Third Eye Diagnostics Inc.
A non-invasive medical device company
Presenter: Terry Fuller PhD, CEO
Monday, December 11, 2017
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About
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Third Eye Diagnostics Inc. has developed the CerePress,™ a non-invasive medical device to measure intracranial pressure (ICP) which is critical for the management of hydrocephalus and for assessing the onset and extent of traumatic brain injuries (TBI). Elevated ICP inhibits blood flow to the brain, placing patients at risk for brain damage and death. Early detection of patients suffering from neurological deterioration due to elevated ICP results in improved patient outcome and reduced hospital stay. However, current ICP monitoring is invasive, performed by drilling a hole in the skull and inserting a pressure transducer into the cranium. As a result, ICP monitoring is only performed on TBI patients who are already critically ill. There are no FDA cleared devices to measure ICP.
In response, Third Eye has developed the CerePress. The system consists of a handheld device and a single- use, patented, disposable optical cap that will result in a trailing revenue stream. The CerePress has been developed to address an estimated $40 billion unmet need for non-invasive ICP measurement. It provides an indispensable “spot check" of ICP in an easy-to-use, accurate and rapid (under 30-second) package. It can be used with minimal training in the ER, ICU, surgical suite, in the battlefield, in sporting and medical transport settings, and potentially in the home.
Third Eye has 4 granted patents and has one pending patent application. The technology has been clinically validated in 2 published studies, and further validated and substantially funded by the National Science Foundation (NSF). Third Eye Diagnostics forecasts revenue in excess of $40MM within 4 years of product launch.
3 Major Issues
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REIMBURSEMENT QUESTION
1. What are the hurdles in obtaining a reimbursement code for ICP monitoring by:
a. Health professionals
i. Contributing to a diagnosis
ii. Following changes in condition and contributing to treatment
b. Patient or family member in the home:
i. Detecting condition change or ruling out perceived symptom within physician
designated norms
MARKETING QUESTION
2. In management of a hydrocephalus shunt patient:
a. What is the average or typical cost to manage a patient having a suspected shunt failure?
b. How many ER visits does such a patient make per year? What percentage of the visits are
shunt failures, i.e., false positive visits/discharge for ER?
c. What percentage of the patients sent for invasive/surgical ICP procedures are found not to
have an elevated ICP? Are such records considered reliable, i.e., will surgeons admit that
there was no elevation of ICP?
REGULATORY/REIMBURSEMENT QUESTION
3. Durable Medical Device designation
a. Do chronic patient monitoring devices qualify for coverage as a DME or Service?
b. How does the clinical indication factor into obtaining DMR coverage?
c. Does the cost of a device impact coverage? An associated disposable?
d. How do digital health or telemedicine devices factor in?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Terry Fuller PhD, CEO will deliver Greene Street's "Elevator" Pitch to the Group
8:20 - A Panel will address three major issues crucial to helping the Company reach the next level.
9:00 - Open discussion: members and guests
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Slides
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