New Japanese MTWA trial results offer SCA prevention hope
November 19, 2009
This week at the annual Scientific Sessions of the American Heart Association (AHA) , the renowned Framingham Heart Study released the alarming findings that one in eight males and one in 24 females in the US who reach the age of 40 are likely to die of sudden cardiac arrest (SCA).
According to the AHA, 12 M Americans are at risk of SCA–and every year, some 350 thousand US individuals die of SCA, making SCA one of this nation’s leading killers.
But—there is hope. Also at the AHA, a Japanese research team released clinical trial results reaffirming that a non-invasive treadmill test developed by Cambridge Heart, Inc., of Tewksbury MA, can effectively predict the risk of sudden cardiac arrest for many cardiac patients—and can quite accurately which patients are NOT at risk. (Disclosure; I’m paid to help Cambridge Heart with media relations).
The test, called MTWA (Microvolt T-wave Alternans) measures a tiny heartbeat irregularity believed to cause SCA. Administered on a treadmill like a stress test, the MTWA test helps doctors assess whether riskier, more costly invasive testing is needed. While studies show that MTWA is often as accurate as invasive testing in predicting SCA, invasive (and potentially risky) electrophysiology tests are still generally used to determine whether cardiac defribrillators—which shock stopped hearts back into action- should be implanted.
The newly reported study, which enrolled 458 patients in 38 medical centers in Japan, was called “ PREVENT-SCD” (PRospective EValuation of VENtricular Tachyarrhythmic Events and Sudden Cardiac Death in Patients with Left Ventricular Dysfunction It included patients with cardiomyopathy and ejection fraction of 40% or lower. In the study, 280 patients underwent non-invasive MTWA testing using the analytic spectral method and were followed for up to three years.
At a median follow-up time of 36 months, patients with an abnormal MTWA test were 4.4 times more likely to experience a life-threatening arrhythmia or SCD than those with a normal test, the researchers found. The 3-year negative predictive value was reported to be 97.0%, indicating that patients with a normal or negative MTWA test are at low risk for experiencing sudden death.
According to lead author Satoshi Shizuta, MD, of Kyoto University Hospital, Kyoto, Japan, “MTWA has a very high negative predictive value for lethal arrhythmias in this population He noted that these patients are at very low risk for SCD in the next three years.
According to Dr. Ali Haghighi-Mood, President and Chief Executive Officer of Cambridge Heart, “The PREVENT-SCD trial further confirms the results of several previously published studies of MTWA in patients with left ventricular dysfunction…The value of MTWA as an accurate predictor of sudden cardiac arrest in this population has become very well established.”
The Japanese trial was not funded by Cambridge Heart, nor was Cambridge Heart aware of the results before they were announced at AHA.
However, the Japanese announcement follows close on the heels of a joint announcement last week by Cambridge Heart and Cardiac Science, a Washington State stress test manufacturer, that the two companies will collaborate on developing a “super stress test” that will include an MTWA testing component.
More information about the Japanese trial is available on Cambridge Heart’s Web site at <http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.cambridgeheart.com%2Fcontent%2FShared%2FFAQ.shtml&esheet=6103292&lan=en_US&anchor=MTWA&index=1&md5=a98add7e8a88beb9b2b0e62edffa32f7> ) . The Web site (www.cambridgeheart.com) also offers information about SCA, other studies of MTWA, and the MTWA test itself. The test is reimbursable by Medicare and many private insurers.
—Anita M. Harris
HarrisComBlog is a publication of the Harris Communications Group of Cambridge MA. We also publish the New Cambridge Observer.
Scientia Advisors of Cambridge, MA, and Palo Alto, CA, has found that while HIT’s share of the $1 trillion healthcare products market by will grow by 25% through 2013, some segments will do better than others as a result of government incentives and regulations and a changing healthcare marketplace, worldwide.
Based on an industry review released today, Scientia, which is my client, says that in order to remain competitive, companies must factor in government incentives, new clinical decision-making and electronic health record requirements, as well as emerging competitors and markets in Asia and elsewhere in the developing world.
“Historically, therapeutics and medical devices have captured more than 90 per cent of worldwide healthcare product sales,” said Harry Glorikian, Scientia Advisors’ managing partner.
“But with declining marginal benefits from new interventional products and greater emphasis on appropriate use of existing interventions, we project accelerating HIT-related sales.” By 2013, indications are that HIT sales will grow from four per cent of the worldwide health care products market to five per cent—representing a 25% increase in HIT’s market share.
The review assessed HIT’s likely impact on “front” and “back office systems,” clinical testing, diagnostics , and pharmacies; how government mandates in North American, Germany, Norway, the UK, China and Australia will affect worldwide HIT opportunity– including a 25% CAGR in China; how the US stimulus bill will impact electronic health records, clinical decision support systems and the adoption of HIT by hospitals of various sizes; and the consequences of CDSS for healthcare market participants.
The review, funded by Scientia itself, was based on extensive primary and secondary research and proprietary analytic methods. It’s available for download from Scientia’s Web site at www.scientiaadv.com.
HarrisComBlog is a publication of the Harris Communications Group of Cambridge, MA. We also publish New Cambridge Observer.
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Despite Recession, Cosmeceutical Market Grows at Rapid Clip
November 6, 2009
In bad economic times, cosmetics ordinarily do fine–because, experts say, women are likely to buy small things, like lipstick, instead of big ticket items–to make themselves feel happier. So I was interested to read in today’s Wall Street Journal that Loreal is planning to offer lower priced items–following a 7 per cent decline in profits, this year.
But there is a bright spot. My client, Scientia Advisors, released a study this week showing that the global market for cosmeceuticals (cosmetics offering health benefits) is growing nearly twice as fast as the overall cosmetics and toiletries market.
Scientia found that in order to sustain such rapid growth, manufacturers and brand owners must fill a relentless demand for new ingredient concepts in a context of changing government regulations, market dynamics and cultural trends.
Cosmeceuticals are personal care products that go beyond cosmetics by providing an added health benefit –such as UV skin protection, wrinkle or acne reduction, or hair or skin moisturizing—but do not claim a therapeutic effect. Cosmeceuticals are also known as biofunctional materials, dermaceuticals, functional cosmetics, performance cosmetics, active cosmetics, and dermocosmetics.
For more info you can download the study from Scientia’s Web site at www.scientiaadv.com.
–Anita Harris
HarrisComBlog is a publication of the Harris Communications Group of Cambridge, MA. We also publish the New Cambridge Observer.
Drug Deliv Device Co’s Need New Strategies
October 28, 2009
This morning, my client Scientia Advisors released a global market review of the parenteral drug delivery device market–that is, devices that penetrate the skin to get medication into the bloodstream or specific tissue.
The main message is that companies will need to rethink their strategies as new therapies and decentralization, in which patients manage their own care, become more prevalent.
The study reviewed the growing market for parenteral technologies such as infusion, injection, catheters and implants that penetrate patients’ skin so that medication can be released into the bloodstream or local tissue.
Based on intensive primary and secondary research and proprietary analytic techniques, Scientia projects market growth of 7%, from $11.8B in 2007 to 16.7B in 2012. Growth in the parenteral market will be driven primarily by the increasing use of biological drugs such as insulin and monoclonal antibodies, which must be delivered through the skin. (If taken orally, they are digested by the gut and rendered ineffective).
While established markets (hospitals, clinics, laboratories, ambulances and the like) are sizable, the segment’s greatest growth will come as individual consumers increasingly manage chronic diseases—such as diabetes—on their own.
Companies would do well to focus on unmet needs for absolute sterility in the production and testing processes, on new formulations for pain-free injections, and on needle-free systems.
The review is available for download from Scientia’s Web site at www.scientiaadv.com.
Scientia Advisors, based in Cambridge, MA and Palo Alto, CA, is a global management consulting firm specializing in growth strategies for health care and the life sciences.
Blog.harriscom.com is published by the Harris Communications Group, a marketing communications and public relations firm in Cambridge, MA. We also publish the New Cambridge Observer.
Scientia Advisors Review: Life Science Tools industry
October 21, 2009
Scientia Advisors, my client, today released a comprehensive review of the Life Science Tools Industry.
Among the key points:
- It’s a complex arena, likely to remain largely in the US for the next few years, despite intense growth in the Asia-Pacific Region.
- The industry is fragmented despite dominance by just a handful of companies. Leading companies face competition as smaller companies consolidate.
- Scientia projects combined annual growth of eight per cent through 2012 and beyond.
- Growth is expected for cell-based assays and cell-isolation technologies; live cell analysis; cell-based assays for drug discovery research and development; kinases, RNAI and biomarker research, and cell preparation and manipulation.
The review is available for download from Scientia’s Web site at www.scientiaadv.com.
–Anita M. Harris
HarrisComBlog is a publication of the Harris Communications Group of Cambridge, MA. We also publish New Cambridge Observer.
My client, Scientia Advisors, says that diabetes care is undergoing a paradigm shift in which insulin is being prescribed earlier, for more conditions, in order to delay the onset of full-blown disease. In a study released today, the global management consulting firm finds that as more drugs go generic, companies offering newer, more expensive drugs will face resistance in markets most constrained by economics.
Harry Glorikian, Scientia Advisors’ managing partner, said: “While there are exciting developments in the non-insulin oral drug categories, the makers of these newer medications would be wise to stay attuned to how to best position their products—especially when marketing in emerging economies, which are extremely sensitive to costs.”
Scientia Advisors is a global management consulting firm specializing in growth strategies for major and emerging companies.
Glorikian said: “We expect that as more drugs become available in generic form, incretin mimetics (which increase insulin secretion) and insulins will generate an increasing share of the revenues. Therapies with benefits beyond glucose management (such as delaying the onset of diabetes or treating co-morbid conditions) will be used earlier in treatment. For a variety of reasons, “
The study outlines basic scientific facts about diabetes, diabetes markets in different parts of the world, and mechanisms of action for various diabetes medications.
It predicts growth and revenue share for individual drugs and describes the ways in which “players” and a changing treatment paradigm are affected by traditional, emerging and future drugs and technologies. The study also analyzes how alternative delivery methods (needle-free injection; intranasal, inhaled, dermal, buccal, rectal and new oral methods) will impact insulin usage.
The study, funded by Scientia itself, is based on extensive primary and secondary research and proprietary analytic methods. It’s available for download from Scientia’s Web site at www.scientiaadv.com.
—Anita M. Harris
HarrisComBlog is a publication of the Harris Communications Group of Cambridge, MA. We also publish New Cambridge Observer.
Scientia Advisors: New dynamic priming vaccine market growth
October 6, 2009
My client, Scientia Advisors, has posted a new study of the changing vaccine market dynamics on its Website at www.scientiaadv.com.
Through in-depth primary and secondary research, Scientia found that technological breakthroughs, national immunization programs and emerging vaccines for treating, rather than preventing, disease are priming the global vaccine market for growth–and that novel vaccine design and delivery methods are changing vaccine industry dynamics.
According to Scientia Managing Partner Harry Glorikian, “Large pharmaceutical companies, which today dominate 90 per cent of the current market, should expect increased competition as more small biotechnology companies enter the global marketplace.
“Vaccine-related companies of every size must understand varying government and global policies, price-setting, and manufacturing standards and should be prepared for sensitive economies of scale.”
The study describes the players and prospects for a variety of prophylactic and therapeutic vaccines; the status of global initiatives to develop vaccines to combat the world’s deadliest diseases; and regulatory and reimbursement trends in North and South America, Europe and Asia.
It’s available for download from Scientia’s Web site at www.scientiaadv.com.
Scientia Advisors, based in Cambridge, MA, and Palo Alto, CA, is a global management consulting firm specializing in growth strategies for major and emerging companies in health care and the life sciences, worldwide.
Anita M. Harris
President, Harris Communications Group
Cambridge, MA
HarrisComBlog is a publication of the Harris Communications Group of Cambridge, MA. We also public New Cambridge Observer.
