Vaso Active Bends Truth About Clinical Trial

Its Web site says the study occurred at a Boston medical center. It didn't.
Publish date:

Updated from 8:49 a.m. EST

Shares of

Vaso Active Pharmaceuticals


were under pressure Wednesday after

reported on an apparent misrepresentation in its promotional literature.

The shares were recently trading for $9.27, down $2.19, or 19%, on the Instinet premarket session. Shares of the tiny medical company had been up 545% since its December IPO.

The latest mystery involves the foot cream, Termin8, that Vaso Active claims is a "remarkably effective cure" for athlete's foot. On the

company's Web site, Vaso Active states: "In a clinical trial conducted at the New England Medical Center, in Boston, MA, 100% of the study subjects given TERMIN8 were cured within 10 days."

Vaso Active has pointed to the clinical trial as evidence that Termin8 and the company's "revolutionary" transdermal technology for delivering medicine through the skin will help it become a big player in the over-the-counter drug market.

Those claims are one of the reasons why shares of Vaso Active, a tiny company with just seven employees and few sales, have skyrocketed.

Trouble is, the New England Medical Center, which is affiliated with Tufts University, didn't actually do the nearly six-year-old study.

All New England Medical Center did was analyze the statistical information gathered by Vaso Active's parent company, BioChemics Inc. -- something the center does all the time for paying customers. The medical center employee who analyzed the statistics said she can't draw any conclusions about the effectiveness of the product, since she had no hand in selecting the patients and gathering the evidence.

Robin Ruthazer, the medical center employee who reviewed the statistics, said she wouldn't refer to the study as one produced by the medical center. "We just analyzed the data. It's not anything special," she said.

In fact, the person who supervised the study was a podiatrist hand-picked by BioChemics.

Even John Masiz, Vaso Active's president and CEO, acknowledges as much when asked about the company's claim. "We approached a podiatrist to conduct the research for us," he said.

In a press release issued after

reported on the trial, Vaso Active said the story contained "inaccuracies" when it "questions the validity of the clinical study" and "the intentions of the company upon reporting the findings."

"Biochemics and Vaso Active Pharmaceuticals, the company responsible for marketing Termin8, are pleased to stand behind the data and the statements made by the management team in the company's recent IPO prospectus document," the statement read.

Vaso Active, a Danvers, Mass.-based company, is more clear about the independence of the study in the prospectus for its December initial public offering. But the details reveal that it wasn't much of a study at all. The prospectus says the study involved "20 severely infected athlete's foot patients," who were "supervised by independent physicians and analyzed by the New England Medical Center."

The study, according to the IPO document, compared Vaso Active's product to



Tinactin, both of which use the antifungal agent Tolnaftate. All of the patients using deFeet, now called Termin8, allegedly had their infections "eliminated" in 10 days. Meanwhile, Vaso Active claims, it took 42 days for Tinactin to "cure its first patient."

This is not the first time Vaso Active has found itself answering questions about Termin8, a product that BioChemics had little success selling for many years.

Last week, an investigator with the

Securities and Exchange Commission

called a Bronx, N.Y., podiatrist, inquiring about an endorsement a medical association gave to the footcare product.

The SEC made the call after Dr. David Z. Ascher told a reporter for


that he did not recall the American Association of Medical Foot Specialists ever endorsing Termin8. But in a subsequent interview with the

, Ascher said he was confused when he talked to a


reporter because Termin8 used to be called deFeet.

Ascher is the president of the little-known association, which used to be headquartered in a New York City hotel but now appears to be run out of Ascher's medical office. Ascher won't say how many members belong to the association. Ascher said the association was standing behind its endorsement, but he wanted Vaso Active to make a donation to an association scholarship program.

Meanwhile, the SEC, according to sources, is continuing to scrutinize other claims Vaso Active has made. An SEC attorney who is investigating Vaso Active could not be reached for comment.

One claim that reportedly is getting looked at is a repeated comment by Masiz that the company's stock is drawing the interest of institutional investors.

Masiz, in a Feb. 19 press release, said a major rationale for the company's 3-for-1 stock split was the "significant demand for our common stock at the institutional level." Masiz made a similar comment about growing institutional interest in shares of Vaso Active after speaking at an investment conference in Italy in November, one month before the company's IPO.

The earliest investors will be able to see for themselves which institutions are investing in Vaso Active won't be until some time in April. That's the period when big investors must declare their quarterly stock holdings.

But Vaso Active is not the kind of stock to which big institutions normally flock.

For starters, the company is small, has no profits and has sales under $100,000 a year. Termin8 isn't even on store shelves right now and may not be until this summer. It can only be purchased online at the company's Web site for $19.99.

The company also has no Wall Street analysts following it and few shares available to the public. Even after the stock splits, Vaso Active has just 10 million shares outstanding, of which more than half are owned by corporate insiders.