Flexible Fiber permits precise CO2 laser delivery.

OmniGuide® Launches the OtoBeam Flexible CO2 Laser Fiber Product Line for Otology

July 10, 2007

For the first time, safety and precision of CO2 laser energy can be delivered through a user-friendly, flexible fiber for otology surgery.

CAMBRIDGE, Mass. July 10 -- OmniGuide, Inc. (www.omni-guide.com) today announced the commercial availability of its new OtoBeam flexible CO2 laser fiber and intuitive handpiece product line for use in otology procedures. The clinical benefits of CO2 laser energy namely precision cutting and coagulation with minimal thermal spread previously had limited applications in otology due to the absence of a flexible delivery system. OmniGuide's breakthrough flexible CO2 laser fiber product for the first time allow this beneficial energy source to be placed at the surgeon's fingertips for accurate control when operating on the delicate structures of the middle and inner ear. OmniGuide's OtoBeam CO2 laser fiber technology opens the way for the broad use of CO2 lasers in otology applications.

Annually, approximately 30 million people are diagnosed with hearing loss due to otosclerosis, and 300,000 people in the U.S. suffer hearing loss as a result from otosclerosis. CO2 laser energy has been widely established as a precise and safe laser wavelength due to rapid absorption by the water-like perilymph present in the inner ear, resulting in minimal thermal spread. These characteristics make the CO2 laser a highly desirable tool in stapedectomy procedures. To date however, the use of CO2 lasers in such procedures has been severely limited due to the absence of a flexible fiber. OmniGuide's breakthrough photonic bandgap fiber technology allows this beneficial laser energy to be guided through a flexible fiber.

Anand K. Devaiah, MD, Assistant Professor in the Department of Otolaryngology at Boston University School of Medicine, performed some of the first otology procedures with the OtoBeam fiber. According to Dr. Devaiah, "The OmniGuide OtoBeam flexible fiber attached to a CO2 laser is an effective and adaptable tool for use in stapedectomy. By reducing the risk to the inner ear with laser energy that does not penetrate beyond perilymph, the safety of CO2 laser energy can be coupled with the ease of fiber delivery."

Prof. Yoel Fink, OmniGuide's cofounder further commented that, "The OtoBeam product line is the result of a major technology breakthrough in our photonic bandgap fiber technology. We believe that the OtoBeam flexible CO2 laser fiber provides the surgeon with a flexible, precise, safe, and intuitive device in stapedectomy procedures. The OtoBeam fiber offers unparalleled accuracy and a high degree of control over penetration into target structures and formation of the footplate rosette. These attributes are critical in stapes surgery."

About OmniGuide Technology

The OmniGuide OtoBeam and BeamPath systems are FDA-cleared devices, and have treated over 600 patients in approximately 100 U.S. medical facilities. CO2 laser energy offers unparalleled precision and a high degree of control over penetration into soft tissue. These attributes are critical in otology, laryngology, head and neck surgery, and pulmonology procedures for which there is the potential to damage delicate untargeted structures. 20,000 CO2 lasers have been deployed in operating rooms throughout the world. However, until now, CO2 lasers have limited applications to invasive surgery due to the absence of a fiber delivery system at their wavelength of operation.

The key to OmniGuide's technology is a revolutionary photonic bandgap fiber that was originally invented and developed at MIT. The company holds an exclusive license from MIT and has added an extensive portfolio of related US and international patents. The technology was first published in Nature in 2002.

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