Welwaze Medical, Inc.

What Welwaze Medical, Inc. does

Welwaze Medical, Inc. is a privately held medical device and digital health company founded in 2016 and headquartered in Miami, Florida. The company develops the Celbrea Platform, an integrated system anchored by the Celbrea Thermal Mapping Device (TMD), an FDA-cleared Class I medical device that uses thermal imaging based on the science of angiogenesis to support early detection of breast abnormalities, positioned as an adjunct to mammography. The platform pairs the device with the Celbrea Companion App and the Welbitz Ecosystem, which the company describes as an AI-on-blockchain health data platform intended to support longitudinal breast health management, particularly for women with dense breasts.

The company's primary customers are women managing their breast health and the prescribing healthcare providers who authorize use of the device under contract. Its revenue model combines hardware sales of the Celbrea TMD, recurring subscription or platform services for the companion app, and licensing arrangements with healthcare provider partners. Distribution is structured as a B2B2C model requiring healthcare provider prescription, with the company also positioning self-funded employers as a secondary customer segment for workforce breast-health screening programs. The company is led by Founder and CEO Alex J. Ness, with an executive team and board drawn from Novartis, Johnson & Johnson, Abbott Laboratories, Medtronic, AstraZeneca, Pfizer, and AXA Group.

Welwaze's commercial stage appears early. Headcount stands at approximately 14 professionals covering executive, regulatory, operations, production, and administrative functions. Revenue is not publicly disclosed, and aside from interest expressed by Boston Scientific at a single industry event, no named enterprise customers, contract wins, or ARR signals are available. The company has accumulated recognition including first place in the 2018 Novartis Innovation Award and multiple Florida-based awards in 2018–2019, and has an active press presence, but visible commercial traction remains limited.

Name

Welwaze Medical, Inc.

Legal name

Welwaze Medical, Inc.

Website

https://welwaze.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

Welwaze Medical is a Miami-based, privately held medical device and digital health company that develops the FDA-cleared Celbrea Thermal Mapping Device and companion app to support early detection of breast abnormalities, distributed via prescribing healthcare providers to women managing their breast health.

Ownership category

akta.pro rank

Product category

Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical Equipment and Supplies Manufacturing (3391)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Connected Medical Devices & Wearables (Sensors, Patches, Implantables) (HLACAPAB)

akta.pro secondary industries

Medical-Grade Device Connectivity & Device Management (MDM) (HLACAFAG), Women’s Health & Fertility Tracking Devices (Ovulation/Temp Sensors, Pelvic Health Devices) (CRACAQAJ)

Keywords

• Breast cancer detection
• Medical imaging devices
• Women's health technology
• Thermal mapping technology
• FDA cleared medical devices

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Sale of Celbrea TMD FDA-cleared medical device for breast health monitoring
2. Platform/Subscription Services: Companion app and platform services for ongoing breast health management
3. Healthcare Provider Partnerships: Healthcare providers prescribe and authorize use of the Celbrea Platform under contractual agreements with Welwaze

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Welwaze Medical develops and sells the Celbrea Platform, an integrated system comprising the Celbrea Thermal Mapping Device (TMD), an FDA-cleared Class I medical device based on the science of angiogenesis for early detection of breast abnormalities, paired with the Celbrea Companion App. The platform runs on the Welbitz Ecosystem, an AI on a blockchain-powered platform for women's breast health management, and is prescribed by healthcare providers under contractual agreement.

Product overview

Welwaze Medical offers the Celbrea Platform, an integrated system comprising two main products: the Celbrea TMD (Thermal Mapping Device), an FDA-cleared Class I medical device that supports early detection of breast abnormalities including breast cancer based on thermal/angiogenesis science, and the Celbrea Companion App, which pairs with the device to allow women to manage their breast health throughout their lives. The platform is positioned as an adjunct to mammography and is designed for women with dense breasts and the general population for ongoing breast health monitoring.

Differentiator

Problem solved

Functional benefit

Brands

• Celbrea: Celbrea® Platform - FDA cleared medical device and companion app for breast health monitoring and early detection of breast abnormalities.
• Welbitz Ecosystem

Products and services

• Celbrea TMD (Thermal Mapping Device) FDA-cleared Class I medical device based on the science of angiogenesis that supports early detection of breast abnormalities including breast cancer. Used as an adjunct to mammography, particularly for women with dense breasts. Prescribed by healthcare providers under contractual agreement with Welwaze.
• Celbrea Companion App A comprehensive companion application that pairs with the Celbrea TMD device, allowing women to manage and track their breast health throughout their lives as part of the Celbrea Platform.
• Celbrea Platform The integrated Celbrea Platform combines the FDA-cleared Celbrea TMD medical device, the Celbrea Companion App, and AI capabilities on a blockchain-powered ecosystem (Welbitz) for women's breast health monitoring and early detection.

Quantifiable outcome

• Celbrea TMD shown effective for women with dense breasts - 47% of U.S. women have dense breasts indicating higher breast cancer risk
• +1 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

One partnership is on record.

• Startup HealthcoreStrategic or Co-development PartnerWelwaze was invited to present at the StartUp Health Festival Health Moonshot Showcase. Partnership with a healthcare innovation and venture platform that supports health transformers and industry change makers.

Scale indicators4 records

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• Hologic: Market leader in mammography and breast health screening (Selenia, Genius 3D). Direct competitor in breast cancer detection infrastructure, with vastly larger scale and hospital channel access.
• GE HealthCare: One of the largest medical imaging and mammography vendors globally (Senographe). Broad incumbent offering overlapping breast imaging capabilities as part of a much wider portfolio.
• Siemens Healthineers: Major mammography and breast imaging vendor (MAMMOMAT). Broad incumbent with overlapping breast cancer detection portfolio in hospital systems.

Direct peers

• UE LifeSciences (iBreastExam): Developer of iBreastExam, a handheld, radiation-free breast examination device for early detection used by community health workers. Closest direct comparable to Celbrea as a non-radiation adjunct device for breast abnormalities.
• Volpara Health Technologies: Provides AI-driven breast density and breast cancer risk assessment software used alongside mammography. Comparable as a software/AI adjunct to mammography targeting the dense-breast population.
• iCAD: AI-based breast cancer detection and breast density assessment solutions sold to radiology departments. Comparable as a software-and-imaging adjunct to mammography workflows.

Emerging players

• Therapixel: AI mammography screening (MammoScreen) for breast cancer detection. Overlapping mission in AI-assisted breast imaging and similar scale as a non-incumbent specialist.
• ScreenPoint Medical: Developer of Transpara, an AI decision-support tool for breast imaging. Comparable emerging AI imaging player targeting the same clinical workflow.
• QT Imaging: Develops radiation-free, ultrasound-based breast imaging as an alternative to mammography. Comparable as a non-radiation breast imaging company targeting dense-breast populations.
• Bexa (early breast examination): Provides a radiation-free, mechanical breast examination technology for early detection. Closely comparable as a non-radiation adjunct device for breast abnormality detection.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/welwaze
• LinkedInlinkedin.com/company/welwaze
• Instagraminstagram.com/welwaze

Revenue estimate

Valuation estimate

Number of profiles

Profiles20 records

Funding overview

Funding rounds2 records

Investors1 record

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 Welwaze Medical, Inc.