Medical Device Daily Correspondent

ZICHRON YA'AKOV — Every year Red Herring selects the top 100, most promising privately held technology companies and start-ups in Europe, the Middle East and Africa (EMEA) driving the future of technology.

This year, Israel ranked fourth on Red Herring list of 100 for Europe, with 10 Israeli start-ups selected, including four medical device developers.

Israel 's total of 10 firms ranked fourth on the list after the UK (24), Germany (14), and France (12), and came in ahead of Switzerland (7), the Netherlands (5), and Ireland (4).

Those four Israeli medical device companies are:

• BrainsGate (Ra'anana), the developer of a miniature implanted device that dilates arteries to electrically stimulate reperfusion across the blood-brain barrier following ischemic stroke, and could be used to deliver drugs to the CNS.

• InSightec (Tirat Carmel), developer of a non-invasive surgery. Its ExAblate system uses MRI in 3D, in real time, to guide Focused Ultrasound (MRgFUS), a non-invasive treatment alternative with the potential to replace traditional surgery, the company says, while reducing trauma and morbidity to patients.

• Lumus (Rehovot), founded in 2000, is developing an innovative optical imaging technology displayed into a visual field of the viewer via a pair of ordinary looking eyeglasses, enabling a wide range of ultra-compact personal displays for mobile applications. This augmented reality optical display could integrate intraoperative mapping and preoperative surgical planning systems (such as that of InSightec) directly into the visual field of a surgeon and team, by projecting images and data from computers, DVD players, or VCRs. The "see-through" technology came out of research that originated in the optics group at El-Op (Rehovot), Israel's largest electro-optic systems developer and manufacturer.

• TransPharma Medical (Lod) developer of a transdermal drug-delivery system for large molecules integrated into ViaDerm. The patented device is based on the company's RF-MicroChannel technology. Because painless, needle-free and user-friendly, the system is designed for home use.

Merging 'miracles'

Ness (Ra'anana, Israel) reportedly is in negotiations to be merged with Bioness (Santa Clarita, California) — a merger of miracles since in Hebrew "ness" means "miracle."

Bioness has the exclusive North American distribution rights for Ness products, including the L300, late non-invasive neuroprosthesis.

Bioness was established in 2004 by the well-known medical device entrepreneur Alfred Mann, the Alfred E. Mann Foundation for Scientific Research, and Ness. In addition to selling and marketing the Ness line of products, Bioness also develops implantable technologies to address the rehabilitation and neuron-recovery markets.

The combined entity would be headquartered in California and run by Yitzhak Zilberman, president/CEO of Bioness.

He told Medical Device Daily that the combination "would bring together proven products that are already in the marketplace and future technologies currently developed by Bioness."

Just last week, Amit Dar, head of R&D for Ness, presented the company's latest non-invasive neuroprosthesis, called NESS L300, at the second Israel Innovation Summit at the International Convention Center (Haifa), where experts in 10 fields including storage and data mining, information security, photonics, cardiovascular diagnostics, rehabilitation, orthopedics, neurosciences, immunotherapy and cancer, met in parallel and together.

Since a picture is a thousand words, Dar provided a video clip demonstrating how the placement of the elegantly designed wireless system is planned to improve gait in people suffering from foot drop, a condition common to individuals suffering from central nervous system trauma, injury or disease that results in weakness or paralysis of muscles of the lower leg.

Shmulik Shany, CEO of Ness, told MDD, "It is hoped that the NESS L300 will both help reduce the overall long-term cost of stroke and lead to better clinical outcomes for individuals suffering from these conditions."

The system consists of an electronic Orthosis that wraps around the knee, an Intelli-Sense Gait Sensor placed under the heel, and a Control Unit.

While the person walks, the sensor detects whether the foot is in the air or on the ground and transmits this information wirelessly to the electronics of the Orthosis. The Orthosis in turn provides synchronized electrical stimulation to the targeted muscles and nerves of the affected leg to provide dorsiflexion of the foot, thereby increasing toe clearance during the swing phase of ambulation and improving the individual's overall gait.

"The NESS L300 device has begun to shift the attitudes for both professional health care providers and individuals suffering from stroke. The NESS L300 may prove to be a new standard in care for these patients, as dramatic changes in gait, or walking patterns, are clearly visible for many NESS L300 users," said Dar.

News of new products

• The ExAblate MRgFUS System from InSightec was approved for sale in Canada (March 12). Health Canada granted regulatory approval to the ExAblate for the treatment of symptomatic uterine fibroids.

• NiliMedix (Haifa) in late March filed a 510(k) fast-track application for FDA approval of its disposable insulin pumps. The company anticipates an answer within 90 days. NiliMedix said that it could commence marketing its products, if approved, immediately.

NiliMedix says that its insulin pumps are small and light, and break down less often since they have no moving parts such as motor or reduction gear.

• Brainsway (Jerusalem) reported that its Deep Transcranial Magnetic Stimulation device produced good intermediate results for patients suffering from depression who have failed to respond favorably to at least two psychotropic drugs. The patients have suffered no significant side effects.

Brainsway conducted safety trials of Deep TMS for depression (which correspond to Phase IIa clinical trials of drugs), and the company said it expects to complete the trial in May or June. If the results are positive, it can apply for the final, multi-center, trial, which corresponds to Phase III clinical trials for drugs.

The company has been negotiating with medical centers for these trials. Brainsway's IPO (January 2007) was four times oversubscribed.