An article from Sunday's (Minneapolis-St.Paul) Star Tribune
Youngblood: With FDA approval, CVProfilor starts marketing to physicians.
Dick Youngblood / Star Tribune
As he was examining heart-attack victims more than 25 years ago, Dr. Jay Cohn got to pondering the meaning of the changes he saw in the blood-pressure waveforms that showed up on bedside monitors as treatment progressed.
Curious about whether the changes offered clinically useful information about a patient's cardiovascular condition, the prominent University of Minnesota cardiologist sought assistance in interpreting them from biomedical engineering professor Stanley Finkelstein.
The data turned out to be significant, indeed. Together the two university professors linked the waveform changes to the comparative elasticity of the arteries and developed a methodology for measuring it.
The result is a non-invasive screening system that its developers say can identify premature hardening of the arteries and thereby warn of potential cardiovascular disease long before it shows up via conventional screening methods.
"Blockages are a very late manifestation of [arterial] disease," Cohn wrote recently in Minnesota Physician, a medical business publication. Thus, his research offers the opportunity to "identify changes [in artery elasticity] before the blockages occur" so that appropriate preventive therapy can be applied early, wrote Cohn, the former head of the university's cardiovascular division.
It has taken a dozen years and nearly $16 million in private and public financing, however, to translate Cohn's and Finkelstein's methodology into a hardware and software package that met federal regulatory requirements for sale to physicians across the United States.
That hurdle was cleared late last year, when Hypertension Diagnostics Inc., the Eagan company Cohn and Finkelstein started in 1988 with several others, received Food & Drug Administration approval to market its CVProfilor to physicians in this country.
Research trials
The device, which resembles a small computer monitor with a blood-pressure cuff attached, went on sale overseas early in 1999 and has been marketed for research purposes in the United States since late last year.
The system has been incorporated by several pharmaceutical companies into clinical research trials of cardiovascular disease medications, including those of Pfizer, Parke-Davis and AstraZeneca. The National Institutes of Health also selected the system recently for use in a 10-year study of heart disease and stroke risk factors.
These overseas and research sales totaled $381,000 in fiscal 1999 ended June 30, rose to $423,000 in fiscal 2000 and are expected to reach $1.5 million in the current fiscal year, Hypertension Diagnostics President Greg Guettler said. He declined to speculate about potential sales of the CVProfilor to physicians in this country, however.
Nonetheless, the performance of the company's thinly held stock (symbol: HDII) during the past year's turmoil on Wall Street would indicate that there's a cadre of true believers out there. Despite the decline in the overall market, HDII has been trading between $5 and $7 a share in the past two months, well above the low of $2.37? in January 2000 and about $1 to $2 ahead of its initial offering price late in 1998.
Veteran securities analyst Ernest Andberg of Miller, Johnson, Steichen and Kinnard is one who believes in the technology, but still has chosen to take a wait-and-see approach to the stock.
"Cohn is a world-renowned cardiologist, but that doesn't guarantee [the company] will be able to get the market to understand and accept the technology," Andberg said.
'Big-win' potential'
Nevertheless, "if they can gain that acceptance, the result could be a significant business and a big-win stock," he said.
Guettler, a veteran of 20 years in the sales and marketing of medical devices hereabouts, hopes to defuse potential resistance to a new and expensive technology by leasing the systems to physicians at "an affordable cost" of $45 per use. The machines will be monitored by Hypertension Diagnostics' central data system, which also will generate invoices and store screening results.
At $45 per use, "if a machine were used just once a day, it would return more than $11,000 a year," Guettler said. And thanks to a substantial pile of capital left from the $10.7 million public offering two years ago, the company has upwards of 400 machines in inventory.
The growth beyond those systems will depend on market acceptance "and our ability to raise capital to fund the lease program," Guettler said.
Although Cohn and Finkelstein developed the methodology, the CVProfiler was designed under the critical eye of Charles Chesney, a biomedical research consultant who was one of Hypertension Diagnostics' co-founders and served as its president during the lean years.
Starting in the basement of his home, Chesney spent eight years conducting clinical research. Then, with $2.7 million in hand from a private offering, he relinquished the president's title in 1986, became the company's chief technical officer and went to work on developing a product.
The CVProfiler is not alone in the race to sell the medical community on a non-invasive means of screening for cardiovascular disease. But Guettler claims that Hypertension Diagnostics' system not only is more accurate and consistent, but the only one able to gauge the elasticity of both large and small arteries.
-- Dick Youngblood can be contacted at yblood@startribune.com, or by voice mail at 612-673-4439 or fax at 612-673-7122.
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