Orangebiomed

What Orangebiomed does

Orange Biomed Co., Ltd. (Orangebiomed) is a Seoul-based medical device startup founded in 2021 by Duke University alumni Yeaseul Park (CEO) and Unghyeon Ko (Co-President), alongside co-founders Seungjin Kang (CDO), Eunyoung Park (CRO), and Luke Jo (Managing Director). The company has developed a single core product, the OBM rapid A1c, a portable point-of-care and at-home glycated hemoglobin (HbA1c) testing system targeting diabetes and prediabetes management. The device addresses a documented health equity gap: current A1C tests, which measure chemical protein biomarkers, can yield inaccurate results for patients with hemoglobin variants common in African, South/Southeast Asian, Hispanic, and Mediterranean ancestry.

The OBM rapid A1c is built on a patented Micro Electro-Mechanical System (MEMS) that uses microfluidic single-cell analysis to measure red blood cell deformability rather than quantifying protein biomarkers. Because it measures a physical property of individual cells, it is unaffected by hemoglobin variant interference, requires only 0.005ml of blood (1/100th the volume of traditional tests), delivers results in 5 minutes versus 2-5 days for laboratory send-outs, has a 24-month shelf life without refrigeration, and requires no recalibration. Clinical validation has been conducted with Asan Medical Center in Korea, with additional US trials underway to support FDA over-the-counter and professional-use 510(k) clearances anticipated in 2025-2027.

The business model is hardware-based: sale of a reusable meter device paired with disposable test kits priced at $16-33 per kit, undercutting competing at-home A1C tests at $79-89. Distribution is hybrid and pre-commercial: an enterprise sales motion targeting healthcare providers and clinical labs (with CPT 83037/83036 reimbursement codes anticipated for the professional version) layered onto a direct-to-consumer e-commerce channel on orangebiomed.com, currently gated behind a notify-me page awaiting FDA OTC approval. As of the available data, the company has no disclosed revenue, has raised approximately 3.1 billion KRW (~$2.3M USD) in pre-Series A funding from three Korean institutional investors (Seoul New Technology Investment Company, Digital Healthcare Partners, and Intops Investment), operates with 1-10 employees, and supports offices in Seoul and Hillsborough, NC.

Name

Orangebiomed

Legal name

Orange Biomed Co., Ltd.

Website

https://orangebiomed.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

Orangebiomed is a Seoul-based medical device startup developing the OBM rapid A1c, a microfluidic point-of-care and at-home HbA1c testing system that delivers lab-quality results in 5 minutes using a single drop of blood, with immunity to hemoglobin variant interference, targeting patients and healthcare providers globally pending FDA clearance.

Ownership category

akta.pro rank

Product category

Diabetes Diagnostics Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Blood Glucose Monitoring Devices (Consumer CGM & Smart Glucometers) (CRACAQAE)

Keywords

• Diabetes diagnostics
• A1C testing devices
• Microfluidic medical devices
• Point-of-care diagnostics
• Glycated hemoglobin testing

Headquarters

HQ city

Seoul

HQ country

South Korea

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. OBM rapid A1c Test Kit Sales: Sale of disposable test kits for the OBM rapid A1c system. Each test kit has a 24-month shelf life and does not require refrigeration, unlike competing products.
2. OBM rapid A1c Meter: Sale of reusable meter device (currently TBA pricing) for long-term at-home and point-of-care use. Reusable for lifetime with no recalibration required.
3. Point-of-Care Professional Testing: Professional-use system for healthcare providers and clinics, with reimbursement through CPT 83037 or CPT 83036. FDA clearance anticipated 2026-2027 for professional version.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

Orange Biomed develops and sells the OBM rapid A1c system, a portable point-of-care and at-home A1C testing device built on patented microfluidic single-cell analysis technology. The system comprises a reusable meter and disposable test kits that measure red blood cell deformability to calculate HbA1c levels, delivering lab-accurate results in 5 minutes from a single drop of blood (0.005ml) without interference from hemoglobin variants.

Product overview

Orange Biomed offers a single unified product: the OBM rapid A1c system, which consists of a reusable portable meter device and disposable test kits. The system uses patented microfluidic technology that analyzes the physical deformability of red blood cells rather than traditional protein-based measurement methods, enabling fast (5-minute), accurate A1C testing without interference from hemoglobin variants. The product is designed for both patients (at-home use) and healthcare providers (point-of-care clinical use), targeting the US market with FDA clearance anticipated.

Differentiator

Problem solved

Functional benefit

Brands

• OBM rapid A1c: Portable at-home and point-of-care A1C testing device using microfluidic technology for diabetes monitoring, providing lab-accurate results in 5 minutes with only one drop of blood

Products and services

• OBM rapid A1c A portable A1C testing system consisting of a reusable meter device and disposable test kits that uses patented microfluidic single-cell analysis technology to measure red blood cell deformability for HbA1c quantification. Designed for both at-home patient self-testing and point-of-care professional use in clinics, delivering lab-quality results in 5 minutes from a single drop of blood (0.005ml) with 24-month test kit shelf life and no refrigeration required.

Quantifiable outcome

• High linearity (R2>0.998) with NGSP standard HbA1c% measurements
• +3 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Three partnerships are on record, tiered flagship and core.

• Mayo Clinic LaboratoriesflagshipStrategic or Co-development Partner · 1 February 2023Orange Biomed was selected by BDMT Global for Mayo Clinic Laboratories-sponsored Pitchfest. Presented technology and prototype to President and CEO Dr. William Morice. Goal of forming collaborations to fulfill healthcare gaps in diabetes diagnostics.
• Asan Medical CentercoreStrategic or Co-development PartnerClinical trials of OBM rapid A1c are being conducted with Asan Medical Center in Korea for validation of the technology.
• Duke UniversitycoreStrategic or Co-development PartnerCo-founders Dr. Unghyeon Ko and Yeaseul Park are Duke University alumni. Professor Shyni Varghese from Duke University collaborated on technology discussions.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Abbott: Major diagnostics incumbent offering the Afinion HbA1c POC system and ARCHITECT lab-based HbA1c assays. Competes with Orange Biomed across both professional POC and central-lab channels and sets the prevailing pricing and reimbursement benchmarks.
• Roche Diagnostics: Operates the cobas family of HbA1c analyzers (e.g., cobas c513, cobas b101) widely used in central labs and increasingly in POC settings. A direct competitor on accuracy, throughput, and installed-base reach in the A1C testing category.
• Siemens Healthineers: Markets the DCA Vantage HbA1c analyzer, one of the most widely deployed POC A1C devices in US clinics and a key incumbent that Orange Biomed must displace in physician offices and outpatient settings.
• Bio-Rad Laboratories: Offers the in2it A1C analyzer and broader diabetes diagnostics portfolio for clinical labs. Comparable as a competitor in the HbA1c analyzer category with established lab-channel presence.
• A. Menarini Diagnostics: Distributes the HemoControl and A1C POC platforms across Europe and other regions. Comparable as a regional incumbent competing for the same clinic-based A1C POC footprint.

Direct peers

• EKF Diagnostics: Sells the QuikRead go HbA1c POC device and other hemoglobin/glycation diagnostics. Closely comparable in target market (clinics and smaller labs), product category (POC A1C), and competitive positioning.
• PTS Diagnostics: Manufacturer of the A1cNow series of professional and consumer/OTC A1C test kits. A direct competitor in both the US POC professional market and the emerging at-home A1C space that Orange Biomed is targeting.
• HemoCue (Danaher): Provides the HemoCue HbA1c 501 system for POC A1C measurement and is part of Danaher's diagnostics portfolio. Direct competitor in clinic-based POC HbA1c testing with established global distribution.
• Trinity Biotech: Specialist diagnostics company focused on hemoglobin disorder and HbA1c testing (e.g., Premier Hb9210, Boronate-affinity assays). Comparable in product specialization, clinical target market, and regulatory pathway.

Regional players

• Osang Healthcare (OBM's parent group competitor): Korean diagnostics manufacturer producing CGM, glucometers, and HbA1c analyzers for global markets. Comparable as a Korean-headquartered A1C/glucometer peer with overlapping channels and technology.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/Orangebiomed
• LinkedInlinkedin.com/company/orangebiomed

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds7 records

Investors3 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 Orangebiomed