Unika Medical Centre Becomes First in North America to Offer Non-Invasive BackPain Treatment with Neurolyser XR

FUSMobile, Inc. is proud to announce that Unika Medical Centre, in collaboration with

the Premier Pain Institute of Toronto, has become the first clinical site in North America

to commercially implement the Neurolyser XR system for the non-invasive treatment of

low back pain. Under the leadership of Dr. Gofeld, Unika Medical Centre has

transitioned from a key clinical research site to the first commercial provider of this

cutting-edge technology.

The Neurolyser XR is a first-of-its-kind device that uses high-intensity focused

ultrasound (HIFU) to non-invasively ablate sensory nerves within the facet

joints—structures that are a leading source of chronic low back pain affecting hundreds

of thousands of adults. Prior to the introduction of Neurolyser XR, standard treatments

were limited to opioid medications, spinal injections, or invasive surgical procedures.

“Patients now have a truly non-invasive alternative,” said Dr. Gofeld. “With Neurolyser

XR, we can offer long-lasting pain relief in under 30 minutes, without the risks

associated with injections or surgery.”

Dr. Arik Hananel, co-founder of FUSMobile, added, “The adoption of focused ultrasound

is accelerating globally, and we believe it is poised to become the new standard of care

across multiple clinical areas.”

FUSMobile has spent the past eleven years developing the Neurolyser XR system. The

device is currently:

 Licensed by Health Canada

 CE Marked for the EU in conformity with the Medical Device Regulation (EU)

2017/745

 Registered in the UK

 FOR INVESTIGATIONAL USE ONLY IN THE UNITED STATES. The company

has also filed for FDA clearance in the United States and is optimistic about a

future U.S. launch.

We take pride in our first regulatory approvals and continue to work diligently to

advance the Neurolyser platform in other markets while seeking additional clinical

indications and regulatory approvals. What was once the realm of science fiction is now

a clinical reality,” said Ron Aginsky, co-founder of FUSMobile. 

About FUSMobile

Founded in 2014 by Dr. Arik Hananel and Ron Aginsky, FUSMobile is dedicated to

developing non-invasive, high-precision therapies for the treatment of chronic pain. In

response to the global rise in musculoskeletal conditions and the aging population,

FUSMobile aims to transform pain care through innovative technology. Dr. Hananel, a

pioneer in focused ultrasound and former Scientific and Medical Director at the Focused

Ultrasound Foundation, envisioned the Neurolyser XR as a faster, safer alternative to

conventional treatments. “With the introduction of the Neurolyser XR, FUSMobile

provides interventional pain physicians an innovative HIFU device that until now was

costly and available only to interventional radiologists and neurosurgeons,” said Mr.

Aginsky. 

“If a condition can be treated non-invasively, it should be,” said Dr. Hananel—a guiding

principle that defines the company’s mission.

About Unika Medical Centre and Dr. Michael Gofeld

Unika Medical Centre is a multidisciplinary clinic specializing in the assessment,

diagnosis, and treatment of chronic pain, spinal and musculoskeletal disorders, and

sports injuries. The clinic integrates advanced technologies, evidence-based

assessments, in-depth clinical evaluations, and state-of-the-art imaging to deliver

accurate and individualized patient care. For more information, visit unikamed.com.

Dr. Michael Gofeld is an internationally recognized expert in interventional pain

medicine and has played a pivotal role in the clinical development and validation of the

Neurolyser XR system.

MEDIA CONTACT

For more information, please contact Bruce Taylor, NRP. Bruce@FUSMobile.com TEL:

954-228-5782