BrachyFoam President and Founder, Tim Showalter, MD featured in UVA Licensing & Ventures Group 2017 Annual Report

Faculty Profile: UVA Cancer Center Radiation Oncologist, Tim Showalter, MD

In medicine, there can be a frustrating paradox where the most innovative forms of treatment are available for patients, but scientific advancements are not simultaneously advancing the tools used to deliver them.

Tim Showalter, MD, a radiation oncologist at the UVA Cancer Center uses an image-guided radiation therapy treatment for cervical cancer patients that has a rudimentary applicator and accessories that have not evolved from their basic design in over 60 years. A graduate of the UVA School of Medicine, Showalter returned to UVA in 2012. Soon after arriving, he had an idea that would make the procedure significantly more comfortable for his patients, and advance the field of radiation oncology.

Specializing in prostate and cervical cancer treatment, Showalter uses a radiation implant procedure known as brachytherapy wherein the radiation source is placed in or near the tumor giving a high radiation dose to the tumor while reducing exposure in the surrounding healthy tissue. A specific type of brachytherapy known as tandem and ovoid brachytherapy is required in the treatment of cervical cancer. Showalter executes this procedure over 200 times annually, more than any other radiation oncologist in the region.

Part of the procedure, conducted while the patient is awake, requires inserting packing material around the perimeter of the cervix in order stabilize the cervical cancer brachytherapy applicator and protect healthy tissue from the high-dose radiation. There are two commercially available options on the market today, one involves manually loading gauze into the area using forceps, while the other is a highly engineered balloon device that costs around $400 per use. A patient with locally advanced cervical cancer would receive a minimum of five tandem and ovoid brachytherapy treatments.  Because the cost of the balloon device is the responsibility of the medical center, most clinicians end up using gauze as a less expensive option.

Showalter’s solution, which would be more comfortable than gauze for patients, and more cost effective than the balloon device, is a self-expanding hydrogel that reacts and expands once inside the vagina, is similar to a spray foam. This material can create the necessary isolation while interacting and absorbing the radiation much better than gauze.

Soon after the conceiving this idea, even before finding a polymer chemistry collaborator, Showalter engaged with LVG to discuss the idea and to identify a commercialization pathway that would bring the hydrogel solution to market. His early engagement with LVG led him towards the 4-VA proof-of-concept grant program, which funded a collaboration for the creation of a hydrogel material with Tim Long, Ph.D., a chemist at Virginia Tech. Showalter’s team includes his colleague, a medical physicist in the UVA radiation oncology department, Bruce Libby, Ph.D., who now co-leads clinical development efforts.

A second grant through the Ivy Foundation at UVA funded the design of a delivery system for the hydrogel and the evaluation of this approach in phantoms and cadavers. Leveraging the LVG network, Showalter and his team connected with David Chen, Program Director for the Coulter Foundation, who shaped a team of UVA biomedical engineering students to build a prototype of a hydrogel delivery system.

“When I first met with Michael Straightiff, he was very supportive in helping make connections for me,” Showalter said. “His introductions created our current network of people, all of whom have been instrumental in the development of this idea. As a clinician with limited experience in translational research, the resources and counsel from LVG have been incredibly valuable in helping me to understand how the process works.”

Patent protection for both the hydrogel and the delivery device have been in progress at LVG since Showalter and his team submitted their first invention disclosure in 2013. LVG coordinates with Virginia Tech on the intellectual property protection and converted one of the provisional patents in July 2017.

Showalter’s initiative in pursuit of this translational research project is rare among clinicians whose priority is patient care. While LVG has been a resource for him to facilitate the technology transfer process, his persistence and resourcefulness drive the creation of this medical device that could change the way radiation oncologists perform tandem and ovoid brachytherapy treatment.

“The available and archaic packing options are a huge personal frustration of mine and represent an area of clinical need in radiation oncology,” says Showalter. “There is nobody in the region more familiar with this issue, and having this specialized knowledge comes with the responsibility of making this solution accessible through commercialization.”