ARTICLE SUMMARY:
It took Insightec a decade and a few false starts with its incisionless focused ultrasound technology before discovering its pioneering use as a noninvasive therapy for Essential Tremor and Parkinson’s Disease, conditions that previously lacked effective device treatments. It took even longer to navigate the uncharted waters of moving from a cash pay to a reimbursement model for both Medicare and private payors, but the company survived the journey and patients are benefiting worldwide.
In medical devices, the path between coming up with a new technology and figuring out a viable clinical application for that approach can be anything but linear. It is not unusual for emerging product companies to try out novel techniques in a number of clinical areas before hopefully finding the perfect fit. While that indirect discovery route is well known in the industry, less obvious is the course by which such a company establishes the market access pathway for that technology since gaining reimbursement depends on knowing a company’s primary clinical space. The uncertainties of the market access process are only heightened when a company is looking to launch an innovative technology that breaks new ground. And when the journey takes more than 20 years, that increases the challenges.
That is the story behind Insightec, which is pioneering the use of MRI-guided focused ultrasound (MRgFUS) using its Exablate system as an incisionless therapy to treat conditions like Essential Tremor and Parkinson’s Disease. These conditions have previously been primarily the province of drug therapy, often with limited success and significant risks resulting from side effects, or extremely risky procedures like deep brain stimulation, which patients are reluctant to undergo.
