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Heart Test Laboratories Inc is an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease. The company aims to enhance healthcare by making cardiac screening more valuable, especially in frontline clinical settings.
Heart Test Laboratories, operating as HeartSciences (NASDAQ: HSCS; HSCSW), provided a business update on December 16, 2022, indicating significant progress toward FDA De Novo resubmission of its MyoVista technology. The company has nearly finished patient enrollment for its pivotal validation study and aims for resubmission by fiscal year-end. HeartSciences also strengthened its intellectual property with new patents and received new CPT codes for AI-assisted ECG assessments. However, the company reported no meaningful revenues for Q2 2023, holding $3.1 million in cash.
Heart Test Laboratories, Inc., operating as HeartSciences (NASDAQ: HSCS; HSCSW), has announced a multi-year collaboration with Rutgers University to develop AI-based ECG algorithms. This partnership aims to enhance the clinical utility of ECGs for cost-effective heart disease detection. Dr. Partho P. Sengupta will lead the initiative leveraging Rutgers' extensive clinical data. The collaboration is expected to significantly speed up HeartSciences' product development pipeline. CEO Andrew Simpson highlights this as a step towards bringing advanced clinical capabilities to ECGs, affirming the company's leadership in cardiac innovation.
Heart Test Laboratories, Inc. (d/b/a HeartSciences) (NASDAQ: HSCS; HSCSW) will have CEO Andrew Simpson present at the 2022 RHK Disruptive Growth Conference on December 5-6, 2022, in New York City. The conference aims to showcase up to 50 growth companies to over 200 institutional and accredited investors. HeartSciences focuses on enhancing ECG technology through AI, with its MyoVista® wavECG device set to revolutionize cardiac screening. The company emphasizes improving healthcare delivery, especially in point-of-care settings.
Heart Test Laboratories, Inc., operating as HeartSciences (NASDAQ: HSCS; HSCSW), announced a study validating its MyoVista® technology in cardiac risk stratification. The independent research highlighted its AI-ECG algorithm's ability to predict major adverse cardiovascular events (MACE) effectively. The study involved 518 patients over 38 months and showed a significantly higher probability of identifying high-risk patients (21%) compared to low-risk (3%). Results align closely with traditional echo-based models, indicating strong potential for AI in clinical settings.
HeartSciences (NASDAQ: HSCS) has secured a patent from the European Patent Office for its proprietary ECG electrode and cable connectors, enhancing its competitive position in the market. This patent builds on existing U.S. protections and aims to diversify the company's intellectual property. CEO Andrew Simpson emphasized the significance of this development as HeartSciences progresses towards commercialization of its MyoVista® device, designed to improve cardiac dysfunction diagnosis through innovative AI technology. The MyoVista® provides a dual-function ECG and is crucial for the company's recurring revenue model.
HeartSciences announced the issuance of new Category III CPT codes by the American Medical Association (AMA) to support the use of AI-driven ECG risk assessments for cardiac dysfunction. Effective January 1, 2023, these codes will facilitate reimbursement and boost the adoption of the MyoVista device, currently in FDA submission. This milestone underscores the potential of AI in enhancing ECG's clinical utility, with millions of ECGs done weekly, making cardiac dysfunction detection more accessible.
Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ:HSCS; HSCSW) will present at the 2022 MicroCap Rodeo Windy City Roundup Conference on October 12-13, 2022, in Chicago, Illinois. CEO Andrew Simpson is scheduled to present on October 12, at 1:30 PM CT. The presentation will be live-streamed and available for replay. Qualified investors can schedule one-on-one meetings with Mr. Simpson. The conference gathers around 60 microcap companies, offering insights into investment opportunities and trends for 2023.
HeartSciences has been granted a new patent for AI-based ECG technology to assess diastolic dysfunction, enhancing its intellectual property portfolio. This advancement positions the company to improve cardiac screening in non-specialist settings, potentially impacting over 100 million ECG tests annually in the USA. The patented MyoVista® Wavelet ECG (wavECG™) aims to provide diagnostic insights that traditional ECGs lack, addressing a critical healthcare need for early cardiac dysfunction detection. With a total of 18 patents granted globally, HeartSciences continues to innovate in medical technology.
HeartSciences (NASDAQ: HSCS; HSCSW) is approaching the completion of patient recruitment for the FDA pivotal clinical validation study of its MyoVista® wavECG™ device, having enrolled over 500 of the targeted 550 patients. The company anticipates resubmitting for FDA De Novo clearance in the current fiscal year. Following a successful IPO that raised $6.375 million, HeartSciences holds $4.3 million in cash as of July 31, 2022, sufficient to support operations through critical milestones. The global ECG market, valued at $8.3 billion in 2020, is expected to reach $18.4 billion by 2030.
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