Body Copy

By Hannah Wallace July 31, 2007

When Robert Cresanti met Sarasota inventor and entrepreneur Dr. Chris Sakezles in February, Sakezles shook his hand and showed him his thigh.

You can bet that’s the first time that’s ever happened to the U.S. Under Secretary of Commerce for Technology, who came to Tampa that day in February to present Sakezles with a Recognition of Excellence in Innovation award.

And it was entirely appropriate that Sakezles bring out his remarkable thigh because it’s a big part of the attention his company, Animal Replacement Technologies, has been attracting from medical device and pharmaceutical manufacturers to cosmetics companies and Hollywood movie studios.

Sakezles, 40, literally invented that thigh. It looks real and, more importantly, feels sickeningly real, right down to the fake blood coursing through its veins.

“I had discussions with a number of scientists when his nomination came up,” Cresanti says. “This technology really stuck out. It was, considering the many innovation awards we’ve given out, among the most unique. The name of the company was kind of odd. But the more I looked at the thoughtfulness, the patents and approach—and I spoke to some of my medical friends about the limitations of present animal testing models—the more interested I was.”

And, as Cresanti pointed out, it’s one thing to read about Animal Replacement Technologies’ design and manufacturing of body parts, but something else to actually hold its work in your hands. “I said to him, ‘When you visit clients, you must have a very interesting experience checking baggage at the airport,’” Cresanti says.

That’s true.

“When I go through the airport with a bunch of penis models,” Sakezles says, “it’s much more interesting. The security people pull them out and wave them around. I get a weird smile and a smirk. Then I have to explain what I do, and I’m not sure they believe me.”

Sakezles made a believer of Cresanti that day in Tampa.

“He’s obviously one of those people who is very passionate and believes in what he’s doing,” says Cresanti. “That carries a lot of weight. He had the whole room hanging on his every word when he made the presentation.”

So why is Sakezles so passionate? He believes that, given a choice, scientists, researchers and corporations would rather not test their new products on animals. That sounds good, of course. After all, most people don’t want to harm animals. But Sakezles actually has developed a product with the potential for replacing animals and a great deal of the costs associated with product testing.

“I’m a former medical device designer,” says Sakezles (the name is pronounced Zak-a-lees). “If you work in that industry, the FDA requires you to do simulated-use testing to prove these devices are safe and effective. People in the industry test on animals, cadavers and models they make up in their laboratories. Right now, the gold standard is animals.”

Politically and ethically, of course, animal testing comes with a heavy price. “Unfortunately, a lot of the testing done in our industry is not just wasteful, it’s expensive. You could pay a couple hundred dollars for a pig and run a study. But you have to perform it at an FDA-licensed facility. You have to have a veterinarian because the federal government requires you to document the fact this animal is being cared for properly. The Animal Welfare Act requires you to write a protocol and have it reviewed by a committee of professionals. It boils down to proving this study is necessary and that the animal is not going to be abused.”

A “simple” test with one animal can cost researchers $15,000, he says—and it may not prove much because animals are notoriously unpredictable and not representative of human anatomy.

“In my experience,” Sakezles says, “the tests that you run in these studies end up being thrown away because you don’t get the results you wanted. You don’t want to explain to the FDA why your device killed this pig. Something always goes wrong. The FDA is always interested in this because they want to know what your device will do to human anatomy. It can be catastrophic to get a bad data point.”

And whether the company in question is developing a coronary stent, a car or a toaster, it’s not a good idea to only rely on a few data points.

“With our products, versus animals or cadavers, it boils down to cost and risk,” Sakezles says. “A company can buy our products and be testing on actual human anatomy without any of that additional overhead. And they can develop infinite data points.”

Animal Replacement’s body parts are interchangeable. Damage a vein and it can be replaced—and nobody dies. They’re made like jigsaw puzzles. There are also no biohazards. And because it’s a reproducible model, companies can use it not only to test their device but they can test a competitor’s device and generate data that shows one device is better than another. “That’s impossible to do without our technology,” he says.

The crazy thing about Sakezles’ creations is that they seem so obvious you’re left wondering why no one thought of it sooner.

“The kernel of this idea developed in 2004 in Princeton, N.J.,” he recalls. “I had started my own consulting practice, Princeton Product Innovation, which is a consulting company that provides contract engineering services to individual inventors and small medical device manufacturers. At PPI we basically helped our clients develop catheters and other disposable medical devices. I was pitching these medical devices to small to medium-size companies. What made it unique was this modeling technology I designed that involves the mimicry of specific body parts. We conceptually break down body parts into individual tissue components (intima, media, tendon, fascia, etc.), develop physical synthetic tissues to mimic each one of these tissues, and then build an artificial body part out of the individual synthetic tissues. The resulting body part may be used for testing medical devices or teaching medical procedures. I started using the technology as a hook to land consulting work.”

But it rapidly became apparent that the best product Sakezles had was not his consulting skill but the ability to make one particular product—incredibly lifelike human body parts—and sell it over and over again.

“When I started out I was making everything myself in my lab, all the materials, all the formulation,” he says. “I started on a table in my home office in Princeton, then I relocated to St. Petersburg and moved the business to my garage.”

That first year, 2005, Sakezles did nothing but file patents and work for one client, Ethicon, a division of Johnson & Johnson. “That whole first year, everything was done under complete secrecy,” he says. “We didn’t want to let the cat out of the bag.”

His first patent was filed in January 2005 but not issued until February 2007. During that time, Animal Replacement Technologies moved three times, from Princeton to St. Petersburg and, in early 2006, to a 2,000-square-foot space in south Manatee County’s Parkland Corporate Center. This is home for Sakezles, who was born in Tampa and earned his undergraduate degree from the University of South Florida and his masters and Ph.D. in polymer science from the University of Florida in 1998.

Curiously, Sakezles knew nothing about anatomy upon graduating.

“Nothing,” he says. “The anatomy side of things I learned on my own. There isn’t any place in the country that trains medical device engineers. You go into the industry and learn on the run.”

So what brought him and his company here?

“Sarasota is trying to develop a simulation center of excellence,” he says. “The idea was that, potentially, there might be monetary support if the company was located here. So far that has not been the case. People here tend to invest in real estate. There is an effort to bring companies like this to the area, but the powers that be want companies that already have 100 employees; they’re not interested in grass roots growth. From a tax base standpoint, we’re nothing.”

In the past year, new buyers for the company’s unique products included St. Jude Medical, Fox Hollow Technologies and Tyco Healthcare.

“We didn’t go to our first trade show or start publicizing until February 2006,” Sakezles says. “We finally went to a trade show in Anaheim; by then we had filed 10 patents and were pretty well-protected.”

And what was the reaction from unsuspecting trade show attendees upon being exposed to Sakezles’ brainchild for the first time?

“Pandemonium,” he says. “It was insane. We didn’t advertise that we would be there but there was constantly a crowd at our booth. There were reps from Chinese and Japanese companies wanting to distribute. Hollywood companies were interested; surgeons, too. This technology cuts across a lot of different industries.”

What’s the big deal? We’re not just talking about an uncanny level of realism here. These products, made of 16 ingredients, but primarily water, fibers and salt, have physical properties that don’t just look and feel right, but are physically similar to human tissue.

When Animal Replacement Technologies ramps up production, Sakezles believes he will revolutionize medical device testing—among many, many other industries.

“There are a thousand different things you could do with this,” he says. “But running a startup company, I know the medical device industry. That’s our core market. But we’ll eventually move into others.”

Since being incorporated in 2005, the company has been capitalized out of the pockets of Sakezles, his friends and family. He currently has 16 part-time employees, a number he plans to double by year’s end.

“We haven’t raised any money since 2005,” he says. “But we’re in the process of running our first open round for anybody interested. That’s $500,000 to fund our expansion. We’re going into California and expanding into surgical simulation, big time. This round will finance development of a complete body—bones, arteries, ears, eyes and organs. If everything goes well, we should have that completed some time in the third quarter.”

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