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InSite Medical Technologies
Medical Devices & Tech
19639 Farwell Avenue
Saratoga, CA 95070 USA
phone:800-614-6780
fax:408-741-5303
Symbol Private
Founded 2007
Employees 3
www.insite-medical.com
Research Sector Medical Devices & Tech
Summary Description
Seeks to shift the epidural anesthesia market from devices with unacceptable risk to a proprietary device that improves safety, accuracy, and ease of use during epidural space access.
Management
Eric Willis, President and CEO; Dr. James Wall, Chief Medical Officer
Keywords
epidural anesthesia, Epiphany Epidural Access System, regional anesthesia, chronic pain therapies, surgery

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Updated: Aug. 29, 2011

Description
InSite Medical seeks to shift the epidural anesthesia market from devices with unacceptable risk to a proprietary device that improves safety, accuracy, and ease of use during epidural space access. The current epidural anesthesia device market in the United States is estimated at $100 million. The potential domestic market based on increased utilization and pricing is upwards of $600 million. Revenues for InSite will be generated initially by device sales through a targeted direct sales force. Long term sales may be facilitated through partnerships with established distributors covering the anesthesia space. InSite initially will focus a marketing campaign on the chronic pain segment to drive adoption. After gaining acceptance in the chronic pain market, adoption of the Epiphany device in obstetric and major surgery segments should follow rapidly as the same physicians provide epidural anesthesia among the segmented markets.
Products / Services
InSite Medical is preparing to market the Epiphany Epidural Access System, a proprietary product for epidural space access in order to facilitate regional anesthesia and chronic pain therapies.
Technology / Differentiation
InSite's proprietary Epiphany technology provides highly controlled access to the epidural space by uniquely engaging and securing surrounding tissue, thereby lowering the risk for inadvertent damage to the delicate structures in this area. Physician testing has provided validation of the product design in a human clinical study as well as in the animal model, and has indicated that the design is fundamentally adoptable by the marketplace.
Market / Customers
The epidural anesthesia market comprises approximately 10 million indications for use each year in the United States of which only 3.4 million patients actually receive epidural anesthesia. The underutilization of epidural anesthesia results from several barriers including the difficulty of the procedure and physician fear of complications. The epidural anesthesia market is segmented into obstetric, surgical, and chronic pain applications. With over 4 million births annually in the United States, obstetrics is the largest segment. Currently, during childbirth, 2.4 million women (60%) receive epidural anesthesia for pain control. The second largest segment consists of major abdominal and chest surgery where, despite known patient-outcome benefits, epidural anesthesia is used in only 500,000 of 1.8 million eligible cases. Finally, spine-related pain syndromes are treated increasingly with epidural steroids and neuropacing devices, accounting for 600,000 annual cases. Outside the U.S., 19 million epidural access procedures are performed each year, with a massive potential international market including 130 million births per year.
Competitors / Substitutes / Alternatives
Epidural devices are manufactured and distributed in kits by large medical supply companies including Arrow International and B. Braun Medical. Minimal differentiation exists between epidural space access devices and the field has seen little innovation in the past decade despite known complications.