We recently interviewed Arun Menawat, PhD, CEO of Profound Medical, a Toronto-based focused ultrasound manufacturer. Dr. Menawat describes what makes the company unique and shares his vision for the future below.
Profound Medical offers a therapeutic platform that provides the precision of real-time MR imaging combined with the safety and accuracy of directional (inside-out) and focused (outside-in) ultrasound technology for incision-free ablation of diseased tissue. Profound’s TULSA-PRO is a catheter based MRI-guided robotic ablation system that combines real-time temperature imaging, thermal ultrasound energy, and process control software for the precise ablation of diseased prostate tissue from the inside out—minimizing side effects and damage to healthy tissue. The company recently acquired the Philips Sonalleve MR-Guided HIFU system and accelerated the path to establishing itself as a platform company in the MR-guided therapeutic ultrasound space.
Tell us about Profound Medical.
Profound has gone through a remarkable transition in the past 24 months. Two years ago, we received the CE Mark for clinical use and commercial sale of TULSA-PRO in Europe. We are in the pilot launch phase of the product and our revenues are growing nicely. We will initiate a full commercial launch after we have completed collecting all of the relevant clinical and market data.
To obtain US FDA and Health Canada clearance, we recently completed enrollment in the TACT multi-center pivotal clinical trial. Initial data are encouraging, and we plan to apply for FDA clearance in the spring of 2019 when the 12-month follow-up data are complete.
In 2017, we acquired the Sonalleve focused ultrasound business from Philips. That platform generates some revenues, but there is still a lot of clinical work and market introduction strategies to develop in order to capitalize on its full growth potential.
Profound is publicly traded on the Toronto Stock Exchange, supported by a pristine, knowledgeable investor base and a strong balance sheet. We are committed to creating a tomorrow where clinicians can confidently ablate diseased tissue with precision; a tomorrow where patients have access to safe and incision-free treatment options for treating serious and life-threatening diseases, so they can quickly return to their active daily lives.
Where do you want to take the company going forward?
We see Profound right in the sweet spot of medical technology enabling better patient care. Surgery has come a long way from open, to laparoscopic, and now to robotic. The trend has been towards continuously reducing invasiveness, improving clinical outcomes, enhancing the surgeon experience and reducing the costs of delivering healthcare. Profound will continue to drive this trend towards incision-free surgery, significantly reducing invasiveness. Our goal is also well aligned with another emerging trend of patient-centric collaboration between the imaging and surgical teams to provide the best possible treatment option.
Incision-free surgery promises tremendous benefits for patients. Long hospital stays, and recovery periods have already shortened significantly with technology developments over recent years. Incision-free surgery will be another significant step forward, enabling patients to leave the hospital the same day and back to full activity shortly thereafter.
The Profound technology is not just a better mouse trap, it is new approach to treatment requiring reassessment of today’s paradigms. We need to evangelize:
- We will work with our clinical partners to continue to develop high-level clinical evidence that will support adoption and reimbursement. This is key to providing access for patients to incision-free surgery.
- Our products already have CE Mark enabling us to market in Europe, but we are also working towards FDA clearance to bring the technology to the United States. Over the longer haul, we will also seek regulatory approval in Asia and the rest of the world.
- We will continue to broaden the scope of the clinical indications of our technology platform. In Europe, TULSA-PRO CE Mark is for the ablation of benign and malignant prostate tissue, with some of our clinical collaborators already performing investigator-initiated study of TULSA-PRO to treat BPH and as salvage therapy for radio-recurrent prostate cancer. Sonalleve is CE marked to treat uterine fibroids and bone metastases pain. We are working with a number of centers on advancing clinical indications on the Sonalleve platform in the areas of musculoskeletal, soft tissue tumor ablation and hyperthermia.
- We are also committed to continuing to advance our technology to further improve surgeon experience and minimize treatment times.
Arun Menawat, Ph.D
How did you get involved with Profound Medical?
I started my career in chemical engineering and later moved into the medical device industry. Profound is the third device company that I have the honor of leading.
First, as President of Cedara Software, we developed the industry’s first diagnostic medical imaging software platform which is now a part of IBM’s Watson. I then spent 13 years as President and CEO of Novadaq Technologies, a fluorescent imaging platform that is used to visualize perfusion and blood flow during surgery. My team and I guided Novadaq from a startup to one of the fastest growing medical technology companies in North America before the company was acquired by Stryker Corporation.
There is a common theme between Profound and my prior two companies, Cedara and Novadaq. All three are about game changing, paradigm shifting ideas, and medical imaging technologies. The first one was about growing medical imaging in diagnosis with sophisticated software, the second about bringing a new imaging modality to surgeons to improve outcomes of their procedures, and Profound Medical is about combining a known set of safe imaging and thermal modalities and creating a whole new way to treat. Profound is a very exciting place to be.
I had joined the Board of Directors of Profound Medical in 2014 and in August 2016, joined Profound as CEO at the invitation of Steve Plymale who was the CEO at the time. I had worked with Steve at Cedara, and he specializes in early startups. He knew that I specialized in commercialization and asked me to lead the company into its next phase of growth. We spent about 6 months together making the transition.
Tell us about the company’s structure: ownership, lead executives, and their roles.
Profound Medical today is publicly traded on the Toronto Stock Exchange (TSXV: PRN). The original technology was developed at the Sunnybrook Hospital in Toronto by brilliant scientists. The technology was licensed by Genesys Capital, a venture fund that created the company in 2008 and provided it with its seed financing. Later, the Business Development Bank of Canada joined the original funders, to continue to support the development of the company. Today our stock is primarily owned by US and Canada based funds that specialize in investing in medical technology, but since our technology also appeals to patients, we also have a retail following.
We are building an entrepreneurial culture at Profound that focuses us on one thing – building the best incision-free treatment of our patients and with the best experience for our surgeons. We shun hierarchy and support knowledge based decision-making. Our leadership includes, Hartmut Warnken, VP of International Sales; Goldy Singh, VP of Regulatory and Clinical Affairs; and Rashed Dewan, VP of Finance. We also have a fantastic team of up-and-coming leaders, including Sanam Riahi, Senior Director of Global Marketing, Mathieu Burtnyk, Director of Clinical Affairs, and Mathieu Allard, Senior Director of Engineering.
What are the benefits of your technology over other companies?
We are the only company that provides treatment solutions using the safety and precise imaging of real time MR imaging and therapeutic ultrasound implemented from outside-into the patient or with a catheter with an inside-out approach. These two approaches provide us with tremendous flexibility to address a broad spectrum of currently unmet clinical needs. We do this with high precision based upon real-time thermometry from high-resolution MR imaging and sophisticated software that uses closed-loop process control algorithm to deliver consistent and precise ablation.
The consistent delivery of high precision, incision-free surgery translates into consistently low complication rates and faster recovery of patients. We have seen our prostate cancer patients go back to work within a couple of days and intimate within a week of the TULSA-PRO procedure. Uterine fibroid patients typically go home the same day and could be back to work the next day. These are significant benefits patients experience as compared to the outcomes of today’s standard of care treatments, which in most cases would be surgery or radiation therapy.
For TULSA-PRO, the trans-urethral approach to treating the prostate from the inside-out has a number of advantages. Heating from the center of the prostate, we are away from anatomical structures critical for function and quality of life. Also, TULSA-PRO can ablate very large amounts of prostate tissue in one treatment. Whereas other companies treat prostates that have a volume of 40 cc, we have easily treated 120 cc prostates in a treatment time of 2 hours.
In terms of flexibility, TULSA-PRO has the ability to treat the whole gland or a part of the gland. In addition to prostate cancer, it can also be utilized in patients with failed radiation therapy or BPH. Its flexibility allows different kinds of therapies in a clinically feasible manner, and I don’t think other technologies can do that.
Have you learned any lessons for watching the experience of the other companies?
That is a great question. Incision-free therapy is a big idea, with many potential applications. A number of companies are working to bring different applications to market and there are plenty of lessons that we can learn from each other routinely. Having the support of multiple companies is increasing the awareness of the idea and will be a big factor as we drive for mass adoption of the technology. We are happy to be part of this large effort. I think that a strong advocacy group such as the Focused Ultrasound Foundation is also an important part of not only creating significant awareness, but also allowing the companies to synergize where it makes sense to do so.
Do you partner with other companies? Which ones?
We have formed partnerships with Philips and Siemens, and we expect more collaboration in the future.
- Profound Medical Completes Enrollment of Prostate Cancer Trial February 2018
- Profound Medical Now Testing Treatment of BPH in Germany November 2017
- Profound Medical Enters Agreement with Philips to Expand Collaboration and Acquire Sonalleve MR-HIFU Business July 2017
- TULSA-PRO Receives Innovation Award November 2016
- First Patient Treated in Profound’s Pivotal Trial for Prostate Cancer September 2016
- Profound Earns European Approval for Prostate Device April 2016 with video “Steven Plymale Discusses Profound's Strategy to Treat the Prostate”
- Profound Medical Presents Successful 12-Month Phase I Outcomes Data October 2015
- Profound Partners with Philips for Prostate September 2015
- Philips Strategically Invests in Focused Ultrasound September 2015
- August 2015 Research Roundup: Profound Medical was able to show accurate and precise conformal thermal ablation of prostate tissue. Read the paper.
- Profound Medical Completes Enrollment in Prostate Cancer Trial April 2014
- Profound Medical to be Publicly Traded in Canada May 2015
- Canadian Study Assessing Thermal Ultrasound Treatment for Prostate Cancer May 2013
- Profound Medical Launches Prostate Cancer Trial May 2013
- Profound Medical Announces Initiation of Tulsa Clinical Trial For Treatment of Localized Prostate Cancer April 2013
- Chipperton departs Profound Medical May 2012
- Profound Medical names Steven Plymale CEO November 2011
- Profound Medical Secures $9.4 million in Venture Capital June 2011
- Profound Medical and Siemens to Conduct Clinical Trials April 2011
- Two U.S. Sites Will Conduct Clinical Trial of Profound Medical’s New MR-Guided Thermal Ultrasound Treatment For Prostate Cancer February 2011
- Province of Ontario Honors Profound Medical May 2010
- First Human Trials for MRI-Guided Trans-urethral Ultrasound Technique for Prostate Cancer: Profound Medical Inc. December 2009
- Profound Medical Inc. – MRI-guided Trans-urethral Ultrasound Device May Offer Better Targeting Accuracy for Prostate Cancer February 2009