Two recent federal grants have supercharged the progress of a non-invasive nerve blocking or stimulating technology from the lab of Pitt associate professor of urology Changfeng Tai as the startup formed around it prepares for clinical trials.
Stephen Popielarski, PhD, had been a mentor for Phase I Ventures, a Philadelphia-based startup accelerator that matches university startups with experienced entrepreneurs, when he was asked to review a batch of new applicants in 2017. As he worked through the proposals, one jumped off the screen at him.
“If we had to pick one application to put our full effort behind it would be Dr. Tai,” Dr. Popielarski said, referring to Changfeng Tai, associate professor of urology at the Pitt School of Medicine. He added that “a drug-free nerve block device that actually blocks pain signals without affecting motor function is a holy grail of medicine. We’re developing platform technologies because these new mechanisms have worked on every nerve we’ve tried.”
Dr. Popielarski interviewed and was selected to be the founding CEO of Thermaquil Inc., a new company formed around Dr. Tai’s discoveries. “Thermaquil’s objective is to alleviate human suffering caused by overactive nerves by developing a portfolio of reversible, drug-free nerve block devices. The ability to block undesired nervous signals represents a breakthrough capability that we look forward to applying to reduce pain and restore normal bodily functions.”
The company was formed in 2017 when Drs. Tai and Popielarski won a $100,000 grant through the Pitt Innovation Challenge (PInCh) to accelerate the commercial translation of the technology. This grant was matched with $100,000 from the Phase 1 Ventures program, and the technology was licensed from the university. The founding team then began to map out a product development and regulatory strategy that included a series of proposals for grants and contract from federal agencies.
Those efforts resulted in two significant developments in late 2020.
First, the company was awarded a $1 million Small Business Innovative Research (SBIR) grant to fund further development and human testing of the world’s first non-invasive nerve block device.
Almost simultaneously, Thermaquil partnered with Dr. Tai’s lab to be the commercialization partner for a $10.4 million Defense Advanced Research Project (DARPA) grant to further develop a nerve blocking and stimulating device to fully restore bladder function for people with complete spinal cord injuries, literally at the press of a button. Thermaquil is responsible for defining product requirements, clinical trials, regulatory submissions and eventual commercialization.
“I am very excited to see many years of research in my lab moving forward now to a possible human clinical trial,” Dr. Tai said of the DARPA-funded research. “I would like to thank the Innovation Institute for the help and assistant provided to me in my effort to commercialize my inventions.”
“I will certainly be encouraging my colleagues to think entrepreneurially when conducting research, which starts with filing IP disclosures as soon as possible before publishing the discoveries,” he added.
Popielarski said the company’s initial products will focus on pain management, specifically utilizing non-invasive nerve block devices to treat patients with headaches, migraines and other head or neck pain of any cause or diagnosis. Additional applications are being pursued to treat pain caused by scars and pain of the ankle, foot, hand or wrist.
“We pivoted our business in March, 2020, to be fully remote-enabled,” he said of enabling patients to try and then continue using Thermaquil’s treatments at home without going to the hospital or clinic. “Since then we’ve had many patients offer to pay thousands of dollars for therapy, but we’re only interested in their usage data and learning from their feedback at this time.”
As he looks ahead to the conclusion of trials and is hopeful of approval to go to market, Thermaquil is working towards reimbursement and lining up a supply chain for manufacturing and distributors to reach pain clinics, trauma centers and other sites of care.
Eventually, he could see the devices offered inside pharmacy clinics where they would be easy for people to try to see if it works for them.
If you are a Pitt innovator interested in starting your commercialization journey, consider the I-Corps Regional Course, which will help you discover the commercial potential of your innovation. Apply today. The course starts Feb 8.