TURNING A REVOLUTIONARY MEDICAL CONCEPT INTO REALITY: THE INSIGHTEC STORY
NOTE: This blog post summarizes a lecture given to students at the Kellogg School of Management, by Kobi Vortman, PhD., INSIGHTEC’s Founder and Vice Chairman of the Board.
Discovering the next medical advancement that will change the face of medicine as we know it today, is a goal that many bio-tech entrepreneurs would like to achieve. The challenge in achieving this goal is that (1) the technology not only needs to prove its clinical efficacy over current medical treatments, but (2) it also needs to prove its commercial value, making it worthwhile for medical institutions to invest in them.
Traditional Surgery & INSIGHTEC: The Value & Lessons Learned
Surgery has been known to mankind for ages. We have proof of Craniotomies that were done ~10,000 years ago and the patient survived. If surgery survived for such a long time in an ecosystem that is changing quite rapidly then it must have a number of highly desired attributes, right?
I believe these unique attributes include focal therapy (to differentiate from systemic therapy), real time feedback on treatment outcome that is generated by vision and palpation, and lastly, the ability to fix functionality if needed.
Surgery’s challenges on the other hand include: Trauma to the body, slow recovery, collateral damage (on the way to the target), 5-10% adverse events on average and unfortunately morbidity.
The Vision Behind INSIGHTEC
The burning desire behind INSIGHTEC was to develop a non-invasive, outpatient therapy that will allow patients to go back to their lives in a matter of days.
We wanted to find a way to treat different indications focally, while maintaining the ability to have real time feedback on treatment outcome, and at the same time, minimize some of surgery’s disadvantages, such as the trauma, morbidity, slow recovery and risk of adverse events.
It took us a while to find a practical way to realize this vision and reach a feasible concept that we could start implementing.
Implementation of INSIGHTEC’S Vision to Reality
So what were the practicalities we were looking for in searching for a way to replace surgery with a non-invasive technology?
We wanted to see through the patient’s body, making it transparent.
Next, we wanted to develop a way to destroy targeted tumor deep inside the anatomy without causing any collateral damage or harm adjacent tissue.
We also wanted to maintain a key advantage of surgery: Real time feedback on tissue viability that will allow us to monitor treatment outcomes in real time.
And, we wanted this new technology to be significantly safer than surgery (our target was less than 1% adverse events) as well as offer fast recovery while minimizing trauma and morbidity.
Now that we had our road map and targets, we started working through the issues one by one.
Our starting point was that we can achieve patient “body transparency” using existing body imaging methods such as CT and MRI (Ultrasound’s imaging capabilities are less efficient).
We came up with a treatment flow where the surgeon is continuously using the imaging capabilities in order to assess the anatomy. This eliminated CT as an option since it uses ionizing radiation and continuous use is unacceptable.
When we looked into real time tissue viability feedback, we understood that the only accepted surrogate to tissue viability is temperature. 100% cell death is achieved at 60ºC for ~0.1sec. MRI has the ability to measure temperatures with 1ºC accuracy and 1mm geometrical resolution.
But a big question remained unanswered: How can we use heat, non-invasively, to target only specific tissue while sparing non-targeted tissue?
We chose an acoustic beam as it propagates through soft tissue with minimal impact. When the beam is focused, intensively, very fast heating takes place, bringing the tissue to ablation.
The acoustic beam could be steered inside the anatomy using a combination of a robotic system and an electronic steering to fully ablate a tumor.
We already have over 120 medical facilities all over the world using MRgFUS. We are constantly working to obtain regulatory approvals for all of our applications, making the case for insurers to cover these treatments to their patients, and educating patients and physicians about MR-guided Focused Ultrasound.