NIA Small Business Showcase: Vasoptic Medical, Inc.
Diagnosing ophthalmic diseases in their earliest stages requires that the diagnostic technique possess sensitivity and specificity characteristics for effective disease management and that diagnostics be positioned in the primary care environment, where individuals with early-stage disease are likely to visit.
Retinal diagnostics have long relied on static anatomical images, but noninvasive optical coherence tomography (OCT) angiography has recently revealed the importance of retinal perfusion in disease pathophysiology. Similarly, retinal blood flow (RBF) dynamics, related to but distinct from retinal perfusion, offers complementary insights that Vasoptic is developing into biomarkers for disease diagnostics. Indeed, the early stages of a number of ophthalmic conditions, including diabetic retinopathy and glaucoma, as well as neuro-ophthalmic conditions like Alzheimer’s disease, are associated with changes in RBF patterns in their early stages.
Vasoptic has developed the portable and non-invasive XyCAM retinal imaging technology, a portable, noninvasive hardware and software system that can capture high-quality fundus photos and complement them with dynamic RBF information. Priced in the same range as fundus cameras, and offering novel structural/functional biomarkers, XyCAM is suitable as a point-of-care diagnostic tool.
The XyCAM will leverage telehealth methods to offer value to patients, providers, and payors by enabling better disease management through timely diagnostics using reimbursable low-cost procedures early in the disease course.
The global market for retinal imaging in primary care has been assessed at $7.2 billion. Vasoptic will initially target the $500 million instrument market for fundus cameras and then expand to the healthcare professionals who could use the XyCAM for screening/diagnosing the more than 29 million Americans with diabetes and the 50 million Americans at risk for glaucoma.
- Obtained preliminary clinical evidence of the XyCAM’s ability to tell the difference between healthy eyes and those with:
- Confirmed glaucoma [Q4 2018]
- Mild to moderate nonproliferative diabetic retinopathy [Q4 2019]
- Mild cognitive impairment (MCI), a precursor to Alzheimer’s disease [Q4 2019]
- Demonstrated high repeatability and reproducibility of XyCAM-based blood flow velocity index measurements (coefficient of variation < 10 percent) in a 20-subject, 4-operator clinical study [Q4 2019]
- Demonstrated the feasibility of a low-weight, low-cost, handheld XyCAM instrument
- Completing clinical imaging of 210 subjects and data assessment for biomarker development as part of multiple ongoing clinical trials [Q4 2020]
- Commencing large-scale XyCAM Retinal Imager (RI) clinical study with a busy overseas eye hospital [Q2 2021]
- Developing novel biomarkers for automated classification of disease status, using computer vision and artificial intelligence (AI)–based methods on acquired image data [Q2 2021]
- Established robust quality management systems, resources, and processes for medical device development and commercialization in compliance with U.S. Food and Drug Administration (FDA) requirements [Q4 2019]
- Submitted a 510(k) application for the XyCAM RI [Q4 2019]
- Having 10 full-time employees (FTEs), with a strong leadership and advisory team [Q2 2020]
- Holding significant patent protection in the United States, Europe, India, and China on intellectual property (IP) developed in-house, as well as through an exclusive licensing agreement with Johns Hopkins University for worldwide rights
- Receiving 510(k) based clearance from FDA to commercialize the XyCAM RI [Q2 2020]
- Deploying the first 10 units of the FDA-cleared XyCAM RI to early adopters and supporting its use [Q2 2021], followed by a focus on revenue growth through sales [Q3 2021 and on]
- Expanding the product portfolio by preparing and submitting a 510(k) application for a multi-functional, cloud-connected XyCAM system (currently under development) [Q4-2021]
- Adding a capability for diagnosing mild to moderate diabetic retinopathy to the system’s indications for use [Q1 2023]
Funding to date includes:
- $5.2 million in grant funding from various sources (e.g., NIH and the Coulter Foundation)
- $815,000 in convertible debt from state- and county-based agencies
- $1.6 million in private investment
Grant-based funds have supported key research and development (R&D) activities, while funds raised through private investment were used in business development and regulatory activities.
Vasoptic anticipates requiring $10 million to:
- Successfully launch the full XyCAM RI product line for ophthalmology and optometry settings in the U.S. and abroad;
- Develop and bring to market (via 510[k]-based clearance) the handheld XyCAM system, and
- Complete planned clinical studies and develop biomarkers for at least two indications: nonproliferative diabetic retinopathy and glaucoma.
Through in-house development and licensing from Johns Hopkins University, the Vasoptic portfolio comprises 9 issued/allowed patents, 13 under-review patent applications (national stage), one PCT patent application, and one provisional-stage patent application on speckle-based flow monitoring technology. These international patents are filed in the United States, Europe, India, and China and cover system embodiments and methodologies of robust blood flow estimation, with high spatiotemporal resolution and artery–vein discrimination, that will allow the XyCAM system to detect pathological changes in the microvasculature.
Product Development and Regulatory Strategy
Vasoptic plans to address the market in three phases. In Phase I, Vasoptic expects to release its tabletop XyCAM RI to early adopters for use in ophthalmology and optometry settings. This system is under review by FDA for 510(k)-based clearance. In Phase II, Vasoptic will develop a handheld enhanced fundus camera with blood flow measurement features and cloud-based data management for widespread deployment in ophthalmology, optometry, and primary care settings. This prototype is under development and will leverage the 510(k) pathway through comparison with the previously cleared XyCAM RI. In Phase III, upon the conclusion of clinical investigations, diagnostic guidance for classifying referable diabetic retinopathy will be added to the XyCAM’s indications for use; this will use the 510(k) pathway by comparison with a split predicate: the XyCAM system and a legally marketed diabetic retinopathy diagnostic. Vasoptic will seek market clearance in Europe, India, and China, typically in the months following FDA clearance for each product.
The XyCAM products offer compelling value during each phase of market rollout. During Phase I, early adopters will value the XyCAM RI’s ability to support R&D on ophthalmic and other systemic ailments that manifest through altered retinal vascular function. During Phase II, the XyCAM’s ability to generate fundus photos as well as retinal blood flow imaging will incentivize users to prefer the handheld XyCAM over a comparably priced standard fundus camera. During Phase III, the primary driver for clinical adoption will be reliable clinical decision support enabled through XyCAM’s automated diagnostics.
1215 East Fort Avenue, Suite 304
Baltimore, MD 21230
Industry: Medical Device
- Founder and President: Abhishek Rege, Ph.D.
- Cofounder and General Counsel: M. Jason Brooke, M.S.E., J.D.
- Vice President, Product Development and Clinical Research: Parag Karmarkar, M.S.
- Cofounder and Business Advisor: Scott Merz, Ph.D.
Point of Contact:
Abhishek Rege, Ph.D.
Email Abhishek Rege
Conference Selected for Showcase: Digital RESI (June 2020)