“Muscle oxygenation as an early predictor of shock severity in trauma patients” is a Harborview Medical Center IRB-approved clinical study on critically ill patients that has been accepted for publication in the journal Shock. Upon publication, copies will be available by request:
Lorilee S. L. Arakaki, Ph.D.
Dept. of Pediatrics
University of Washington
Opticyte received a regulatory opinion from Drug and Device Development Co. (DDD), Inc. in October 2015. In that opinion, Martha Feldman, President of DDD anticipated that the cell oximeter would be a Class II device, likely with a medical device 510(K) application submitted for review to the Cardiovascular Device Branch of the Center for Devices and Radiological Health of the FDA. Her opinion was based on the fact that the Company’s oximeter technology has a known intended use and indication for use, and the availability of predicate device summaries for guidance on the data that will be required for a 510(K) submission.
Opticyte has not filed for FDA 510(K) clearance or CE certification.
Opticyte is currently working on the design and development of the product and has not started selling activities.
Opticyte completed an exclusive license agreement with the University of Washington for development and commercialization of its cell oximeter technology on September 1, 2016. The IP encompassed in that agreement (application number 13/883,279) will protect features of the device that distinguish it from competitors: a unique system of light illumination onto the surface of the skin, a set of algorithm process steps, and the initial design concept for the OHP™ disposable, noninvasive sensor.
In August 2016, Opticyte was awarded at $1M Phase II SBIR grant from NIH. Prior to that, Drs. Schenkman and Arakaki have received over $2M in grants to pursue novel cellular oximeter technology, and during the past six years have accelerated applied research efforts resulting in a laboratory prototype of the CellSat™device. The sources of this funding include NIH, Coulter Foundation, WA Life Sciences Discovery Fund, NIH STTR Phase I, SBIR Phase II, CoMotion Innovation, and Medic One.