UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report: January 14, 2010

(Date of earliest event reported)

 

 

ENTEROMEDICS INC.

(Exact name of registrant as specified in its charter)

Commission File Number: 1-33818

 

Delaware		48-1293684
(State or other jurisdiction of incorporation)		(IRS Employer Identification No.)

2800 Patton Road, St. Paul, Minnesota 55113

(Address of principal executive offices, including zip code)

(651) 634-3003

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

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Item 7.01

Regulation FD Disclosure.

On January 14, 2010, EnteroMedics Inc. issued a press release to announce clinical results from two studies of VBLOC^® vagal blocking therapy, including additional data from its EMPOWER^TM study in obesity and interim clinical results from its ongoing VBLOC-DM2 ENABLE study in diabetes. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K and in the accompanying exhibit shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Current Report on Form 8-K and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by EnteroMedics Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press release dated January 14, 2010.

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: January 14, 2010

 

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EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press release dated January 14, 2010.

Exhibit 99.1

Contact:

EnteroMedics Inc.

Greg S. Lea

(651) 789-2860

ir@enteromedics.com

ENTEROMEDICS ANNOUNCES WEIGHT LOSS, HYPERTENSION AND

DIABETES DATA FROM EMPOWER AND ENABLE STUDIES

ST. PAUL, Minn., January 14, 2010 – EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced clinical results from two studies of VBLOC^® vagal blocking therapy, including additional data from its EMPOWER™ study in obesity and interim clinical results from its ongoing VBLOC-DM2 ENABLE (DM2) study in diabetes using the next-generation rechargeable (RC) device. For all studies, the Maestro^® System continues to meet its safety goals, with no therapy-related serious adverse events reported across the various study populations.

“Results from multiple studies of the Maestro System, which include over 400 implanted subjects, remain encouraging, with signs of clinically meaningful weight loss and control of obesity related co-morbidities as well as a safety profile unmatched among bariatric surgical procedures,” said President and CEO Mark B. Knudson, Ph.D. “Patients in the DM2 study, who use the RC Maestro System for approximately 14 hours a day, experience both meaningful weight loss and significant reductions in their HbA1c levels. Further, because the DM2 study uses the next-generation RC device, it shows promise in resolving patient compliance for those patients that did not use the device for the prescribed amount of time in the EMPOWER trial and earlier studies.”

Dr. Knudson added: “We look forward to meeting with the FDA during the current quarter to determine the appropriate regulatory path forward for the Maestro System as a treatment for morbid obesity and its related co-morbidities, diabetes and hypertension.”

Additional EMPOWER Study Results

The Company today announced additional data from a detailed review of its EMPOWER study, which included the following:

 

•

Weight loss corresponded directly to hours of use for patients in the treatment arm. At 12 months, results were as follows:

 

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•

Weight loss corresponded directly to hours of use when both the treatment and control arms are combined:

 

The EMPOWER study is a randomized, double-blind, controlled pivotal study designed to evaluate the safety and efficacy of the Maestro System in the treatment of obesity. EnteroMedics previously announced preliminary findings from a detailed review of the study which suggest 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 suggested that weight loss effects were evident in both the treatment and control arms because 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.

VBLOC-DM2 ENABLE study

The DM2 study is an ongoing feasibility study of the Maestro System in obese patients with Type-2 diabetes mellitus. The study includes subjects implanted with the RC device and was designed to evaluate the system’s safety and efficacy. Study data include:

 

•

HbA1c change (baseline 7.7%):

 

 

•

Percent excess weight loss (BMI Method from Implant):

 

 

•

Change in mean arterial pressure in Hypertensive Subjects (baseline 99.5 mmHg, average) in mmHg:

 

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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 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 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. EnteroMedics is currently conducting a feasibility study examining VBLOC Therapy’s effects on blood glucose levels in diabetic patients outside of the United States. For more information, visit www.enteromedics.com.

Forward-Looking Safe Harbor Statement:

This presentation 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 regulatory approval for our Maestro^® System for the treatment of obesity; our preliminary findings from our EMPOWER pivotal trial; our ability to complete our other clinical trials, or significant delays in the completion of our clinical trials; our ability to timely 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; 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; our ability to obtain and maintain intellectual property protection for our technology and products; and risks related the offering and ownership of our common stock. These and additional risks and uncertainties are described more fully in our Form 10-K filed with the SEC on March 12, 2009. We are providing this information as of the date of this presentation including our best estimates on obesity and bariatric surgery market calculations 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 U.S. Federal law to investigational use.

The implantation procedure and usage of the Maestro(R) System carry some risks, such as the risk generally associated with laparoscopic procedures and those related to treatment as described in the EMPOWER clinical trial informed consent.

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