Summit Medical gains FDA clearance on U of M-developed jaw fracture device
The University of Minnesota and Summit Medical, Inc. announced today that a new, non-invasive device to support jaw fracture recovery based on U of M research has received clearance from the U.S. Food and Drug Administration. With receipt of FDA clearance, Summit Medical can now market the device for widespread use in surgeon’s offices, hospitals and clinics across the U.S.
Minne Ties Agile MMF, based on technology developed by Dr. Alan Johnson during his time as a senior innovation fellow at the U of M, uses a collection of sutures inserted between the teeth to securely and evenly fix the jaw in place to promote proper recovery. The sutures can be applied more quickly and with less discomfort than traditional, wire-based methods.
“It is extremely rewarding to be a part of a disruptive technology that is redefining the industry and making a positive impact on patients, surgeons and hospital teams,” said Kevin McIntosh, president of Summit Medical, Inc. “Working with the University of Minnesota and Dr. Johnson on commercializing Minne Ties has been a thoroughly positive experience, and we are thrilled to collaborate with their team and now to help introduce this device to the market.”
Jaw fractures most commonly result from blunt force trauma, such as from vehicle crashes, sports injuries and physical assault, but may also come from complications of certain forms of cancer. According to a recent U.S. study, the jaw bone is the second most fractured bone in the face, and such fractures may take up to six weeks to fully recover, depending on the severity of the injury.
The conventional method for securing a broken jaw in place to promote healing requires metal wiring that can lead to discomfort, abrasions on the lips and gums, and gingivitis. These wires are sharp and can pose a safety threat for surgeons, who risk catching diseases from patients if they experience wire sticks.
Minne Ties sutures have a smooth clasp head, are blunt-tipped, more comfortable than metal wiring, and promise to reduce gum irritation and dental hygiene problems. A surgeon can apply the device more quickly and safely, and may even be able to apply it in a clinic setting, potentially reducing the costs and delays that can accompany a scheduled visit to the operating room.
Dr. Johnson, now a Grand Forks, N.D., otolaryngologist – head and neck surgeon, developed the technology behind Minne Ties in 2012. Johnson, who attended the Medical School and served his otolaryngology residency at the University of Minnesota, was part of the Innovation Fellows Program at the University’s Medical Devices Center (MDC) at the time. While at MDC, Johnson worked closely with co-inventors Laura-Lee Brown and Christopher Rolfes, both MDC fellows, and Samuel Levine, M.D., professor in the Department of Otolaryngology, Head, and Neck Surgery. Johnson’s invention marks the first technology from this program to finish navigating the complex path to FDA clearance and reach the market.
“The Minne Ties system wouldn’t have gotten off the ground without a number of different people from the community who are good-willed, good-natured medical device supporters,” Johnson said. “I am excited to see this device reach the market and start helping people who suffer from jaw fractures experience a less invasive and more comfortable recovery process.”
In 2014, Summit Medical, Inc. licensed use of the technology for further development through the U’s Office for Technology Commercialization, which promotes the transfer of University-developed technologies to industry partners.
“We have watched this technology come a long way, from its inception at the U of M to its development at Summit Medical,” said Arthur Erdman, Ph.D., director of the U’s Medical Devices Center and mechanical engineering professor in the College of Science and Engineering. “This technology holds enormous potential to benefit society, which is a big part of our mission as a public research university. We could easily imagine it as a future go-to resource for surgeons treating broken jaws across the country.”
About the Office for Technology Commercialization
The Office for Technology Commercialization facilitates the transfer of University of Minnesota research to licensees for the development of new products and services that benefit the public good, foster economic growth and generate revenue to support the University’s research and education mission. The U currently holds 900 patents and 1,800 licenses for U of M technology.
For more information on the Minne Ties Agile MMF, visit www.minneties.com.
For the story of how Dr. Johnson developed the technology behind Minne Ties, visit: http://wp.me/p4wAsQ-1ei.
Citations for studies referenced in text
Allareddy, Veerasathpurush, Allareddy, Veerajalandhar, Nalliah. Epidemiology of facial Fractures. Journal of oral and maxillofacial surgeons. June 2011.
Widell, Thomas. Mandible Fracture. http://emedicine.medscape.com/article/825663-overview#a6