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Koios Medical

Koios Medical

Buffalo, United States· Est.
koiosmedical.com
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Private Company

Total funding raised: $18M

Overview

Koios Medical is a private, commercial-stage diagnostics company founded in 2014 and headquartered in Buffalo, New York. The company has developed a proprietary AI/ML software platform, Koios DS™, which provides real-time decision support for radiologists interpreting breast and thyroid ultrasound scans, aiming to improve cancer detection rates and standardize diagnoses. With regulatory clearances in the US and EU, the company is actively deploying its software globally, supported by strategic investment from entities like Mitsui & Co. Koios operates a B2B software-as-a-medical-device (SaMD) business model, generating revenue through its commercial products.

Oncology

Technology Platform

Proprietary AI/ML algorithms trained on >500,000 pathology-linked ultrasound images for real-time clinical decision support in breast and thyroid lesion classification. Cloud-based, vendor-agnostic software (Smart Ultrasound®) that integrates with existing ultrasound systems.

Funding History

2
Total raised:$18M
Series A$15M
Seed$3M

Opportunities

The large and growing market for AI in medical imaging, particularly in breast and thyroid ultrasound where variability in interpretation is high, presents a significant opportunity.
Strategic partnership with Mitsui & Co.
provides a channel for expansion into the vast Asian healthcare market.
The company's first-mover FDA status for breast ultrasound AI creates a competitive barrier to entry.

Risk Factors

Intense competition from both AI startups and large medical imaging OEMs developing similar tools.
Challenges in securing widespread insurance reimbursement and driving clinical adoption among radiologists.
Inherent risks associated with algorithmic bias, performance across diverse populations, and potential liability.

Competitive Landscape

The competitive landscape is crowded and includes pure-play AI radiology companies (e.g., Aidoc, Zebra Medical Vision), large imaging equipment manufacturers (GE, Siemens, Philips) integrating AI into their platforms, and other specialized ultrasound AI startups. Koios's differentiation lies in its specific FDA-first status for breast ultrasound AI, its large proprietary dataset, and its focus on seamless workflow integration.

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