Whiteboard2Boardroom presents innovations from regional universities, hospitals, research organizations to encourage commercialization.

1. Dual Function Camera-cytology Device
for Gastrointestinal Diagnosis & Imaging
June 18, 2020

2. What is the problem?
• By 2030, in many countries, 1 in 100 men may develop esophageal cancer (American
Journal of Gastroenterology).
• Rise in the prevalence of conditions affecting the upper gastrointestinal tract including
• gastroesophageal reflux disease
• Barrett’s esophagus
• eosinophilic esophagitis
• squamous dysplasia of the esophagus
• Patients with gastroesophageal reflux disease (GERD) or Barrett’s esophagus have an
increased risk of developing cancer of the esophagus and therefore must be monitored
carefully.
• The current protocol for biopsies of the esophagus only collects 5% of the esophageal
mucosa.
• There is a need for a low cost screening tool for these conditions that has the potential to
reduce human suffering globally.

3. How does product solve problem?
• Small camera/collection device that collects samples all along the surface of the
esophagus, increasing disease detection rate.
• Small (pill-sized) retractable capsule device containing a tiny balloon that can be inflated to
project a set of integrated plastic strip brushes with medical grade nylon bristles. Once the
balloon deflates, the sample is kept safely protected within the capsule.
• The capsule also has a micro-CMOS camera attached to the front, which takes pictures of
the esophagus as it travels down. The camera that is connected digitally to a computer to
monitor and record live video.
Prototypes in Development

4. How does product solve problem?
• The present invention is designed to be portable and easy to perform by a nurse or health
care worker (non-professional) during a regular patient visit.
• Sedation and/or anesthesia are not expected to be necessary with use of this device. It
reduces the –
(1) the requirement for physical location
(2) the need for a physician to perform the procedure
(3) the inconvenience and secondary effects on patients
Prototypes in Development

5. What is the market use?
• Device features both camera and cytological “collectors” activated via
pressurized air. The device allows direct visualization and tissue sampling of the
esophagus and the stomach lining.
• The functionality of the device is similar to an endoscope, but likely much less
invasive with increase in detection rates
• The procedure should not require sedation and can be done by a nurse or
health care worker at a regular patient visit.
• Unique “pneumatically activated cytology” demonstrates novel approach.
Improves simplicity, safety, and patient comfort over other methods
• In the case of cancer, this device can provide a minimally invasive method to
monitor progression and/or regression of the disease throughout treatment.

6. What competition exists?
• Dual functions – imaging and cell collection – combined in one device
• The brushes that project from the balloon are conceivably an improvement
over the current endoscopic tweezers and needles that are used to collect cells.
• A broad collection of cells occurs with use of a brush, that reduces the sampling
error significantly and therefore disease detection rates may be increased.
• Polymer components drastically reduce costs allowing for a completely
disposable device. Allows for broad utilization in low-income markets (Asia,
Africa)
• This procedure collects much more of the mucosa and increases chances of
detecting cancer earlier and reduces sampling error.
• Eliminates need for endoscopy in order to diagnose conditions affecting the
upper gastrointestinal tract

7. What is the status of the intellectual property?
United States Patent Application Publication # 20190387961 entitled
“Imaging and Collection Device and Related Systems and Methods”
filed January 31, 2017

8. What is the stage of development?
Prototype of the device available and tested in vitro
In vivo testing in animals is in progress

9. What is needed for further development?
• Determine most effective “cell collector” design via further in vitro
testing
• Improve camera integration within custom parts (mounting, image
quality. etc)
• Address all safety concerns regarding class II FDA approvals
• Develop relationships with vendors and suppliers to acquire
parts/improve processes
• Preliminary in vivo animal testing, refinement
• Clinical trials

10. Questions?