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Inflammatory bowel disease (IBD) affects 6 million people in the US & Europe. This is a debilitating, chronic condition, resulting in severe inflammation of the gastrointestinal (GI) tract. These patients suffer from severe abdominal pain, rectal bleeding, and chronic diarrhea. Accompanying this is a significant impact on quality of life and social stigma. New treatment options are urgently needed to improve the standard of care for this overlooked population and improve their quality of life.

Currently, the most effective treatment is the self-administration of a medicated enema overnight, which is challenging for patients with active disease experiencing frequent bowel movements. As a result, 70% of cases are diagnosed as having uncontrolled disease. The chronic nature of the disease, combined with poor treatment options, leads to direct spending exceeding $15 billion/year with a total economic burden above $30 billion/year. Outpatient medication alone accounts for $5 billion/year in spending.

A device that could maximize local tissue concentrations of medication while reducing the necessary retention time of the enema could significantly improve clinical remission rates, the quality of life for these patients, and save millions of dollars to the healthcare system.

We have created the SuonoCalm, a hand-held device for the administration of treatment directly to the site of disease. This technology originated in the labs of Professor Robert Langer at MIT. Utilizing low-frequency ultrasound, the device is able to gently propel medication into tissue, resulting in ultra-rapid delivery of the required therapeutic in only one minute. The SuonoCalm can be used by patients at home to self-administer their medication in the same format as currently available therapies. This technology has been reported on in Science Translational Medicine, the device has won numerous awards, including the Lemelson National Invention Prize, and has been highlighted by Popular Science, The Boston Globe, Forbes, and the World Economic Forum Agenda, among others.

The SuonoCalm could be used by patients at home to control their disease. When treatment is required, patients insert a pre-filled cartridge containing the medicated enema into the device. The patient then self-administers treatment. The device automatically expels the medicated enema while simultaneously emitting ultrasound. After a short, one-minute treatment, the patient removes the device, disposes the expended medication cartridge, and returns the device to storage. Importantly, it does not require the patient to learn a new method of administration.

The core values of our device are the superior clinical outcomes and ease and convenience of use. The SuonoCalm will significantly reduce the burden of enema administration, which currently requires patients to remain lying down for at least 30 minutes and often for hours. The greatest commercial value of the SuonoCalm is the fact that it is a platform technology. It can successfully deliver a wide range of medications, including biologics. In the context of IBD, this will allow for targeted delivery of immunosuppressive biologics currently used systemically by patients with severe disease to afford superior outcomes and limit adverse events associated with systemic administration.