NewCardio, Inc., (OTCBB: NWCI)

Dear Reader,

Without a doubt NewCardio, Inc. is on the move. We've brought you several significant news events demonstrating how it is executing its business plan. NewCardio is driven to revolutionize one of the most commonly used technologies in the rapidly growing health care sector - the ECG - indeed a monumental feat. But one is clearly determined to accomplish.

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.

News From NewCardio, Inc.

Press Release Source: NewCardio, Inc.
Tuesday October 21, 8:00 am ET

SANTA CLARA, Calif., Oct. 21 /PRNewswire-FirstCall/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI - News) a cardiac diagnostic and services company, today announced Dorin Panescu, PhD, has agreed to join NewCardio as its Chief Technical Officer and Vice-President of Research and Development, effective October 20. Dr. Panescu joins NewCardio from St. Jude Medical, Inc., (NYSE: STJ - News) a $4.1 billion medical technology and services company, where he most recently served as Director, Technology Development, for the Company's Cardiac Rhythm Management Division. In this role, he managed broad functional teams tasked with the development of heart failure trending and wireless remote monitoring features for implantable cardiac defibrillators and pacemakers. Dr. Panescu is credited with 130 issued U.S. patents and 70 published or pending U.S. patent applications covering a wide spectrum of technologies for medical devices, specifically related to devices and methods for medical imaging, diagnosis and therapies, as well as cardiac mapping and ablation.

Before joining St. Jude Medical, Inc. Dr. Panescu served as Vice President of Research and Development, Operations and Intellectual Property for Refractec, Inc., where he directed R&D and Operations for the development of keratoplasty radiofrequency ablation equipment and set the company's IP strategy. Refractec, Inc. was the first company to get PMA approval from the US Food and Drug Administration for the surgical treatment of presbyopia. Previously, he served as Senior Director of Systems Development for Boston Scientific Corporation, directing new product development for the Electrophysiology Division. Boston Scientific, Electrophysiology, is the world market leader in radiofrequency cardiac ablation systems.

Mark W. Kroll, PhD, FACC, FHRS and Chairman of NewCardio's Board of Directors, commented, "I have known Dorin for almost 15 years and have closely followed his impressive career. Dorin is a true innovator and a leader who will provide significant expertise to NewCardio's innovative three-dimensional ECG platform and prove invaluable as the Company delivers added value to each of the hundreds of millions of ECGs performed each year. I am very happy to welcome Dorin to NewCardio and consider this a major accomplishment for this Company and a win for our shareholders."

Dr. Panescu commented, "I am excited to join NewCardio and eager to help this incredible platform reach its full potential. I would not have left a stable career and a job I loved at St. Jude Medical to join NewCardio if this was just another algorithm for analyzing ECGs in two dimensions. NewCardio's three-dimensional platform brings the first relevant innovation to electrocardiology in decades and holds the promise to add true and tangible value to each ECG analysis performed around the world. This technology can save lives, improve diagnoses, accelerate drug development, enhance remote patient monitoring and improve the quality of life for patients with chronic conditions. In addition, our technology has the capability to give doctors, life insurance companies, patients and consumers actionable, accurate, easy-to-understand information. NewCardio can accomplish this without changing the well-accepted 12-lead ECG collection practice used by physicians for generations."

View the Entire News Release HERE
 

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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:
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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.

Recent News from NewCardio

Press Release Source: NewCardio, Inc.
Friday October 17, 8:00 am ET

SANTA CLARA, Calif., Oct. 17 /PRNewswire-FirstCall/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI - News) a cardiac diagnostic and services company, today announced the hiring of three key executives to complete the Company's client services team. Greg Sadowski joined NewCardio as Senior Vice President, Client Services. Kathleen A. Walsh joined as Vice President, Product Management. Gilbert V. Molina joined as Director, Corporate Systems.

Mr. Sadowski brings 11 years experience in the Clinical Research sector and a proven track record in rapidly creating new functional groups, business units and technical architectures from the ground up. He joins NewCardio from eResearchTechnology (eRT), where he most recently served on the Executive Management Team as Senior VP of eRT's new Electronic Patient Reported Outcomes (ePRO) business unit while retaining responsibilities as the company's senior executive for the Information Technology and Customer Care groups. Mr. Sadowski will be responsible for effectively preparing, delivering and supporting the NewCardio cardiovascular diagnostic technology solutions, to include the Professional Services, Information Technology, Customer Care and Quality Assurance groups.

Mrs. Walsh also joins NewCardio from eRT, bringing over 11 years of Corelab Management experience. As Vice-President, Project Management she was responsible for leading the Global Project Management department, the Online Reporting Services department and the Training Academy department. She was specifically responsible for developing, implementing and streamlining processes to maximize revenue while maintaining and enhancing client satisfaction. At NewCardio, Mrs. Walsh will be responsible for Product Management, working with both internal and external teams to effectively define and deliver the strategic cardiovascular diagnostic technology solutions that will be derived from the NewCardio 3Dimensional platform technology.

Mr. Molina is a proven IT manager with nine years experience working at diverse, fast-paced and rapidly-growing organizations. He brings a track record of working with diverse groups and managing complex, mission-critical projects. Most recently, he served as Manager, Information Technology where he oversaw IT Operations at eRT's headquarters. At NewCardio he will be responsible for developing and supporting the IT infrastructure, to include hardware, networks and corporate systems, required to support the strategic growth initiatives of the company.

Vincent Renz, NewCardio's President, commented, "I have worked closely with each of these three professionals and as such, have great respect for their capabilities and expertise in working together as a team to bring quality solutions to market. I'm excited to have them join NewCardio, providing a solid foundation for building a world class Client Services organization focused on working together for our customers. This represents a milestone event for NewCardio, as not only will this team prove instrumental in accelerating our commercialization efforts, but will also send a clear signal to our potential customers across the life sciences and health care industries of our commitment to providing stellar service and compelling value."

View the Entire News Release HERE

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
 

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
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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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