Dual function camera webinar presentation for webpage
- 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?