Take us back to 1972. What was the landscape like then for focused ultrasound? Was it just Dr. Fry and you?
Professor Frank Fry had just joined IU Medical School with his colleagues from Illinois to work with Dr. Heimburger who was the neurosurgeon who had used focused ultrasound to treat brain cancer. However, the treatments stopped in 1975-76. Thereafter, we were doing experiments to improve technology, but nothing was as rigorous as what you see today with focused ultrasound. I still remember going to the American Institute of Ultrasound in Medicine annual conference in 1975 or 1976 – and there were about 10 people who attended the session on high-intensity focused ultrasound (HIFU).
The late Frederic Lizzi, who was then a young scientist working at the Riverside Research Institute in New York, started collaborating with ophthalmologists at Cornell Weill Medical College to treat glaucoma using HIFU in the 1980s. They successfully treated glaucoma with Dr. Lizzi’s HIFU device and formed a company. The device received FDA approval for the treatment of glaucoma. Unfortunately, the company was not able to be sustained because laser technology came out around the same time, and the laser device was an easier way to treat glaucoma.
Dr. Padmakar P. Lele was a professor at MIT who continued HIFU research and published some significant papers, but he did not treat humans. And there were some scientists in Japan and elsewhere who also were investigating HIFU for other medical conditions but there was no significant impact in medical society.
People saw the promise, but there was no proper instrumentation and technology available to bring the pieces together.
Focused ultrasound was used in the past to treat glioblastoma. Why isn’t it used for that purpose now?
At that time, the instrumentation was limited. Sound waves can’t pass through the skull bone easily. That’s a major obstacle because the inner part of the skull bone is a honeycomb type structure, which alters the sound waves and requires fairly sophisticated technology to correct the aberrations.
In those days, a large section of the skull had to be removed, and then a wire mesh was placed on the brain tissue. Then the flap of the skin covered the hole.
It’s easy to understand why patients would not want that type of procedure.
Correct. That’s major surgery. Doing something that invasive defeats the purpose of focused ultrasound, which is to offer a noninvasive or minimally invasive option to traditional treatments. However, at the time, it was necessary to remove the skull to test the feasibility of focused ultrasound.
But patients were still reluctant, even if it could potentially save their lives?
We really did not get too many patients to accept that kind of invasive procedure, and the medical societies did not accept that procedure either. We had to stop doing what we were doing, and we said, “Let’s improve the technology to a point where it can be proven to be safe and effective.” So, the helmet invention by Insightec and others is an improved approach for treating brain cancer. If you can get the cancer-fighting drug into the brain, through the blood-brain barrier, you can control the tumor and perhaps a combination therapeutic approach can yield better outcomes.
When we started working on prostate disease, I found that it required much easier HIFU instrumentation. Years back, prostate cancer was detected at a very late stage. And by the time it was diagnosed, it had grown and become metastatic – so surgeons were forced to remove the whole prostate gland. Now, due to advances in diagnosis and improved imaging technology, prostate cancer is detected in its earlier stages, which allows for minimally invasive and effective treatment, for which HIFU is ideal.
So imaging and diagnosis advancements were necessary to advance to less invasive treatment options like HIFU?
Yes, now you are able to treat a very small tumor. You don’t need to remove the whole organ. There is no magic about it, if you identify the tumors early on, then you can treat them. Early detection is the most important part.
There are a couple keys to working with focused ultrasound. First, early detection, and second, ability to localize the disease. Where exactly is the tumor? So that is extremely important in the prostate cancer management. You need instrumentation and the ability to visualize or find a location. It’s like your GPS.
You need that GPS to get there. If you get there, focused ultrasound is a great tool. It can go deep inside the body, without damaging anything nearby and you can pinpoint the cancer.
Looking back on your career, what do you think is your most important contribution?
The way I saw the world was a little bit different. I could have stayed in the academic setting; but I had the urge to transform technology and bring the laboratory into the real world. That was something different … I don’t know what the word is maybe an “entrepreneur?”
You’ve said that your wife told you to “just go do it.”
Yes … that’s a funny story.
In 1987, Frank Fry and I had some success in licensing the HIFU technology for a very established medical device company. The company had some nice assets, and we did some good work with them. But in 1994 the company divested its business from the medical field and left our HIFU technology “orphaned.”
In 1995, along came, Mr. K. Takai, a businessman from Japan, who had received an approval from the Ministry of Health and Welfare to treat BPH with the Sonablate. Mr. Takai said, “Hey, this is a great thing that you have. Why could you not manufacture it?”
I approached the chairman of our department with this opportunity and said that Mr. Takai and his staff are going to bring some ideas and investment possibilities. Our chairman called an outsider for help to prepare for the meeting with the Japanese investors because, he said, he would like to have someone who knows how to run the business. However, that outsider person decided not to show up for the meeting.
At that time my wife said, “Why don’t you start the company?” So in collaboration with the University, the Japanese investor, my colleagues and I started Focus Surgery Inc. in Indianapolis in 1995.
And the rest is history.
It took its own course. People have been very kind to me. It’s a great feeling of gratitude for accomplishing something.
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