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October 17, 2006

October 17th to October 23rd

October 17th: RITA Medical Systems Announces FDA 510(k) Clearance of HABIB 4X Laparoscopic(TM) Device

RITA Medical Systems, Inc. (Nasdaq: RITA ), a publicly-traded medical device company focused solely on cancer therapies, today announced that the HABIB 4X Laparoscopic(TM) resection device received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA).

Anticipated commencement of sale of the new product continues to be ahead of schedule, as reported in the Company's second quarter 2006 earnings conference call. The Company expects to make first domestic shipments of the product to its customers in the second half of the fourth quarter of 2006. The Company expects to complete CE mark certification so that sales of the product in Europe may begin at the same time product begins shipping in the U.S.

The Habib 4X Laparoscopic resection device coagulates a surgical resection plane to facilitate a fast dissection with limited blood loss. The Company believes this technology will be utilized in a variety of cancer surgeries, including liver and kidney, as it is designed to minimize blood loss and blood transfusion during resection. Additionally the Habib 4X Laparoscopic resection device is designed to work on the current RITA RFA platform of 1500X(TM) Generators.

The HABIB 4X Laparoscopic resection device is intended to be used to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures.

The Company has been selling the Habib 4X(TM) Resection Device since the third quarter of 2005. The new HABIB 4 X Laparoscopic resection devices incorporates technology licensed by RITA Medical Systems, Inc. from United Kingdom based EMcision Limited. "Habib" is a licensed trademark of EMcision Limited.

October 19th: Datascope to Exit Vascular Closure Market, Phase Out Interventional Products Business

Datascope Corp. announced today that it will exit the vascular closure market and will phase out its Interventional Products business (IP) and most of the workforce of that business by fiscal year-end.

"Although our On-Site™ next-generation vascular closure device has gained some traction in the market with a relatively small sales force, we are neither prepared to accept the current level of expenses of the IP business, nor make the additional investment in distribution needed to move ahead more quickly," stated Lawrence Saper, Chairman and CEO of Datascope. "IP losses have offset a significant portion of profit growth of our other businesses for some time, and would continue to do so, absent the exit from the closure business and the phase-out of the IP business."

Datascope will continue to fill customer orders and provide clinical support for its vascular closure devices, VasoSeal® and On-Site, until the close of fiscal year 2007. Datascope's Cardiac Assist direct sales force, augmented by a portion of the IP sales force, will sell the Safeguard™ manual compression assist device. Datascope will continue sales of ProLumen™ and ProGuide™, IP's products for the interventional radiology market, while it explores opportunities for the sale or independent distribution of these products. Datascope expects to complete the redesign and PMA Supplement submission of the X-Site® vascular closure device and seek the sale or independent distribution of this device as well. Datascope also plans to seek a buyer for the On-Site and VasoSeal products.

Datascope expects to record a pretax charge in its second fiscal quarter of approximately $3.2 to $3.5 million for severance and other costs related to the IP exit. The Company has not yet determined what write-offs, if any, would be applicable to IP assets, nor the accounting treatment for such write-offs.

Datascope also announced a plan to reduce operating expenses in its Patient Monitoring (PM) division through the elimination of approximately 26 positions. As a consequence, Datascope expects to record a pretax charge for severance and other related benefits in the second fiscal quarter of approximately $0.5 million.

 

 

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