Universally Friendly Obturator

Solution Pitch

The Problem

Cervical cancer is the leading cause of death from cancer amongst women, disproportionately affecting low-income countries where 80 percent of cases are diagnosed. Late-stage cervical cancer has a 5 percent survival rate contributing to 311,000 deaths globally every year. Current methods rely heavily on the use of transcutaneous needles, pushed through multiple layers of skin and healthy tissue, in order to irradiate the tumor—a highly invasive, time-intensive, and difficult procedure to perform.

The Solution

The Universally Friendly Obturator (UFO) is a 3D-printed applicator that addresses issues with current brachytherapy methods by completely eliminating the need for transcutaneous needles. Physicians place the obturator head of the UFO into the vaginal canal until the head rests against the cervix. The user interface, where the needles are initially inserted, sits outside of the vaginal canal. The physician places needles through the angled internal channels, which span the length of the entire UFO, until they reach the tumor. This unique design treats the full extent of a 9 cm tumor without the use of a single transcutaneous needle, minimizing patient morbidity typically associated with brachytherapy. 

With this approach, the cost, time, and expertise needed to complete the procedure are also lowered. To ensure broad implementation, the UFO is uniquely adaptable to both patient anatomy and compatible  with all brands of equipment. 

Stats 

The UFO is expected to treat over 500 patients within Texas in its first year and thereafter expand throughout the U.S., Nigeria, and Tanzania to treat 60,000 women by 2023

Market Opportunity

The UFO plans to target medical professionals working in brachytherapy clinics, primarily in low-resource settings—a market estimated at $96,903,125 million. 90 percent of deaths due to cervical cancer occur in low resource settings because of a lack of accessibility to treatment. The UFO is the first of its kind to not only optimize brachytherapy treatment but also increase accessibility to treatment by lowering treatment time and expanding the workforce of brachytherapy professionals.

Organization Highlights

• Winner of the Collegiate Inventors Competition hosted by the National Inventors Hall of Fame

• Recipient of the Healthcare Technologies for Low-Resource Settings Prize in the DEBUT Challenge, The Innovation Award by the Rice 360 Institute for Global Health, and the Grand Prize in the Design of Medical Devices Conference hosted by the University of Minnesota 

Partnership Goals

The UFO team currently seeks:

• Advice from a regulatory/compliance expert or another entrepreneur on applying for an FDA 510K exemption and the necessary accompanying quality assurance documentation

• Guidance on a monitoring & evaluation plan for assessing the device’s impact

• Marketing & PR guidance to develop and promote the UFO brand 

• Developer support to create a product website to promote (and later sell) the UFO