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April 26, 2010

Persistence Pays | Drug Firms Spurned QuikClot; Now Z-Medica Is Saving Lives Around The World And At Home

Z-Medica, a Wallingford company born out of frustration that drug giants couldn’t see the value in a new idea, is busy revolutionizing the way triage and acute care is managed.

Its blood-clotting agent, QuikClot, is the go-to first-aid product for front-line soldiers and police, for rescue workers and in operating rooms in the developing world.

And that’s just the start, say company executives. Soon the product will be in every home and office, as ubiquitous as common gauze.

Since 2008 all of the U.S. Armed Forces have made Combat Gauze Z-fold vacuum pack, a topical gauze impregnated with QuikClot, as part of its standard issue to troops. Z-Medica officials cite military statistics that estimate that the firm’s Combat Gauze Z-Fold has reduced the death toll among wounded soldiers from 26 percent to 11 percent.

It is also used by a growing number of hospitals, fire departments, police and emergency services departments in the United States and around the world.

“There is a world-wide market for this product,” said Frank Hursey, vice chairman of Z-Medica. Today, QuikClot “is the hemostatic agent of choice.”

Hursey is an entrepreneur, inventor, and mechanical engineer, with half a dozen patents to his name, who first had his eureka moment that a cheap, easy to apply product to stop bleeding could work.

Hursey started in 1978 manufacturing oxygen machines. His company — On Site Gas in Newington — manufactures filtering machines the military uses to separate oxygen and nitrogen from air. The machines remove moisture from the air using a clay-based product, called zeolite, that works like a water magnet.

That led Hursey to start thinking about blood, which is about 90 percent water. From those musings, Hursey created what eventually became QuikClot and other related products that stop bleeding.

As good as it all sounds, Hursey said, that it has taken years to get the product to the market, even after he got the patent in 1989.

His product was repeatedly rejected by pharmaceutical companies and it wasn’t until he decided to form Z-Medica in 2002 and manufacture QuikClot on his own that the product started gaining notice.

The big break came later that year. The Marines were testing 10 clotting agents. When one of the companies dropped out of the tests, Hursey and Z-Medica Vice President Bart Gullong wiggled in at the last minute.

“It was pure luck,” Hursey said, that Z-Medica was at the right place at the right time.

At those trials QuikClot blew away the competition, Hursey recalls. QuikClot was the least expensive and safest by far. It is vacuum-sealed with a shelf life of three years.


AmeriCares Foundation

Sometimes even disasters can have silver linings. That certainly was the case when a major hurricane hit Haiti. Dr. Frank Bia, professor emeritus at Yale University and medical director of AmeriCares Foundation, said Z-Medica was among the many companies that stepped up to help. It was the first time Bia became aware of QuikClot.

“I think this is a major advance in acute care,” Bia said.

While Z-Medica still used zeolite in the first and second generation of products, the main ingredient in its third generation is an inert mineral made of aluminum silicate clay powder called kaolin. Kaolin is found in the medications Kaopectate and Pepto-Bismol, and is even used to make high-end glossy magazine paper.

It has been known since the 1920s that kaolin clots blood 10 times faster than it would clot naturally, Bia said. But Z-Medica became the first to impregnate the nano-particles of the non-toxic mineral into regular medical gauze. A blue strip that shows up under X-ray is added.

Bia said with QuikClot, blood “clots 10 times faster than it would naturally,” taking 7 to 10 minutes to stop bleeding.

“It can be absolutely life-saving,” Bia said. “It is a real major addition to what we have.”

Bia said AmeriCares is partnering with Z-Medica to make the product part of all first response modules. When a natural disaster strikes anywhere in the world, the first plane to land will have QuikClot on it.

Bia said there are many other medical scenarios where QuikClot can be invaluable.

In developing nations, reliable supplies of untainted blood for transfusions are not often readily available, he said, and QuikClot can help manage excessive bleeding in the operating room. “The less blood you use the better,” Bia said.

“Hundreds of thousands of women in developing countries die of blood-loss each year,” Bia said, noting postpartum bleeding is the major cause of natural death in some areas.

QuikClot would buy time, and would be a real life-saver in developing nations, Bia said.

AmeriCares provided about $1 billion in pharmaceutical and medical supplies to countries around the world last year.

Another advantage to using the gauze is that it doesn’t take a lot of training to use. “One folder explains how it works, and then we let people go to town with it,” Bia said.

Many of Z-Medica’s products are only available through prescriptions, but some are available for retail purchase, such as QuikClot for sports injuries. Z-Medica also sells products that can be used to stop nose bleeds, a problem for those who suffer from high blood pressure, Bia said.

By coincidence, it turned out that the co-inventor and chief medical officer at Z-Medica, Dr. Giacomo Basadonna, is a former classmate of Bia’s at Yale.

Basadonna, who originally hails from Italy, has been affiliated with Z-Medica since 2005. He is an organ transplant surgeon and a professor at the University of Massachusetts. It may be just a coincidence, but during the trial stages of QuikClot, Basadonna used a pasta machine to extrude the kaolin paste onto gauze.

“Bleeding is ubiquitous, from India to the kitchen when you cut yourself with a knife,” Basadonna said. “I don’t think there is any area where bleeding isn’t a problem.”

Basadonna and his UMass students are continuing to test the Z-Medica products, looking for other new applications.

Meanwhile, testimonials to QuikClot’s effectiveness roll in.

Col. Gregory Brown has been with the Hillsborough County Sheriff’s Department in the Tampa, Fla., area for 32 years. The agency has been using QuikClot products for six years and Brown said that it has saved the lives of suspects, victims and their own deputies. Every one of their police vehicles carries the same Combat Gauze Z-fold that is sold to the military.

“It is one of the few products that does everything it says it does,” Brown said. The department has about 4,000 employees, 1,200 of which are sworn law enforcement officers. “It hasn’t let us down yet,” Brown said.

“It saves lives and it works,” Brown said. “It’s idiot-proof. It really is awesome. It is revolutionary. Any progressive agency that deals with emergencies” should have this product.

Sales are soaring. Brian Herrman, Z-Medica’s chief executive officer since 2008, said the privately held company has seen triple-digit percentage growth in the last year.

He said their biggest challenge has been skepticism.

“QuikClot sounds too good to be true,” Herrman said.

To combat that skepticism, Herrman said, the sales team has been giving free samples to healthcare professionals.

“We are confident that the results speak for themselves, and are seeing hospital and private practice professionals recognize how useful a tool it can be,” Herrman said.

On the military side of the business, Z-Medica has introduced two new products in the past six months, and plan on launching another by year-end. On the hospital side, Herrman said, a research and development team of medical professionals is working on new products.

Also, suggestions for new products are gathered from end users and specialized doctors. That feedback plays an integral role in designing and bringing new applications to market, he said. The firm is also developing product extensions into the dental and veterinary markets.

At Z-Medica’s facility in Wallingford, about 20 employees work two shifts to assemble and check the quality of 17 core products that are shipped to 10 countries.

Z-Medica has been the exclusive supplier to all the U.S. Armed Forces for hemostatic devices for two years. The original Combat Gauze product was introduced two years ago and two new products were developed after input from soldiers in the field.

“We envision a day when QuikClot becomes as common place as gauze,” Herrman said, predicting it will eventually reach home medicine cabinets.

“QuikClot should be available anywhere that someone bleeds, whether it is anticipated or accidental, and it is our mission to get it there,” Herrman said.

Z-Medica’s motto is, “The Greatest Privilege is to Make a Difference,” and the employees understand the importance of getting each detail right. “The cool thing is we make a product that saves lives,” says Daniel Burns, the manufacturing manager at Z-Medica.

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