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October 10, 2006

October 10th to October 16th

October 10th: The US Food and Drug Administration Clears Syneron's LiteTouch Dental Laser for a Wide Range of Hard and Soft Tissue Procedures

Syneron Medical Ltd today announced that the FDA granted clearance to market its dental laser device, the LiteTouch. The LiteTouch dental laser was developed by Syneron subsidiary, Light Instruments, a company specializing in advanced dental laser devices.

The LiteTouch dental laser has been cleared by the FDA to be marketed in the US for a wide range of hard and soft tissue applications used in dentistry and oral surgery. Applications for which the LiteTouch has been cleared include, but are not limited to, caries treatment and removal and root canal procedures, as well as a wide range of oral and dental surgical procedures, such as the excision and incision of oral soft tissue, and dental implants.

The LiteTouch is a compact high power dental laser that is based on proprietary technology developed by the Light Instruments subsidiary of Syneron. The LiteTouch is ideally designed to fit into the space-limited dental office with a very compact user friendly design and very low maintenance cost. The LiteTouch has excellent performance parameters enabling fast and effective use by dentists and oral surgeons for a wide range of hard and soft tissue applications.

Syneron Medical Ltd. manufactures and distributes medical aesthetic devices that are powered by the proprietary, patented elos combined-energy technology of Bi-Polar Radio Frequency and Light.

October 11th: EPOCAL Receives FDA Approval to Market the EPOCTM Blood Analysis System

Epocal is pleased to announce receipt of 510(k) clearance from the US Food and Drug Administration to market its first product - the EPOCTM Enterprise Point of Care Blood Analysis System - in the United States.

The EPOC system is a blood analyzer that rapidly performs a panel of the most critical acute care tests at the patient bedside. The product features smart-card-like diagnostic test cards and a portable PDA analyzer with wireless connectivity to the hospital information system.

"We will now commence the commercialization phase of the Company's first product," announced Imants Lauks, Epocal Chief Executive Officer. "As is typical for new technology entrants into the market, we will begin with a controlled launch of our product in the United States in the first quarter of 2007, followed by broader commercialization later in the year."

Dr. James H. Nichols, Director of Clinical Chemistry at Baystate Medical Center, a 700-bed hospital in Massachusetts, has performed clinical evaluations of the EPOC system and had the following comments, "This is the first handheld wireless blood gas and electrolyte analyzer to be introduced into the point of care testing market. With technical performance comparable to blood gas analyzers currently on the market, it will certainly be competitive given its advantages of handheld portability and wireless data connectivity."

October 11th: Baxter Announces Launch of BAXJECT(R) II Needle-Less Transfer Device for ADVATE(R)

Baxter Healthcare Corporation today announced the availability of BAXJECT II, an innovative needle-less transfer device designed to make the reconstitution and mixing of hemophilia factor therapies easier, faster and safer (as compared to the original BAXJECT and needles). BAXJECT II is the newest convenience feature to be added to ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin- Free Method], the only factor VIII therapy free of blood-based additives. Unlike other devices, BAXJECT II is compatible with existing injection ports and butterfly sets.

"With a busy schedule, mixing an infusion is time consuming," says patient, Ellis Sulser. "The BAXJECT II device is an improvement in that it speeds up the process while making it safer by eliminating the need for needles to mix my factor VIII."

BAXJECT II is the latest needle-less transfer device from Baxter that has been totally redesigned with features that patients may find make mixing of hemophilia therapy easier, faster and safer (as compared to the original BAXJECT and needles). With its integrated filter, it allows patients to use the butterfly infusion set of their choice.

The new BAXJECT II design makes mixing easier by avoiding the need for valve turning and air injection while facilitating connection with a straightforward color-coding system. Mixing time is faster -- less than a minute(1) -- thanks to fewer mixing steps; and safety is improved by the inclusion of built-in filters to maintain product purity, as well as a reduced risk of injury because the needle-less design contains no glass parts or syringes.

The BAXJECT II device is intended for use with a single vial of FVIII product and is for single use only. Therefore, reconstituting and withdrawing a second vial into the syringe requires a second BAXJECT II device.

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other conditions. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

 

 

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