MIPS Project Detail:
Company
Company Description:
Vasoptic Medical Inc. is a medical device company developing and commercializing high-quality, cost-effective products for the non invasive, dynamic assessment of retinal blood flow and vascular status. Vasoptic Medical has developed a low-cost, portable, noninvasive retinal imaging instrument (the XyCAM), which can complement fundus photographs with retinal blood flow information obtained at high spatio-temporal resolution without the introduction of any dyes. This handheld retinal imager has the potential to help detect a number of clinical conditions, including diabetic retinopathy (DR), glaucoma, and age-related macular degeneration. Early detection can often prevent vision loss. The XyCAM device is being designed to detect these conditions inn their earliest stages to help healthcare providers manage and prevent DR and glaucoma progression through a convenient, low-cost, minimally invasive procedure.
MIPS Project
XyCAM RI Study: Early Clinical Assessment
Project #
5215
|
MIPS Round
52
|
Starting Date:
Aug 2013
MIPS Project Challenge:
The goal of this MIPS project was to collect clinical data to validate the performance and reliability of Vasoptic’s hand-held imaging system as a precursor to its development for disease detection, including the diagnosis and monitoring of diabetic retinopathy (DR), glaucoma, and age-related macular degeneration. Vasoptic needed first-in-human retinal images to optimize its system for the intended use case.
Project Scope:
Through this MIPS project, researchers conducted a small, early feasibility clinical study to capture retinal images using the XyCAM and a clinical standard (color fundus photography). They then analyzed and compared image qualities and the robustness of blood flow measurements based on objective metrics.
Results:
The goal of the first MIPS project was achieved—testing of the XyCAM RI prototype for the first time in human subjects and assessing its most crucial aspect, its ability to estimate retinal blood flow. The study validated the first handheld retinal imager capable of reliably measuring retinal blood flow. An abundance of data was collected, analysis of which continued beyond the MIPS project, and results were reported both through peer-reviewed publications and through presentations at scientific venues.
The project helped obtain key evidence pertaining to the feasibility of the XyCAM system in the clinic. The results justified the XyCAM’s continued development and consideration as an affordable and convenient diagnostic instrument. The project also helped Vasoptic in fundraising and making significant strides towards regulatory approval. Multiple presentations were made at ARVO, the most widely attended scientific meeting for ophthalmology worldwide.
Vasoptic has raised over $3 million in funding to date.
Principal Investigator:
Osamah
Saeedi
Associate Professor, Department of Ophthalmology and Visual Sciences
Project Manager:
Matthew
Brooke
CEO & General Counsel
Technologies:
Medical Instrumentation / Equipment
