In 2014, FUSMobile co-founders Arik Hananel, MD, and Ron Aginsky, LLB, MBA, identified a need for a compact, mobile, and user-friendly focused ultrasound device. They set out to create such a product, and less than five years later, the company has completed a pilot clinical trial using their Neurolyser device.
We interviewed Dr. Hananel, CEO, and President Ron Aginsky to learn more about this revolutionary company and how they are contributing their ideas for using focused ultrasound to treat pain.
How was the company started, and how did you both get involved?
We started FUSMobile with a vision to make focused ultrasound easier to access and operate by physicians so they could better treat patients. We wanted to create the personal computer or tablet equivalent for the focused ultrasound world. To achieve this, we relied on our intimate knowledge of the field, wherein we recognized the barriers that limited the adoption of the technology in the past.
We met at Insightec, where we worked closely together for more than 10 years. We became good friends and eventually decided to establish FUSMobile.
Tell us about your company business structure.
FUSMobile is a private company that is registered in Delaware as a C-Corp with headquarters in Alpharetta, Georgia, and a subsidiary in Israel. Our initial funding came from friends and family. In July 2017, OrbiMed Advisors led our first institutional funding round. At this point of the company life cycle, we share roles and responsibilities, benefiting from our diverse backgrounds and extensive experience in sales, marketing, operations, research, and product development.
Tell us about the origins of your treatment platform. Does your device have a name?
Our device is called the Neurolyser. It is a nice combination of a clinical procedure (neurolysis) and the famous "Neurolizer" device from the movie Men in Black. The Neurolyser platform enables the adoption of different modalities for imaging guidance depending on the physician’s needs and practices. We developed this platform with the goal of addressing a specific clinical need in the field of interventional pain management in a technical and operational way that would minimize barriers to adoption, achieving market acceptance in a fast, smooth, and cost-effective manner by all major stakeholders in the modern healthcare ecosystem.
What are some of the technical challenges your group has had to overcome?
To fulfill our vision, we had to design a small, portable system that uses current imaging guidance employed by interventional pain clinicians and that follows the existing workflow, excluding the last step of inserting a needle. The result is a tool that is extremely intuitive to use for those specific clinicians and that eliminates the need for a sterile environment.
We also wanted to ensure that the end user price is equivalent to other standard-of-care devices but our system could potentially provide better efficacy and pain control.
What challenges do you have to tackle moving forward?
We are currently striving to generate the clinical data to support approval from the regulatory bodies, focusing on North American markets as a first stage. Our aim for the future is to investigate additional clinical indications within the field of interventional pain management.
Tell us about your clinical studies and the results.
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 we accumulated experience during the study, we made several changes to the protocol to improve the procedure for patients and physicians. For example, according to the initial study protocol, the procedure was performed in two sessions to treat the right and left sides separately. Following the creation of fast learning curves from the first treatments, it was clear that both sides could be treated in the same session safely and within a short time period so the patients would not have to return for another treatment session. These modifications were intended to reduce procedure time and increase efficiency while enhancing patient comfort and safety.
All patients completed the treatments well without the need to stop due to either patient discomfort or technical issues. The safety profile is excellent, and initial effectiveness results are promising.
What are the benefits of your technology over other companies?
Compared to other platforms in the field of interventional pain management, the noninvasive Neurolyser procedure has the potential to provide better clinical outcomes, fewer complications, reduced operating costs, and lower radiation exposures.
Compared to other focused ultrasound platforms, the Neurolyser uses current, widely available imaging guidance and does not disrupt patient flow or ownership. The Neurolyser is also compatible with our clinician setting and imaging modality. From an economic stance, the Neurolyser equipment is cost equivalent to the standard of care devices with the benefits of having a lower operating cost and requiring significantly less user training.
Have you learned any lessons from watching the experience of the other companies?
The most significant lesson we learned was about the need to develop a focused ultrasound device with strong, compelling advantages that avoids barriers to adoption and keeps the patient and physician workflow as similar to the current standards of care as possible.