InSightec – 2013 Fierce 15

InSightec CEO Kobi Vortman

Based: Tirat Carmel, Israel
Founded: 1999
CEO: Kobi Vortman

The Scoop: The secret's out that Israel is a global breeding ground for innovation in medical technology, but while Given Imaging ($GIVN) and its PillCam grab most of the headlines, the lesser-known InSightec has quietly become Israel's most interesting medical device outfit. The company has long since demonstrated the value of its focused ultrasound technology in treating uterine fibroids, and now InSightec is gearing up for its most ambitious project yet, training its device on the brain with the goal of treating Parkinson's and other neuropathic diseases.

What Makes It Fierce: InSightec began not with a spinout, a tech transfer or even a disease target. Instead, CEO and co-founder Kobi Vortman said, the Israeli ultrasound pioneer was formed around a single question: What is good and bad about surgery?

"Surgery today is not that different from surgeries done hundreds of years ago. The tools have changed, sure, but at the end of the day, it's still a surgeon using his knowledge and vision to operate on a patient," Vortman said. "We wanted to replace existing surgeries with a completely noninvasive, outpatient, next-day-back-to-your-life-technology."

Pooling their experience as trained engineers in Israeli's huge defense industry, Vortman and his colleagues came up with ExAblate, technology that pairs magnetic resonance imaging with ultrasound ablation, allowing surgeons to blast away diseased tissues while leaving nearby flesh unscathed. The device works by using a highly focused acoustic beam to rapidly increase the temperature of targeted tissue. Using MR, surgeons measure in situ temperature within 1 degree, Vortman said, and ExAblate can burn away dysplasia while barely affecting tissues just 1 millimeter away.

InSightec's first target was uterine fibroids, using ExAblate to provide a non-invasive therapy for an affliction whose gold-standard therapy has long been hysterectomy. After years of clinical study, the company secured FDA approval for the system in 2004 and has since installed ExAblate in about 110 hospitals, Vortman said. This year, InSightec secured Health Canada and Chinese FDA approvals for the system, helping it expand its footprint around the globe.

But perhaps most promising is ExAblate Neuro, InSightec's bet that targeted ultrasound energy can do for thalamic dysplasia what it does for uterine tissues, giving the company a chance to treat Parkinson's disease and related ailments.

In a pilot trial, the system successfully suppressed essential tremor, a Parkinson's-related disorder that affects about 10 million people in the U.S. alone. Last month, InSightec kicked off a pivotal trial aimed at FDA approval for ExAblate Neuro, and Vortman said the company expects to get it indicated for essential tremor by 2016. After that, the company plans to expand the system into Parkinson's and neuropathic pain--it's already CE marked to treat both overseas.

And InSightec's cranial focus doesn't stop there. The next dispatch for ExAblate Neuro will be epilepsy and brain tumors, and InSightec has some promising early data on its technology's potential to blast away cancerous cells without requiring so much as a scratch.

To get there, it'll need more R&D money, something that hasn't been in short supply. InSightec is largely bankrolled by GE Healthcare ($GE), and the global giant ponied up $27.6 million of InSightec's $30.9 million Series C in December.

What To Look For: The applications for InSightec's technology are virtually limitless, Vortman said, and the company has its eye on increasing tissue permeability for targeted drug delivery and ablating tumors in the liver, to name just two. But the end goal, he said, is leading the way toward "an operating room of the future," in which every attribute of surgery that got tossed in the "bad" column all those years ago is rendered obsolete, and most procedures can be done noninvasively.

For more:
InSightec rides into Canada with uterine fibroid device
InSightec takes to China with uterine fibroid device
InSightec's surgery-free brain tech eases tremor in study
GE Healthcare vet to lead Israeli devicemaker
InSightec scores $13.75M from GE

-- Damian Garde (email | Twitter)

InSightec – 2013 Fierce 15