Non-invasive test predicts risk of sudden cardiac arrest

A meta-analysis and four additional studies published in the March 2009 Heart Rhythm journal show clearly that Cambridge Heart’s non-invasive MTWA test can accurately predicts the risk of sudden cardiac arrest–the leading killer in the US.

I’m helping Cambridge Heart and Kogs Communications get out the good news that the company’s non-invasive test, which is administered much like a stress test, on a treadmill, accurately predicts the risk of sudden cardiac arrest–the leading killer in the US.

Here’s today’s release:

Tewksbury, Mass., March 3, 2009 – Cambridge Heart, Inc. (OTCBB-CAMH), today announced the publication of five articles supporting the use of Microvolt T Wave Alternans™ (MTWA) testing in a supplement to the March issue of the Heart Rhythm journal. Featured in the supplement is a comprehensive meta-analysis of 6,000 patients confirming the value of MTWA as a non-invasive marker of risk for sudden cardiac arrest (SCA).

The MTWA test, administered much like a stress test on a treadmill, was developed by Cambridge Heart as a diagnostic tool to help physicians determine a patient’s risk of sudden cardiac arrest — the leading cause of death in the United States.

The meta-analysis, conducted by a group led by Stefan Hohnloser, MD, FHRS, of the JW Goethe University Division of Cardiology in Frankfurt, Germany, assessed 13 MTWA clinical studies involving approximately 6,000 cardiac patients.

“The results demonstrate that MTWA testing is a consistently accurate predictor of sudden cardiac death and cardiac arrest in patients who do not already have implantable cardiac defibrillators (ICDs),” said Dr. Stefan Hohnloser. “These are the patients for whom MTWA testing is intended.”

The meta-analysis authors also conclude that:

· Patients who test negative for MTWA abnormalities are at extremely low risk (0.3%) for SCA in the next 12 months.

· MTWA testing can help doctors guide ICD therapy to appropriate patients and overcome the widespread reluctance of patients and referring physicians to accept ICD therapy.

· In clinical trials, appropriate ICD shocks are an unreliable surrogate endpoint for SCA and can skew results of risk stratification studies.

“This comprehensive analysis confirms the findings of numerous peer-reviewed studies which underscore the important role of MTWA in assessing a patient’s risk of sudden cardiac arrest,” said Ali Haghighi-Mood, PhD, Chief Executive Officer of Cambridge Heart.

The Heart Rhythm supplement also includes:

· A second meta-analysis of MTWA testing in patients with non-ischemic heart disease, authored by Gaetano De Ferrari, MD and Antonio Sanzo, MD of the Department of Cardiology at Fondazione IRCCS Policlinico San Matteo, Pavia Italy. Analyzing eight available trials involving 1,450 patients, the paper indicates that in this population negative MTWA results can help patients and their physicians decide whether ICD therapy may safely be avoided.

· An article by Michael J. Mirro, MD, Medical Director of the Parkview Health System Clinical Research Center in Fort Wayne Indiana, who describes how his center has incorporated MTWA testing into clinical practice to complement other methods for identifying and educating patients about the risk of SCA.

· A review of numerous studies concerning the underlying cellular mechanisms of T-wave alternans. The authors conclude that microvolt T-wave alternans is a marker of cellular changes that make the heart susceptible to sudden cardiac arrest. The review was carried out by Michael Cutler, DO, PhD, and David S. Rosenbaum, MD, of the Heart and Vascular Research Center at the Department of Biomedical Engineering at Case Western Reserve University in Cleveland.

· A review by Navinder Sawhney, MD and Sanjiv Narayan, MD of the University of California at San Diego that underscores the value of MTWA testing in patients who have had heart attacks but do not fall within current guidelines for ICD implantation.

The articles in the supplement can be found on the Heart Rhythm journal website at:

http://www.heartrhythmjournal.com/issues/contents?issue_key=S1547-5271(09)X0006-8

About Cambridge Heart, Inc.

Cambridge Heart develops and commercializes non-invasive diagnostic tests for cardiac disease, with a focus on identifying those at risk for sudden cardiac arrest (SCA). The Company’s products incorporate proprietary Microvolt T-Wave Alternans measurement technologies including the patented Analytic Spectral Method^® and ultrasensitive disposable electrode sensors. Medicare reimburses the Analytic Spectral Method^® under its National Coverage Policy. Cambridge Heart, founded in 1990, is based in Tewksbury, MA. The company’s Microvolt T-Wave Alternans™ (MTWA) test, developed by Cambridge Heart (OTCBB: CAMH), is based on research originally conducted at the Massachusetts Institute of Technology. http://www.cambridgeheart.com.

Statements contained in this press release are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. In some cases, we use words such as “believes”, “expects”, “anticipates”, “plans”, “estimates”, “could”, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements. Factors that may cause or contribute to such differences include failure to achieve broad market acceptance of the Company’s MTWA technology, failure of our sales and marketing organization to market our products effectively, inability to hire and retain qualified clinical applications specialists in the Company’s target markets, failure to obtain or maintain adequate levels of third-party reimbursement for use of the Company’s MTWA test, customer delays in making final buying decisions, decreased demand for the Company’s products, failure to obtain funding necessary to develop or enhance our technology, adverse results in future clinical studies of our technology, failure to obtain or maintain patent protection for our technology and other factors identified in our most recent Annual Report on Form 10‑K/A under “Risk Factors”, which is on file with the SEC and available at www.EDGAR.com. In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so except as may be legally necessary, even if our estimates should change.

The New Cambridge Observer is a publication of the Harris Communications Group of Cambridge, MA.

Scientia Advisors launches life science "knowledge network"

ScientiaNET, Scientia Advisors’ new knowledge network, now 10 thousand strong, is accepting new member/experts and clients for life science consultation, surveys, and opinions.

I’m pleased to announce that Scientia Advisors has launched ScientiaNET, a “knowledge network” for health care and the life sciences. ( True, they are my client, but I AM pleased).

The network now has 10 thousand member/experts and is seeking additional ones. Members are leading scientists, physicians, practitioners, academics and industry professionals who are paid their hourly rates to provide Scientia and its clients with analyses, opinions, surveys and consultation on life science tools and technologies, medical devices, diagnostics, biotechnology, pharmaceuticals, functional foods, and regulatory issues.

The member/experts typically consult with business leaders and decision-makers on industry trends and developments, operational problems/solutions, or specific products/services.

If you’d like to become a ScientiaNET member or engage one (or many) please visit www.scientiaadv.com.

AMH

Scientia Advisors, based in Cambridge, MA and Palo Alto, CA, is a global management consulting firm specializing in strategic growth and operational strategies for major and emerging companies in health care and the life sciences.

New Cambridge Observer is a publication of the Harris Communications Group of Cambridge, MA.

Shepard Fairey Revisited Again

On closer inspection, it becomes clear that Fairey has greatly transformed the photo, which he uses in a provocative interchange with the colors, images, slogans, stencils, newspaper clippings and other elements typical of (and original to) his work.

Yesterday, I returned to the Shepard Fairey Exhibit at the ICA–this time, with visitors from out of town.

We were impressed with how prolific Fairey has been, with the precision and beauty of his images, and with his complex, ironic juxtaposition of past and present. (His backgrounds include a lot of old newspaper clippings and many references to art forms of the past).

In one work, Fairey selectively uses and amplifies portions of the American dollar bill–included an eye, which I’d never noticed until Jessie pointed it out; a man carrying a briefcase of money in one hand and flowers in the otherm and a woman, probably his wife, carrying a small missile in her arms. A caption reads: “No cents.”

This time, I studied the controversial Obama “Hope” poster, which, from across a large room DOES look like a colorized version of the copyrighted Associated Press photograph on which it was based.

But on closer inspection, in this version, it becomes clear that Fairey has greatly transformed the photo, which he uses in a provocative interchange with the colors, images, slogans, stencils, newspaper clippings and other elements typical of (and original to) his work.

Black “brushstrokes” highlighting Obama’s facial features serve as a frame for those elements, which in turn, provide the color, shading and chiseled shaping of Obama’s head.

As a result, the poster becomes a figure-ground study portraying many past events, conflicts and dilemmas that brought the US to the crises with which Obama is grappling, today.

The poster’s intertwining of past and present with the Obama image bring a definite irony to the slogan “Hope.” (One of the newspaper headlines in the background reads:”Congress Blames Hoover for Having No Sense of Humor).

Donna pointed out that the portrait is yet another example of Fairey’s overriding message: how the slogans, art and icons of advertising are used to move us to obey–whether the order be “buy”, “peace”, “shoot” or “hope.”

Fairey employs the same techniques for his portraits of Martin Luther King and other political leaders, musicians, artists and even one of a Campbell’s soup can– referencing and repeating the work of Andy Warhol, whose photography-based work, like Fairey’s, used advertising’s methods to comment on and exhibit the medium’s power.

Regarding Fairey’s recent arrest for illegally postering public property: Nancy (who happens to be a judge) and I wondered what controversy would arise if his work were posted as paid-for advertising–to sell what some might view as subversive, anti-establishment or propagandist ideas.

She later commented “Fairey seeks to reframe the constitutional debate so that artistic expression/speech is favored over commercial speech/intellectual property”.

Doree questioned whether Fairey’s work is political commentary or art. I’d have to say: it’s both.

Comments welcome!

AMH

New Cambridge Observer is a publication of the Harris Communications Group of Cambridge, MA.

Heads and Tales Review

If Heide Hatry’s provocative photographic show—Heads and Tales–at the Peirre Menard Gallery, (10 Arrow St. in Cambridge) is meant to shock: it does.

Hatry photo, Menard Gallery Heads and Tales

If Heide Hatry’s provocative photographic show—Heads and Tales–at the Peirre Menard Gallery, (10 Arrow St. in Cambridge) is meant to shock: it does. In fact, for a few moments, it made me fear for the mental health of the artist, who has (beautifully–even lovingly) photographed her sculptures portraying female victims of violent death.

Hatry, who grew up in Germany and moved to New York City in 2003, sculpted life-sized female mannequins from clay and covered them with untreated pigskin (a cold wet sample of which is available in the gallery with the notice: “please touch”). She added raw meat for the lips and fresh pig eyes—and in some cases, flies, safety pins, and other props—creating, according to the gallery writeup, “the illusion of life where there is none”.

Hatry then photographed the mannequins—some enlarged to 20”x 30”, others more life-size, at 12” x 18”.

Viewed from afar, the photographs appear lifelike, but close up, you realize the subjects are constructs—adding physical and intellectual layers to the artist’s statements on the horrifying situations faced by many women—and on photography’s role in bringing the inanimate to life.

Hatry’s “views” are further emphasized by accompanying tales about the “women’s” lives (and deaths) as imagined by 27 writers—some of them well known feminists.

The show is well-conceived and displayed, which makes its subject matter all the more disturbing.

The exhibit, which opened Feb 13, 2009, will run through March 15. It corresponds with the release of Hatry’s book, Heads and Tales, and with readings, book signings and the premiere of a play.

AMH

New Cambridge Observer is a publication of the Harris Communications Group of Cambridge, MA.

No Valentine for Microsoft

Much as I appreciated the companionship on Valentine’s night, the relationship is just not working out. It’s hard to break up with Microsoft…but, clearly, it’s something I have to do.

On Valentine’s night, I spent two hours chatting with one of my new tech support friends, in India. Eventually, he determined that the huge icons on my desktop were not caused by a previously diagnosed corrupted user account or Vista–that my computer—a bad hard drive–was to blame.

The next morning, Walt, from a list serve I subscribe to, suggested a two-click fix.

If you need to create PDF files, you can try PDFCreator — open source and free. Much cheaper than Adobe Pro 9. In fact, the only real good reason to get Adobe Acrobat Pro anymore is if you want to use their review, annotation, and editing tools. For PDF creation, PDFCreator works great, and evidently FoxIt is the better reader.

If your icons are large because of a setting, then try the following — http://www.mydigitallife.info/2007/12/09/how-to-resize-and-change-vista-desktop-icons-size/

Both solutions worked.

Later, my Indian tech support friend emailed to tell me that he was glad to have resolved my issue, was closing the case, and that it was a pleasure serving me.(Having previously spent 64 hours trying to resolve MS issues, I was remarkably patient, it I do say so myself).

Still, much as I appreciated the companionship on Valentine’s night, I’m afraid the relationship just isn’t working out. It’s not easy to break up with Microsoft…but, clearly, that’s something I need to do.

Comments (and lawyers!) welcome!

AMH

New Cambridge Observer is a publication of the Harris Communication s Group of Cambridge, MA.

Free Vista, Comcast help: you get what you pay for and a new social life

It’s not that I don’t appreciate my new social life and those late night calls from apologetic tech support professionals in India, but now that I’m in my 61st hour of a Microsoft Vista meltdown and my sixth day of a Comcast email failure, I hope that the companies will send in reinforcements or that a lawyer will start a class action lawssuit or two.

I know there’s nothing more boring than other peoples’ computer problems but now that I’m in my 61st hour of Microsoft Vista difficulties and my sixth day of being unable to use Comcast email for my business, I’m going public in hopes that Microsoft and Comcast will take note and send reinforcements–or of finding a lawyer who would like to start a class action suit or two.

If anyone is interested in either saga or has any advice, I’ll be happy to post the details (or email them–should that become a possibility). In the meantime, I look forward to continuing my newfound friendships and morning, noon and late night phone calls with the tech support communities in India, New Jersey, Nova Scotia, Boston, Newfoundland, and North Carolina . Everyone has been most gracious and sympathetic, and I do appreciate finally having a social life.

AMH
PS–Did you know that Microsoft will help with Vista issues for free? From the support web site, it looks like you have to pay $59 per call or online chat–so I wasted three months emailing back and forth with 24-hour response time. According to the site, free support is available only for Service Pack I will be available only through March 31, 2009, but at the rate my case is being resolved, it should be available for years to come. Click here for the url.

New Cambridge Observer is a publication of the Harris Communications Group of Cambridge, MA.