ST. PAUL, MN--(Marketwire - March 12, 2012) - EnteroMedics Inc., (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that it has been notified by the American Medical Association that its Current Procedural Terminology (CPT) Committee has approved an application for six new Category III codes for vagal blocking therapy employed by EnteroMedics' VBLOC® vagal blocking therapy. The change in the CPT code book will take effect with the publication of the July 2012 edition.
Category III CPT codes are a set of temporary tracking codes that allow data collection for new and emerging technologies like VBLOC Therapy. These codes will provide the opportunity for reimbursement rates to be negotiated with health plans following Food and Drug Administration (FDA) approval of the Company's anticipated Premarket Approval (PMA) application for the Maestro® System, and ultimately could result in permanent Category I CPT codes.
"The approval of these Category III codes by the AMA's CPT Committee is another marker of progress for VBLOC Therapy and shows the support from multiple medical societies for the potential of our therapy based upon our published clinical data," said Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer. "These codes will help us build a broad experiential data base, from physicians and patients in the ReCharge Study and other clinical trials, to support an eventual application for a Category I CPT Payment Code pending an approval by the FDA of VBLOC Therapy. In the coming months these codes will also assist us in our effort to collect data and educate payors and providers about the potential for neuroblocking therapy to treat obesity and certain co-morbid conditions, such as diabetes."
About EnteroMedics Inc.
EnteroMedics is a development stage medical device company focused on the design and development of devices that use neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders. EnteroMedics' proprietary neuroblocking technology, VBLOC® vagal blocking therapy, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. These electrical impulses are delivered by a neuroregulator, EnteroMedics' Maestro® System, which is powered by an integrated rechargeable battery. For more information, visit www.enteromedics.com.
About VBLOC Therapy
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. VBLOC Therapy is delivered via the Maestro® System through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. VBLOC Therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.
About the ReCharge Study
The ReCharge Pivotal Trial is a randomized, double-blind, parallel-group, multicenter pivotal clinical trial in 233 patients at 10 sites testing the effectiveness and safety of VBLOC® vagal blocking therapy in EnteroMedics' second generation Maestro® Rechargeable (RC) System. All patients in the study 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 study period. All patients are expected to participate in a weight management counseling program.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our lack of commercial regulatory approval for our Maestro® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our preliminary findings from our EMPOWER™ pivotal trial; our ability to comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro System and VBLOC® vagal blocking therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company's filings with the Securities and Exchange Commission, particularly those factors identified as "risk factors" in the current report on Form 8-K filed September 28, 2011. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Caution - Investigational device. Limited by Federal (United States) law to investigational use.
The implantation procedure and usage of the Maestro® System carry some risks, such as the risks generally associated with laparoscopic procedures and those related to treatment as described in the ReCharge clinical trial informed consent.