Regulatory News:
SpineGuard (FR0011464452 ALSGD), an innovative company that deploys its DSG (Dynamic Surgical Guidance) local conductivity sensing technology to secure and streamline the placement of bone implants, today announces its third quarter 2025 revenue.
Pierre Jérôme, Co-founder, Chairman and CEO of SpineGuard, stated: "The steep improvement of our operational result thanks to the significant reduction of our structural costs logically continues to impact our revenue in particular in the US where our strategic partner, Omnia Medical, is now leading our commercial network and the development of PediGuard sales. The logistics transfer is the next step of our common roadmap in order to bolster the competitiveness and new markets access for our two companies' products. We have good momentum in Europe, our second most important market after the US, and are making progress towards getting Chinese regulatory approval for the curved and miniaturized versions of PediGuard which are well suited for pediatric surgeries. We are also advancing discussions with several new potential industry partners interested in powered, robotic, and dental applications of DSG
Q3 2025 revenue
€ thousands IFRS (Unaudited) | 2025 | 2024 | Variance
|
First Quarter | 1,206 | 1,351 | -10.7% |
Second Quarter | 915 | 1,095 | -16.4% |
Third Quarter | 770 | 1,174 | -34.4% |
Year-To-Date 9 months | 2,891 | 3,620 | -20.1% |
SpineGuard's consolidated revenue for the first nine months of fiscal year 2025 amounted to €2,891K, down 20.1% at current exchange rates (-19% at constant exchange rates) compared to the same period in 2024.
In the United States, revenue at the end of the third quarter of 2025 was down 25.8% in dollar terms to $2,023K, compared to $2,728K at the end of the third quarter of 2024. This decrease is due to the gradual transformation of SpineGuard's business model from direct sales in the United States to a distribution model as part of its strategic partnership with Omnia Medical. This change is reflected in an apparent decline in short-term revenue, but should result in an improvement in the operating margin for the full 2025 financial year.
In SpineGuard's other main markets, revenue at the end of the third quarter of 2025 was up 1% in Europe and 30% in Asia, but down 11% in Latin America and 35% in the Middle East, where a large order related to a recently won tender in Saudi Arabia is expected in the coming months.
4,212 DSG units were sold at the end of the third quarter of 2025, compared to 4,813 units at the end of the third quarter of 2024, representing an overall decline of 12.5%. 1,523 units were sold in the United States at the end of the third quarter, representing 36% of total units sold.
Outlook
SpineGuard is continuing its efforts to achieve operational break-even by the end of 2026. The gradual transformation of its business model in the United States will contribute significantly to this goal. The ongoing sale of SpineGuard Inc. to Omnia Medical remains subject to customary conditions precedent, primarily the repayment of bonds issued to Norgine Venture and Harbert European Growth, with the final monthly payment due in January 2026. At the same time, the Company is working to establish strategic partnerships, strengthen its financial resources, and obtain approval for the curved and XS PediGuard devices in China.
The Company's cash position as of September 30, 2025 amounts to €618K.
Given the bond financing of up to €1 million agreed on September 10, 2025, its commercial and financial forecasts, the reduction in its expenses, and the progress made in discussions with potential partners with a view to concluding new strategic industrial agreements, the Board of Directors has adopted the ongoing concern assumption. SpineGuard believes it will be able to cover its financing needs until the second quarter of 2026.
SpineGuard is currently exploring various options and measures to strengthen its financing horizon and is working to forge new strategic partnerships to expand the scope of applications for its DSG technology.
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 embedding its technology. Over 100,000 surgical procedures have been secured worldwide thanks to DSG and 39 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 is expanding the scope of its DSG technology to the treatment of scoliosis via anterior approach, sacroiliac joint fusion, dental implantology and innovations such as the smart pedicle screw and power drill or 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
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251009412555/en/
Contacts:
SpineGuard
Pierre Jérôme
CEO Chairman
Tel: +33 1 45 18 45 19
p.jerome@spineguard.com
SpineGuard
Anne-Charlotte Millard
CFO
Tél: +33 1 45 18 45 19
ac.millard@spineguard.com
NewCap
Investor Relations Financial Communication
Mathilde Bohin Aurélie Manavarere
Tel: +33 1 44 71 94 94
spineguard@newcap.eu
