision the co-development of a DSG enabled single step pedicle screw system with three key milestones triggering payments:
1) evaluation of the registration process and market access path,
2) product design and submission of the registration dossier, and
3) product clearance.
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: “This three-pronged agreement is a significant step forward for SpineGuard and the deployment of our x-ray free real time sensing technology in China, the largest market for spinal surgical devices after the United States. With XinRong, we took the time to elaborate a common strategy and tailor our partnership based on our early collaborative experience introducing the original version of PediGuard in China. We now have a clear roadmap and dedicated funds to successfully market our smart drilling devices and secure spinal fusion procedures across Chinese provinces.”
Christine Zhang, CEO of XinRong Medical, added: “I am thrilled about the three-pronged agreement between SpineGuard and XinRong. It is indeed a significant step forward for XinRong, and I commend the board, the company XinRong and SpineGuard team for taking the time to collaborate and develop a common strategy. The dedication to tailoring out partnership based on both sides’ early collaborative experience introducing the original version of PediGuard in China is a testament to SpineGuard commitment to providing innovative medical devices to the global medical community. The dedicated funds to market SpineGuard x-ray free real time guidance technology across Chinese provinces is a great opportunity to expand SpineGuard's presence in the Chinese market. I am confident that this innovative technology will provide more precise and safer spinal surgery for Chinese patients. Once again, I greet this milestone achievement, and I look forward to seeing the continued success of SpineGuard and XinRong.”
About 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 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, a China leader in medical technology, is dedicated to increasing patient affordability and providing the most advanced solution for surgeons such that they can deliver the best patient care. XinRong Medical offers innovative solutions in orthopaedic surgery, neurosurgery, and reconstructive surgery. XinRong Medical is a professional orthopaedic implants manufacturing enterprise invested by the world’s leading investment institution The Black Stone Group, (NYSE: BX). It has constantly innovated and moved forward to new materials, new techniques and minimally invasive therapy field. Established in 2000, XinRong Medical was one of the first companies in China cleared by SFDA to manufacture orthopaedic implants. For additional information, visit www.XRBest.Com.
Disclaimer
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.
What agreements were signed between SpineGuard and XinRong Medical?
SpineGuard and XinRong Medical signed three agreements, including an exclusive distribution extension, funding for the registration process of new products, and potential co-development of a Smart Screw system.
What will the funding from XinRong Medical be used for?
The funding from XinRong Medical will be used for the NMPA registration process of new SpineGuard products for the Chinese market.
How will SpineGuard fund the registration process?
SpineGuard will issue 500,000 new shares priced at €1.00 per share to fund the registration process.
What is the potential co-development between SpineGuard and XinRong Medical?
The potential co-development involves creating a DSG enabled single step pedicle screw system for the Chinese spinal surgery market.
What is the size of China's spine market?
China's spine market is the second-largest in the world.
