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: April 6, 2015
(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. |
(c) On April 6, 2015, EnteroMedics Inc. (the “Company”) announced that Scott A. Shikora, M.D., FACS has been named Executive Vice President of Medical Affairs and Chief Medical Officer of the Company, effective June 1, 2015.
Dr. Shikora has over 20 years of experience in the field of obesity. Currently, he is an Associate Professor of Surgery at Harvard Medical School and the Director of the Center for Metabolic and Bariatric Surgery at Brigham and Women’s Hospital in Boston. Prior to that, Dr. Shikora worked at Tufts Medical Center in Boston for over 16 years, where he was the Director of the Weight and Wellness Center, and Chief of the divisions of Bariatric and General Surgery. He is a member of several medical societies and was active in leadership in the American Society for Parenteral and Enteral Nutrition where he is a Past President and former board member. He is past president of the American Society for Metabolic and Bariatric Surgery and a former Executive Council member. Dr. Shikora is Editor-in-Chief of Obesity Surgery, an Associate Editor of the surgical journal Surgery for Obesity and Related Diseases and has authored numerous book chapters and journal publications and made hundreds of presentations internationally on bariatric surgery, new technologies and nutrition support topics. He received his M.D. from the Columbia University College of Physicians & Surgeons and completed his surgical residency and Nutrition Support fellowship at New England Deaconess Hospital in Boston.
There are no arrangements or understandings between Dr. Shikora and any other person pursuant to which Dr. Shikora was appointed as Executive Vice President of Medical Affairs and Chief Medical Officer of the Company. Dr. Shikora does not have a direct or indirect material interest in any currently proposed transaction to which the Company is a party, nor has Dr. Shikora had a direct or indirect material interest in any such transaction since the beginning of the Company’s fiscal year.
Dr. Shikora has no family relationship with any other officer or director of the Company. Neither Dr. Shikora nor any immediate family member of Dr. Shikora has a material interest in any transaction with the Company involving the payment or receipt of at least $120,000.
| Item 8.01 | Other Events. |
(a) The Company also announced on April 6, 2015 that Tonya Dowd, MPH, has been appointed Vice President of Reimbursement of the Company, effective April 13, 2015. Ms. Dowd previously served as Director of Reimbursement Policy and Market Access at Quorum Consulting. Prior to joining Quorum Consulting, Ms. Dowd spent nine years at Johnson & Johnson, co-founded a reimbursement consulting company and worked for numerous medical device and pharmaceutical companies including Covance Healthcare Economics and Outcomes Research and National Data Corporation. Ms. Dowd holds an undergraduate degree from the University of Michigan in Health Policy and a Master of Public Health from the University of California Los Angeles.
(b) On April 7, 2015, the Company issued a press release announcing that the Company has certified 15 centers and trained 19 physicians in implanting and administering vBloc Therapy as of the end of the first quarter of 2015, supporting the Company’s goal of training 20-25 vBloc Therapy centers and physicians by the end of 2015. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| 99.1 | Press release of EnteroMedics Inc. dated April 7, 2015. | |
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 Operating Officer | ||
Date: April 8, 2015
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press release of EnteroMedics Inc. dated April 7, 2015. | |
Exhibit 99.1
April 7, 2015
EnteroMedics Announces Update on vBloc Therapy Trained Centers and Physicians
Fifteen Centers Certified and Nineteen Physicians Trained as of the end of the First Quarter of 2015
ST. PAUL, Minn., April 7, 2015 /PRNewswire/ — EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that 15 centers have been certified and 19 physicians were trained in implanting and administering vBloc Therapy as of the end of the first quarter of 2015, supporting the company’s goal of training 20-25 vBloc Therapy centers and physicians by the end of 2015.
“Since receiving approval for vBloc Therapy in mid-January, we have been focused on identifying and training centers and physicians in key self-pay markets then working to integrate vBloc Therapy into their accounting and quality-assurance systems, a process that can take 2-3 months per center,” said Brad Hancock, Chief Commercial Officer of EnteroMedics. “In parallel, we have been developing materials and programs to support patient access to vBloc Therapy, including a partnership with a healthcare lending company, American HealthCare Lending, as well as hosting well-attended patient webinars to educate patients on vBloc Therapy and building resources to help patients navigate their insurance programs. These efforts have put us on track to begin U.S. commercial implants this quarter.”
EnteroMedics’ bariatric center selection, training and certification process follows a defined protocol that includes rigorous center qualification criteria and didactic and surgical training. Once the center criteria are met, the Company’s field staff trains the surgeon and staff on vBloc Therapy, theory of operation, and program implementation. This is followed by procedure and system operation training and one or two supervised surgeries, after which the surgeon is certified.
“The strong reception of vBloc Therapy by patients, centers and physicians has reinforced our belief that this first-of-its-kind treatment option fills the gap that exists between behavior modification or pharmaceutical options and anatomy altering and restricting surgery,” said Mark B. Knudson, PhD, President and CEO of EnteroMedics. “We are pleased with the progress we have made with qualifying and training centers in the first quarter. We believe we have a solid pipeline of patients, physicians and centers to support our goals during this initial, controlled phase of our commercialization rollout in 2015 and look forward to providing additional updates on our progress as the year unfolds.”
If you are interested in learning more about vBloc Therapy, please visit our physician locator at http://enteromedics.com/vbloc or call 1-800-MY-VBLOC.
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 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, CE Mark and is listed on the Australian Register of Therapeutic Goods.
Information about the Maestro® Rechargeable System and vBloc® 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 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/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 lack of 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 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® 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 13, 2015. 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.