EnteroMedics Inc. (NSDQ:ETRM) said yesterday that it expects to enroll the first patient in a clinical trial for its new obesity controlling therapy by the end of the second quarter and have enrollment completed by year’s end.
The announcement was part of the St. Paul, Minn.-based anti-obesity device maker’s first quarter results in which the company reported a loss of $5.1 million, or 18 cents per share, compared with a loss of $4.8 million or 66 cents per share in the same period a year ago.
The company did not report any revenue and has $32.2 million in cash. Total operating expenses were $4.9 million, up from $4.4 million a year ago with most of the expenses associated with clinical trials of its VBLOC vagal blocking therapy, delivered through EnteroMedics’ Maestro system, according to the company.
The VBLOC therapy is not yet approved in the United States and has had major ups and downs. Initial results from the Empower VBLOC therapy clinical study on more than 400 patients showed the company did not hit its designed targets with people losing weight irrespective of whether they used or did not use the Maestro device. The newly designed clinical study that is now enrolling patients was dubbed ReCharge.
The company believes that its Maestro system is the first obesity therapy under clinical evaluation to regulate or block the vagus nerves. VBLOC therapy is delivered through laparoscopically implanted leads to intermittently block vagal nerve trunks and blocking those nerves can help in the management of obesity. Vagus nerves are cranial nerves that extend from the brain to the abdomen.
The company in March won CE Mark approval for European marketing of its Maestro RC weight loss system and began taking steps for approval in Australia.
In December, the company closed a $29.8 million public offering of common stock and warrants that the company plans to use to support regulatory approvals for the neuroblocking system.