Modulim
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.
- Company typePrivate
- Founded2008
- HeadquartersIrvine, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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).
Modulim firmographics
Firmographics- 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
Modulim industry classification
Industry- 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
Where Modulim is headquartered
LocationHeadquarters
- HQ city
- Irvine
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Modulim business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations, Supply Chain
Revenue model
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Per-image reimbursement via CPT 0061U (PLA code) |
| Other | Multi-year contract | Enterprise Clarifi Imaging System purchase + Modulim Cloud subscription |
Go-to-market motion1 record
Distribution channels5 records
Marketing channels7 records
Modulim product offering
Product offeringCore 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
Companies that use Modulim
Customer profileNamed customers9 records
Segments4 records
Ideal customer profiles4 records
Modulim technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature7 records
Modulim partnerships and signals
Strategic signalPartnerships
20 partnerships are on record, tiered flagship, core and minor.
- Beckman Laser Institute at UC IrvineflagshipOriginating 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 CaliforniaflagshipResearch 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 ArizonaflagshipMulti-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)flagshipLong-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)flagshipUSAMMDA 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)coreMTEC facilitated the $2.5M USAMMDA contract with Modulim for the handheld burn assessment tool development. MTEC is a DoD medical technology consortium.
- Satellite HealthcarecoreSatellite 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 HealthcoreNorthwell 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 BrandsminorBalboa Brands logo is featured on Modulim's partner wall.
- University of ArizonacoreUniversity of Arizona logo is featured on Modulim's partner wall as a research partner.
- USC Keck School of MedicinecoreKeck logo is featured on Modulim's partner wall as a research partner.
- Boston UniversityminorBoston University logo is featured on Modulim's partner wall as a research partner.
- UC Irvine Beckman Laser InstituteflagshipUCI Beckman logo is featured on Modulim's partner wall; the originating institution where SFDI was invented and where the company was incubated.
- University of MaineminorUniversity of Maine logo is featured on Modulim's partner wall as a research partner.
- University of Notre DameminorNotre Dame logo is featured on Modulim's partner wall as a research partner.
- Dartmouth CollegeminorDartmouth College logo is featured on Modulim's partner wall as a research partner.
- Indiana University HealthminorIndiana University Health logo is featured on Modulim's partner wall as a research/healthcare partner.
- US Department of Veterans Affairs (VA)coreVA 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)coreUSAISR 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)minorA*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
Modulim competitors and assessment
Company assessmentBroad 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
Modulim social profiles
Digital presenceModulim compliance and trust
Trust signalCompliance4 records
Modulim financial estimates
Financial estimateRevenue estimate
Valuation estimate
Modulim leadership team
Management profileNumber of profiles
Profiles5 records
Modulim funding detail
Funding detailFunding overview
Funding rounds4 records
Investors8 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Modulim M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Modulim
What does Modulim do?
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.
Is Modulim a public or private company?
Modulim is a private company. It is classified as venture growth investor backed and is currently operating.
When was Modulim founded?
Modulim was founded in 2008. It employs 11 to 50 people.
Where is Modulim based?
Modulim is headquartered in Irvine, United States, in the North America region.
How does Modulim make money?
Six revenue lines are on record. Hardware & capital equipment sales (Clarifi Imaging System) is the primary driver. The others are per-test reimbursement (CPT Code 0061U), modulim Cloud & Magnifi software services, government / defense contracts, NIH SBIR/STTR grant funding and channel / reseller distribution revenue.
Who are Modulim's main competitors?
Broad incumbents on record are GE HealthCare, Smith+Nephew and Masimo. Direct peers are Kent Imaging, MolecuLight, HyperMed Imaging, Spectral MD and WoundVision. Emerging players are Swift Medical and Tissue Analytics (a Net Health company).
Does Modulim have an API?
No public API is recorded for Modulim.
What industry is Modulim in?
Modulim's product category is Microvascular Optical Imaging Devices. Its primary akta.pro industry code is HLAHACAI, Chronic Disease Remote Monitoring (COPD/CHF/HTN, Weight & Symptom Tracking), with a secondary code of HLACANAG, SaMD – Imaging & Signal Analysis (AI/ML). Its NAICS code is 334510 and its SIC code is 3841.