Notal Vision Submits IPO Filing Following $60M Series D Funding to Advance At-Home AMD Monitoring Technologies

The anatomical structure of the human eye is exceptionally complex. Within this intricate system, any minute structure is susceptible to abnormalities, ultimately compromising normal visual function.

Age-related macular degeneration (AMD) is an easily overlooked yet irreversible ocular disease that severely impairs quality of life, with both its prevalence and severity increasing with age. In 2020, the COVID-19 pandemic transformed the methods of clinical monitoring and patient self-assessment for AMD, opening up new possibilities for remote monitoring and home-based self-testing of macular pathology.

Notal Vision, as a diagnostic service company and healthcare provider, has brought macular degeneration self-testing technology into the home. Through a validated platform that leverages artificial intelligence to analyze large volumes of personalized health data, it extends disease management from clinical settings to the home, improves patients' visual outcomes, reduces treatment burden, and enables healthcare professionals to remotely monitor patients' conditions.

On June 1, 2021, Notal Vision announced the completion of a $60 million Series D financing round co-led by Soleus Capital and Ganot Capital, with participation from existing shareholders Elron and Evergreen. The company stated that the proceeds will be used to support the growth of its current business and to advance its ForeseeHome AMD monitoring program as well as the commercialization strategy for its Home OCT pipeline technology.

Macular degeneration is typically a natural consequence of advanced aging. As age increases, retinal tissue degenerates and thins, leading to a decline in macular function. With the advent of a globally aging society, the incidence of fundus diseases among middle-aged and elderly populations continues to rise year by year. According to statistics, the incidence rate among individuals aged 60 and above in China is 10.6%. Among these conditions, macular degeneration is a highly detrimental yet easily overlooked fundus disease in middle-aged and older adults, manifesting as degenerative visual impairment—blurred vision and decreased visual acuity.

As of the end of 2020, macular degeneration was one of the top three causes of blindness globally. According to World Health Organization (WHO) estimates, the number of AMD patients aged 30–97 worldwide reached 196 million in 2020. According to Frost & Sullivan estimates, there were approximately 3.7 million patients with wet AMD in China in 2020. Given that wet AMD accounts for 10%–20% of all AMD cases, calculated at 15%, the total number of AMD patients in China in 2020 was approximately 25 million.

Due to the symptomatic similarity between macular degeneration and presbyopia, coupled with a lack of proper disease awareness among most elderly individuals—who often attribute these symptoms to normal ocular aging—the optimal treatment window is frequently missed, resulting in irreversible consequences.

According to statistics, among individuals aged 75, the 15-year cumulative incidence of early AMD in at least one eye is 24%, while that of late AMD is 8%. AMD leads to the loss of central vision, with patients suffering from late AMD having a visual acuity of less than 0.1. With the aging of the population, the incidence of AMD is showing a significant upward trend. By 2050, the number of early AMD patients is projected to be twice the current figure, while cases of severely blinding AMD will be 2.6 times higher.

Delayed treatment is a major cause of blindness in macular degeneration. AMD is classified into two types: the "wet" form, characterized by subretinal neovascularization, and the "dry" form, characterized by geographic atrophy. Wet AMD is the most destructive form of the disease. Dry AMD accounts for 90% of all cases. When AMD progresses from dry to wet, there is a high risk of blindness. Due to delayed diagnosis following disease progression, patients often fail to maintain good functional vision. Only 34% of wet AMD patients retain driving vision at the time of diagnosis.

Dry age-related macular degeneration progresses rapidly to wet age-related macular degeneration. If not diagnosed and treated promptly, it can lead to severe vision loss. Therefore, early screening and timely detection of lesions are essential.

The FDA-approved ForeseeHome monitoring device, provided by Notal Vision, enables early detection of wet age-related macular degeneration (AMD) in patients with intermediate dry age-related macular degeneration (AMD).

The clinical utility of ForeseeHome was established in the Home Ocular Monitoring (HOME) study, a component of the AREDS2 study sponsored by the National Eye Institute. In this study, 94% of patients using ForeseeHome twice weekly maintained useful vision upon progression to wet AMD, compared to only 62% of patients who maintained useful vision through routine eye examinations or upon presentation with symptoms. These findings also demonstrate that Notal Vision’s monitoring system enables earlier detection of choroidal neovascularization (CNV).

Additionally, patient self-monitoring results will be automatically transmitted to the Notal Vision Data Monitoring Center. When significant changes occur in the monitoring baseline, the physician's office will receive an alert, enabling timely follow-up and treatment of the patient's condition. Physicians may then, at their discretion, bring the patient into the office for evaluation and treatment.

In addition, Notal Vision has successfully developed another FDA-approved product—the Home OCT System. This AI cloud-based optical platform is the first AI-powered program to utilize a home-based Optical Coherence Tomography (OCT) device for monitoring neovascular age-related macular degeneration (nAMD), primarily designed for the remote monitoring of retinal fluid changes in patients diagnosed with wet age-related macular degeneration (AMD). The Home OCT System enables wet AMD patients to perform technician-free scans at home, which is particularly beneficial for elderly patients at risk of vision loss.

The Notal OCT Analyzer (NOA) is a proprietary companion machine learning algorithm developed by Notal Vision that automatically analyzes Home OCT scans and generates reports for physicians upon detecting physician-specified changes in disease activity. NOA can also analyze outputs from other commercial OCT devices. Published research data indicate that when each device is compared against an expert panel, NOA's performance in detecting disease activity is comparable to that of retinal specialists.

The Notal Vision Diagnostic Clinic (NVDC) is a diagnostic clinic operated by Notal Vision. NVDC provides patient data to referring physicians via an online portal. Additionally, physicians will have 24/7 access to scan images from all patients undergoing Home OCT testing, enabling them to annotate fluid locations on each scan. It is reported that Notal Vision's Home OCT has the potential to support advancements in current and future retinal disease management.

In the United States, ForeseeHome is available by prescription and is covered by Medicare and most private insurance plans.

In June 2021, this healthcare services provider headquartered in Manassas, Virginia, completed a $60 million Series D funding round. The financing was co-led by Soleus Capital and Ganot Capital, with existing shareholders Elron and Evergreen participating in the investment. Notal Vision stated that the proceeds will be used to support the growth of its current business and advance the commercialization strategy for its ForeseeHome AMD monitoring program and its Home OCT technology pipeline.

“The secured funding will allow us to expand our ophthalmic diagnostic clinic business, establish referral partnerships with ophthalmologists, and provide remote patient monitoring services to a growing number of optometrists in China,” said Keith Nunn, CEO of Notal Vision.

Throughout its 21-year history as an ophthalmic diagnostic service company, Notal Vision has maintained a steady and solid business trajectory. In 2003, the company secured $4 million in Series A financing; in 2010, it closed two Series B rounds totaling $13 million; and between 2012 and 2016, it raised $23 million across four Series C rounds.

As a pioneer in the eye care industry, Notal Vision developed and launched the first home-based monitoring system for AMD patients, the ForeseeHome™ AMD Monitoring Program, which received FDA clearance.

In December 2018, Notal Home OCT was granted Breakthrough Device designation by the FDA and was selected for the FDA's OCT Innovation Pilot Program.

In January 2020, the American Medical Association (AMA) established three Category III Current Procedural Terminology (CPT) codes for reporting patient-initiated remote retinal OCT scans, enabled by Notal Vision's Home OCT.

On August 19, 2020, Notal Vision announced a partnership with a health information technology company. XIFIN provides Notal Vision with a Revenue Cycle Management (RCM) platform designed to ensure claims accuracy and timely reimbursement. This platform enables Notal Vision to scale appropriately to meet the growing claims and payment demands driven by the expansion of remote monitoring services.

The global ophthalmology market exceeds USD 50 billion and is poised for continued growth. According to Frost & Sullivan, the global ophthalmic pharmaceutical market grew from USD 24.7 billion in 2015 to USD 33.7 billion in 2019, representing a compound annual growth rate (CAGR) of 8.0%. In 2017, the global market for ophthalmic medical devices and vision care products reached USD 23 billion, with a projected CAGR of 4% from 2018 to 2023. Specifically, the ophthalmic surgical market was valued at approximately USD 9 billion in 2017, while the vision care market stood at approximately USD 14 billion, both expected to maintain a CAGR of 4% through 2023. By aggregating the ophthalmic pharmaceutical market with the ophthalmic medical device and vision care product markets to define the overall ophthalmology market size, the global market reached approximately USD 58.6 billion in 2019 (excluding ophthalmic medical services).

China's overall ophthalmology market size reached RMB 170 billion in 2019. According to Frost & Sullivan and 《China Medical Device Industry Development Report》, the total size of China's ophthalmology market reached RMB 170 billion in 2019, of which the ophthalmic medical services market accounted for RMB 124 billion (73%), the ophthalmic device market stood at RMB 26.7 billion (16%), and the ophthalmic pharmaceutical market reached RMB 19.3 billion (11%).

According to a report by Decision Resources, from 2013 to 2023, the age-related macular degeneration (AMD) pharmaceutical market across the United States, Japan, and the five major European markets (France, Germany, Italy, Spain, and the United Kingdom) is projected to grow at a compound annual growth rate (CAGR) of 6%, reaching nearly $9 billion by 2023. Factors driving the growth of the AMD market include: an increased prevalence of AMD due to an aging population, rising rates of polypharmacy, and the anticipated launch and rapid market uptake of the first therapies targeting geographic atrophy (an advanced form of dry AMD).