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Shared "Uncommon" Vision Leads to Birth of Regenerative Medicine

Richard E. Caruso, Founder and Chairman, Integra LifeSciences Corporation

In 1987, Richard Caruso, PhD founded the The Uncommon Individual Foundation in a quest to better understand "why and how individuals wind up where they are doing what they are doing." How, he wanted to know, did he-the son of Italian immigrant parents-achieve what most define as success? What role did mentors play along the way? And what constitutes success anyway?

In 1987, Caruso could hardly imagine that over the next twenty years he would obtain the FDA's first-ever approval of a product to regenerate skin, the body's largest organ. He would also commercialize two more biotechnology products, be named Ernst & Young Entrepreneur Of The Year® 2006 for the United States, and coin the term "regenerative medicine" in the process.

Caruso earned a degree in accounting on a football scholarship to Susquehanna University and an MSBA from Bucknell University, landing shortly thereafter at LFC Financial Corp., where he quickly demonstrated a talent for creative leasing and marketing strategies. Some twenty years later, he was wealthy but unfulfilled.

"While my partners and outsiders considered me very successful because of my financial success," says Caruso, "I did not personally feel successful because, in my mind, I could not point to my substantive real accomplishment other than my financial success."

From MIT to Marketplace

Caruso took a two-year partial sabbatical to address these concerns, by the end of which he had defined a new "open system model of mentoring," earned a PhD from the London School of Economics, and established a set of criteria for the pursuit of a new career that included working with leading edge technology.

During his pursuit, Caruso came to the conclusion that, once the alternatives were understood, the highly respected practice of taking body parts from cadavers and implanting them into living patients would be considered primitive. Still, in those days, a proposal to develop replacement parts for the human body was no easy sell, especially for someone with no medical background.

Undeterred, Caruso discovered an artificial skin technology that had been developed jointly in the 1970's by a materials engineer at MIT, Dr. Ioannis Yannas, and a burn surgeon at Harvard, Dr. John Burke. Caruso learned that this technology, known as Integra, had been licensed by MIT to pharmaceutical company Marion Laboratories in Kansas City, Missouri., founded by Ewing Marion Kauffman in 1950 in the basement of his home. Over the years, with strong backing from Mr. Kauffman, Marion had invested heavily in wound care products, including some $35 to $50 million to develop Integra, and had acquired Colla-Tec, Inc., in Plainsboro, New Jersey, to manufacture and supply the collagen raw material needed to produce it.

However, after Marion's merger with Merrill-Dow in 1989, the company divested its wound care division. Development of Integra, perceived by the company as a wound care product rather than the first regenerative medicine product it was destined to become, was being questioned by the FDA, shelved and Colla-Tec put on the market.

Caruso discovered soon after acquiring Colla-Tec in May 1991 that the Integra research project was also for sale and entered into negotiations to convince Lita Nelsen, director of the technology licensing at MIT then and now, and Drs. Yannas and Burke, to agree to re-license the technology to his company, which he subsequently renamed Integra LifeSciences.

"Yannas had confidence in him," recalls Nelsen. "He would commit to raising the money, and we didn't have a lot of other choices. That's usually the issue with unproven technology. It's not like you have ten people who want to do it. Fortunately, we turned out to be riding the right horse."

Meeting of the Minds

Still, at the outset, Caruso may have seemed like the only one who hadn't given up on Integra. But that wasn't exactly true, as Caruso discovered in early 1993, when he traveled to Kansas City for the first time to inspect the Integra manufacturing facility and equipment and finalize its acquisition.

"The day I arrived," recalls Caruso, "I was told that, although he was very sick, Ewing Kauffman came in that day to talk to me about the importance of the Integra technology.

"When I met Mr. Kauffman, I was incredibly impressed and inspired by his enthusiasm and genuine sincerity. I remember him saying to me, 'Richard, regenerating body tissues and organs is an important future of medicine. The Integra technology is in the forefront of this.'

"Mr. Kauffman surprised me when he asked if I was accepting outside investments in my new company. I got the feeling that, as a true entrepreneur, he was asking to be supportive of me in this effort. I told him that once I prepared a business plan, I would consider outside investments."

Unbeknownst to Caruso, Mr. Kauffman had only a short time to live and died in August.

"While I was unable to present to him the opportunity to review my business plan," he says, "his inspiration helped Integra's development more than any financial investment could have. I can factually say that Integra LifeSciences would not exist today if it were not for Ewing Kauffman's influence on me and the original commitment he and Marion Laboratories made to the development of the Integra technology."

Success and Beyond

Between 1989 and 1995, Caruso raised more than $25 million and personally invested another $15 million in equity and loans to develop the product.

Since 1996, when Integra Artificial Skin was named by the FDA as one of the year's notable breakthrough devices, Integra LifeSciences has gone on to commercialize DuraGen, which regenerates the brain covering after surgery, and NeuroGen, which regenerates severed peripheral nerves. Today, the company employs nearly 2,000 associates, does business in one hundred countries with annual sales approaching $400 million and a market capitalization of $1.2 billion.

What's next for Caruso? At sixty-three, he's not ready to retire but would like to devote more time to expanding access to open-system mentoring. Open mentoring is designed to enable each individual to become the entrepreneur of their own lives.

For the past nineteen years, The Uncommon Individual Foundation, based in Rosemont, Pennsylvania, has worked with companies, schools and nonprofit groups to help individuals develop the benefits of relationships with multiple mentors over time and help mentors learn how their careers and personal satisfaction can be enhanced through these relationships. Caruso has invested more than $1 million in the foundation's effort to make open mentoring technology available online by the end of 2006.

Former Marion Laboratories associates will remember Mr. Kauffman as a mentor extraordinaire who showed the world how to run "An Uncommon Company."

Caruso says it's a coincidence the name of The Uncommon Individual Foundation is so similar…or is it truly that great minds think alike?

© 2006 Ewing Marion Kauffman Foundation. All rights reserved.

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