Regulatory News:
SpineGuard (FR0011464452 – ALSGD), an innovative company
that deploys its DSG® (Dynamic Surgical Guidance) unique sensing
technology using electrical conductivity local measurement in real
time to secure and streamline the placement of bone implants, today
announces having reached 100,000 surgeries secured with the DSG
technology and having passed 30 scientific publications.
Pierre Jérôme, Chairman, CEO and co-founder of
SpineGuard, said: "Reaching these symbolic thresholds is a
great pride for the whole SpineGuard team. It reminds us that so
many patients suffering from back pain have already benefited from
the accuracy of our real time surgical guidance platform and that
we enable numerous surgical teams across the globe to significantly
reduce their radiation exposure and associated risks in using it
routinely. The clinico-economic value of DSG now leans on 32
scientific studies in a large spectrum of applications. I wish to
warmly thank all those who accompany us in this wonderful
adventure: all the surgeons who trust our DSG technology, our
shareholders, the inventors of DSG, our advisors, as well as our
industry and commercial partners. Nonetheless, it is only a step in
the development of the Company. We are implementing our roadmap, as
presented during our recent capital increase, to get back to
double-digit growth this year, fueled by our new US sales
organization and the successive launches of three new
products."
Randal R. Betz M.D., Pediatric Spine Specialist, Institute
for Spine and Scoliosis, Lawrenceville, NJ and Head of the
Scientific Advisory Board (SAB) of SpineGuard since its
inception, added: “This is a great milestone not only for the
Company but for the hundred thousand patients who have benefited
from safer surgery avoiding neurologic injury and from less
radiation. Kudos to Pierre Jérôme and Stéphane Bette for their
top-level leadership and staying the course using DSG in newer ways
to keep advancing spine surgery. With robotic assistance becoming
adopted by many spine surgeons, the combination with real time
feedback provided by DSG will drive further acceptance and trust in
robotically assisted surgery.”
In 2023, eight new studies about DSG have been published in
peer-reviewed scientific journals including three on surgical
robotic work and five on non-sponsored clinical studies
highlighting DSG strong benefits in various spine surgery
indications via anterior and posterior approach. This brings to
thirty-two the total number of scientific publications
demonstrating DSG’s technology value, which represents a
significant acceleration compared to previous years. Below are the
eight recently published articles:
Saghbiny et al - Protocol for Electrical Conductivity Signal
Collection and Processing in Scoliosis Surgery. This French
study establishes a protocol to collect electrical conductivity
signals in spine surgery with synchronization to the depth of the
instrument. Real-time conductivity signal feedback alerts the
surgeon of a probable breach in the spinal canal, allowing for a
change of direction/trajectory within the pedicle.
Leblanc et al - Automatic Spinal Canal Breach Detection
During Pedicle Screw Placement. The results in this other
French study demonstrated that the specialized algorithm could
predict perforations and prevent the robotic setup from causing an
unwanted breakthrough in 100% of 24 drilled vertebrae. In addition,
this proved that using electrical conductivity combined with a
robotic setup allowed for the detection of imminent perforations of
the spinal canal during pedicle drilling.
Timmermans et al - State-of-the-Art of Non-Radiative,
Non-Visual Spine Sensing with a Focus on Sensing Forces, Vibrations
and Bioelectrical Properties: A Systematic Review. This
systematic review from a Belgium team explores the current state of
non-visual, non-radiative spine sensing for robotic spine surgery,
with a focus on enhancing surgical techniques and automation. This
review emphasizes the shift towards achieving surgeon-like
autonomous behavior and surgical accuracy in robotics, and the need
to go beyond traditional engineering precision. The review also
identifies the 6DOF f/t sensor, microphone and electrical
conductivity measurement as commonly used sensors, highlighting
their respective characteristics.
- Anterior/Vertebral Body Tethering (VBT) scoliosis
treatment
Da Paz, Trobisch & Baroncini - The Use of Electronic
Conductivity Devices Can Effectively Reduce Radiation Exposure in
Vertebral Body Tethering. This German team noted that they
reduced intro-operative radiation by 41% thanks to the use of
Electrical Conductivity Local Measurement.
Courvoisier et al - Vertebral Body Tethering in Adolescent
Idiopathic Scoliosis Management – A Preliminary Report. This
French team indicated that in their study, Electrical Conductivity
Local Measurement proved to be helpful to secure screw precise
trajectory without adding intra-operative radiation.
- Posterior scoliosis multi-modality comparison
treatment
Kudo et al - Accuracy of Pedicle Screw Placement by
Fluoroscopy, a Three‑Dimensional Printed Model, Local Electrical
Conductivity Measurement Device, and Intraoperative Computed
Tomography Navigation in Scoliosis Patients. This Japanese
study incorporating several modalities for screw placement
assistance concluded that electrical conductivity local measurement
is useful to prevent perforations.
- Novice & experienced surgeon comparison
Bhogal et al - Bone Conductivity and Spine Fluoroscopy,
Hand‑Eye‑Ear Dialogue, during Pedicle Screw Positioning: a New
Human Cognitive System for Precision and Radiation‑Decrease; Better
than Artificial Intelligence and Machine Learning System? This
single center Belgium study involved two surgeons - one novice and
one experienced. The novice surgeon in this study showed a 50%
reduction of fluoroscopy radiation usage (in time measurements)
when using electrical conductivity local measurement.
- Cervicothoracic treatment
Santos et al - Accuracy and safety of 3D Printed Surgical
Guides Combined with Monitored Guidewires for Placement of
Cervicothoracic Pedicle Screws: Technical Note. This Portuguese
study demonstrated that electrical conductivity local measurement
provided the investigator with additional assurance of an
intra-osseus trajectory. The authors mentioned that the safety and
real-time feedback of electrical conductivity local measurement may
also assist with preventing neuro-vascular injuries if one of the
3D printed guides was flawed or incorrectly adapted to the
vertebra.
Stéphane Bette, Deputy CEO and co-founder of SpineGuard,
concluded: “Our DSG technology shines particularly in two new
fast-growing applications where it has no equivalent. In anterior
approach surgery, it is not easy to use Navigation or Robotics
because of a deep wound in quite mobile regions, which limits the
precision of these technologies. As for Neuromonitoring, it is of
limited use in the thoracic segments. Besides, we have the only
real-time feedback technology direct from the tissues at the tip of
the effector, that has demonstrated its efficacy and can be
seamlessly embedded into surgical assistance platforms."
Perspectives
Backed by these factors and in order to get back to double digit
growth from 2024 onwards, SpineGuard is intensifying its commercial
efforts, in particular in the United States, and will be
introducing three new products derived from its DSG technology:
- PediGuard Threaded adapted to scoliosis correction via anterior
approach;
- Cannulated PediGuard for sacroiliac fusion in collaboration
with Omnia Medical; and
- DSG Drill Bit compatible with power drills and navigation.
In parallel, the Company is actively working on obtaining the
clearance of the whole PediGuard product range in China and seeking
partners for dental implantology and surgical robotics.
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
32 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240206130924/en/
SpineGuard Pierre Jérôme CEO & Chairman Tel: +33 1 45
18 45 19 p.jerome@spineguard.com
SpineGuard Anne-Charlotte Millard CFO Tel.: +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
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