Kōli Treating Gallstone Disease without Surgery:
An Interview with Matt Callaghan of Kōli

What is the need that Kōli seeks to address?

Symptomatic gallstone disease occurs when gallstones obstruct the outlet of the gallbladder and prevent the flow of bile. If untreated, this blockage can cause significant pain and lead to dangerous infection. Currently, the most common treatment for gallstone disease is cholecystectomy; the surgical removal of the gallbladder. However, many patients aren’t eligible for surgery because of advanced age or complicating medical conditions. Moreover, the surgery itself has risks. So we wanted to find a way to help patients with gallstone disease who either aren’t eligible or prefer not to have surgery.

What key insight was most important to guiding the design of your solution?

In the US alone, roughly one million cholecystectomy surgeries are performed each year. Yet five million patients are symptomatic. And the total population of patients with gallstones is closer to 20 million. This means that there are approximately 15 million patients in the US who have gallstones but don’t become symptomatic. We wanted to find out why that was. Through our research, we figured out how to convert a symptomatic person back into an asymptomatic one.

How does your solution work?

We essentially put people’s gallstones in remission by trapping the gallstones in the wider base of the organ so they can't migrate into the narrow duct and create an obstruction.

"We essentially put people’s gallstones in remission...."

We do this using a catheter-implanted device. We leverage an access approach that has been used for 30 years to place drains in the biliary system. But instead of placing a drain or a stent, we use the same over-the-wire, needle-guided ultrasound and fluoroscopic approach to place a filter in the gallbladder. Then we remove the catheter, and that's it. The whole procedure, once we're up and running, should take less than 30 minutes. And because it’s so quick, it only requires a local anesthesia, which makes it safe for elderly and sick patients. Importantly, the procedure also enables patients to keep their gallbladders, maintaining normal digestive function.

Considering the large population of patients with symptomatic gallstone disease, we think the decreased procedure time, faster recovery time, and overall reduction in related healthcare expenses will be significant.

At what stage of development is the solution?

We're currently performing overseas clinical studies. We've got a study running in Warsaw, Poland, and we’re just initiating one in Manila, for the Philippines.

KoliCEO Chris Cheng and founder Matt Callaghan with a physician after their first animal study at the PLA General Hospital in Beijing.

Going forward, our plan is to obtain CE mark then launch first in nationalized health care systems like the National Health Service [NHS] in the UK. The NHS currently can’t handle the volume of patients that need gallstone surgery—there’s a resource limitation. These patients end up on a waitlist, and many re-obstruct while they're waiting for their surgery. For the NHS to bring enough operating rooms online to manage the number of cholecystectomies that are needed, they would have to run one additional, fully staffed operating room every week, for every one million people in the UK. It's just not economically feasible.

Koli The Kōli technology is intended to provide a minimally-invasive, non-surgical alternative for treating patients with gallstone disease.

So we’ll likely start in places like this, where there is a clear need for risk palliation even in patients who are good surgical candidates but just can't get into the operating room soon enough.

Tell us about a major obstacle you encountered and how you overcame it.

When we first started working to launch our clinical studies, I wanted strong academic centers. I wanted compliant patients who wouldn't be lost to follow-up. I wanted centers based in the EU with strong reputations so we could potentially use the data for our CE mark.

What I didn't realize is that there has to be a benefit to patients. We underestimated the concern these individuals would have about being the first patient. Nobody wants to be first. 

Poland has a nationalized healthcare system that seems to work well, so patients there had little incentive to enroll in our study. We’re not allowed to pay them. And their health care is free, so even if we cover their cost of care they're not getting anything from us. The only people we’ve been able to entice are the ones who can't get out of work for their surgery. But that’s a very small number of compared to the total number of patients eligible for our procedure.

"We underestimated the concern these individuals would have about being the first patient."

What I didn't realize is that there has to be a benefit to patients. We underestimated the concern these individuals would have about being the first patient. Nobody wants to be first.

For these reasons, we’re shifting to Manila because Manila doesn't have a strong national care system. It's a relatively poor country, and many patients pay out-of-pocket for their treatments. So it's a benefit for us to cover the cost of participating in our study, plus paying for a gold-standard laparoscopic cholecystectomy at the end of the trial. I'm hoping this will speed-up our enrollment in Manila. But it has been a real obstacle for us. I'm optimistic that we have address this challenge by expanding the venue of our initial study to a more appropriate location.

Reflecting on your experience, what advice do you have for other health technology innovators?

Don't make implants. It takes too long and costs too much!

“We knew what we wanted and needed from a solution before we actually invented something.”

But seriously, you shouldn’t move forward with one of these projects unless the insight is solid. I think this is one thing we did right—we knew what we wanted and needed from a solution before we actually invented something. So I hope that will propel us all the way into patient care.

Matt Callaghan, founder and Chief Medical Officer of Kōli, is an alumnus of the 2008-09 Biodesign Innovation Fellowship.

Disclaimer of Endorsement: All references to specific products, companies, or services, including links to external sites, are for educational purposes only and do not constitute or imply an endorsement by the Byers Center for Biodesign or Stanford University.

The Kōli delivery system.
The Kōli team

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