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Non-invasive test predicts risk of sudden cardiac arrest

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"

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

Obama-hope poster

Obama-hope poster

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

Hatry photo, Menard Gallery Heads and Tales

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

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 Communications Group of Cambridge, MA.




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

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.




Fairey bruhaha enhances coffers–especially lawyers'.

After spending Friday night in jail,  today,  street artist Shepard Fairey was arraigned today in Boston for allegedly  pasting “Andre The Giant” graffiti near an entrance to the Massachusetts Turnpike and the Boston University bridge across the Charles River–nine years ago.   Fairey also countersued the Associated Press–who  sued him last week   for basing his now famous Obama “Hope” poster on a copyrighted  AP photograph.

Having seen the poster at Fairey’s opening at the Institute of Contemporary Art last week, I agree with him that the poster significantly transformed the photo (actually, I think, improved it and turned it into art)  and, thus, does not violate copyright law.  What’s more, Fairey has not sold the work–and, while he might have enhanced (and now harmed) his reputation by distributing it for free, he did not directly use it for financial gain.

The “tagging” of public places and ensuing  arrests are part and parcel of Fairey’s art.   He  and his work present a provocative and humorous challenge to authority; the bruhaha  publicizes Fairey’s image and images,  delights upstarts, and, I suppose, infuriates the powers that be. It also  promises to enlarge the coffers of Fairey,of the ICA (whose director,  Jill Medvedow recently sent out an email of support on Fairey’s behalf)  and, especially, of the lawyers.

Still,  with the world  going to rack and ruin, it’s nice to know that some people are making money– and  fun to have a new set of old issues to focus on.

AMH

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




Review: Shepard Fairey Restrospective, ICA Boston

Shepard Fairey and poster

Shepard Fairey and poster

Kudos to Boston’s Institute for Contemporary Art for mounting a spectacular 20-year restrospective of Shepard Fairey’s work–which opened for members on Feb. 4, 2009.

Entitled  “Supply and Demand,”  the show, which runs through August 16, 2009,  includes some 200 stickers, posters, portraits, and murals, including the now iconic Barack Obama “Hope” poster which has found its way all over the world.

The show  traces Fairy’s work  to the 1980s when, as a teenager in Charleston, South Carolina, he was attracted to counter-cultures like skateboarding and punk rock–and their stickers–and began making his own.

As a student at the Rhode Island School of Design in 1988,  Fairey instructed a friend in making a paper cut stencil using an image of Andre the Giant, who a popular figure in the World Wrestling Federation, am  ICA handout explains.  The two then paired the face with the phrase “Andre the Giant has a posse,”  and over the next six years, produced more than a million hand-printed and cut stickers, which Fairey sent to friends who posted them all over the US.

(On a huge campaign billboard, he also used one to cover the face of then-Providence mayor Buddy Cianci, who says sheepishly in an accompanying video that this disturbed him because it was defacing property. It’s all the funnier in hindsight, knowing that Cianci was later jailed on corruption charges).

Toward the end of the 1990s,  Fairey started to challenge what the ICA calls the “corporate advertising machine…He asks  us to consider whether the so-called ‘public space’ is really public.

“Most advertising takes an ‘in your face’ approach to sell or influence consumers. Fairey’s Obey giant campaign–which features the word “obey” and other slogans [on a variety of images ]sells nothing but its mysterious imagery, ambiguity and underground appeal  has made passers-by worldwide question the visual noise that crowds our streets”–as well as the insidious advertising messages used to command us.

One large room features portraits–some of which  incorporate the “obey” command.  One print portrays George W. Bush as a vampire, with blood running out of his mouth.  Other portraits feature musicians, guerilla leaders, gang members,  Muslim women, and additional political leaders.

A highlight is  Fairey’s iconic “Hope” portrait of Barack Obama, which “has spread like a virus on TV, in print and online, on t-shirts and buttons, and guerilla-style on streets all over the globe.”

The poster seems particularly poignant with Obama, now in his third week as President,   facing not only a terrible economic situation and two wars, but also the disintegration of a seemingly promising leadership team whose members betrayed him and us for personal greed.

The exhibit, co-curated by guest curator Pedro Alonzo and Emily Moore Bouillet, former assistant curator at the ICA, and sponsored by Levi-Strauss culminates with a set of four stunning, intricately designed,  murals.

Commissioned by the ICA, the murals, along with  the other components and the exhibit as a whole  are inspirational.

Not only do they each  convey provocative messages about individuals’ relationship to power and commerce,  but they  embody and communicate  an individual’s ability to  follow his creative instincts and passion to achieve artistic and, ironically,  commercial success.

*

Having arrived on time for the opening, I didn’t have to wait in line–but in a lovely wine reception on the second floor, was told that people who  got there early had to stand outside in the cold until the official opening time. in leaving, at around 8 PM, I had to cut around long, winding lines of people in the lobby who were waiting to sign in.

My only beef  was the lack of beef…the wine was fine, but my companion, Mark H. and I would have appreciated a few chips to go along with it.  Next time, I’ll definitely arrive on time–and eat before I go.

AMH

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