The underwriters are Craig-Hallum Capital Group, Wedbush PacGrow Life Sciences and Roth Capital Partners.
EndoStim is medical device producer that developed a neurostimulation system for the treatment of severe gastroesophageal reflux disease, or GERD. The company’s approach targets the main cause of GERD, the lower esophageal sphincter. The EndoStim neurostimulation system, which has a form and function similar to a pacemaker, delivers low energy electrical stimulation to this muscle. In clinical trials to date, this stimulation has been shown to significantly reduce pathological reflux symptoms. The implantation of the neurostimulation system is minimally-invasive, reversible and preserves the anatomy of the esophagus and stomach.
The company has incurred net losses since its inception in 2009, including net losses of $7.5 million and $5.5 million before deduction for the accretion of redeemable preferred stock and undeclared dividends. At the end of June, the accumulated deficit was approximately $29.5 million.
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In clinical trials to date, over 130 patients have been implanted with the neurostimulation system, 65 of whom have been treated in open-label clinical trials. These trials have been conducted in Europe, Asia and South America with positive results. Endostim received approval from the FDA for its Investigational Device Exemption and plans to conduct a clinical trial in the U.S. with a minimum of 110 patients.
EndoStim would continue on to say, “Provided our United States clinical trial is successful, we do not believe there would be any material hurdles to receiving FDA approval that would permit us to sell our neurostimulation system in the United States.”
The company has previously received approval in Europe, Asia and South America, and it is already working through specialized distributors on these continents to commercialize its neurostimulation system.
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