Heartpoint Inc

Heartpoint Inc

Due to an editing error, a figure reporting venture capital raised by Heartport Inc. (Redwood City, California) was incorrectly stated in the December 1995 issue. The correct figure is $25 million, rather than $425 million.

Table 9


* Advanced Technology Laboratories (ATL; Bothell, Washington) and Hitachi Medical Corp. (Tokyo) have reached agreement to establish a joint venture for the development of advanced ultrasound technologies. The agreements also call for Hitachi to be ATL’s distributor in Japan, with emphasis on ATL’s HDI 3000 ultrasound system.

* ALZA Corp. (Palo Alto, California) and U.S. Bioscience (West Conshohocken, Pennsylvania) have signed a distribution agreement for Ethyol, a U.S. Bioscience cytoprotective agent for the reduction of the cumulative renal toxicity associated with repeated administration of the chemotherapeutic drug cisplatin in patients with advance ovarian cancer. The drug received Food and Drug Administration approval for U.S. marketing in December 1995.

* Hycor Biomedical Inc. (Irvine, California) has Signed a development and manufacturing agreement with Vital Scientific NV (Spankeren/Dieren, the Netherlands), a manufacturer of scientific instrumentation, including blood chemistry analyzers. The agreement will provide Hycor with an instrument for use with its Hy-Tec allergy and autoimmune diagnostic tests. Vital Scientific is a subsidiary of Novitron International Inc. (Newton, Massachusetts).

* Inhale Therapeutic Systems (Palo Alto, California) has entered into an agreement with Asahi Chemical Industry Co. (Tokyo) to test a pulmonary version of an Asahi proprietary drug for osteoporosis using Inhale’s deep-lung drug delivery technology. Inhale will develop a dry powder formulation for use in the Inhale delivery system and, with Asahi Chemical, will test that formulation in initial human clinical studies.

* LaserSight Inc. (Orlando, Florida) has signed an exclusive license agreement with the University of Southern California (Los Angeles) to commercialize a new device that will improve photorefractive keratectomy with any excimer laser. The device, developed by Dr. Peter McDonnell and others at the university’s Doheny Eye Institute, allows the ophthalmic surgeon to more precisely remove the epithelial layer of the cornea and begin corneal sculpting.

* Ostex International (Seattle, Washington) has entered into a worldwide agreement with Wyeth-Ayerst Laboratories (Philadelphia, Pennsylvania) to promote the sale of both the Ostex bone resorption assay, Osteomark, and Wyeth-Ayerst’s osteopororis therapy, Premarin conjugated estrogens.

Source: The BBI Newsletter

Product briefs

* Anagen plc (London) has received Food and Drug Administration approval for U.S. marketing of a new assay designed to measure testosterone levels. The assay is the 16th for which Anagen has received FDA approval for use with the company’s AuraFlex automated immunoassay system.

* Baasel Lasertechnik (Stamberg, Germany) has developed the Vasognost flash-lamp, pumped-dye laser, featuring modular construction, selectable wave lengths, pulse durations and pulse frequencies. The system includes dye kits that are available up to 60,000 pulses.

* Behnk Elektronik (Norderstadt, Germany) has launched its TRT Thrombotimer, a manually operated coagulometer using an opto-mechanical measurement system. Battery or main power supply can be used.

* Biocircuits Corp. (Sunnyvale, California) will file 510(k) pre-market notifications with the FDA for three new assays, including a test for thyroid stimulating hormone, a serum pregnancy test and a quantitative hCG pregnancy test.

* Biomedica (Vienna, Austria) has available a new ELISA autoimmune test kit that detects and quantifies the presence in serum samples of human autoantibodies to oxidized low-density lipoproteins (OXLDL). The three-hour ELISA microplate assay only needs a 50-microliter patient serum sample.

* Bosch & Sohn (Jungingen, Germany) is offering a digital computerized sphygmomanometer for self-measurement, which needs neither stethoscope nor microphone. Pressure fluctuation oscillations produced by pulse waves are evaluated by the instrument, with systolic and diastolic blood pressure and pulse rate values displayed digitally.

* Dufner Instrumente (Tuttlingen, Germany) has enlarged its thorascopy line with the new Dufner Mictec instrumentation to provide a complete operative thorascopy product line, including models for palpation and dissection.

* Finnish Orion (Helsinki, Finland) has received an approvable letter from the FDA for its Fareston breast cancer drug.

* Fiopharma (Milan, Italy) has developed a portable ultrasonic nebulizer, the Fiosonic, which weighs only 170g and is battery powered. Developed for home use in the treatment of asthma and respiratory diseases, the device uses patented technology to develop high reliability and performance levels.

* Imtec Immundiagnostica (Zepernick, Germany) has expanded its line of autoimmune diagnostic reagents by adding an assay for detection of primary biliary cirrhosis, using an SP100 antigen detection assay. It is said to be the first commercialized enzyme immunoassay for the detection of SP100 autoantibodies.

* Inamed Corp. (Las Vegas, Nevada) said its European subsidiary, McGhan Ltd. (Arklow, Ireland), has received the CE mark for two of the company’s silicone gel-filled breast implant products.

* Kretztechnik (Zipf, Austria) has available for use with the Combison 530 and Combison 420 ultrasound systems the Angio Color Imaging Upgrade, a new technique providing a color display of very weak and slow perfusions of tissue.

* Lifecore Biomedical (Chaska, Minnesota) has received FDA approval to begin a pivotal clinical trial evaluating Lubricoat 0.5% ferric hyaluronate gel as an aid in reducing post-surgical adhesions. The trial will involve about 200 female patients at about 12 clinical centers in the U.S. and Europe, and follows a pilot trial involving 25 patients at a single U.S. clinical site.

* Lohmeier Medizin Elektronik (Munich, Germany) has a new modular monitoring system M915, designed for monitoring in anesthesia and intensive care. The system is fitted with a multi-level alarm hierarchy that automatically differentiates between technical, serious and life-threatening situations.

* NeoRx. Corp.’s (Seattle, Washington) Verluma imaging agent for small-cell lung cancer has been recommended for approval by an FDA advisory committee.

* Oasis (Moscow) has developed a line of new biocompatible polymers for use in numerous forms. Early applications have been in polymer pins for orthopedic bone fixation and in osteosynthesis for hip fracture treatment. Successful clinical trials have taken place in Russia, Belgium, France and Germany.

* Rimed (Raanana, Israel) has launched the Intraview transcranial Doppler ultrasound system, said to be the first to operate under Windows software, supporting most types of printers and allowing operation with standard Windows-type commands.

* Seelab (Wesselbuhren, Germany) has developed Photosom-3, a hemoglobin derivative for use with photodynamic therapy in tumor therapy. Photosom-3, which has been developed using German federal government funding, is of low toxicity and is well tolerated.

* Toshiba America Medical Systems (Tustin, California) has received FDA clearance for U.S. marketing of its multi-purpose, all-digital R&F X-ray diagnostic imaging system, the MAX-1000A, for diagnostic radiographic and fluoroscopic, non-vascular interventional and general angiographic procedures.

* Utah Medical Products (Midvale, Utah) has received U.S. marketing clearance from the FDA for its Cordguard II device, which is used by an obstetrician to clamp and cut the umbilical cord in order to acquire an uncontaminated neonatal blood sample immediately after birth.

* Vision-Sciences Inc. (Natick, Massachusetts) has received FDA approval for U.S. marketing of its Fiber Optic ENT Scope. Vision-Sciences is a manufacturer of flexible endoscope products using disposable sheaths.

* Vital Signs Inc. (Totowa, New Jersey) has received FDA marketing approval for its Viringe vascular access flush device for both saline and heparin applications. Vital Signs said it expects to begin marketing the device, used to flush intravenous catheter lines to prevent clotting at the top of the catheter, in March 1996.

* Viva Diagnostika (Hurth, Germany) has introduced the CINApool cytomegalovirus (CMV) antigen detection system, which uses two highly specific monoclonal antibodies against the PK65 antigen of CMV. Viva says high sensitivity of the immunofluorescence assay makes possible the detection of infected leucocytes only a few hours after infection.

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