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Tuesday, 02/05/2019 9:02:47 AM

Tuesday, February 05, 2019 9:02:47 AM

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Latex maker ready to stretch
Updated Dec 18, 2009
By Mary Welch, For the AJC

The global marketplace for natural rubber latex raw material is $2.4 billion spread across multiple fields such as hospital gloves, balloons, toys, bedding materials and clothing.

But latex has a regrettable by-product: The more you use it, the more likely you will develop an allergy to it. Discovering alternatives to latex or finding a way to remove the naturally-occurring proteins that cause the allergic reactions would be an exceedingly lucrative venture.

A Duluth company says it has done the latter.

“Latex is the best protection – whether it’s for hospital use or a condom,” said Bill Doyle, chairman of the board, president and CEO of Vystar Corp.

“What we have discovered is a way to remove most of the proteins in latex that cause the allergies.” He said Vytex Natural Rubber Latex (NRL) retains the positive characteristics of protection, strength and tactile sensitivity, but with “virtually undetectable levels of the antigenic proteins that cause the allergies.”

Roughly 8 percent of the U.S. population and possibly up to 17 percent of health care workers are allergic to latex, according to the American Latex Allergy Association. Those most at-risk are those who work in gloves, such as doctors, nurses, food service workers and cleaners, along with people with spina bifida and those who have undergone multiple surgeries.

Symptoms can range from skin rash and swollen eyes to hives to life-threatening anaphylaxis.

Sue Lockwood, executive director and co-founder of the Latex Allergy Association, based in Slinger, Wis., said allergies became a major issue in the early and mid-1990s, prompting a search for alternatives.

“It’s taken a long time for companies to come to market with products,” she said. “One (reason) is just finding the alternative itself, whether you want to take the proteins out, like Vystar, or come up with another natural alternative or get a plastic or nonnatural material. And, then you have the [Food and Drug Administration] process that isn’t too quick.”

Vystar was founded in 2000. In May, the FDA approved the first product using its technology. Alatech Healthcare of Eufaula, Ala., introduced the Envy condoms made with Vytex NRL at the Atlanta AIDS Walk in October.

Alatech received FDA clearance in July for exam gloves using Vytex NRL and will bring them to market in early 2010.

Latex is the product of the milk sap of commercial rubber trees grown mainly in Malaysia. During manufacturing, latex is concentrated by a process called centrifugation and mixed with chemical agents that may be responsible for the health problems.

Natural rubber latex contains more than 200 proteins, of which 13 are known allergens. Vystar’s process pulls out the proteins, leaving a dramatically reduced protein latex that can be added into any product. Vytex NRL is biodegradable, odor-free, all-natural and contains no VOCs or known human carcinogens.

Vytex NRL can be substituted in more than 40,000 products where traditional latex or synthetic substitutes are used. More than 55 manufacturing trials worldwide are under way using Vytex NRL as a main ingredient.

“Our customers are the end-product manufacturers,” said Doyle.

He said the company plans conservative growth in 2010, and then to “start expanding with a variety of companies” during 2011. He said he’d be happy to be involved in 10 to 20 percent of the market for medical gloves, of which up to 30 billion a year are sold domestically and 50 billion globally.

“You can create a very viable company with ten percent of the medical gloves business,” he said. “I don’t see it unrealistic for us to easily get to $240 million a year in revenue within 10 years.”

One of Vystar’s primary backers sees a lucrative buyout down the road.

“This product will easily bring in $250 million in revenues, but I’m not sure it will be with Vystar,” said Mike Queen, chief executive of Universal Capital Management Inc, a Delaware-based venture capital firm. UCM has a management agreement with Vystar in exchange for warrants that amount to approximately 10.9 percent of the company.

“You have a product that is very much needed and no one else has it,” Queen said. “All medical personnel have to wear protective gloves. Even if you’re not initially allergic, the fact is that you may become allergic to latex. This product can dominate the market and it’s a growing market.”

Queen thinks a larger company will buy Vystar to avoid losing market share to it.

To date the company has done three private placements that raised just shy of $8 million.

Travis Honeycutt, a Georgia Tech graduate, chemist and serial entrepreneur started Vystar. Doyle joined in 2004 and become its CEO in 2008 when Honeycutt retired.

Although Vystar is the first to market with a latex product with significantly low levels of antigenic protein, others are competing. Several synthetic hospital gloves are available, and Yulex Corp. from Maricopa, Ariz., received FDA approval for a medical synthetic rubber glove using the guayule shrub.

“Vystar has a very interesting product,” said Lockwood, of the Latex Allergy Association. “They have been very honest and open about what they’re doing. . . We’ll see if the gloves using Vytex natural latex works with people who already have existing allergies. We have to wait for the answer.”
https://www.ajc.com/business/latex-maker-ready-stretch/QxnnphAMuQPffHBJIh6bqJ/

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