EXCLUSIVE: Issuance Of New Reimbursement-Related Codes Validates Commercial Opportunity For HeartSciences' Flagship Product
The American Medical Association has issued new industry-first Category III Current Procedural Terminology (CPT) codes for AI assistive algorithmic ECG risk assessment for cardiac dysfunction.
What Happened: These codes are expected to cover the AI cardiac dysfunction algorithm incorporated in Heart Test Laboratories Inc's, doing business as HeartSciences (NASDAQ: HSCS), MyoVista Wavelet ECG Cardiac Testing Device.
MyoVista is HeartSciences' first product candidate for FDA De Novo clearance.
It is a resting 12-lead ECG designed to provide diagnostic information related to cardiac dysfunction, which has traditionally only been available through cardiac imaging.
The MyoVista also provides conventional ECG information in the same test.
The business model, which involves using the MyoVista device and consumables for each test, is expected to be "razor-razorblade" as the electrodes used with the MyoVista are proprietary to HeartSciences, and new electrodes are required for every test performed.
Why It Matters: CPT Category III codes facilitate emerging technologies' use, adoption, and potential reimbursement.
The new CPT codes go into effect in the CPT codebook on January 1, 2023.
"This is a major milestone for HeartSciences...It also further validates the commercial opportunity for the MyoVista," stated Andrew Simpson, Chief Executive Officer of HeartSciences."
Price Action: HSCS shares closed at $1.61 on Tuesday.
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