EnteroMedics Reports 2008 Year-End Financial Results.ST. PAUL, Minn. -- EnteroMedics Inc., (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ETRM ETRM Energy Trading and Risk Management ETRM Enterprise Technology Reference Model (Massachusetts) ), the developer of medical devices using neuroblocking technology to treat obesity, its associated co-morbidities, and other gastrointestinal disorders, today announced financial results for the three months and full year ended December 31, 2008. For the full year 2008, the Company reported a net loss of $37.9 million, or $2.25 per share, research and development expenses of $27.7 million, and general and administrative expenses of $8.6 million. For the fourth quarter ended December 31, 2008, the Company reported a net loss of $7.8 million, or $0.46 per share. Expenses were primarily associated with the cost of supporting the Company's multiple ongoing clinical trials as well as the continued development of VBLOC[TM] vagal vagal /va·gal/ (va´gal) pertaining to the vagus nerve. va·gal adj. Of or relating to the vagus nerve. vagal pertaining to the vagus nerve. blocking therapy (VBLOC Therapy) delivered through the Company's Maestro[TM] System. On December 31, 2008, the Company's cash, cash equivalents and short-term investments totaled $26.3 million. "In 2008, the Company continued to acquire data that support the use of its technology in obesity as well as the early, yet significant, effects of VBLOC Therapy on the co-morbidities of diabetes and hypertension," said President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Mark B. Knudson, Ph.D. "These results speak to the potential of this technology to directly address the healthcare costs associated with obesity while helping people achieve significant weight loss. We believe that 2009 will see the Company achieve a number of key milestones, including further data in Type 2 diabetes type 2 diabetes n. See diabetes mellitus. and hypertension, and the unblinding of our pivotal EMPOWER trial, the results of which, if favorable, will support our 2009 PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy submission to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for marketing approval of the Maestro System." Gregory S. Lea, Senior Vice President and Chief Financial Officer of EnteroMedics added: "With the EMPOWER trial fully enrolled and all subjects implanted, a significant portion of the expense associated with that study is now behind us." He concluded, "In addition, we are projecting that our current cash position is sufficient to fund our comprehensive development and regulatory efforts for 2009." 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[TM] vagal blocking therapy, is designed to intermittently block the vagus nerves vagus nerve n. Either of the tenth pair cranial nerves that originate from the medulla oblongata and supply multiple vital organs, including the lungs, heart, and gastrointestinal viscera. using high-frequency, low-energy, electrical impulses. EnteroMedics has met its enrollment goal under an FDA-approved Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) for the EMPOWER Study using the Maestro[TM] System, its initial product for the treatment of obesity. EnteroMedics is currently recruiting patients outside of the United States for a feasibility study "A Feasibility Study" is an episode of the original The Outer Limits television show. It first aired on 13 April, 1964, during the first season. It was remade in 1997 as part of the revived The Outer Limits series with a minor title change. examining VBLOC Therapy's effects on blood glucose levels blood glucose level, n level of glu-cose in the bloodstream, normally about 70 to 115 mg/dL after fasting overnight. Higher levels may indicate diseases such as diabetes mellitus. in diabetic patients. For more information, visit www.enteromedics.com. Forward-Looking Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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[TM] System for the treatment of obesity; our inability to complete our EMPOWER pivotal trial and 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[TM] 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; 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. dated March 13, 2008. 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 law to investigational use. The implantation procedure and usage of the Maestro[TM] System carry some risks, such as the risk generally associated with laparoscopic Laparoscopic A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen. Mentioned in: Obstetrical Emergencies procedures and those related to treatment as described in the EMPOWER clinical trial informed consent. (See Attached Table) [TABLE OMITTED] [TABLE OMITTED] |
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