The Health Industry Manufacturers Association (HIMA; Washington) unveiled a new name last month. The trade association now will be called the Advanced Medical Technology Association, or AdvaMed. The organization is hoping that the changed name will give it a higher profile in the minds of legislators, insurers, and consumers, but its essential goals will remain the same, according to Pamela Bailey, president of the group representing about 800 medical technology firms.

Bailey said the association had been exploring adoption of a possible name change for the past year, and that the new name had received broad approval from the membership. A marketing organization hired by HIMA to study the issue had found that two words in the association's name – "industry" and "manufacturers" – had strong negative associations, especially for consumers. The new name, of course, also substitutes the flashier term "medical technology" for "health."

In response to questioning from reporters during a conference call, Bailey said she saw no negatives in the renaming. She didn't foresee any confusion in the minds of legislators, and said the association was planning to launch a broad publicity effort to explain the new name and its significance. That significance, she said, was in the innovations produced by the medical device/technology sectors over the past three decades. Listing various new technologies – primarily in cardiology, imaging, and minimally invasive surgery and other procedures – Bailey said that at the time the association was formed in 1974, these technologies were "probably not even imaginable." She added, "These dramatic advances in the last 26 years are the result of our fundamental commitment to improving patient care. And it has come with significant effort." Device manufacturers invest up to 13% of revenues in research and development, a figure she said was matched only by the pharmaceutical industry.

The change of name "comes at a time when AdvaMed is extremely active on behalf of our companies making technologies available to all patients, including Medicare patients," Bailey said. "It encompasses the range of our work and the range of our companies much more accurately." The name change signals no essential change in direction, but is part of the group's long-term strategic plan, she said. If anything, she sees it as part of a broad effort to gain greater recognition for the association and the industry. "It's important for us to operate in a broader arena, encompassing many stakeholders," she said.

She said that there was no special timing significance for unveiling the name change, but did foresee advantages to it coming in an election year. The Gore and Bush camps, she said, have made statements favoring innovation in medical technology. "We're very encouraged that there is a much higher level of visibility about medical technology .... both candidates are recognizing the work our companies are doing. Our major focus makes it possible for companies to bring their innovations to patients. That means focusing on public policy barriers that stand between innovation and the ability of physicians to work with patients."

German study uses Imatron scanners

Imatron (South San Francisco, California) reported the launch of a study using "modern methods for the prediction of heart attack." The Heinz Nixdorf Foundation is providing the major funding for the study, which will be led by Professor Raimund Erbel, principal investigator and chairman of the department of cardiology at the University Clinics (Essen, Germany). He will lead a multi-disciplinary team of experts from the universities of Essen, Duesseldorf, Cologne, Munich, and Witten/Herdecke.

By the end of this year, researchers will begin recruiting 4,500 men and women from a random sample of the general population in the Ruhr district of Germany. The study is focused on the direct detection of atherosclerosis as opposed to predicting the probability of atherosclerosis based on risk factors. The group said Imatron's high-performance electron beam tomography (EBT) scanners provide "a unique opportunity to directly visualize coronary atherosclerosis and will be compared against other measures of atherosclerosis in different vascular territories, namely the carotid and peripheral arteries." A number of emerging risk factors, including psychosocial and genetic factors, inflammatory and lipid markers also will be analyzed. Health economic analyses are an inherent part of the study. "This will be most important with regard to current health politics and cost restraints," the statement said.

According to Erbel, "The objective is for our team of scientists to provide recommendations in line with standard guidelines for the early recognition and treatment of coronary heart disease. The design of this study has undergone extensive review by senior scientists in both Europe and the U.S." He added that "approval for funding of the project underlines not only acknowledgment that heart disease victims will soon outnumber those from infectious diseases worldwide, but also confidence in the selection of EBT with electrocardiography, inflammatory markers and laboratory chemical measures, as the most appropriate, non-invasive, practical and accurate methods for the early detection of coronary heart disease."

Many aspects of the rationale of the study are explained in a review article authored by Erbel and colleagues in the May 2000 European Heart Journal article titled, "Electron-beam computed tomography for detection of early signs of coronary arteriosclerosis." According to the authors, only a strategy of primary risk reduction will substantially reduce cardiovascular mortality, as in-hospital treatment will only help a limited number of patients. The study describes EBT as currently the technique of choice for the assessment of calcified lesions and states that EBT is superior to intravascular ultrasound, since it is not limited to segments of the coronary artery tree that can be reached by the catheter.

$4.2M for artificial heart development ....

LDS Hospital (Salt Lake City, Utah) and MedQuest Products (also Salt Lake City) have received a four-year $4.2 million grant from the National Institutes of Health (NIH; Bethesda, Maryland) to develop total artificial heart technology. The grant is the first award to artificial heart researchers under the NIH's new Bioengineering Research Partnership program. The grant "reaffirms Utah's world leadership in the development and clinical use of artificial heart technology," said James Long, MD, director of the artificial heart program at LDS Hospital, and a grant investigator. The funds will be used to complete development of the HeartQuest, a magnetically suspended total artificial heart that has no friction-based internal parts. The HeartQuest will be 30% to 40% the size of existing total artificial hearts.

Dr. Don Olsen, president of the Utah Artificial Heart Institute and the grant's lead investigator, said that because of its unique design features, the HeartQuest "may add 10 to 20 years of quality life for hundreds of thousands of people who would otherwise die of heart failure every year."

Thus far, a design team has completed both a prototype device and the design for a clinical trial to be carried out over the next two years. The effort will receive continued funding from the LDS Hospital-Deseret Foundation's Heart & Lung Research Foundation. LDS Hospital launched the effort in April of 1995 when a team led by Long implanted a CardioWest C-70 total artificial heart in a Boise resident as a bridge to transplantation.

... and other news of new funding

EntreMed (Rockville, Maryland) said it will raise $20.58 in a public offering of 1 million shares priced at $22 per share. Proceeds, it said, will be used to develop current and future products, for working capital and for general corporate purposes. EntreMed specializes in clinical-stage research on anti-angiogenesis, or the inhibition of abnormal blood vessel growth associated with a broad range of diseases such as cancer and atherosclerosis.

Hemagen Diagnostics (Waltham, Massachusetts) completed a previously announced private placement of senior subordinated convertible notes, raising $6.3 million dollars. Proceeds were used to re-finance a $3.8 million dollar bank debt and to provide working capital, and it reduces the company's current interest rate from 13% to 8%. Hemagen also said it will close its Waltham facility and relocate portions of manufacturing to an underused facility in Columbia, Maryland. Jerry Ruyan, chairman and CEO, called the closing "a difficult but necessary decision" to streamline company operations. Hemagen makes more than 148 FDA-cleared proprietary kits for the diagnosis of autoimmune and infectious diseases and sells the Analyst clinical chemistry analyzer used to measure blood constituents in humans and animals.

InterCure (New York and Neve-Ilan, Israel), a firm that calls itself "an eCare and medical device company," reported receiving $5.4 million in new equity financing. InterCure is developing technology treating chronic diseases with interactive therapeutic devices combined with e-healthcare. The company said the new funds will be used to launch its RESPeRATE for Lower Blood Pressure program in the U.S., an effort focused on hypertension. It filed a 510(k) application for the device in February.

Repair (Boston, Massachusetts) said it raised $2 million in seed financing to develop therapies for cardiovascular diseases based on its proprietary drug delivery and angiogenesis technologies. The funds will support the development and entry into clinical trials of the company's first product, a sustained-delivery formulation of fibroblast growth factor to treat coronary artery disease. Institutional founders and investors of Repair include Maine Medical Center and Masthead Venture Partners.

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