What is your vision for INSIGHTEC?
My vision for Insightec is to transform the lives of millions of patients. Our mission is to forge a new paradigm in healthcare, one that allows medical treatments to be performed with surgical precision but without incisions, all but eliminating the risk of infection and allowing patients to go home the same day. As focused ultrasound (FUS) becomes a mainstream treatment worldwide, this will have a considerable impact on reducing healthcare costs. More importantly, patients can quickly return to the important things in life.
Tell us about your company.
Insightec is one of the most exciting medical companies. We are experiencing rapid growth and adoption of our innovative FUS technology by physicians and medical centers around the globe.
Over the last 18 months, I have taken the helm with fresh capital to accelerate the expansion of MR-guided FUS. During that time, our first neurosurgery application, for essential tremor (ET), received FDA approval; a second peer-reviewed article was published in the New England Journal of Medicine; and we have begun the journey of obtaining reimbursement for FUS to treat ET. We have also expanded our footprint with offices in Israel, US, Japan, and China, and our global team of experts now exceeds 200 employees.
What are the key treatment areas in which you are operating?
We have developed a robust and flexible platform that can be applied to multiple clinical indications. Our strategy is to focus on the brain, although we have identified close to 100 applications appropriate for FUS. We see our greatest opportunity in diseases that have no good treatments to date. For example, the healthcare industry has poured billions of dollars of research into curing neurodegenerative disease, but decades of research have not produced a treatment that prevents, slows, or reverses many of these diseases. FUS has the potential to treat these as well as other diseases of the brain. Our company’s first commercial application in the brain is for the treatment of ET.
Let’s get technical here. Tell us about INSIGHTEC’s FUS technology and your system(s).
The company markets two commercial MR-guided FUS platforms. The Exablate is our workhorse and has performed more than 15,000 treatments for uterine fibroids and palliation of bone metastases. It was approved by the FDA in 2004 for treating uterine fibroids and in 2012 for pain palliation of metastatic bone cancer.
The Exablate Neuro platform (FDA approved in 2016 for ET) is simply a feat of technological excellence. The ultrasound transducer features advanced algorithms that allow 1,024 ultrasound beams to pass through the skull and target a focal point deep in the brain. This had never been done before now, and it is the first FUS device approved by the FDA to treat medically refractory ET.
What are some of the technical challenges your group has had to overcome to develop a fully noninvasive system?
The road has been filled with many challenges, but one of the major hurdles has become a key success of the company – neurosurgical procedures through an intact skull. Delivering ultrasound waves through an intact skull is not trivial and had never been done before. We are the first! Insightec devoted enormous resources and thousands of man-hours into developing sophisticated hardware and software that delivers treatment through varying skull shapes and thicknesses to a target deep inside the brain. The research and development (R&D) team has had major technological breakthroughs and has amassed considerable intellectual property during these efforts.
What do you see as your company’s key success factors?
First and foremost, our people. Our people are experts in their fields, whether it is engineering, software development, or marketing. Next, our commitment to technological innovation and excellence. We currently hold 90 worldwide patents. Finally, and most importantly, the impact we have on patients through our successful collaborations with leading academic centers around the world.
What challenges will you have to tackle moving forward?
The biggest challenge that we are tackling is making FUS a standard of care. Obtaining regulatory approvals, such as FDA, is the key step in achieving widespread use of FUS. The challenge for the industry is the lengthy time and enormous costs required to get new clinical applications approved and available for patients. Even after receiving regulatory approval, a treatment does not immediately become widely adopted. Reimbursement must be in place and be at an appropriate level. Here again is a difficult hurdle for us to cross. Before approving a new medical technology for reimbursement, insurance payers need to analyze clinical and economic data to determine the cost benefit of the new product compared to available treatments. We continue to build the evidence base to get reimbursement. In the interim, patients with ET who want to be treated with FUS have to rely on personal savings or crowdfunding to pay the expense out of pocket.
With more than 7,000 rare diseases affecting an estimated 30 million people in the US, there is a huge opportunity for non-invasive FUS. However, the process of getting a new treatment to a patient takes much too long - years of clinical studies for FDA regulatory approval and then years of data collection for reimbursement.
Let’s switch gears to Insightec’s clinical studies. What can you tell us about the scope of your clinical experience?
Insightec has invested more than $300 million into developing our MR-guided FUS technology to solve real clinical needs. Our clinical experience is considerable with more than 16,000 patients treated for a range of clinical applications including ET, pain palliation of bone metastases, and uterine fibroids.
We have conducted 48 clinical trials so far for hundreds of patients around the world and published more than 250 peer reviewed articles in scientific journals. The key clinical studies ongoing now include: the focal treatment of prostate cancer; disruption of the blood-brain barrier; epilepsy; brain tumors; targeted drug delivery for Alzheimer’s; neuro treatments with different targets in the brain; and lumbar back pain.
Tell us about your commercial success. How many systems you have installed around the world and what is the regulatory status of your FUS systems?
Our Exablate systems are currently in more than 80 medical facilities around the world and have performed more than 16,000 procedures.
The company has just begun commercialization of the ET procedure, with 553 patients treated worldwide, as of June 30, 2017. Many hospitals already have a backlog of patients waiting to receive treatment as well, and the list of centers performing the treatment is growing.
The company is also working to expand the indications of FUS in the brain; the roadmap includes neurodegenerative diseases like Parkinson’s, epilepsy, OCD, and depression. In parallel, thanks to more than 15 years of extensive clinical research, we are on the precipice of developing FUS technology to not just ablate, but to also disrupt and open the blood-brain barrier. This development is of monumental importance for the treatment of various brain diseases because it holds the potential to deliver targeted drug therapies. We are very early in the process, but have been encouraged with the early safety data on this technique.
Is there anything you would like to add regarding INSIGHTEC’s hopes and plans for the future?
Insightec is one of the most exciting companies in healthcare today. The company began with a vision almost 20 years ago, and today we are on the cusp of transforming healthcare in a way that hasn't been seen in a very long time. We are focused on our mission and completely committed to innovation because innovation improves lives - the lives of individuals who face challenging diseases.
Readers can visit http://usa.essential-tremor.com/blog/story to hear the stories of patients in their own words.