0 Bewertungen0% fanden dieses Dokument nützlich (0 Abstimmungen)
88 Ansichten2 Seiten
NewCardio, Inc. (OTC BB: NWCI) is a cardiac diagnostic and services company. The company develops proprietary platform technology to dramatically improve accuracy and significantly increase diagnostic value of the standard 12lead electrocardiogram.
NewCardio, Inc. (OTC BB: NWCI) is a cardiac diagnostic and services company. The company develops proprietary platform technology to dramatically improve accuracy and significantly increase diagnostic value of the standard 12lead electrocardiogram.
Copyright:
Attribution Non-Commercial (BY-NC)
Verfügbare Formate
Als PDF, TXT herunterladen oder online auf Scribd lesen
NewCardio, Inc. (OTC BB: NWCI) is a cardiac diagnostic and services company. The company develops proprietary platform technology to dramatically improve accuracy and significantly increase diagnostic value of the standard 12lead electrocardiogram.
Copyright:
Attribution Non-Commercial (BY-NC)
Verfügbare Formate
Als PDF, TXT herunterladen oder online auf Scribd lesen
Corporate Headquarters and cardiac status for The Company’s technology uses the widely NewCardio, Inc. (OTC BB: NWCI), a cardiac diagnostic Corporate Facts NewCardio, Inc. acute and chronic accepted, standard 12-lead ECG input and and services company, develops proprietary platform tech- (as of December 31, 2009) 2350 Mission College Blvd., Suite 1175 patient management. displays the signals in a three-dimensional nology to dramatically improve accuracy and signifi- output, providing significantly increased Santa Clara, CA 95054 FY End: Dec. 31 cantly increase the diagnostic value of the standard 12- The FDA requires that sensitivity accuracy and precision and the Phone: 203-644-5200 lead electrocardiogram (ECG). NewCardio’s products all new drugs be Stock Price: $0.72 Fax: 408-907-8923 capability to automate what has historically incorporate novel, state-of-the-art technology that manage- tested for potential 52-Week Range: $0.37-1.90 used more costly and labor-intensive manual www.newcardio.com ment believes will significantly improve the diagnostic cardiac toxicity early in Shares Out: 42.5 M or semi-automated processes. accuracy and precision of the analysis and use of signals development. Current Investor Relations Contact from ECGs, without disrupting the well-established 12-lead methods are costly Fully diluted: 59.0 M The Company is developing three unique Jeff Stanlis ECG practice. The Company’s technology is based on a and time-consuming. Mkt. Cap: $42.5 M solutions using its core platform technology, Hayden IR three-dimensional approach to modeling cardiac activity New drugs are often addressing three distinct and rapidly growing 11 Penn Plaza, 5th Floor, Suite 5090 using standard 12-lead ECG signals. Accordingly, NewCar- tested on more than 1,000 subjects, with ECGs collected at segments of the industry and creating New York, NY 10001 dio is poised to, over time, derive value from each of the multiple time points. Using NewCardio’s 3D approach, drug planned revenue diversity. Phone: 602-476-1821 375 million ECGs performed annually around the world. sponsors and CROs can automate this process, signifi- NewCardio’s first solution, QTinno™, offers cantly reducing the cost and accelerating the test the first realistic opportunity for fully www.haydenir.com NewCardio is applying its proprietary technology to assess times for drugs in development. A leading independent automated testing in Thorough QT (TQT) jeff@haydenir.com cardiac safety of new drugs in development and to improve industry analyst estimated this market to exceed $650 clinical diagnosis and assessment of patients with sus- and cardiac safety clinical trials. The FDA million annually. requires that all new drugs be tested (TQT) pected and established heart disease. Management be- The foregoing compilation relates to NewCardio, Inc. and lieves this technology represents a highly significant ad- NewCardio’s products could change the way patients with for potential cardiac toxicity early in clinical contains forward-looking statements, which are made development. Current testing methods are vance and has the opportunity to be a disruptive force in chronic heart conditions will monitor their disease outside pursuant to the safe harbor provisions of the Private markets that exceed $4.5 billion in aggregate annually. the acute care setting. The Company is developing a hand- costly and time-consuming. Management Securities Litigation Reform Act of 1995. The forward- looking statements involve risks and uncertainties that held device that could transmit the Visual ECG and synthe- believes QTinno will significantly increase could cause actual results to differ materially from the NewCardio has several clinical studies in progress to vali- sized 12-lead data to doctors remotely. This will enable accuracy and productivity of the cardiac forward-looking statements. When used in this document, date, further develop and refine its technology and prod- complete cardiac assessment, in contrast to current de- toxicity assessment. the words "anticipate," "believe," "estimate," "expect" and ucts. The Company recently launched its lead product, vices that enable arrhythmia monitoring only. A recent similar expressions as they relate to NewCardio or its QTinno, and announced its first commercialization agree- The Company’s initial studies have management, are intended to identify such forward- study by Frost & Sullivan estimated this market to confirmed that QTinno delivers virtually ments. Revenue is targeted from QTinno during early 2010. approach $2 billion. looking statements. NewCardio’s actual results, identical accuracy to the existing semi- The first commercial announcement was that a top-five performance or achievements could differ materially from automated “gold standard”, but at far lower the results expressed in, or implied by these forward- global pharmaceutical company selected QTinno as its The Company believes its diagnostic tools will substantially looking statements. For more detailed information the automated solution and would include this in RFPs for TQT improve the accuracy and timeliness of the diagnosis and cost and with fully automated tests reader is referred to NewCardio’s Form 10-K and other studies going forward. In addition, the Company has signed response to patients arriving at Emergency Departments completed in hours, as compared to weeks related documents filed with the Securities and Exchange Master Services Agreements (MSAs) with two major (top with suspected acute coronary syndromes (heart attack of labor-intensive manual review by Commission. This does not constitute an offer to buy or five) CROs and a Dedicated Phase One unit. and related conditions). NewCardio’s Visual3Dx will enable cardiologists when semi-automated sell securities by the Company and is meant purely for informational purposes. Hayden IR (HIR) its affiliates, doctors to diagnose acute coronary syndromes more approaches are used. NewCardio management includes thought leaders from the quickly and accurately than with traditional methods, possi- officers, directors, subsidiaries and agents have been semiconductor industry (Intel), pharmaceuticals, medical The Company has assembled a team of compensated by the Company for the creation of this bly saving thousands of lives annually and reducing costs talented and experienced entrepreneurs and document. NewCardio and HIR have entered into a four- devices (St. Jude Medical), Core Labs and the investment associated with unnecessary hospital admissions. With year term effective February 8, 2008. HIR currently industry. The Company believes its broad-based manage- business managers, including leaders from more than 70 million ECGs performed in ERs each year in receives $3,500 per month as well as 100,000 warrants ment team is particularly well-suited to advance the Com- various industries like technology, pharma, the U.S. alone at an average (current) reimbursement of vesting 25,000 per year. HIR has relied upon information pany’s goals and develop its technology into a set of es- academics, and a wide range of other received from the Company, which, although believed to $30 each, this market could exceed $2 billion annually sential diagnostic tools for the ECG segment of the cardiac scientists and professionals. The Company’s be reliable, cannot be guaranteed. This information is not at current reimbursement rates. diagnostics industry. new chairman is the most-prolific inventor of an endorsement of the Company by HIR. HIR is not responsible for any claims made by the Company. You Additional applications include sports medicine, screening electrical medical devices in the world; Market Opportunity and monitoring, significantly increasing the total market virtually every ICD (Implantable Defibrillator) should independently investigate and fully understand all risks before investing. Key initial applications include cardiac toxicity (lethal ar- opportunity for this innovative application. manufacturer licenses patents covering rhythmias) determination during new drug development, technology invented by the chairman. NewCardio’s 3D ECG Platform Technology Leadership and Advisors Board of Directors The electrocardiogram (ECG) is a proven clinical tool for diagnosis and treatment individuals. By associating abnormal ECGs with their corresponding heart Mark W. Kroll, PhD, FACC, FHRS, Chairman: the most-prolific of heart disease and it plays a critical role in determining the extent and severity abnormalities, various cardiac diseases are associated with and identified from inventor of electrical medical devices in the world with over 260 of cardiac issues. The ECG is the most common cardiovascular laboratory certain ECG "patterns." However, the best readers of 12 lead ECGs are trying to, U.S. patents. Served as Sr. VP & CTO for St. Jude Medical Inc. procedure with as many as 375 million ECGs performed annually around the based on the 12 waveforms, synthesize in their mind electrical activity of the world. The standard ECG is a heart. The human mind is not able to accomplish this diagnostically critical step Senior Management universally accepted diagnostic tool, and indeed synthesize three dimensional electrical activity of the heart. Branislav Vajdic, PhD, Co-Founder and Chief Executive Officer: but it is not without significant 23-years of product development at Intel Corporation. Held NewCardio’s 3D ECG platform technology is a set of algorithms and tools that limitations. It lacks both sensitivity and various senior management positions in Intel’s Pentium and Flash provide a comprehensive method to describe cardiac electrical activity in time specificity, often failing to detect memory divisions. Designed first Flash memory device for Intel. and space, introducing modern computer and software-based technology create significant cardiac disease and Author of several key flash memory design patents. a new and more diagnostically valuable and easy to read way of utilizing ECG alternatively suggesting significant Vincent W. Renz, President: Joined NWCI from ClinPhone where data. This 3D ECG technology extracts additional information from standard 12- cardiac disease when the heart is he served as COO. He previously worked for eResearch lead ECG signals and uses it to generate a 3D representation of cardiac structurally sound. Technology, Inc. as the Executive VP & CTO. electrical activity as a function of time. To further enhance understanding and The standard clinical ECG includes interpretation, the program superimposes the diagnostically relevant electrical Dorin Panescu, PhD, - Chief Technical Officer and VP of recordings from 12 leads. “Pattern information on an intuitive, revolving 3D anatomic model of the heart. The Research and Development: Most recently served as Director, recognition” is the most prevalent Company believes this enables the 3D platform technology to detect potentially Technology Development, for the Company’s Cardiac Rhythm method for ECG interpretation. The fatal diseases such as acute coronary syndromes with far greater sensitivity and Management Division for St. Jude Medical, Inc., (NYSE: STJ). observer reviews the findings of the 12 specificity than is possible with the standard ECG. Previously was VP of Research and Development, Operations lead ECG and compares it to the range of expected findings in normal and Intellectual Property for Refractec, Inc. Ihor Gussak, MD, PhD, FACC - VP and Chief Medical Officer: A world-recognized expert in electrocardiology and cardiac safety NewCardio Solutions with five years experience with eResearchTechnology, Inc., where he served as VP of Global Medical Affairs. He has also worked NewCardio’s technology provides dramatically higher ECG sensitivity for emergency and real-time cardiac diagnostics with leading pharmaceutical companies, serving as a senior executive for Boehringer Ingelheim Pharmaceuticals and QTinno™ CardioBip™ Visual3Dx™ previously as a key executive for Aventis Pharmaceuticals Inc. The Visual3Dx™ is a Richard D. Brounstein, CFO: Joined NWCI from Calypte QTinno™ is a The CardioBip™ Biomedical Corporation, most recently as CFO. Served as CFO software suite system is a unique clinical diagnostic tool providing a comprehen- for Certicom Corporation. From 1997 to 2000, he was CFO for that provides solution to the prob- VidaMed, Inc., a medical device company. Previous experiences automated, lem of urgent ECG sive method to describe cardiac electrical activity include Arthur Andersen, as well as an appointment to the SEC comprehen- telemonitoring, Advisory Committee on Smaller Public Companies. sive analysis capable of providing in time and 3D space. It uses modern mathemati- Kenneth Londoner, Senior Director, Business Development: of QT intervals far more comprehensive and accurate transtele- Proven history as an institutional money manager with J. & W. and other phonic ECG data than any other integrated device cal, computer and software-based technology which enables the Visual3Dx: Seligman & Co., Inc., and a co-Founder of Safe Ports, Inc. ECG-based currently in use which are capable of arrhythmia (1) to extract key additional information from Joseph Esposito, Senior Business Advisor: President and CEO of cardiac safety monitoring only. It is comprised of a mobile ECG standard 12-lead ECG signals and eResearchTechnology, Inc. (Nasdaq: ERES) from 2001 to 2006 for the pharmaceutical industry and drug regu- recording and transmitting device, and a diagnos- (2) to generate a 3D representation of car- and President and COO from 1998 until 2001. lators. Its key features include: tic center which receives, processes and analyzes (1) full automation, with minimal to no human the data. The unique data collected by the Car- diac electrical activity over time. In addi- Scientific Advisory Board intervention required, greatly improving dioBip provides sufficient information to allow tion, the program superimposes the diag- nostically relevant electrical information Mark Josephson., MD., Chairman: Mark Josephson is the Herman the productivity of the trial; accurate, immediate reconstruction of a complete Dana Professor of Medicine at Harvard and Chairman of (2) accuracy and precision that the Company 12-lead ECG from a calibrated, patient-specific on an intuitive, revolving 3-D anatomic model of the heart, which further en- Cardiology at Beth Israel Deaconess Medical Center in believes is equal to the best manual transformation matrix. These features enable Boston. He is credited with developing clinical cardiac assessments; more accurate and timely diagnoses of acute hances understanding and clinical inter- pretation. Importantly, the Visual3Dx also electrophysiology from an intellectual curiosity to a powerful tool (3) the ability to provide high-quality quantita- cardiac events, and facilitate immediate interven- for the diagnosis and management of cardiac arrhythmias. He has tive data from a broad range of difficult-to- tion in life-threatening situations. The small form includes algorithms that “normalize” the ECG input signal, insuring accurate and published more than 300 original publications and 200 chapters, read ECGs. factor and fully integrated electrodes without any reviews and editorials. His textbook, Clinical Cardiac wires make this device an ideal candidate for the balanced representation of all heart re- gions including remote, difficult-to- Electrophysiology, is the fundamental textbook in the field. integration with popular mobile phone/PDA plat- forms. diagnose regions such as the posterior