Clairity, Inc. Market Research Report

Background

Overview

Clairity, Inc., founded in 2020 and headquartered in Austin, Texas, is a pioneering company in the field of artificial intelligence (AI) and deep learning, focusing on enhancing breast cancer risk assessment through advanced imaging technologies. The company's mission is to shift the standard of care from reactive diagnosis to proactive prevention, ensuring that individuals understand their health risks regardless of race, ethnicity, or gender.

Mission and Vision

Clairity's mission is grounded in the belief that everyone deserves to understand their health risks, regardless of race, ethnicity, or gender. The company envisions transforming healthcare risk assessment by leveraging AI to uncover subtle patterns in routine mammograms, thereby enhancing early detection and personalized care plans.

Primary Area of Focus

The company's primary focus is on developing AI-driven platforms that analyze mammographic images to predict an individual's five-year risk of developing breast cancer. By identifying high-risk individuals early, Clairity aims to enable clinicians to implement personalized prevention strategies, monitor lifestyle choices, and track changes in health over time.

Industry Significance

Clairity's innovative approach addresses significant challenges in breast cancer screening, including the need for more accurate risk assessments and the reduction of racial and ethnic biases in healthcare. By integrating AI into routine mammography, Clairity contributes to the advancement of precision medicine, potentially improving early detection rates and patient outcomes.

Key Strategic Focus

Core Objectives

Proactive Prevention: Shift the standard of care from reactive diagnosis to proactive prevention by identifying individuals at elevated risk of breast cancer through AI analysis of mammograms.

Personalized Care Plans: Enable clinicians to develop and evolve personalized care plans based on AI-driven risk assessments, considering factors such as lifestyle choices, health changes, and family history.

Equity in Healthcare: Address and reduce racial and ethnic biases in breast cancer risk assessment, ensuring equitable access to life-saving early detection and prevention strategies.

Specific Areas of Specialization

AI and Deep Learning in Medical Imaging: Utilize advanced AI algorithms to analyze mammographic images at the pixel level, uncovering patterns invisible to the human eye.

Breast Cancer Risk Prediction: Develop models that predict an individual's five-year risk of developing breast cancer, facilitating early intervention and personalized care.

Key Technologies Utilized

Deep Learning Algorithms: Employ sophisticated AI models trained on extensive datasets to enhance the accuracy of breast cancer risk predictions.

Radiomics: Analyze medical imaging data to extract quantitative features, providing insights into tumor characteristics and potential risks.

Primary Markets or Conditions Targeted

Healthcare Providers: Offer tools for clinicians to improve breast cancer screening processes and patient outcomes.

Patients at Elevated Risk: Provide individuals with personalized risk assessments to inform preventive measures and treatment decisions.

Financials and Funding

Funding History

Clairity has secured significant funding to support its growth and technological development:

Series A Funding: In January 2021, Clairity completed a Series A funding round, raising an undisclosed amount.

Series B Funding: In October 2022, the company raised $6.67 million in a Series B funding round.

Notable Investors

Santé Ventures, a specialized healthcare and life sciences investment firm, has been a key investor in Clairity, supporting the company's mission to revolutionize breast cancer care through AI-driven solutions.

Intended Utilization of Capital

The funds raised are intended to:

Product Development: Advance the development of Clairity's AI-driven breast cancer risk assessment platform.

Market Expansion: Support the global launch and adoption of the platform, aiming to reach a broader patient population.

Operational Scaling: Enhance operational capabilities to meet the demands of a growing user base and ensure the delivery of high-quality services.

Pipeline Development

Key Pipeline Candidates

CLAIRITY BREAST: The company's flagship product, CLAIRITY BREAST, is an AI-based platform designed to predict an individual's five-year risk of developing breast cancer from routine screening mammograms.

Stages of Clinical Trials or Product Development

FDA Authorization: In May 2025, CLAIRITY BREAST received De Novo authorization from the U.S. Food and Drug Administration (FDA), marking a significant milestone in the company's product development.

Target Conditions

Breast Cancer Risk Assessment: Focus on individuals undergoing routine mammography screenings to identify those at elevated risk of developing breast cancer.

Relevant Timelines for Anticipated Milestones

Commercial Launch: The company plans to launch CLAIRITY BREAST in the second half of 2025, following FDA authorization.

Technological Platform and Innovation

Proprietary Technologies

AI-Driven Imaging Analysis: Clairity's proprietary AI algorithms analyze mammographic images at the pixel level to detect subtle patterns indicative of future breast cancer risk.

Deep Learning Models: Utilize deep learning techniques to enhance the accuracy and reliability of risk predictions, reducing human error and bias.

Significant Scientific Methods

Radiomics: Extract quantitative features from medical imaging data to provide insights into tumor characteristics and potential risks.

Predictive Modeling: Develop models that integrate imaging data with clinical information to predict individual risk profiles.

AI-Driven Capabilities

Automated Risk Assessment: Enable automated analysis of mammograms, providing clinicians with actionable insights to inform decision-making.

Bias Reduction: Address and reduce racial and ethnic biases in breast cancer risk assessment, promoting equitable healthcare practices.

Leadership Team

Executive Profiles

Jeffrey R. Luber, JD, MBA – Chief Executive Officer (CEO): Appointed in November 2024, Luber brings extensive experience in healthcare leadership, including roles at binx health and Exact Sciences.

Constance “Connie” Lehman, MD, PhD – Co-Founder: A leading authority in breast imaging AI, Dr. Lehman co-founded Clairity and has a background in radiology and medical imaging.

Philippe Raffy – Chief Technology Officer (CTO): Oversees the technological development of Clairity's AI platforms, ensuring innovation and technical excellence.

Merle Waterman – Chief Financial Officer (CFO): Manages the company's financial operations, supporting strategic growth and investment initiatives.

Shriram Narayanan – Software Engineering Manager: Leads the software engineering team, focusing on the development and implementation of Clairity's AI solutions.

Board of Directors

Kevin Lalande – Co-Founder, Board of Directors Managing Director, Santé Ventures: Provides strategic guidance and oversight, leveraging his experience in healthcare investments.

Joe Cunningham, MD – Board of Directors Managing Director, Santé Ventures: Offers expertise in medical investments and strategic direction for the company.

Gabriella Antici, MS – Founder, Protea Institute M.S. MIT Sloan School of Management: Contributes to the board with a background in management and healthcare innovation.

Competitor Profile

Market Insights and Dynamics

The breast cancer screening market is evolving with the integration of AI and machine learning technologies, aiming to improve early detection and personalized care. The global market for AI in healthcare is experiencing significant growth, driven by advancements in technology and increasing demand for precision medicine.

Competitor Analysis

Kheiron Medical Technologies: Develops AI-powered mammography analysis tools to assist radiologists in detecting breast cancer.

Zebra Medical Vision: Offers AI-based imaging analytics for various medical conditions, including breast cancer detection.

ScreenPoint Medical: Provides AI solutions for mammography interpretation, focusing on early detection of breast cancer.

Strategic Collaborations and Partnerships

Clairity has established significant collaborations to enhance its market position:

Santé Ventures: An early-stage healthcare and life sciences investment firm.

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