Problem

 
PROBLEM #1:  (COVID-19)


Covid-19 causes greater need for a diagnostic screening that can reach the masses 

  • 1 billion obese patients and rising
  • Central visual testing is inadequate 
  • Earliest microvascular changes occur in the periphery of the eye which is not seen without dilation

Dilation 

  • Time consuming
  • Expensive for the doctor and patient
  • Inefficient for screening of the masses
  • Should be reserved for screened patients shown to be at risk

Current methodology

  • Extremely expensive
  • Unavailable / Not portable 
  • Does not provide a comprehensive enough field of view
PROBLEM #2:  INSUFFICIENT AND INADEQUATE SCREENING  FOR DIABETIC PATIENTS

Screenings are needed for hundreds of millions of patients
 
  • Over 35 million patients with diabetes in North America require annual exams yet only about 50% arc ever seen by an eye doctor!
  • Inadequate number of eye care providers
    • Current providers globally
      (Only 210,730 Ophthalmologists / 250,000 Optometrists)
      • Limited patient access
      • Inappropriate costly use of specialists
  • Current technology is not available to assist the diagnosis of the earliest stages of diabetic retinopathy (200 Degree FOV) on a global scale
  • Current technology is not available to assist the diagnosis of the earliest stages of diabetic retinopathy (200 Degree FOV) on a global scale
Significant Unmet Clinical Need:
A problem with diagnosing diabetic retinopathy and maculopathy is that they typically begin at the periphery of the retina, which is difficult to see, and then works its way towards the center of the retina, at which point it can be too late and blindness can set in. Physicians often use microscope-like devices with or without an attached camera that have a fixed field of view (typically between 20-50 degrees) to try to diagnose diabetic retinopathy.  
However, such examination sometimes does not reveal signs of retinopathy present at the periphery of the retina because of the limited field of view.  In order to see the periphery of the retina, it is desirable to increase the field of view when diagnosing retinopathy.
In addition, dilating the pupils of diabetic patients is considered risky, because the dilated pupil may not properly constrict and resume normal function afterward.  This exacerbates the problem because it is harder to look through a 2 mm pupil than a dilated one. The normal pupil size in adults varies from 2 to 4 mm in diameter in bright light to 4 to 8 mm in the dark.
  • Retinopathy (a degenerative disease of the retina) is one of the most common effects of diabetes.
  • Left untreated, diabetic retinopathy and maculopathy can lead to permanent blindness.
  • Current diagnostics sometimes do not reveal early signs of retinopathy present at the periphery of the retina because of their limited field of view.
  • Dilating the pupils (used with current diagnostics) of diabetic patients is considered risky, because the dilated pupil may not properly constrict and resume normal function afterward.
There is a need for a simpler and more affordable device and method that allows for simplified but accurate imaging of a person’s retina to detect symptoms of diabetic retinopathy.
  • Detected early and treated effectively, retinopathy can be stopped so that vision can be maintained.
  • Early diagnosis is a critical factor in broadening care and prevention. 
  • There is a great unmet need for a simpler and more affordable device and method to detect symptoms early - especially at the periphery of the retina.
  • The RetinalGeniX system is intended to provide the next generation of cost-effective, ultra-wide imaging technologies to examine the periphery of the retina, at up to a 200-degree field of view, to detect early signs of diabetic retinopathy without having to dilate the patient's pupil.
  • The RetinalCam™ Home Monitoring and Physician Alert System will allow patients to monitor themselves. Home monitoring with real-time alerts to their physician may result in sight saving interventions. 
PROBLEM #3:  Growing Shortages of Eye Care Professionals
 

Shortages of doctors loom while population increases. We can no longer afford to treat potentially preventable disorders that are diagnosed too late at a cost that is so impractical it is overwhelming the system.

Globally Situation:

  • For many individuals blindness is the first sign that a problem exists
  • Increasing numbers of adults age 65 and older
  • Increasing diabetes and individuals with diagnosed and undiagnosed diabetes
  • Many people have moved into an expanded category referred to as “High Risk”:
    1. Obesity
    2. Type 1&2 diabetes
    3. Heart disease
    4. Strokes
    5. Macular degeneration, wet and dry
    6. Chronic lung or moderate severe asthma
      Weakened immune systems