Invest in the Future of Disease Detection.
Help us with our goal to save millions of lives through earlier disease detection by investing in our Reg CF offering.
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The Problem We're Solving
Lung cancer is the leading cause of cancer deaths worldwide, claiming more lives than breast, prostate, and colorectal cancers combined. When detected early, the 5-year survival rate jumps from 6% to over 60%. Yet current screening methods face significant challenges:
Only ~6% of high-risk individuals comply with recommended low-dose CT screening
CT scans expose patients to radiation and generate costly false positives
Invasive biopsies create additional risk and patient anxiety
Our breakthrough technology addresses these barriers by offering a simple breath test that can detect lung cancer biomarkers with remarkable accuracy—creating a pathway to widespread, accessible screening that patients will actually use.
OneBreath™: Transformational Technology
Patented Diagnostic Platform
Our proprietary OneBreath™ technology analyzes volatile organic compounds (VOCs) in exhaled breath using liquid chromatoraphy mass spectrometry and AI algorithms to detect cancer-specific molecular signaturesm, as well as other diseases.
Clinically Validated Accuracy
Proven in studies with over 800 patients, achieving 94% sensitivity and 85% specificity for lung cancer—comparable or superior to low-dose CT screening without radiation exposure or invasive procedures.
Patient-Centered Design
One single exhale breath collection process requires no special preparation and can be administered in any clinical setting. Compared with other breath sampling technologies that can take upwards of 15-30 mins for the patient, we require just one breath.
lung cancer TAM
sensitivity
specificity
With 20 million Americans eligible for annual lung cancer screening and an aging global population, demand for efficient, non-invasive diagnostics is surging.
Investment Opportunity Details
This Regulation CF offering democratizes access to an early-stage medical technology investment typically reserved for venture capital firms. Your investment directly supports our path to FDA approval and commercial launch, potentially transforming cancer diagnostics while creating shareholder value.
How Your Investment Drives Impact
Clinical Trials & FDA Submission
Fund pivotal clinical studies and regulatory filings to validate OneBreath™ for FDA approval.
Laboratory Infrastructure
Expand testing capabilities and reference laboratory facilities to support clinical validation and early commercial adoption.
Healthcare Partnerships
Establish strategic relationships with leading cancer centers and healthcare networks for initial deployment and real-world validation.
Market Preparation
Develop commercial infrastructure, marketing materials, and distribution channels to ensure rapid adoption post-approval.
Why Invest Now: Market Timing & Momentum
Clinical & Regulatory Momentum
With strong preliminary clinical results and strategic regulatory planning, OneBreath™ is positioned for potential fast-track designation. Early investors benefit from significant value creation milestones expected on the immediate horizon.
Our multidisciplinary leadership team bridges medicine, chemistry, engineering, and business expertise. Backed by nearly $7.7 million in prior capital, we've consistently hit development milestones and established strong intellectual property protection.
Proven Team & Progress
Differentiated Solution
OneBreath™ offers substantially higher patient compliance potential compared to current standards. Our non-invasive approach is poised to disrupt the diagnostic market by removing key barriers to widespread screening adoption.
While lung cancer detection is our initial focus, our breath analysis platform has demonstrated potential applications for other conditions including pneumonia, COPD, and tuberculosis—creating multiple pathways for future growth and market expansion.
The convergence of advanced sensor technology, machine learning capabilities, and growing healthcare emphasis on early detection creates a perfect storm of opportunity for breath-based diagnostics to emerge as a new standard of care.
Scalable Platform Technology
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Understanding Investment Risks
This offering involves securities of a development-stage medical technology company. Investments of this nature carry significant risks including potential loss of your entire investment. Shares are restricted and may not be easily resold for an indefinite period.
Regulatory Uncertainty
FDA approval timelines may extend beyond projections, delaying market entry and revenue generation. Our regulatory strategy incorporates contingency planning for various approval scenarios.
Market Adoption
New diagnostic technologies face adoption barriers in conservative healthcare systems. Our clinical validation and KOL engagement strategy is designed to accelerate acceptance.
Competitive Landscape
While we maintain strong IP protection, other companies are exploring breath diagnostics. Our first-mover advantage and extensive clinical validation provide competitive differentiation.
No federal or state securities commission has approved, endorsed, or reviewed this offering. Investors should perform their own due diligence and be prepared to hold their investment indefinitely without expectation of liquidity.
Our Expert Leadership Team
Breath Diagnostics is led by a multidisciplinary team with decades of combined experience in medical device development, clinical research, regulatory affairs, and successful healthcare startups. Our leadership includes:
By investing in Breath Diagnostics, you're backing a potential paradigm shift in cancer screening with real-world impact and financial upside. Our OneBreath™ technology could fundamentally change how we detect lung cancer and other diseases, potentially saving millions of lives through earlier detection while creating substantial shareholder value.
Your investment directly contributes to bringing this life-saving technology to market. Starting at just $3 per share, you can be part of this revolutionary approach to cancer detection and participate in the next generation of precision medicine.
160K
Lives At Stake
Annual U.S. lung cancer deaths that could be significantly reduced through earlier detection
94%
Detection Rate
Clinical sensitivity of OneBreath™ technology in patient trials
$3
Entry Point
Minimum investment amount per share to join our mission
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This offering is being conducted pursuant to Regulation Crowdfunding and is made available exclusively through Equifund Technologies, LLC, a FINRA-registered funding portal. Investors should not invest unless they can afford to lose their entire investment. Investments in private companies are highly speculative, illiquid, and involve a high degree of risk, including the risk of complete loss.
An Offering Statement regarding this offering has been filed with the U.S. Securities and Exchange Commission (SEC). The SEC has qualified that offering statement, which only means that the Company may make sales of the securities described. It does not mean that the SEC has approved, passed upon the merits, or passed upon the accuracy or completeness of the information in the offering statement. The complete Offering Circular can be reviewed [here] and should be carefully examined before investing. All investments must be made through Equifund at https://invest.equifund.com/offering/breathdiagnostics/.
Forward-Looking Statements
The offering materials, including information available on www.breathdiagnostics.com, may contain forward-looking statements and information relating to, among other things, the Company, its business plan and strategy, its industry, and its products. These forward-looking statements are based on the beliefs, assumptions, and information currently available to the Company’s management. When used in the offering materials, words such as “estimate,” “project,” “believe,” “anticipate,” “intend,” “expect”and similar expressions are intended to identify forward-looking statements, which are inherently subject to risks and uncertainties. Actual results may differ materially from those contained in such statements due to various factors, including those described in the “Risk Factors” section of the Offering Circular. Importantly, the Company’s diagnostic tool is a medical device that requires FDA approval and is not currently approved for clinical use. There can be no assurance that FDA approval will be obtained, or that the product will ever be commercialized. Investors are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date made. The Company undertakes no obligation to revise or update these statements to reflect future events or circumstances.