Sonablate Corp. is a global leader in high-intensity focused ultrasound (HIFU) treatment of prostate disease, with more than 40,000 patients treated worldwide. The company’s device, the Sonablate, is approved in over 50 countries and has been in use in the United Kingdom (UK) via its wholly owned subsidiary, UKHIFU, for nearly 19 years.
We spoke with the company’s Chief Commercialization Officer, Alex Gonzalez, about the company, its business in the UK, and how their technology is changing lives.
Where is the company headquartered? Any additional locations?
Sonablate Corp. is a an American company with headquarters in North Carolina, USA, with a wholly owned subsidiary, UKHIFU, Ltd., based in Bristol, England. We also have a repair and training center there in Bristol and regularly have clinical teams operating in and around London. You can learn more at https://www.sonablate.com/.
How was the company started?
UKHIFU started almost 20 years ago as a whole-gland focused ultrasound treatment for the prostate and was first introduced in the UK by Professor Mark Emberton of University College London (UCL) who performed the first focused ultrasound cases for the prostate in the UK around 2003-2004. That was really our first site using focused ultrasound for the prostate, followed by Oxford University where the urology team was already using other forms of focused ultrasound. As Prof. Emberton’s department at UCL grew and began devoting more time to focused ultrasound research, other National Health Service (NHS) and private sites started their own Sonablate HIFU programs. UCL became the focused ultrasound hub of activity helping foster young, innovative, and brilliant physicians such as Professors Hash Ahmed and Caroline Moore, amongst other early focused ultrasound pioneers who have been relentless at proving that focused ultrasound for the prostate could be as effective at controlling disease as radical treatments while preserving quality of life such as sexual and urinary function.
UKHIFU steadily established a greater presence in the UK that served multiple needs. UKHIFU offered capital sales for the European market, physician training, patient education, customer service, and clinical support for the work that was being done at UCL. The company also established a mobile service that brought the equipment and training on an as-needed basis to other physicians and hospitals that were not able to purchase a system. From the beginning there was always an emphasis on promoting clinical research, collecting the data, and tracking clinical outcomes very carefully which have been the base enabling the evolution of Sonablate HIFU into the most clinically proven prostate focal treatment for prostate. We now have more than 15 years of data and thousands of patients treated.
How did you get involved in starting or joining the company?
My role as chief commercial officer started more than 19 years ago, when I was one of the first two employees hired by an American company who was originally charged with funding and completing US Food and Drug Administration (FDA) clinical trials with the Sonablate technology. Although, our original task was to secure FDA clearance and commercialize the technology in North America, we expanded our role when we acquired Focus Surgery, the manufacturer of the Sonablate system, and obtained the global distribution rights. The company helped fund research that would later evolve into the first focal therapy treatments with the Sonablate platform.
Throughout my time at Sonablate, I have held many roles across the entire commercialization spectrum – from developing the commercialization plans that introduced this disruptive technology across dozens of countries to implementation of awareness campaigns for physicians and patients, spearheading the teams that would secure global regulatory approval, directing the company’s global sales teams, helping train physicians and engineers on the installation and use of the equipment, and educating patients who were looking for an alternative to radical treatments. Fast forward to now, and the company has grown by leaps and bounds. The initial team of two people has grown to almost a team of 100 across three countries. I now oversee marketing and sales worldwide.
Tell us about your company structure, including lead executives and their roles.
The company’s CEO is Richard Yang, and he has an international business and manufacturing background. He became involved with the company as an investor and Board member. In 2021, he stepped into the role of CEO because he was compelled by the technology and its immensely positive impact on healthcare. Through Mr. Yang’s extensive business network in Asia, he has helped develop and deploy an expansion strategy that has led to much of our success expanding into China, Taiwan, Hong Kong, and Malaysia.
Ralf Seip, PhD, is our chief technology officer. Dr. Seip is responsible for defining and executing the long-range strategy for the company and bringing to market new therapeutic ultrasound products. He is an expert in product development, cancer therapy, and ultrasonics which have made him an ideal leader within the focused ultrasound space. Prior to Sonablate, Dr. Seip also spent nearly 10 years at Philips as director of ventures, where he led a team at Phillips Research to explore the areas of ultrasound mediated agent delivery therapies, ultrasound based stroke therapies, and ultrasound device development.
Narendra Sanghvi is our chief scientific officer and is a globally recognized name in focused ultrasound. Mr. Sanghvi was one of the original pioneers who brought HIFU for the prostate into the market in the early 90s. His research has been the cornerstone of many focused ultrasound developments, and he continues to provide insight to the Sonablate and UKHIFU teams.
Karen Cornett is our vice president of clinical operations. She oversees the global implementation process, from the time the device is sold, installed, and started in use. She also oversees the biomedical engineering, clinical, and applications teams. Mrs. Cornett excels at leading the multidisciplinary teams that make the building of a customers focal therapy program possible. She has orchestrated the implementation of Sonablate programs around the world.
What are the day-to-day operations of the UK Headquarters?
UKHIFU serves as a training and support hub for customers in the UK, and essentially all of Europe. In some countries, UKHIFU has agreements in place with distribution partners, but in others, our team services customers directly. UKHIFU is a training center for the service personnel affiliated with these distribution partners. For those that we service directly, we provide assistance with sales, training of physicians and nursing personnel, and maintenance of the system.
Can you describe the training process?
Training is split up into four phases:
- After a customer acquires one of our robotic focused ultrasound systems, the first training phase is a series of self-paced online modules, both for the physician and the support personnel. The basic physician modules cover ultrasonography as it relates to HIFU, proper patient selection, pre- and post-operative patient management, and treatment techniques.
- Once the online component is complete, we schedule a one-on-one interactive case simulation session with the physicians and put into practice what they learned in the basic modules. We present a prostate from our library, and the physician and an experienced application specialist will then perform a mock HIFU case.
- The third phase is when we are on-site, sitting next to the physician, and we will do at least six or more cases with them over several days.
- Finally, we offer Sonalink, a telemedicine platform, where the physician can see us, and we can see the treatment screen in real time. This is like training wheels after they have completed the initial three phases. We also offer this if perhaps the physician has not done a case in awhile or it is a highly technical case.
What is the current status of your company in the UK?
We have been active in the UK for more than 19 years with different versions of the Sonablate device. We earned the CE Mark around 2002-2003, well before we received US FDA clearance. Currently there are more than 15 sites, both public NHS hospitals as well as private hospitals that have access to a Sonablate device in the UK. By the end of this year, we plan to increase that number to over 20 sites.
Who are the key advocates driving adoption in the UK?
The patients themselves have played a significant role in the adoption and overall awareness of focal therapy. Patients have become quite proficient at searching for alternatives to the radical treatments conventionally offered and every year become stronger advocates for access to newer, less invasive, and less toxic treatments. Once a patient has experienced the benefits of this HIFU treatment they become even more passionate about sharing with others going through the due diligence post diagnosis.
One group in particular that has really spearheaded the patient-lead advocacy for greater access to minimally invasive, precision based treatments using focused ultrasound is Prost8 UK. This UK-based charity was founded by a former patient who was told by several institutions that he had to have radical treatment for his prostate cancer. Fortunately, this gentleman was extremely persistent and diligent in looking at different options. He learned about Sonablate HIFU and was treated by Professor Hashim Ahmed of Imperial College London. He was so pleased with his treatment and its lack of side effects that he started a charity to advocate for patients and to compel law makers to further examine and fund technology that demonstrated a better balance of priorities to spare the patients quality of life along with achieving disease control.
There has been a recent push from the All-Party Parliamentary Group that was formed to examine access to noninvasive treatments and patient demand. The group released a report last summer that indicated only 10 percent of cancer patients in the UK are offered noninvasive treatments. So there has been a political push that still needs further follow up and ultimately further funding so that more men can have access to this technology.
Finally, it is critical to mention the brave and innovative British physicians that searched for something different than the status quo, challenged the thought process of how to balance clinical outcomes while preserving quality of life, and who spearheaded the creation of this focal therapy discipline within urology. These physicians have been relentless at conducting the more than 15 years of research and clinical publications and creating global collaborations forming communities with their international counterparts.
What challenges have you encountered?
I think any disruptive technology that challenges the status quo will face some critics. Historically in our field, the option was either you employ a strategy of active surveillance or you treat the disease radically. Oftentimes that means that if there is a question between the two, patients may opt for surveillance because of the life-altering side effects associated with radical treatment or resign to likely losing sexual and/or urinary function to feel like they have taken an active role and treated the disease. Tissue preservation is used for the kidneys, for lung, for the brain and for breast disease. Why not for the prostate?
Making a compelling argument that we are now in a place and time where we can really stratify the disease and therefore can use this information to treat it with precision based technology like focused ultrasound has been more challenging than we thought. Our challenge is convincing the medical community that we are no longer simply considering whether the patient has the presence of disease or has no evidence of disease. We now have the great privilege of understanding the disease of the prostate based on focality, volume, severity, genetic type and can now image and categorize the disease and track its progress based on advanced imaging. After making this argument then convincing the medical community that you can treat using image guidance and precision with an ultrasound, despite now having 15-year data, has been challenging, albeit less now that more and more focal programs are opening up around the world. Don’t get me wrong here, we are not advocating the replacement of radical surgery or radiation but rather advocating for a less toxic approach using focused ultrasound that has been shown to be able to treat anywhere from 50%-70% of prostate patients.
Why is the UK market important to Sonablate?
There is no more significant tip of the spear than the UK for focal HIFU in the prostate space. There are countless pioneering physicians that, for the past 19 years, have really believed in this concept of a more precise and quality of life preserving treatment and have taken on the massive challenge of engaging in the research to prove that it works. In my opinion, the most significant work involving HIFU and focal therapy has been led by the globally recognized research teams at University College Hospital London and Imperial College London. These two programs are also some of the most recognized focal therapy training centers having hosted now physicians from all around the world. We must also recognize the network of physicians in and around the greater London area that have participated in this industry-changing research.
What challenges do you have to tackle moving forward?
One thing that challenges all focused ultrasound technologies is the ability to keep up with complimentary medical technology, as it changes so quickly and innovations are made on a daily basis. This can be something like the emergence of better ways to stratify or diagnose the disease. As those evolve, how will we respond and integrate? I’m happy to say that Sonablate HIFU was the first to adopt the integration of multi parametric MRI fusion and the concept of focal therapy, a reason why we lead the industry in peer reviewed publications. I think technologically, our challenge will be to continue to be very aware of new ways to better diagnose and stratify disease and find ways to integrate to offer better treatments for our patients. We feel an enormous amount of pressure being the industry leaders in focal treatment for the prostate to ensure that we continue to be the first and the most significant out there in the market.
Tell us about your clinical studies and the results.
One of the most interesting studies we have seen is a propensity matched study where 246 patients who underwent radical prostatectomies were matched with 246 focal therapy patients. Of those focal therapy patients, over 80% of them received HIFU treatment with the Sonablate device. The others underwent cryotherapy treatment. Oncological outcomes over eight years were similar between focal therapy and radical prostatectomy. For the radically treated patients, at five and eight years the Failure Free Survival (FFS) rate was 82% and 79%, respectively, while the focal therapy patients at the same time intervals had FFS rates of 86% and 83%.
The results showed that both groups had equal cancer control, but the focal therapy group experienced much fewer side effects, including significantly less urinary dysfunction and erectile dysfunction.
Another recent study published in the journal European Urology centered around cancer control outcomes in 1,379 men following focal therapy using the Sonablate. This was a multi-institute, 15-year experience where the population of D’Amico Risk* was 93% for intermediate-high risk. Metastasis-free survival and prostate-specific mortality at seven years was 100%, and adverse events were consistent or less than rates associated with post radical surgery or radiation.
Another UK lead study of 1,032 men published in the British Journal of Urology demonstrated freedom from radical treatment was 98%, 91%, and 81% at 24, 60 and 96 months following Sonablate focal treatment.
There are also studies demonstrating how HIFU can be repeated with little morbidity, and HIFU does not affect a patient’s ability to receive a radical treatment should the cancer recur.
*The D’Amico Risk Classification for Prostate Cancer assesses 5 year failure of treatment based on clinical factors.
Which other health conditions or diseases will your technology be used for?
In some countries, we have approval to use our HIFU technology for the treatment of both prostate cancer and benign prostatic hyperplasia (BPH). In the same way that the technology can precisely ablate an area of cancer, it can also destroy benign tissue that is overgrowing and obstructing the urethra. We are not treating BPH in the UK, but globally, specifically in Asia, it is being explored further.
Incorporating MRI image fusion, precision guided biopsy, and Sonablate HIFU technology has proven to be a quality of life preserving alternative to radical treatment for properly selected and consented patients. An organized and implemented focal therapy program can be a vital compliment to a surgical and radiation therapy program. As patients become more aware of tissue preservation benefits for the prostate, the topic of focal treatment will become more prevalent and more useful.
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