Dr. Allison Campbell, a PNNL researcher
Thwarting Biofilms
October / November 2004
Volume 2 Number 5
Bacterin International, Inc., a new biotechnology company in Belgrade, Montana, has licensed a new coating technology from the Pacific Northwest National Laboratory that will help make medical devices safer for patients. Bacterin's anti-infective coatings will greatly reduce post-surgical infections caused by bacteria-ridden biofilms on the surfaces of medical implants.
Nestled in the mountains of Montana, the formerly sleepy little town of Belgrade is now buzzing with the activity of a new company that promises to be a powerful force against infectious biofilms. Bacterin International, Inc., founded by company president Guy Cook, is growing faster than the infectious bacteria it seeks to stop with its new bioactive coating technologies.
Biofilms can grow on any surface where bacteria and water exist—€”like the plaque on your teeth or the slime on a river rock. "The hallmark characteristic of a biofilm is that once the bacteria are stuck to a surface, the bacteria then behave differently, and are more resistant to antimicrobial attack," said Cook.
Biofilms secrete a slimy substance that can adhere to all types of materials, especially metals, plastics, and ceramics—€”materials used in the manufacture of medical devices. Where a biofilm on teeth isn't necessarily life threatening, a biofilm growing on a medical device can be devastating to an already weakened immune system of a patient undergoing surgery.
According to the National Institutes of Health, more than 80 percent of microbial infections in the body are caused by bacteria growing as a biofilm. A biofilm's propensity to attach itself to medical devices such as catheters, shunts, and orthopedic implants, causing life-threatening deep bone and tissue infections, is the problem that Cook's company has committed to solve. Cook was one of the first people to use confocal microscopy, an advanced imaging technique, to look at the biofilm problem. His involvement with biofilm technology began when he was the confocal microscopist and image analysis specialist the Center for Biofilm Engineering at Montana State University in Bozeman—€”a National Science Foundation Engineering Research Center with a mission to understand and control biofilms. NIH has invested more than $80 million in the research and development of biofilm technology.
"When we started about six or seven years ago, biofilms were not a commonly accepted term or theory as to how these bacteria live on medical devices. It was very much a hot topic of discussion, and since that time, everyone concedes that the sources of these problems are biofilms," Cook said.
Cook was instrumental in developing several propriety testing models for the medical device industry and in 1997 started Bacterin International as a spinoff from the center. He and one technician "just rented some lab space" in Bozeman and operated as an independent testing laboratory for medical device manufacturers including Johnson & Johnson, Boston Scientific, and Tyco International. Bacterin, a for-profit, private company, now employs 60 people and according to Cook has been "cash flow positive since day one."
Bacterin is concentrating on the next generation of anti-infective coatings that can be applied to medical devices that will kill or inhibit bacteria and prevent the spread of infections. Bacterin's technologies are garnering attention from big players such as the Department of Defense, which recently awarded the company $1.4 million in appropriations to develop anti-microbial coatings for battlefield applications.
"Seventy-five percent of battlefield injuries are extremity orthopedic traumas, and seventy percent of infections occur before the soldier returns to stabilized care. If the soldier gets a deep bone infection from biofilms that get loose on the screws sticking right into the bones, it can result in amputation," said Cook.
Cook seeks patents and technologies that will promote Bacterin's reputation as the biofilm experts and to grow their product base. He saw potential to grow his company's mission to create and sell anti-infective coatings using the patented thin film coating technology developed at the Pacific Northwest National Laboratory (PNNL) in Richland, Wash., a laboratory operated by Battelle for the Department of Energy.
"We have always been familiar with Battelle and the work that they do," said Cook. "The technology transfer people recognized that we were a small company that had growth potential and they were really willing to work with us."
Bacterin licensed a bioactive calcium phosphate coating from PNNL in August 2003. The transferred technology involves thin films incorporating a biologically active substance that is deposited on a surface. Functional groups such as carboxylates, sulfonates, phosphates, alkyl, amine, hydroxyl, thiol, silyl, phosphoryl, cyano, metallocenyl, carbonyl, and phosphate can be deposited on the surfaces of metals, plastics, polymers, glasses, and ceramics.
Preferred materials for the thin film are phosphates (e.g., calcium apatite) in which the biologically active molecule can be a protein, peptide, nucleic acid, or an antimicrobial. A biologically active substance produces a detectable, or acceptable, result in the body rather than a rejection or foreign body result when placed in contact with a living organism. Therefore, introducing a biocompatible device covered with a coating specific to the patient's injury eases the body's ability to accept the object while the coating attacks the biofilm that may be infecting the surface of the device.
Dr. Allison Campbell, acting director of the William R. Wiley Environmental and Molecular Sciences Laboratory at PNNL, developed and patented the bioactive calcium phosphate coating that Bacterin licensed. She presented the biocompatible properties of the mineralized coating to Cook using titanium knee implants as an example during his visit to PNNL.
"Titanium is not biocompatible, so putting a coating made of the same material your bone is made of helps your body not see it as a hunk of metal; it sees it as bone and grows into it," said Campbell. "We can place anti-infective and therapeutic agents into the coating, making it anti-infective and biocompatible."
Bacterin's next biotechnology target is to create bioactive coatings to add to spinal allografts, which are grafts of tissue obtained from a donor of the same species as, but with a different genetic make-up from, the tissue transplant recipient. Scientists at Bacterin are working to develop a method to incorporate adult stem cells into bioactive coatings that will enhance the overall performance of spinal allografts in addition to coatings that will improve the body's ability to accept implanted devices.
The bioactive calcium phosphate coating from PNNL has already been tested and found compatible with stem cells. Cook envisions the creation of a "smart" allograft. "The patient could use his own stem cells for a customized implant.
We see this as the next generation of coatings," said Cook. "With the spinal allograft market now totaling $600 million in the U.S. alone, it's a smart move for Bacterin."
Bacterin is currently negotiating the acquisition of the U.S. Tissue Center in Salt Lake City, an FDA-regulated accredited tissue bank featuring state-of-the-art tissue and cellular facilities for storing cord blood, tissue, and adult stem cells. The company recently filed with the U.S. Securities and Exchange Commission to become a publicly held company. It is currently awaiting approval.
Jennifer Irlam is a communications specialist and writer at Pacific Northwest National Laboratory in Richland, Washington. She routinely covers commercialization activities within the lab.
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