Summary: Impleo Medical, a medical device company based in St. Paul, Minnesota, is developing the next generation technology, a novel, less invasive and less costly treatment for acid reflux (GERD), the most common GI diagnosis. The technology is already FDA-approved for another indication, urinary incontinence. We are using similar mechanism of action to address the market of 65 million GERD patients in the US alone. The key benefits of our technology are:
Minimally invasive, outpatient procedure
Provides durable relief from acid reflux
Fills a treatment gap between medications and surgery
Represents cost savings to the healthcare system
Generates additional revenue for gastroenterologists
The Company’s previous trial generated clinically meaningful and statistically significant results. The FDA has already approved the protocol for the Company’s final study which will take place at Beth Israel (Harvard Medical School) hospital, Stanford University, Washington University, Northwestern Memorial Hospital, and others. CMS issued positive reimbursement coverage for Impleo’s procedure in the trial.
Need: GERD affects 1 in 4 adults Americans (65M in US). In addition to being #1 GI diagnosis, it leads to other disorders including Barrett’s esophagus and esophageal cancer. GERD medications called Proton Pump Inhibitors (PPIs) are the most common treatment. They are indicated for a few days but are often taken by patients for years due to the lack of better alternatives. Chronic use of PPIs is associated with heart attacks, kidney disease, dementia, bone fracture, interference with other drugs, and early death. Plus, a third of patients who take PPIs still have symptoms. The alternative is a surgical procedure that is invasive and changes patients’ anatomy forever.
Value: In GERD, where surgeries are invasive and irreversible, while medications have significant risks, we offer an outpatient one-time injection treatment that provides durable relief from GERD symptoms. Our injectable device fills a treatment gap between medications and surgery. It’s outpatient, minimally invasive and durable, representing cost savings to the healthcare system while generating additional revenue to GIs. Impleo’s device has demonstrated clinically meaningful and statistically significant results in GERD pilot study with no serious adverse events. We have an issued patent covering the use of our device in the lower esophagus and an exclusive license to injectable composition patents in the field of gastroenterology. Reimbursement CPT codes for the injection procedure have already been established. Moreover, CMS approved coverage of our injection procedure and device even in the pivotal clinical trial. Impleo has the potential of bringing to the forefront a minimally invasive, long-lasting and effective treatment of GERD for most patients.