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PMA Application

FDA to review VBLOC Therapy PMA Application

Compasny also enters ATM equity distribution agreement

EnteroMedics has announced that the FDA has accepted for filing the company's Premarket Approval (PMA) application for approval of the Maestro Rechargeable System's VBLOC vagal blocking therapy as a treatment for obesity.

"The Maestro System holds the potential to fill a significant gap in the obesity treatment landscape, offering a unique, patient-friendly approach to addressing the long term challenges associated with obesity," said Dr Mark B Knudson, EnteroMedics' President and CEO. "FDA acceptance for filing of our PMA application is an important step toward this goal. We look forward to working closely with the FDA during the review process, continuing through an advisory committee panel and approval decision, as we prepare for US commercialisation of the Maestro System."

The FDA has previously indicated in a pre-PMA meeting that, subject to a detailed review of the submitted data, the company can anticipate presenting the PMA before a future FDA Advisory Committee panel. The accepted PMA application includes data from the company's ReCharge Pivotal Trial, a prospective, double-blind, sham-controlled clinical trial involving 239 randomised patients (233 implanted) at ten sites in the US and Australia.

All patients in the trial received an implanted device and were randomized in a 2:1 allocation to treatment or control groups. The control group received a non-functional device during the trial period. In February 2013, EnteroMedics announced that its ReCharge Trial demonstrated a statistically significant and clinically meaningful excess weight loss (EWL) outcome and excellent safety profile.

This included an average EWL of approximately 25% for VBLOC Therapy-treated patients, with over 50% of those patients achieving at least a 20% EWL. While the results demonstrated an excellent safety profile that met the pre-specified trial measures, with both a positive benefit-risk equation and a medically meaningful and clinically significant effect over the control group, the results did not meet the study's predefined super-superiority efficacy endpoints.

EnteroMedics developed VBLOC vagal blocking therapy to offer bariatric surgeons and their patients a less invasive alternative to existing surgical weight loss procedures that may present significant risks and alter digestive system anatomy, lifestyle and food choices.

The Maestro RC System delivers VBLOC vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the oesophagus and the stomach. The Maestro RC System is powered by an internal, rechargeable battery. The battery is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week.

The Maestro RC System has received CE Mark and has been listed on the Australian Register of Therapeutic Goods.

Separately, the company has entered into an ‘at-the-market’ (ATM) equity distribution agreement with Canaccord Genuity Inc. acting as sole agent. Under the terms of the distribution agreement, the company may, from time to time, sell shares of its common stock having an aggregate offering value of up to $20.0 million through Canaccord Genuity. The company will determine, at its sole discretion, the timing and number of shares to be sold under this ATM facility.

The ATM facility is intended to replace the company's $45.0 million equity financing facility with Terrapin Opportunity, which has been discontinued.

"With $23.3 million in current cash and equivalents, and the ability to sell shares under our new ATM facility, EnteroMedics will have the necessary resources to continue executing on its pivotal regulatory strategy and commercialization activities into 2014," said Greg S Lea, Senior Vice President, Chief Financial Officer and Chief Operating Officer.

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