Huxley Medical, Inc. - Comprehensive Analysis Report

Summary

Huxley Medical, Inc. is a privately held medical technology company founded in 2019 and headquartered in Atlanta, Georgia. Its core mission is to develop products and services that streamline patient care, anywhere. The company focuses on creating innovative medical devices and advanced algorithms to facilitate the simultaneous diagnosis and treatment of various diseases, primarily in cardiac and sleep health. Huxley Medical aims to democratize clinical-grade healthcare by enhancing the accessibility of effective diagnostics, playing a significant role in advancing home-based medical care.

1. Strategic Focus & Objectives

Core Objectives

Huxley Medical's main business objectives are to streamline care processes, eliminate the need for lengthy referral processes and multiple clinic visits, and provide on-demand testing directly to patients. The company is committed to democratizing clinical-grade healthcare by making advanced diagnostics more accessible, particularly for home-based medical care.

Specialization Areas

The company specializes in revolutionizing cardiopulmonary care through advanced wearable diagnostic devices. Its key areas of expertise include the detection of sleep and heart disorders, simplifying complex diagnoses through machine-learned algorithms, and leveraging advanced biosensor technology. Huxley Medical's unique value proposition lies in its ability to offer comprehensive, multi-functional diagnostic solutions from a single, easy-to-use device.

Target Markets

Huxley Medical primarily targets the home-based medical care market. Its solutions are designed for patients requiring diagnosis for sleep-related breathing disorders, such as obstructive sleep apnea (OSA) and central sleep apnea (CSA), and those needing insights into cardiac arrhythmias. The company's strategy positions it to serve patients who can benefit from remote, clinical-grade diagnostics.

2. Financial Overview

Funding History

Huxley Medical has raised a total funding of $24.8 million across eight funding rounds since its first round on June 1, 2020. Notable institutional investors include GRA Venture Fund, America's Seed Fund, and HHS.

Detailed Breakdown of Recent Funding Rounds:
November 14, 2025: Secured $5.9 million in a Series A round.
December 2024: Successfully raised $4.6 million.
June 2023: Raised $7.22 million in a Series A round.

The capital raised is strategically utilized to accelerate the development and deployment of its flagship product, SANSA. It also supports enhanced research and development efforts, scales production capabilities, and drives broader adoption in healthcare settings. Huxley Medical's estimated annual revenue is approximately $9 million.

3. Product Pipeline

Key Products/Services

Huxley Medical's primary pipeline asset and flagship product is the SANSA home sleep apnea test.

Product Name: SANSA home sleep apnea test
Description: SANSA is a wearable, chest-worn, single-point-of-skin-contact diagnostic patch. It is designed to aid in the evaluation of sleep-related breathing disorders, including obstructive sleep apnea (OSA) and central sleep apnea (CSA), and to provide simultaneous insights into cardiac arrhythmias. The device combines nine physiological channels, including oximetry, respiratory effort, sleep/wake staging, and a reference ECG.
Development Stage: Commercialized with multiple expanded FDA clearances.
Target Market/Condition: Patients suspected of having sleep-related breathing disorders (OSA, CSA) and those needing diagnostic insight into cardiac arrhythmias, such as atrial fibrillation.
Expected Timeline: The product is commercially available, with ongoing expansion of its functionalities. The company plans to share real-world data on SANSA's arrhythmia detection capabilities at upcoming electrophysiology meetings.
Key Features and Benefits:
Received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on July 31, 2024, as the first and only FDA-cleared chest-worn patch to integrate advanced signal processing and AI for sleep-disordered breathing detection with a simultaneous electrocardiogram (ECG) reference channel.
Announced FDA clearance on February 5, 2025, for cellular data upload capabilities, eliminating the need for Bluetooth pairing or smartphone apps.
Received FDA 510(k) clearance and commercial release for central sleep apnea (CSA) detection on December 17, 2025. A clinical study demonstrated 100% sensitivity and 99% specificity for CSA detection.
Received FDA regulatory clearance on December 18, 2025, to be used as a diagnostic ECG monitor, making it the first home sleep apnea test capable of offering diagnostic insight into cardiac arrhythmias from a single patch.
Validated in a 340-patient clinical trial across seven institutions, demonstrating accuracy against gold-standard polysomnography.

4. Technology & Innovation

Technology Stack

Huxley Medical's technological platform is built around its wearable multi-sensor patch, SANSA, designed for comprehensive cardiopulmonary monitoring. The system integrates advanced hardware with sophisticated software analysis.

Proprietary Developments

The SANSA device features a patented combination of sensors and materials that precisely measure physiological channels without requiring additional attachments, wires, belts, or hoses. The patch incorporates a reflective Photoplethysmography (PPG) sensor, a single-lead Electrocardiogram (ECG) sensor, and a 3-axis accelerometer. Data is uploaded through built-in cellular capability, enabling an app-free and hands-free workflow for patients. The Huxley Hub serves as a cloud-native platform that allows physicians and clinics to optimize the diagnostic platform, providing real-time re-scoring and automated report generation.

Scientific Methodologies

The platform leverages advanced signal processing and artificial intelligence (AI) with machine-learned algorithms for the accurate detection of sleep-disordered breathing and diagnostic ECG monitoring. This AI-powered scoring system enhances diagnostic accuracy and streamlines patient care. The clinical efficacy and accuracy of SANSA have been validated through robust clinical trials against gold-standard methods.

Technical Capabilities

Key technical capabilities include:
Multi-sensor data acquisition from a single chest-worn patch.
Integrated cellular data upload for seamless, app-free data transmission.
AI-powered algorithms for real-time analysis and scoring of physiological data.
Cloud-native platform (Huxley Hub) for clinician access, re-scoring, and automated report generation.
Ability to simultaneously detect multiple conditions (OSA, CSA, cardiac arrhythmias).

Patents and Intellectual Property

Huxley Medical holds numerous patents related to its biosensor technology and data processing, including:
U.S. Patent 11,464,451: "PATCH FOR IMPROVED BIOMETRIC DATA CAPTURE AND RELATED PROCESSES"
U.S. Patent 11,717,221: "PATCH FOR IMPROVED BIOMETRIC DATA CAPTURE AND RELATED PROCESSES"
U.S. Patent 11,660,005: "PROCESSING AND ANALYZING BIOMETRIC DATA"
U.S. Patent 12,076,117: "PROCESSING AND ANALYZING BIOMETRIC DATA"
U.S. Patent 12,109,010: "PHOTOPLETHYSMOGRAPHY SENSORS AND PROCESSES"
U.S. Patent 12,114,980: "DISPOSABLE SENSOR PATCH AND TEMPLATE, POD, AND PROCESSES FOR USING SAME"
U.S. Patent 12,171,576: "PATCH FOR IMPROVED BIOMETRIC DATA CAPTURE AND RELATED PROCESSES"
U.S. Patent 12,178,552: "SYSTEMS AND PROCESSES FOR DETECTING OXYGEN SATURATION AND COMPENSATING FOR SKIN TONE VARIATION"
Other granted patents include "Photoplethysmography sensors and processes" (Patent No. 12279853, 12328771, 12328772) and "Processing and analyzing biometric data" (Patent No. 12329497).

5. Leadership & Management

Executive Team

Chris Lee, PhD - Co-Founder, Chief Executive Officer, President & Chairman
Professional Background: Dr. Lee is a seasoned medical technology entrepreneur and angel investor with a track record of seeding and advising successful healthcare and technology startups. He previously co-founded and served as President & CEO of Vertera Spine, which was acquired by NuVasive. His career includes leadership roles at MedShape, Inc., and research positions at Georgia Institute of Technology, Cornell University, and MIT.
Notable Achievements: Led Vertera Spine to a successful acquisition. Holds a PhD in Biomedical Engineering from Georgia Institute of Technology and Emory University.
Key Contributions: Drives the company's overall vision, strategy, and entrepreneurial direction, leveraging his extensive experience in medical technology development and commercialization.
Brennan Torstrick, PhD - Co-founder, President of Product & Market Strategy, Chief Scientific Officer
Professional Background: As CSO, Dr. Torstrick is instrumental in expanding SANSA's functionality and executing the company's clinical and technology strategy. He is an inventor listed on several of Huxley Medical's patents.
Key Contributions: Leads scientific innovation, product development strategy, and ensures the robust clinical validation and technological advancement of the SANSA platform.
Chris Hallett - Co-Founder and Chief Commercial Officer
Professional Background: Mr. Hallett brings over 25 years of experience in the medical device field, with a focus on developing physician engagement programs for sleep physicians and cardiologists.
Key Contributions: Focuses on commercial strategy and market adoption, emphasizing SANSA's role in removing diagnostic barriers for physicians and patients in sleep apnea and comorbid arrhythmias.
Daniel Burnham - Chief Technology Officer
Professional Background: Joined Huxley Medical in March 2023. His previous roles include Director of Software and Systems