Risk Factors Update Summary
- CMS issued a final 2024 rate announcement, phasing in a new Medicare Advantage risk adjustment model. This will impact payments: 67% of the 2020 model in 2024 and 33% in 2025.
- The company ceased marketing QuantaFlo for heart dysfunction diagnosis, seeking new FDA clearance for expanded use.
- The company wrote off the entire $2.5 million investment in Insulin Insights in December 2023.
- The company extended a loan to Monarch for EndoTool, with $4.5 million loaned out of the committed $5.0 million.
- The company may need to develop or discontinue aspects of its business strategy due to competitive factors.
- The company's ability to commercialize QuantaFlo and other products may depend on coverage and reimbursement policies.
- The company may face challenges in adapting to changes in FDA policies, impacting market authorization and profitability.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1554859&owner=exclude
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