How Cool is This?
“Therapeutic hypothermia is when you lower the body temperature to help slow down the cellular metabolism.”
— Tony Voiers
By Katie Mosher
Moments matter when someone goes into cardiac arrest. Quickly cooling the patient can limit neurological damage and buy precious time to get to a hospital.
That message — with an NC State twist — is resonating from the Research Triangle to the U.S. Patent and Trademark Office and international medical technology circles. In December, federal officials issued a final patent for a technology developed by biomedical engineer Andrew DiMeo and five of his NC State College of Engineering senior design students in 2007-08.
“Therapeutic hypothermia is when you lower the body temperature to help slow down the cellular metabolism,” explains Tony Voiers, CEO and co-founder of Novocor Medical Systems. Voiers and DiMeo founded the company last year to license the new technology.
The goal of therapeutic hypothermia is to use ice-cold saline as soon as possible. The NC State students developed a technology to use an endothermic chemical reaction similar to cold packs to cool the saline during the infusion process.
Novocor’s first medical device, known as HypoCore, is in its final refinement stages. Company leaders anticipate regulatory submission to the Food and Drug Administration later this year so it can be cleared and in rescue vehicles by 2015.
The device’s “elegantly simple“ design and its potential to help some of the 500,000 heart attack patients per year are key factors generating investor interest, notes Peyton Anderson, a founder of SciQuest and a mentor to Novocor through the Blackstone Entrepreneurs Network. “The product can increase quality of life while also reducing overall health care costs,” Anderson says.
The cooling technology has taken years to travel from initial concept through business development to the marketplace. That process has involved two dozen or more undergraduate and graduate students, professionals in the university’s Office of Technology Transfer and expert entrepreneurs, DiMeo notes.
Kelly Sexton, NC State’s director of technology transfer, is delighted to see DiMeo’s years of dedicated effort come to fruition. “We are hopeful that Novocor will soon have a product on the market that will save patients’ lives,” she says. “That is the real payoff for this type of innovation.”
In their undergraduate days, before they married, Kathryn Sauer Cox and Nathan Cox were emergency medical technicians. Many times they responded to patients having heart attacks. Even though Wake County was an early leader in cooling these patients in the field, front-line EMTs often would lose precious minutes waiting for a supervisor to arrive with refrigerated saline.
The Coxes’ EMT experiences fueled brainstorming for a biomedical device that they would design for the senior course with DiMeo. Working with teammates Steven Grove, Samuel Lee and Luke Oltmans, they met with experts at Wake County Emergency Medical Services and WakeMed Hospital.
The team identified specific problems that EMTs had in trying to cool patients. Then they developed and refined their prototype device to solve those problems. “We had to look at the market and where we could insert ourselves,” Nate Cox adds.
In the years since, Kat Cox — now an emergency medicine resident at Duke University — has gained even more perspective on therapeutic hypothermia. “It is the standard of care,” she says.
Nate Cox is a process engineer with Novartis in Holly Springs. Others on the original student team moved away to focus on careers in research, prosthetics and pharmaceuticals, but they have been updated on the patent process and the company’s development.
DiMeo vividly recalls a discussion with the team. “Users asked for something portable and rechargeable,” he says of the “a-ha” moment. “But what they needed was on-demand cooling — something we determined could be done without any power at all.”
The discussion led to a burst of diagramming. “The value seemed instantaneous,” DiMeo says, citing existing clinical studies on the role of cooling patients.
Over several years, he made sure the ball never got dropped, knowing the technology had a niche.
NC State tech transfer experts worked with DiMeo to explore potential interest from existing companies. When that option did not work out, he suggested that an undergraduate management class taught by Richard Kouri take on the business plan as a class project. Kouri is executive director of the BioSciences Management Initiative in the Poole College of Management.
Keegan Guizard, who was studying entrepreneurship and supply chain management, was a team leader on the business plan project. “I was interested in the technology and in the amount of good it could do for patients in emergency situations,” he recalls.
The class provided strong professional experiences for Guizard, now founder of Collegiate Skate Tour. He is also a founding fellow of ThinkHouse Raleigh, a co-living space for new entrepreneurs working to launch companies.
DiMeo also teaches a graduate class in the joint UNC–Chapel Hill and NC State biomedical engineering program. Volunteer mentors for the class included Voiers and Javier de Ana.
One semester, the graduate students were looking for ideas that could generate startups. DiMeo opened his senior design archive. A team immediately latched onto the cooling concept. “They picked up the torch,” he explains, noting that even more UNC–CH students became involved through a Launching the Venture course sequence in the Kenan-Flagler Business School.
At that time, Voiers knew that the corporation where he was working would be closing its North Carolina operations. He focused on finding a topic for a startup. “Tony wanted to put in some elbow grease,” DiMeo says. “That is when things took off. It was an incredible inflection point.”
de Ana moved to the Triangle after his employer identified the strengths of the universities and the business climate here as key elements for busi¬ness operations. And he was eager to be part of the new venture with Voiers and DiMeo. “In a startup, you are wearing a lot of hats. That is where I thrive: constantly thinking of new ideas,” adds de Ana, who now leads product development for Novocor.
At the 2013 international TEDMED conference focusing on medical innovation, Novocor was one of just 50 startups showcased in a strategic setting known as The Hive. The crowd responded to the “tangible outcome” of the cooling technology, Voiers says. “Normally a company will develop a product and then try to show the value.”
At the 2013 Southeast Bio meeting, Novocor won the Early Stage Company competition. That award followed funding from the NC IDEA competition, a loan from the North Carolina Biotechnology Center, and other investments.
“Our whole community has pitched in to help this company,” Anderson says. “It is good to help bright young entrepreneurs. I have made mistakes over 20 years. If I can help someone else learn from those mistakes, I will.”
Novocor uses administrative space at HQ Raleigh and lab space in Chapel Hill. The team schedules meetings in Durham coffee shops. “We made a decision to do as much as we can within the Triangle region,” Voiers notes, citing local experts in design engineering and production, regulatory affairs, business and patent law, contract manufacturing and even machine shops that quickly adapt or update the working prototypes.
“We can meet face to face, do things in real time,” he adds. “And not have a big travel budget.”
Charles Brady, who earned his NC State bachelor’s degree, recalls DiMeo’s excitement over Novocor’s incorporation. “I went up after class and said I would like to be involved. He told me to read up on heat transfer.” That initiative paid off. Brady started working for Novocor last summer.
“My priority is teaching my current students,” DiMeo describing his balance between academics and the startup. But the connection is clear in his laboratory and office on NC State’s Centennial Campus.
“Right here is the intersection of Initiative Way and Entrepreneur Drive,” he says, pointing out the window.
Each semester, he shares the Novocor story. “I can say to students: You can do this. Don’t let go. You can take initiative and be entrepreneurs.”
Even if their lives take other turns, students still may see their ideas in the market. “I would love to be in the emergency department and have a patient come in with the device,” Kat Cox says with a smile.
Daugherty Fund Boosts Startups
An NC State endowment fund established to bridge pure research and product commercialization recently awarded grants to 11 startups.
The Richard L. and Marlene V. Daugherty Centennial Campus Entrepreneurialism Endowment honors the retired IBM executive, who ran the company’s Research Triangle Park area operations for 23 years, and his wife. Daugherty is a trustee of the Kenan Institute at NC State and board member for the university’s Entrepreneurship Initiative. He also served as director of the Centennial Campus Partnership Office.
“This is a dynamic group of companies with strong scientific backgrounds,” notes Leah Burton, director of Centennial Partnerships and fund coordinator. “It’s exciting for the Daugherty Fund to have a hand in their early success.”
The companies showcase a spectrum of NC State expertise.
- Air Glow Inc. has developed an atmospheric plasma solution with potential applications that include water and surface treatments, and agricultural uses. Driven by electricity and ambient air, the solution exists outside of a containment vessel, giving it great flexibility.
- Benanova Inc. develops antimicrobial products for disinfectant, cosmetic and agricultural industries. Nature-inspired, environmentally benign nanoparticles combine high efficacy with a degradable design, offering antimicrobial/antifungal protection while increasing safety for humans and the environment.
- BioCentric Media LLC has developed life-science mobile apps that can be used in classrooms. OpenLab.Bones is designed for touch screen mobile technologies, primarily tablets. The app is available from iTunes, Barnes and Noble, Google Play and Amazon.
- Galaxy Diagnostics is commercializing medical diagnostic applications for animal and human health. Its initial product, a patented microbial growth medium, increases the sensitivity of Bartonella DNA detection, thus facilitating a diagnosis of bartonellosis in patients with chronic illnesses.
- Harrison Analytic Technologies LLC is developing technology to provide accurate state-of-charge and state-of-health estimations for rechargeable batteries. It meets industry needs for better accuracy and reliability of battery information, especially in electric vehicles.
- Mlinzi Group is developing a patented platform technology that enables production of live vaccines capable of safely immunizing humans and animals against disease-causing bacteria, such as Salmonella, E. coli and 2,600 other species of the enteric bacteria family.
- Novocor Medical Systems is developing a device emergency responders can use to quickly cool room-temperature saline to less than 3°C during the infusion process. This is achieved through an endothermic chemical reaction.
- Polymer Braille Inc. seeks to develop and commercialize a new generation, multiline to full-page Braille display, on which Braille dots can be dynamically refreshed.
- RJL Interactive LLC is developing its first product: Drug2Market, an educational computer game designed to help university students and industry trainees learn about commercialization of new drug products.
- Scientific Organizational Solutions LLC is providing a new way to assess interpersonal traits related to job performance. The software application seeks to reduce the time required to take the assessment test and to make it more difficult to fake.
- Tethis Inc. is developing a water filtration application based on a superabsorbent polymer made from crosslinked materials that can be sourced from agricultural and paper wastes. The product will bond with salts, heavy metals and other dissolved ions in water.