NIH Study Demonstrates InforMedix Med-eMonitor Improves Medication-Compliance in Patients with Schizophrenia.Business Editors/Health/Medical Writers BIOWIRE2K ROCKVILLE, Md.--(BUSINESS WIRE)--Oct. 8, 2003 Article in Peer-Reviewed Drug Information Journal Cites Ease of Use and Enhanced Medication Compliance with Use of Computerized, Hand-Held Monitor InforMedix, Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB: IFMX IFMX Informix Corporation .OB) reported today that a National Institutes of Health-sponsored study of patients with chronic schizophrenia demonstrated its Med-eMonitor(TM), a computerized monitoring and compliance device, improved the rate of medication and clinical protocol-compliance. Study findings were published in the prestigious peer-reviewed Drug Information Journal (DIJ DIJ Death in June (band) DIJ Dijon, France - Longvic (Airport Code) ). The study, along with other recent similar findings, further strengthens InforMedix's bid to have the Med-eMonitor System integrated into organized clinical drug trials, which are plagued by questionable patient-adherence data. The study, conducted by the Veterans Administration Capital Health Care Network in conjunction with the University of Maryland University of Maryland can refer to:
1) It was easy to learn. All patients and caregivers learned to use the monitor, in one brief session, in the clinic. 2) It facilitated "central evaluation of patients by treating professionals," reducing the need for onsite evaluation. Med-eMonitor automatically forwards data to an Internet-accessible online database, which clinicians can then access from their office PCs. 3) It helped patients take their medications and enter clinical status data more regularly. Through tonal prompts and an LCD that displays instructions, patients are given precise and timely directions to take medications and enter clinical data. Opening of the medication reservoirs was correlated with the patients' and caregivers' answers to the "Early Warning Signs Scale," a clinical questionnaire used to predict psychotic relapse in schizophrenic schiz·o·phren·ic adj. Of, relating to, or affected by schizophrenia. n. One who is affected with schizophrenia. patients. Confirms Findings of CHF CHF In currencies, this is the abbreviation for the Swiss Franc. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. Study The NIH-sponsored study follows closely on the heels of a Wayne State University Wayne State University, at Detroit, Mich.; state supported; coeducational; established 1956 as a successor to Wayne Univ. (formed 1934 by a merger of five city colleges). study that showed Med-eMonitor significantly improved medication compliance, protocol-adherence, and quality-of-life in an elderly population of congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. (CHF) patients (July/August issue of Heart & Lung). "This further substantiates that the Med-eMonitor device may be beneficially used in organized clinical studies, including those with patients who presumably pre·sum·a·ble adj. That can be presumed or taken for granted; reasonable as a supposition: presumable causes of the disaster. have difficulty using computerized compliance devices -- the mentally ill and the elderly," noted Bruce A. Kehr, M.D., chairman 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. of InforMedix. Candidate for Diary Replacement in Billion-Dollar Market Kehr said that Med-eMonitor is being considered as a replacement for paper diaries that are used by millions of patients in organized clinical trials to record their behaviors, medication compliance, quality-of-life (QOL QOL, n quality of life, a subjective assessment of one's emotional and physical well-being. ) information, and adverse events. The patient diary A Patient Diary is a tool used during a clinical trial or a disease treatment to measure treatment compliance. An Electronic Patient Diary registers the diary in a storage device and allows for monitoring the time the medication was taken. market is estimated to be $800 million for 2003, rising to an estimated $3 billion in 2005. A study earlier this year published in The British Medical Journal The British Medical Journal, or BMJ, is one of the most popular and widely-read peer-reviewed general medical journals in the world.[2] It is published by the BMJ Publishing Group Ltd (owned by the British Medical Association), whose other revealed that the vast preponderance of patients routinely faked their medication-ingestion entries in paper diaries. A full 89 percent of entries evaluated did not correlate with the actual ingestion ingestion /in·ges·tion/ (-chun) the taking of food, drugs, etc., into the body by mouth. in·ges·tion n. 1. The act of taking food and drink into the body by the mouth. 2. of medications and overall protocol adherence -- either through incorrect retrospective entries, or "forward-filling" of data into the patient diaries. This finding indicates that studies using paper diaries may be profoundly compromised, and highlights the need for better compliance-reporting techniques -- such as Med-eMonitor -- to ensure that study results are both valid and accurate. "We're heartened by these results," noted Janet Campbell, president and COO of InforMedix, "because they not only confirm that Med-eMonitor enhances compliance, but also demonstrate that even severely mentally ill patients can easily learn how to use Med-eMonitor. The study also found the device's usage reduced the need for onsite evaluation by physicians, since they can monitor patient behaviors, protocol-adherence, QOL and other indices by viewing behavioral data that is uploaded, via telephone line, from the patient's home." The DIJ report said the findings support the use of the Med-eMonitor not only for clinical practice, but also for clinical drug trials. "Current methods of monitoring patients and collecting data in clinical trials often rely upon paper-and-pencil diaries and pill counts to determine symptom response, side effects Side effects Effects of a proposed project on other parts of the firm. , adverse events and medication-compliance. These methods lack the accuracy of real-time data Real-time data denotes information that is delivered immediately after collection. There is no delay in the timeliness of the information provided. Some uses of this term confuse it with the term dynamic data. capture, and the daily dose-response monitoring capabilities of the Med-eMonitor." Med-eMonitor is a hand-held device that prompts patients by emitting a tone that repeats until the patient pushes a button on the device. An arrow on the screen then points to the appropriate medication compartment (the device has five), and displays specific instructions on an LCD screen. The device automatically registers all times the compartments are opened, and also records any medication doses that are missed or taken at unscheduled unscheduled Adjective not planned or intended Adj. 1. unscheduled - not scheduled or not on a regular schedule; "an unscheduled meeting"; "the plane made an unscheduled stop at Gander for refueling" times. The device also captures electronic diary data, and enables correlating this data with the medication compliance data. When the device is returned to its cradle, collected data is uploaded daily via the Internet, to a patient database that can be accessed via standard browser by study personnel, and changes to the protocol can be simultaneously downloaded to the device. The report indicated that Med-eMonitor's combination of (1) prompting and interactivity; (2) medication compartments that correlate patient entries with actual physical evidence; and (3) ability to upload to a remote online database, were key factors that made the system a suitable candidate for patient investigations. It further noted that other computerized compliance devices, especially those based on personal digital assistants (PDAs) with Palm(R) operating systems Operating systems can be categorized by technology, ownership, licensing, working state, usage, and by many other characteristics. In practice, many of these groupings may overlap. , "may not be user-friendly...due to small display screens that can display only a limited amount of data, a small font size which may be difficult to read, and inability to directly monitor medication compliance, and the need for use of a stylus stylus: see pen. (1) A pen-shaped instrument that is used to "draw" images or select from menus. Styli (the plural of stylus, pronounced "sty-lye") come with handheld devices that have touch screens, such as PDAs and video games. to enter data." About InforMedix InforMedix, Inc. manufactures and markets the Med-eMonitor System, which provides real-time medical management and patient communications in clinical drug trials, to reduce cost and speed time-to-market of new pharmaceutical compounds. Med-eMonitor reduces complex protocols to an automated prompt-and-record process that interacts with the patient at specific intervals during the day. Designed for use by patients of all ages, management believes it will be an integral component of clinical trials conducted by pharmaceutical companies, clinical research organizations, site-management companies, and academic research centers. 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. Provisions This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby. Such forward-looking statements include statements regarding our future capital needs and our proposed private placement. The terms of any actual private placement could differ materially from that projected in the forward-looking statements, as a result of known and unknown risk factors and uncertainties. References made to the discussion of the risk factors are detailed in the Company's filings with the Securities and Exchange Commission, including the report on Form 10-QSB for the quarter ended June 30, 2003, our Annual Report on Form 10-KSB for the year ended December 31, 2002, our prospectuses, dated November 9, 2001 and April 8, 2003, as supplemented, and our other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update or revise the information contained in any such forward-looking statements, whether as a result of new information, future events or otherwise. |
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