Ocular Technologies

220 million people worldwide suffer from preventable blindness but unable to access eye care. In US alone, there are 100 million ophthalmic conditions every year, yet only 20 thousands ophthalmologists. As a result, it takes weeks to schedule appointments and 40% diagnoses made at emergency care facilities are inaccurate. COVID-19 further exacerbated the problem as patients are unable to pay in-person visits at clinics, but video calls and selfie photos can’t provide the level of details required to make a diagnosis. Ocular Technologies is working to solve the access problem. Today, we allow clinicians to capture videos of anterior segments using our retrofit imaging systems that bolt onto slit lamps and enable remote consultations. Meanwhile, we are developing machine learning applications to guide exams and score videos. Eventually, our novel device will automate the eye exam procedures and can be deployed at places like nursing homes and CVS Health.

In 2018, ophthalmology was the second most expensive Medicare part B specialty payment at $7.1billion. According to MEPS in 2016, an office-base ophthalmologist visit cost $307 on average, and out-of-pocket payments are required 56% of the time with an average of $125 per visit. 

Based on CDC data, there are ~100 million ophthalmic conditions in the U.S every year. The problem is exacerbated as a result of aging demographics and increasing occurrence of chronic diseases. The shortage of eye specialists leads to lack of access for patients, especially for urgent conditions such as conjunctivitis and corneal ulcer. As it takes weeks to schedule ophthalmologist appointments, many patients resort to emergency departments and urgent care centers. 

Unfortunately, general practitioners lack proper tools and expertise to diagnose eye conditions. 40% of the diagnoses made at these facilities are inaccurate. This results in adverse outcomes ranging from extended episodes of pain to vision loss for the patients, medical malpractice liability for providers and excessive medical costs for payers.

Furthermore, in times of pandemics, telemedicine plays a critical role in providing patients with the care they need when a visit to the ophthalmology’s office is extremely difficult and poses great risk of disease transmission.

Our telemedical solution enables remote anterior segment exam through a phased approach detailed below: 

Phase 1 enables telemedical consultations with three components:

●  TelEye - End-to-end encrypted telemedical platform

●  EyeCap - Video recording and processing software

●  Video-Equipped Slit Lamp - captures high resolution, high magnification videos of the front of the eye 

Originating site clinicians will examine a patient and send the recorded exam to a remote eye doctor. A doctor will make a diagnosis and treatment plan using the video and return their findings to the exam site.

Phase 2 focuses on deploying software that helps clinicians acquire and pre-process videos to assist clinicians that lack ophthalmic training. We have begun development of software and ML models that will achieve two goals: 

●  Guided Exam Capture - real-time instructions guiding operators to capture high quality and complete exams

●  Exam Scoring - evaluates the quality and completeness of an eye exam and either upload it to TelEye or request that the clinician re-capture an exam

Phase 3 includes a novel medical device, a fully automated, digital slit lamp that can administer eye exams without the need for a trained operator or a traditional slit lamp. 

As a two-sided telemedicine platform, our end users are physicians at general practices (urgent care, primary care) and eye specialists. The key influencers and beneficiaries are the patients. Our end users, the eye care providers, include 10,000 urgent care centers (according to Urgent Care Association), 175,000 primary care providers (IBIS), 33,000 optometry practices (IBIS), 19,000 ophthalmologists (AAO). We have interviewed over 70 eye doctors, 20 emergency department providers, and 20 urgent care providers, including 10 decision makers (CMO, president). 

Since the outbreak of COVID-19, we have been focusing on ophthalmology and optometry practices to enable them to provide asynchronous care, reduce patient contacts and manage patient backlog more efficiently. Over the past 8 weeks, we have distributed 1500+ slit lamp shields at cost to eye professionals as PPEs for their practices. It has enabled us to build a contact list of 200+ private practices that we are starting conversations with on telemedicine. Today, we are working on clinical studies proposals using our device with four academic hospitals and we have already received approval with one of them.

One of our cofounders, Grayson Armstrong is the chief resident of ophthalmology at Massachusetts Eye and Ear Hospital. He has seen first hand how COVID-19 exacerbated the problem of access to eye care. Before COVID-19, there is already significant waste in health care spending caused by overutilization of emergency rooms for eye conditions as patients struggle to make same-day appointment. On the other hand, while many elderlies rely on regular eye exams to screen for vision impairing conditions, COVID-19 has made those visits to eye doctors extremely risky if not impossible. 

We see three different types of competitors.

First are virtual primary care companies that are looking to provide more comprehensive coverage. Examples include OneMedical ($3bn market cap) and Doctor on Demand ($160mm raised). The entry barrier for them is the complexity in capturing high quality anterior segment videos that can be used to make an accurate diagnosis.

Second are digital optometry and prescription services, such as Digital Optometrist and 20/20Now. We have had conversations with key executives at both companies. They are constrained by traditional slit lamps. Our automated device will be a key differentiator and enable us to scale users beyond the trained professionals. 

Third are automated diagnostic solutions for back-of-eye diseases. IDx ($52mm raised) has developed an FDA cleared automated screening device for diabetic retinopathy and Verily (Google, >$1B raised) has launched their first application in India for diabetic eye diseases. They’re great companies, but the same dataset doesn’t exist for anterior segment. Therefore a phased approach like ours required. We’ll develop proprietary data as we also drive revenue through our network of teleconsultations and digital slit lamps.

Ocular is enabling a tele-ophthalmic exam by breaking the constraints imposed by traditional slit lamps. Our core technology consists of three parts

1. Automated Exam Administration 

We enable 5 degrees of freedom using a solid-state optical design. This improves robustness and reduces system size and cost.  Most importantly, it allows for programmable control of each axis, enabling remote or automated exam administration. We use real-time machine learning models to help administer and capture a complete and high quality exam. Our models adjust imaging and illumination parameters to adapt to the patient’s gaze, blink and pupil dilation. Together, our system’s automation eliminates the need for a skilled operator

2. Digital Recording 

We capture an exam using an array of cameras that can reproduce a 3D recording of the eye as well as accurately measure anatomical features. Existing digital attachments to slit lamps only capture 2D imagery, stripping the exam of important stereo depth cues that aid in diagnosis. These stereo cues are present during traditional visual use of the slit lamp. High-fidelity recordings of exams can then be transmitted to doctors across the room or across the world for diagnosis.

3. Automated Triage and Diagnostics

Our device will help compile the first large-scale video database of anterior segment exams. Pathology will be labeled by ophthalmic reviewers and the data will train classifier models to determine the presence of an ophthalmic condition. Initially, the focus will be on triage decision making but eventually we will develop automated diagnostics for certain anterior segment conditions.

Our first generation devices are installed in three clinics in Boston. 

COVID-19 has significantly changed people's behaviors and preferences. Telemedicine has become mission critical for every provider while ophthalmology has seen 80% reduction in patient volume due to the constraints imposed by technology. Today, we are starting with clinical studies to prove the effectiveness and quantify the efficiency gains of remote diagnosis using our 3D videos comparing to in person exams. The research and data will help us develop partnership with key opinion leaders in ophthalmology as well as initiate our conversations with regulators and payers. In the near to medium term, we will deploy our solutions in urgent care centers, ophthalmology / optometry practices, and expand our network of remote eye specialists, more patients will benefit from the convenience of asynchronous telemedical eye care. It creates a virtuous cycle and encourages more clinics to adopt our solutions.

Over the long term, we expect tele-ophthalmology to become standard of care, separating the technical part of performing an exam and the diagnostic part that requires a trained medical professional, similar to the development of tele-radiology where a radiologist is remote to the patient who gets and MRI. Then our automated eye device will be deployed at nonclinical setting such as skilled nursing facilities, CVS Health and even patients' home to enable universal eye care.

Today, we are working with four academic hospitals to develop clinical studies which will impact 200-300 patients. We expect to deploy 300 devices in 2021 and each device can process 300-500 exams per year, impacting >100,000 patients. In five years, we will be affecting millions of patients not only through our telemedical platform, but also through the applications that can be developed from the database of anterior segment videos that we would be building up.

Within the next year, we are going to market with our first generation product of the retrofit stereo imaging systems that allow clinicians to easily capture the videos of eye exams and share with remote consultants. We expect to establish partnership with 30 hospitals / clinics and we expect our solutions to help them mitigate COVID-19 impact to 1) reduce the number of people that need to be in touch with the patients; 2) manage the backlog of patients more efficiently; 3) allow patients to get an exam at a remote location without having to travel to where the ophthalmologists are. 

In the meantime, we are continuing R&D of our automated eye exam device as well as advancing our machine vision models. Over the next five years, we expect to deploy our solution through collaboration with large chain of retail optometry locations to scale up to reach mass market.

In the next year, the major barriers are to expand our clinical partner network, develop manufacturing capabilities that will support our go-to-market plan and seek regulatory clearance. Over the next five years, we expect technical challenges as we develop the automated eye exam device as well as machine learning models, which will require more financial resource to fund R&D. We will also need to navigate the regulatory and medical reimbursement landscape. In addition, we need to build partnership with larger organizations to reach scale, such as CVS Health or LensCrafters. 

We have started working with academic hospitals in Boston on clinical studies and we are exploring collaboration with potential manufacturing partners. In the near term, our devices will be covered under investigational device exemption as part of our clinical studies. In the meantime, we are also seeking emergency use authorization from FDA. For product R&D and technical challenges, we are leveraging support from HAX accelerator. We are also raising a seed round to secure financial resource. 

3 full time. 8 summer interns. 1 contractor

The three cofounders bring complementary skillset and experience to the team. 

Brett Sternfield: MBA'2020 @ MIT, MS Optical Engineering, BS Biomedical Engineering @ University of Rochester. Brett was an optical engineer for six years, designing and building AR/VR optics to aerial imaging systems. He also led a 510k submission for numerous medical endoscopes, establishing the safety and efficacy of their imaging systems.

Zona Liu: MBA'2020 @ MIT, BS Econ & Finance @ University of Hong Kong. Zona started her career in the strategic investment team at Goldman Sachs, where she co-led the effort of setting up a multi-bank FinTech joint-venture and sat on the company board. Prior to MIT, she was the director of business development at an early stage VC, driving corporate partnership and helping raise a $250m fund. 

Grayson Armstrong: Chief Resident in Ophthalmology @ Harvard Medical School, Director of Ocular Trauma @ Mass. Eye and Ear, Board Member @ American Medical Association, MPH @ Harvard, MD @ Brown, BA @ UNC Chapel Hill. Grayson has seen many cases of avoidable eye conditions exacerbated by misdiagnosis and has also helped spearhead the future of tele-medicine nationally as part of AMA.

We have started our first clinical study in partnership with New England College of Optometry and Boston Laser. We are also collaborating with Mass Eye and Ear, Boston Medical Center, VA Boston to develop respective clinical studies. In the meantime, we are actively exploring partnership opportunities with EHRs and other telemedical platforms. 

Today, we charge a monthly rental fee for hospitals & private practices that deploy our imaging systems that enable consultations with their own ophthalmologists to mitigate COVID-19 impact. 

As we expand our network of eye specialist, we expect to charge the origination site a recurring fee for using our device and software, while sharing the reimbursement with the remote consultant. Every remote exam performed with our system is covered by existing CPT codes that apply for inter-professional consultations. Current medical insurance pays both the originating site (UCC) and the consulting doctor $40 respectively. We expect the telemedicine reimbursement landscape to continue to evolve as a result of the COVID-19 impact.

In the next year, we are funding our work with grants (MIT Delta-v, Sandbox and MIT100K). We are also currently raising a seed round. In the meantime, we plan to generate revenue from clinical partners that are using our devices for clinical studies and mitigating COVID-19 impact. Over the next 3 years, we expect to reach breakeven selling our current device and generating recurring revenues. We are also planning to raise Series A in late 2021, and use the proceeds to fund our development for the automated eye exam device. 

We look forward to expanding our clinical partnership network through the Solve community. We'd also like to seek advisor and mentors who can help us navigate payer relationship as well as regulatory clearance. The funding will also help us address near term working capital need.