- FUS Instruments is a focused ultrasound device manufacturer based in Toronto, Canada.
- It specializes in developing simple and reliable preclinical research systems for brain applications, such as blood-brain barrier opening and neuromodulation.
- We interviewed Marc Santos, PhD, FUS Instruments’ engineering scientist, to learn more about this growing company.
FUS Instruments is a focused ultrasound device manufacturer based in Toronto, Canada. Founded by two well-known pioneers in the field, the company specializes in developing simple yet robust (and highly reliable) preclinical research systems for brain applications, such as increasing the permeability of the blood-brain barrier (BBB), sonodynamic therapy, mild hyperthermia, thermal ablation, and neuromodulation. The devices developed by FUS Instruments are highly used by researchers who are pushing the boundaries of focused ultrasound. In fact, searching PubMed for the company’s name reveals an impressive publication stream of new advances in the field.
We recently interviewed Marc Santos, PhD, engineering scientist at FUS Instruments, to learn more about this growing company.
What is the mission of the company?
FUS Instruments strives to accelerate discovery in the field of focused ultrasound by lowering the technology barrier to engaging in the field and providing turnkey platforms for preclinical research.
Where is the company headquartered?
Our offices are in Room M7-124c, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada. We rent space in the research area of Sunnybrook Health Sciences Centre (a Focused Ultrasound Center of Excellence).
How was the company started?
Kullervo Hynynen, PhD, and Rajiv Chopra, PhD, two academic scientists from the Sunnybrook Research Institute’s therapeutic ultrasound department, started FUS Instruments in 2009. Their goal was to provide a research ultrasound platform for scientists, clinicians, and companies across the globe. Because the company seeks to eliminate the technology hurdle for researchers, FUS Instruments is solely focused on designing, building, selling, and supporting preclinical research platforms.
What is your research background?
I completed my PhD at the University of Toronto on the combination of focused ultrasound hyperthermia (mild temperature elevation) with temperature-sensitive liposomal chemotherapy. I used focused ultrasound hyperthermia to locally deliver chemotherapy drugs using temperature-sensitive, liposomal carriers. These liposomes circulate harmlessly throughout the body until they reach the target region, which has been heated above a certain threshold temperature using focused ultrasound noninvasively. The liposomes then release their chemotherapy payload in very high concentrations specifically within the heated regions. The idea is to try to improve patient outcomes while reducing treatment-associated systemic effects of chemotherapy. I used a mouse model of skin cancer together with a microscope that allowed us to visualize the capillary-level microcirculation in the tumors. This visualization allowed us to test various heating schemes designed to simplify the treatments to determine which one was the most efficient at releasing the drug.
What is your role in the company?
I began contributing to FUS Instruments around 2014 or 2015 while I was doing my PhD, and Kullervo was one of my PhD advisors. I became a full-time employee of the company after my graduation in 2020. When I was a graduate student, my role was consulting. I conducted experiments with some of the earlier prototypes of the systems that are being marketed now. As a system user, I contributed my experience doing experiments to improve them and address some issues. Although I loved the academic side of research and that is my background, I really enjoy the commercial side as well, and I am continually working to improve the technology. I’m still an engineering scientist, but my current focus is growing the company. We are such a small company that my role encompasses most of the day-to-day operations of the company at this time.
Why was the company started; what was the unmet need?
Many research groups wanted to use focused ultrasound for research applications, but they did not have the technological expertise, knowledge, or background to do so. Rajiv and Kullervo created the company with the idea of designing and fabricating focused ultrasound systems that could be easily used for turnkey, repeatable experiments. With more than 30 years of experience with focused ultrasound technology, the founders wanted to build devices at an affordable price for researchers to allow them to do preclinical experiments.
When the company started, the unmet need was that researchers needed access to equipment that they could use without a lot of knowledge of the background physics behind the device. They wanted to conduct experiments with the parameters that they needed, wanted, and understood.
Now, in 2022, there is another unmet need: There is growing demand and interest in using focused ultrasound to deliver agents to the brain across the BBB or to mechanically disrupt or destroy tissue in the brain. These brain applications span a broad range of expertise in neuroscience and oncology, but many researchers do not have the engineering or ultrasound knowledge to develop their own solutions for these kinds of experiments. FUS Instruments can step in to fill this need.
Tell us about your company structure: ownership, lead executives, and their roles.
FUS Instruments is privately held by its founders, Kullervo and Rajiv, along with Rod Engeland who is an executive director of research operations and finance within the research institute of Sunnybrook Health Sciences Centre, which holds a small ownership stake, and a few other initial investors.
How many employees does the company have?
We have four full-time employees, and we are in the process of hiring a college student to fill in for the next few months. I am an engineering scientist and the day-to-day operations manager. We have two system engineering technicians in manufacturing production who order parts, fabricate inventory, and build and test the systems. Our current full-time co-op student* is working on software development and calibration tools, and we recently hired a software contractor. Finally, we have plans to hire a mechanical engineering co-op student to help us in clinical design and small improvements in some of the some of the devices.
*In Ontario, Canada, co-op students come from undergraduate engineering programs (e.g., the University of Waterloo). They work with us for four months, full time during the school year. The program is designed for the students to go to classes for one semester, then they take a semester to work in a company that does engineering to learn on the job, and then they go back to classes for a semester. The co-op opportunities are paid positions.
In general, what is the current status of the company?
The company is in a growth phase, and we are working to increase sales and shifting our focus to marketing and sales outreach. Most of our sales right now are in North America, so we have begun to establish relationships with distributors around the world, such as in China and Japan. As a small company, we do not have a large marketing footprint, so we are hoping that distributor relationships will help increase our international sales. We are also trying to expand our business in Europe.
How many devices does your company make, and what do they do?
Our two main focused ultrasound devices are the RK-50 and the RK-300. We also manufacture our own MRI coils, MRI-compatible ultrasound transducers for research, and water degassers for use in MRI or laboratory. Finally, we are developing software for our system applications and for automating some aspects of the manufacturing process.
- RK-50. The RK-50 is a portable, stereotactic-guided focused ultrasound system designed for laboratory benchtop use. It is a brain research system.
- RK-300. The RK-300 is a therapeutic ultrasound system designed for use in small-bore MRI systems. It works well in 7.0T to 9.4T Bruker MRI scanners and we hope to gain experience in more field strengths as well.
- MRI Coils. We manufacture MRI coils for the RK 300 system because, from an MRI signal standpoint, a water-filled ultrasound transducer can distort the coil’s sensitivity. We manually tune the coils we manufacture to an environment that mimics the standard setup as closely as possible to reduce noise during experiments. Because they are so small, preclinical MRIs create a very homogeneous magnetic field, especially with smaller bore sizes. The smaller MRI bores create incredibly stable magnetic fields that produce beautiful high-resolution images, and we do everything in our power to make sure our systems do not impact this.
- Transducers. We manufacture MRI-compatible ultrasound transducers for research applications. These transducers are built in house from raw materials for each system. We have the ability and expertise to build custom transducers.
- Water Degassers. We manufacture water degassers for use in MRIs or the laboratory. They are specially designed to produce degassed water for focused ultrasound experiments as a cost-effective, time saving alternative to boiling water.
- Software. We are designing software for some of our focused ultrasound applications and are hoping to offer it by the end of the year. The new software will provide data analyses for our users to help them interpret the results and determine whether they are observing a focused ultrasound bioeffect. The program will allow us to more quickly answer user questions, even at the on the same day as the experiment.
Which focused ultrasound applications do your devices address?
Researchers are using them for BBB opening, sonodynamic therapy, mild hyperthermia, thermal ablation, and neuromodulation.
What are some of the technical challenges your group has had to overcome?
It was challenging to make our RK 300 device fit into the small-bore diameters of preclinical MRI magnets that have two-axis motorized positioning systems and a manual third axis because research systems have small, spatially constrained openings. Our goal is to make our systems usable with all of the Bruker preclinical MRI suites. We have had to redesign our motor frame several times.
What challenges do you have to tackle moving forward?
Moving forward, we will be putting more effort into the sales development side of the business. In the past, most of our customers have contacted us; now we plan to initiate more conversations about whether we can provide a system that is suitable for new customers. We will be working each day to develop marketing materials, identify potential customers, reach out to them, and grow our business.
What are the benefits of your technology over companies?
Our systems can be used preclinically to increase the permeability of the BBB, and most of our customers are heavily focused on conducting BBB experiments. Our systems produce reliable, repeatable BBB opening experiments for agent delivery of any kind in mice and rats. By integrating an acoustic hydrophone to our transducers and monitoring the backscattered ultrasound signals, more reliable experiments can be performed and analyzed.
We have licensed the patents for real-time acoustic feedback controller and MRI-guided focused ultrasound treatment planning, making the use of these techniques available to our customers. Our licensed intellectual property is designed to help our customers do these kinds of experiments reliably.
We provide excellent customer service by making ourselves as available as possible to researchers. We like to help new researchers understand some the subtleties and details of ultrasound experiments (e.g., important parameters on which reviewers might comment).
Tell us about the development of your collaborative open-source software.
On his own, a researcher at the University of Calgary named Samuel Pichardo, PhD, developed open-source, python-based, image-guided therapy software that connects to and interacts with all MRI scanners – Bruker, Phillips, GE, Siemens, and more. Dr. Pichardo’s software package allows researchers to interact with focused ultrasound equipment, so we adopted it for FUS Instruments’ systems. We had to customize it for our hardware with the help of Dr. Pichardo, which took about a year and a half.
There were many questions about whether competitors would copy it, but those questions did not prevail, and it was a great decision to have a collaborative software program. We have about a dozen (and growing) groups on the same platform. It makes collaboration easier. I would love to see more of this kind of international collaboration in the field of focused ultrasound. It is easier to do with a common platform for sharing tools, sequences, and methods – and that is our motivation. It obviously has a commercial element too because the company is a profitable company. Moving to open-source software was a big decision for the company. It seems right for our customer base because most researchers prefer software that they can modify and change over time. We continue to add modules and functionality based on user feedback.
Have you learned any lessons by watching the experience of the other companies?
We have tried to make our devices as reliable and affordable as possible and have steered away from creating complicated or ultra-sophisticated focused ultrasound systems. Our devices use simple yet robust, single-element, cost-effective transducers that are designed for use in spatially constrained experiments. We take feedback from our customers and help them do their experiments in a more reliable way, as partners in their research.
Do you partner with other companies?
Because of the overlap with almost all of our MRI customers, we are working to develop a more formal relationship with Bruker. Design-wise, it would be helpful to have access to some of the detailed engineering drawings for their loading beds. For sales, we are partnering with international distributors to open communication channels with new customers in new regions of the world.