Tympanogen's gel treatment for perforated eardrums is less invasive and expensive and allows for faster healing, its creators say. (Photo courtesy Tympanogen)
Sometimes everything just gels.
Elaine Horn-Ranney was a biomedical engineering graduate student at Tulane University in New Orleans in 2014, and her husband was in medical school. She and lab mates were working on a nerve regeneration gel, but there were no clinical applications for the product, and she asked her husband to consider some possibilities. A couple of weeks later, he came home following an ENT (ear, nose and throat) rotation at a pediatrics hospital talking about an ailment in need of a better treatment: perforated eardrums.
A common occurrence, perforated eardrums affect about 150,000-170,000 people in the United States each year, mostly children. Chronic ear infections and insertion of draining tubes can cause permanent perforations that won’t heal and can lead to more infections and hearing loss.
The standard treatment since the 1960s has been surgery, which can take two to four hours and cost up to $18,000, but the gel could offer an alternative that is less invasive and expensive, done in an office visit setting in minutes without putting a child under general anesthesia.
Realizing the implications for eardrum repair was an a-ha moment that resulted in the birth of Horn-Ranney’s business, Tympanogen, a bioengineering concern in the Virginia Bio+Tech Park in Richmond. She is chief executive officer and co-founder with her husband, pediatric hospitalist Jesse Ranney, who is also an advisor for the company. The third co-founder is Parastoo Khoshakhlagh, Horn-Ranney’s friend and lab partner in graduate school at Tulane, who is currently working a postdoctoral fellowship at Harvard Medical School.
The gel, called Perf-Fix, is polymer based, about the consistency of jam, “really thick and sticky,” says Horn-Ranney. An ENT can spread it across the perforated eardrum, aka the tympanic membrane, then use a blue light and “cure” it, much like the curing light device used by dentists. The gel can be applied in about 10 minutes and serves as a scaffold for cells to grow on and rebuild the eardrum, eating the gel as they go. It takes about two or three weeks to heal, while surgical repair may take six to eight weeks, says Horn-Ranney.
“We were trying to make it faster and safer,” she says.
The product is in development. Tympanogen in August announced that it had earned a $1.48 million grant through the National Institutes of Health for regulatory testing needed to get the product on the market. The grant allows the company to skip Phase I, feasibility stage work, and proceed to Phase II testing because the researchers had already demonstrated the product's viability.
Horn-Ranney says the company wants to complete the safety testing and submit its information at the end of next year, then have a clinical study completed at the end of 2021.
The startup is also investigating other applications. In December, its product was sent to the International Space Station, where it is undergoing testing as a wound dressing that delivers medication directly to the wound. The NASA video below includes Horn-Ranney describing the project.
