/C O R R E C T I O N -- Ultromics/

In the news release, Ultromics granted Category III CPT reimbursement code for EchoGo® Heart Failure, issued 02-Jul-2024 by Ultromics over PR Newswire, we are advised by the company that in the third paragraph, the second sentence should read "The new CPT code, 0932T, will replace the previous HCPCS outpatient code for EchoGo® Heart Failure, C9786" rather than "The new CPT code, 0923T, will replace the previous HCPCS outpatient code for EchoGo® Heart Failure, C9786," as originally issued inadvertently. The complete, corrected release follows:

Ultromics granted Category III CPT reimbursement code for EchoGo® Heart Failure

OXFORD, England, July 2, 2024 /PRNewswire/ -- Ultromics announced today that the American Medical Association (AMA) has issued a Category III Current Procedural Terminology (CPT) code for EchoGo® Heart Failure, a crucial advancement in enhancing the accessibility of Ultromics' ground-breaking technology in hospital outpatient settings.

EchoGo^® Heart Failure uses AI to detect heart failure with preserved ejection fraction (HFpEF) from a single, routinely acquired echocardiographic video. The technology leverages large datasets and advanced algorithms to identify patterns and correlations that may go undetected by traditional diagnostic methods. The AI insights aid clinicians in diagnosis, monitoring, and expediting treatment responses, significantly enhancing the detection and management of patients with this challenging subtype of heart failure.

This is the only artificial intelligence CPT code specific to supporting HFpEF diagnosis through echocardiography and was released on July 1^st this year on the AMA's website, becoming effective January 1^st, 2025. The new CPT code, 0932T, will replace the previous HCPCS outpatient code for EchoGo^® Heart Failure, C9786.  EchoGo^® Heart Failure is also covered in the hospital inpatient setting, using the New Technology Add-on Payment (NTAP) code XXE2X19.

Ross Upton, PhD, Chief Executive Officer and founder of Ultromics, stated, "This recognition by the AMA underscores the significant impact our technology is having in the field of heart failure care. HFpEF represents a significant and growing patient population, accounting for 50% of heart failure cases worldwide, and may go undiagnosed in up to 64% of cases.¹  We believe that EchoGo^® Heart Failure will transform diagnostic pathways for these patients, enable earlier intervention, improve quality of life, and deliver benefits to payors and healthcare systems."

In the US, CPT codes are used by public and private health insurance programs and offer doctors and healthcare professionals a method to identify medical services and procedures for reimbursement. Category III CPT codes are temporary codes assigned to new and developing technologies, procedures, and services.

Additional Data on EchoGo^® Heart Failure

EchoGo^® Heart Failure was granted FDA 510(k) clearance in December 2022 and has been awarded FDA Breakthrough Device Designation.²

Recent data on the tool was published last year in JACC: Advances, showing superior efficacy of EchoGo^® Heart Failure in identifying HFpEF over the current clinical standard.

Specifically, the AI-based system was able to correctly assign a diagnosis to 74% of patients who had returned non-diagnostic results on the commonly used HFA-PEFF and H2FPEF clinical scores.³ This improvement could translate to more patients receiving accurate and timely diagnoses and management.

EchoGo^® Heart Failure demonstrated high sensitivity and specificity, detecting 88% of patients who had HFpEF, and 82% of patients that did not.³ These results exceed what is usually observed in routine clinical practice.

For the study, investigators retrospectively assessed independent data on 6,756 patients who underwent a comprehensive TTE at Mayo Clinic in Rochester, Minnesota, between January 2009 and December 2020. It was then independently tested in geographically distinct areas within Mayo Clinic Enterprise sites across the United States on a dataset that included 1,284 patients.

The authors concluded, "EchoGo^® Heart Failure's exceptional discrimination capabilities, combined with its ability to identify patients with higher mortality risks, hold great promise for improving patient outcomes and enabling faster access to treatment."

References:

1. Borlaug et al., Heart Failure With Preserved Ejection Fraction: JACC Scientific Statement. J Am Coll Cardiol 2023;81:1810–1834.

2. Ultromics receives FDA Clearance for its Breakthrough Device EchoGo Heart Failure: An AI-based platform that enables precision detection of heart failure with preserved ejection fraction. News release. Ultromics. December 2, 2022.

3. Akerman AP, et al. Automated Echocardiographic Detection of Heart Failure with Preserved Ejection Fraction Using Artificial Intelligence. JACC Adv. 2023:1;2(6):100452–2.

About Ultromics:

Ultromics is a pioneer in precision heart failure detection. Our ground-breaking platform, EchoGo®, is transforming the way heart failure is diagnosed using artificial intelligence and cardiac ultrasound as a modality.  The technology empowers clinicians to make precise, efficient, and accurate assessments of heart failure, leveraging the largest known heart disease dataset in echocardiography. The model was trained on thousands of patients to accurately detect disease and was validated against 5-year patient outcomes.  The technology has been built in collaboration with Mayo Clinic and the NHS England. Ultromics' mission is to stop heart failure in its tracks with its precision detection platform.

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