SBIR Phase II: Improving the safety and efficacy of epidural anesthesia

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This Small Business Innovation Research Phase II project is focused on commercializing a proprietary medical device to provide safe and accurate delivery of epidural anesthesia. Epidural anesthesia provides excellent pain control for childbirth, major surgery, and chronic back pain without having to expose patients to the risks of general anesthesia. Epidural anesthesia involves (1) accessing the epidural space, a miniscule potential space adjacent to the dura, the thin protective covering of the spinal cord, then (2) delivering local anesthetic to bathe the spinal nerve roots and block pain sensation. Currently, epidural access requires blind insertion of a sharp-tipped needle through the back that is immediately halted just prior to entering the dura. The difficulty of the current method poses risks of anesthetic delivery to incorrect anatomic locations and injury to nearby critical structures. Complications are estimated to occur in 6-25% of cases. InSite Medical Technologies has developed a technology that eliminates the sharp needle tip and provides highly controlled access to the epidural space by uniquely engaging surrounding tissue. During the Phase II project InSite will finalize product design, establish a quality manufacturing system, attain an FDA 510(k) approval and achieve the first human use of the device. The epidural anesthesia market comprises an estimated 9.8 millions eligible patients 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 procedure difficulty 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 is surgical anesthesia 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 implanted stimulators, accounting for 600,000 annual cases. Outside the U.S., 19 million epidural access procedures are performed annually with a massive potential international market including 130 million births per year. By creating a safer and more accurate system for delivering epidural anesthesia, InSite Medical Technologies sees an opportunity to produce a premium medical device that positively impacts patients' experience with epidural anesthesia.