Averts $5.1M in trial costs
By Katie Pfaff
Bariatric and gastrointestinal medical device firm Apollo Endosurgery Inc. has won FDA authorization to terminate its Lap-band lower BMI (LBMI) post-approval study due to long-term data on safety and effectiveness in already published evidence. LBMI's early termination will amount to about $5.1 million in savings for the company, expected over the length of the research. The study was anticipated to enroll as many as 325 patients at 20 sites; 181 patients had since the end of 2017 been enrolled at 13 clinical sites.
Apollo won FDA approval in 2011 for an expanded indication of Lap-band for patients between 30 and 35 BMI and with at least one comorbidity, and was thus required to complete the post-approval study, LBMI. The study was designed as an open-label, multicenter, prospective safety and efficacy trial for patients with BMI between 30 and 39.9 and one or more comorbidities tied to obesity. LBMI was intended to follow patients for as long as ten years after surgical implantation.
Austin, Texas-based Apollo's final report to the FDA referenced 25 published studies as evidence for its Lap-band device's safety and effectiveness. Most recently, HERO-002, which wrapped up in September of last year, evaluated patients with Lap-band devices. Study results included an average of 18 percent long-term sustained total body weight loss over five years, plus or minus 12.7 percent, amounting to 51.7 percent loss of excess weight. At the same time, the rate of device explant was 8.74 percent compared to the designated safety objective rate of lower than 39.4 percent at the five year mark.
The single-arm, multicenter, prospective, five year post-approval HERO-002 study included 672 enrollees who had BMI between 35 and 40, and one or more comorbidity. The participants received the Lap-band at 17 sites in the U.S. and Canada. Patients also were 100 or more pounds over their ideal weight. Results of the trial were positive with no unanticipated adverse device effects, and most of the adverse event were mild (70.3 percent) or moderate (23.7 percent). Common adverse events were vomiting (33 percent), gastroesophageal reflux disease (20.6 percent) and dysphagia (22.3 percent).
Lap-band AP adjustable gastric banding system works by putting pressure to the top of the stomach with a laparoscopically placed band. The band's pressure creates a sense of fullness in the stomach, leading to less eating.
Additional devices, FDA letter
Late last year, Apollo won 510(k) clearance for Overstitch Sx, a full-thickness flexible endoscopic suturing system used with single-channel flexible endoscopes. The device added to the compatibility of dual and single channel endoscopes. Overstitch will increase maneuverability and visualization, and it is expected to reach the European and American markets later this year. (See BioWorld MedTech, Nov. 29, 2017.)
Last summer, Apollo, which makes the Orbera intragastric balloon system, issued further information and a statement regarding an FDA letter suggesting physicians screen and monitor patients with gastric balloons more carefully. The Aug. 10, 2017, letter followed five deaths of patients between 2015 and 2017, which were reported to the FDA. (See BioWorld MedTech, Aug. 14, 2017.) Four of the patients received Orbera and one received San Clemente, Calif.-based Reshape Medical Inc.'s integrated dual balloon system. Apollo held a conference call to discuss the letter, which did not suggest causes of death for the patients, but noted the deaths occurred one month or less from surgery.
"The FDA issued the letter to raise awareness among physicians, and the letter does not require any action by physicians or patients, nor does the FDA indicate that the patient deaths were attributed to Orbera," said Newton in the call. FDA was alerted to the cases as part of the "company's normal and ongoing global product surveillance program."
Company statement, investor confidence
"In each of these cases, we are not aware of any evidence that suggests a device malfunction or failure," said Newton. From Jan. 1, 2006, to March 31, 2017, 21 patient deaths were reported among those Orbera device patients. During that same time, 277,000 patients received the device, equating to "an incident rate of less than one-hundredth of 1 percent," said Newton. The percentage of deaths since the August 2015 FDA approval is unchanged, he said, adding that other gastric surgeries carried greater risk, including endoscopy, laparoscopic gastric banding and laparoscopic sleeve gastrectomy.
At that time, Roth Capital Partners commented the FDA letter should not worry investors, and issued a buy rating based on the company's history, that the information was voluntarily self-reported, and that the FDA letter was not a warning.
"Overall, while the headline is ugly, and the FDA's rationale for putting out the letter remains perplexing, we do not expect this to have a material impact on Orbera's U.S. commercial prospects going forward as these events have been already properly recorded in the FDA's Maude database and are properly presented to and understood by APEN's physician customers," said Chris Lewis of Roth Capital. (See BioWorld MedTech, Aug. 14, 2017.)
Competition in the marketplace
Obesity market competitor, St. Paul, Minn.-based Enteromedics Inc. acquired private firm Reshape Medical in a $5 million cash, common stock and series C convertible stock deal last fall. The deal was valued at $61 million. Enteromedics shared its goal of becoming the industry leader at that time, based in part on Reshape's low cost dual balloon system, which is placed into the stomach through endoscopy. Reshape's two balloon system is for patients with 30 to 40 BMI who are unable to lose weight and not candidates for surgery. (See BioWorld MedTech, Oct. 4, 2017.)
Enteromedics has received FDA clearance for its pacemaker-like Vbloc neurometabolic therapy system, which addresses hunger sensation by interrupting vagus nerve signals. (See BioWorld MedTech, May 21, 2015.) Enteromedics acquired Bariosurg Inc., of Lake Forest, Calif. for $2 million in cash, 1.38 million unregistered shares of common stock, and 1 million unregistered shares of conditional convertible preferred stock last year. Bariosurg offers its Gastric Vest system, which reduces stomach volume without changing the structure. (See BioWorld MedTech, May 24, 2017.)
Published March 14, 2018