Feature

SpineGuard unveils latest results for real-time digital guidance in orthopedic surgical robotics

French robotics technology delivers sub-millimeter precision identifying bone margins, automatically avoiding drilling into vertebra. By​​​​​​​ Bernard Banga.

Credit: Shutterstock/Ilya Lukichev

SpineGuard SA has unveiled the latest results for its real-time Dynamic Surgical Guidance system (DSG) used in robot-assisted surgery. A team of French research specialists from the Institute for Intelligent Systems and Robotics (ISIR) showcased their work at the 12th Conference on New Technologies for Computer and Robot Assisted Surgery (CRAS), held late September at Sorbonne University Pierre and Marie Curie Campus in Paris, France. “Having the scientific paper accepted at a renowned conference further validates the value and feasibility of improving orthopedic surgical robot functionality using DSG, as recognized by the scientific community,” Stephane Bette, co-founder and deputy managing director of SpineGuard SA, told Medical Device Network.

Positioning pedicle screws: the weak spot in spinal column surgery

Set up in 2009 by Pierre Jerome and Stephane Bette, Paris-based SpineGuard SA developed Dynamic Surgical Guidance (DSG) technology, able to alert surgeons in real time to potential pedicle problems. Although anchoring with pedicle screws has become the gold standard in spinal column surgery, “20% of pedicle screws are fitted poorly, leading to neurological complications in 2% to 7% of cases, and vascular complications in 4% of cases,” said Pierre Jerome, SpineGuard chief executive. 

SpineGuard’s multi-patented technology relies on measuring electrical conductivity of tissue locally in real time, without using X-rays. This is accomplished using a sensor located at the tip of the drilling tool. This innovation improves the safety and ease of bone implant placement. Bette claims that “the reliability and sub-millimeter precision of our guidance technology have been demonstrated in more than 95,000 surgeries worldwide, and validated in 25 academic studies published in leading medical journals”.

I got funding for a very brave Siemens engineer, to come into the warzone and go around and repair and maintain all the equipment that they had.

Dr Stephen Kingsmore, President and CEO of Rady Children’s Institute for Genomic Medicine.

DSG for orthopedic robots

SpineGuard has been working alongside the Institute for Intelligent Systems and Robotics (ISIR) since 2017. ISIR is a Paris-based public research institute partnered with Sorbonne University, specializing in advanced research in robotics and intelligent systems. This partnership is part of the European project “Functionally Accurate Robotic Surgery” (FAROS). “The aim is to demonstrate scientifically that a robot, equipped with DSG technology, can consistently and automatically identify bone gaps during surgical drilling. This capability enables the robot to perform bone implant placement directly and independently,” claims Bette. 

“The experiment recently presented was designed to automatically halt the drilling process once the robot-guided tool approaches the bone margin during autonomous vertebral drilling. For greater realism and to demonstrate how effective DSG is, the trajectory mimicked the pedicular path. This trajectory included tangential configurations closely resembling clinical scenarios where precision is vital, such as avoiding the vertebral canal housing the spinal cord, and ensuring that the tool tip doesn’t make perpendicular contact with the bone surface,” explained Brahim Tamadazte, CNRS Research Director, ISIR member, and co-author of the paper.

100% success rate, unequivocal outcome

The detection algorithm was fine-tuned before the series of 50 drilling maneuvers, and no adjustment or calibration was necessary for any sample. “It’s important to note that the ex vivo validation model involved pig vertebrae sourced from a butcher and so did not involve animal sacrifice,” said Bette. 

The drilling maneuvers recorded a 100% success rate, meaning they were all halted within a corridor considered clinically safe. This corridor spans two millimeters either side of the interface between the bone and the spinal canal. To be precise, all drilling maneuvers fell within a range of -0.9 to +1.4 mm, with a mean distance of 0.7 mm. Remarkably, these results were attained even though the drilling was entirely blind, with no support from pre- or intra-operative imaging. 

Validating the experimental part of the study was awarded funding from the European Union’s Horizon 2020 research and innovation program.

Internal funding to support innovation and promote business expansion

SpineGuard, valued at $11.5 million on the Euronext Paris stock exchange as of October 3rd, is aiming to expand the scope of its DSG technology. The SpineGuard team, based in Paris and Boulder, Colorado, USA, has formed partnerships to broaden the applications for its DSG technology. These new ventures include the development of “smart” pedicle screws, the DSG Connect visualization and recording interface, advances in dental implantology, and contributions to surgical robotics. 

According to a recent analyst note from BioStrategic Partners SAS in Paris, SpineGuard boasts a healthy cash position of $3.8 million. However, to support its innovation projects and commercial expansion, particularly in the USA, SpineGuard is currently exploring the possibility of raising equity financing. This move aims to minimize dilution of its shares, which currently account for 96.1% of floating stock.