SpineGuard Receives Regulatory Clearance to Sell Its PediGuard® Platform in
“We are very proud to have achieved the regulatory clearance process in Russia
for SpineGuard, and we are excited to be partnering with SpineGuard to make
spine surgery safer throughout Russia.”
Alexey N. Ishchenko, Ph.D.
SAN FRANCISCO & PARIS -- February 26, 2013
SpineGuard announced today that it has received regulatory approval from the
Roszdravnadzor, the Russian healthcare agency that oversees medical devices,
to market PediGuard in Russia.
SpineGuard further announced that it is partnering with Moscow-based
Multi-Systems Technology (“MST”) to sell PediGuard in Russia. MST has an
extensive network of 53 distributors across Russia - from Kaliningrad in the
west across seven time zones to Khabarovsk in the Russian Far East. MST
specializes in products for neurosurgery, spine surgery, trauma and
“This regulatory clearance is the result of a very effective collaboration
with MST, which is promising for the adoption of PediGuard in Russia,” said
Pierre Jérôme, Co-founder and Chief Executive Officer of SpineGuard. “I am of
course delighted that Russian spine surgeons and their patients can now
benefit from PediGuard, whose value in pedicle screw placement accuracy has
been dramatically demonstrated in several peer-reviewed medical journals.”
PediGuard® has been used in more than 24,000 procedures in over 40 countries.
There are approximately 300 spine surgeons who are now using PediGuard on a
Co-founded in 2009 by Pierre Jérôme and Stéphane Bette, former executives at
Medtronic Sofamor-Danek and SpineVision, SpineGuard’s mission is to make spine
surgery safer. For further information, visit www.spineguard.com.
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108
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