There are many applications where a drug-eluting suture can prevent infection and ultimately save lives. The team's initial target application is a cervical cerclage (suture), which is utilized to prevent premature birth by bolstering the strength of a mother's weak (incompetent) cervix from the beginning of their third trimester. Despite closing the cervix with a cerclage, devastating infections are known to occur from bacteria that migrate through the cervix and infect the fetus. Typically oral antimicrobials or vaginal pessaries are prescribed to prevent infection. However, the oral route may adversely affect healthy stomach bacteria, and both methods rely on patient compliance. By incorporating a localized drug delivery for the full three month duration needed to bring the fetus to term this new technology can usurp current treatments.
In 3% of all surgical and traumatic wounds a patient develops an infection, necessitating an average 6.5-day hospital stay, adding $35-40 billion in expenses in the United States alone. While orally-administered antibiotics have an established efficacy towards preventing infection, they come with inherent risks. Instead, the technology developed in this effort delivers the minimally-effective dose of a powerful broad-spectrum antimicrobial directly from a suture, minimizing side effects. Further, administration of the antimicrobial from the suture ensures 100% patient compliance with the drug regimen. At the end of the project, the team will have a woven, prototype suture that has been examined more thoroughly for drug release and strength and has gone through preliminary in vivo animal trials at the Medical University of South Carolina. The team will also have a go/no go decision with regard to potential commercialization of the technology.
NSF I-Corps Final Project Report Team: Drug Eluting Fibers D. E. Hirt (PI), Clemson University C. J. Reynolds (Entrepreneurial Lead), Clemson University M. R. Gevaert (Mentor), KIYATEC Inc. Summary of Project: The purpose of this project was to determine the market desire and feasibility to convert the NSF-nurtured technology "Drug Eluting Fibers" into a sustainable business. As with all I-Corps teams the key individuals (PI, Mentor, and Entrepreneurial Lead) attended opening and closing instructional sessions hosted by the NSF and local entrepreneurial authorities, and participated in weekly progress meetings. These meetings served to provide short-term feedback during the 80 interviews our group conducted with doctors, hospital administrators, and business development personnel relevant to our technology. The interviews and feedback from I-Corps advisors guided the development of a viable business strategy. Intellectual Merit: Discovering the market viability for our technology provided valuable insights of the market drivers, liabilities, scale, and time to market. Understanding each of these insights was key to developing a solid market strategy. During the I-Corps process of building a business-model canvas and meeting with various customer segments, we learned that the originally intended end-use was not likely to be sustained by the market. Through the guidance of our Mentor and I-Corps advisors we discovered alternative products that provided greater margins, making it more likely to succeed in the marketplace. Once focused on a viable product and market niche we researched potential regulatory pathways, a minimally viable product for market entry, and began talks with potential market partners. These talks led us to the conclusion that there was a viable business opportunity, so on November 11, 2012, we incorporated as Additive Drug Delivering Devices LLC, or AD3 LLC. We are currently licensing the relevant NSF-funded technology from Clemson University, developing a business plan, and working with a commercial partner to potentially add our technology to one of their existing product lines. Broader Impacts: The technology developed has the potential to have a pronounced effect on the rate of surgical site infections and rate of wound healing. The depths of the possibilities are unknown and will be pursued using both commercial and academic means. As Clemson University currently owns the license and will retain usage of the technology (inherent in their license agreements) it presents an opportunity to coordinate research between the University and AD3, which will ultimately involve students in the research and entrepreneurial phases of company development. Also, through the I-Corps program, the entrepreneurial lead (a postdoc) had the invaluable experiences of interacting with potential collaborators from many levels within a hospital system and with proposal writing. The benefits to society of forming a company to create products for infection mitigation and wound healing include: better patient care, cost savings from lower infection rates, fewer cases of misused prescriptions (as the drug dosage is inherent in the fiber), and job creation.
