SBIR Phase I: Koli: A Non-Surgical Treatment for Gallstone Disease

This Small Business Innovation Phase I Research project will support development and testing of a novel medical technology to replace gallbladder surgery with a minimally invasive solution. Gallstone disease affects over 20 million Americans and carries a direct cost of more than $6 billion. Surgical removal of the organ is currently the only definitive treatment for symptomatic gallstone disease and many patients are unwilling or unfit for surgery. If successful, this project will result in a validated device ready for use in animal studies in SBIR Phase II as a critical step towards clinical studies in human subjects. The broader impact/commercial potential of this project is in addressing a critical and unmet need in management of gallstone disease ? preventing recurrent attacks without the need for general anesthesia and surgery while preserving organ function. Symptomatic gallstone disease presents acutely and often requires urgent if not emergent intervention. Patients are referred for surgery from their primary care provider or the emergency room. With such a large referral base, scheduling logistics and medical co-morbidities delay or prevent surgery in many patients. Without definitive treatment, recurrence is common and especially dangerous in cases of acute cholecystitis or pancreatitis. Commercialization of this novel percutaneous device will also provide a significant economic benefit to the healthcare system by reducing the number of surgical procedures, the number of repeat admissions in patients who cannot have surgery, and increasing the quality of life of patients.