Emerging Drug Developer: Sharklet

Fledgling Sharklet takes a cue from nature

Every day hospitals in the U.S. are engaged in a life-and-death fight against hospital-acquired infections. And for many, the primary weapons at their disposal are the disinfectants the hospital staff uses to wipe surfaces clean.

But the disinfectants don't always work. And the infections keep coming.

That unmet need has helped inspire the small staff at the fledgling Sharklet Technologies, a biotech company based in Alachua, Florida.

With only a modest amount of financial backing, the company has been developing a new surface technology that can naturally repel the bacterial invaders--including Staph a., Pseudomonas aeruginosa and E. coli--before they form durable biofilms that are easily spread by fleeting human contact. And Sharklet is claiming some significant results from the initial studies on the effectiveness of their clean approach.

"Nothing releases from our surface, which we think is the real power of it," says CEO Joe Bagan. "It's eco-friendly. We're making the world a better place, and not at the expense of the environment."

Sharklet's surface technology was developed by Dr. Anthony Brennan, who founded the company and is now chairman of the scientific advisory board. Brennan, a professor at the University of Florida in Gainesville, seized on the idea that you could create an unstable surface that required too much energy for bacteria to grow, colonize and flourish on.

"He was actually working with the Navy at the time, experimenting with a lot of topographies," says Bagan. "He was in Pearl Harbor and a marine biologist suggested that he look at the shark."

The shark was one of only a few species that move slowly in the water, but are never fouled by microorganisms in the same way as boats and other slow-moving objects.

"Everything else that moves slowly is fouled," says Bagan, "including turtles and whales and so on."

Brennan decided that the design in the shark's skin created an unstable surface that kept it clean, and believed that the same approach could work for bacteria. That led to the company's contact material, a thin sheet only two or three microns thick with an uneven surface of raised bars engineered to stop bacteria in their tracks.

"Bacteria, especially dangerous pathogens in hospitals, colonize in the form of biofilms," says Bagan. "They cannot do that on our surface. The channels in the surface design interrupt they way they signal to one another." And Bagan believes that as bacteria approach the Sharklet surface, they can sense the uninviting topography, which prevents them from moving in.

Bagan says that Sharklet's conclusions have been verified by an unnamed government agency and an independent disease lab that tried the surface and found that it repelled seven or eight pathogens.

"We are running a field trial with a hospital in California," notes Bagan. "The results will take us about five weeks to get. We believe that we will be selling hygienic surface covers this year in hospitals and medical devices will take a little longer."

Because there are no chemicals involved, Sharklet won't have to go through the FDA to get an approval to market its surface technology to hospitals. Changes in medical devices incorporating the design will have to be reviewed, and that will take longer.

Kept clean in a dry environment, he says, the surface material can remain effective against bacteria indefinitely. And even in a high-touch environment, he adds, a hospital could expect to get three months of use before needing to apply a new surface.

Right now, Sharklet has a staff of seven working out of the Sid Martin Biotechnology Incubator. And once the company starts to get busy selling its surface material, Bagan says that number is likely to grow.

In the meantime, Bagan says he's looking to find the last two million dollars to complete the three million dollars in financing he needs to go commercial.

In the biotech world, that's not a lot of money. But Bagan notes that Sharklet isn't a capital-intensive operation. And he doesn't expect it to become one.

"We don't anticipate having 500 people covering 6,000 hospitals in the U.S.," he says. "We'll eventually get to enough hospitals to start talking to companies with distribution into the hospital system." As for medical devices, he adds, manufacturers are likely to want to license the technology for use.

But the technology also has uses outside of healthcare.

It can work "wherever you don't want organism growth," says Bagan, including places like industrial inlet our outlet pipes or other marine environments such as oil rigs.

For now, though, Sharklet is focused on a market that is anxiously looking for some better way to control the spread of bacteria.

Emerging Drug Developer: Sharklet

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