News:
Spirus Medical Announces Complete Examinations of the Small Intestine By Physicians Using Endo-Ease™
Spirus Medical Announces 510(k) Clearance from FDA For Expanded Use of Endo-Ease® Discovery SB™
Spirus Medical's Endo-Ease™ Advancement System for Colonoscopy Now "CE Marked" for Sales in Europe
Spirus Medical Launches Revolutionary System for Colonoscopy
Spirus Medical Starts US Evaluations with Advancement System for Colonoscopy; Receives 510(k) for New Enteroscopy Device
Spirus Medical Announces Formation of Medical Advisory Board
Spirus Medical Raises $5.9 Million in Preferred Equity Financing; Receives 510(k) Clearance for Endo-Ease™ System
Spirus Medical Announces Complete Examinations of the Small Intestine By Physicians Using Endo-Ease™
CHICAGO, IL, May 29, 2009 — Spirus Medical, Inc. (www.spirusmed.com), a leading developer of diagnostic and therapeutic advancement systems for gastroenterology, urology and gynecology, announced that physicians using its Endo-Ease™ line of devices have performed complete examinations of the small intestine, or pan-endoscopy. Spirus is presenting at Digestive Disease Week 2009 in Chicago, May 30 through June 4.
Complete examination of the small intestine has been elusive in regular practice due to the difficulty in maneuvering an endoscope through the long, tortuous path in the body. The small intestine is about 20 to 23 feet long and other methods for reaching and studying its full length, whether starting through the mouth (antegrade) or the colon (retrograde), have proven challenging.
Spirus Medical has developed the Endo-Ease line of devices aimed at revolutionizing GI endoscopy. A patented spiral “over-tube” promotes faster, easier advancement of an endoscope, which helps physicians better examine and treat upper and lower GI disorders. Spiral enteroscopy allows for rapid small bowel access which can give the physician the ability to diagnosis and treat immediately, rather than the patient coming back for a second endoscopic and/or surgical procedure.
Recently, a pan-endoscopy was completed under conscious sedation by Dr. Stephen Hughes at Southmead Hospital in Bristol, England. Drs. Khaled Zachariah and Peter Marden were among those present for the case, which was performed using a slim enteroscope with the Endo-Ease Discovery SB® over-tube from an antegrade approach. Using the spiral enteroscopy technique, the medical team was able to traverse the small bowel and reach the ileo-cecal valve in 44 minutes.
A second pan-endoscopy was completed in two procedures by Dr. Luis Lara at the University of Texas Southwestern Medical Center. The Discovery SB was used first for the antegrade approach and the maximum depth was marked. The second procedure was performed on the same patient at a later date using the Endo-Ease Vista® retrograde and Dr. Lara reached the spot previously marked. In both procedures the patient was sedated with Propofol.
Spirus Medical, Inc., headquartered in Stoughton, Mass., was incubated and founded in 2005 by STD Med, Inc., a Stoughton-based manufacturer and developer of medical technologies. In addition to Spirus, other companies that began at STD Med are Angiolink Corporation, Arthrosurface Incorporated, and Cardiosolutions, Inc. For more on Spirus Medical, visit www.spirusmed.com
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Spirus Medical Announces 510(k) Clearance from FDA For Expanded Use of Endo-Ease® Discovery SB™
Unique “rotate to advance” device enables deeper enteroscopy
SAN DIEGO, CA, May 18, 2008 — Spirus Medical, Inc. (www.spirusmed.com), a leading developer of diagnostic and therapeutic advancement systems for gastroenterology and urology, announced at Digestive Disease Week 2008 that it has received 510(k) clearance from the FDA for an expanded indication for use with its Endo-Ease Discovery SB device in endoscopic procedures.
Spirus Medical has developed the Endo-Ease line of products aimed at revolutionizing GI endoscopy. The products’ patented spiral feature promotes easier advancement of an endoscope, which helps physicians examine and treat GI disorders.
In clinical evaluations using a slim enteroscope, the Spirus Medical Endo-Ease Discovery SB proved effective in achieving an insertion depth of 400 cm beyond the Ligament of Treitz, and is now indicated to aid endoscopic insertion and advancement to the mid-ileum. Because physicians are able to provide better diagnosis and treatment with greater small bowel access, the Discovery SB is uniquely positioned to expand the capabilities of the endoscopist.
There are over twelve million EGD (esophagogastroduodenoscopy) procedures performed worldwide each year. A significant portion of those patients could benefit from an examination of the small bowel extending beyond the reach of gastroscopy, according to the company. Due to the limitations of existing technology, only a small fraction of these procedures are currently performed using 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 deep small bowel insertion is possible" said Dr. Paul Akerman, Director of Therapeutic Endoscopy and Endoscopic Oncology at Rhode Island Hospital, and member of the Spirus Medical Advisory Board. "Spirus' technology is overcoming the challenges endoscopists have traditionally faced when evaluating the small bowel."
"We're pleased to have received the expanded indication for the Discovery SB system, which we began marketing earlier this year" said Steve Tallarida, Spirus Medical president and chairman. Spirus has established a patient registry at top medical institutions across the US to document findings and results from continued use of the Discovery SB.
The company also announced 510(k) clearance for a proprietary medical lubricant it developed for use with Discovery SB applications and to facilitate other endoscopic procedures.
In 2007, Spirus Medical was recognized by Frost & Sullivan as U.S. Endoscopy Entrepreneurial Company of the Year, in recognition of its development of new technology to diagnose and treat gastrointestinal complications.
Spirus Medical, Inc., headquartered in Stoughton, Mass., was incubated and founded in 2005 by STD Med, Inc., a Stoughton-based manufacturer and developer of medical technologies. In addition to Spirus, other companies that began at STD Med are Angiolink Corporation, Arthrosurface Incorporated, and Cardiosolutions, Inc. For more on Spirus Medical, visit spirusmed.com
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Spirus Medical's Endo-Ease™ Advancement System for Colonoscopy Now "CE Marked" for Sales in Europe
Company lays groundwork for product expansion overseas
STOUGHTON, MA, January 5, 2007 - Spirus Medical, Inc. (www.spirusmed.com) today announced that it has CE Marked its Endo-Ease Advantage™ and Endo-Ease Vista™ products for colonoscopy and is planning to market the products in Europe. The two products leverage the company's one-of-a-kind Endoluminal Advancement System (EAS™), used in conjunction with a conventional colonoscope to aid advancement through the colon with the ease of rotation. The EAS system uses a soft spiral component fixed on an active, flexible overtube to facilitate a more efficient approach to colonoscopy.
"Both Endo-Ease Advantage and Vista have been extremely well received by gastroenterologists and surgeons in the US, and we are now strategically positioning ourselves to market the Endoluminal Advancement System across Europe," said Steven Tallarida, president and CEO of Spirus Medical. "With the application of the CE Mark on these two revolutionary devices, Spirus is building a solid foundation for growth in the European Union."
Both Endo-Ease products attach easily onto a slim or pediatric colonoscope. Endo-Ease Advantage and Endo-Ease Vista can help move the colonoscope through the colon and also provide a conduit through which the scope can be advanced. Other products in the pipeline utilizing Spirus Medical's revolutionary platform technology include the Endo-Ease DiscoveryT SB for small bowel enteroscopy and the Uro-EaseT family of products for urology.
The shorter Endo-Ease Advantage is designed to aid advancement of a colonoscope through the tortuous sigmoid colon, where physicians often experience the most difficulty. Once the sigmoid colon has been traversed, the scope is unlocked from the device. The Endo-Ease Advantage then remains in place to stabilize the sigmoid colon while the scope is advanced traditionally through the rest of the colon to complete the procedure. The Endo-Ease Vista is a longer version designed to enable rotational advancement of the scope beyond the sigmoid colon. The Endo-Ease Vista also provides a stable conduit through which a colonoscope can be passed to complete a colonoscopy.
Spirus Medical, Inc., headquartered in Stoughton, Mass., was incubated and founded in 2005 by STD Med, Inc., a Stoughton-based manufacturer and developer of medical technologies. Spirus has developed a revolutionary Endoluminal Advancement System (EAS) for GI Endoscopy that represents a significant breakthrough by enabling gastroenterologists to perform flexible endoscopy procedures more efficiently. In addition, Spirus is developing other devices incorporating this same proprietary platform technology for use in urological and gynecological procedures.
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Spirus Medical Launches Revolutionary System for Colonoscopy
STOUGHTON, MA, November 8, 2006 - Spirus Medical, Inc. (www.spirusmed.com) has announced the launch of its Endo-Ease Advantage™ and Endo-Ease Vista™ products for colonoscopy. The two new products leverage the company's one-of-a-kind Endoluminal Advancement System (EAS™), used in conjunction with a conventional colonoscope to aid advancement through the colon with the ease of rotation. The EAS system uses a soft spiral component fixed on an active, flexible overtube to facilitate a more efficient approach to colonoscopy.
Both Endo-Ease products attach easily onto a slim or pediatric colonoscope. Endo-Ease Advantage and Endo-Ease Vista can help move the colonoscope through the colon and also provide a conduit through which the scope can be advanced.
"The EAS is literally and figuratively revolutionary. Rotation with a spiral to advance instruments through tortuous bodily passageways makes more sense than trying to push your way through. Colonoscopists have been starving for simple, innovative solutions like the Endo-Ease Advantage and Vista to increase their treatment options," said Steve Tallarida, president and chairman of the board of Spirus Medical.
The shorter Endo-Ease Advantage is designed to aid advancement of a colonoscope through the tortuous sigmoid colon, where physicians often experience the most difficulty. Once the sigmoid colon has been traversed, the scope is unlocked from the device. The Endo-Ease Advantage then remains in place to stabilize the sigmoid colon while the scope is advanced traditionally through the rest of the colon to complete the procedure. The Endo-Ease Vista is a longer version designed to enable rotational advancement of the scope beyond the sigmoid colon. The Endo-Ease Vista also provides a stable conduit through which a colonoscope can be passed to complete a colonoscopy.
Spirus Medical, Inc., headquartered in Stoughton, Mass., was incubated and founded in 2005 by STD Med, Inc., a Stoughton-based manufacturer and developer of medical technologies. Spirus has developed a revolutionary Endoluminal Advancement System (EAS) for GI Endoscopy that represents a significant breakthrough by enabling gastroenterologists to perform flexible endoscopy procedures more efficiently. In addition, Spirus is developing other devices incorporating this same proprietary platform technology for use in urological and gynecological procedures.
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Spirus Medical Starts US Evaluations with Advancement System for Colonoscopy; Receives 510(k) for New Enteroscopy Device
STOUGHTON, MA, September 5, 2006 - Spirus Medical, Inc. (www.spirusmed.com) announced it has commenced physician evaluations of its Endo-Ease Advantage™ and Endo-Ease Vista™ products for colonoscopy at several US sites. The company also announced that it received 510(k) clearance in August from the US Food and Drug Administration for its Endo-Ease Discovery™ SB, a unique advancement system for enteroscopy via the upper gastrointestinal tract.
The Endoluminal Advancement System (EAS™), Spirus Medical's one-of-a-kind technology, is used in conjunction with conventional flexible endoscopes. The technology uses rotation to facilitate a gentler, easier and more efficient approach to gastrointestinal (GI) endoscopy, while enhancing the scope's diagnostic and therapeutic functionality.
"Endo-Ease's EAS technology will help physicians revolutionize the way endoscopy is performed," said Bill Bookwalter, Spirus Medical vice president of sales and marketing. "We are extremely pleased with how physicians have received the products in the US and are preparing to launch the Endo-Ease for colonoscopy into an enormous US market."
Spirus is ramping up production of its two colonoscopy products for a full US market launch later this year. In preparation for the launch, Spirus Medical has appointed two new regional sales managers to further broaden its US market coverage.
"In addition to beginning our evaluations in the US, the FDA 510(k) clearance for the Endo-Ease Discovery SB marks another significant milestone for Spirus," said Robert Ailinger, chief operating officer and director of Spirus Medical.
"The small bowel remains the great frontier of endoscopy. The Discovery SB is an exciting technology that has the potential for visualization of the entire small bowel in a rapid manner and works with standard endoscopes and therapeutic accessories," said Dr. Paul Akerman, Director of Therapeutic Endoscopy and Endoscopic Oncology, Assistant Clinical Professor of Medicine & Surgery, Rhode Island Hospital, Providence, RI.
Spirus Medical continues to intensively explore other gastrointestinal applications, such as trans-gastric and trans-colonic surgery for its EAS platform technology. "Based on my experience with the Spirus devices, I believe their technology can provide a platform to make trans-gastric and trans-colonic surgery a reality," said Dr. Richard Rothstein, Chief, Section of Gastroenterology and Hepatology, Professor of Medicine at Dartmouth Medical School, Hanover, NH.
"The EAS platform technology is truly a hidden gem, with widespread applicability in GI endoscopy and beyond," said Steve Tallarida, president and chairman of the board of Spirus Medical. "Studies of new applications of the technology thus far show great promise."
Spirus Medical, Inc., headquartered in Stoughton, Mass., was incubated and founded in 2005 by STD Med, Inc., a Stoughton-based manufacturer and developer of medical technologies. Spirus has developed a revolutionary Endoluminal Advancement System (EAST) for GI Endoscopy that represents a significant breakthrough by enabling gastroenterologists to perform flexible endoscopy procedures more efficiently. In addition, Spirus is developing other devices incorporating this same proprietary platform technology for use in urological and gynecological procedures.
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Spirus Medical Announces Formation of Medical Advisory Board
STOUGHTON, MA, May 16, 2006 - Spirus Medical, Inc. (www.spirusmed.com), a leading developer of endoluminal technology for gastroenterology, urology and gynecology, announced the formation of its medical advisory board. The new board draws upon experts from some of the nation's most renowned medical facilities.
Through its medical advisory board, Spirus Medical seeks to revolutionize the way diagnostic and therapeutic devices are advanced, positioned and secured in various lumens of the body.
"We're honored to have such a highly esteemed group of physicians embrace our mission," said Bill Bookwalter, Vice President of Sales & Marketing for Spirus Medical. "With their leadership and direction, we are well positioned to address the needs of physicians in some of the world's largest medical markets."
The members of the Spirus Medical Advisory Board are:
- Richard Rothstein, M.D., Chief, Section of Gastroenterology and Hepatology, Professor of Medicine at Dartmouth Medical School, Hanover, NH
- Michael Rocchio, M.D., F.A.C.S., General Surgery and Endoscopy, Former Clinical Assistant Professor of Surgery, Brown University School of Medicine, Providence, RI
- Paul Akerman, M.D., Director of Therapeutic Endoscopy and & Endoscopic Oncology, Assistant Clinical Professor of Medicine & Surgery, Rhode Island Hospital, Providence, RI
- Charles Monier Jr., M.D., Owner and Director, Thibodaux Endoscopy, Thibodaux, LA
- Robert Gannan, M.D., Ph.D., President & Partner of Northwest Gastroenterology Associates, Bellevue, WA, Founder and National Medical director of Physician's Endoscopy, Inc. Doylestown, PA
- Steven Edmundowicz, M.D., Chief of Endoscopy, Division of Gastroenterology, Professor of Medicine, Washington University School of Medicine, St. Louis, MO
- Ram Chuttani, M.D., Chief Interventional Gastroenterology, Beth Israel Deaconess Medical Center, Assistant Professor of Medicine, Harvard Medical School, Boston, MA
- Dicken S.C. Ko, M.D., Surgical Director, Renal Transplantation, Departments of Surgery and Urology, Massachusetts General Hospital, Harvard Medical School, Boston, MA
Spirus Medical, Inc., headquartered in Stoughton, MA, was incubated and founded in 2005 by STD Med, Inc., a Stoughton-based manufacturer and developer of medical technologies. Spirus has developed a revolutionary Endoluminal Advancement System (EAST) for GI Endoscopy that represents a significant breakthrough by enabling gastroenterologists to perform flexible endoscopy procedures more efficiently. In addition, Spirus is developing other devices incorporating this same proprietary platform technology for use in urological and gynecological procedures.
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Spirus Medical Raises $5.9 Million in Preferred Equity Financing; Receives 510(k) Clearance for Endo-Ease™ System
STOUGHTON, MA, January 3, 2006 - Spirus Medical, Inc. (www.spirusmed.com), a leading developer of diagnostic and therapeutic advancement systems for Gastroenterology, Urology and Gynecology, announced that it has raised $5.9 million in Series A Preferred Stock financing. BioVentures Investors, Point Judith Capital and Village Ventures, along with a group of accredited individual investors, participated in the financing and Boston Equity Advisors, LLC served as placement agent for the offering. The company also announced it has received 510(k) clearance from the FDA for its first product line, the Endo-EaseT Endoluminal Advancement System (EAST).
Endo-Ease's one-of-a-kind technology, in conjunction with a conventional flexible endoscope, uses rotation to facilitate a gentler, easier and more efficient approach to gastrointestinal (GI) endoscopy, while enhancing the scope's diagnostic and therapeutic functionality. The inexpensive, single-use design of the EAST also means no added capital equipment costs.
"This financing represents a major milestone for Spirus. With this investment capital we are now well positioned to bring our innovative EAST platform technology to an ever expanding market," said Steve Tallarida, President and Chairman of the Board of Spirus Medical. "We are also very pleased to have received 510(k) clearance to market our Endo-Ease product line," said Robert Ailinger Chief Operating Officer and Director of Spirus Medical. "This funding provides us with the resources to begin manufacturing and commercialization of the Endo-Ease product line later this year." said Ross Garofalo, Spirus chief financial officer.
"We believe that the EAST is one of the most significant developments in flexible GI endoscopy," said Marc Goldberg, Managing Director of BioVentures Investors. "We are very pleased with the progress that the Spirus team is making in addressing this enormous market opportunity." With the completion of this financing, Marc Goldberg of BioVentures Investors, Gina Raimondo of Point Judith Capital and Michael Benoit, an individual investor, will join Spirus co-founders Bob Ailinger, Jim Frassica, Steve Tallarida and Andrea Patisteas on its board of directors.
Spirus Medical, Inc., headquartered in Stoughton, Mass., was incubated and founded in 2005 by STD Med, Inc., a Stoughton-based manufacturer and developer of medical technologies. Spirus has developed a revolutionary Endoluminal Advancement System (EAST) for GI Endoscopy that represents a significant breakthrough by enabling gastroenterologists to perform flexible endoscopy procedures more efficiently. In addition, Spirus is developing other devices incorporating this same proprietary platform technology for use in urological and gynecological procedures.
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