Spirus Medical Announces 510(k) Clearance from FDA for Expanded Use of Endo-Ease(R) Discovery SB(TM)

Monday, May 19, 2008 General News
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SAN DIEGO, May 18 Spirus Medical, Inc.(www.spirusmed.com), a leading developer of diagnostic and therapeuticadvancement systems for gastroenterology and urology, announced at DigestiveDisease Week 2008 that it has received 510(k) clearance from the FDA for anexpanded indication for use with its Endo-Ease Discovery SB device inendoscopic procedures.

Spirus Medical has developed the Endo-Ease line of products aimed atrevolutionizing GI endoscopy. The products' patented spiral feature promoteseasier advancement of an endoscope, which helps physicians examine and treatGI disorders.

In clinical evaluations using a slim enteroscope, the Spirus MedicalEndo-Ease Discovery SB proved effective in achieving an insertion depth of 400cm beyond the Ligament of Treitz, and is now indicated to aid endoscopicinsertion and advancement to the mid-ileum. Because physicians are able toprovide better diagnosis and treatment with greater small bowel access, theDiscovery SB is uniquely positioned to expand the capabilities of theendoscopist.

There are over twelve million EGD (esophagogastroduodenoscopy) proceduresperformed worldwide each year. A significant portion of those patients couldbenefit from an examination of the small bowel extending beyond the reach ofgastroscopy, according to the company. Due to the limitations of existingtechnology, only a small fraction of these procedures are currently performedusing an enteroscope to achieve greater insertion depth in the small bowel.The Spirus Endo-Ease Discovery SB addresses this emerging market opportunity,which could exceed $1 billion.

"Studies with the Endo-Ease Discovery SB show that safe and easy deepsmall bowel insertion is possible" said Dr. Paul Akerman, Director ofTherapeutic Endoscopy and Endoscopic Oncology at Rhode Island Hospital, andmember of the Spirus Medical Advisory Board. "Spirus' technology isovercoming the challenges endoscopists have traditionally faced whenevaluating the small bowel."

"We're pleased to have received the expanded indication for the DiscoverySB system, which we began marketing earlier this year," said Steve Tallarida,Spirus Medical president and chairman. Spirus has established a patientregistry at top medical institutions across the US to document findings andresults from continued use of the Discovery SB.

The company also announced 510(k) clearance for a proprietary medicallubricant it developed for use with Discovery SB applications and tofacilitate other endoscopic procedures.

In 2007, Spirus Medical was recognized by Frost & Sullivan as U.S.Endoscopy Entrepreneurial Company of the Year, in recognition of itsdevelopment of new technology to diagnose and treat gastrointestinalcomplications.

Spirus Medical, Inc., headquartered in Stoughton, Mass., was incubated andfounded in 2005 by STD Med, Inc., a Stoughton-based manufacturer and developerof medical technologies. In addition to Spirus, other companies that began atSTD Med are Angiolink Corporation, Arthrosurface Incorporated, andCardiosolutions, Inc. For more on Spirus Medical, visit spirusmed.com

SOURCE Spirus Medical, Inc.

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