You have to know “when to hold 'em and when to fold 'em,“ the song advises, and Synovis Life Technologies (St. Paul, Minnesota) has decided to fold – at least for now – its clinical study of PSD-Veritas, a material used as a buttress in conjunction with colorectal surgeries.

The company reported Friday that it was closing down what Karen Larson, its president and CEO, termed a “marketing study“ of the product after spending $250,000 thus far on its development. The move avoids having to spend up to another $3.2 million or more in projected development costs through 2007, according to company estimates.

Synovis said that study researchers had reported, at mid-March, 11 adverse events in 85 surgical procedures – and two deaths, but both in the control, or non-buttress, group. But Larson was emphatic in saying that the key troubling issue was not one of safety but rather the inability to clearly interpret a group of complicated results from the procedures.

“We couldn't come up with objective information,“ Larson said, in summarizing the main difficulty of the trial.

PSD-Veritas is a product made from bovine tissue that Larson said is placed on a type of circular stapler used in bowel surgery related to cancer treatment. The buttress is intended to improve the surgical outcomes, for instance, in preventing leaks, she said.

She said there had been “a variety of complications“ but declined to detail the various adverse events in this case, given the complexities of the procedures and the advanced illness of many of the patients.

While the product has been FDA-approved, Larson said that the company has not attempted to sell it and the study was primarily a “marketing evaluation.“

She said she was unsure as to the next step for the product, adding: “We'll find some way to collect more objective data.“ And she promised that the company will follow the patients thus far enrolled “as an obligation you should meet.“

Synovis shares fell 59 cents to close at $10.02 Friday, compared to a 52-week high of $11.09.

Turning to future prospects, Larson emphasized for the company “a very large opportunity in bariatric surgery,“ a space the company targets with products for controlling leaks at staple lines.

She said the company has seen 62% in growth in this product, with a brightening future given recent opinions by the Center for Medicare and Medicaid Services that the service is safe for older people, as well as the possibility of new approvals for reimbursement.

For year 2005 the company reported net income of $189,000, on $16.8 million in revenue, vs. no net income for the previous year on $14.6 million in revenue.

In another report that does focus on safety issues, ophthalmology titan Bausch & Lomb (B&L; Rochester, New York) on Friday issued a statement commenting on reports from Asia concerning “an unusual incidence of fungal keratitis among contact lens wearers,“ using lenses from a variety of manufacturers.

The company said that in February that there had been reports of an outbreak of the Fusarium keratitis in Singapore and Hong Kong – where it is a leading supplier of its ReNu multi-purpose solutions – but no demonstrated connection with its product.

However, the company said it had suspended sales of ReNu in these regions while an investigation is ongoing and that it is collaborating with authorities around the world, including the Center for Disease Control and Prevention, to track down the cause of the infections.

In reporting the problem, B&L suggested that it may be related primarily to poor care and cleaning of lenses, and it warned against use of unregulated lenses and “knock-off“ products.