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June 6, 2006

June 6 – June 12th

June 7th: Siemens Tim Technology Breaks All Records with 1,000th Installation at St. Jude Children's Research Hospital

Marking a major milestone of Tim® (Total imaging matrix) technology in medical practices throughout the world, Siemens Medical Solutions today announced that St. Jude Children's Research Hospital has become the 1,000th facility to install Tim technology. Since its introduction in November 2003 at the Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Tim technology has redefined the magnetic resonance imaging (MRI) industry, improving workflow by eliminating the need for patient repositioning and manual coil changes while providing significantly enhanced image quality.

In a little more than two short years, Siemens Tim technology has gone from the new technology on the block to the gold standard in MRI with 1,000 installations worldwide. Siemens Tim technology is the first seamless, whole body surface coil design that combines up to 102 seamlessly integrated coil elements with up to 32 independent radio frequency channels, opening the door to the most advanced clinical applications available today. Tim technology enables flexible coil combinations to encompass local high resolution imaging to large anatomical coverage up to 205 cm (6'9"). Other systems require the radiologist to change coils and reposition the patient three times for a whole-body MRI procedure. Tim also enables the use of integrated Parallel Acquisition Techniques (iPAT), such as syngo® SENSE and syngo GRAPPA, in all body regions, reducing examination times. As a result, image quality is increased by up to 100 percent signal-to-noise ratio and acquisition times are shortened.

St. Jude Children's Research Hospital is internationally recognized for its pioneering work in finding cures and saving children with cancer and other catastrophic diseases. Siemens Medical Solutions of Siemens AG with headquarters in Malvern, Pennsylvania, and Erlangen, Germany, is one of the largest suppliers to the healthcare industry in the world.

June 8: Haemonetics to Acquire Arryx in $26 Million Transaction

Haemonetics Corporation (NYSE: HAE ) and Arryx, Inc., a privately held nano-technology company, today announced that they have signed a definitive agreement whereby Haemonetics will acquire the outstanding shares of Arryx that it does not already own for $26 million in cash. Haemonetics and Arryx have been collaborating since October 2004.

Arryx's proprietary technology uses light to form optical traps to move and manipulate small objects. Using laser beams and holograms, the systems can independently and in parallel hold, move, separate, and otherwise manipulate hundreds of microscopic and nanoscopic objects. Arryx's first product, the BioRyx 200® system, is used to handle cells and other objects in a laboratory environment.

The transaction is expected to close in the third quarter of calendar year 2006 and is subject to satisfaction of customary closing conditions. Arryx's personnel and operations will remain in Chicago.

Haemonetics expects an additional $0.08 - $0.10 of earnings per share dilution associated with operating expenses and amortization in fiscal 2007. The Company's new pro-forma earnings per share guidance are $2.05 to $2.17.

June 8: Renal Solutions(TM), Inc. Announces FDA 510(k) Clearance of the Allient(R) Sorbent Hemodialysis System for Chronic and Acute Hemodialysis

Renal Solutions, Inc., the exclusive provider of advanced sorbent hemodialysis products and services for treatment of patients with renal failure, announced today that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance of the Allient® Sorbent Hemodialysis System, including the SORB(TM) series and HISORB(TM) series cartridges, for chronic and acute hemodialysis applications. The FDA clearance of the Allient System addresses recent system enhancements which enable improved reliability and performance.

The Allient System opens new treatment options to dialysis professionals and patients by virtue of its ability to provide short, standard or extended duration hemodialysis therapy using just 1 & 1/2 gallons of ordinary drinking water. Numerous clinical studies have shown that an increased cumulative dialysis dose results in better patient outcomes. The Allient System provides the increased dose advantage without the need for an independent water system or large volumes of sterile fluid. This translates into increased transportability, flexibility and ease of system use.

Renal Solutions, Inc., a medical device and health-care service company, is commercializing a revolutionary technology/service solution for the chronic and acute dialysis market and has a distinct competitive advantage as the exclusive provider of dialysis products and services utilizing sorbent-based toxin removal technology and a unique pressure controlled blood movement system.

June 9: FDA Clears BioSphere Medical's Next Generation Sequitor(TM) Steerable Guidewire

Biosphere Medical, Inc a medical device company that pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a procedure called embolization, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Biosphere Medical Sequitor(TM) Steerable Guidewire ("Sequitor") Premarket Notification (510K) that allows Sequitor to be marketed in the United States. Sequitor is expected to begin shipping in the United States in July 2006.

Biosphere’s internally developed Sequitor guidewire is the newest addition to the company's line of embolic delivery products. Designed specifically to address the needs of interventionalists, Sequitor facilitates the placement of catheters within the peripheral vasculature for various interventional procedures, including both uterine fibroid embolization and embolization of hypervascularized tumors, such as liver tumors.

Following the completion of certain documentation requirements to conform to European regulations, Biosphere also expects to complete the CE marking of Sequitor and to launch it in Europe in July 2006. CE marking denotes conformity with European Medical Device Directive (EC Council Directives 93/42/EEC) and allows for marketing in European Union countries.

Biosphere Medical, Inc., a medical device company based in Rockland, Massachusetts, seeks to pioneer and commercialize minimally invasive diagnostic and therapeutic applications based on proprietary bioengineered microsphere technology.

June 9: Ascension Orthopedics Receives FDA Approval for PyroCarbon Foot Implant

Ascension Orthopedics, Inc. announced today that it has received FDA approval on the first PyroCarbon implant for the foot. The Ascension® PyroSphere® implant is designed for the fourth and fifth tarsometatarsal joints of the foot and is intended for people suffering from the debilitating effects of arthritis in the foot.

The Ascension® PyroSphere® is a revolution in TMT arthroplasty providing a new option to foot surgeons. The PyroSphere® is manufactured from the patented material, On-X® Carbon, which offers characteristics superior to those of other pyrocarbon material and is available only to Ascension Orthopedics. The material has shown improved wear qualities compared to other industry standard materials, thus enhancing the life of the implant.

The Ascension® PyroSphere® is the first PyroCarbon implant to be approved by the FDA in the lower extremity. This approval adds to the many firsts for Ascension Orthopedics in the extremity market.

The company has expanded its product platforms to include arthroplasty, trauma, and tissue regeneration. Ascension currently offers more than ten arthroplasty products, a complete elbow trauma set, and a tissue regeneration portfolio that includes a nerve conduit and an adhesion prevention product. The entry into the foot market for Ascension marks its continued growth into the upper and lower extremity market.

 

 

 

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