Key Points
- Arrayus Technologies Inc., is a Canadian company developing a noninvasive focused ultrasound therapy platform to revolutionize cancer care.
- We spoke with Arrayus’ President and CEO, James O’Reilly, about the company’s current trials and next steps.
- The company was formerly known as Harmonic Medical.
Arrayus Technologies Inc. is a Canadian medical technology company that is developing a noninvasive focused ultrasound therapy platform to revolutionize the standard of oncological care. The company, which was formerly known as Harmonic Medical, is creating a next-generation, MR-guided focused ultrasound system that can deliver multimodal energy for treating a large variety of clinical applications in the pelvis and abdomen.
We spoke with Arrayus’ President and CEO, James O’Reilly, about the company’s current trials and next steps.
Where is the company headquartered?
The Arrayus headquarters is in Burlington, Ontario, Canada, and there is a second office in Toronto.
How was the company started?
The company was founded by Kullervo Hynynen, PhD, a global pioneer in the field of focused ultrasound who has more than 30 years of basic and clinical research in this space, over 400 published papers, and 20 patents. Dr. Hynynen’s teams at Brigham and Women’s Hospital in Boston and at Sunnybrook Health Sciences Centre in Toronto developed several proprietary technologies that enabled, for the first time, the creation of large-scale, dense-phased arrays for therapeutic use. Arrayus was formed to bring this exciting innovation to market and provide patients around the world with new and improved options for cancer care.
What is Arrayus’ current status?
We have completed enrollment in a clinical trial for our first indication, uterine fibroids, and are looking toward regulatory submission and commercial sales.
What is your vision for the company?
We are strong believers that focused ultrasound is a true revolutionary technology that will one day be an essential tool in every cancer care center, hospital, and physician’s office globally. We aim to play a key role in this vision of the future through the development of a versatile focused ultrasound system that can improve clinical outcomes and decrease cost of care for patients across a broad range of oncological disorders.
How did you get involved with Arrayus?
Before joining Arrayus, I founded and ran a successful consulting firm focusing on technology development, funding, and regulatory affairs in the medical device space. It was in this capacity that I first became involved with what is now Arrayus. I am honored to make the advancements that Dr. Hynynen and his team have developed available for patient care.
Tell us about your company structure: ownership, lead executives, and their roles.
In addition to myself, we have a chief financial officer and a director of business development.
Michael Mays, our Chief Financial Officer, leads the company’s operational and financial strategy, governance and risk management, and development of financial systems. He has 25 years of professional experience working in public and private companies in both the USA and Canada.
Lauren Killip, PhD, our Director of Business Development, has an impressive track record of medical technology commercialization and international business development. Her expertise includes strategic business planning, relationship development, and operational execution in fast-growing startup companies.
Tell us about your products.
Our next-generation, MR-guided focused ultrasound system can deliver multimodal energy for use in a large variety of clinical applications in the pelvis and abdomen. Incorporating more than two decades of technical and clinical innovations by global leaders in the field, our system uses a radically different approach to array design and driving electronics than current commercial systems. While current systems use large-element, spherically curved arrays (≈200 elements) with limited steering range, we have developed the world’s largest flat, fully electronically steered dense phased array (6,144 elements) for clinical use. This provides technical benefits that will greatly improve the safety and efficacy of existing ultrasound therapies and enable treatments that are not currently possible with existing technology.
Is your system or equipment approved for commercial use in any markets? If so, how is it being used in these markets?
Our platform is not yet approved for commercial use in any market; however, we have sold several systems for use in research settings.
Which health conditions or diseases will your technology be used for?
Our multimodality platform supports all therapy modes for the broadest clinical versatility on the market. With a primary focus in oncology, our system can be used as a noninvasive alternative or complement to traditional cancer treatments, including surgery, chemotherapy, radiation therapy, and immunotherapy. The first indication we have pursued is uterine fibroids, the most common female pelvic tumor, with a prevalence of 70% to 80% of women by age 50. Additional indications where we anticipate our system will have significant clinical benefits include diseases of the liver, pancreas, and kidney.
If applicable, tell us about your related clinical studies and the results.
We completed our first-in-human clinical study at Sunnybrook Health Sciences Centre in Toronto. This study evaluated the safety and feasibility of using our device for treating uterine fibroids. Our preliminary results suggested compelling clinical and economic benefits for the millions of women who suffer from this disease worldwide. Additional clinical studies are being planned to explore the use of our system for other oncological indications.
What are some of the technical challenges your group has had to overcome?
The benefits of a large aperture, densely populated, phased array like ours had been known for some time, but we had to overcome numerous technical obstacles that had previously prevented their construction and use in therapy applications. First, there are several complexities of having a 6,000+ element, fully steerable (i.e., λ/2-spaced) array that can deliver high power without grating lobes. Second, to deliver adequate radiofrequency power to small transducer elements, we had to overcome the challenge of high electrical impedance. Because each transducer element needed to be connected to its own individual driving circuit, we also had to develop a solution to overcome the electrical interconnect problem. Third, we needed to develop a reliable method to use our system that contained all of these electronics near the magnetic field created by the MR bore. Lastly, we had to find a way to manufacture clinical systems in a robust, cost-effective way.
What are the benefits of your technology over other companies?
Our focused ultrasound platform provides several key benefits over existing commercial systems (which consist mainly of large element, spherically curved arrays with limited steering range). First, our unique approach to array design – a flat, 6,144-element, dense phased array – enables faster and safer treatments over larger treatment volumes. In addition, our system does not rely on mechanical parts to move the array, which results in increased system reliability and reduced manufacturing costs.
Second, our fully electronically steerable array provides unparalleled flexibility in tailoring the acoustic field for optimal control in a variety of treatment situations. Furthermore, using our real-time dynamic motion (RDM) technology, we are able to support advanced sonication patterns (including rapid scanning, multi-foci, etc.). This control and monitoring of energy deposition provides true patient-customized treatments and is expected to both increase safety and reduce treatment times. The speed of this electronic focusing could also be used to treat moving organs, something that is not possible with current mechanical systems.
Third, our system has been designed to have the broadest clinical versatility on the market. It supports multimodal energy delivery and real-time monitoring of both thermal and mechanical effects. In addition, our forward-looking hardware and software design ensures that we will be able to take advantage of future global research into novel bioeffects and optimal treatment strategies.
Do you partner with other companies or research teams?
We have been fortunate to collaborate with several leading academic institutions and industry partners as we work toward building the field’s most versatile focused ultrasound system. One relationship that we are particularly privileged to have has been our close affiliation with the exceptional researchers at Sunnybrook Health Sciences Centre. Their unparalleled experience in focused ultrasound continues to be instrumental in advancing the science and supporting new clinical studies.
Another exciting partnership of ours is with the McMaster Centre for Software Certification, a group internationally renowned in the field of safety-critical, software-intensive systems. We have been working together to develop novel methods and tools for integrating engineering and quality assurance processes. This project will help ensure that focused ultrasound systems such as ours are reliable, robust, and safe with the goal of enhancing confidence in our product to clinicians, patients, and regulators.
The potential applications where we believe our system can add significant clinical benefit are extensive, and we welcome additional partnerships to help us undertake new projects.
Past Coverage
Meeting Report: IEEE International Ultrasonics Symposium (IUS) 2021 October 2021
Harmonic Medical Rebrands as Arrayus Technologies June 2021
Focused Ultrasound Manufacturer Funded with $2.1 Million Investment September 2019