DOBI Medical International

What DOBI Medical International does

DOBI Medical International is a privately-held medical device company headquartered in Southborough, Massachusetts, that develops and commercializes the ComfortScan System, a Dynamic Optical Breast Imaging (DOBI) platform designed as an adjunctive diagnostic tool to mammography. The system uses high-intensity near-infrared light-emitting diodes, a soft silicone membrane breast holder that applies gentle external pressure, a CCD camera, and proprietary image-processing algorithms to detect hemoglobin concentration and deoxyhemoglobin dynamics indicative of tumor angiogenesis — the abnormal vascularization surrounding tumors. The non-invasive, non-ionizing exam takes less than 10 minutes, can identify lesions below 4-5mm in size, and is positioned to address documented mammography shortcomings in women with dense breast tissue, premenopausal women, and in differentiating benign from malignant lesions to reduce avoidable biopsies. A next-generation system, ComfortScreen, is under development for broader standalone screening applications.

The company operates a channel-partner go-to-market internationally, with national distribution secured through XinAoMDT in China under a five-year agreement signed September 2010, an exclusive West European partnership with Novaura Health Solutions signed June 2013, and a long-term Italian partnership with Socrate Medical signed in 2011 for distribution, co-development, and OEM manufacturing. Hardware is sold as an outright purchase and is priced at roughly one-third the cost of new digital mammography systems (which list at $450,000-$600,000), with an alternative pay-per-use / per-procedure model and anticipated gross margins of approximately 70% after distributor discounts. Approximate scale signals: 40+ installations across China and Italy, an additional 50 orders reportedly secured for 2012, an employee base in the 11-50 range, and regulatory clearances including ISO 13485, CE Mark (February 2011), and SFDA approval in China (July 2011); US entry is explicitly gated on FDA 510(k) or PMA approval pending a planned Series A financing.

Founded circa 2000 by acquiring the ComfortScan intellectual property developed over the prior eight years with roughly $45M invested, the company spent approximately $38M on marketing development from 2000-2006, became DOBI Medical International, Inc. via a reverse public offering in December 2003, and returned to private ownership in June 2010 when XinAoMDT acquired DOBI Global, which now operates as DOBI Medical International. Key leadership includes co-founder, President, CEO, and Chairman G. John Zhang, Ph.D., co-founder and board member Lei Zhao, Ph.D., and board member Weiping Wang, Ph.D. The stated exit thesis references a non-exclusive license or sale to a large imaging company.

Name

DOBI Medical International

Legal name

DOBI Medical International, Inc.

Website

https://dobimedical.com

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

11–50 employees

Short description

DOBI Medical International is a privately-held medical device company that develops the ComfortScan System, a non-invasive Dynamic Optical Breast Imaging platform using near-infrared LEDs, CCD cameras, and proprietary image-processing algorithms to detect tumor angiogenesis for breast cancer diagnosis.

Ownership category

akta.pro rank

Product category

Medical Imaging Equipment

NAICS

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

SIC

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

akta.pro primary industry

Mammography & Breast Imaging Systems (HLAHABAF)

Keywords

• Medical imaging devices
• Breast cancer diagnostics
• Optical breast imaging
• Tumor angiogenesis detection
• Adjunctive mammography tools

Headquarters

HQ city

Shirley

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Hardware Sales - DOBI System: DOBI System sold as outright purchase to healthcare providers. Low manufacturing cost with anticipated gross margins of approximately 70% after discounts to distributors. Competitive pricing with analog mammography and ultrasound devices, approximately one-third the price of new digital mammography systems ($450,000-$600,000 range).
2. Pay-per-use/Per Procedure Revenue: DOBI System available on 'pay-per-use' basis, allowing customers to pay per procedure examination. Per procedure costs competitive with current costs of diagnostic mammography and ultrasound, enabling rapid and sustainable revenue stream.
3. Service and Support: Service capabilities to support DOBI System in the field including 24/7 on-line support or toll-free telephone access during business hours. Resellers trained and certified to provide on-site maintenance and parts.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

DOBI Medical International designs and manufactures the ComfortScan System, a Dynamic Optical Breast Imaging (DOBI) device that uses near-infrared light, high-intensity LEDs, a CCD camera, and proprietary image-processing algorithms to non-invasively detect tumor angiogenesis (abnormal vascularization associated with tumors). The system serves as an adjunctive tool to mammography and ultrasound for improved breast cancer detection, with full exams completed in under 10 minutes.

Product overview

DOBI Medical International offers a portfolio of dynamic optical breast imaging products centered on the ComfortScan System as the core product. The ComfortScan System is a non-invasive medical imaging device that detects tumor angiogenesis through near-infrared light imaging and proprietary image-processing algorithms. The company is also developing ComfortScreen as a next-generation screening tool for broader market applications. The product line is designed as an adjunct to mammography, with plans for standalone and tandem use with other imaging modalities.

Differentiator

Problem solved

Functional benefit

Brands

• ComfortScan: Dynamic optical breast imaging system designed as an adjunctive tool to mammography for improved breast cancer diagnosis by providing physiological information through detection of tumor angiogenesis.
• ComfortScreen

Products and services

• ComfortScan System A dynamic optical breast imaging system that uses high-intensity LEDs, gentle external pressure via a soft silicone membrane breast holder, and CCD camera technology to detect abnormal vascularization (tumor angiogenesis) associated with breast cancer. Designed as an adjunctive tool to mammography for healthcare providers including hospitals, imaging centers, radiology practices, and specialty breast clinics.
• ComfortScreen Next-generation breast cancer screening system under development for women of all ages worldwide. Intended for broad-based cancer screening applications as both a standalone tool and in tandem with other imaging modalities.

Quantifiable outcome

• Potential to reduce 80% of 2.5 million annual unnecessary biopsies in US
• +4 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature3 records

Partnerships

Four partnerships are on record, tiered core and major.

• Novaura Health Solutions (NHS)coreChannel Partner/ Reseller/ Distributor · 12 June 2013Exclusive distribution partnership signed June 12, 2013 for 'Digital Optical Breast Imaging' products in West Europe. Both companies jointly pursue scientific program for clinical case collection and processing to establish common protocols and 'best practices'.
• XinAoMDTcoreChannel Partner/ Reseller/ Distributor · 29 July 2011Five-year distribution agreement signed September 16, 2010 for national distribution in China. XinAoMDT responsible for China market development, product OEM and sales efforts. SFDA Market Approval for DOBI ComfortScan obtained July 29, 2011, enabling sales in China.
• Socrate MedicalmajorChannel Partner/ Reseller/ Distributor · 27 February 2011Distribution agreement signed February 27, 2011 for revolutionary early breast cancer diagnostics device. Long-term partnership signed November 30, 2011 for co-development, system improvements, and OEM manufacturing. Three DOBI ComfortScan units delivered to Italian distributor in July 2011.
• Intertek (Notified Body)coreOthers · 2 February 2011ISO 13485 and CE Marks approval obtained February 2, 2011 through notified body Intertek, enabling European market access for DOBI ComfortScan.

Scale indicators8 records

Recent moves9 records

Expansion highlights6 records

Emerging players

• Volpara Health: Volpara Health provides AI-driven breast density assessment and mammography quality software - an emerging player in the broader breast imaging workflow that competes for technology budget against novel adjunctive devices like DOBI's ComfortScan.

Direct peers

• Hologic: Hologic is the dominant mammography and breast health systems vendor (e.g., 3Dimensions, Selenia Dimensions) and directly competes with DOBI in breast imaging for hospitals, imaging centers, and radiology practices, with far greater scale, FDA-cleared products, and CPT-coded reimbursement.
• Delphinus Medical Technologies: Delphinus developed the SoftVue ultrasound tomography breast imaging system - a direct niche peer to DOBI's ComfortScan as an alternative non-ionizing, adjunctive breast imaging technology targeting dense breast tissue and screening applications.
• iCAD: iCAD provides AI-powered breast cancer detection and breast health solutions (ProFound AI for mammography, DBT) used by the same radiology practices DOBI targets. While iCAD focuses on software/AI rather than imaging hardware, it competes for the same clinical decision-support budget in breast imaging.
• Dilon Technologies: Dilon Technologies manufactures the Dilon 6800 gamma camera for molecular breast imaging - a direct niche competitor to DOBI's ComfortScan targeting the same adjunctive-to-mammography breast cancer detection workflow in hospitals and breast centers.
• Planmed: Planmed designs and manufactures digital mammography systems (Clarity, Sophus) targeting the same breast imaging centers and women's health clinics as DOBI's ComfortScan, with overlapping global distribution channels in Europe and Asia.
• Fujifilm Healthcare: Fujifilm (formerly Fujifilm Medical Systems) markets digital mammography systems (Amulet Innovality) directly competitive with DOBI's ComfortScan in breast imaging centers and radiology departments, with comparable technology positioning around women's health screening.

Broad incumbents

• Siemens Healthineers: Siemens Healthineers (MAMMOMAT mammography systems) is a broad incumbent in mammography and women's imaging, offering established FDA-cleared digital mammography systems with full radiology IT integration that compete for the same clinical workflow share as DOBI.
• GE HealthCare: GE HealthCare offers a broad mammography and women's health imaging portfolio (Senographe systems) alongside a much larger diagnostic imaging and ultrasound business, making it a broad incumbent competing for the same hospital breast imaging budgets as DOBI.
• Philips Healthcare: Philips offers comprehensive women's health imaging including mammography (MicroDose SI) and ultrasound within its broader diagnostic imaging portfolio, making it a broad incumbent competing for women's health capital across enterprise hospital systems.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

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 DOBI Medical International