After years of hearing from patients how bothersome — and sometimes painful — ureteral stents are, Dr. Lee Ponsky, chair of the Department of Urology at University Hospitals, experienced the discomfort himself. Twice.
These stents help ease the flow of urine along the ureter, which connects the kidney to the bladder. They help prevent kidney damage caused by kidney stones, strictures or swelling of the ureter. While some patients don't have any pain, Ponsky said upwards of 60% to 80% of patients with these ureteral stents currently available will have problems or complaints, including urine reflux, flank pain and bladder spasms. These can lead to additional medical attention and sometimes the need for replacements.
About a decade ago, he began redesigning the stent, creating what he's dubbed the Relief Stent, which in March secured its 510k clearance from the U.S. Food and Drug Administration and allowed it to be marketed in the United States for patients suffering from kidney stones and other issues causing difficulty draining the kidney.
"I always had an interest in ways that we can improve some of the discomfort that a patient has, but there's nothing more of a motivator than being a patient yourself," said Ponsky, also a master clinician in urologic oncology, and the Leo & Charlotte Goldberg chair in Advanced Surgical Therapies at UH.
The Relief Stent's design offers the potential to reduce some of the side effects associated with existing ureteral stents, according to UH. It allows the ureteral orifice to close naturally to reduce reflux and also avoids irritating the floor of the bladder, which causes pain and bladder spasms, Ponsky said.
To help advance the device, Ponsky founded the Ureteral Stent Co. as a subsidiary of Cleveland-based Walden Medical Companies.
Walden Medical seeded Ureteral Stent with $200,000 in founding shares that then converted into a series A financing that ultimately raised a total of $2 million in March 2020, said Mike Bunker, president of both Walden Medical and Ureteral Stent. Right now, they've not decided to raise a full series B, but to provide resources through 2023, they raised $1.5 million internally through a convertible note round from existing investors, Bunker said.
UH Ventures, the commercialization arm of University Hospitals, invested in the company and helped Ponsky also obtain funding from Ohio Third Frontier's Technology Validation and Start Fund, which aims to accelerate the translation of technologies through Ohio startup companies. ProMedica Innovations — the innovation arm of ProMedica — invested in Ureteral Stent Company, as well, after consulting urologists in the health system and hearing existing ureteral stents were a pain point for patients, said Zach Philipp, investment associate for ProMedica Innovations.
"The feedback was resounding that this is something that would be an improvement compared to what's currently on the market," he said. "And so not only were we able to validate it with shared due diligence with UH, when we went through this process, but we also validated it internally and that's really what got our attention."
UH Ventures has had co-hospital system investors on most of its deals since it launched in 2017, said Neil Wyant, vice president of investments and commercialization at UH Ventures.
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An early-stage company getting multiple hospital systems using and investing in its product helps it gain credibility much faster, Wyant said.
Dr. Kyle Scarberry, a reconstructive urologist at UH, is the principal investigator of an ongoing Relief Stent study looking at safety that aims to enroll 30 patients.
Bunker said down the road, the Relief Stent "really belongs in the hands of a urology company that has a full suite of products," such as devices to retrieve kidney stones or ultrasound machines to break them up. He said the team plans to consult notable stone management physicians to demonstrate they have the right product design.
"The first thing out of the gate is really, let's get some real-world feedback on the product before we say that it's ready for, you know, a huge commercial launch and investment that that would entail," Bunker said.
Bunker said he and Ponsky last met with some of these experts in 2019 at the American Urological Association meeting and essentially used the insights they gained there to create a blueprint for their work in the past couple of years to take the product through this latest milestone. They've designed and are currently vetting a study to prove the Relief Stent is "superior in patient comfort, healthcare economics and lowering reflux."
"The design is fairly obvious, but we've not proven that," Bunker said. "We only can prove that we can drain urine from the kidney to the bladder."
Though they haven't proven those claims, it's an option for a post-market study in order to sell the benefits of the stent, Bunker said. Other decisions ahead include remaining independent, partnering with another entity or even having an option to acquire the company.
"There's lots of variables that could come in here," he said, "and we'll know a lot more in the next few months."
This story first appeared in our sister publication, Crain's Cleveland Business.