In April the Carlsbad, Calif.-based company, which makes a gas-filled balloon designed to treat obesity, revealed plans to lay off 50% of its employees, including all of its direct sales force, in a pivot toward company-owned or managed retail centers. Obalon later tapped an advisory firm to explore “strategic alternatives.”
The $17.3 million offering, registered with the U.S. Securities & Exchange Commission June 21, is slated “to launch our transition to company-owned or managed Obalon-branded retail centers,” according to a regulatory filing.
Obalon, which won 510(k) clearance from the FDA last December for a new system for placing its weight loss balloon without needing X-rays, also touted clinical results from a study of that system. Data from the Cobalt study, of 397 balloon administration assessments from 155 patients, was presented last week by co-primary investigator Dr. Michael Seger of the Bariatric Medical Institute in San Antonio, Texas.
Obalon said the study met both primary endpoints, showing 100% correct decision-making suing the navigation device without X-ray and 100% agreement between the navigation system and X-rays collected but not used during the procedure. The adverse event rate was 3.9%, with no serious adverse events and none relating to the navigation device or dispenser, the company said.
“These results suggest that the Navigation device can be used to safely and accurately administer Obalon Balloons without the use of radiography,” Seger said in prepared remarks. “Prior studies support the ability to achieve safe and effective weight loss with the Obalon Balloon System, and the use of Navigation can remove a key barrier to balloon administration when X-ray imaging is not accessible.”
“These data demonstrate the robustness of our Navigation System, which like our gastric balloon, continues to perform well in clinical studies and in commercial use,” added chief regulatory & clinical officer Amy VandenBerg. “We remain dedicated to improving the performance, usability and economics of the Obalon Balloon System and making this safe and effective technology more readily available to individuals with a BMI between 30 to 40 kg/m2 who are ready to lose weight and improve their overall health.”