- FUSMobile’s first clinical trial in the US will assess the safety and efficacy of its NeurolyserXR focused ultrasound device to treat chronic low back pain.
- Up to 90 participants will be enrolled at ten sites across the US.
- The NeurolyserXR is a portable system designed to noninvasively heat and destroy target tissue under x-ray guidance.
FUSMobile has launched its first clinical trial in the US investigating its NeurolyserXR focused ultrasound device for chronic low back pain. This pivotal trial will assess the safety and efficacy of the treatment, the latter as measured on a numerical pain rating scale.
The NeurolyserXR is a portable, noninvasive treatment system designed to heat and destroy neural tissue associated with chronic low back pain and other conditions, such as knee and hip arthritis. The treatment is performed using therapeutic ultrasound under x-ray guidance.
In this pivotal trial, up to 90 participants with diagnosed facet-related low back pain will be treated at ten sites mainly across the East Coast. To date, four of those sites – located in Georgia, New York, North Carolina, and Virginia – are currently recruiting patients, and the other sites expect to begin enrolling in the coming months.
The study is a double-blinded design to assess and eliminate any placebo effects. Participants will be randomly assigned to either the procedure group or a sham group unbeknownst to the patient. Those in the sham group will undergo a procedure, but no actual treatment will be administered. After an observation period of one to three months, participants whose symptoms have not improved would be offered the opportunity to cross over.
Last year, the results of the company’s pilot trial in Canada were published in Pain Medicine and suggested the procedure is safe and well-tolerated. The Foundation funded a portion of the initial safety study, and the trial has since been expanded and is treating additional patients in Canada. The company has a third ongoing clinical trial in Haifa, Israel.
FUSMobile was founded by the Foundation’s previous Medical Director, Arik Hananel, MD, MBA, and Ron Aginsky, LLB, MBA, a management executive with extensive experience in medical device business development, sales, and marketing.
“Our goal at FUSMobile is to offer focused ultrasound devices at various points of care that are highly efficient and cost effective,” said Mr. Aginsky.
“This pivotal trial is a big step toward realizing our vision of improving the lives of those suffering with chronic pain by eliminating the need for invasive method and reducing the use of opioids or other medications,” Dr. Hananel added.
If you are interested in learning more about the US clinical trial, it is listed in clinicaltrials.gov.
The following sites are now actively enrolling participants.
The Physicians Spine and Rehabilitation Specialist of GA | Atlanta, Georgia
Contact: Anna Armstrong | (404) 574-1547, ext. 2020 or email@example.com
Ainsworth Institute of Pain Management | New York, New York
Contact: Sofia Rosenberg | (212) 203-2813 or firstname.lastname@example.org
Center for Clinical Research | Winston-Salem, North Carolina
Contact: Brooke Marsh | (336) 765-6181, ext. 282 or email@example.com
Gershon Pain Specialists | Virginia Beach, Virginia
Contact: Steve Gershon, MD | (757) 496-2050 or firstname.lastname@example.org