SPINEGUARD - Make spine surgery safer  
PediGuard
Welcome to SpineGuard’s temporary website. Our expanded website will be available in the coming months.

For any questions or comments about our company or products, please contact us at contact@spineguard.com

Pierre Jerome and Stephane Bette
SpineGuard™ Co-Founders
Mission
SpineGuard’s mission is to MAKE SPINE SURGERY SAFER.

Vision
The primary objective of SpineGuard is to establish PediGuard® as the STANDARD OF CARE FOR SAFER PEDICLE SCREW PLACEMENT to the benefit of patients, surgeons and health care providers as well as the shareholders, employees and partners of SpineGuard.

Secondarily, SpineGuard is exploring other applications for the PediGuard technology platform provided that they are in line with the SpineGuard mission.

Genesis
SpineGuard was founded in 2009 by Pierre JEROME and Stephane BETTE.

The founders established SpineGuard on the premise that the patented PediGuard® technology platform deserves the full focus of the Team to make the most of its clinical, technological and market potential. Close to 1 million procedures using pedicle screws were performed in 2008 (I-Data Research US, Europe & Asia Pacific Spine reports) and this number will continue to increase in the coming years. This increase will be driven by the growing number of patients requiring surgical treatment, a larger number of surgeons being trained in technologies requiring pedicle screws and substantial technological advancements (i.e. Minimally Invasive Surgery, Bone Substitutes, Dynamic Stabilization, etc.). Yet even today, publications show high rates (10 to 40%) of screw misplacements leading to various degrees of complications[1-5]. Pedicle screw placement is more than ever the number one safety challenge in spine surgery. With over 8,000 procedures performed since PediGuard®’s introduction in more than 25 countries and with initial results of U.S. and European multi-centric clinical studies confirming its potential, the PediGuard® is emerging as the most compelling answer to this clinical need.

The founders of SpineGuard have years of experience and a proven track record in spine as former executives at Sofamor-Danek and SpineVision. With the support of Aelios Finance, they managed to raise $15 million in the midst of the recent financial turmoil from four venture capital investors namely C.A.P.E., Innoven Partenaires, A Plus Finance and Delta Partners to acquire the PediGuard® technology from SpineVision and finance the development of SpineGuard. A substantial portion of these funds will be invested in clinical studies, training, marketing and R&D to allow more spine surgeons throughout the world to use PediGuard® and more patients to benefit from safer spine stabilizations.

pdf SpineGuard raises $11 million and acquires PediGuard® business unit from SpineVision

pdf SpineGuard raises $4 million from Delta Partners, and elects two new directors: Maurice Bourlion and Dr. Joe Mason

Pierre and Stéphane have assembled a Team of 15 talented individuals divided between San Francisco and Paris, all with solid experience in the spine industry. The original inventors of PediGuard®, Ciaran Bolger, MD PhD and Maurice Bourlion, PhD are part of the endeavor as well as Randy Betz, MD, leader of SpineGuard’s international clinical study group.

Headquarters
SpineGuard, S.A.
5-7, rue de l’Amiral Courbet 94160 St Mandé, FRANCE
+33 1.45.18.45.19

SpineGuard, Inc.
301 Howard Street, Suite 970 - San Francisco CA 94105, USA
+1 415.512.2500

PediGuard®
Overcome the challenges of pedicle screw placement...
Pedicle screw-based stabilization has become the gold standard to treat spine instabilities and deformations. This market is growing at a double digit rate due to the increasing number of patients requiring surgical treatment and a larger number of surgeons being trained in pedicle screw-based technologies. In addition, numerous technological advancements are being proposed, such as Minimally Invasive Surgery, Bone Substitutes, Dynamic Stabilization and the placement of screws in the thoracic spine.

Accuracy of pedicle screw placement is a critical issue in spine surgery: published rates of intraoperatively ‘misplaced’ screws range from 10 to 40 percent[1-5], some of which result in pathological consequences such as spinal cord damage[3]. Consequently, liability risks for spine surgeons are high.

pdf Making spine surgery safer for patients and doctors

PediGuard® is the first and only handheld, wireless device that can detect possible cortex perforation during pedicle preparation for screw placement. PediGuard® can alert the surgeon prior to a breach by accurately analyzing the electrical conductivity of the surrounding tissues in real time via audio and visual signals.

PediGuard Electromagnetic Sensor Monitors Real Time Changes In Electrical Conductivity

How PediGuard® Works
The scientific principle behind PediGuard® is based on the analysis of the tissue’s electrical conductivity (property of a material to allow current to flow). When the electrical conductivity of the tissue at the tip of the PediGuard® changes, the surgeon is alerted by changes of:
• Sound pitch and cadence
• Flashing LED cadence

PediGuard

PediGuard® advantages and benefits:
PediGuard Powerful Detection
"Cortical bone, cancellous bone and soft tissues are differentiated
Even small breaches can be detected (99% accurate[7])
True real-time monitoring: immediate alert of impending vertebral pedicle breach
Works on all spine levels (lumbar, thoracic & cervical)

Key Benefits
Reduction of pedicle breach risk and revision
rate[6]
Less Radiation Exposure (up to 30% less[6])
Time and cost saving[6]
Decrease the resident’s surgical learning curve

Ease of Use
No change in surgical procedure
Brief learning curve
No Capital Equipment required
No additional personnel needed
No Anesthesia limitations (unlike EMG)

PediGuard
The PediGuard® technology is effective in Minimally Invasive Surgery.
PediGuard

Main PediGuard® Publications
Betz RR, Samdani AF, Djurasovic M, Bailey SI, Brown C, Asghar J, D'Andrea LP, Dimar J, Shufflebarger HL, Gaughan J: PediGuard, a solution for the challenges of pedicle screw placement. Temple Univ J Orthop Surg Sports Med 3:18-22, 2008.

Bolger C, Kelleher MO, McEvoy L, Brayda-Bruno M, Kaelin A, Lazennec JY, Le Huec JC, Logroscino C, Mata P, Moreta P, Saillant G, Zeller R: Electrical conductivity measurement: a new technique to detect iatrogenic initial pedicle perforation. Eur Spine J 16(11):1919-1924, 2007.

Bolger C, Bourlion M: Pedicle navigation in spondylolisthesis, ch. 28, In: Gunzburg R, Szpalski M: Spondylolysis, Spondylolisthesis and Degenerative Spondylolisthesis, Lippincott Williams & Wilkins, 2006.

Bolger C, Carozzo C, Roger T, McEvoy L, Nagaria J, Vanacker G, Bourlion M: A preliminary study of impedance measurement to detect iatrogenic initial pedicle perforation (in the porcine model): Eur Spine J 15: 316-320, 2006.



Bibliography

1. Spinal Pedicle Fixation: Reliability and Validity of Roentgenogram-Based Assessment and Surgical Factors on Successful Screw Placement, Weinstein et al., Spine V13-N19. 1988.
2. Accuracy of Pedicle Screw Placement In Lumbar Vertebrae, Castro et al., Spine, V21-N11, 1996
3. Neurophysiological Monitoring during Pedicle Screw Placement, Toleikis et al., Neurophysiology in Neurosurgery: A modem Intraoperative Approach (2002)
4. Accuracy of Pedicle Screw Insertion with and without Computer Assistance: a Randomised Controlled Clinical Study in 100 Consecutive Patients, Laine et al., Eurospine Journal, 9(3): 235-40 (2000) discussion 241.
5. Pedicle Screw Placement Accuracy – A Meta-analysis, Kosmopoulos et al., Spine, V32-N3, 2007
6. PediGuard™: A Solution for the Challenges of pedicle Screw Placement, Randal R. Betz, MD, Amer F. Samdani, MD, Mladen Djurasovic, MD, Stewart I. Bailey, MD, Courtney Brown, MD, JahanGir Asghar, MD, Linda P. D’Andrea, MD, John Dimar, MD, Harry L. Shufflebarger, MD, John Gaughan, PhD, Temple University Journal. Volume 3. Spring 2008
7. Electrical Conductivity Measurement : a new technique to detect iatrogenic initial pedicle perforation, C. Bolger, M. O. PeKelleher, L. McEvoy, M. Brayda-Bruno, A. Kaelin, J-Y Lazennec, J-C Le Huec, C. Logroscino, P. Mata, P. Moreta, G. Saillant, R. Zeller, European Spine Journal, Vol 16, June 2007
8. A preliminary study of reliability of impedance measurement to detect iatrogenic initial pedicle perforation (in the porcine model), Ciaran Bolger, C. Carozzo, T. Roger, Linda McEvoy, Jabir Nagaria, Gérard Vanacker and Maurice Bourlion, European Spine Journal, Vol 15, March 2006
9. Pedicle screw placement in spinal surgery at lumbar level : interest of guidance by conductivity measurement in the placement of 104 pedicle screws, J.F. Bocquet, PhD Thesis, University Hospital of Rennes, France, May2005
10. Pedicle navigation in spondylolisthesis, C. Bolger and M. Bourlion, in Spondylolysis, Spondylolisthesis, and Degenerative Spondylolisthesis, Robert Gunzburg MD, PhD; Marek Szpalski MD, Chapter 28. ISBN: 0-7817-7633-3, Nov 2005,
11. The innovative new hand-held pedicle drilling tool – A new help for pedicle screw insertion, a report by Pr. André Kaelin, Touch Briefing Global Surgery – Future Directions 2005,
12. PediGuard – A new standard of care in pedicle screw placement, a report by Pr. Ciaran Bolger, Touch Briefing Global Surgery – Future Directions 2005.

The information on this website is provided for informational purposes only. Please see the package insert for labeling limitations, intended uses, relevant warnings, precautions, side effects and contraindications. Caution: Federal (USA) law restricts the sale and use of this device to a prescription of a physician.

© 2009 SpineGuard S.A. All rights reserved. SG