Cognoptix

What Cognoptix does

Cognoptix is a privately held U.S. diagnostics company developing the SAPPHIRE II System, a drug-device combination platform intended to enable non-invasive, office-based detection of Alzheimer's disease (AD) before cognitive symptoms appear. The system pairs a compact laser eye scanner with a topically applied fluorescent eye ointment — Fluorescent Ligand Eye Scanning (FLES) — whose small-molecule ligands bind beta-amyloid aggregates in the supranucleus region of the lens. The scanner excites the bound ligands and quantitatively measures emissions, achieving 85% sensitivity and 95% specificity versus amyloid PET imaging in clinical studies, with no serious adverse events reported in a 43-subject pre-pivotal study. Beta-amyloid detection in the lens is presented as possible decades before brain lesions form, addressing a clear gap left by costly ($5,000+), invasive, radiation-based PET imaging.

The company plans a multi-stream commercial model once FDA approval is secured: one-time device sales at a target $75,000 per SAPPHIRE II unit into primary care, neurology, and ophthalmology offices; recurring per-test consumable revenue at approximately $400 per scan; and licensing income from pharmaceutical partners using the platform as a companion diagnostic and patient-stratification tool in amyloid-targeting drug trials. Distribution is intended to be a direct enterprise field sales motion in the United States, supplemented by pharma licensing agreements. Pricing is publicly undisclosed but target economics are well-articulated in investor materials.

Operationally, Cognoptix completed a full recapitalization in 2020 under a new CEO (Dr. Susanne Wilke), consolidated $30M+ of legacy rounds into Series R/common stock, raised a fresh $2.6M Series R led by Launchpad Venture Group with HBS Alumni Angels and New York Angels, and rebuilt its Scientific Advisory Board and executive team to drive the FDA pivotal study and submission. The product remains investigational-only under U.S. federal law, with FDA approval previously targeted for 2023.

Name

Cognoptix

Legal name

Cognoptix Inc.

Website

https://cognoptix.com

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

1–10 employees

Short description

Cognoptix is a privately held U.S. diagnostics company developing the SAPPHIRE II System, a non-invasive eye-scan-plus-fluorescent-ointment platform for early detection of Alzheimer's disease, targeting physicians and pharmaceutical trial sponsors pending FDA approval.

Ownership category

akta.pro rank

Product category

Alzheimer's Disease Diagnostics

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Ophthalmic Goods Manufacturing (339115), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

Surgical & Medical Instruments & Apparatus (3841), Optical Instruments & Lenses (3827)

akta.pro primary industry

Retinal Imaging & OCT Systems (OCT/OCTA, Fundus Cameras, Fluorescein/ICG Angiography) (HLAHAJAB)

akta.pro secondary industries

Ocular Drug Delivery Devices (Eye Droppers/Inserts) (HLAHAIAL), Medical Imaging AI (HDAAAEAH)

Keywords

• Alzheimer's diagnostics
• Eye scanning devices
• Medical diagnostics platform
• Non-invasive imaging
• Neurological disease detection

Headquarters

HQ city

Marlborough

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Others

Revenue model

1. Medical Device Sales: Future revenue from selling the SAPPHIRE II laser scanning device to healthcare providers. Planned device price of $75,000 per unit for use in physician offices, neurology, ophthalmology, and other outpatient clinical settings.
2. Diagnostic Test Revenue: Revenue from per-test consumables including the fluorescent eye ointment/ligand compound. Planned test cost of approximately $400 per scan, compared to $5,000+ for PET scans.
3. Pharmaceutical Partnership Licensing: Licensing the Sapphire II technology to pharmaceutical companies for patient stratification and monitoring in Alzheimer's drug clinical trials, serving as a companion diagnostic for emerging amyloid-targeting treatments.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Cognoptix develops the SAPPHIRE II System, an investigational drug-device combination platform for the early detection of Alzheimer's disease. The system consists of a laser eye scanning device paired with a fluorescent eye ointment (Fluorescent Ligand Eye Scanning/FLES) that detects beta-amyloid aggregates in the lens of the eye. The technology enables non-invasive, office-based Alzheimer's screening with demonstrated 85% sensitivity and 95% specificity in clinical trials, positioning it as a lower-cost alternative to amyloid PET brain imaging.

Product overview

Cognoptix offers the SAPPHIRE II System, a diagnostic platform for early detection of Alzheimer's disease. The system consists of two integrated components: (1) the SAPPHIRE II laser eye scanning device and (2) a fluorescent eye ointment that contains beta amyloid-specific small molecules (Fluorescent Ligand Eye Scanning/FLES technique). The ointment is applied topically to the eye, where the small molecules bind to amyloid aggregates in the lens. The laser scanner then excites the fluorescent ligands and quantitatively measures emissions in specific anatomical locations to detect and confirm beta-amyloid presence. This drug-device combination system is currently investigational and pending FDA approval, positioned to provide a non-invasive, radiation-free alternative to PET brain scans at a fraction of the cost.

Differentiator

Problem solved

Functional benefit

Products and services

• SAPPHIRE II System A combined laser eye scanning device and fluorescent eye ointment (Fluorescent Ligand Eye Scanning/FLES) that detects beta-amyloid aggregates in the lens of the eye for the early diagnosis of Alzheimer's disease. Achieved 85% sensitivity and 95% specificity in clinical trials, with results comparable to amyloid PET brain imaging. Designed for use by physicians (primary care, neurologists, ophthalmologists) in outpatient clinical settings as a non-invasive, radiation-free alternative to PET scans at a fraction of the cost.
• SAPPHIRE II Pharmaceutical Licensing Program Licensing arrangement of the SAPPHIRE II technology to pharmaceutical companies for use as a companion diagnostic for patient stratification, enrollment monitoring, and efficacy assessment in Alzheimer's drug clinical trials targeting amyloid.

Quantifiable outcome

• 85% sensitivity and 95% specificity in differentiating Alzheimer's patients from healthy volunteers in clinical studies
• +3 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Five partnerships are on record, tiered core and foundational.

• Dr. Marwan SabbaghcoreStrategic or Co-development Partner · 10 August 2021Director of translational research at Cleveland Clinic Lou Ruvo Center for Brain Health. Previously Director of Alzheimer's and Memory Disorders Division at Barrow Neurological Institute. Published over 320 scientific articles on Alzheimer's Disease. Joined Scientific Advisory Board to guide strategic direction for FDA approval.
• Dr. Jeffrey L. CummingscoreStrategic or Co-development Partner · 18 November 2020Director of Chamber-Grundy Center for Transformative Neuroscience at University of Nevada, Las Vegas and Director Emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health. Serves as Scientific Advisory Board Clinical Chair. Recognized with Lifetime Achievement Award from Alzheimer's Association.
• Dr. Philip ScheltenscoreStrategic or Co-development Partner · 18 November 2020Director of Alzheimer Center at Vrije Universiteit Medical Center in Amsterdam, Netherlands. Recognized research leader in Alzheimer's biomarkers and contributor to diagnostic criteria for Alzheimer's disease used in clinical trials worldwide.
• Dr. Martin R. FarlowcoreStrategic or Co-development Partner · 18 November 2020Co-Director of Indiana University Alzheimer's Disease Center and Professor Emeritus at Indiana University School of Medicine. Founding member of American Society of Experimental Neurotherapeutics and major contributor to developing Aricept.
• Brigham and Women's HospitalfoundationalStrategic or Co-development PartnerCo-founding institution of Cognoptix. Dr. Lee Goldstein and Dr. Leo Chylack co-founded the company based on research conducted at Brigham and Women's Hospital, Harvard Medical School.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• ALZpath: ALZpath developed a proprietary p-tau217 antibody used in blood-based Alzheimer's diagnostic tests, representing a rapidly emerging competitor in the non-invasive Alzheimer's diagnostic space. Like Cognoptix, ALZpath is targeting the pre-symptomatic and early-stage detection market where a scalable, low-cost test is needed.
• Araclon Biotech: Araclon Biotech developed ABtest, a blood-based test measuring amyloid peptides for early Alzheimer's detection. As an emerging diagnostics company with a similar non-invasive, blood-based approach, Araclon competes with Cognoptix for the same early-detection clinical use cases and pharma partnerships.
• Hummingbird Diagnostics: Hummingbird Diagnostics is developing blood-based microRNA biomarkers for early detection of Alzheimer's and other neurodegenerative diseases. While using a different biological modality, the company targets the same unmet need for scalable, non-invasive, early-stage Alzheimer's diagnostics that Cognoptix addresses with its eye-scan platform.
• Diadem srl: Diadem is developing AlzoSure, a blood-based prognostic test for Alzheimer's disease that competes in the same early-detection market as Cognoptix. Both companies target similar patient populations and pharma clinical trial sponsors seeking scalable, non-invasive diagnostic and prognostic tools.

Direct peers

• C2N Diagnostics: C2N Diagnostics developed the PrecivityAD blood test for amyloid detection, a direct non-invasive competitor to Cognoptix's SAPPHIRE II eye scan for early Alzheimer's diagnosis. Both companies target the same clinical use case — early Alzheimer's detection via a less-invasive modality than PET — and compete for the same pharma companion diagnostic partnerships.
• Quanterix: Quanterix's Simoa platform enables ultra-sensitive blood-based measurement of neurodegeneration biomarkers including p-tau217, providing a competing non-invasive diagnostic modality for Alzheimer's detection. Both companies serve pharmaceutical trial sponsors and healthcare providers seeking scalable, early-detection Alzheimer's diagnostics.

Broad incumbents

• Roche Diagnostics: Roche offers the Elecsys CSF biomarker assays for Alzheimer's (Amyloid beta, p-tau), the established clinical alternative for biochemically-confirmed Alzheimer's diagnosis. Roche's global diagnostics infrastructure, regulatory expertise, and pharma relationships position it as both a potential partner and a significant competitor in the Alzheimer's diagnostic space.
• GE Healthcare (Vizamyl): GE Healthcare manufactures Vizamyl (flutemetamol), a competing FDA-approved amyloid PET imaging agent for Alzheimer's diagnosis. As a large incumbent medical imaging company, GE offers established distribution, reimbursement infrastructure, and clinical workflow integration that any new Alzheimer's diagnostic must compete against.
• Fujirebio: Fujirebio is a leading developer of CSF-based Alzheimer's biomarker assays (including the FDA-approved Lumipulse p-tau217/β-amyloid 1-42 plasma ratio test), directly competing with Cognoptix's eye-scan approach for biochemical Alzheimer's diagnosis. Its established global diagnostics distribution creates a significant incumbent advantage.
• Eli Lilly (Amyvid): Eli Lilly manufactures Amyvid (florbetapir), one of the FDA-approved amyloid PET imaging agents that serves as the current gold standard for Alzheimer's diagnosis and the comparator against which Cognoptix positions SAPPHIRE II. As a major Alzheimer's therapy developer, Lilly is both a potential customer (for trial stratification) and a competitive threat.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/213190548867612
• LinkedInlinkedin.com/company/cognoptix

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds10 records

Investors12 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cognoptix