For people being treated for chronic kidney disease, an early step in dialysis is critical but can be challenging. Cannulation, or the process of inserting a needle with a thin tube into a blood vessel, is necessary to begin dialysis, but it can be uncomfortable and stressful. It’s also something that patients undergo often, as they may be going into dialysis two or three times per week.
“This can be a part of the procedure that patients and even the technicians can be a little nervous about,” said Josh Makower, co-founder of X9, a startup looking to solve the problem. “They want to get it right.”
X9 was launched out of medical device incubator ExploraMed, through a partnership with DaVita, one of the two largest dialysis providers in the U.S. ExploraMed, based in Mountain View, California, has supported several companies that have been acquired by medtech firms, such as Acclarent, which makes a balloon sinus dilation system and was sold by Johnson & Johnson to Integra last year, and urology firm NeoTract, which sold to Teleflex in 2017.
X9 is building an ultrasound-guided device to help clinicians with cannula placement. An ultrasound helps visualize the blood vessel, and an indicator shows when the device is properly aligned. With the push of a button, the cannula is inserted into the vessel.
Many people undergoing treatment have a fistula, where an artery and vein are connected in the arm, as an access point for dialysis. The dimensions of that vessel can vary, which can make it more challenging to place a cannula, Makower said.
DaVita took an interest in the concept because improper cannulation can not only be painful for patients, but it can also drive up the cost of care. Cannulation problems can lead to infection, or if a fistula isn’t working, a patient may need to go to a hospital to get a catheter placed for dialysis, said Misha Palecek, DaVita’s chief transformation officer. Palecek hopes that treating grafts in a reliable and repeatable way will yield benefits for patients over time.
DaVita Venture Group helped incubate X9 with ExploraMed. The venture group invested in the X9’s initial seed round in 2022 and led a later Series B round.
Makower said the company started the project with a problem to solve and “a blank piece of paper.” The team sought to learn first about how care technicians work with patients, what are the challenges of the dialysis process and where a device might need to be cleaned and stored. They decided to go with an approach that keeps the human element of the cannulation process with a handheld system.
X9 already has Food and Drug Administration clearance for an ultrasound-only version of the device and plans to pursue authorization of a version with a power-assist needle feature. In November, the company finished a first-in-human feasibility study of the system. Makower did not provide a timeline for when the company plans to bring that device to market.
DaVita’s Palecek hopes to use the device in the company’s centers and for a broader impact.
“DaVita’s excited about it because there’s use cases, hopefully, a lot further beyond DaVita, which are really going to have an impact on the American healthcare system,” Palecek said.
