It's a Small, Small World

Business and nanotechnology partner to bring a biomedical product to market

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When you hear about a revolutionary new biomedical, biocompatible bone substitute material that just won the first-place prize of $30,000 in a nanotech competition, you expect it to look worthy of a guest appearance on Star Trek.

"Like little lumps of bread," observed Matthew Vaughn, as he pulled three small hunks of what looked like, well, Wonder bread, from a plain old sandwich bag stuffed in his backpack.

Voilà, the CitrOSponge—a cutting-edge synthetic biomedical product that may one day commonly be used to repair bones fractured by injury or disease. Porous, so that it encourages the development of blood vessels, and elastic, which allows a surgeon to compress it to a very small size for the purposes of implantation, the CitrOSponge is an example of the medical breakthroughs made possible by the science of nanotechnology.

Vaughn, a veteran researcher with a Ph.D. in pharmacology, is part of a business venture, Citrics Biomedical, that is manufacturing and marketing the product. The venture also includes Notre Dame finance alum A.J. Noronha ('03) and Guillermo A. Ameer, an associate professor of biomedical engineering and surgery in the Biomedical Engineering Department of Northwestern University, who developed the technology originally.

In March, Citrics Biomedical won the inaugural Nanotechnology New Ventures Competition, sponsored by Purdue University and the University of Notre Dame. The venture also won the Nanotechnology New Ventures Award in this year's McCloskey Business Plan Competition of Mendoza's Gigot Center for Entrepreneurial Studies.

As Noronha and Vaughn explained in their presentations during the business plan competitions, when a patient needs a bone replaced because of disease or injury, there are three options: move bone from another part of the body; transplant bone from a cadaver or animal; or patch with a synthetic material.

Moving bone can be expensive and requires more surgery. Bone transplants pose sterilization and biocompatibility issues. Synthetics present both compatibility and biomechanical (sturdiness) issues.

Citrics's CitrOSponge is designed to fill the void temporarily, providing a "scaffold" upon which real bone can regenerate. When the material's work is done, the softer part—a polymer made from citric acid, abundant in citrus fruits and naturally in the body—can be harmlessly reabsorbed, the company says. The harder part of the material, a ceramic made of hydroxyapatite, the substance that gives bone its hard outer layer, remains in place as new bone grows over it.

The company founders say the crystals of the ceramic are engineered at a submicroscopic or nano scale. This became possible only about two decades ago with the advent of nanotechnology.

Nanotechnology is the study of manipulating matter on the molecular or atomic scale. A nanometer is one-millionth of a meter. Red blood cells, visible under a microscope, are about 7,000 nanometers in diameter. Nanotechnology didn't become practical until the invention of the scanning tunneling microscope—which can show individual atoms—in 1981.

Twenty years of research and development later, nanotechnology is beginning to spawn not only scientific breakthroughs but business opportunities aplenty.

The Citrics team exemplifies a growing trend in academia: professors joining forces with business people to speed scientific discoveries to market—usually with the blessing of the academics' employer.

Notre Dame's Office of Technology Transfer helps University researchers identify and commercialize promising new technologies. The partnerships it forges with industry are expected not only to make professors' discoveries available to the public sooner, but to generate new research collaborations with businesses and introduce Notre Dame students to potential employers.

The partnerships also are money-makers. Licensing revenue from patents issued to Notre Dame researchers totaled $553,000 in 2010. The revenue is typically shared with the inventing professors.

About 60 Notre Dame science and engineering faculty are involved in nanotech research, according to Robert Dunn, managing director of NDnano and the Midwest Institute for Nanoelectronics Discovery (MIND). Faculty pursuits include higher-efficiency solar cells, higher-output batteries and a more efficient method for tying together semiconductor chips.

Mendoza students sometimes play a role in the transfer of Notre Dame-grown technology. The team of MBA students Eugene Kim, Viral Kothari, Michael LaGrand and Israel Peck took the runner-up prize ($5,000) in this year's McCloskey competition for their business plan for Sorian, a startup that holds an exclusive license to sell optimization kits for wind-turbine blades. The kits reduce drag and improve performance using a patented technology developed by Thomas C. Corke, Clark Professor of Aerospace and Mechanical Engineering and Director of Notre Dame's Institute for Flow Physics and Control and Hessert Laboratory for Aerospace Research.

The MBA team also won the Pace Global Best Presentation Award and the Notre Dame Office of Technology Transfer Award.

The Citrics team came together by way of Northwestern's Kellogg School of Management.

While doing his Ph.D. in pharmacology at the Johns Hopkins University School of Medicine, Matt Vaughn says he took a business course for scientists that was developed by Johns Hopkins in conjunction with Kellogg. When he later moved to Chicago, he contacted one of the Kellogg faculty members involved with the course. The professor put him in touch with Ameer, the biomed professor, and Noronha, the Mendoza alum.

Noronha says more than a million bone-graft procedures are performed each a year in which the Citrics bone substitute could be used. As the population ages and sustains an increasing number of bone fractures, the demand for the product could see steady growth. "The U.S. market is more than $3 billion annually and continues to grow at a double-digit rate," says Noronha.

"Our expectation is that the CitrOSponge will speed up the recovery time so the patients are able to return to work, return to their daily life, and not have to stay in a hospital bed for weeks to recover from a bone fracture," says Vaughn. "They can live an active life."

The founders' immediate challenge is to raise $3 million to continue testing the material in animals, develop a scalable manufacturing process, and submit their results to the FDA.

Realistically, they say, the product is two to three years from market.