EnteroMedics Maestro Obesity Management Implant PMA Slated For 2008
This article was originally published in The Gray Sheet
Executive Summary
EnteroMedics expects to file an investigational device exemption with FDA by year end for U.S. trials of its Maestro obesity management implant
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Financings In Brief
EnteroMedics plans IPO: Developer of the Maestro obesity management implant files preliminary prospectus May 25 with the Securities & Exchange Commission for an initial public stock offering to help fund preparations for a PMA submission in the first half of 2009. Intended as an alternative to gastric bypass or gastric banding procedures, the system is based on the firm's VBLOC (Vagal Blocking for Obestity Control Therapy) technology, which uses high frequency, low power pulses of electrical energy to block satiety and hunger signals carried by the vagus nerve between the brain and digestive organs. EnteroMedics plans to begin a 220-patient, U.S. pivotal trial by the end of September. The St. Paul, Minn. firm initially planned to file a PMA by mid-2008; the company currently projects FDA approval and a U.S. launch in 2010 (1"The Gray Sheet" Aug. 7, 2006, p. 10)...
Financings In Brief
EnteroMedics plans IPO: Developer of the Maestro obesity management implant files preliminary prospectus May 25 with the Securities & Exchange Commission for an initial public stock offering to help fund preparations for a PMA submission in the first half of 2009. Intended as an alternative to gastric bypass or gastric banding procedures, the system is based on the firm's VBLOC (Vagal Blocking for Obestity Control Therapy) technology, which uses high frequency, low power pulses of electrical energy to block satiety and hunger signals carried by the vagus nerve between the brain and digestive organs. EnteroMedics plans to begin a 220-patient, U.S. pivotal trial by the end of September. The St. Paul, Minn. firm initially planned to file a PMA by mid-2008; the company currently projects FDA approval and a U.S. launch in 2010 (1"The Gray Sheet" Aug. 7, 2006, p. 10)...
Financings In Brief
IntraPace raises funds for obesity control implant: Clinical trials of IntraPace's endoscopically delivered, implantable gastric stimulator for treatment of obesity will commence in 2007, supported by a $30 mil. private placement announced Aug. 14, according to the company. The funds will be used to "complete product development and worldwide clinical studies," IntraPace says. Competing products under development include EnteroMedics' Maestro obesity management implant, in Phase I trials (1"The Gray Sheet" Aug. 7, 2006, p. 10). IntraPace's Series D financing round was led by Vulcan Capital. Additional investors include Boston Scientific, Johnson & Johnson, L Capital Partners, DFJ ePlanet, Oxford Bioscience Partners, Toucan Capital, CB Health Ventures, Halo Fund II and The Angel's Forum...