Product Development and Regulatory Approvals - The VIVO System has been utilized in over 1,000 procedures in the U.S. and EU by more than 30 physicians, with no reported device-related complications[252]. - The Company has received FDA clearance to market the VIVO System in the U.S. as a pre-procedure planning tool for patients with structurally normal hearts[252]. - The VIVO System has received CE Mark designation, allowing marketing in EU member countries[253]. - The Company has commenced limited sales of the VIVO System in Europe and the UK through independent distributors[254]. - LockeT® device recognized its first sale in May 2024 and received its first patent in China in September 2024[255]. - In April 2025, LockeT obtained CE Mark approval for marketing in the EU, Switzerland, and Turkey, leading to new distributor agreements in multiple countries[256]. - Clinical studies for LockeT began in 2023, aiming to demonstrate faster wound closure and lower healthcare costs[258]. Financial Performance and Revenue - Revenue for the three months ended September 30, 2025, increased by approximately $130 thousand, driven by a $92 thousand increase in LockeT sales and a $38 thousand increase in VIVO System sales compared to the same period in 2024[287]. - For the nine months ended September 30, 2025, revenue increased by approximately $310 thousand, primarily due to a $322 thousand increase in LockeT sales, partially offset by a $12 thousand decrease in VIVO System sales[287]. - Cost of revenues increased by approximately $8 thousand and $12 thousand for the three and nine months ended September 30, 2025, respectively, mainly due to increased LockeT sales and higher product margins[288]. - Selling, general and administrative expenses rose by approximately $0.1 million for the three months and $1.1 million for the nine months ended September 30, 2025, attributed to increased professional fees, stock-based compensation, and salaries[289][290]. - Research and development expenses increased by approximately $0.2 million for the three months and $0.4 million for the nine months ended September 30, 2025, primarily due to higher professional fees and salaries[291][292]. - Acquired in-process research and development expenses increased by approximately $2.0 million for the nine months ended September 30, 2025, related to two asset acquisitions completed in 2025[293]. Financing and Cash Flow - The Company anticipates the need for additional financing to support ongoing operations and product development[242]. - The May 2025 PIPE Financing raised gross proceeds of $1.5 million, with additional shares of preferred stock and warrants issued[264]. - As of September 30, 2025, 868,582 shares were sold under the At Market Offering Agreement for gross proceeds of $4.0 million[274]. - Net cash used in operating activities was $6.8 million for the nine months ended September 30, 2025, primarily due to a net loss of $11.8 million[303]. - As of September 30, 2025, the company had cash and cash equivalents of $1.1 million and an accumulated deficit of $303.8 million[298]. - The company expects operating losses and negative cash flows to continue unless sales and gross profit increase sufficiently to cover operating expenses[300]. - During the nine months ended September 30, 2024, net cash provided by financing activities was $4.2 million, consisting of $2.6 million from the issuance of common stock and $1.5 million from notes payable due to related parties[307]. Internal Controls and Financial Reporting - The Company has identified material weaknesses in internal control over financial reporting, which could affect the accuracy of financial results[243]. - The Company is subject to extensive regulatory scrutiny, and product approvals may be delayed or denied[243]. - The company has not engaged in any off-balance sheet arrangements during the periods presented, indicating a straightforward financial structure[308]. - The company regularly evaluates estimates related to asset acquisitions, including provisions for legal contingencies and income taxes, which may materially affect financial results[310]. Accounting and Valuation - The fair value of trading debt securities is determined using a probability weighted expected return model, which incorporates significant unobservable inputs[314]. - The company recognizes a liability for royalty fees based on actual sales of products, with future estimated royalty payments recorded at fair value[316]. - Royalties payable due to related parties are remeasured at each reporting period, with changes recorded in the statements of operations[317]. - The company applies an internally developed revenue adjusted discount rate to discount forecasted royalty payments, reflecting the product revenue's risk profile[317]. - New accounting pronouncements are described in the financial statements, including expected adoption dates and estimated effects on operations[318].
RA MEDICAL SYSTE(RMED) - 2025 Q3 - Quarterly Report