Promising trials for InSightec's brain-zapping treatment

Insightec on Wednesday reported encouraging Phase 1 clinical test results for its pioneering ExAblate Neuro system, which provides a non-invasive alternative for treating chronic neurological disorders.

The trials were conducted on 30 patients suffering from Parkinson's, essential tremor, and neuropathic pain.

InSightec is a private company, 69% owned by Elbit Medical, the medical division of Moti Zisser's Elbit Imaging group. Its ExAblate Neuro system aims focused ultrasound beams guided by magnetic resonance through the skull to treat tissue deep in the brain without requiring incisions or radiation. The system demonstrated the ability to burn away targeted tissue deep in the brain with high precision. The treatment could become an alternative for patients on whom surgery can't be performed or for those refusing to undergo invasive brain procedures.

InSightec CEO Kobi Vortman explained that the system focuses treatment at the center of the brain and destroys two to three millimeter areas of the thalamus, the collection of neurons near the midbrain responsible for sensory information processing. This causes a significant reduction or complete cessation in symptoms such as tremors, speech difficulties, and walking difficulties among Parkinson's patients.

This treatment for patients with neurological diseases can provide an alternative to surgery or other invasive procedures, such as deep brain stimulation (DBS ) in which electrodes are placed at the center of the brain in order to electrically stimulate the nerve center. According to estimates, 10% of sufferers from functional neurological illnesses now require surgery, radiation, or DBS.

Vortman added that a significant number of patients in the study were found to respond to treatment with low-intensity ultrasound beams - that is, at relatively low temperatures which do not damage the brain. According to Vortman, 30 of the 33 patients meant to take part in the Phase 2 study have already been recruited, and he expects the company to begin the next stage of clinical trials midway through 2012.

InSightec was founded in 1999. Its ExAblate Neuro system has been used until now to treat uterine fibroids, but has been hampered by the fact that, despite having U.S. Food and Drug Administration approval, few U.S. insurers include the treatment in their coverage. Among those that do, UnitedHealth Group only offers refunds for its premium policy holders. Tricare - the health care provider for members of the U.S. defense establishment and armed forces - also offers coverage for the procedure, but both companies only provide coverage equivalent to the cost of the alternative treatment, hysterectomies, at $8,000.

InSightec has so far treated about 7,500 of these patients, 427 of them in Israel through systems installed at Rambam Medical Center in Haifa and Sheba Medical Center at Tel Hashomer. But in Israel too this is limited by insurance coverage by the major health funds. InSightec's revenues for the second quarter of 2011 were $1.3 million, compared with $2.1 million in the parallel quarter of 2010.

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Promising trials for InSightec's brain-zapping treatment