San Antonio — There are obvious physical difficulties that people with spinal-cord injuries face. One that may not be top of mind, but can be both physically and emotionally taxing, is the inability to control their bladders, says Pratap Khanwilkar of San Antonio’s InCube Labs.
InCube Labs is working with a researcher from the University of Pittsburgh to build a medical device that may allow those people to once again normally use their bladders—or at least to replicate normal use. The Department of Defense awarded Changfeng Tai, an associate professor of urology at University of Pittsburgh, a $10 million, four-year contract to build a device that can be submitted to the FDA for regulatory testing . The university has subcontracted InCube to help Tai do so.
“It’s very debilitating from a quality of life perspective,” says Khanwilkar, InCube’s vice president of product development and the project’s manager. “You want to restore people to their quality of life, to as normal or near normal as possible.”
The device that Tai developed is an implant, which uses electricity to trigger neuromodulators in the bladder and the urinary sphincter. Those nerves would normally interact with the brain through the spinal cord—to either tense the urinary sphincter to make it store urine in the bladder or to relax it in order to help a person urinate, as well as to contract the bladder. However, they lose that connection after a spinal-cord injury, Khanwilkar says.
But even if the connection is lost, the nerves are still active and intact, allowing something like this medical device to cause the bladder to contract and the sphincter to operate, he says.
“It’s the sensitization between the two, between the bladder and the urinary sphincter, that this project aims to resolve,” Khanwilkar says. “Can you get the bladder to store normal amounts of urine? And the second part is can you pee when you want to and not at any other times?”
Tai has already had some success with the device when studying it in cats, Khanwilkar says. While Tai remains the principal investigator on the research, InCube will work alongside him to help make the device a viable product, determine where the implant can fit inside the body, how to power it, and how to manufacture it, among other details, Khanwilkar says.
When the company has gathered that information, as well as conducted further testing in animals for safety, a decision will be made about whether to apply to the FDA for premarket approval as a class three medical device, Khanwilkar says. It’s also possible that the project could be turned into a spinout company—but a decision on that won’t be made until after the product has been further developed and there are more results from animal testing, he says.
The Department of Defense funding, which was first reported yesterday by the San Antonio Business Journal, is intended to support the project to the point of submitting an investigational device exemption to the FDA, the company said in a statement. If accepted, testing could begin in humans.
InCube Labs, which has offices in San Antonio and San Jose, CA, is a medical device and drug therapy incubator of sorts, spinning out businesses based on technologies that it sees as viable products. The company was founded by inventor Mir Imran in 1995, and is now incubating six businesses in its San Antonio office, which opened in 2010.
The connection between InCube and the University of Pittsburgh is longstanding. Before joining InCube in 2015, Khanwilkar was the director of a program at the university’s engineering school that identified and funded research that had commercialization potential (called the Coulter Translational Research Partners II Program, which is one of 14 nationally). Imran, the CEO of InCube, is on the oversight committee for the program. Additionally, InCube is also working with Tai, the university researcher, on another device to treat overactive bladder.
If the technology, which Khanwilkar notes is promising but unproven, is able to reach its potential, it could be a significant improvement over the standard of care–a catheter, he says.
“No other technology we have seen solves both the problems simultaneously—the bladder and the sphincter and the timing between them,” Khanwilkar says.