Spurred by a doctor's revolutionary treatment of a spinal injury that permanently sidelined former Buffalo Bills tight end Kevin Everett, Rochester entrepreneur Michael Amalfi invented a medical device that could provide life-saving early treatment to heart attack and stroke victims.
Amalfi, founder and CEO of Rochester-based Body Cool LLC, last year left a job as senior vice president of UltraScan Corp. in Buffalo to work full-time at Body Cool.
Body Cool and UltraScan, which makes an ultrasonic fingerprint reader, are backed by Paychex Inc. chairman Thomas Golisano. Amalfi, a scion of a local supermarket family and longtime Golisano colleague, remains an investor in UltraScan.
Amalfi predicts rapid expansion for Body Cool. Its product is a chemically activated cooling vest designed to reduce body temperatures as a means of stalling ill effects of heart attacks and traumatic injuries.
A drop from the normal 98.6 degree range to 95 to 96 degrees slows body processes and thus retards the ill effects of severe injuries or heart attacks. Such cooling long has been seen as the key to the survival of people who fell into and stayed submerged under icy winter waters long enough to have drowned.
A rabid Bills fan and hockey fanatic who stood with Golisano when the billionaire closed a deal to buy the Buffalo Sabres, Amalfi was in the stands at Ralph Wilson Stadium in September 2007 when Everett was injured.
Given the scope of his cervical spine injury, Everett was not expected to walk again. But after Everett's injury, Bills team doctor Andrew Cappuccino M.D. administered a cooling epidural directly to Everett's spine. Everett might never play football again, but three years after the accident, the former tight end has regained partial use of his legs.
"I saw that Andy Cappuccino administered an epidural coolant and that got me to thinking," Amalfi said.
He wondered if such treatment could be delivered earlier, would it not produce even better results than that experience by Everett? With timely therapeutic cooling, might spinal-injury sufferers avoid paralysis?
Amalfi obsessively researched possible methods of producing controlled hypothermia and consulted on spinal injuries with experts at the Buoniconti Fund to Cure Paralysis in Miami. He hired a SUNY at Buffalo chemist to research chemicals that might be used to produce the result he wanted.
Only a pure grade of ammonium nitrate precisely mixed with water would produce the desired result, the chemist found. With those results in hand, Amalfi designed a vest that would apply cold precisely to patients' blood vessels. He then applied for a patent and made arrangements to start having vests manufactured locally.
He found a firm in Kansas City, Mo., that could supply the grade of ammonium nitrate he needed and arranged for the vests to be shipped to Kansas City, where they are filled and sent to customers.
Because there are relatively few spinal injuries that would benefit from Body Cool-some million a year in the United States-Amalfi initially saw an important but probably limited market for Body Cool vests.
In late 2010, however, Body Cool hit what Amalfi sees as the equivalent of the medical device lottery: The American Heart Association, which previously had considered induced hypothermia a possibly helpful therapy, put out a recommendation calling for early body cooling treatment of heart attack victims.
The startup venture has gained a small core of customers and expects to sell some 2,000 of the disposable $149 Body Cool vests this year, Amalfi said. As a result of the heart association's 2010 recommendation, he hopes to see the market grow by as much as a hundredfold.
Ambulance companies and other emergency medical first responders would be the firm's primary market, Amalfi said. Companies and organizations such as large entertainment venues and sports stadiums that keep portable defibrillators on hand could be a sizable secondary market. He is working on a cooling hood that would be used on stroke sufferers.
Like other cooling vests on the market, the Body Cool vest works by a chemical process not unlike the technology employed in hand warmers. Breaking a seal allows a chemical to mix with water, which triggers a reaction that gives off heat or with Body Cool vests produces a chill.
The difference between Body Cool and other cooling vests lies in the grade of ammonium nitrate-the highest available-Body Cool uses, Amalfi said. Other vests cool by a modest amount, but the Body Cool product brings down body temperatures low enough and steadily enough to produce therapeutic results, he said.
The benefits of bringing down body temperatures to allay heart damage have been documented for at least a decade. Hospital emergency departments have long deployed devices to bring down heart attack sufferers' body temperature. The AHA's 2010 recommendation highlighted the benefits of doing it in the field before patients get to a hospital.
Since the AHA recommendation, both commercial ambulance companies serving the Rochester area, Rural Metro Inc. and Monroe Ambulance Inc., have added refrigeration compressors that their EMTs use to cool saline solution. Administered intravenously, the saline goes to cool heart attack victims.
The new protocols recommend the use of an external cooling agent such as an ice pack or chemically activated device along with the saline drip. The goal is to induce a return of blood flow and thus minimize heart damage. Further hypothermia-producing treatment in an emergency department is supposed to follow.
In the field
As part of a Food and Drug Administration trial, Monroe Ambulance EMTs have used Body Cool vests for months to augment intravenous saline interventions, said Michael Bove, Monroe Ambulance EMT chief and assistant operations manager.
"We haven't sat down and analyzed all the data, yet, but anecdotally I'd say they've made a significant difference," Bove said.
In the four or five instances that Monroe Ambulance EMTs used the vests to cool heart attack victims, the vests performed admirably, helping to restart blood flow to the heart and, he believes, well outperformed other chemically activated competitors.
"With these vests we've been able to get spontaneous return of circulation," Bove said, a result he sees as a significant improvement over chemical-pack cooling treatments. "It's great technology."
Because Body Cool vests can bring down body temperatures sufficiently to induce a therapeutic effect on their own, they can be used on-site at accident scenes or other locations where administration of a cooled-saline drip might not be accomplished easily, Bove added.
Ambulance companies in several other states along the Eastern Seaboard are testing the product, Amalfi said. A point on which the Pittsford resident is adamant: He will not move manufacturing overseas and will not move it to a right-to-work state.
New York's cost of doing business is high, Amalfi conceded. But as a lifelong Rochester-area resident, he said, he intends to keep the business and whatever jobs it brings in this area.
Body Cool currently employs four including Amalfi and his son, Michael Amalfi Jr., who is the startup's vice president. Amalfi declined to name the vests' two local manufacturers.
Each contract manufacturer is capable of turning out enough product to meet the spike in demand he expects soon.
After graduating from a two-year Rochester Institute of Technology business program in 1981, Amalfi went to work alongside several brothers in Amalfi's Market, a single-store local supermarket on Portland Avenue that his Italian immigrant grandfather founded some 70 years ago. The Amalfis sold the market to Family Dollar Stores Inc. several years ago.
Amalfi already had left the market some eight years ago when he joined UltraScan. After founding Body Cool in 2009, he left UltraScan to work full-time developing the startup last year.
"I hope this works out," Amalfi said. "I left a pretty good job to do it."
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