NewCardio Awarded Key Patent - Buyout in the works

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NewCardio Awarded Key U.S. Patent for CardioBip
U.S. Patent and Trade Office (PTO) Approves Patent for Device and Methodology for Transtelephonic Transmission of ECG Data for Monitoring of Acute Cardiac Conditions

Press Release Source: NewCardio, Inc. On Thursday January 14, 2010, 8:00 am EST  
http://finance.yahoo.com/news/...-prnews-2727517628.html?x=0&.v=1

SAN JOSE, Calif., Jan. 14 /PRNewswire-FirstCall/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, announced today that on January 12, 2010, it received notice of allowance for U.S. patent 7,647,093, titled "Apparatus and method for cordless recording and telecommunication transmission of three special ECG leads and their processing," from the U.S. Patent and Trademark Office. This represents the core patent for CardioBip™ and, in conjunction with the two encouraging validation studies announced on January 5, 2010, validates the CardioBip technology, positioning NewCardio as an emerging leader in remote cardiac monitoring.

The CardioBip is a unique, hand-held device that provides a solution for ECG telemonitoring. Patients can carry the CardioBip with them and use it to generate and transmit synthesized, accurate 12-lead ECGs at physician prescribed intervals of time, during ordinary daily activity or when symptoms develop. What makes CardioBip unique is its extreme ease of use, combined with the ability to generate recordings substantially equivalent in quality with standard 12-lead ECGs. The CardioBip works without any cables, cumbersome leads, wires or inconvenient skin electrodes, as the device's electrodes are integrated, offering potential compatibility with popular hand-held PDA platforms.

Branislav Vajdic, Ph.D., chief executive officer of NewCardio, Inc., commented, "This patent strengthens our intellectual property protection creating a significant barrier to entry for a competing device. We believe the CardioBip technology fills an important technological and diagnostic void, enabling not only rhythm diagnosis, but also detection of ischemic ECG changes and precise reconstruction of atrial activity. At present there is no convenient and reliable method for remote monitoring and detection of either ischemic events or derangements of atrial electrical activity, but this patent and the two recently completed validation studies indicate that the CardioBip may potentially fill this need. This patent protects the core technology underlying the CardioBip. The patent comes immediately following the encouraging results from two validation studies, which confirmed CardioBip's ability to record, reconstruct and transmit an accurate, high-resolution 12-lead ECG. NewCardio is committed to advancing the widely accepted 12-lead ECG to deliver innovation to the cardiac sciences. We are gratified by the U.S. Patent and Trademark Office's grant of patent rights and pleased that they approved all 33 claims."

Dorin Panescu, Ph.D., NewCardio's Chief Technical Officer and Vice-President of Research and Development, added, "NewCardio remains committed to an aggressive and comprehensive intellectual property (IP) strategy. The Company's IP portfolio evenly covers innovation and invention for all three of our solutions: QTinno™, CardioBip and Visual3Dx™. The patent issued today stresses the importance NewCardio places on patient-friendly, effective and accurate remote wireless patient monitoring, an important, emerging and under-served segment of health care."

About NewCardio, Inc.

NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). NewCardio's three-dimensional ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit www.newcardio.com.

14:15 min  http://www.ustream.tv/recorded/3936678

Breakthrough Technology
 
http://www.newcardio.com/what-we-do-breakthrough-technology.php
 
The standard 12-lead electrocardiogram (ECG or sometimes called EKG) is a diagnostic recording of cardiac electrical activity over time. The 12-lead ECG is cardiology's most frequently used screening and diagnostic tool. Over 200 million ECGs are obtained in the developed 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.
 
Unknown by many, the standard ECG contains latent information about cardiac electrical activity that in total represents the three dimensional (3D) operation of the heart. However, 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.
 
The past 40 years have brought us remarkable gains in computational power. This creates an opportunity to extract substantially more diagnostically valuable information from the ECG signal. By continuing to develop appropriate mathematical algorithms and software, NewCardio believes that its proprietary 3D approaches can significantly enhance the ECG's diagnostic utility, reduce its complexity, and improve its ease of use for the medical professional. Results of first medical trials of NewCardio's technology at Harvard University Medical School and elsewhere indicate initial results to be very encouraging.

 

http://www.b2i.us/profiles/investor/...mp;GoTopage=&Category=1202
 
Jul 30, 2009
Top-Five Global Pharmaceutical Company Names NewCardio as its Provider of Automated Thorough QT Solution
 
Aug 27, 2009
NewCardio Announces Master Services Agreement With Top-Three Contract Research Organization
 
Sep 09, 2009
NewCardio Announces Master Services Agreement with Top Five CRO
 
Jan 14, 2010
NewCardio Awarded Key U.S. Patent for CardioBip
 
...

http://www.b2i.us/profiles/investor/...p;LangID=1&s=0&ID=8337
 
Dear Fellow Shareholders,  
As we approach the end of a transformational year, we are pleased to report to you that our management and board remain very excited about the opportunities before us. The successful commercialization of our initial product, QTinno™, has validated our platform technology which underlies our entire product portfolio. With this platform we believe that we have the potential to add value to virtually every one of the over ¼ billion ECGs taken annually today. In addition, we took steps to strengthen our balance sheet, despite the challenges within the financial markets, by successfully raising $2.9 million in additional growth capital. Members of our management team and board of directors purchased over half of the offering. This raise, coupled with our $3 million line of credit, is expected to fund our operations through the second half of 2010, by which time QTinno is expected to be generating positive cash flow. And finally, we enter 2010 with a strong team of proven industry leaders and the resources to execute our strategic plan.
 
This year was one of accomplishments. Most notable was the launch of QTinno, and the many efforts to reinforce our 3-D platform technology should not go unnoticed. To date, we have validated QTinno performance in more than 65,000 ECGs from seven drug safety studies, including four Thorough QT (TQT) studies. In all of these clinical validation studies, QTinno demonstrated accuracy and precision equal to or higher than core lab manual readings, with a consistent ability to detect drug induced QT prolongation induced by the moxifloxacin class of drugs (i.e. the “moxi” profile), as required by the FDA and other drug regulatory bodies.
 
Building on positive industry attention to cardiac safety and our increasingly robust clinical validation, we officially launched QTinno in August. QTinno provides an automated analysis of cardiac safety in drug development. This launch was enabled by an extensive effort by us to ensure organizational readiness to effectively support the sale, implementation and support of QTinno. As many of our shareholders know, every drug in development must undergo a TQT study to determine cardiac toxicity, and currently these studies involve manual or semi-automated readings by cardiologists.. We believe QTinno will replace this primarily manual process with a fully automated solution which promises higher quality results and a more efficient approach.
 
With our lead product launched, we continue to make steady progress toward securing revenue-generating studies. Notable commercialization-related achievements include:
 
A top-five pharmaceutical company named QTinno as the technology that will be used in all of its fully automated TQT studies. This pharmaceutical company evaluated several automated cardiac safety solutions before choosing QTinno.
 
A Master Services Agreement (MSA) was signed with a top-three Clinical Research Organization (CRO), which will use QTinno as their technology in fully automated Phase I TQT studies delivered by their centralized ECG core lab. We expect to collaborate on the first fully automated study in the near future and anticipate the customer will increasingly deliver fully automated studies with QTinno.
 
Another top-five CRO also signed an MSA with us, licensing QTinno in all TQT studies where fully automated readings are obtained. QTinno will enable them to eliminate the need to utilize ECG core labs for TQT studies delivered by their Phase I units. Ultimately, QTinno will provide the CRO with incremental revenue opportunities by capturing fees that were previously outsourced to ECG core labs.
 
Dedicated Phase I, an innovative provider of clinical research services signed an MSA with us, licensing our QTinno software solution in all TQT studies where fully automated readings are obtained.
 
We expect these initial commercial successes to be followed by additional MSAs with leading CRO’s, ECG core labs, Phase I units and potentially some pharmaceutical sponsors who currently perform TQT studies internally. This increased market presence will provide increasing access to the pharmaceutical companies that need to conduct TQT studies on all of their compounds. We anticipate that our first revenue generating studies will be in place in the near term.
 
Scientific validation coupled with the growing interest by FDA and industry to embrace an automated solution is the other cornerstone to success. In this regard, to support our 3-D platform technology and our lead product, our senior leadership has presented at a wide range of high profile industry events during the last year:
 
 
Dr. Ihor Gussak chaired the automated cardiac safety solution segment of the Cardiac Safety Vendor Workshop in London. The segment featured a Who’s Who in the cardiac safety industry focusing on the market adoption of the automated solution. Here, FDA representatives reinforced their support of the use of automated solutions in TQT studies.
 
Dr. Sam George, our Senior Medical Consultant, joined a distinguished roster of speakers, moderators and panelists at the Cardiac Safety Research Consortium (CSRC) annual meeting in October. At this meeting, we presented the results from our clinical validation studies clearly showing the superior quality of the data processed by QTinno. In addition, we also demonstrated how validation efforts with QTinno uncovered issues with data processed by the semi-automatic methodology practiced by ECG central core labs, bringing into question the accuracy of the methodology currently considered the standard by the core labs.
 
We presented two abstracts and discussed new clinical data from analytical and clinical applications of our proprietary platform technology at The Heart Rhythm Society (HRS) 30th Annual Scientific Sessions.
 
At the DIA Cardiovascular Safety and QT/Arrhythmia Assessment in Drug Development - Optimizing Drug Development Conference, co-sponsored by the FDA and the HRS, we presented our technology and clinical validation results along with our primary automatic solution competitors, and the audience reaction clearly indicated that our results were superior.
 
These presentations and industry events help increase awareness of our 3-D platform technology and our product offerings. This growing interest has included the opportunity to present QTinno to the FDA, who viewed both the technology and our clinical validation results favorably as they indicated they would accept data processed by QTinno in a prospective TQT study for review. In addition to QTinno, we are excited about the opportunities for our platform technology beyond drug development. We are making progress in our efforts to develop CardioBip™ and Visual3Dx™. We are currently exploring strategic opportunities to include product licensing and, or co-development relationships that would align our resources with large global organizations to accelerate further development and marketing of these exciting platform products. Relationships such as these would accelerate revenue generation and create upside potential to our current plan.
 
CardioBip is a wireless medical device providing information equivalent to a full 12-lead ECG machine. CardioBip’s target market is outpatient populations with higher risk for, or with diagnosed, cardiovascular disease. The prototype of CardioBip is a trans-telephonic system comprised of a mobile ECG recording and transmitting device and a diagnostic center which receives, processes and analyzes the data. CardioBip allows a patient to record ECG data with a mobile recorder by easily self-placing it on the patient’s chest. We believe there is emerging opportunity in remote patient monitoring, especially using a wireless device. Recent comments by the FDA, and current trials, indicate that this is a particular area of focus with increasing investment and regulatory attention. Atrial fibrillation (AF) monitoring is a new, yet potentially lucrative, opportunity for CardioBip. AF, the most common type of arrhythmia, is a rapid uncoordinated generation of electrical impulses by the atrial chambers of the heart. In the US alone, more than two million patients are estimated to have AF. AF is commonly treated by use of anti-arrhythmic drugs, but the effectiveness of this therapy is limited and the resulting side effects may not be well tolerated. In order to assess the clinical progression of patients that undergo AF treatment procedures, the HRS Atrial Fibrillation Task Force recommends that AF patients be monitored, using an event monitor, for recurrent arrhythmias for up to two years. This new trend in AF remote patient monitoring opens up an opportunity for deployment of devices such as CardioBip.
 
Visual3Dx provides a comprehensive method to assess cardiac electrical activity in time and space. This product applies our 3-D algorithms in order to significantly enhance the value of a standard ECG, targeting the urgent care market initially. The product extracts additional information from standard 12-lead ECG signals by incorporating algorithms for real-time vectorial analysis and normalization tools to ensure accurate representation of all heart regions. This enables Visual3Dx to assess potentially fatal diseases and conditions, including acute coronary syndrome (ACS), with far greater accuracy than possible by standard ECG. Clinical results to date indicate there can be a 20% improvement in sensitivity. This demonstrates a substantial potential for improvement in accuracy in diagnosis of acute MI.
 
For 2010, our goals are to build upon our R&D and clinical validation successes that are driving the adoption of QTinno, in order to generate revenues sufficient to achieve profitability by the end of the year. We continue to develop additional relationships with sponsors, CRO’s, clinical pharmacology units and ECG core labs to achieve this goal. The industry is moving in the direction of automated studies, and our solutions provide the ideal method to achieve their objectives. We also plan to ramp up our new product development in conjunction with the appropriate strategic partners. We will be investing in additional R&D to advance Visual3Dx and CardioBip as we pursue these relationships, some of which may result in incremental revenue opportunities as early as 2010. We are particularly excited about the opportunities for the wireless CardioBip platform with the increasing industry focus on AF.
 
In summary, 2009 was a milestone year and 2010 brings a new focus – wireless – as we become a growing commercial enterprise. We have developed a disruptive technology that is ideally suited for the direction the drug industry is moving. We have received positive reactions from regulators and specifically the FDA, and are receiving an encouraging reaction from pharmaceutical companies. We have an exceptionally deep and talented team in place, and we are well-positioned for success in 2010 and beyond. Our board and management team remain excited about our opportunities and potential, and we trust you share this enthusiasm.
Sincerely,  
 
 
Branislav Vajdic, Ph.D.  
CEO  
 
Vincent W. Renz, Jr.  
President and COO  

http://www.newcardio.com/products-qtinno.php
 
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. New drugs are often tested on more than 1,000 subjects, with ECGs collected at multiple time points. Current semi-automated methods for arrhythmia induced cardiac toxicity are costly and time-consuming. Using NewCardio’s 3-D approach, drug Sponsors and Contract Research Organizations (CROs) can automate this process, significantly reducing the cost and variability compared with non-automated methods, and reducing the time required to test new drugs in development.
 
QTinno™ Tools
 
QTinno™ is a software suite that provides accurate, fully automated and comprehensive analysis of QT intervals, and other ECG markers for cardiac safety assessment in drug development.
Key features
 
    * novel, fully automated assessment tool
    * sophisticated, proprietary curve-fitting algorithms to identify key cardiac events
    * fast, accurate and precise QT data from a broad range of difficult ECGs, and
* QTinno Client™ provides user friendly software platform for fast, informative human overview of QTinno™ results, if desired.
 
The QTinno™ algorithm first processes the input signal into a 3D representation of cardiac electrical activity over time. It then generates a "virtual sphere" of normalized cardiac electrical activity that includes balanced and complete information from all parts of the heart. This improves the signal-to-noise ratio and shows difficult-to-detect events with substantially greater clarity than the standard 12-lead display. In addition, QTinno™ incorporates novel curve fitting algorithms that ensure a high degree of accuracy. These advantages enable reliable, fully automated identification of key cardiac events - a problem previously unsolved.
 
QT Client™
 
QT Client™, which provides a user friendly software platform for fast, informative overview of QTinno™ results.
 
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, we believe that for the first time, the definitive solution for automated, thorough or routine QT studies is being offered. QTinno™ by NewCardio will be differentiated in the market by the following features.
 
    * QTinno™ offers productivity and precision of automation and highly accurate results – even on more “difficult” ECGs
* Robust QTinno™ technology potentially adaptable to rapidly emerging problem of drug-induced propensity to increased rates of adverse cardiac events
    * NewCardio’s solution provides more accurate, more efficient, lower cost, and lower risk assessments of cardiac safety.
 
QTinno™ performance was validated using thousands of ECGs. Two drugs under development were evaluated for cardiac toxicity using QT interval change as the marker. Both studies returned remarkable agreement with the gold standard that was generated by extraordinary careful manual or semi-automated reading by multiple highly qualified cardiologists. Peer reviewed publications are in preparation.
 

A QT Client™ user screen – one of several displays possible for user inspection of QT results.

Visual3Dx™ -  
 
http://www.newcardio.com/products-visual-ecg.php
 
Although diagnostically valuable, the standard 12-lead ECG has significant limitations. The ECG is a 2-dimensional representation of cardiac electrical activity, an inherently 3-dimensional event. As a consequence, significant amounts of important information are not used because the human mind is not capable of synthesizing all of this complex information. In addition, errors in interpreting the standard 12-lead ECG are common and can lead to serious clinical mismanagement. Errors of “major proportions” have been identified in 4% to 32% of ECG interpretations. The fear of wrong diagnoses and the associated legal liability results in many unnecessary admissions to hospitals of patients with chest pain. Many independent estimates put the cost of these unnecessary admissions in the US at well over $5 billion. New analysis approaches are urgently needed to reduce interpretative error and to improve diagnostic accuracy.
 
Visual3Dx™ Software
 
Visual3Dx™ is a set of algorithms and tools that provide a comprehensive method to describe cardiac electrical activity in time and space. Visual3Dx™ 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 ease of use, the program superimposes the diagnostically relevant electrical information on an intuitive, revolving 3-D anatomic model of the heart.
 
A key aspect of Visual3Dx™ 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, Visual3Dx™ 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.
 
We believe Visual3Dx’s features enable it to detect serious cardiac diseases with far greater sensitivity and specificity than is possible with a standard ECG. Importantly, however, Visual3Dx™ 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. Moreover, Visual3Dx™ displays the standard 12-lead ECG along with its novel 3-D analytical presentations. This allows the physician to make correlations between displays and provides reassurance that no information has been lost.
 

A typical Visual3Dx™ output that is easy to read and thus requires less training to interpret, when compared with the standard 12-lead display.

 

 

 
http://www.foxbusiness.com/story/markets/...-nwci-awarded-key-patent/
 
Friday, January 15, 2010
"Buyout in the Works" After NWCI is Awarded Key Patent
 
 
Jan 15, 2010 (BAYSTREET NEWSWIRE via COMTEX) ----The same biotech news portal that reported RXI Pharmaceuticals' (Nasdaq:RXII) now confirmed partnership talks weeks ahead of time is now reporting that another buyout in the sector may be in the works at this moment.
 
Their report comes on the heels of Thursday morning's key patent news announcement for small cap innovator, NewCardio (NWCI.OB).
 
According to BioMedReports, the Silicon Valley based company with a very small share float became the subject of some "credible buyout rumors" on the last day of the recent healthcare conferences in San Francisco.
 
"Rumors began to fly that the company was suddenly in deep negotiations regarding a buy out," reports M.E. Garza. "After chasing the story, and seeing a key patent announcement hit the news wires on Thursday morning, its my opinion that if the buyout occurs, it will could send shares of NewCardio somewhere between $10 and $14." According to Garza, the company has a hot new technology that is shaping up to be not only the next great diagnostics tool in cardiovascular medicine, but could also turn into "the ultimate medical phone app." There is talk about a hardware/software combo that would allow anyone to hold a smart phone-like device up to their chest in order to interpret/communicate the readings directly to a doctor.
 
Designers of this technology (who come from a tech background designing chips and microprocessors) have figured out that a great number of doctors simply do not know how to interpret heart monitor signals either correctly or accurately. They feel that EKG technology is "under utilized" as a diagnostics tool and see a multi-billion dollar market for their products.
 
According to an upbeat presentation at the OneMedForum in San Francisco this week, NewCardio is said to be entering the commercial phase as a cardiac diagnostic and services company.
 
The company's proprietary software platform technologies reportedly provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). NewCardio's three-dimensional ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. Developing...
 
Copyright 2010 BAYSTREET NEWSWIRE

 

1/17/2010 2:24 AM  ET
http://www.rttnews.com/Content/...spx?Node=B1&pageNum=2648_4209_2

(RTTNews) -  Visual3Dx is NewCardio's product under development, which has the potential to significantly enhance the value of a standard ECG in assessing potentially fatal diseases and conditions, including acute coronary syndrome. According to the company, Visual3Dx has demonstrated 20% improvement over standard ECG in sensitivity in clinical studies.

CardioBip is yet another product under development. It was awarded a core patent by the U.S. Patent and Trade Office on Thursday. The CardioBip is a hand-held wireless device that provides a solution for ECG telemonitoring. CardioBip's target market is outpatient populations with higher risk for, or with diagnosed, cardiovascular disease.

With promising opportunity in remote patient monitoring, NewCardio sees a lucrative, opportunity for CardioBip, specifically in AF (atrial fibrillation) monitoring. AF, the most common type of arrhythmia, characterized by irregular and often rapid heart rhythm, affects more than two million patients in the U.S. alone. The ageing and baby boomer population also presents a significant market opportunity for the product.

The company plans investing in additional R&D to advance Visual3Dx and CardioBip and the products are expected to be on the market by 2011-2012.

With increasing attention on lowering costs and improving efficiency in healthcare, NewCardio's electrocardiography platform technology that allows faster, more accurate and less expensive assessment of cardiac status, deserves a look and so may the stock. Stay tuned...

NewCardio awarded core patent concerning its CardioBip ECG telemonitoring solution
 
17. Januar 2010 23:57 - THE MEDICAL NEWS
http://www.news-medical.net/news/20100117/...monitoring-solution.aspx
 
NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, announced today that on January 12, 2010, it received notice of allowance for U.S. patent 7,647,093, titled "Apparatus and method for cordless recording and telecommunication transmission of three special ECG leads and their processing," from the U.S. Patent and Trademark Office. This represents the core patent for CardioBip™ and, in conjunction with the two encouraging validation studies announced on January 5, 2010, validates the CardioBip technology, positioning NewCardio as an emerging leader in remote cardiac monitoring.
 
The CardioBip is a unique, hand-held device that provides a solution for ECG telemonitoring. Patients can carry the CardioBip with them and use it to generate and transmit synthesized, accurate 12-lead ECGs at physician prescribed intervals of time, during ordinary daily activity or when symptoms develop. What makes CardioBip unique is its extreme ease of use, combined with the ability to generate recordings substantially equivalent in quality with standard 12-lead ECGs. The CardioBip works without any cables, cumbersome leads, wires or inconvenient skin electrodes, as the device's electrodes are integrated, offering potential compatibility with popular hand-held PDA platforms.
 
Branislav Vajdic, Ph.D., chief executive officer of NewCardio, Inc., commented, "This patent strengthens our intellectual property protection creating a significant barrier to entry for a competing device. We believe the CardioBip technology fills an important technological and diagnostic void, enabling not only rhythm diagnosis, but also detection of ischemic ECG changes and precise reconstruction of atrial activity. At present there is no convenient and reliable method for remote monitoring and detection of either ischemic events or derangements of atrial electrical activity, but this patent and the two recently completed validation studies indicate that the CardioBip may potentially fill this need. This patent protects the core technology underlying the CardioBip. The patent comes immediately following the encouraging results from two validation studies, which confirmed CardioBip's ability to record, reconstruct and transmit an accurate, high-resolution 12-lead ECG. NewCardio is committed to advancing the widely accepted 12-lead ECG to deliver innovation to the cardiac sciences. We are gratified by the U.S. Patent and Trademark Office's grant of patent rights and pleased that they approved all 33 claims."
 
Dorin Panescu, Ph.D., NewCardio's Chief Technical Officer and Vice-President of Research and Development, added, "NewCardio remains committed to an aggressive and comprehensive intellectual property (IP) strategy. The Company's IP portfolio evenly covers innovation and invention for all three of our solutions: QTinno™, CardioBip and Visual3Dx™. The patent issued today stresses the importance NewCardio places on patient-friendly, effective and accurate remote wireless patient monitoring, an important, emerging and under-served segment of health care."
SOURCE NewCardio, Inc.

Partnership/Buyout Rumors Make Sense for NewCardio Inc. (NWCI.OB)

  Posted on: Thu, 21 Jan 2010 09:49:38 EST
http://www.tradingmarkets.com/news/stock-alert/...wci-ob--718123.html

Rumors about a buyout or partnership with a major medical device player continue to gather steam around cardiac diagnostic and services company NewCardio Inc. (NWCI.OB). With a market opportunity of $5 billion, backed by statistics showing more than 250 million heart ECGs taken annually, the company believes that there is a huge opportunity for its products and the stock market has taken notice following their recent presentation at the OneMedPlace Finance Forum on January 12.

The key to the discussions, which several sources close to the company have continued to confirm, are many of the patents held by company and it's Chief Technical Officer and Vice-President of Research and Development, Dorin Panescu, Ph.D.

In October, the world's leading professional association for the advancement of technology in the biomedical and healthcare industries recognized Panescu and awarded him the IEEE Engineering in Medicine and Biology Society (EMBS) 2009 Professional Career Achievement Award for "groundbreaking contributions to the invention and development of medical devices for cardiac ablation, mapping, imaging and cardiac resynchronization therapy." He holds more than 130 U.S. patents in addition to the 70 published or pending U.S. patent applications. He joined NewCardio from St. Jude Medical, Inc., a $4.1 billion medical technology and services company in October of 2008.

It may not be long before Panescu is part of another multi-billion cap company given NewCardio's various unique and proprietary platform technologies. The company may not only be on the cusp of revolutionizing the way doctors and researchers use ECG data as a monitoring tool, they also appear to have key patents on a hardware and software combination that at least one major player in the medical device arena would like to commercialize.

Interestingly, one of NWCI's competitors, United Therapeutics Corporation (Nasdaq: UTHR) has also been gaining ground recently and closed last Thursday at its third consecutive new high for the year, trading at nearly $60 per share. That company holds the rights to the CardioPAL SAVI Wireless Cardiac Event Monitor which allows patients suspected of having cardiac arrhythmia to wear a portable device which monitors and collects ECG data then send it to a seperate wireless Smartphone via Bluetooth. According to UTHR, their proprietary software on the Smartphone then analyzes the ECG and sends the clinically relevant symptomatic and asymptomatic data to a monitoring center where certified cardiac technicians review it and prepare reports for the patient's doctors.

One of UTHR's subsidiaries, Medicomp, Inc. holds the rights to the only FDA cleared ECG algorithm to analyze rate, rhythm, morphology, and p-wave abnormalities, but NewCardio's propriety electrocardiography platform technology uses a smarter and more robust three dimensional (3D) approach to electrocardiography that allows for much faster, more accurate and less expensive assessment of cardiac status. In addition, the diagnosis of previously difficult or undiagnosable conditions using a single device could signal a significant paradigm shift.

NewCardio recently launched its first product, QTinno™, a fully automatic cardiac safety solution for Thorough QT and Phase I studies in Drug Development. That product is fully compliant and can analyze, at a minimum, 10,000 ECGs per hour resulting in a significant cost savings for sponsors conducting Thorough QT and Phase I clinical trials. Immediately, at least two top Clinical Research Organizations (CRO) signed a licensing agreement with NewCardio to use the technology and in doing so provided itself a powerful competitive advantage and differented itself from its competitors. In addition, NewCardio can deliver TQT/QTc studies for upload to the FDA digital ECG warehouse with greater accuracy and lower intrinsic variability than the legacy manual or semi-automated methodologies provide. NewCardio's software suite minimizes the risk of false positives or false negatives and delivers them in a more timely and cost-effective manner than any of the current core lab methodologies allow.

These types of innovations are what give whispers about NewCardio's potential buyout or partnership more volume. The stock continues to appear vastly undervalued, even after it's recent run up and subsequent profit taking pull-back.

NewCardio's Chief Medical Officer, Dr. Ihor Gussak, to Present at  Prestigious Cardiac Electrophysiology Conference in Tokyo
 
 Date : 02/04/2010 @ 8:00AM
Source : PR Newswire
Stock : (NWCI)
 
http://ih.advfn.com/...pid=nmona&article=41396179&symbol=NWCI  
 
NewCardio's Chief Medical Officer, Dr. Ihor Gussak, to  Present at Prestigious Cardiac Electrophysiology Conference in Tokyo  
 
Dr. Gussak to Provide Special Lecture at the Japanese  Idiopathic Ventricular Fibrillation (J-IVFS) Annual Meeting on  February 8, 2010
 
SAN JOSE, Calif., Feb. 4  /PRNewswire-FirstCall/ --
 
NewCardio, Inc., (OTC Bulletin  Board: NWCI) a cardiac diagnostic technology provider, announced today  that its Chief Medical Officer, Ihor Gussak MD, PhD, FACC,  world-recognized expert in electrocardiology and cardiac safety, will  provide a special lecture at the prestigious Japanese Idiopathic  Ventricular Fibrillation (J-IVFS) Annual Meeting at the Sankei Plaza  convention center in Tokyo, Japan on February 8, 2010. Dr. Gussak's  presentation, Early Ventricular Repolarization: ECG Phenomena and  Arrhythmogenic Potentials" will be Chaired by Prof. Kaoru Sugi (Toho  University Ohashi Medical Center)
 
The  45-minute presentation will show how a three-dimensional (3D) ECG  analysis, made possible by NewCardio's technology, provides additional  information on subtle or non-conclusive changes, which clinicians can  use to assess risk of sudden cardiac arrest more appropriately and  effectively. NewCardio's platform technology, which applies  advanced 3D techniques and modern computer software, can help clinicians  to identify patients at risk of fatal arrhythmias by providing  clinicians a deeper look and additional information compared to  traditional techniques
 
"NewCardio remains committed to  deploying state-of-the-art science and technology to enable more  accurate diagnosis and risk stratification of serious cardiac conditions  and to advance the prevention and treatment of life-threatening  conditions, including electrical diseases of the heart," commented Dr.  Gussak. "I am excited to share our latest developments and discuss the  far-reaching potential of our platform technology at the J-IVFS."
 
 The J-IVFS is one of the most prestigious Cardiac Electrophysiology  events in the world, covering areas of particular focus in Japan where  idiopathic sudden cardiac arrest is endemic and very problematic.  Distinguished attendees at the event include Dr. Masakazu Hiraoka  (Ministry of Health, Labor and Welfare, Labor Health Appeal Committee),  Professor Kazutaka Aonuma (University of Tsukuba), Naohiko Aihara  (National Cardiovascular Center), Dr. Masahiko Takagi (Osaka City  University Graduate School of Medicine), Dr. Yukio Sekiguchi (University  of Tsukuba), Dr.Yasuhiro Yokyama (National Disaster Medical Center),  Professor Hirotsugu Atarashi (Nihon Medical University Tama Nagayama  Hospital) and Dr. Akihiko Nogami (Yokohama Rosai Hospital), and Dr. Sami  Viskin (Israel)
 
Dr. Gussak is a Fellow of the American  College of Cardiology, and serves on the Clinical Cardiology Council of  the American Heart Association. He is a member of the American Academy  of Pharmaceutical Physicians, the International Cardiac  Electrophysiology Society, the International Society for Holter and  Noninvasive Electrocardiology, the Drug Information Association, and the  International Scientific Committee on Arrhythmogenic Right Ventricular  Dysplasia-Cardiomyopathy. He has published several textbooks and  numerous peer-reviewed articles on these and other subjects in clinical  cardiology
 
NewCardio's innovative 3D ECG platform technology  dramatically improves the accuracy and significantly increases the  diagnostic value of the standard 12-lead electrocardiogram (ECG).  NewCardio's lead product is QTinno(TM), a software suite that provides  an automated, comprehensive analysis of QT intervals and other ECG-based  cardiac safety for the pharmaceutical industry and drug regulators. The  Company believes that its QTinno(TM), software-based, analytical  technology is the industry's first solution for the reliable automated  analysis of ECGs used to determine cardiac toxicity during drug  development
 
About NewCardio, Inc
 
NewCardio is a  cardiac diagnostic and services company developing and marketing  proprietary software platform technologies to provide higher accuracy  to, and increase the value of, the standard 12-lead electrocardiogram  (ECG). NewCardio's three-dimensional ECG software platform reduces the  time and expense involved in assessing cardiac status while increasing  the ability to diagnose clinically significant conditions which were  previously difficult to detect. NewCardio's software products and  services significantly improve the diagnosis and monitoring of  cardiovascular disease, as well as cardiac safety assessment of drugs  under development. For more information, visit http://www.newcardio.com/  
 
Forward-Looking Statements
 
This press release  contains forward-looking statements. Forward-looking statements include,  but are not limited to, statements that express our intentions,  beliefs, expectations, strategies, predictions or any other statements  relating to our future activities or other future events or conditions.  These statements are based on current expectations, estimates and  projections about our business based on currently available information  and assumptions made by management. Although we believe that the  assumptions on which the forward-looking statements contained herein are  based are reasonable, any of those assumptions could prove to be  inaccurate given the inherent uncertainties as to the occurrence or  nonoccurrence of future events. These statements are not guarantees of  future performance and involve risks and uncertainties that are  difficult to predict. Therefore, actual outcomes and results may, and  are likely to, differ materially from what is expressed or forecasted in  the forward-looking statements due to numerous factors, including the  potential risks and uncertainties set forth in Item 1A of our Annual  Report on Form 10-K for the year ended December 31, 2008 and relate to  our business plan, our business strategy, development of our proprietary  technology platform and our products, timing of such development,  timing and results of clinical trials, level and timing of FDA  regulatory clearance or review, market acceptance of our products,  protection of our intellectual property, implementation of our  strategic, operating and people initiatives, benefits to be derived from  personnel and directors, ability to commercialize our products, our  assumptions regarding cash flow from operations and cash on-hand, the  amount and timing of operating costs and capital expenditures relating  to the expansion of our business, operations and infrastructure,  implementation of marketing programs, our key agreements and strategic  alliances, our ability to obtain additional capital as, and when,  needed, and on acceptable terms and general economic conditions specific  to our industry, any of which could impact sales, costs and expenses  and/or planned strategies and timing. We assume no obligation to, and do  not currently intend to, update these forward-looking statements
 
 To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0  
 
Investor Contact: Hayden IR Jeff Stanlis, Partner (602)  476-1821
 
DATASOURCE: NewCardio, Inc
 
CONTACT:  Investors, Jeff Stanlis, Partner at Hayden IR, +1-602-476-1821,
 
 , for NewCardio, Inc
 
Web Site: http://www.newcardio.com/

Goldman Small Cap Research rates NewCardio (NWCI:OB) a speculative buy

Written by BioMedReports.Com
Tuesday, 09 February 2010 04:50

http://biomedreports.com/articles/most-popular/...peculative-buy.html

Goldman Small Cap Research share some interesting insights as they initiate coverage of NewCardio (NWCI:OB) with a Speculative Buy recommendation. In his report, analyst Rob Goldman cites several factors for his $4.00 price target.

“With a combined $5 billion annual market for the Company’s first three solutions, NewCardio is well-positioned to capture maket share in the cardiac safety, urgent care and chronic care markets. The Company is led by a first-class management team with a history of success. Now, with NewCardio, they have launched a blockbuster technology platform. As investors become more familiar with the NewCardio story, and management continues to execute, the stock could reach $4.00, said Goldman..”

NewCardio's offerings are used to determine the cardiac toxicity of new drugs in clinical trials and development, and to evaluate cardiac status during acute and chronic patient management. NewCardio's unique 3D ECG approach enables faster, more accurate and less expensive assessment of cardiac status than products/services currently in use, and can provide diagnosis of previously difficult or undiagnosable conditions.

According to Goldman, “NewCardio recently began marketing marketing its flagship cardiac safety product QTinno™, and it has already signed several Master Service Agreements, with more likely in the offing.”

A free copy of the report is available at the Company’s website, www.goldmanresearch.com.

About Goldman Small Cap Research: Led by former Piper Jaffray analyst and mutual fund manager Rob Goldman, Goldman Small Cap Research produces stock market research reports. The Firm produces research via two formats: Goldman Select Research and Goldman Opportunity Research. The Select product reflects the Firm’s internally generated stock ideas while the Opportunity product reflects sponsored research reports. It is important to note that while performance maybe tracked separately, the same coverage criteria is utilized in determining coverage of all stocks in both research formats.

A Goldman Small Cap Research report is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed. Please read the report’s full disclosures and analyst background fund on our website before investing. To download our research or for more information, visit www.goldmanresearch.com.

NewCardio, Inc. NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). Â NewCardio's three-dimensional ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. Â NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit http://www.newcardio.com.

22.02.2010 14:05
http://www.finanznachrichten.de/...n-abstract-suggesting-impr-008.htm

Study of NewCardio's CardioBip Demonstrates Performance for Remote Wireless Monitoring and Detection of Atrial Fibrillation / Abstract Suggesting Improved Clinical Outcomes to Be Presented at Prestigious Heart Rhythm Society Annual Meeting

SAN JOSE, Calif., Feb. 22 /PRNewswire-FirstCall/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, announced today that the Heart Rhythm Society (HRS) has accepted an abstract detailing the superior performance of NewCardio's patented CardioBip(TM) technology for remote wireless monitoring and detection of atrial fibrillation (AF). The study results, which discuss the use of CardioBip for improved AF monitoring and detection, are scheduled for oral presentation at the Heart Rhythm Society 31st Annual Scientific Sessions, May 12-15, 2010, in Denver, Colorado.

The abstract, titled "Three-dimensional Atrial Signal Reconstruction Facilitates Remote Detection Of Atrial Fibrillation," was written by Alexei Shvilkin, MD, PhD, Dejan Vukajlovic, MD, Vladan Vukcevic, MD, Ihor Gussak, MD, PhD, Bosko Bojovic, PhD, Uros Mitrovic, MS and Goran Simic, MS. The abstract highlights a new AF detection algorithm based on NewCardio's proprietary 3-D ECG processing platform.

Alexei Shvilkin, MD, PhD, of Beth Israel Deaconess Medical Center and Harvard Medical School, the abstract's first author and principal investigator, commented, "Reliable detection of AF represents an important clinical objective that could improve outcomes for remotely monitored patients. Because of the low amplitude of atrial electrical activity and noise associated with use of remote monitoring, current systems predominantly rely on heart rate variability to detect AF. As a result, some patients may be misdiagnosed, especially those undergoing post-ablation AF monitoring. In this study, we showed that NewCardio's CardioBip-based wireless technology enables the assessment of atrial activity by using ensemble signal processing, 12-lead ECG reconstruction, and 3-D processing of atrial activity. The new algorithm detects the difference in atrial activity between AF and sinus rhythm and does not rely on heart rate variability measurements. It has the potential to improve patient monitoring outcomes by differentiating AF from other confounding arrhythmia (e.g. atrial flutter, atrial tachycardia) that may occur after AF ablation."

Mark Kroll, PhD, Fellow of the HRS and NewCardio's Chairman of the Board of Directors, added, "We are excited to share this important clinical advancement with scientists, medical professionals and industry leaders at the HRS Annual Scientific Sessions. We are grateful that the HRS accepted this abstract for oral presentation. This provides the Company with added confidence in the science behind its solutions for chronic care."

The CardioBip is a unique, hand-held device that provides a solution for ECG remote monitoring. Patients can carry the CardioBip with them and use it to generate and transmit synthesized, accurate 12-lead ECGs at physician prescribed intervals of time, during ordinary daily activity or when symptoms develop. What makes CardioBip unique is its extreme ease of use, combined with the ability to generate recordings substantially equivalent in quality with standard 12-lead ECGs. The CardioBip works without any cables, cumbersome leads, wires or inconvenient skin electrodes, as the device's electrodes are integrated, offering potential compatibility with popular hand-held PDA platforms. On January 12, 2010, the U.S. Patent and Trademark Office issued patent 7,647,093, titled "Apparatus and method for cordless recording and telecommunication transmission of three special ECG leads and their processing." This represents the core patent for CardioBip.

HRS is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. The Annual Scientific Sessions attract more than 9,000 professionals representing the allied specialties of cardiac pacing and cardiac electrophysiology. More information is available at http://www.hrsonline.org/Sessions/ on the Internet.

About NewCardio, Inc.

NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). NewCardio's three-dimensional ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit http://www.newcardio.com/.

25.02.2010 14:46
http://www.finanznachrichten.de/...-d-ecg-platform-technology-008.htm

NewCardio Receives Notice of Allowance for Vital Patent for Cardio3KG(TM) / Represents Core Patent for NewCardio's 3-D ECG platform technology

SANTA CLARA, Calif., Feb. 25 /PRNewswire-FirstCall/ -- NewCardio, Inc. (BULLETIN BOARD: NWCI) a cardiac diagnostic technology provider, announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent covering technology relating to NewCardio's Cardio3KG solution (formerly VisualECG or Visual3Dx). This represents the core patent for NewCardio's anticipated emergency/urgent care solution, Cardio3KG.

The Cardio3KG solution is comprised of a set of algorithms and tools that provide a comprehensive method to assess cardiac electrical activity in time and space, and to extract additional 3-dimensional information from standard 12-lead ECG signals. This may enable Cardio3KG to assess potentially fatal diseases and conditions, including acute coronary syndrome, with greater speed and accuracy than possible by standard ECG.

When issued, together with US patent 7,266,408, this will be NewCardio's second U.S. patent covering broad aspects of the Company's 3-D ECG platform technology and, particularly, specifics of Cardio3KG, the first solution targeted to take full advantage of this intellectual property.

"This action by the USPTO reinforces our continuing investment in and commitment to our novel cardiovascular diagnostic platform technology, which provides 3-D analysis of the heart's electrical activity," stated NewCardio's CEO, Branislav Vajdic, PhD. "We believe the Cardio3KG solution will substantially improve the accuracy and timeliness of response and diagnosis for patients arriving at emergency departments with heart attack symptoms and related conditions. NewCardio's Cardio3KG will enable 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. We also believe Cardio3KG, along with QTinno(TM) and CardioBip(TM), represent important steps forward in validating our 3-D ECG platform's ability to improve cardiac diagnosis, clinical outcomes, and drug safety. We are pleased that patent offices in both the US and Europe are acknowledging our proprietary claims to our core technologies."

About NewCardio, Inc.

NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). NewCardio's three-dimensional ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit http://www.newcardio.com/.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.

To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0

Investor Contact: Hayden IR Jeff Stanlis, Partner (602) 476-1821 jeff@haydenir.com

NewCardio, Inc.

CONTACT: Jeff Stanlis, Partner of Hayden IR, +1-602-476-1821,
jeff@haydenir.com, for NewCardio, Inc.

Web Site: http://www.newcardio.com/


© 2010 PR Newswire

Coming Next Week: Updates on ..., NWCI and More

Written by Staff and Wire Reports
Friday, 26 March 2010 06:18

http://biomedreports.com/articles/most-popular/...-nwci-and-more.html

Also next week, we'll have an update on NewCardio, Inc. (NWCI.OB). This is a company we've been watching closely in anticipation of a partnership development and our sources tell us that the company may have additional news regarding revenue generating contracts in the coming days. NewCardio, Inc., a development-stage cardiac diagnostic company, focuses on the research, development, and commercialization of proprietary software platform technology solutions for the non-invasive diagnosis and monitoring of cardiovascular disease, as well as for the cardiac safety assessment of drugs under development. The company?s technology platform provides real-time and 3-D analysis of the heart's electrical activity as detected at the body surface by standard 12-lead electrocardiogram(ECG) electrodes. Its developing products include QTinno, a phase I trial product, which is an automated cardiac safety solution that replaces the manual and/or semi-automated methodologies with algorithms that automatically measure, analyze, and report on the ECGs collected; and CardioBip, a mobile ECG transtelephonic system comprising a mobile ECG recording and transmitting device, and a diagnostic center that receives, processes, and analyzes the data.

Clinilabs Signs MSA with NewCardio, Inc. for QTinno

Date : 04/08/2010 @ 8:00AM
Source : PR Newswire
Stock : Newcardio (BB) (NWCI)

http://ih.advfn.com/...8608&article=42299034&symbol=NB%5ENWCI

Master Services Agreement Enables Clinilabs to Add ECG Core Lab Services, Extending its Scope of Services and Capturing Additional Revenue

PR Newswire

NEW YORK, April 8

NEW YORK, April 8 /PRNewswire-FirstCall/ --

Clinilabs, a New York-based contract research organization that provides early phase and specialty clinical drug development services to the pharmaceutical industry, announced today that it has signed a Master Services Agreement (MSA) with NewCardio, Inc. (OTC Bulletin Board: NWCI), a cardiac diagnostic technology provider. Clinilabs has licensed NewCardio's QTinno™ software solution in order to perform fully-automated cardiac safety analyses in cardiac intensive and thorough QT studies. In addition, Clinilabs has signed a services work order, including standard operating procedures (SOP) and validation kits, as well as professional services, so NewCardio can assist Clinilabs in developing an ECG core laboratory.

The Master Services Agreement enables Clinilabs to utilize QTinno to provide customers with advanced, accurate, and efficient fully-automated cardiac safety studies at its clinical research unit (CRU) in Manhattan. The relationship with NewCardio also will enable Clinilabs to compete in the market for ECG core laboratory services by providing the professional services needed to integrate ECG core lab functions into Clinilabs' existing core data center, which currently serves clinical trials in 33 countries. NewCardio is expected to recognize revenue from this relationship beginning in March 2010 with the installation and validation of its systems. Clinilabs is expected to recognize revenue as early as Q3 2010 from clinical trials conducted with the QTinno software solution.

"This announcement is further evidence of the growing adoption of QTinno™ by innovative clinical trial service providers looking to deliver quality cardiac safety analysis with higher accuracy and lower intrinsic variability in a timely and cost-effective manner," said Vincent Renz, NewCardio's President and Chief Operating Officer. "Our target customers are clinical trial service providers looking to deploy our proven technology to expand services and grow market opportunities. For Clinilabs, adding to its available scope of services by utilizing QTinno accomplished these two important goals."

Gary K. Zammit, PhD, President and CEO of Clinilabs, added, "NewCardio's QTinno, coupled with its team's history and expertise in delivering cardiac safety services to leading pharmaceutical companies, has given us an incredible opportunity to expand our service portfolio and deliver value to our clients. We can now provide a differentiated and low cost solution for ECG data analysis to an industry that has been seeking a meaningful alternative to existing methods for some time."

Both NewCardio and Clinilabs will be present at the upcoming 19th Annual Partnerships in Clinical Trials conference to be held in Orlando, FL April 12-14th. NewCardio will be at booth # 624 and Clinilabs at booth # 650. To schedule a private meeting with the Clinilabs and NewCardio teams, please contact Jeanine M. Estrada, Clinilabs' Director of Business Development, at 646.438.4431.

About Clinilabs, Inc.

Clinilabs is a contract research organization (CRO) that provides clinical drug development services to industry. The Company offers teams, facilities, processes, and technology solutions for the conduct of early phase and specialty studies, and also operates a core data center that processes biomedical device data from global, multicenter projects. Since 2001, the company has worked with nine of the top 20 pharma companies in the world on trials conducted in 33 countries to support nine successful new drug applications. For more information, visit www.clinilabs.com.

About NewCardio, Inc.

NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). NewCardio's three-dimensional ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit www.newcardio.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding NewCardio. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward- looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2008 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.

To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0

Investor Contacts:

Clinilabs, Inc.

Ron Falcone, Controller

(646) 215-6407

rfalcone@clinilabs.com

NewCardio

Hayden IR

Jeff Stanlis, Partner

(602) 476-1821

jeff@haydenir.com

SOURCE NewCardio, Inc.

NewCardio to Perform First Revenue-Generating QT Study Using QTinno / NewCardio Now Has Master Services Agreements (MSAs) in Place with Three of the World's Leading CROs

29.04.2010 14:09
http://www.finanznachrichten.de/...-place-with-three-of-the-w-008.htm

SANTA CLARA, Calif., April 29 /PRNewswire-FirstCall/ -- NewCardio, Inc., (BULLETIN BOARD: NWCI) a cardiac diagnostic technology provider, announced today that a leading global biopharmaceutical services provider has signed a MSA, licensing NewCardio's QTinno(TM) software solution to enhance its delivery of fully automated cardiac safety analyses for early phase QT studies. The CRO is expected to deploy QTinno in several clinical unit locations worldwide.

In addition, the CRO has signed a services work order related to the first study using QTinno, which is scheduled to be initiated this June.

"NewCardio now has agreements with three of the leading CROs in the industry," said Vincent Renz, NewCardio's President and Chief Operating Officer. "We are excited about the prospects of this latest agreement, which will result in initial study-related revenue for NewCardio. We continue to believe the transition from semi-automated to fully automated cardiac safety analysis in early phase QT studies is inevitable and accelerating, and the successful completion of our initial studies is expected to lead the market to shift to more high quality, cost effective fully automated studies in the near future. For the CRO, this agreement expands their scope of services in QT studies, enabling them to enhance delivery of high-quality cardiac safety analyses."

NewCardio's innovative 3D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12-lead electrocardiogram (ECG). NewCardio's lead product is QTinno, a software suite that provides an automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. The Company believes that its QTinno, software-based, analytical technology is the industry's first solution for the reliable automated analysis of ECGs used to determine cardiac toxicity during drug development.

About NewCardio, Inc.

NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead ECG. NewCardio's 3-D ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit http://www.newcardio.com/.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.

To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0

Investor Contact: Hayden IR Jeff Stanlis, Partner (602) 476-1821 jeff@haydenir.com

NewCardio, Inc.

CONTACT: Investors, Jeff Stanlis, Partner of Hayden IR, +1-602-476-1821,
jeff@haydenir.com, for NewCardio, Inc.

Web Site: http://www.newcardio.com/


© 2010 PR Newswire

02.06.2010 14:39
http://www.finanznachrichten.de/...-congress-on-heart-disease-004.htm

NewCardio Selected to Make Presentations at 15th Annual World Congress on Heart Disease

Presentations Highlight the Company's Advances in Telemedicine

NewCardio, Inc., (OTCBB: NWCI) a cardiac diagnostic technology provider, announced today that two of its most recent medical and technical submissions have been accepted for presentation at the prestigious 15th Annual World Congress on Heart Disease to be held in Vancouver BC on July 24-27, 2010. The Company will present data from both the advanced coronary artery disease (CAD) and atrial fibrillation (AF) clinical studies, with additional information from ongoing CardioBip™ clinical studies. The data supports CardioBip's suitability for long-term monitoring of patients with CAD and AF.

The Company believes that acceptance of these submissions - which present important clinical data supporting the accuracy and effectiveness of its CardioBip product - reflects the growing interest in telemedicine and the recognition of NewCardio's technologies as effective solutions in the field. CardioBip is a unique, hand held device that gives accurate and timely diagnoses of acute cardiac events, and facilitates immediate intervention in life-threatening situations - even when the patient is far removed from a medical care center. Images of the CardioBip are available at www.newcardio.com/products-cardio-bip.php.

Branislav Vajdic, Ph.D., NewCardio's CEO, commented, "Our acceptance to the 15th Annual World Congress on Heart Disease reflects the remarkable and ongoing success of our academic medical collaborators, and our technical and scientific teams. We believe that they will provide strong technical and clinical evidence supporting the potential of CardioBip as a key telemedicine solution for monitoring patients with very serious and unfortunately common cardiac diseases. CardioBip, without any leads and wires, is patient tolerable and provides reconstructed full 12-lead ECG data. Many cardiac patients would benefit from this improved diagnostic tool and its better long-term monitoring options."

The Congress will provide the opportunity for a comprehensive overview of the latest research developments in cardiovascular medicine, primarily in the areas of molecular biology, coronary artery disease, heart failure, cardiac arrhythmias and cardiac surgery.

... (weiter siehe LINK!)

29.07.2010 18:16
http://www.finanznachrichten.de/...trategic-relationships-and-008.htm

NewCardio Announces New $1.5 Million Line of Credit with Existing Shareholders / Strengthens Company's Position for Strategic Relationships and Facilitates Ongoing Commercialization of QTinno

SANTA CLARA, Calif., July 29 /PRNewswire-FirstCall/ -- NewCardio, Inc., (BULLETIN BOARD: NWCI) a cardiac diagnostic technology provider, today announced that it has entered into a new line of credit with three of its existing shareholders, one of which is represented on the Board of Directors, to strengthen its financial position. This will allow the company further time to fully commercialize its lead solution, QTinno(TM).

In conjunction with signing this credit line, the company withdrew the S-1 registration statement, previously filed with the Securities and Exchange Commission (SEC) as it does not currently intend to pursue the public offering. Management believes that the company has sufficient operating capital to sustain its operations and fund its business plan at this time.

The credit facility is part of a series of steps designed to improve the company's ability to identify and attract potential strategic relationships and/or investors, which is intended to enable the company to maximize the value to be derived through continued development of its 3D platform technology.

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