SonaCare Medical CEO Dr. Mark Carol is a neurosurgeon with more than 30 years of experience in medical device and healthcare services in publicly traded and privately held companies.
Widely viewed as the "father of IMRT" and a household name in Radiation Oncology, he has a proven track record of taking nascent disruptive technology, in multiple disparate fields, from conceptualization through commercialization. Dr. Carol earned a BS from Amherst College, where he graduated Magna Cum Laude, and an MD with Distinction in Research from the University of Rochester. Dr. Carol completed his residency in neurosurgery and a fellowship in neurotrauma at the University of Maryland. He also spent time in the graduate program in artificial intelligence at the University of Massachusetts, and is an Adjuvant Assistant Professor of Radiation Oncology at Brown University.
Q: Tell us a bit about your background and how you got involved with SonaCare.
I trained as a neurosurgeon working with [FUSF founder] Dr. Kassel during the early days of stereotactic radiosurgery. I went on to found NOMOS, the pioneer in the early development of intensity modulated radiation therapy and ultrasound guided radiation therapy. I joined SonaCare in 2012 to help move the technology development forward along the lines I had undertaken in radiation oncology.
Q: What is your current vision for SonaCare?
For SonaCare to be a global leader in developing and providing therapeutic ultrasound technology to physicians so that they can improve the quality, reduce the cost, and advance the outcomes for the treatment of a wide range of clinical disorders.
Q: What is the current scope of the company for treating prostate – e.g., number/name of marketed systems, installation base, number of countries with regulatory approval, number of patients treated, etc.?
We have installed more than 100 Sonablate systems in 49 countries around the world where the device is approved for the treatment of prostate cancer; more than 15,000 patients have been treated to date. We have sold approximately 15 systems in the US market for the ablation of prostate tissue since the device was cleared by the FDA mid-October of last year. In most markets, including the US, we sell a second probe – cleared for the laparoscopic ablation of soft tissue – that works with the same basic device used with Sonablate.
Q: What is unique about your Sonablate system?
It is a multimodality system designed to support a range of probes, each designed to address specific needs. Taking a page from my background, it draws on the rich heritage of technology advancement in radiation therapy, image guided surgery, and robotics, to bring to minimally invasive and non-invasive ablation the best of developments in other fields. Sonablate has many advanced and unique aspects, from the ability to fuse preexisting multiparametric MRI data with intraoperative ultrasound data to precisely target the region to be ablated, to the use of advanced image processing algorithms that allow us to assess the tissue impact of the dose we deliver.
Q: What do you see as the ideal role for HIFU in the treatment of prostate disease?
In the US Sonablate can be used to treat either the entire gland or a portion of the prostate determined by the physician to be appropriate for ablation. Outside the US, Sonablate is being used in the treatment of primary and recurrent prostate cancer by ablating the entire gland or a portion of the gland (focal therapy). Sonablate also is being used in most countries other than the US for the treatment of BPH, and is being investigated as an enabler of immunotherapy interventions.
Q: What is your go-to-market strategy for success in the US?
We believe that many urologists desire the ability to ablate a portion of the prostate rather than attacking the entire gland. The goal of a focal intervention is to preserve quality of life while still treating tissue that benefits from ablation and allows patients to walk out of the hospital after the procedure in the same condition as when they walked in before the ablation. We will capitalize on Sonablate’s ability to realize this goal, as well as its multimodality design, which allows a buyer to amortize the initial investment over a growing set of additional probes and applications.
Q: Where does the US market for prostate fit into your overall company plans?
Right now it is the engine that is driving the rest of the company. There is a lot of pent up demand for an image-guided tool for focal ablation, a demand that will last for some time to come. That will allow us to get our base systems into hospitals and surgicenters, thereby preparing the way to place additional probes (currently in development) that will extend the reach of focused ultrasound into other organs and other clinical applications.
Q: What is your strategy for gaining US reimbursement?
Right now, prostate ablation is cash pay. We expect to work with others in the field, most likely through your Foundation, to develop a coordinated reimbursement strategy that will benefit manufacturer, provider, payer, and patient all at the same time.
Q: What are the next indications that you are pursuing?
In addition to targeted ablation for other solid organs, we think that the market opportunities in using focused ultrasound as an enabling technology for other modalities is huge. Immunotherapy, stem cells, drug delivery, etc. – it looks like all will benefit from combining them with the use of targeted therapeutic ultrasound. We have already begun developing technology and exploring clinical studies in these and related areas.
Q: Any interesting challenges/opportunities you are pursuing?
Mapping dose – that is, knowing what you have delivered where – is a major challenge given that heat causes tissue to change size/shape/location. Figuring out how to identify and track these changes will help the field realize its full potential as a precision tool for achieving a desired end.
Q: Where do you see the field of focused ultrasound going?
I think it is very realistic to imagine a world where therapeutic ultrasound, in one form or another, plays a role in every medical intervention, be it as a monotherapy or in conjunction with some other therapy including drugs, radiation, surgery, and the body’s own natural agents (such as components of the immune system or stem cells).
Q: What has been the value of the Focused Ultrasound Foundation to your company and/or the field?
Having a knowledgeable partner who is committed to the advancement of therapeutic ultrasound regardless of form factor or underlying technology has been invaluable in messaging that there is a sound clinical approach for what we do, and that our approaches are in sync with the general movement in medicine toward less invasive and focal therapy.
Q: What role do you think that the Focused Ultrasound Foundation should play?
Despite each company in the field working to be successful on its own, having a “place” where we can discuss problems and issues – and have addressed needs – that are common to all of us will be important for the field’s success and for the success of each player in the field. FUSF has taken the lead in getting the message out and in increasing awareness as to the current and potential role therapeutic ultrasound does and can play. FUSF is ideally suited to act as a focus for efforts such as clinical trials across technologies, garnering reimbursement, and lobbying for recognition among national associations – in short, doing more of what it has been doing so successfully.