Modulim

What Modulim does

Modulim (legal entity Modulated Imaging, Inc.) is a privately held medical device company founded in 2008 and headquartered in Irvine, California, that has developed and commercialized Spatial Frequency Domain Imaging (SFDI), a patented optical imaging modality invented at UC Irvine's Beckman Laser Institute by founder David Cuccia. The company's core commercial product is the Clarifi Imaging System, the first and only FDA-cleared optical platform powered by SFDI, which non-invasively quantifies five hemoglobin biomarkers (HbO2, HbR, HbT1, HbT2, StO2) of tissue oxygenation and perfusion across a 15cm x 20cm field in approximately 10 seconds at the point of care. The platform is CE-marked (December 2020) and supported by a proprietary CPT PLA code (0061U) priced by CMS at $27.85 per image on the Medicare Clinical Laboratory Fee Schedule, with multiple granted US patents protecting the underlying method.

Modulim monetizes through a combination of capital equipment sales (Clarifi hardware), recurring per-image reimbursement via CPT 0061U, subscription-style cloud and software services (Modulim Cloud and Magnifi worklist), and US federal government contracts (notably a $2.5M, two-year USAMMDA award in May 2023 for a handheld burn-assessment tool). The company bundles these components into vertical solutions, most notably the LAMP (Limb Assessment, Management, & Preservation) Solution launched in July 2022 to address the value-based nephrology and CKD/ESRD population via CMS's Kidney Care Choices Model, following a multi-site pilot at Fresenius Medical Care dialysis clinics in Southern California.

The customer base spans healthcare providers (hospitals, wound care centers, vascular and podiatry clinics), nephrology and dialysis providers (Fresenius Medical Care, Satellite Healthcare), integrated health systems (Kaiser Permanente, Northwell Health, Indiana University Health), the US Department of Veterans Affairs, and US Department of Defense channels (USAMMDA, USAISR). Backers include Pangaea Ventures, Fresenius Medical Care Ventures, Grey Sky Venture Partners, Mitsubishi Capital, Hamamatsu Photonics, The Cove Fund at UCI Applied Innovation, and Fouse KK, with cumulative private and grant capital of approximately $21M raised to date (including $11M+ in NIH SBIR/STTR grants).

Name

Modulim

Legal name

Modulated Imaging, Inc.

Website

https://modulim.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

Modulim is a privately held medical device company that commercializes its patented Spatial Frequency Domain Imaging (SFDI) technology through the FDA-cleared Clarifi Imaging System, enabling point-of-care, non-invasive microvascular assessment for hospitals, dialysis providers, and wound-care clinicians serving patients with diabetes, kidney disease, and peripheral arterial disease.

Ownership category

akta.pro rank

Product category

Microvascular Optical Imaging Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845), Measuring & Controlling Devices, Nec (3829)

akta.pro primary industry

Chronic Disease Remote Monitoring (COPD/CHF/HTN, Weight & Symptom Tracking) (HLAHACAI)

akta.pro secondary industries

SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG), Cardiometabolic RPM & Chronic Disease Management (diabetes, hypertension, CHF, obesity) (HLALAFAA)

Keywords

• Microvascular imaging devices
• Optical tissue assessment
• Diabetic foot ulcer screening
• Non-invasive diagnostic imaging
• Medical imaging hardware

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Hardware & capital equipment sales (Clarifi Imaging System): Sale of the Clarifi Imaging System device to hospitals, clinics, dialysis providers, and research centers. FDA-cleared (2017/2019) and CE-Marked (2020) medical device enabling international distribution. One-time / capital purchase per site.
2. Per-test reimbursement (CPT Code 0061U): American Medical Association granted PLA CPT code 0061U for transcutaneous measurement of tissue oxygenation and hemoglobin using SFDI. CMS priced the code at $27.85 per image on the 2019 Medicare Clinical Laboratory Fee Schedule, allowing healthcare providers to bill Medicare, Medicaid, and commercial payers for each Clarifi image. Usage-based / per-image revenue model.
3. Modulim Cloud & Magnifi software services: Subscription-style cloud-based platform for HIPAA-compliant storage, indexing, archiving, data sharing, and clinical worklist tools. Drives recurring revenue tied to active accounts.
4. Government / defense contracts: Direct contracts with US federal agencies including a 2-year, $2.5M USAMMDA contract (facilitated through MTEC) for the handheld digital burn assessment tool. Multi-year milestone-based contract revenue.
5. NIH SBIR/STTR grant funding: Non-dilutive R&D grant revenue from NIH institutes including NIDDK (SBIR Phase II $1.8M in 2016), National Institute of Aging (SBIR Phase 2), and over $11M in cumulative SBIR/STTR grants. Funds technology development and clinical studies.
6. Channel / reseller distribution revenue: Resale and distribution through channel partners, distributors, and resellers — particularly in international markets enabled by CE Mark — to fulfill product and information requests to customers and prospects.

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels7 records

Core offering

Modulim develops and sells the FDA-cleared Clarifi Imaging System, a non-contact optical imaging platform powered by its patented Spatial Frequency Domain Imaging (SFDI) technology. The system quantifies and maps five hemoglobin biomarkers of tissue oxygenation and perfusion at the point-of-care in seconds, enabling clinicians to identify compromised microvascular circulation in the lower limb before ulceration or amputation. The hardware is bundled with Modulim Cloud (HIPAA-compliant storage and data sharing), Magnifi software worklist, and the LAMP value-based care solution for nephrology/CKD/ESRD populations.

Product overview

Modulim delivers a unified platform anchored by the FDA-cleared Clarifi Imaging System, which is powered by its proprietary Spatial Frequency Domain Imaging (SFDI) technology for non-contact, point-of-care microvascular assessment. The platform extends through several integrated modules and solutions: Modulim Cloud provides HIPAA-compliant secure data storage and sharing; Magnifi Software offers a tailored worklist with remote disposition and collaboration features; Clarifi Data Analytics delivers microvascular insights, clinical dashboards, and population health analytics; and the LAMP (Limb Assessment, Management, & Preservation) Solution bundles Clarifi with Modulim Cloud for value-based nephrology and CKD/ESRD care. The company's legacy product is the Ox-Imager CS (FDA cleared in 2017), and Reflect RS is a registered Modulim trademark. A new Handheld Digital Burn Assessment Tool is currently in development under a US Army / MTEC contract, marking expansion into a portable form factor.

Differentiator

Problem solved

Functional benefit

Brands

• Clarifi: FDA-cleared and CE-marked optical imaging system (Clarifi® Imaging System) powered by SFDI for non-contact, point-of-care microvascular assessment of tissue oxygenation and perfusion.
• Ox-Imager CS
• Reflect RS
• LAMP (Limb Assessment, Management, & Preservation)
• Modulim Cloud
• Magnifi Software

Products and services

• Clarifi Imaging System First and only FDA-cleared, non-contact, non-invasive optical imaging platform powered by SFDI that quantifies and maps five hemoglobin biomarkers of oxygenation and perfusion at the point-of-care in seconds for microvascular assessment of the lower limb; for hospitals, wound care centers, podiatry/vascular clinics, and dialysis providers.
• LAMP (Limb Assessment, Management, & Preservation) Solution Integrated solution combining Clarifi imaging, Modulim Cloud, and Magnifi software worklist tools to assess patients, manage care between caregivers via secure data sharing, and preserve limbs through coordinated multidisciplinary care; tailored for value-based nephrology and CKD/ESRD populations.
• Handheld Digital Burn Assessment Tool Portable, miniaturized SFDI-based handheld device for assessing burn severity in real time by measuring tissue oxygenation and perfusion; designed for military and civilian emergency/burn-center use under a USAMMDA contract (in development).
• Ox-Imager CS FDA-cleared legacy non-invasive optical imaging system that measures oxy-hemoglobin (HbO2), deoxy-hemoglobin (HbR), and tissue oxygen saturation (StO2) with both surface and subsurface views in one device, 15cm x 20cm wide field of measurement, 10-second image acquisition; predecessor to Clarifi.

Quantifiable outcome

• 75% sensitivity and 69% specificity in predicting diabetic foot ulceration one year after imaging, independent of clinical metrics (252-subject Kaiser Permanente study)
• +3 more outcomes

Named customers9 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

20 partnerships are on record, tiered flagship, core and minor.

• Beckman Laser Institute at UC IrvineflagshipStrategic or Co-development PartnerOriginating research institution: SFDI was invented at the Beckman Laser Institute / Photonic Incubator at UC Irvine (by founder David Cuccia and colleagues). Collaboration with Beckman Laser Institute produced the Laser Speckle + SFDI patent (US 8,509,879). Beckman Laser Institute also partners with Modulim on US Air Force Office of Scientific Research (AFOSR)-funded research on optical technologies for battlefield soldier health. Featured on Modulim's partner wall.
• Kaiser Permanente Southern CaliforniaflagshipStrategic or Co-development PartnerResearch collaboration at Kaiser Permanente Southern California podiatry clinic (led by Dr. Suzette Lee, Regional Coordinating Physician) evaluating SFDI biomarkers as quantitative ulcer risk metrics; 252-subject study published in The Journal of Diabetes and Its Complications, funded by NIDDK.
• University of ArizonaflagshipStrategic or Co-development PartnerMulti-study research collaboration with the University of Arizona, including Dr. Craig Weinkauf on PAD studies (Journal of Vascular Surgery) and microvascular disease stratification work published in the Journal of Diabetes Science and Technology. Partner logo featured on Modulim's partner wall.
• USC Keck School of Medicine (Dr. David Armstrong)flagshipStrategic or Co-development PartnerLong-running research collaboration with Professor David G. Armstrong (Director, Southwestern Academic Limb Salvage Alliance — SALSA) at USC Keck School of Medicine. Co-authored BMJ Open Diabetes Research & Care case series (March 2021), vascular steal case study (April 2021), International Symposium on the Diabetic Foot poster (May 2019), and co-investigator on multiple PAD and DFU studies. Featured on Modulim's partner wall.
• United States Army Medical Materiel Development Activity (USAMMDA)flagshipStrategic or Co-development PartnerUSAMMDA awarded Modulim a 2-year, $2.5M contract (facilitated through the Medical Technology Enterprise Consortium / MTEC) on May 18, 2023 to develop a handheld digital burn assessment tool based on SFDI. Contract supports miniaturized optics and electronics R&D for military and civilian burn care.
• Medical Technology Enterprise Consortium (MTEC)coreStrategic or Co-development PartnerMTEC facilitated the $2.5M USAMMDA contract with Modulim for the handheld burn assessment tool development. MTEC is a DoD medical technology consortium.
• Satellite HealthcarecoreChannel Partner/ Reseller/ DistributorSatellite Healthcare logo is featured on Modulim's partner wall, indicating it as a dialysis provider partner for Modulim's lower-limb microvascular assessment and LAMP solution deployment.
• Northwell HealthcoreChannel Partner/ Reseller/ DistributorNorthwell Health logo is featured on Modulim's partner wall as a partner organization, indicating deployment of Modulim's microvascular assessment tools across the Northwell Health system.
• Balboa BrandsminorChannel Partner/ Reseller/ DistributorBalboa Brands logo is featured on Modulim's partner wall.
• University of ArizonacoreStrategic or Co-development PartnerUniversity of Arizona logo is featured on Modulim's partner wall as a research partner.
• USC Keck School of MedicinecoreStrategic or Co-development PartnerKeck logo is featured on Modulim's partner wall as a research partner.
• Boston UniversityminorStrategic or Co-development PartnerBoston University logo is featured on Modulim's partner wall as a research partner.
• UC Irvine Beckman Laser InstituteflagshipStrategic or Co-development PartnerUCI Beckman logo is featured on Modulim's partner wall; the originating institution where SFDI was invented and where the company was incubated.
• University of MaineminorStrategic or Co-development PartnerUniversity of Maine logo is featured on Modulim's partner wall as a research partner.
• University of Notre DameminorStrategic or Co-development PartnerNotre Dame logo is featured on Modulim's partner wall as a research partner.
• Dartmouth CollegeminorStrategic or Co-development PartnerDartmouth College logo is featured on Modulim's partner wall as a research partner.
• Indiana University HealthminorStrategic or Co-development PartnerIndiana University Health logo is featured on Modulim's partner wall as a research/healthcare partner.
• US Department of Veterans Affairs (VA)coreStrategic or Co-development PartnerVA logo is featured on Modulim's partner wall. Particularly relevant given diabetes is the most common reason for hospitalization among veterans.
• US Army Institute of Surgical Research (USAISR)coreStrategic or Co-development PartnerUSAISR logo is featured on Modulim's partner wall as a military research partner.
• Agency for Science, Technology and Research (A*STAR) Institute of Bioengineering and Bioimaging (IBB)minorStrategic or Co-development PartnerA*STAR IBB logo is featured on Modulim's partner wall, indicating a Singapore-based research/industry partner relationship.

Scale indicators12 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• GE HealthCare: GE HealthCare is a global medical imaging and diagnostics incumbent with deep hospital relationships across radiology, vascular, and surgical imaging. It represents the broader medical imaging incumbent set against which Modulim's focused SFDI platform competes for hospital capital budgets and clinician mindshare.
• Smith+Nephew: Smith+Nephew's Advanced Wound Management division sells a broad portfolio of wound care products, dressings, and adjunctive imaging/assessment tools to the same wound care, podiatry, and surgical customer base that Modulim addresses through Clarifi.
• Masimo: Masimo is a global leader in non-invasive patient monitoring and pulse oximetry, with growing presence in hospital-wide monitoring and tissue perfusion. As a broad incumbent in non-invasive optical sensing, it competes indirectly with Modulim in clinical perfusion assessment and was previously an employer of Modulim's VP Sales, Gary Marston.

Direct peers

• Kent Imaging: Kent Imaging develops Snapshot NIR, a near-infrared tissue oxygenation imaging platform used in wound care, plastic surgery, and vascular assessment — directly comparable to Modulim's Clarifi SFDI system in product category, clinical use cases, and customer base (wound clinics, podiatry, surgical specialties).
• MolecuLight: MolecuLight produces point-of-care fluorescence imaging devices (i:X and DX) that detect bacteria and measure wound surface area in real time — a directly comparable wound-care imaging platform sold to the same podiatry, wound clinic, and hospital customers as Modulim's Clarifi.
• HyperMed Imaging: HyperMed Imaging offers the HyperView hyperspectral tissue oxygenation and hemoglobin imaging system, a directly comparable optical tissue oxygenation imaging product positioned for wound care, burn assessment, and surgical applications — overlapping closely with Modulim's SFDI technology and clinical positioning.
• Spectral MD: Spectral MD develops the DeepView wound imaging system, which uses multispectral imaging and AI to assess burn and wound healing — a direct peer in optical imaging for wound and burn assessment, sharing Modulim's emphasis on quantitative tissue characterization.
• WoundVision: WoundVision provides the Snapshot fluorescence imaging platform for subclinical infection detection and wound measurement in long-term care and post-acute settings — directly comparable to Clarifi as a point-of-care wound imaging device sold to overlapping clinical buyers.

Emerging players

• Swift Medical: Swift Medical offers AI-powered smartphone-based wound imaging and documentation software (Swift Skin and Wound), targeting similar wound care, home health, and post-acute customers as Modulim. It overlaps in the wound imaging space but competes on software/AI rather than proprietary optical hardware.
• Tissue Analytics (a Net Health company): Tissue Analytics provides AI-powered wound imaging and analytics software integrated into EHR workflows, serving wound care clinicians and health systems — overlapping Modulim's clinical and digital health footprint through software-first wound documentation and analytics rather than proprietary optical sensors.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/modulatedinc
• YouTubeyoutube.com/channel/UC5Lb4NBCH8X71DV6wHR8Ejw?view_as=subscriber
• Facebookfacebook.com/moduliminc
• LinkedInlinkedin.com/company/modulim
• Instagraminstagram.com/modulim?igshid=YmMyMTA2M2Y=

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds4 records

Investors8 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 Modulim