Press release

Synaptive Medical Presented Mid-Field MRI Safety Data for Medical Device Implants at the 57th American Society of Neuroradiology (ASNR) 2019 Annual Meeting

Sponsored by Businesswire

Synaptive Medical, a global pioneer in automated surgical planning and
robotics, announced today that the Company presented new findings
related to its mid-field MRI system research and design at the 57th
American Society of Neuroradiology (ASNR) Annual Meeting at the Hynes
Convention Center in Boston, MA from May 18 – 23. The oral presentation
of the Company’s abstract, titled, “Increasing MRI Safety for Patients
with Implanted Medical Devices: Comparisons of a 0.5 T Head-Only MRI to
1.5 T and 3 T,” took place at 5:33 p.m. EDT on Monday, May 20, during
the meeting’s Artificial Intelligence (AI)/Advanced Imaging in the Spine
and Brain session.

The presentation highlighted the potential for improved safety of an MRI
scanner outfitted with a magnet operating at mid-field strength—0.5
Tesla (T)—relative to conventional 1.5 T MRI scanners in patients with
medical device implants. Implants with neuro-stimulator leads can cause
dangerous levels of heating to surrounding tissue when exposed to the
external radio-frequency fields produced by MRI systems, which relegates
some patients to scans of low quality, long duration or may prevent
patients from receiving necessary scans altogether. To investigate
whether a mid-field MRI scanner may cause relatively diminished tissue
heating within range as deemed safe for such patients, a study conducted
by Synaptive compared local specific absorption rate (SAR) of metal
rods—a measure used to infer the extent of implant-proximal tissue
heating—embedded in a phantom non-conducting mass to simulate a human

MR image results demonstrated that when compared to conventional 1.5 T
and even to 3.0 T MRI systems, mid-field 0.5 T systems produced a lower
maximum SAR in the metal rods, which may correspond to levels of patient
tissue heating that lie within accepted MR safety standards.
Importantly, due to recent advances in the quality of mid-field
technology, the images exhibit high quality to display diagnostically
relevant information in the context of patient scans. Together, these
results indicate that moving forward with patient studies in the context
of mid-field MRI may be warranted.

The study results presented pertain to Synaptive’s mid-field, head-only
MRI system called EvryTM, which is expected to be launched in
Canada later this year. Designed to include a magnet operating at 0.5 T
field strength, as well as high-performance system components like
powerful gradients and a custom head coil, Evry is expected to target
point-of-care installation outside of hospital imaging departments to
provide scans for cases that require immediate evaluation, such as acute

“Regardless of the urgency, medical device implants have long posed
serious risks for patients requiring MRI scans,” said Cameron Piron,
President and Chief Strategy Officer of Synaptive. “At Synaptive, we
believe we must exercise due diligence in identifying the parameters of
MRI, an irreplaceable diagnostic tool, that will work for everyone,
particularly in urgent care settings. The technology we used to design
Evry not only holds the potential to add critical functionality to
emergency neurological cases, but we hope it will prove to be accessible
for the first time to a historically excluded patient population.”

“As with any visualization technology, we must ask ourselves what
consequences collecting an anatomical image may have on patients,” said
Ian Connell, MRI Scientist at Synaptive. “I hope these promising results
will be reproduced in patient studies. Historically, we’ve had to
sacrifice image utility for patients with certain implants, but
mid-field MRI has come a long way to the point where, very soon, we may
be able to offer the capability to make critical diagnostic decisions
using magnetic fields that are safe around implants.”

About Synaptive Medical

Synaptive Medical Inc., a Toronto-based medical device and technology
company, designs hardware and software technologies that cross
traditional barriers in hospitals and improve patient care in and beyond
the operating room. Synaptive’s Modus V™ and integrated BrightMatter™
solutions—including surgical planning, navigation and visualization, and
an informatics platform—give leading clinicians and healthcare systems
the information they need to ensure the best possible outcomes for