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Tag: HeartSciences

  • Heart Test (HSCS) Stock Gains After-Market Following Volatile Trading

    Heart Test (HSCS) Stock Gains After-Market Following Volatile Trading

    Heart Test Laboratories, Inc. (NASDAQ: HSCS), operating under the trade name HeartSciences, experienced a notable rebound on the U.S. stock market. Following a regular-session loss of 4.61%, where shares closed at $2.90, the stock rose 8.62% after-hours, reaching $3.15. This fluctuation is attributed to HeartSciences’ recent financial developments and strategic advancements.

    Financial Advances and Extended Capital Runway

    Recent non-dilutive financing arrangements were completed by Heart Test Laboratories, which raised $1.9 million in net funds via an 18-month unsecured loan note. The recent extension of a $500,000 loan note to September 2025 is being followed by this additional funding.

    Since late August, Heart Test has increased its capital runway by $2.4 million through such non-dilutive measures, positioning itself favorably for impending FDA submissions and commercial objectives.

    Progress in AI-ECG Solutions and Upcoming FDA Submissions

    HeartSciences is advancing in the development of both cloud and device-based AI-ECG technologies. These innovations are designed to enhance heart disease detection across various healthcare settings, from large hospitals to mobile testing services managed by nurses.

    Heart Test reported holding $4.3 million in cash and cash equivalents and $5.9 million in shareholders’ equity. Following the recent financing, HSCS balance sheet has been further bolstered, extending its financial runway. The MyoVista Insights AI-ECG cloud platform is progressing towards the completion of its Phase 1 version by the end of 2024.

    Pre-validation efforts for the low ejection fraction (LVEF ≤ 40) algorithm, licensed from the Icahn School of Medicine at Mount Sinai, are set to commence shortly. Successful pre-validation will pave the way for FDA validation studies using retrospective data, with regulatory submission anticipated in the latter half of 2025.

    FDA Submission Timelines and Device Developments

    The MyoVista wavECG device is on track for its FDA 510(k) submission in the first quarter of 2025. Heart Test (NASDAQ: HSCS) has resolved previous hardware and software issues, and work on the updated age-adjusted algorithm is nearing completion. A final pre-submission meeting with the FDA will finalize the validation study reporting processes.

    Patient recruitment and core-lab work for the MyoVista validation study have been completed, and, contingent on a satisfactory pre-submission meeting, the final validation process is expected to proceed promptly.

  • Financial Results Sent HeartSciences (HSCS) Stock Soaring

    Financial Results Sent HeartSciences (HSCS) Stock Soaring

    The shares of Heart Test Laboratories, Inc. (NASDAQ: HSCS) finished the previous session much higher, increasing 12.59% to $0.1771. Heart Test shares, d/b/a HeartSciences, increased when the company’s quarterly results were made public.

    HeartSciences (HSCS) released a business update along with its financial results for the second quarter of its fiscal 2024, which concluded on October 31, 2023. HeartSciences made every attempt to turn a profit during the time under review, but the firm did not disclose any noteworthy revenue during the second fiscal quarter of 2024.

    By October 31, 2023, there was around $100,000 in cash and cash equivalents and a $1.6 million deficiency in shareholders’ equity. At the end of the fiscal Q2 2024, $9.3 million in net proceeds from the sale of common stock were received, and $1.1 million in debt was converted to equity.

    About its business upgrades, HSCS completed agreements with the Icahn School of Medicine at Mount Sinai, New York, bringing about revolutionary development. The agreements encompassed patent rights, technology, and an industry-leading portfolio of AI-based ECG/EKG algorithms for cardiovascular disease screening and diagnosis.

    During the quarter under review, HeartSciences transitioned from a single-device, single-algorithm product base to a broad range of algorithms to be supplied via the MyoVista wavECG device and a cloud-based hardware agnostic platform.

    Additionally, HeartSciences was given approval by the FDA to switch from the more involved De Novo process to a more regular submission method for their MyoVista wavECG device. The FDA clearance of the MyoVista is anticipated in calendar year 2024; however, the procedure will effect certain modifications to HSCS’s MyoVista application, which should result in a speedier clearance overall.

    It is anticipated that the acceptance and use of retrospective data for clinical validation would save years and millions of dollars in developing new algorithms. HeartSciences also made headway in completing the core-lab work for the MyoVista validation trial after announcing earlier in the year that patient enrollment was completed.

    The business continued to expand its portfolio of intellectual property, resulting in 42 overall patents (nine in the United States and 33 abroad). Additionally, HSCS increased its global distribution networks by entering into new distributor agreements in Denmark and India, which included the entirety of India as well as the Nordic nations including Denmark, Finland, Norway and Sweden.