News Article

Farmington startup seeks mechanical solution to dry mouth
Date: Aug 22, 2016
Author: Joe Cooper
Source: Hartford Business ( click here to go to the source)

Featured firm in this article: Oral Fluid Dynamics LLC of Farmington, CT



For many bioscience startups obtaining funding is usually a roadblock, but Farmington's Oral Fluid Dynamics has found early success, raising $175,000 in two years, with hopes of raising another $1.5 million by September.

The early momentum could be related to the uniqueness of Oral Fluid's product, as well as the size of its potential customer base.

The company is developing an artificial salivary gland to help the estimated 60 million people in the U.S. who suffer from dry mouth, a possible side effect for hundreds of prescription and nonprescription drugs that can also be brought on by aging, tobacco use, cancer therapy or autoimmune diseases such as HIV/AIDS and Sjogren's Syndrome.

Currently, over-the-counter mouthwashes are the only treatment option.

"I know people who suffer from this and I know there has been no solution either over the counter or prescription that works," said Robert Kelly, a UConn School of Dental Medicine reconstructive sciences professor who developed Oral Fluid Dynamics' technology. "These people are desperate."

The solution Kelly and his partners -- Douglas Adams, a mechanical engineer with a Ph.D., who works in orthopeadic surgery at UConn Medical School, and Martin Freilich, an implant surgeon and prosthodontist at UConn Dental School -- have come up with is a dental implant with a pump that takes fluid already present from the mandible bone and supplies it to the mouth. Kelly says it's the first mechanical solution for dry mouth.

Oral Fluid Dynamics is about three years out from clinical trials and is working on getting a $1.5 million grant from the National Institutes for Health (NIH) by September. The startup is currently testing its product on rabbits with miniature pigs up next.

"By the end of this we should have enough information for the Food and Drug Administration (FDA) for a limited clinical trial," that will focus on a small number of people to test the implant's safety, Kelly said. There are potential infection risks related to changes to the jawbone, where the implant is placed, similar to how a dental implant is done.

Kelly, who owns 60 percent of the company, said people have already been trying to get on the waiting list when human clinical trials begin.

"It's either going to work really well or it isn't," Kelly said during a recent interview in a conference room outside his UConn Health office in Farmington.

The company's main competition comes from the University of Texas Health Center at San Antonio and Rice University, which are working on another possible solution for dry mouth that focuses on tissue engineering through the use of cells to grow salivary glands.

"It's not going to work. The technology isn't far enough along and won't be for 30 years," Kelly said. Kelly doesn't express those words with any form of braggadocio. He has a scientist's detachment when discussing his device. His excitement, it seems, comes more in the response to the new world his invention has opened for him.

In July, for example, he took a trip to Basel, Switzerland, to meet with the heads of three companies that could manufacture the implant if it eventually receives FDA approval. The implants could also be made as close as Andover, Mass. "We don't want to manufacture this ourselves," he said.
Local connections

So far, Oral Fluid has raised money from various sources including Connecticut Innovations, the state's quasi-public venture arm, the UConn SPARK Technology Commercialization Fund and Acclerate UConn.

Recently, the company picked up an MBA student on a half-time fellowship because Oral Fluid Dynamics received $10,000 for general business purposes as part of Accelerate UConn, a university startup incubator and funder made possible by a grant from the National Science Foundation Innovation Corps.

The student gets a $5,000 stipend. Outside of some specialty accountants and lawyers, Kelly said he has found most of the support Oral Fluid Dynamics needs in Connecticut.

"This is pretty well funded," Kelly said, acknowledging that he and his partners are not entrepreneurs with killer business instincts. "We're out there to provide solutions to desperate people."

One funding option the company has avoided so far is venture capital, and its not by accident. Using venture funds would mean turning over control of the company, something Kelly doesn't want to do.

Still, all funding is important because the inventors need about $1 million annually for the next five years to get the product to market. Kelly hopes a manufacturing partner covers that expense because the reward could be worth it.

If the product eventually gets regulatory approval, about 200,000 people can be treated in the first five years because of the capacity of dentists who can perform the work on an annual basis, Kelly said.

"But you're looking at hundreds of millions in profits per year," Kelly estimates. That's just in the U.S. treating about 5 percent of the people who are affected by dry mouth.

Initial profit, Kelly said, based on "rough, back of the envelope figures," would be $5,000 per implant, which insurance companies, at least right now, don't cover.

"We have no problem with people spending $25,000 to rebuild their mouths," Kelly said. "There are people out there who can afford it."