G-Tech Medical, the Fogarty Innovation company that is developing a low-cost, non-invasive diagnostic solution for patients with chronic gastrointestinal disorders, is celebrating several successes – with more to come.
The solution has two main uses: as a post-op product to help hospital staff make decisions about how soon to feed a patient and when to send them home, and as an ambulatory product to be used by traditional physicians with patients who suffer from gastrointestinal problems such as irritable bowel syndrome (IBS) and irritable bowel disease (IBD) – conditions that spur approximately 45 million office visits a year.
Its first 2022 success was receiving FDA clearance in January – just 90 days after applying. “We had to prove to the FDA that the measurements we make are real – that we are really measuring a signal from the stomach, the small intestine and the colon, which they said wouldn’t be easy,” says G-Tech CEO Steve Axelrod, Ph.D. “When we were done, they literally said, ‘Thank you. You made our job easy.’”
Since then, G-Tech has attracted interest from a variety of organizations and institutions and has multiple exciting partnerships and studies under way.
Full speed ahead with clinical studies
G-Tech is beginning a two-pronged study push to reach both the hospital post-op recovery and ambulatory markets. So far it has worked with 20 post-op patients at Yale New Haven and should be starting up soon at Beth Israel Deaconess Medical Center, Mayo Clinic Jacksonville and Northwestern in the Chicago area. It also has restarted a successful post-op study at El Camino Hospital and continues to work with the Children’s Hospital of Philadelphia.
The company also started an ambulatory study with gastroparesis patients through Dr. Brian Lacy, an industry luminary who currently practices at the Mayo Clinic in Jacksonville while serving as the co-editor-in-chief of the American Journal of Gastroenterology.
In addition, they are working with another key opinion leader, Jean-Fred Colombel, at Mount Sinai on an IBD study looking at motility in ambulatory ulcerative colitis patients.
The goal of the studies on the post-op side is to show the device’s potential to save days of costly hospital stay. On the ambulatory side, they hope to gain more clarity on how the gut works. “It’s highly nuanced because there are so many gut-related symptoms and dozens of reasons for them,” Steve says. “All of these studies taken together should help us understand more. No one has ever been able to gather this much insight into the actual workings of the gut – not just in the doctor’s office, but also what’s going on when people are at home.”
To that end, G-Tech received its own CPT3 code, which is used in reimbursement. “It’s very unusual for a company at our stage to get a code, as it usually comes once the device is ready for commercial use,” says Steve. “However, we wanted to get a head start since reimbursement is a critical component of commercialization.”
Gaining industry attention
G-Tech is actively documenting its research, with its fifth peer-reviewed article recently published in the Journal of Surgical Research. The piece, “Gastrointestinal Myoelectric Measurement via Simultaneous External and Internal Electrodes in Pigs,” was done in conjunction with Stanford Hospital and shows how G-Tech’s system correlates well with electrical measurements made internally in a pig model.
The company also had two scientific posters presented at Digestive Disease Week, the conference of the American Gastroenterological Association which took place in May in San Diego, in collaboration with its partners at UCLA and Children’s Hospital of Philadelphia.
Looking ahead to more success
The future is bright, with many plans in the works. To help the company pursue new opportunities, G-Tech recently added Stu Brogadir, MD, MBA, as part-time director of medical affairs. With decades of clinical practice and healthcare consulting experience, Stu is instrumental in his capacity to introduce them to some of the top gastroenterologists and the best hospitals in the country.
Coming up next are investigator-initiated studies in constipation, the effects of nutrition and therapeutic massage on IBS, the toxicity of oncology drugs and the feasibility of G-Tech’s use in telehealth.
In order to fund these exciting developments, G-Tech is seeking a $15 million Series A round. So far, a major pharmaceutical company and a private IBD grant institution have expressed strong interest in being involved. The money will be used to complete the engineering work to run the studies to collect the data they need, and then conduct a full launch into the post-op market and a soft launch into the ambulatory market.
Steve has no doubt success is imminent. “There’s a huge need for a measurement of gastrointestinal motility, in particular one that is noninvasive like ours and that can watch the gut under normal circumstances over multiple days, while being easy for the patient,” he says. “These are the key criteria that spur the interest of the practitioners we talk to.”