Medical Device Daily Contributing Writer

Along with Israel's strength in diagnostics (highlighted in yesterday's issue), the country's active entrepreneurial community features a broad range of companies in imaging, life sciences and biological processing.

Following is a review of some of the most interesting players in these spaces.

• Biological Industries (Kibbutz Beit Haemek) manufactures reagents and kits that are sold to the life sciences R&D market for use in animal cell culture and for molecular biology. Its line of tissue culture products includes proprietary media products that are used in cytogenetics laboratories for amniocentesis and leukemia testing.

These products have a large market share in European and Asian countries and are sold directly to end-users in the U.S. Current R&D efforts are directed at developing novel products for use with stem cells and for in vitro fertilization.

• Molecular Cytomics (Ramat Gan) has developed the Optical LiveCell Array, a high-content analysis (HCA) and high-content screening (HCS) tool that enables both the study of individual living, adhering cells as well as individual, non-adhering cells such as blood or bone marrow, within a population.

Its disposable format can be used with any standard upright or inverted microscope and does not require a major capital investment in mainframe equipment. Current cytometry methods do not offer long-term sequential measurements on the same individual cells or group of cells.

• OrSense (Rehovot) develops noninvasive blood monitors. Its devices perform spot or continuous monitoring of glucose, hemoglobin, hematocrit and oxygen (Sp0₂), and other blood constituents and cardiovascular markers. OrSense's patented technology is known as “occlusion spectroscopy.“ It involves the extraction of strong optical signals by performing short occlusions of the blood flow in a patient's finger using a pneumatic air cuff combined with sensitive optical measurements.

Occlusion spectroscopy overcomes key technological barriers related to the very low signal-to-noise ratio inherent in blood measurements which are not resolved by competitive approaches.

The company recently started to market its NBM-100 noninvasive device that determines hemoglobin levels. It is targeting anemia screening and monitoring of blood donations, critical care and other clinical applications. The NBM-100 received the CE mark in January 2005 and market clearance from the FDA is being sought. In development is a noninvasive blood glucose monitor for home use and in-patient use.

• Glucon Medical (Petach Tikvah) is developing a noninvasive and continuous blood glucose monitoring device for clinical and personal use. The device employs patented photoacoustic technology. It is light weight and wearable. The combination of optical and sound-based technologies results in enhanced specificity and sensitivity of the glucose measurements that are obtained directly from inside the blood vessel. The company's desktop prototype device is currently undergoing clinical trials. Initial results compare favorably with conventional invasive blood glucose tests.

• Itamar Medical (Caesarea) markets a line of products for diagnosing sleep apnea that use the peripheral artery tone (PAT) signal as a noninvasive window to the autonomic nervous system. Its Endo2000 unit provides an objective assessment of endothelial function by measuring the PAT signal response to reactive hyperemia. The Watch-PAT 100 is a home-care device for diagnosing sleep apnea disorders. The company has developed unique signal processing algorithms for using arterial peripheral arterial tonometry in various clinical applications for understanding and managing cardiovascular, respiratory and nervous system disorders.

• Oridion (Jerusalem) is a marketer of respiratory monitoring systems and breath testing analyzers. The company's Microstream core technology is based on molecular correlation spectroscopy. Its clinical applications are for capnography and breath test diagnostics. Capnographs are used to monitor a patient's ventilation status and for ensuring the proper placement of endotracheal tubes. The company's VitalCap portable capnograph can be integrated with installed bedside and central station displays. Point-of-care testing of CO₂ in breath is used for assessing liver function, gastric emptying disorders and peptic ulcers (H. pylori).

• Medisim (Airport City) develops a line of instant thermometers that utilize its patented technology, dubbed R.A.T.E. (Rapid, Active, Temperature Establishment).

This conduction-based technology is used to measure heat flux emitted from deep tissue, unlike infrared thermometers which only measure skin surface temperature. It utilizes algorithms and a proprietary sensor to accurately determine body temperature in six to eight seconds. Medisim's M5T thermometer can provide readouts from measurements taken under the arm, orally or rectally and is suitable for neonates and infants. Its FHT product line includes the FHT1 forehead thermometer and the FHT2 forehead and underarm thermometer.

Its CaseOnline advanced wireless temperature monitoring system is used for continuous measurement of body temperature 24 hours a day. Medisim's thermometry technology is being used by global OEM manufacturers.

• QuantomiX (Rehovot) markets in the U.S. and Japan a system that enables scanning electron microscopes to image and analyze wet samples of cells and tissue biopsies in their native environment without compromising sample integrity. It can be used to image lipids in cells and tissues for quantitative analysis in metabolic syndrome research. For treating obese and diabetic patients, the system is used to monitor the accumulation of lipids in the tissues at the cellular and subcellular levels.

• V-Target Technologies (Tirat HaCarmel) has developed a nuclear medicine imaging technology that provides high resolution reconstructions and enhanced sensitivity. Based on its BroadView imaging platform, V-Target's technology generates images that enable the detection of abnormalities as small as a few millimeters in size and with efficiency greater than that of conventional Gamma/SPECT cameras currently in use. This new imaging capability can improve diagnostic testing, surgical guidance and treatment monitoring for a wide variety of indications. The company's first products are a miniature transrectal camera for early detection of prostate cancer and a very high speed cardiac functional camera.

• TopSpin Medical (Lod) has developed a novel technology for local high-resolution MR imaging using a miniature hand-held probe incorporating all magnetic field sources and eliminating the need for external magnets and a costly MRI scanner. This technology extends the tissue characterization capabilities of MRI to a new range of clinical applications, such as the detection and staging of cancer in the prostate and colon, as well as for intravascular imaging.

Use of TopSpin's MRI catheter during cardiac catheterization will enable interventional cardiologists to guide therapy to vulnerable plaques and potentially reduce cardiac event rates.

• Spring Diagnostics (Rehovot) has developed a system to identify bacteria by utilizing a fingertip type profile of the bacteria surface antigens. This information can be used to determine the virulence and antibiotic resistance, helping to define a course of treatment.

The system yields results in only two to six hours. It is based on a signal obtained from the reaction of the tested bacteria with a large series of specific markets immobilized onto a diagnostic surface. A digital camera photographs the diagnostic surface and image analysis is used to determine the diagnostic profile of each tested bacterium. The number of markers needed for determining the bacterial type and species ranges from a few to several hundred and is stipulated by the special characteristics of each species. The technology has potential application in the medical, veterinary and food industries.

• NeuroTrax (Modiin) markets the Mindstreams interactive computer program to physicians for objectively measuring cognitive function for use as a diagnostic aid and for guidance in making treatment decisions. Its principal application is for the early detection of dementia. It can also be used in evaluations of attention deficit hyperactivity disorder, Parkinson's disease, traumatic brain injury and drug abuse. Mindstreams objectively measures performance in the domains of memory, attention, visual spatial perception, information processing speed, verbal skills and motor skills via a battery of game-like interactive tests. A Mindstreams assessment report is available to the physician within seconds and contains clinically useful graphs and written summaries of the test results.