PARIS & BOULDER, Colorado–(BUSINESS WIRE)–Regulatory News:
SpineGuard (FR0011464452 – ALSGD) (Paris:ALSGD), an innovative company using its DSG (Dynamic Surgical Guidance) sensor technology to secure and streamline the placement of bone implants, announces the launch of a new three-year collaboration program with two laboratories CNRS and Inserm of Sorbonne University: ISIR (Intelligent Systems and Robotics Institute) and LIB (Biomedical Imaging Laboratory).
DSG is based on the local measurement of the electrical conductivity of tissues in real time without X-ray imaging with a sensor located at the tip of the drilling instrument. Its effectiveness has been proven by more than 90,000 surgeries worldwide and 19 scientific publications. SpineGuard entered into a collaboration with ISIR in 2017 to apply DSG to surgical robots and improve their safety, accuracy and autonomy.
SpineGuard and ISIR benefit from first order results published so far…
Completing a first phase of the collaboration, SpineGuard announced experimental results with sub-millimeter accuracy in detecting bone boundaries and automatically stopping a vertebral drilling performed by a robot using DSG technology. These impressive results were presented consecutively at the Hamlyn Medical Robotics Conference in London in May 2019, where they received first prize for best scientific paper, and then in November in a plenary session at the SMISS Minimally Invasive Spine Surgery (SMISS) in Las Vegas 2021 and most recently during the CRAS conference in Naples in April 2022.
… and join forces with the LIB lab to add ultrasound to the project.
Encouraged by this success, the research and development teams want to go even further in the advancement of surgical robots: the guidance technologies that allow the robot to position itself correctly relative to the patient to find the drill entry point now rely on dangerous X-ray imaging for health, in combination with space-consuming optical registration. SpineGuard has long investigated the possibility of using ultrasound in addition to DSG for this preliminary step before the instrument penetrates the bone and has been awarded two international patent families on the subject. The LIB laboratory, which has international expertise in the field of ultrasound imaging, enthusiastically accepted the invitation to join the project. SpineGuard, ISIR and LIB are launching a new 3-year collaboration that is expected to produce breakthrough results in this field.
Stéphane Bette, Co-Founder and Deputy CEO of SpineGuardsaid: “We are excited to launch this partnership that will enable us to go even further in improving surgical robots in orthopedics. This new phase of the project aims to enable robots to perform bone drilling and cutting as well as implant placement in the human skeleton in a safe and more autonomous manner. Our goal is to implement a first-class collaboration between French research and industry and to launch commercial ventures in the orthopedic field through strategic agreements with industrial partners.”
Guillaume Morel, Professor at Sorbonne University and ISIR Director, and Brahim Tamadazte, Researcher at CNRS and member of ISIR, added: “We are pleased to continue the close and dynamic collaboration with SpineGuard that started in 2017. The arrival of robotics and the new technologies associated with it in the operating room is undoubtedly one of the greatest medical advances of the last twenty years. Robotic approaches often enable less invasive, more accurate, safer, and more intuitive surgical gestures in many surgical procedures. The first results of the previous collaboration gave us more insight into the clinical added value that a robot with original and effective sensors can bring to orthopedic surgery in general and the spine in particular. This new collaboration is about ultrasonic sensors combined with robotics. This original and promising association will allow the surgeon to accurately and non-invasively define the entry point and trajectory of the pedicle screw without having to rely on ionizing or expensive preoperative imaging (scanner, MRI). The merger of two prestigious laboratories from the Sorbonne University (ISIR and LIB), whose skills highly complement SpineGuard’s industrial vision, creates a stimulating work environment conducive to innovation. The journey with SpineGuard continues for three more years with the aim of developing several technological and scientific innovations for patients and caregivers.”
Quentin Grimal, Professor at the Sorbonne University and leader of the Ultrasound and Imaging for Bone Quality Characterization team at the LIBcloses: “The use of ultrasound to position a surgical instrument is particularly relevant. Ultrasound is harmless and provides real-time information about interfaces, bone anatomy and even bone mechanical quality. Using an ultrasound probe should allow the robotic arm to be optimally positioned to place pedicle screws. In general, echography does not allow looking beyond the bone surfaces because ultrasound is highly reflected at the surface and greatly attenuated as it propagates through the bone. However, low amplitude signals coming from inside the bone can be exploited through specific treatments that are a specialty of our team. A pioneer in the use of ultrasound to examine bone, our team has introduced several approaches that offer an alternative to X-rays for characterizing trabecular or cortical bone health. For our team, this partnership with SpineGuard and ISIR is a great fit: it will accelerate the development of methods and tools for a broader use of ultrasound in orthopedic surgery. We are very pleased to be part of this innovative project.”
Founded in 2009 in France and the US by Pierre Jérôme and Stéphane Bette, SpineGuard is an innovative company that uses its proprietary real-time non-radiation sensor 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 90,000 surgical procedures worldwide. Nineteen studies published in peer-reviewed scientific journals have demonstrated the multiple benefits that DSG® offers patients, surgeons, OR staff and hospitals. Building on these strong foundations and multiple strategic partnerships, SpineGuard has expanded the scope of its DSG® technology to 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, MD, Ph.D., and Alain Vanquaethem, Biomedical Engineer. SpineGuard has been involved in several ESG initiatives.
For more information, see www.spineguard.com
ISIR is one of the largest French research organizations in robotics and intelligent systems and reports mainly to the Sorbonne University, the CNRS (National Center for Scientific Research) and the Inserm (National Institute for Health and Medical Research). It brings together more than 50 teaching researchers and permanent researchers, as well as about 80 doctoral and post-doctoral students. ISIR is structured around 6 research teams focused on Artificial Intelligence and Machine Learning, Mobile Robotics, Small Robotics, Assistive Robotics (Physiotherapy and Mobility Assistance), Human-Robot Interaction and Surgical Gesture Assistance. ISIR has extensive know-how in the development of innovative robotic architectures, simulation and control, clinical validation and transfer of results with high industrial potential. In the past 5 years, 10 preclinical or clinical studies have been carried out at ISIR. 8 patents were granted and 2 start-up companies founded.
The Laboratory for Biomedical Imaging (LIB) specializes in basic and applied research for biomedical morphological imaging methods, functional and molecular in small animals and humans. It reports to the Sorbonne University, the CNRS and the INSERM. It brings together 35 permanent researchers and teaching researchers, half of whom are also hospital practitioners, about 10 engineers and technicians and more than 30 doctoral and post-doctoral students. LIB is structured around 6 teams whose focus corresponds to 21 key prioritiesSt Century Public Health: cancer, cardiovascular and neurological diseases, bone quality. LIB develops new diagnostic and treatment methods using different modalities: Ultrasound, MRI, CT, SPECT-PET, etc. LIB is strongly committed to technology transfer. In the last 5 years, 6 patents have been granted, 7 software registered and 5 startup companies founded.
SpineGuard’s securities may not be offered or sold in the United States because they have not been and will not be registered under the Securities Act or the securities laws of the United States, and SpineGuard does not intend to make a public offering of its securities in the United States . This is an announcement, not a prospectus, and the information contained herein does not constitute an offer to sell or a solicitation of an offer to buy, nor will any sale of the securities referred to herein be made in the United States where such offer, solicitation or such sale would be unlawful prior to registration or exemption from registration.