Screenings are needed for hundreds of millions of people worldwide

• Over 35 million patients with diabetes in North America require annual exams yet only about 50% are ever seen by an eye doctor!
• Inadequate number of eye care providers currently providing eye care services to patients (they may or may not provide screening for diabetes)
  • Current eyecare providers globally: 
    (Only 210,730 Ophthalmologists / 250,000 Optometrists)
    • Limited patient access
    • Inappropriate costly use of specialists
• Additional screenings now needed for COVID-19 pandemic patients

2019 update: 463 million adults worldwide with diabetes 2045 projection: 700 million adults worldwide with 334 million in the Asia/Pacific region — The International Diabetes Federation (2019)

With an affordable system without dilation of the pupil, there is tremendous potential to screen millions of individuals globally for diabetic retinopathy.

Although no organization keeps global statistics for HC workers, the 2006 World Health Report  (WHO) conservatively estimated the global healthcare workforce at 59 million workers. Current projections from the WHO estimate a creation of 40 million new healthcare workers by 2030 in upper-middle and high-income countries. Healthcare worker jobs for low-income countries are also estimated to increase.

Potential customers include:

• Ophthalmologists, Optometrists, Retinal Specialists
• Any medical specialty (Primary Care, GP, Pediatrician, Internal Medicine, OBGYN, ENT, and others)
• Hospitals, Clinics and Outpatient Surgery Centers 
• Community Care, Urgent Care Centers, and Emergency Rooms
• Assisted Living
• Military: Clinics, Hospitals, and Family Care Centers
• Schools and Community Centers

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 in order to diagnose the earliest changes in diabetes.

In addition, dilating the pupils of diabetic patients is considered risky, because the dilated pupil may not properly constrict and resume normal function and may precipitate an attack of narrow-angle glaucoma in patients who may or may not know they have it. It is harder to look through a 2 mm pupil than a dilated one, however, up until now the technology was not available.  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 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
• dilating can precipitate an attack of angle-closure glaucoma

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™ Imaging System is intended to provide the next generation of:

• Cost-effective, ultra-wide imaging technologies
• Examination of the periphery of the retina, at up to a 200-degree field-of-view
• Detection of the early signs of diabetic retinopathy without having to dilate the patient's pupil
• Documentation of high-resolution imaging the patient record for future reference

The RetinalCam™ Home Monitoring and Physician Alert System will provide:

• Patient monitoring themselves in real-time communication with their physicians
• Value to telehealth patients and patients identified as “high risk”
• Care for patients needing immediate intervention
• Value for the disabled or those living far from healthcare facilities