CHICAGO - Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), a company specializing in AI-driven precision cardiovascular medicine, has announced that its PrecisionCHD and Epi+Gen CHD tests have received preliminary pricing determinations from the Centers for Medicare & Medicaid Services (CMS). This development is a significant step towards obtaining Medicare reimbursement for the tests, which are designed to enhance the risk assessment and management of coronary heart disease (CHD) in Medicare patients.
The preliminary decision to price both tests on a 'gapfill' basis was made following the Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting on June 25, 2024. If this decision is finalized, it will be effective for claims with dates of service starting January 1, 2025. Medicare contractors will determine the pricing for these tests based on actual cost data from Cardio Diagnostics and report preliminary gapfill pricing for the 2025 calendar year by April 1, 2025.
Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics, expressed pride in reaching this milestone with CMS, emphasizing the potential impact of their cardiovascular tests on Medicare patients. The PrecisionCHD and Epi+Gen CHD tests utilize an AI-powered approach to evaluate genetic and epigenetic markers for diagnosing CHD and assessing the three-year risk for a CHD event, such as heart attacks.
Cardiovascular disease remains the leading cause of death in the United States, particularly among those over 65, with CHD being the most prevalent form. In 2022, heart disease caused 702,880 deaths, and CHD specifically claimed 371,506 lives. The PrecisionCHD and Epi+Gen CHD tests, which received dedicated CPT Proprietary Laboratory Analysis (PLA) codes from the American Medical Association effective April 1, 2024, are part of Cardio Diagnostics' efforts to make cardiovascular disease prevention, detection, and management more accessible and personalized.
The information presented in this article is based on a press release statement from Cardio Diagnostics Holdings, Inc.
In other recent news, Cardio Diagnostics Holdings, Inc. has been at the center of several noteworthy developments. The AI-focused company has reported a cash balance of $1.6 million at the end of the first quarter of 2024, with a cash burn of $1.2 million. Additionally, the firm has launched a new website, designed to enhance user engagement and streamline access to information for investors, healthcare providers, and patients.
The independent analyst firm, Benchmark, has raised its price target for Cardio Diagnostics shares to $2.00, maintaining a Speculative Buy rating due to a positive outlook on the company's market prospects. In further developments, Cardio Diagnostics has published a study suggesting its PrecisionCHD™ test could potentially result in significant healthcare cost savings.
Lastly, the company has made progress in commercializing its CHD tests, securing CPT PLA codes from the American Medical Association, a key step in the billing process for laboratory tests. These are among the recent developments for Cardio Diagnostics.
InvestingPro Insights
As Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO) advances towards potential Medicare reimbursement for its AI-driven cardiovascular tests, investors should consider some key financial metrics and insights from InvestingPro.
According to InvestingPro data, CDIO's revenue growth has been impressive, with a 1363.1% increase over the last twelve months as of Q2 2024. This aligns with the company's innovative approach to cardiovascular diagnostics and the potential market demand for their PrecisionCHD and Epi+Gen CHD tests.
However, investors should note that the company is currently operating at a loss, with an adjusted operating income of -$8.43 million over the same period. This is reflected in an InvestingPro Tip which indicates that CDIO is "quickly burning through cash." This financial situation underscores the importance of the potential Medicare reimbursement, which could significantly impact the company's revenue stream and path to profitability.
Another relevant InvestingPro Tip suggests that CDIO is a "niche player in the diagnostics industry." This specialization in AI-driven cardiovascular diagnostics could be a double-edged sword, offering unique market positioning but also potentially limiting broader market appeal.
For those considering an investment in CDIO, it's worth noting that InvestingPro lists 15 additional tips for this stock, providing a more comprehensive analysis of its financial health and market position. These insights could be particularly valuable given the company's current developmental stage and the potential impact of the CMS pricing determinations on its future performance.
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