NewCardio, Inc., (OTCBB: NWCI)

Dear Reader,

You’ve heard us say it often in StockUpTicks: We like innovation in growth markets.

And when the ‘better mousetrap’ enhances one of the most commonly used technologies in the rapidly growing health care sector, our head turns. Revolutionizing the ECG as today’s featured company, NewCardio, Inc., (OTCBB: NWCI), aspires to do, is indeed a monumental feat.

On the heels of today’s massive bounce in the stock market we offer you a profile that introduces one company’s attempt to change the effectiveness of treatments of the heart.

A detailed StockUpTicks profile is below.
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About NewCardio, Inc.

NewCardio, Inc., "NewCardio""NWCI" is a Silicon Valley based company with the mission of fully developing and commercializing a three dimensional (3D) approach to electrocardiography. NWCI is developing and validating a novel, patent pending electrocardiography (ECG) platform technology to dramatically improve the diagnostic accuracy and value of the standard 12 lead ECG for common acute and chronic heart disease and for evaluating cardiac safety of new drugs.

NewCardio's 3-dimensional ECG approach allows faster, more accurate and less expensive assessment of cardiac status, and diagnosis of previously difficult or undiagnosable conditions. NWCI's services for clinical drug trials will help ECG core labs and pharmaceutical and biotech companies to rapidly detect cardiac toxicity, when present, for drugs involved in clinical development. 

NewCardio's hand-held products could change the way patients with chronic heart conditions will monitor their disease outside the clinical setting.

NWCI was incorporated in 2004 and is based in Santa Clara, California. The three primary products of NWCI in development for commercialization are: 

• QTinno, an automated software tool suite that provides QT interval data from a range of ECGs
• VisualECG, a set of algorithms and tools, which provide a method to describe cardiac electrical activity
• CardioBip, a mobile ECG transtelephonic system comprising a mobile ECG recording and transmitting device

NewCardio’s products incorporate novel, state-of-the-art technology that management believes represents a highly significant advance in technology and has the opportunity to be a disruptive force in markets that exceed $1 billion in aggregate annually. 

NewCardio has several clinical studies in progress to validate, further develop and refine its technology and products. Results of the first medical trials of NewCardio's technology at Harvard University Medical School and elsewhere indicate initial results to be very encouraging. NWCI recently reported:

NewCardio management includes thought leaders from the semiconductor industry (Intel), pharmaceuticals, Contract Research Organizations (CROs) and the investment industry. NWCI believes its broad-based management team is particularly well-suited to advance the Company’s goals and develop its technology into a set of essential diagnostic tools for the ECG segment of the cardiac diagnostics industry.

Key initial applications include cardiac toxicity (lethal arrhythmias) determination during new drug development, and cardiac status for acute and chronic patient management. The FDA requires that all new drugs be tested for potential cardiac toxicity early in development. Current semiautomated methods are costly and timeconsuming. New heart drugs are often tested on more than 1,000 subjects, with ECGs collected at multiple time points. Using NewCardio’s 3D approach, drug sponsors and CROs can automate this process, significantly reducing the cost and accelerating the test times for drugs in development.

With more than 17.4 million ECGs performed in ERs each year in the U.S. alone, this market could exceed $522 million annually at current reimbursement rates.

The NWCI Visual ECG hand held technology will enable complete cardiac assessment by doctors to diagnose acute coronary syndromes more quickly and accurately than with traditional methods, possibly saving thousands of lives annually and reducing costs associated with unnecessary hospital admissions. And NewCardio’s products could change the way patients with chronic heart conditions will monitor their disease outside the acute care setting. 

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WHAT IS AN ECG?

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terminology

An electrocardiogram (ECG or EKG, abbreviated from the German Elektrokardiogramm) is a noninvasive transthoracic graphic produced by an electrocardiograph, which records the electrical activity of the heart over time. In the US, the abbreviation "EKG" is often preferred over "ECG", while "ECG" is used universally in the UK and many other countries. 

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The ECG is the most widely used and invaluable clinical tool for the detection and diagnosis of a broad range of cardiac conditions, as well as a technique that has contributed to the understanding and treatment of virtually every type of heart disease. More than 86.2 million ECGs are performed in the United States each year, making ECG the most commonly performed cardiovascular diagnostic test. 

The clinical utility of the ECG derives from its immediate availability as a noninvasive, inexpensive, and highly versatile test, one that may detect arrhythmia, heart muscle diseases, life-threatening metabolic disturbances, or increased susceptibility to sudden cardiac death. With improvements in treatment of acute myocardial infarction, an increasing amount of attention has been focused on the ECG's diagnostic sensitivity and specificity of the ECG. More than ever, there is a need for more accurate and timely forms of ECG information than currently exist.

Over 326 million ECGs are obtained in the world each year, making it the most commonly performed cardiovascular diagnostic test. The ECG has a central role in screening and diagnosis of acute coronary syndromes (heart attack) and many other common forms of heart disease, and often provides the primary basis for critical therapeutic decisions.

Today's standard 12-lead ECG merely represents that data as a series of 2-dimensional time and voltage readings, which must be synthesized into a 3D model of the heart operation by a clinician. It is very difficult, and in the case of some critical parameters impossible, for humans to perform this 3D synthesis in their mind.

NewCardio has developed a new patented and patent pending technology which can process this standard ECG data, and utilize and present it an easy to read format with additional 3D clinically significant diagnostic information. Importantly, no change in clinician practice of how ECG data is collected. Simply said - NewCardio does not change the standard practice for ECG collection.
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The Market

A leading independent industry analyst estimated this market to exceed $485 million annually. In addition, screening for risk of drug-induced adverse cardiovascular events (such as those recently identified with Vioxx and Avandia) could add $600 million in annual market opportunity.

NewCardio Products

By associating abnormal ECGs with their corresponding heart abnormalities, various cardiac diseases are associated with and identified from certain ECG "patterns." However, the best readers of 12 lead ECGs are trying to, based on the 12 waveforms, synthesize in their mind electrical activity of the heart.
The human mind is not able to accomplish this diagnostically critical step and indeed synthesize three dimensional electrical activity of the heart.

NewCardio’s methodology, the 3D ECG platform technology, is a set of algorithms and tools that provide a comprehensive method to describe cardiac electrical activity in time and space, introducing modern computer and softwarebased technology create a new and more diagnostically valuable and easy-to-read way of utilizing ECG data. 

This 3D ECG technology extracts additional information from standard 12-lead ECG signals and uses it to generate a 3D representation of cardiac electrical activity as a function of time. To further enhance understanding and interpretation, the program superimposes the diagnostically relevant electrical information on an intuitive, revolving 3D anatomic model of the heart. Management at NWCI believes this enables the 3D platform technology to detect potentially fatal diseases such as acute coronary syndromes with far greater sensitivity and specificity than is possible with the standard ECG.

QTinno is a software suite that provides automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. Its key features include full automation with minimal to no human intervention required, greatly improving the productivity, accuracy and precision of clinical trials. 

Its key proprietary features include:

• full automation, with minimal to no human intervention required
• accuracy and precision that the NWCI believes is equal to the best manual assessments
• the ability to provide high-quality quantitative data from a broad range of difficult-to-read ECGs

The FDA requires that all new drugs be tested for potential cardiac toxicity early in development. Screening for the risk of drug-induced adverse, often lethal, cardiovascular events – such as those identified with Vioxx®, Seldane®, and Avandia® is of utmost importance for drug developers, and the public health in general. Using NewCardio’s QTinno, the process is faster with greater clarity and using the QTinno proprietary algorithms: Automated.

The QT Client™ user interface has been carefully designed to meet user needs, both in display and data analysis. Among other things, QT Client provides the user with an output that identifies the exact time of all key cardiac events used in analysis – such as Q onset, end of the T wave, heart rate, raw and rate-corrected QT interval, and statistical analysis.

In summary, NWIC management believes that for the first time, the definitive solution for automated, thorough or routine QT studies is being offered. 

A) QTinno offers productivity and precision of automation and highly accurate results – even on more “difficult” ECGs. 

B) Robust QTinno technology potentially adaptable to rapidly emerging problem of drug-induced propensity to increased rates of adverse cardiac events. 

C) NewCardio’s solution provides more accurate, more efficient, lower cost, and lower risk assessments of cardiac safety. 

D) QTinno performance was validated using thousands of ECGs. 

VisualECG is a set of algorithms and tools that provide a comprehensive method to describe cardiac electrical activity in time and space. VisualECG extracts additional information from standard 12-lead ECG signals and uses it to generate a 3D representation of cardiac electrical activity as a function of time. 

A key aspect of VisualECG is its suite of algorithms to correct the problem of variation in electrical attenuation across the chest wall. This leads to regional inconsistency and poor diagnostic sensitivity in remote regions of the heart. To correct this problem, VisualECG includes algorithms to normalize electrical attenuation, which results in a "virtual sphere" of normalized electrical activity, and ensures accurate and balanced representation of all heart regions.

Management at NWCI believes VisualECG’s features enable it to detect serious cardiac diseases with far greater sensitivity and specificity than is possible with a standard ECG. Importantly, however, VisualECG requires no change in standard 12-lead ECG practice. The ECG is obtained exactly as it is now, with the electrodes placed in the same locations without need for additional electrodes. 

PLUS

The CardioBip system is a unique is solution to the problem of urgent ECG telemonitoring, capable of providing far more comprehensive and accurate transtelephonic ECG data than any other integrated device currently in use which are capable of arrhythmia monitoring only. It is comprised of a mobile ECG recording and transmitting device, and a diagnostic center which receives, processes and analyzes the data. The unique data collected by the CardioBip provides sufficient information to allow accurate, immediate reconstruction of a complete 12-lead ECG from a calibrated, patient-specific transformation matrix. These features enable more accurate and timely diagnoses of acute cardiac events, and facilitate immediate intervention in life-threatening situations. The small form factor and fully integrated electrodes without any wires make this device an ideal candidate for the integration with popular mobile phone/PDA platforms.

About 70 million Americans have some form of chronic cardiovascular disease. Of those, about 14M have documented coronary artery disease (CAD), with almost one million new cases diagnosed each year. Rapid response to an episode of arrhythmia or ischemia (heart attack) is critical to survival. In a moment of a heart attack, the survival of the patient depends radically on obtaining urgent medical care, essentially based on an ECG recording. Delays in accurate diagnosis are not only costly, but can be fatal. Earlier and more accurate diagnosis allows treatment within the first two hours (“golden hours”) when it is known to be most beneficial.

Research has shown that about 70% of the delay between the onset of the chest pain associated with a heart attack (myocardial infarction) and the intervention is attributed to the patient’s hesitation in seeking medical help. Many factors contribute to this delay, however the key is failure of the patient to recognize the seriousness of the symptoms and the need to immediately go to, an often overcrowded, emergency room. Thus a pocket size ECG machine that would be always with the patient, or high risk person, is needed. Instant wireless transmission of the ECG recording is necessary to dramatically shorten the time between the onset of symptoms and the intervention.

The current, available pocket-size ECG machines suffer from at least one of two drawbacks. They are either easy to use, but offer only a couple of channels, which reduces them to arrhythmia monitors, or they have leads (wires) that typically require a trained person (nurse) to attach them to the patient’s body.

CardioBip  is a unique, hand held device that offers the solution to the problem of urgent ECG telemonitoring, capable of providing truly comprehensive and accurate ECG data that is being transmitted wirelessly. CardioBip is unique due to its extreme ease of use, as it employs only three integrated electrodes, combined with the ability to generate a standard 12 lead ECG recording. 

• No patient connection by leadwires. 
• Recordings are simply made by holding the instrument against the patient’s chest. 
• 3 integrated leads that make contact with the patient’s chest. 
• Unique data collection unriveled by competitors. 
• Can be analyzed with the VisualECG array of 3-D analytical tools. 

Recent News from NewCardio

Press Release Source: NewCardio, Inc. 
Tuesday September 16, 8:00 am ET 

SANTA CLARA, Calif., Sept. 16 /PRNewswire-FirstCall/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI - News) a cardiac diagnostic and services company, today announced that several members of senior management have, in aggregate, purchased approximately 118,000 shares of NewCardio common stock in open market transactions in the last three weeks. Vincent W. Renz, the Company's new president, Ihor Gussak, MD, PhD, FACC, the Company's new Chief Medical Officer and Vice President, and Kenneth Londoner, the Company's Senior Director, Business Development and Corporate Finance, each acquired shares of NewCardio's common stock in the open market subsequent to the effectiveness of the registration statement at the end of August.

In aggregate, officers and directors now own approximately 36% of the outstanding stock in NewCardio.

Mr. Renz commented, "I believe the current share price, impacted by the recent registration of shares from our initial financing and broader market conditions, does not accurately represent the long-term value NewCardio is creating. Despite being the most widely used diagnostic tool in cardiology, the ECG is not without flaws and I believe NewCardio's innovative, 3D cardiac activity modeling software platform is poised to address these issues and add value to diagnostic, screening and drug development initiatives around the world." MORE

Press Release Source: NewCardio, Inc. 
Wednesday August 13, 7:00 am ET 

SANTA CLARA, Calif., Aug. 13 /PRNewswire-FirstCall/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI - News) a cardiac diagnostic and services company, today revealed the results of its third external validation study of QTinno(TM) (the "NCE3 Study"). The study was led by an independent industry leading cardiac safety expert with extensive experience in pharmaceutical clinical trials. The study evaluated the accuracy, precision and speed of NewCardio's lead product, QTinno(TM), in producing fully automated measurements of drug-induced QT prolongation, a key cardiac safety indicator. Such data is now required by drug regulatory bodies worldwide for all new drugs in development, and at present must be obtained by expensive and time-consuming manual or semi-automated methods.

The NCE3 study was a randomized, blinded study of more than 2,500 digital ECGs acquired from healthy research subjects treated with either placebo or a cardiac drug with significant QT-prolonging properties and a known propensity to cause serious cardiac arrhythmias. QT intervals were determined on all study ECGs by QTinno(TM) and by the current "gold standard" approach: careful manual reading by a single cardiologist with extensive expertise and experience in ECG evaluation. The primary endpoint, time-matched, placebo-controlled QT prolongation induced by drug, was chosen because drug-induced QT prolongation is the primary parameter that regulatory bodies evaluate to assess the cardiac arrhythmia risk of a new drug candidate.

Results from the NCE3 study showed that QTinno(TM) was accurate in measuring drug-induced QT prolongation. The automated determination derived at by QTinno(TM) and the "gold standard" manual measurement were virtually identical (well under 1 millisecond difference), and individual measurements showed a high degree of precision (standard deviation of less than 10 milliseconds between the two approaches).

The NCE3 results show excellent agreement with the Company's prior external clinical validation studies (NCE1 and NCE2). Moreover, they extend the clinical validation of QTinno(TM) in at least two important ways. First, ECGs in the NCE3 study had much higher levels of electrical noise and artifacts than ECGs from NCE1 and NCE2 studies. Accordingly, the NCE3 study validates QTinno(TM) performance in a significantly more challenging environment than is typical for early-stage QT assessment. Second, the NCE3 study validates QTinno(TM) performance in an instance where the study drug not only causes substantial QT prolongation and T wave abnormalities, but is also known to induce significant and potentially lethal cardiac arrhythmias.

Branislav Vajdic, Ph.D., President and Chief Executive Officer, commented, "The exceptional accuracy of the QTinno(TM) tool was clearly validated by this third, and most challenging clinical study to date. The evidence unequivocally demonstrates that the QTinno(TM) is not only faster at measuring the QT interval compared to current manual and semi-automated approaches, but that it also provides proven levels of accuracy even in challenging conditions and with complex compounds. We believe it provides an important additional independent validation that will help potential customers recognize the value of NewCardio's cardiac assessment tool. In aggregate, the three independent studies collectively provide NewCardio with a robust clinical validation portfolio that demonstrates QTinno(TM) accuracy and precision in measuring key drug safety metrics across a broad range of compounds, and in comparison to a variety of manual and semi-automated 'gold standard' measurements from three different sources."

Dr. Vajdic continued, "The Company is now actively pursuing commercial validation of QTinno(TM) and is in discussion with potential CRO partners. We also anticipate developing an interface to discuss these important and compelling clinical validation data with drug regulators. We will soon augment our senior management team in an effort to add sales and marketing leadership to accelerate the commercialization initiative." MORE

Press Release Source: NewCardio, Inc. 
Tuesday August 5, 8:00 am ET 

SANTA CLARA, Calif.--(BUSINESS WIRE)--NewCardio, Inc. (OTCBB: NWCI - News), a cardiac diagnostic and services company, announced today that Ihor Gussak, M.D., Ph.D., FACC, world-recognized expert in electrocardiology and cardiac safety, has joined the Company as its new Chief Medical Officer and Vice President, effective immediately.

Dr. Gussak joins NewCardio from Boehringer Ingelheim Pharmaceuticals, where he held a senior executive role for the past year. Previously, Dr. Gussak served 5 years as Vice President, Global Medical Affairs for eResearchTechnology, Inc., and held a key executive position with Aventis Pharmaceuticals Inc, employed by Mayo Clinic, and the ECG Core Lab at St. Louis University Health Sciences Center. He has participated in management of many clinical trials, consulted with many contract research organizations (CROs), and is credited with major contributions and publications in the field of cardiovascular medicine. MOREa

NewCardio, Inc. (OTCBB: NWCI), a development-stage cardiac diagnostic and services company, announced that it has received a Certificate of Grant from the European Patent Office covering CardioBip™, its proprietary device and methodology for transtelephonic transmission of comprehensive ECG data. MORE
 

Management at NewCardio

• Branislav Vajdic, PhD, Co-Founder and Chief Executive Officer:
23-years of product development at Intel Corporation. Held various senior management positions in Intel’s Pentium and Flash memory divisions. Designed first Flash memory device for Intel. Author of several key flash memory design patents.

• Vincent J. Renz – President
Vinnie has more than 26 years of experience in the information technology industry, specifically in the development and commercialization of technology products and services. He joined NewCardio from ClinPhone, the world's leading Clinical Technology Organization which was acquired by PAREXEL International Corporation, a leading global biopharmaceutical services organization. At ClinPhone, Mr. Renz served as Chief Operating Officer. Previously, he worked for eResearch Technology, Inc. as the Executive Vice President and Chief Technology Officer and played a key role in building eResearch Technology's clinical technology business. Mr. Renz was also instrumental in developing the global business development and client services infrastructure to support the company's rapid growth and profitability. Mr. Renz earned an M.B.A. in Management Information Systems from Indiana University and a B.B.A. in Finance from the University of Notre Dame.

• Richard D. Brounstein, CFO: 
Joined NWCI from Calypte Biomedical Corporation, most recently as CFO. Served as CFO for Certicom Corporation. From 1997 to 2000, he was CFO for VidaMed, Inc., a medical device company. Previous experiences include Arthur Andersen, as well as an appointment to the SEC Advisory Committee on Smaller Public Companies.

• Ihor Gussak, MD, PhD, FACC - VP and Chief Medical Officer: 
A world-recognized expert in electrocardiology and cardiac safety with five years experience with eResearchTechnology, Inc. (Nasdaq: ERES) a leading CRO, where he served as VP of Global Medical Affairs. He has also worked with leading pharmaceutical companies, serving as a senior executive for Boehringer Ingelheim Pharmaceuticals and previously as a key executive for Aventis Pharmaceuticals Inc. He has participated in management of many clinical trials, consulted with many CROs, and is credited with major contributions and publications in the field of cardiovascular medicine.

• Kenneth Londoner, Senior Director, Business Development:
Proven history as a mutual fund manager with J. & W. Seligman & Co., Inc., and a co-Founder of Safe Ports, Inc.

• Bosko Bojovic, PhD, Co-Founder and Chief Technical Officer:
Head of the RF Accelerating Group of the TESLA cyclotron project at the CERN Laboratory in Geneva, Switzerland. Holds a Ph.D. in applied electromagnetism and has published over 35 peer-reviewed papers.

• Samuel George, MD, FACC, JD – Senior Medical Consultant
Sam was formerly Director of Medical Affairs at CV Therapeutics, a cardiology faculty member and Director of the Cardiac Study Program at Duke University Medical Center, and an Established Investigator of the American Heart Association. He was also a biomedical patent attorney with Latham & Watkins LLP and is registered to practice before the U.S. Patent and Trademark Office. He holds M.D. from Washington University (St. Louis) and JD from Duke University.

• Joseph Esposito, Senior Business Advisor: 
President and CEO of eResearchTechnology, Inc. (Nasdaq: ERES) from 2001 to 2006 and President and COO from 1998 until 2001.
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Financial Highlights For NewCardio

A) NWCI's technology uses the widely accepted, standard 12-lead ECG input and displays the signals in a three-dimensional output, providing significantly increased sensitivity accuracy and precision and the capability to automate what has historically used more costly and labor intensive manual or semi-automated processes.

B) NWCI is developing three unique products: QTinno™, VisualECG™, and CardioBip™, to target three distinct and rapidly growing segments of the industry and creating planned revenue diversity.

C) The FDA requires that all new drugs be tested for potential cardiac toxicity early in clinical development. Current semiautomated methods for cardiac safety testing are costly and time-consuming. Through its QTinno lead product, NewCardio offers the first realistic opportunity for fully automated testing, which management believes will significantly increase accuracy and productivity of the cardiac toxicity assessment.

D) NWCI initial studies have confirmed that QTinno delivers virtually identical accuracy to the existing semiautomated “gold standard”, but at far lower cost and with fully automated tests completed in hours, as compared to weeks of labor-intensive manual review by cardiologists when semi-automated approaches are used.

E) NWCI has assembled a team of talented and experienced entrepreneurs and business managers, including leaders from various industries like technology, pharma, academics, and a wide range of other scientists and professionals. NWCI's new chairman is the most-prolific inventor of electrical medical devices in the world; virtually every ICD (Implantable Defibrillator) manufacturer licenses patents covering technology invented by the chairman.

Company Contacts

Corporate Headquarters
NewCardio, Inc.

2350 Mission College Blvd., Suite 1175, Santa Clara, CA 95054
Phone: 203-644-5200 - Fax: 408-907-8923
www.newcardio.com

Investor Relations Contact: Jeff Stanlis
Hayden Communications, Inc.
11 Penn Plaza, 5th Floor, Suite 5090, New York, NY 10001
Phone: 602-476-1821 or e-mail: jeff@haydenir.com

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