Addressing the largely unmet diagnostic, economic, and social needs in ophthalmology: Notal Vision, Inc.

“We enable physicians to extend eye disease management from the clinic into the patient’s home to obtain optimal vision outcomes.”

Age-related macular degeneration, commonly referred to as AMD, is a progressive and irreversible disease of the eye that affects the macula, the central six millimeters of the retina. The maculais responsible for our detailed vision used to read, recognize faces, and drive. AMD is the most common cause of irreversible vision loss in people over the age of 55 in the developed world.

Headquartered in Manassas, VA, Notal Vision is advancing vision care and improving vision outcomes for patients by extending diagnostic testing from the clinic to the patient’s home. The company has created the first cloud-based, patient-activated platform that connects patients and eye doctors between office visits. ForeseeHome^®, Notal’s first product to market, is a simple yet very effective, daily, at-home test that can detect the progression from the more prevalent dry AMD to the advanced, serious wet form of the disease earlier, while the patient’s vision remains good. This permits the patient to begin treatment earlier which has been demonstrated to result in better retention of their good vision over time.

Notal Vision is led by industry veteran CEO, Quinton Oswald, who brings a long pedigree of ophthalmic successes in large and small companies to Notal, including the launch of Lucentis^®, the paradigm changing treatment for wet AMD, and the development of Xiidra^®, acquired by Shire. Oswald has assembled a seasoned team of US-based industry experts to lead the pioneering enterprise, including commercial, medical, and financial executives that complement Notal Vision’sIsrael-based research and product development experts.

The company’s integrated platform employs proprietary AI algorithms to detect vision and anatomical changes, providing diagnostic decision support to eye care practitioners. Using a monthly recurring revenue model akin to a subscription service model, the platform provides the basis forcost-effective solutions that enhance compliance and improve patient outcomes. While ForeseeHome is the first application of Notal Vision’s innovative platform, their second product, home-based optical coherence tomography (OCT) is in development.

Notal Vision’s additional pipeline programs further optimize the vision benefits of timely and continuous disease detection and diagnosis, leveraging Notal Vision’s ability to place medical diagnostics in patients’ homes and data in doctors’ offices.

Conversing with CEO of Notal Vision, Quinton Oswald:

What led to the inception of the company?

I describe Notal Vision as a brand new 17-year-old company. While the company was founded in Israelin the early 2000s, the company’s direction and mission have evolved. Today, Notal Vision leverages state of the art technology to address current unmet needs in retina disease management with the first patient-activated, AI driven, cloud-based platform that connects patients and eye doctors.

Notal’s innovative Tel Aviv-based R&D team developed a home-based diagnostic device, ForeseeHome, that alerts physicians to changes in their patients’ vision indicative of progression from dry to wet age-related macular degeneration (AMD). More than 10 million Americans over 55 have dry AMD and are at risk of progressing to the advanced wet form of the disease. Because doctors cannot predict who will progress, or when, and the change and resulting vision loss happens quickly, identifying the change as soon as possible is critical for patients to begin the treatment that will preserve their vision. Notal’s R&D team developed ForeseeHome, an artificial intelligence enabled device that analyses patient’s home-testing data in real time, in the cloud. We did a lot of work to obtain FDA clearance in the US;our development program included a collaboration with the US National Eye Institute (NEI) in the AREDS2*HOME study. The results, published in three peer reviewed journals, showed the significant vision benefit that dry AMD patients converting to wet AMD achieved when testing with ForeseeHome compared to those patients without ForseeHome. Fifty percent more patients that were diagnosed with wet AMD retained good, functional vision when testing with ForeseeHome compared to those who did not. This is the difference between driving, and not driving – reading, and not reading, for a significant group of patients.”

The HOME study was a definitive longitudinal clinical trial. The outcomes were irrefutable. Notal Vision launched the product commercially to a US test market in January 2016. Our home-based AMD monitoring program garnered Medicare reimbursement, which is pretty much 95% of the AMD market. What we’ve been doing since then is putting together what I call an “ecosystem”, which combines the device, the artificial intelligence, and a patient education and support environment with digital remote monitoring. What Notal Vision has accomplished since 2016 is really a move from purely a device-based company to an ecosystem; we have created a platform where the patient, the doctor and the company can interface using the cloud as a platform.

Discuss the obstacles faced at the beginning.

Financing at the early stage was a challenge because the entire concept was very much in its infancy, though it is starting to become very popular now. But at the early stage, digital imaging was kind of a star in the future. This was a challenge when we were raising cash to overcome. We were fortunate to have some visionary investors behind us.

The next real issue was creating an integrated ecosystem. The combination of skill sets needed for this are not typically associated with a medical device company or an AI company. When we started this process, our infrastructure was designed to support a 1500 patient clinical trial. It was not designed to scale to hundreds of thousands of patients which is the current market opportunity. There are more than 8M dry AMD patients in the US, of which 3.8M have intermediate AMD and are at higher risk of progressing to Wet AMD. These high risk patients are ForeseeHome candidates presenting a significant market opportunity for Notal Vision.

How do you maintain a healthy and constant relationship with patients?

The most important part is education. So, one of the elements that we are building is an ongoing education platform both for the web and interface with our diagnostic testing facility. We connect with patients who are prescribed ForeseeHome and we educate them about their disease and the importance of testing. When a change in their testing is detected, we notify the patient’s doctor. So, what we have developed is an ongoing patient relationship that leverages a combination of both technology tools and personalized communication.

Can you briefly explain the ForeseeHome process?

Eye care doctors prescribe the ForeseeHome AMD Monitoring Program to the patient and we take it from there. Our Diagnostic Testing Facility connects with the patient and educates them on their disease and ForeseeHome. The device is delivered to the home and the patient receives personalized set up instruction; we teach them how to use the device, why the doctor prescribed it, and what to expect going forward. The first thing the patient completes when testing is to establish a baseline as a reference for future test results. Once baseline is established, we advise patients to test daily. Motivation to preserve your vision is strong and the compliance with routine testing across our patients is very high. Our Diagnostic Facility monitors patients’ testing results day in and day out and as I described, and when the testing results indicate a significant change from the baseline, the Diagnostic Testing Facility contacts the doctor to share the change and the need for immediate physician follow-up.

ForeseeHome is designed to detect the switch from dry to wet AMD. The other side of the equation is optimizing the treatment and outcomes of wet AMD. Our engineers and scientists have developed a home-based optical coherence tomography (OCT) device permitting wet AMD patients to test at home using the same methodology as ForeseeHome. The data is sent to the cloud and analysed with a machine learning AI algorithm to identify the moment the test detects wet AMD associated fluid in the retina. Here too, physicians are notified of the event by the Testing Facility and are able to bring the patient to the office for sight-preserving treatment.

What is the future roadmap for Notal Vision?

Currently, our focus is ophthalmology. However, the platform we are building will enable us to enter other therapeutic areas with home monitoring. In 2019 we will roll out ForeseeHome nationally and we expect to achieve significant growth by early 2020. Furthermore, Notal Vision’s pipeline includes Home-based OCT which has entered the clinic and will reach the market within the next two years. For the vast majority of the 1.5 million eye injections delivered each year in the US, Home-based OCT will enable eye doctors to treat based on individualized, continuous assessments of each patient’s disease status, moving from a standardized treatment regimen to personalized medicine.

Leading a great team:

Quinton Oswald, CEO:Oswald is an ophthalmic industry veteran. Prior to joining Notal Vision in 2016, he served as CEO of Neurotech Pharmaceuticals. As CEO of SARcode Bioscience, he was instrumental in the clinical development of lifitegrast ophthalmic solution 5% (Xiidra^®) for the treatment of dry eye disease, and its subsequent sale to Shire, PLC. Previously, Oswald was Vice President & Business Unit Head for Genentech’s Tissue Growth and Repair Business.During his tenure at Genentech, Oswald oversaw the highly successful commercial launch of Lucentis^® (ranibizumab injection) for the treatment of wet AMD. Prior to Genentech, Oswald led the North American Ophthalmology business for Novartis, which, in conjunction with QLT, Inc., pioneered Visudyne^® (verteporfin for injection), the first drug treatment for wet AMD.