Key Developments For EnteroMedics Inc.
EnteroMedics Inc. (ETRM.O) (Consolidated Issue listed on NASDAQ Global Market)
EnteroMedics Inc. Announces Preliminary Results From Detailed Review Of EMPOWER Study
EnteroMedics Inc. announced preliminary findings from its ongoing detailed review of its EMPOWER study, a randomized, double-blind, controlled pivotal study designed to evaluate the safety and efficacy of the Maestro System in the treatment of obesity. On October 2, 2009, the Company announced that the study did not meet its primary and secondary efficacy endpoints, as results in the control and treatment arms were statistically indistinguishable, while achieving all of its safety endpoints. The ongoing detailed review suggests that vagal blocking therapy may promote safe and effective weight loss as an adjunct to behavioral support, diet and exercise in morbidly obese patients. The review further suggests that these effects were evident in both the treatment and control arms. The Company is continuing a comprehensive analysis of all clinical, statistical, and engineering data to understand this finding. Based on the analysis to date, the control arm of the trial, which was intended to be inactive, apparently provided a low-intensity blocking signal that introduced VBLOC Therapy in human subjects. The EMPOWER study met all of its safety goals, including the finding that there were no therapy-related serious adverse events reported across the entire study population. Results from the two arms of the EMPOWER study as well as from our previous VBLOC Therapy trials were consistent with each other, suggesting a pattern of positive clinical outcome when blocking the vagus nerve.
EnteroMedics Inc. Announces Reduction in Workforce; Comments On Q4 2009 Charge Guidance
EnteroMedics Inc. announced that it has implemented a plan to reduce its workforce and operating costs. The reduction in force will lower the number of employees by 40%, to a total of 33, by November 15, 2009. The reduction in force is expected to result in approximately $3.2 million in reduced operating expenses in 2010. The Company expects to incur a charge of approximately $0.5 million related to the workforce reduction in the fourth quarter of 2009. Individuals subject to the reduction have been offered severance agreements.
EnteroMedics Inc. Announces $4.9 Million Financing
EnteroMedics Inc. announced that it has entered into a definitive agreement with an institutional investor to sell 6,161,068 of the Company's common shares in a registered direct offering, at a price of $0.80 per share, for gross proceeds of approximately $4.9 million, before deducting placement agent fees and estimated offering expenses. Canaccord Adams Inc. acted as the sole placement agent for the offering. The transaction is expected to close on or about October 7, 2009, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds of this offering to fund clinical studies of VBLOC Therapy in obesity, hypertension and diabetes, as well as for general working capital purposes.
EnteroMedics Inc. Announces Preliminary Results of its EMPOWER Study
EnteroMedics Inc. announced the preliminary results from its EMPOWER Study. Based on an initial analysis, the study did not meet its primary and secondary efficacy endpoints. There were no therapy-related serious adverse events reported in the study. The EMPOWER Study is a randomized, double-blind, placebo-controlled pivotal study designed to evaluate the safety and effectiveness of the Maestro System for the treatment of obesity.
EnteroMedics Inc. Receives CE Mark Certification For Maestro System For Obesity Therapy
EnteroMedics Inc announced that it has received CE Mark approval of VBLOC Therapy delivered via the Maestro System for the treatment of obesity. The Maestro System is the first to treat obesity using neuroblocking technology and represents a less invasive alternative to existing surgical weight loss procedures, which alter digestive system anatomy, lifestyle and food choices and may present significant risks. CE Mark approval gives EnteroMedics the ability to market the Maestro System to countries of the European Economic Area. VBLOC Therapy is undergoing clinical testing in the United States and Australia in a pivotal trial known as the EMPOWER study. Provided a positive outcome from the study, EnteroMedics will use data from the EMPOWER trial to support a premarket approval (PMA) application for the Maestro System, which it expects to submit to the U.S. Food and Drug Administration in late 2009.
