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EnteroMedics Achieves Major Milestones in Global Regulatory and Commercialization Strategy for the Maestro System
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EnteroMedics Inc. has announced that the Company has received conditional approval for its Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA). The IDE outlines plans for conducting a pivotal trial, the ReCharge Trial, evaluating the safety and efficacy of VBLOC® vagal blocking therapy delivered via the Company's second-generation Maestro® RC System in the treatment of obesity.
The Maestro System is the first obesity treatment to use 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.
The Company also announced its plans to commercialize the Maestro RC System in Australia and expects to file an application for approval and listing with the Australian Therapeutic Goods Administration (TGA) upon receiving CE Mark certification for the Maestro RC System. EnteroMedics hopes to receive TGA approval during the second half of 2011. The Company continues to explore commercialization opportunities in other markets outside of the United States.
With the decision to commercialize in Australia, the Company recently entered into formal discussions with the Australian Institute of Weight Control (AIWC), a network of surgical clinics specializing in laparoscopic weight loss surgery and clinical research for the morbidly obese, to become the first group of surgeons to implant the Maestro RC System commercially when Australian regulatory approval is obtained.
The discussions also include the intent to enter into an agreement between AIWC and EnteroMedics under which AIWC will provide services including surgeon and clinic training as well as research, regulatory affairs, marketing, and reimbursement support related to the Maestro RC System in Australia.
"EnteroMedics has achieved two key objectives in its effort to bring a safe and effective treatment option to major global markets where obesity has become an epidemic," said Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer. "Conditional approval of our IDE application is the next step forward toward U.S. regulatory approval for VBLOC Therapy. Importantly, the ReCharge trial also advances our second-generation Maestro RC System. Insight gained from the over 400 patients worldwide treated with VBLOC Therapy provides us with the confidence to embark on our commercialization path outside the U.S. and look ahead to the ReCharge study as part of our U.S. commercialization strategy."
Commenting on EnteroMedics' discussions with the AIWC, Dr. Knudson said: "The AIWC group of surgeons are internationally known, have extensive experience with the Maestro System, have participated with EnteroMedics in our earliest clinical studies and are strong advocates for this new therapy. The AIWC is an ideal partner for the commercialization of the Maestro System in Australia, a country whose rate of obesity surgery has risen over 800 percent in the last decade."
The Maestro System is the first obesity treatment to use 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.
The Company also announced its plans to commercialize the Maestro RC System in Australia and expects to file an application for approval and listing with the Australian Therapeutic Goods Administration (TGA) upon receiving CE Mark certification for the Maestro RC System. EnteroMedics hopes to receive TGA approval during the second half of 2011. The Company continues to explore commercialization opportunities in other markets outside of the United States.
With the decision to commercialize in Australia, the Company recently entered into formal discussions with the Australian Institute of Weight Control (AIWC), a network of surgical clinics specializing in laparoscopic weight loss surgery and clinical research for the morbidly obese, to become the first group of surgeons to implant the Maestro RC System commercially when Australian regulatory approval is obtained.
The discussions also include the intent to enter into an agreement between AIWC and EnteroMedics under which AIWC will provide services including surgeon and clinic training as well as research, regulatory affairs, marketing, and reimbursement support related to the Maestro RC System in Australia.
"EnteroMedics has achieved two key objectives in its effort to bring a safe and effective treatment option to major global markets where obesity has become an epidemic," said Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer. "Conditional approval of our IDE application is the next step forward toward U.S. regulatory approval for VBLOC Therapy. Importantly, the ReCharge trial also advances our second-generation Maestro RC System. Insight gained from the over 400 patients worldwide treated with VBLOC Therapy provides us with the confidence to embark on our commercialization path outside the U.S. and look ahead to the ReCharge study as part of our U.S. commercialization strategy."
Commenting on EnteroMedics' discussions with the AIWC, Dr. Knudson said: "The AIWC group of surgeons are internationally known, have extensive experience with the Maestro System, have participated with EnteroMedics in our earliest clinical studies and are strong advocates for this new therapy. The AIWC is an ideal partner for the commercialization of the Maestro System in Australia, a country whose rate of obesity surgery has risen over 800 percent in the last decade."
