Obalon Therapeutics (NSDQ:OBLN) today touted that it has never received a report of a death related to the use of its Obalon six-month gas-filled gastric balloon system designed to aid in weight loss in light of a recent FDA notice warning of five deaths related to liquid-filled gastric balloon systems.
The San Diego-based company clarified that the FDA notice released earlier this week, which mentioned deaths related to the use of both Apollo Endosurgery (NSDQ:APEN) and ReShape Lifesciences (NSDQ:RSLS) liquid-filled gastric balloon devices, did not apply to its gas-filled balloons.
“Our first concern is for the patients and families, as well as the health care professionals that care for these patients, who are impacted by these adverse events. Patient outcomes, especially safety, has always been the highest priority at Obalon. We believe we have a novel product that is performing very differently than the liquid-filled balloons and a team of people at Obalon who are responsibly and ethically building this important new therapy category for the treatment of obesity,” prez & CEO Andy Rasdal said in a press release.
Obalon touted its efforts to track adverse events related to the Obalon balloon system, and said that it will continue to track any issues with the system and will appropriately report them to the FDA and other regulatory bodies.
“Obalon has always believed that obesity is a serious chronic disease, which if left untreated, is the gateway to the progression of more serious health events, such as diabetes and cardiovascular disease. Based on the data collected in the Obalon Commercial Registry, as well as the low number of reported events, we believe the Obalon Gas-Filled Balloon is performing with the same strong safety profile as it did in our Pivotal Trial and provides an important treatment option for obese patients who cannot lose weight with diet and exercise alone,” regulatory affairs VP Amy VandenBerg said in a prepared statement.
In March, Obalon saw shares fall after posting fourth-quarter and full-year results that failed to meet both its own expectations and the consensus forecast on Wall Street.