Tirat Carmel, Israel-based Insightec Ltd. has inked a deal for a series F financing of up to $150 million led by Koch Disruptive Technologies (KDT), a subsidiary of Koch Industries. The round, which has a post-money valuation of $1.3 billion, is earmarked for continued study of the company’s low-intensity, focused ultrasound technology in treating certain movement disorders.

KDT, which is making its second direct investment in Insightec, has pledged $100 million in the round, which is scheduled to close March 18. The remaining funds will be invested at a later closing.

“Including the signing of this latest investment, the company has raised more than $500 million to date,” Maurice Ferré, Insightec’s chairman and CEO, told BioWorld.

Insightec’s Exablate Neuro incisionless neurosurgery platform is the first magnetic resonance (MR)-guided focused ultrasound device to receive U.S. FDA approval for two movement-related neurological indications. The device was approved from medication-refractory essential tremor in 2016 and for medication-refractory tremor from Parkinson’s disease two years later. The device also has CE marking for those two indications, as well as for neuropathic pain.

Focused ultrasound works by focusing multiple high-intensity sound waves to heat and ablate the affected area deep inside the brain without the use of surgical instruments. MR imaging aids in procedure planning, real-time temperature monitoring and assessing the immediate results of the treatment.

Could improve medication response in Alzheimer’s patients

The technology could prove beneficial in treating other neurological disorders, and Insightec has tested Exablate Neuro in patients with Alzheimer’s disease and amyotrophic lateral sclerosis (ALS).

During the Radiological Society of North America meeting in December 2019, researchers presented initial results from a phase II clinical trial to assess the device’s safety and efficacy in the hippocampus and entorhinal cortex, regions of the brain that are key to memory formation and involved early on in Alzheimer’s disease.

The study plans to enroll 10 patients, but these early results were based on just three women with early-stage Alzheimer’s disease and evidence of amyloid plaques. Following each of three successive treatments at two-week intervals, MRI revealed that the blood-brain barrier was open and that it closed again within 24 hours. The technique could help drug candidates penetrate the blood-brain barrier, enabling them to be more effective.

“We’re excited about the progress in the Alzheimer’s research study and continue to enroll patients in the open multicenter trial,” Ferré said, adding that interim clinical data is under review for peer-reviewed publication. The Alzheimer’s study is on slated to conclude by December 2020.

Available worldwide

Insightec’s Exablate technology is being evaluated in a number of other clinical trials as well, including as a blood-brain barrier disrupter in glioblastoma patients, to treat benign brain tumors in children and as a treatment for epilepsy patients who don’t respond to medication.

“Insightec’s focused ultrasound technology is disrupting the way surgery has been performed for generations,” said Chase Koch, president of Koch Disruptive Technologies. “KDT is focused on empowering innovative companies and helping them realize their potential to improve the lives of millions of people.”

Exablate Neuro is currently available in more than 65 treatment centers in North America, Latin America, Europe, Asia, Australia and the Middle East, and the essential tremor treatment has coverage approval in the U.S. and a number of countries.

With growing adoption of its technology and a series F financing underway, Insightec could be in the position to consider longer-term strategy and an initial public offering. Ferré, who joined Insightec in 2014, has prior experience ushering companies through that process; as CEO of Mako Corp., he guided the surgical robotics company through its 2008 IPO and its later 2013 sale to Stryker Corp. for $1.65 billion.

But he insists an IPO is not on Insightec’s radar just yet. “With this financing, we and our investors are focused on growing this technology and our business, not on an exit strategy,” he said.

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