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: August 12, 2016
(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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(d) On August 15, 2016, the Board of Directors (the “Board”) of EnteroMedics Inc. (the “Company”) appointed Gary Blackford to serve as a director of the Company. The appointment was made to fill the vacancy created by the decision of Catherine Friedman not to stand for re-election to the Board at the Company’s annual meeting on May 4, 2016. Mr. Blackford will serve as a Class III Director until the Company’s 2019 annual meeting or until his successor is elected and qualified.
In addition, on August 12, 2016, Anthony P. Jansz informed the Board of his decision to resign from the Board, effective as of the date of Mr. Blackford’s acceptance. Mr. Jansz’ resignation was not due to any disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
Mr. Blackford, age 59, has been leading healthcare companies for over thirty years, with a focus on driving change and innovation that creates value for investors, employees and healthcare consumers. Mr. Blackford was most recently Chairman and Chief Executive Officer of Universal Hospital Services, Inc. (“UHS”) from 2002 until 2015, where he transformed UHS from a regional medical equipment rental company to a national leader in medical equipment outsourcing and life cycle solutions. He currently sits on the board of directors of Wright Medical Group, Inc., Halyard Healthcare, Inc. and PipelineRX. He received his BBA (accounting) from the University of Iowa and his law degree from Creighton University.
In making the appointment, the Board determined that Mr. Blackford’s significant executive leadership experience, his experience working with hospitals and alternative care providers in all fifty states and his experience as a board member of public medical device companies make him well suited to serve as a member of the Board. The Board has determined that Mr. Blackford qualifies as “independent” pursuant to the rules of the NASDAQ Stock Market.
As consideration for Mr. Blackford’s agreeing to become a member of the Board, the Company granted Mr. Blackford an option to purchase 1,667 shares of the Company’s common stock. The option has an exercise price equal to $0.17, which was the closing sale price of the Company’s common stock on the Nasdaq Stock Market on August 15, 2016, and vests such that twenty-five percent of the option vested immediately with the remainder vesting in 36 equal monthly installments following the date of grant. The option has a ten-year term subject to earlier termination in connection with a termination of directorship.
Mr. Blackford has no family relationship with any other officer or director of the Company. Neither Mr. Blackford nor any immediate family member of Mr. Blackford has a material interest in any transaction with the Company involving the payment or receipt of at least $120,000.
A copy of the press release issued by the Company on August 17, 2016 announcing the appointment of Mr. Blackford is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 8.01 Other Events.
On August 15, 2016, the Company issued a press release to announce 24-month results for the Company’s ReCharge Clinical Study. A copy of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release dated August 17, 2016 regarding the appointment of Gary Blackford | |
| 99.2 | Press Release dated August 15, 2016 regarding the ReCharge Clinical Study | |
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 | ||
| Chief Financial Officer and Chief Compliance Officer | ||
Date: August 17, 2016
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press Release dated August 17, 2016 regarding the appointment of Gary Blackford | |
| 99.2 | Press Release dated August 15, 2016 regarding the ReCharge Clinical Study | |
Exhibit 99.1
| Media Contact: | Investor Contact: | |
| Eliza Schleifstein | Greg S. Lea | |
| Argot Partners | Chief Financial Officer | |
| (917) 763-8106 | EnteroMedics Inc. | |
| eliza@argotpartners.com | (651) 634-3003 | |
| glea@enteromedics.com |
EnteroMedics Announces Appointment of Gary Blackford to its Board of Directors
ST. PAUL, Minnesota, August 17, 2016 – EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases, and other gastrointestinal disorders, today announced the appointment of Gary Blackford to its Board of Directors, effective August 16, 2016. The Company also announced that Anthony Jansz will step down from the Board effective August 16, 2016.
“On behalf of the Board of Directors, I would like to thank Mr. Jansz for his contribution and service to the company. We wish him well in his future endeavors,” said Mark Knudson, PhD, Chairman of the Board of EnteroMedics. “We are extremely fortunate to have Mr. Blackford join our Board at such an important time for the company. His insight and guidance will be invaluable as we continue to work towards our goals of expanding vBloc usage and obtaining broad reimbursement coverage.”
Mr. Blackford brings to EnteroMedics over 30 years of executive experience in the healthcare industry, having most recently served as Chief Executive Officer of Universal Hospital Services Inc., a nationwide provider of medical equipment management and service solutions for the healthcare industry, from 2002 to 2015. Prior to Universal Hospital Services, Inc., from 2001-2002, Mr. Blackford was Chief Executive Officer of Curative Health Services, Inc., a specialty healthcare services and pharmacy distribution company. From 1994 to 1998, Mr. Blackford served in executive roles at pharmacy benefit management companies including Medintell Systems Corporation and ValueRx (acquired by Express Scripts). He currently serves as a member of the board of directors for Wright Medical Group N.V., Halyard Health, Inc. and PipelineRx.
“vBloc Therapy has demonstrated a great potential to play a crucial role within the obesity treatment paradigm,” said Mr. Blackford. “I am delighted to join the EnteroMedics Board, and look forward to helping the company achieve its long-term goals.”
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by a pacemaker-like device called the Maestro® Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics’ Maestro Rechargeable System has received U.S. Food and Drug Administration approval and CE Mark approval.
Information about the Maestro® Rechargeable System and vBloc® Neurometabolic Therapy
You should not have an implanted Maestro Rechargeable System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat. The most common related adverse events that were experienced during clinical study of the Maestro Rechargeable System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.
Talk with your doctor about the full risks and benefits of vBloc Therapy and the Maestro Rechargeable System. For additional prescribing information, please visit www.enteromedics.com.
If you are interested in learning more about vBloc Neurometabolic Therapy, please visit www.vbloc.com or call 1-800-MY-VBLOC.
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 limited commercial sales experience with our Maestro® Rechargeable System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our ability to regain and then maintain compliance 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® Neurometabolic 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 annual report on Form 10-K filed March 28, 2016. 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.
Exhibit 99.2
| Media Contact: | Investor Contact: | |
| Eliza Schleifstein | Greg S. Lea | |
| Argot Partners | Chief Financial Officer | |
| (917) 763-8106 | EnteroMedics Inc. | |
| eliza@argotpartners.com | (651) 634-3003 | |
| glea@enteromedics.com |
EnteroMedics Announces Publication of 24 Month ReCharge Clinical Study Data in Obesity Surgery
– vBloc® Therapy Demonstrates Durable Weight Loss, Reduction of Comorbidities, and Favorable Safety Profile at 24 Months –
ST. PAUL, Minnesota, August 15, 2016 – EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced the publication of 24 month results from the Company’s ReCharge Clinical Study. The article, titled “Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial,” was published in Obesity Surgery (DOI: 10.1007/s11695-016-2325-7), and is available online here.
“The ability to sustain meaningful weight loss is vital when considering a viable long term solution for treating obesity and its related comorbidities,” said Caroline M. Apovian, MD, FACP, FACN, Director, Nutrition and Weight Management, Professor of Medicine at Boston University School of Medicine, and lead author of the article. “vBloc has consistently set itself apart, demonstrating sustained weight loss combined with a compelling safety profile. These findings underscore vBloc Therapy’s potential to serve as a favorable, effective therapy in patients struggling with obesity who prefer not to undergo an anatomy-altering or lifestyle-restricting bariatric procedure.”
Durable Weight Loss
The ReCharge Pivotal Trial is a randomized, double-blind, sham-controlled, multicenter pivotal clinical trial of vBloc Neurometabolic Therapy in 239 patients with obesity. At 24 months, 76% percent of the randomized vBloc participants (n=123) remained in the trial. The mean excess weight loss (EWL) among vBloc participants who presented for their 24-month visit was 21%, with a mean percent total weight loss (TWL) of 8%. Of the 24 Sham control patients who had not yet crossed over to vBloc at 24 months, the EWL and TWL was 4% and 1%, respectively. The authors noted that comparative randomized controlled trials for conventional bariatric procedures demonstrated only 6% TWL for laparoscopic adjustable gastric banding (LAGB) at the same time point. Patients’ quality of life improvements, as measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, were shown to be durable with a sustained increase of 20 units from their preoperative level, and the Three-Factor Eating Questionnaire (TFEQ) showed that patients continued to have a 50% reduction in hunger.
Comorbidity Improvements
Among participants with pre-diabetes or metabolic syndrome at baseline, approximately 50% demonstrated resolution of pre-diabetes or metabolic syndrome at 24 months compared to baseline. Among the subset of participants with abnormal cardiovascular or metabolic conditions at baseline, statistically significant improvements were observed in mean low density lipoprotein (LDL) cholesterol (–16 mg/dL) and high density lipoprotein (HDL) cholesterol (+4 mg/dL), triglycerides (–46 mg/dL), systolic (–11 mmHg) and diastolic blood pressures (–10 mmHg), and hemoglobin A1c (HbA1c) (–0.3 %).
Safety Benefits
The authors noted that the safety profile of vBloc Therapy remained favorable at 24 months compared to complications observed with conventional bariatric procedures such as sleeve gastrectomy and gastric bypass. Ninety-four percent of all adverse events were reported as mild or moderate in severity, and 83% of events had resolved by 24 months. Three serious adverse events were reported and adjudicated by the independent clinical events committee to be unrelated to vBloc therapy.
“Without altering the anatomy of the gastrointestinal system, vBloc’s potential for serious adverse events is minimal, and the ReCharge study helps solidify this important fact. vBloc’s safety profile may serve as a future benchmark for obesity treatment options.” said Scott A. Shikora, MD, FACS, Chief Medical Officer of EnteroMedics.
“These findings are crucial as we continue to advance towards our goals of both expanding the reach of this proven technology, as well as obtaining reimbursement for patients in need,” says Dan Gladney, Chief Executive Officer of EnteroMedics. “These results, in combination with the first-hand patient success stories we’ve had the privilege of learning about, leave us confident that vBloc combined with the vBloc Achieve program, a comprehensive, personalized weight loss support program to help vBloc patients reach and maintain health goals, hold strong potential to serve as a highly effective option in patients in dire need of new approaches to treat their obesity.”
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by a pacemaker-like device called the Maestro® Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics’ Maestro Rechargeable System has received U.S. Food and Drug Administration approval and CE Mark approval.
Information about the Maestro® Rechargeable System and vBloc® Neurometabolic Therapy
You should not have an implanted Maestro Rechargeable System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat. The most common related adverse events that were experienced during clinical study of the Maestro Rechargeable System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.
Talk with your doctor about the full risks and benefits of vBloc Therapy and the Maestro Rechargeable System. For additional prescribing information, please visit www.enteromedics.com.
If you are interested in learning more about vBloc Neurometabolic Therapy, please visit www.vbloc.com or call 1-800-MY-VBLOC.
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 limited commercial sales experience with our Maestro® Rechargeable System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our ability to regain and then maintain compliance 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® Neurometabolic 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 annual report on Form 10-K filed March 28, 2016. 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.