Koli: A non-surgical solution for gallstone disease

Symptomatic gallstone disease affects nearly 5 million people in the United States and consumes over $6.3B annually. Complications occur when gallstones move from the wide body of the gallbladder and enter the narrow system of ducts connecting the gallbladder to the small intestine. The incidence of gallstones increases with age and is higher in women and obese people. Other risk factors include pregnancy, hormone replacement therapy, rapid weight loss, diabetes, Crohn's disease, family history, older age, and prolonged fasting. As Western-style diets gain traction across the globe, the worldwide rate of gallstone disease is rising quickly in areas where surgical treatment is not always available. The most common and effective treatment for gallstone disease today is surgical removal of the gallbladder, or cholecystectomy. Unfortunately, surgery is not always an option. Patients may be unable to tolerate surgery due to comorbidities such as uncontrolled heart or lung diseases which make general anesthesia impossible or they have temporary conditions which delay surgery, for example a recent heart attack, stroke, or sepsis. The risk of a recurrent gallstone-related complication increases with waiting time and patients with a surgical contraindication or scheduling delays are subject to increasing risk of developing gallstone-related complications. Acute cholecystitis can force a decision to perform emergency surgery in these patients with very high mortality and morbidity risks. Kōli has developed a non-surgical alternative to treat gallstone disease. A small implantable filter is deployed in the gallbladder to prevent complications associated with gallstones obstructing the outlet of the organ. Kōli replaces surgery with a minimally invasive outpatient procedure designed to be safe in high risk patients, including the elderly, pregnant women, and patients with recent MI, stroke, or surgery. Kōli fits into existing referral and reimbursement patterns, would utilize conventional ultrasound and fluoroscopic techniques, and will be performed by interventional radiology, gastroenterology, or general surgery. The company’s technology was developed with support from an NSF SBIR award (#1248295) and private investment. Over the past 5 years, Kōli has advanced their novel gallstone filtering system from proof-of-concept bench testing, GLP-like large animal studies, and recently completed a successful first-in-human clinical feasibility study in the Philippines. The current iteration of the Kōli system relies on sharp barbed anchors to penetrate the luminal wall of the gallbladder and hold the self-expanding filter in place. Penetrating anchors carry risks associated with perforation, scarring, and mechanical failure. Once deployed, the anchored device cannot be removed without surgery. To address these risks, Kōli has partnered with Hoowaki, LLC to integrate a novel anti-migration micro surface into our filtering system in place of barbed anchors. This approach will eliminate risks associated with the current anchors and the filtering system will be easier to manufacture, easier to deploy, and completely removable up to months after placement. This project represents the first time a micro surfaced implant will be used in the biliary system and a starting point for a number of innovative applications in gastroenterology. This Direct to Phase II award will fund advanced development of the filtering system, including incorporation of an innovative micro surface textured coating to replace the current barbed metal anchors, integration of radiopaque tantalum markers, and validation of the updated system in bench and large animal studies Completion of these activities will allow the company to begin pre-submission discussions with FDA for an early feasibility study that will form the basis of a Phase IIB application.