ADGM 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-11

• We have also developed a faster, smaller next-generation vCLAS Ultra Ventricular Ablation System, which is designed to improve customer usability and integration with the existing ablation laboratory workflow. vCLAS Ultra features a more flexible, smaller diameter shaft that is compatible with the i…

• We believe that our purpose-built solutions have the potential to drive additional market growth in the ablative treatment of the large, underserved VT patient population.

• We have established a robust cadence of clinical data designed to evaluate our ULTA technology and support regulatory approvals of our product portfolio. Preliminary data suggest that our approach to treating VT offers a favorable combination of safety, acute and chronic effectiveness compared to th…

• On June 12, 2026, we received a notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that the listing of our common stock was not in compliance with Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market, as the minimum b…

• Cost of revenue was nil for the three months ended June 30, 2026, compared to $0.3 million for the three months ended June 30, 2025, representing a decrease of $0.3 million, or 100%. The decrease was primarily attributable to the pause in commercial activity in Europe.

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• We believe that our purpose-built solution has the potential to drive additional market growth in ablative treatment of the large, underserved VT patient population.

• We have established a robust cadence of clinical data designed to evaluate our technology and gain regulatory approvals of our product portfolio. Preliminary data suggest that our approach to treating VT offers a favorable combination of safety, acute and chronic effectiveness, compared to the curre…

• We are also currently developing a next generation ULTA technology for VT. We received IDE approval from the FDA in April 2026 to expand the Company’s FULCRUM-VT trial to evaluate the safety and effectiveness of our next-generation vCLAS ULTA Ventricular Ablation System for the treatment of Sustaine…

• Management expects the research and development expenses to increase in future periods, as we will incur incremental expenses associated with our ULTA products that are currently under development and in pre-clinical and clinical trials. Product candidates in later stages of clinical development gen…

• Cost of revenue was nil for the three months ended March 31, 2026, compared to $0.3 million for the three months ended March 31, 2025, representing a decrease of $0.3 million, or 100%. The decrease was primarily attributable to the pause in commercial activity in Europe. Depreciation expense related…

相对上期新增的文字 · 来源:10-Q · 2026-08-11

• If we fail to meet all applicable requirements of Nasdaq and Nasdaq determines to delist our common stock, the delisting could adversely affect the market liquidity of our common stock and the market price of our common stock could decrease.

• On June 12, 2026, we received a letter from Nasdaq, notifying us that the listing of our common stock was not in compliance with the Minimum Bid Price Requirement. In accordance with Nasdaq Listing Rule 5810(c)(3)(A) we were provided an initial period of 180 calendar days, or until December 9, 2026,…

• There can be no assurance that we will regain compliance with the requirements for listing our common stock on Nasdaq. If we are unable to satisfy the Nasdaq criteria for continued listing, our common stock would be subject to delisting. A delisting of our common stock could negatively impact us by,…