“FUSMobile has developed the Neurolyser platform as the only non-invasive treatment system optimized to destroy neural tissue associated with chronic low back pain (facet arthritis) and other conditions such as knee and hip arthritis.”
The technology uses X-ray guidance to direct multiple high intensity focused ultrasound beams from outside the body to a focal point. Once the acoustic energy converges at the target area, it generates localized heat to ablate the neural tissue, leaving skin and other tissue along the pathway intact.
“The proposed investigational use for the technology is designed to reduce the pain and eliminate the risk of infection or bleeding associated with more invasive procedures such as radiofrequency (RF) ablation, which is the current standard treatment.”
“Our vision and work started in 2014,” FUSMobile Co-Founder and President Ron Aginsky, LLB, MBA told us. “We took the lessons we learned from past endeavors with the desire to find a better way to introduce focused ultrasound for patients who suffer from pain. We believe with confidence that we have found that path.”
From a 2019 profile, “We successfully completed the first in human pilot study (10 patients) in Canada at two sites – McGill University in Montreal and Silver Medical Group, a private clinic in Toronto. The study was initiated by Dr. Jordi Perez at the Center of Innovative Medicine (CIM), which is part of McGill University, and was extended to include Dr. Michael Gofeld from Silver Medical Group.”
As of June 2022, clinical studies continue in Canada and Israel. First patient was already treated in the USA as part of an FDA IDE pivotal study.
What have Arik and Ron learned about regulatory bodies and pathways, funding strategies and partners in their experience, both legacy and recent?
Evidence of a massive shift in regulatory pathway and strategy
“A lot of innovators hear ‘U.S. FDA’ and start to shiver,” Ron said. “They shouldn’t. The FDA is a valuable resource. We have seen that ourselves. We were initially hesitant to engage the agency directly. But we have learned that if you engage them early and present your idea, they can shape your technology and regulatory pathway with you, along with providing valuable inputs on clinical study design. In retrospect, we should have approached them much earlier and communicated much more frequently than we have done.”
“Listen closely to what they have to say,” FUSMobile Co-Founder and CEO Arik Hananel, MD, MBA said. “We see, again and again, when we get stuck, we had received the relevant feedback previously, but just missed it. Listen, then implement. Every word they use or share has a meaning. They know what they want to see. They will not lower the threshold, but will do what they can to help you cross it.”
“Not long ago, CE mark achievement in Europe was almost always an easier market entry point,” Ron said. “That has changed to the point that today regulatory approval in Europe is much more difficult as the regulatory bodies there undergo a significant transformation. There is a great deal that is not known yet about practical interpretations of new regulations. This puts levels of limitations on companies’ abilities to provide the right information into European regulators’ hands that might make a United States first strategy much more attractive.”
Related: The FDA’s Total Lifecycle Advisory Program, set to soft launch in FY 2023, may bring a seismic shift in commercialization pathways and timelines.
From Medical Design and Outsourcing, “The long-term vision for a successful TPLC Advisory Program (TAP) is to help spur more rapid development as well as more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance,” the FDA said in the letter. “A mature TAP will also help ensure the sustained success of the breakthrough devices program.”
A significant feature of the TAP pilot is that it would offer “regular, solutions-focused engagement” between medical device developers and patients, healthcare providers and payers.
On funding: always ask more more than you think you need
Arik: “We have learned everything costs twice as planned and takes three times longer. Medical device development is much more capital intensive than an app or software. “
Ron: “Raise for what you want to do. Value that properly. Do your math. $500,000 will not get a pilot study done. Be transparent.”
Arik: “We funded our proof of concept and initial data sets ourselves. Friends and family helped fund early preclinical work needed to develop our first clinical prototype.
“More ‘professional’ investors including Atlanta Technology Angels and Orbimed Ventures got us through our initial pilot study. Our most recent round, which included support from Avanos, and existing shareholders should see us almost all the way through our FDA pivotal study and refinement of our follow on commercialization efforts.”
Arik told us the FUSmobile team is considering another round of funding in the near future to generate an additional 18 to 24 months of runway including needed buffer, development of additional indications and initialize commercialization.
“Our first meeting with Avanos was an incidental one at an industry dinner,” Arik said. We’ve found their entire team, especially engineers, as eager to innovate in the interest of patients first through procedure improvement. It didn’t hurt to be ‘neighbors,’ either.”
“Exploring partner relationships is very much like dating,” Ron said. “Feelings and indications of growth, the potential for something fruitful, is important. Enthusiasm, alignment of values and building trust is important. We found all this, and built upon it, with our colleagues at Avanos.
“Though this is not specific to funding, be persistent, be flexible, be creative and be willing to do things outside of your scope of skills. I learned how to execute on preclinical work even though my primary role has been [business development.] Conversely, Arik, whose great strength is clinical and engineering, pored over our partnership and investment documentation asking all kinds of valuable questions along the way.”
What else would you like to share with the Southeast Life Science ecosystem of investors, innovators, solution providers, universities?
“State level support for medical technology innovation in Georgia needs improvement, especially compared to other states in the region like Virginia, the state in which we originally incorporated FUSMobile,” Ron said.
“We are also eagerly seeking collaborators in the higher ed realm, particularly for animal health research collaboration. We would encourage those interested in that work to contact Arik at email@example.com.
Southeast Life Sciences thanks Arik, Ron and the Avanos team for making this content available for us to share.