Montreal, Canada – January 30, 2006
Resonant Medical Inc. announced today that it has received a full Health Canada Medical Device license to commercialize RESTITU™, its 3D ultrasound image-guided radiotherapy platform. Resonant is making the RESTITU™ Platform immediately available to Canadian cancer clinics who wish to use it to improve the quality of external beam radiation therapy.
The RESTITU™ Platform is already being used by nearly 20% of all radiation oncology centres in Canada under investigational protocols to perform cutting edge clinical research on prostate cancer as well as head and neck cancer. "This regulatory approval now allows those early adopters to go clinical with RESTITU™ and gives all other Canadian centres the opportunity to deliver the benefits of accurate 3D ultrasound image-guided radiotherapy to their patients", commented CEO Frédéric Francis.
The RESTITU™ Platform is designed to increase the accuracy and reduce the side effects of radiation therapy, resulting in improved quality of life for cancer patients as well as enhanced productivity of cancer centres. Its proprietary 3D ultrasound technology allows clinicians to target tumors more accurately while safeguarding surrounding healthy tissues. Using RESTITU™, radiation oncologists and medical physicists can now successfully visualize, analyze and correct for daily changes in tumour position, shape and volume. RESTITU™ enables them to achieve the level of confidence required to plan and deliver today's ever more conformal radiotherapy treatments such as IMRT.
This license is predicated on the ISO 13485 certification received by the company in early 2005. "This acknowledges Resonant's commitment to delivering the highest quality medical products and services to theoncology community", explained COO Luc Sirois. Health Canada licensing and ISO 13485 certification requirestrict adherence to standards which are among the highest of any industry.
"Our goal is to have RESTITU™ enable fundamental improvements in radiotherapy planning and delivery. This milestone is Resonant's first opportunity to help physicians, medical physicists and therapists improve the treatment of Canadian cancer patients", adds CTO Dr. Tony Falco. "We will endeavor to continue developingrobust and accurate image-guidance for Canadian healthcare providers."
About Restitu™: The Restitu™ Platform accurately visualizes and corrects daily changes in tumor position, shape and size, thus ushering in a new era of 3D ultrasound (U/S) multimodality radiotherapy treatment planning and image guidance. Installed in CT-Sim rooms, Restitu U/S Sim allows for better definition of planning tumor volumes with its patented IMPLICIT REGISTRATION™ technology that automatically fuses 3D U/S to CT data. With U/S-Sim, multimodality treatment planning has now been made possible and affordable for all clinics, with or without PET or MRI. Installed in treatment rooms, Restitu U/S Guide allows for highly accurate patient position verification and alignment, with its proprietary MUTUAL REFERENCING™ technology that uses assisted segmentation for efficient and robust intramodality 3D U/S image-guidance.
About Resonant Medical
Resonant Medical (Montreal, Canada) develops, manufactures and commercializes 3D ultrasound image-guided adaptive radiotherapy products. Originally developed at McGill University Health Center, Resonant's technologies are available in more than 50 cancer centers in the U.S., Canada and Europe, helping cancer centers make significant improvements in radiation therapy planning, verification and delivery--advancing patient care.
For more information, please contact:
Michèle Jémus
Chief Financial Officer
Resonant Medical
M.: 514.518-0449
T.: 514-985-2442 x 270
F.: 514.985-9662
mjemus@resonantmedical.com