Roseville, Minnesota-based EnteroMedics said Monday, that it expects to implant its first patient with its obesity controlling therapy by the second quarter of the year and all implants completed by year end.
The announcement was part of the 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.
The VBLOC therapy is not yet approved in the United States and has had major ups and downs. Initial results from the Empower clinical study of 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. Now, a newly designed pivotal clinical study dubbed ReCharge is underway in the United States.
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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.
