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: June 22, 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)) |
| Item 7.01 | Regulation FD Disclosure. |
On June 22, 2010, EnteroMedics Inc. (the “Company”) issued a press release to announce that updated clinical results from its VBLOC-DM2 ENABLE study will be presented on June 26, 2010 at the Annual Meeting of the American Society of Metabolic and Bariatric Surgeons being held this week in Las Vegas, Nevada. The Company also announced updated data from its EMPOWERTM study in obesity. 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 June 22, 2010. | |
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.
| ENTEROMEDICS INC. | ||
| By: | /S/ GREG S. LEA | |
| Greg S. Lea | ||
| Senior Vice President and Chief Financial Officer | ||
Date: June 22, 2010
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 |
Press release dated June 22, 2010. | |
Exhibit 99.1
Contact:
EnteroMedics Inc.
Greg S. Lea
(651) 789-2860
ir@enteromedics.com
DATA FROM ENTEROMEDICS’ VBLOC-DM2 ENABLE STUDY TO BE PRESENTED AT
AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY MEETING
Company Announces Updated Data from EMPOWER Study
ST. PAUL, Minn., June 22, 2010 – EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced that updated clinical results from the Company’s VBLOC-DM2 ENABLE (DM2) study will be presented on June 26, 2010 at 11:30 AM PT at the 27th Annual Meeting of the American Society of Metabolic and Bariatric Surgeons (ASMBS), being held June 21-26 in Las Vegas, NV. The Company also announced today updated data from its EMPOWER™ study in obesity.
“The Maestro System has been studied in over 400 people to date, with some patients into their fifth year of follow-up,” said President and CEO Mark B. Knudson, Ph.D. “Across a number of studies, we have observed clinically significant weight loss and control of obesity related co-morbidities as well as a safety profile that distinguishes this system from all other bariatric surgical procedures. We are particularly encouraged by the strong, positive feedback from the metabolic and bariatric surgery community.”
The Maestro® System, which delivers VBLOC® vagal blocking therapy, continues to meet all of its safety goals, with no therapy-related serious adverse events reported across all of the various study populations.
Updated VBLOC-DM2 ENABLE Study Data
The DM2 study is an ongoing feasibility study of the Maestro System in obese patients with Type-2 diabetes mellitus. The study was designed to evaluate the safety and efficacy of the Company’s next-generation Maestro RC System. The Maestro RC System is powered by an internal battery recharged via an external mobile charger and transmit coil worn by the patient for a short time each week. Patients in this trial are averaging approximately 14 hours per day of therapy.
“The DM2 study is noteworthy in that we see significant, sustained improvements in glycemic control and blood pressure as well as clinically meaningful weight loss, without a compromise in patient safety,” said James Toouli, M.D., professor of surgery at Flinders University in Adelaide, Australia, and one of the study’s investigators. “These results are comparable to changes seen with other procedures and do not appear to be dependent only on reduction of the glycemic load.”
“The study’s glycemic control data are particularly promising, as published research indicates an HbA1 c level below 7 percent is associated with fewer microvascular complications and reduced cardiovascular disease,” Dr. Toouli added, noting the National Health and Nutrition Examination Survey Data. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 1999-2002. “I look forward to further investigating the potential of VBLOC Therapy in the treatment of obesity and its related co-morbidities.”
Study data presented at the ASMBS meeting include:
| • |
HbA1 c change (Company updated data): |
| Visit (post-device activation) |
HbA1c change | Percent HbA1c | N | p | ||||
| Week 1 (Baseline 7.8%) |
-0.3 | 7.5 | 28 | <.002 | ||||
| Week 4 (Baseline 7.8%) |
-0.7 | 7.1 | 28 | <.002 | ||||
| Week 12 (Baseline 7.7%) |
-0.9 | 6.8 | 26 | <.002 | ||||
| 6 Months (Baseline 7.8%) |
-0.9 | 6.8 | 25 | <.002 | ||||
| 12 Months (Baseline 7.4%) |
-0.8 | 6.6 | 17 | =.01 |
Interim analysis. Ns are patients who have reached the reported time points.
| • | Percent excess weight loss (BMI Method from Implant, Company updated data): |
| Visit (post-device activation) |
EWL | N | P | |||
| Week 1 |
-8.9 | 28 | <.0001 | |||
| Week 4 |
-13.7 | 28 | <.0001 | |||
| Week 12 |
-20.8 | 26 | <.0001 | |||
| 6 Months |
-24.4 | 25 | <.0001 | |||
| 12 Months |
-25.1 | 17 | <.0001 |
Interim analysis. Ns are patients who have reached the reported time points.
Updated EMPOWER Study Results
The Company today announced updated 20 month data on Excess Weight Loss (EWL) for the EMPOWER study:
| Visit |
EWL | N | |||
| 4 Months |
-16.66 | % | 260 | ||
| 8 Months |
-17.66 | % | 253 | ||
| 12 Months |
-16.34 | % | 265 | ||
| 16 Months* |
-18.56 | % | 205 | ||
| 20 Months* |
-19.02 | % | 150 |
| * | Patients are averaging approximately 9 hours of device use daily Interim analysis. N at 16 and 20 months are patients who have reached those time points. |
Commenting on the EMPOWER data, Dr. Knudson added: “The sustained pattern of weight loss and favorable safety profile seen as we approach two years of follow-up in the EMPOWER study
reinforce the Maestro System’s potential to become the minimally invasive alternative of choice over existing surgical treatments for obesity. We continue to see a correlation between hours of daily device use and excess weight loss. This result is important because our second generation RC device, used in our DM2 study as described above, delivers, on average, a greater duration of VBLOC Therapy thanks to its convenient rechargeable delivery system.”
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 part of a comprehensive support program 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.
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 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 regulatory approval for our Maestro® System for the treatment of obesity; 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; 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; potential 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 Company’s Form 10-K dated March 29, 2010. 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 U.S. Federal law to investigational use.
The implantation procedure and usage of the Maestro® 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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