Medical Device Daily Contributing Writer
ZICHRON YAAKOV, Israel – The Israel Venture Association 's (IVA) annual Hi-Tech Conference, this year dub-bed, “From Idea to Value Creation,” was alive with life – life scientist participants, that is, showing off their medical device inventions in progress to their high-tech counterparts, and especially to the nearly trillion dollars in venture funding estimated to be represented among the 1,000 participants June 19-20 at the David Intercontinental Hotel in Tel Aviv.
The top nine entries to the first Israeli Startup Contest, sponsored by Red Herring, the American technology magazine, in conjunction with the IVA were selected as finalists in three parallel competitions – communications, software and life sciences.
The three life science winners were all medical devices, two with a strong IT component.
Brainsgate (Raanana) won out as the life science category champion over Deepbreeze (Or Akiva) and Mazor Surgical Technologies (Caesaria). But Red Herring owner, chairman and chief editor Alex Vieux, who led some of the liveliest conference sessions, hastened to add, “These finalists are all winners, chosen for their future vision, technological breakthroughs into application and potential global impact” – the criteria for nomination.
“No one else is using our unique approach. Our NeuroPath System uses a miniature electrode implanted in the roof of the mouth. It is triggered by a wire to electrically stimulate the spheno-pallatine ganglion [SPG],” Raveh Gill-More, BrainsGate vice president of business development, told Medical Device Daily.
He added: “Stimulation of the SPG augments blood flow by opening vessels and also increases permeability of the blood-brain barrier.”
Gill-More said, “We are working on two major application platforms: to deliver drugs that now do not reach the CNS, and also in treatment of acute ischemic stroke via increased blood perfusion.”
With the data from animals, and now from clinical studies of patients with end-stage glioblastoma, Brainsgate hopes to obtain FDA and CE-mark approval for brain cancer, while starting trials for the ischemic stroke application. Gill-More said there are more than 1.7 million stroke cases annually in the U.S. and European Union.
There is a critical six- to 12-hour window after stroke within which early intervention to bring blood flow to the affected area of the brain can prevent stroke damage.
Brainsgate has raised $23 million since it was founded in 2000.
Mazor Surgical Technologies has developed a surgical-assist robot for exacting spinal procedures that operate within 1 mm to 5 mm of the spinal cord. About 10 hospitals have installed SpineAssist, including three in the U.S.
SpineAssist enables precise medical image-driven robotic guidance and navigation for precise and repeatable insertion of implants in a patient's lumbar spine, using micro-incision and minimal exposure to harmful X-irradiation, yet bringing dramatically superior result, CEO Ori Hadomi told MDD.
He showed how the patented miniature robotic guidance device automatically pinpoints the designated site for surgical intervention based on a physician's digital surgical plan obtained by preoperative scanning with Spine Assist.
Used in combination with the Hover-T-Bridge, the physician threads a miniature operating tool through the SpineAssist guidance arm to implement the planned intervention, tested with implant systems manufactured by Johnson & Johnson, Medtronic, Abbott Spine, Zimmer, Stryker and other leading manufacturers.
“With over 500,000 spine surgeries carried out annually in the U.S. alone, mistakes are commonplace, with high risk of irreparable nerve or other damage,” Hadomi said. “Our high level of precision opens the door to a new era of spinal and other surgery, which we hope will set a far higher standard in orthopedic operating rooms within a few short years.”
Mazor has raised $20 million since it was founded in 2001.
Igal Kushnir, a physician, said that he never approved of the wide-scale use of X-irradiation to screen for possible disease signs in the body, so he developed Vibration Response Imaging (VRI), which measures energy generated in the lungs and can give doctors real-time images of the lungs without dangerous radiation.
Deep Breeze's proprietary, radiation-free, acoustic imaging core technology seeks to become the leader in non-invasive lung and cardiac diagnostic solutions, currently focused on completing the development of its initial revolutionary product, the Passive Acoustic Lung Imaging Scope.
VRI has received the CE mark and is ISO-certified. Deep Breeze said the VRIXP system has received a CE mark, allowing the company to market the technology to physicians in European Union countries.
Vibration Response Imaging provides physicians with a dynamic image of the lungs, Deep Breeze is currently conducting clinical studies globally, evaluating VRIXP efficacy in critical-care patient management, interventional pulmonology, and monitoring of asthma, congestive heart failure and lung transplant patients.
Deep Breeze has raised $19 million since it was founded in 2001.
The Israeli finalists are the cover story of the June 19 issue of Red Herring.
One of the competition judges, Dr. Shimon Eckhouse, was himself honored with the Israel Hi Tech Award. IVA Chairman Yoram Oron, said, “The award is a token of gratitude for his impressive achievements as a veteran entrepreneur, a role model for all new entrepreneurs.”
Eckhouse is chairman of Syneron Medical and was instrumental in founding and management of a number of other med-tech companies, including start-ups CardioDex, ColorChip, Edge Medical Devices, OrSense, NanoCyte and Replicom. He serves on the board of WideMed, and was an essential founder of ESC Medical Systems (now Lumenis).
Alan Hevesi, comptroller for the state of New York, was also was awarded this honor. He manages the $100 billion NYS Common Retirement Fund (NYSCRF). Under his management, NYSCRF has become the major investor in leading Israeli investment fund Markstone Capital Group; and recently committed NYSCRF to an additional $100 million investment in Israeli venture capital funds.
CritiSense raises $1.2 million
Israeli device start-up CritiSense has raised $1.2 million to take CritiView (CRV), its first generation product to clinical trials in 2007.
CRV is a patient monitoring system providing real-time continuous information via four physiological parameters, sensed at the tissue level that indicate a patient's systemic metabolic state, especially important in patients undergoing surgery or in intensive care units.
The round was led by U.S. venture capital firm Bridge Investment Fund (Cleveland), along with Clarion Group CEO Morton Cohen, Pontifax and Docor International.
CritiSense, founded in 2004 on the basis of intellectual property bought from Vital Medical, which closed operations, developed CRV by the company's co-founder and chief scientist, Avraham Mayevsky, former department head of life sciences and dean of the faculty of natural sciences at Bar Ilan University.
CRV uses an optical sensor for continuous, real-time multi-parametric physiological data at the tissue and cellular level, by monitoring mitochondrial function, microcirculatory blood flow and oxygen saturation, by way of tissue titration therapy.
Bridge Investment was founded to invest primarily in early stage Israeli medical device companies that are backed by venture capital, and are looking to establish a presence in Northeast Ohio. Symbionix is one of its portfolio companies.
It has $6 million for investment, but aims to raise another $15 million. It is managed in Ohio by former AOL business development manager Michael Goldberg, and in Israel by Avshalom Horan, former RadBiomed manager and Bank Leumi, chief technology investment officer; and Ariel Halperin, Tene Investments partner.
Horan said, “CritiSense didn't approach us because of our money. Rather, it was interested in taking advantage of Bridge's relationships with the Cleveland Clinic, University Hospitals of Cleveland and BioEnterprise Corp., a non-profit organization that assists Northern Ohio healthcare companies.”
Blood sugar measurement breakthroughs
OrSense (Nes Ziona) and Glucon (Petach Tikva) both reported encouraging results of clinical trials at the American Diabetes Association 's (Alexandria, Virginia) annual meeting in Washington earlier this month.
No other companies had data from non-invasive blood sugar testing.
The OrSense device, the NBM-100G, uses a ring-like finger cuff that reads using occlusion spectroscopy, a method shown to generate continuous real-time optical signals across the finger, overcoming the key technological barrier to high sensivity needed to decipher the very low signal-to-noise ratio.
A study of 24 patients at the Sheba Hospital (Tel Hashomer) found that the optical readings were as sensitive and as accurate as needle pricks taken by Type 1 and Type 2 diabetic patients under home conditions.
Glucon's device for blood-sugar measurement reads blood glucose levels directly from a blood vessel, without puncturing the skin, using a novel photo-acoustic (optical and sound-based) technology, to give results that are as precise as invasive blood sugar measurement devices.
Both companies are preparing to mount FDA-guided clinical trials to prove that their devices are precise and sensitive enough to be approved as alternatives to glucometer readings, which need a drop of blood obtained by fingerstick.