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"With our products, versus animals or cadavers, it boils down to cost and risk."

 
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Medical researchers, Hollywood filmmakers and animal rights activists stand to benefit from Chris Sakezles' synthetic human body parts.

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.”



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