Profound Medical Inc
June 24, 2013 Issue
The Most Powerful Name In Corporate News and Information
Making a Difference in Men's Lives, Profound Medical Inc. is Developing and Commercializing a Groundbreaking, Minimally Invasive Treatment for Localized Prostate Cancer Using Ablation Techniques and MRI Image Guidance
About Profound Medical:
PMI is a Canadian medical device company that is developing and commercializing a unique, minimally invasive treatment for prostate cancer. PMI’s novel technology combines Magnetic Resonance Imaging (MRI) guidance and high-energy ultrasound to deliver thermal ablative therapy to the prostate gland. Delivered via a trans-urethral approach, the technique combines the image quality of MRI with thermal ultrasound as the treatment tool. This method of prostate cancer treatment affords highly accurate and precise treatment within the prostate gland in a short time span in an outpatient setting. The potential of this technology is currently being demonstrated in Phase I clinical trials.
For more information, please contact:
Tel: +1 647 476 1350 ext. 401
+1 647 847 3739
Mr. Plymale’s 25-year career in medical devices includes working with start-ups, early stage companies, and turnaround operations. His expertise has focused on Executive Management, Quality and Regulatory Affairs, Business Development and Operations. He has led the commercialization efforts of a number of high tech, medical device products into North American and International markets. In 2002, his extensive Quality and Regulatory experience helped lead CryoCath to a PMA approval of a ground breaking Class III cardiac device. The company was recently acquired by Medtronic for $380M. He has since held executive roles in several high tech medical device companies such as Natus Medical, CroyCath, Claron Technologies and the Bluehaven Consulting Group.
Since 2008 he has expanded his skills and experience to include working in corporate governance with several Board appointments. He has been an active member of the Institute of Corporate Directors since 2008 and most recently has accepted Board appointments to the Ontario BioScience Innovation Organization (OBIO) and St Elizabeth’s Healthcare Foundation. He regularly works as a mentor to new CEO’s and other senior executives and their emerging life sciences companies.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – June 24, 2013
CEOCFO: Mr. Plymale, before you were CEO you were on the board of directors at Profound Medical. Why did you make the decision to take over at the helm of the company?
Mr. Plymale: The opportunity to take on a more significant role presented itself and through the course of my time as director, I became very committed to this technology and wanted to do everything I could to see it progress. Profound was ready to transition from R&D into clinical trials, strategic partnerships, and commercialization and the Board felt my skills and experience gave Profound the best shot at success in these areas.
CEOCFO: What is the concept at Profound Medical?
Mr. Plymale: Profound Medical is developing a new novel technology to treat localized prostate cancer. It uses a blend of ultrasound thermal energy, a minimally invasive approach and MRI image guidance so that we get real-time image feedback to the treatment. This is a groundbreaking new approach to treating localized prostate cancer with ablation techniques and image guidance.
this been treated so far and how is your approach different?
CEOCFO: Where are you in the process of development?
Mr. Plymale: We have been working diligently in the background developing the technology and perfecting it to a stage where it can be used in humans. Late last year Health Canada approved the first safety feasibility trial for our device and on March 13th we treated our first patient. We have launched into a clinical stage of our growth and we expect that we will progress quickly through the first clinical trial which will prove that this device is safe and that we can feasibly treat localized cancer with this technology. In the coming months we will be expanding our trial and it will become a multi jurisdictional trial with additional sites in Europe and we are also applying for approval with the FDA to expand this trial into the United States.
CEOCFO: Has this approach been thought of before and not been able to be implemented or is the concept of combining all of this unique to Profound Medical?
Mr. Plymale: The trans-urethral ultrasound energy is unique to Profound and we have exclusive license to the intellectual property with respect to this technology so in that case we would say that we are quite distinct since we are the only ones who have the ability to commercialize the device that does it exactly this way.
CEOCFO: Would you tell us about the market opportunity and if the prostate treatment is in favour today?
Mr. Plymale: This is the single most prolific disease out there for men. About a half-million men a year are diagnosed with prostate cancer each year. In Canada I think one in six or one in seven men. The choices for treatment have to date been not the greatest for men. They are forced to make tough choices with the most prevalent choice being ‘waiting’, a choice which is understandably somewhat risky. Many men are now actively choosing to sit on the sidelines of this disease, taking an approach called active surveillance rather than intervene because of the poor risk profiles and quality of life outcomes associated with many of the currently available interventions. What we hope to do is improve their scope of choices by coming up with a simple straightforward outpatient minimally invasive technique for treating this cancer and achieve the types of outcomes and quality of life that patients deserve.
CEOCFO: Will you be bringing in partners?
Mr. Plymale: We are pioneering the technology on our own and are working with world renowned clinical institutions to develop the clinical data. In order to attract the types of partnerships that will help us propel our growth we’ll be presenting strong clinical data on the technology that is driving the growth that we are in right now. We look forward to expanding our reach with strong partnerships in many different areas of the healthcare industry and expect tremendous interest as the data comes forward.
CEOCFO: Will you be receiving additional funding as you move forward?
Mr. Plymale: We are well funded at this time in terms of this trial but obviously there will come a point where in order to continue the growth Profound will need to engage in a round of funding.
CEOCFO: Are you going to be doing trials in Europe as well as the US?
Mr. Plymale: That is correct.
CEOCFO: How do you decide where and when?
Mr. Plymale: That is a good question. There are world renowned urologists who are pioneering all sorts of research and we are establishing strong relationships right now in Germany. We hope to expand into other countries in Europe as a priority and we will also be looking forward to the key research institutions in the United States who are also interested in joining us in developing the clinical data for this trial.
CEOCFO: Is it one treatment or a series of treatments?
Mr. Plymale: Our procedure is completed in one treatment. The patients, after being screened for inclusion criteria, receive a biopsy in the normal course of their diagnosis. Based on the results of the inclusion criteria for the trial they will enrol and have a MRI scan prior to the treatment and we register the data collected. The patient is prepared for treatment and the device is engaged. We do careful planning to identify the area of treatment, but the actual energy delivery takes only approximately thirty minutes. After that treatment we do another scan to verify the treatment. What is great about our technology is that while the treatment is ongoing we get updates in real-time so every five seconds we have an image showing the success of the treatment as we apply the energy. Patients are going home shortly after the procedure after a short recovery time. This is a tremendous departure from the more significant invasive techniques that are used to treat the disease today and we are very excited about it.
CEOCFO: Does the machine automatically change dosage if needed or is there much interpretation from the doctor or technician performing the procedure?
Mr. Plymale: It is all automated through an algorithm and controller that detects the delivery of energy which measures and monitors the delivery of energy in real-time. As we heat the tissue we can see the extent of that heating using real-time thermometry from the MRI and this gives us visibility as to the progress of the treatment while it is occurring. Many of the other techniques that are used today are more of a point and shoot approach and the actual results are not really known until some time later.
CEOCFO: This is a substantial breakthrough!
Mr. Plymale: This is. We believe in our hearts that this has the potential to become a new standard of care for how localized prostate cancer can be treated and that is what we aim to prove. We are in the early stages of our clinical data collection and once we finish this we will try to get it into the hands of early adopters who are very anxious to try this new technique with their patients.
CEOCFO: You have a twenty-five year history working with medical device companies ands start-ups. What are some of the most important lessons that you have learned over time that are helpful for you as you continue to develop Profound Medical?
Mr. Plymale: I think it comes down to the people, especially in a small company where people are wearing multiple hats and working very diligently to progress the technology. It comes down to the commitment, skills and experience inherent in your team. I am fortunate in that respect to have colleagues who are very committed to the success of this technology and very experienced in what they do so we are confident we have the right blend of skills and experience to make this happen.
CEOCFO: Why should the business and investment community pay attention to Profound Medical?
I think we
are the little company that could. While it’s true there is a significant
business opportunity here, what will drive that success is that what we are
doing here really makes a difference. I think I will send you a picture of
one of our first patients ever treated. The smile on his face and the
genuine gratitude for what we have been able to do with his choice in
treating his prostate cancer is personal. What we are doing makes a
difference and we all believe that this could be a huge advance in the way
this disease is managed, giving men a new choice and we are quite proud of
“While it’s true there is a significant business opportunity here, what will drive that success is that what we are doing here really makes a difference… and we all believe that this could be a huge advance in the way this disease is managed, giving men a new choice and we are quite proud of that.”- Steven Plymale
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