Latest news with #FDA510k
Globe and Mail
3 days ago
- Business
- Globe and Mail
Intelligent Bio Solutions Reports Fiscal 2025 Fourth Quarter and Full Year Results, Highlighting Progress on Planned U.S. Market Expansion, Revenue Growth and Increased Operational Efficiencies
Company advanced efforts to secure U.S. FDA 510(k) clearance to advance on path towards planned U.S. market expansion beyond Forensic Use Only settings Fourth quarter sequential and year-on-year revenue growth of 16%, supported by increased demand for drug testing cartridges NEW YORK, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its financial results and operational highlights for the fiscal fourth quarter and full-year ended June 30, 2025. Fiscal 2025 marked a year of growth for the Company, driven by higher-margin cartridge sales, operational streamlining, and regulatory advancements that support future expansion in the U.S. market, beyond current Forensic Use Only settings. The Company continues to expand its commercial presence internationally, with an active customer base exceeding 450 accounts across 24 countries, and 18 distribution partners. 'Fiscal 2025 was a pivotal year for our business as we continued to lay the foundation for global growth,' said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. 'We delivered sequential growth over fiscal quarters three and two, driven by increased cartridge revenue, improved operational discipline, and growing international momentum. As we enter fiscal 2026, we're focused on three strategic priorities: further accelerating growth, advancing operational excellence, and expanding beyond Forensic Use Only settings in the U.S. Our FDA regulatory pathway remains on track, and we are committed to achieving FDA clearance to expand into the U.S., the world's largest drug screening market, and deliver our non-invasive solution to more organizations seeking fast, dignified, and reliable testing alternatives.' Progress Toward FDA Clearance and U.S. Market Expansion INBS remains focused on securing FDA 510(k) clearance for its opiate test system for codeine in the U.S., enabling broader use beyond current Forensic Use Only settings. In fiscal 2025, the Company advanced its regulatory strategy through increased engagement with regulatory consultants, refined clinical study design, and the generation of new scientific and clinical data to support its submission. The Company's submission to the FDA was supported by a comprehensive dataset comprising new positive data that further validates the security and performance of its innovative fingerprint sweat-based drug screening technology. INBS submitted performance data derived from advanced quantification methods, including human eccrine sweat testing. An Ultra-Micro Balance scale confirmed the system's capability to detect and analyze the minute sweat volumes present in a single fingerprint. The application reflects strategic input from specialized FDA consultants and expert third party partners. Regulatory expansion efforts beyond the U.S. continue, with active scoping underway in Canada, Indonesia, and the Philippines. U.S. market research efforts have progressed beyond initial scoping, with micro-level analysis underway to assess regulatory barriers, relevant drug testing legislation, population distribution, and regional industry concentrations. Expansion Across Key Markets Revenue from sales of goods in fiscal Q4 increased by 16% year-on-year and quarter-on-quarter, supported by increased demand for drug testing cartridges, steady account acquisition across safety-critical sectors and growing partnerships. Cartridge sales remained the Company's highest-margin revenue stream, contributing a growing share of total income and reinforcing the strength of its recurring revenue model. 2025 fiscal fourth quarter revenue reached $843,884, up 16% year-on-year from 2024 fiscal fourth quarter revenue of $727,824 and up 16% quarter-on-quarter from 2025 fiscal third quarter revenue of $728,867, reflecting steady sequential growth. Revenue from cartridge sales increased 9% quarter-on-quarter, 24% year-on-year for the fiscal fourth quarter, and 14% year-on-year for the full fiscal year. Revenue from reader sales increased 15% quarter-on-quarter. The Company secured 115 new accounts throughout the year, bringing the total active customer base to over 450. The Company expects this accelerated pace of new active account growth to continue into the future. New distributor partnerships and deployments in large-scale transport, logistics and construction networks underpinned strategic growth across the UK, Europe, and the Middle East. Operational Efficiencies and Business Localization Strengthen Fundamentals The Company implemented targeted measures to improve gross margins and reduce net loss, including product enhancements, manufacturing improvements, systems upgrades and the use of localized strategies and automation. The multilingual upgrade of the Intelligent Fingerprinting Drug Screening System was completed, with support for Arabic and Latin American Spanish now available. Regionally localized websites were launched in Italian, Spanish and Arabic, supporting international partners and end users in Europe, the Middle East, and Latin America. The Company fully optimized its CRM system, HubSpot, enabling region-specific workflows, lead tracking, and automation efforts to improve conversion tracking, marketing effectiveness and customer engagement. The Company commenced implementation of a new accounting system that will enhance its internal controls by improving efficiency, accuracy, and reliability in financial reporting and data management. Additionally, it commenced implementing a new accounting system for its subsidiary Intelligent Fingerprinting Limited and plans to complete this by the third fiscal quarter of FY 2025–26. The addition of a sixth U.S. patent strengthened the Company's intellectual property portfolio and reinforced its long-term defensibility. 'We've achieved an enormous amount over fiscal 2025, delivering quarter-on-quarter growth, with accelerated momentum in the second half,' said Spiro Sakiris, Chief Financial Officer at Intelligent Bio Solutions. 'This consistent performance reflects the growing traction of our testing solutions in key markets and gives us confidence in our trajectory as we move into fiscal 2026.' About Intelligent Bio Solutions Inc. Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company's current customer segments outside the US include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners. For more information, visit Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.'s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent Bio Solutions' public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Investor & Media Contact Valter Pinto, Managing Director KCSA Strategic Communications PH: (212) 896-1254 INBS@ Intelligent Bio Solutions Inc. Consolidated Balance Sheets As of June 30, As of June 30, 2025 2024 ASSETS Current assets Cash and cash equivalents $ 1,019,909 $ 6,304,098 Accounts receivable, net 594,614 429,704 Inventories, net 635,215 777,537 Research and development tax incentive receivable 734,408 525,332 Assets held for sale 327,500 - Other current assets 826,976 497,572 Total current assets 4,138,622 8,534,243 Property and equipment, net 251,325 565,850 Operating lease right-of-use assets 69,520 306,744 Intangibles, net 3,790,319 4,372,026 Total assets $ 8,249,786 $ 13,778,863 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities Accounts payable and accrued expenses $ 4,534,246 $ 1,704,568 Current portion of operating lease liabilities 84,659 274,834 Deferred grant income - 2,486,668 Current employee benefit liabilities 534,990 469,381 Notes payable 197,146 515,282 Total current liabilities 5,351,041 5,450,733 Employee benefit liabilities, less current portion 84,921 63,615 Operating lease liabilities, less current portion - 81,324 Total liabilities 5,435,962 5,595,672 Commitments and contingencies (Note 16) Shareholders' equity Common stock, $0.01 par value, 100,000,000 shares authorized, 7,323,377 and 7,323,261 shares issued and outstanding, as of June 30, 2025, respectively; 3,456,116 and 3,456,000 shares issued and outstanding, as of June 30, 2024 respectively 73,230 34,557 Treasury stock, at cost, 116 shares as of June 30, 2025 and 2024 (1) (1) Additional paid-in capital 65,783,916 60,971,740 Accumulated deficit (62,533,065) (51,964,332) Accumulated other comprehensive loss (327,944) (712,614) Total consolidated Intelligent Bio Solutions Inc. equity 2,996,136 8,329,350 Non-controlling interest (182,312) (146,159) Total shareholders' equity 2,813,824 8,183,191 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 8,249,786 $ 13,778,863 Intelligent Bio Solutions Inc. Consolidated Statements of Operations and Other Comprehensive Income (Loss) Year ended June 30, 2025 2024 Revenue $ 3,052,532 $ 3,111,781 Cost of revenue (exclusive of amortization shown separately below) (1,805,673) (1,686,155) Gross profit 1,246,859 1,425,626 Other income Government support income 816,901 424,776 Operating expenses Selling, general and administrative expenses (8,883,917) (9,258,496) Development and regulatory approval expenses (2,396,513) (1,673,806) Depreciation and amortization (1,207,875) (1,201,274) Impairment of long-lived assets (220,062) - Total operating expenses (12,708,367) (12,133,576) Loss from operations (10,644,607) (10,283,174) Other income (expense), net Interest expense (60,890) (167,140) Realized foreign exchange loss (911) (1,178) Fair value gain on revaluation of financial instrument - 175,738 Interest income 101,522 84,822 Total other income, net 39,721 92,242 Net loss (10,604,886) (10,190,932) Net loss attributable to non-controlling interest (36,153) (34,173) Net loss attributable to Intelligent Bio Solutions Inc. $ (10,568,733) $ (10,156,759) Other comprehensive income (loss) Foreign currency translation gain (loss) 384,670 (137,118) Total other comprehensive income (loss) 384,670 (137,118) Comprehensive loss (10,220,216) (10,328,050) Comprehensive loss attributable to non-controlling interest (36,153) (34,173) Comprehensive loss attributable to Intelligent Bio Solutions Inc. (10,184,063) (10,293,877) Net loss per share, basic and diluted $ (2.00) $ (6.38)
Yahoo
4 days ago
- Business
- Yahoo
HeartBeam Reports Second Quarter 2025 Results
Executing on Commercial Readiness Plans in Anticipation of FDA 510(k) Clearance for Groundbreaking 12-lead Electrocardiogram (ECG) Synthesis Software Engaged in Ongoing Productive Discussions with FDA Related to the 510(k) Application Increased Business Development Resources to Match Inbound Interest from Industry Partners Management to Host Webcast and Conference Call Today at 4:30 p.m. ET SANTA CLARA, Calif., August 13, 2025--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, has reported its financial and operational results for the second quarter ended June 30, 2025. Second Quarter & Subsequent 2025 Operational Highlights The Company continues to make significant progress towards commercial readiness, along with key clinical and regulatory achievements on the HeartBeam System. 12-Lead ECG Synthesis Software FDA Submission: Productive discussions are ongoing with FDA on 510(k) submission for the 12-lead ECG synthesis software in arrhythmia assessment. Timeline for FDA clearance remains firmly on track, expected by the end of the year. Presented results from pivotal VALID-ECG study in April, demonstrating that HeartBeam successfully met the clinical endpoints, with a 93.4% overall diagnostic agreement indicating that the synthesized 12-lead ECG can support diagnosis of arrhythmias in a manner consistent with standard 12-lead ECGs. Commercial Readiness Plans: Anticipate initiating commercialization upon receiving 510(k) clearance for the 12-lead ECG synthesis software. Executing on commercial readiness plans, including finalizing cardiology reader service to provide on-demand cardiologist reviews of synthesized 12-lead ECGs and triage patients. Established infrastructure for customer service, contract manufacturing, and logistics and fulfillment efforts. Proximity to FDA Clearance and commercialization is intensifying business development activity. Expanded the business development team with recognized industry expert. Other Highlights: Abstract on HeartBeam AI algorithm accepted for presentation at HRX Live 2025 in September. New international patent issued, increasing the Company's moat around its core technology; total of 21 issued patents worldwide. Received two additional industry recognitions, adding to the growing list of recent industry recognitions: Awarded the Innovation Award in Remote Cardiac Diagnostics as part of the 2025 Medical Device Network Excellence Awards for its groundbreaking ECG technology. Named finalist in 2025 Octane High Tech Awards, which recognizes innovators, entrepreneurs and technology leaders with a presence in Orange County. Cash, cash equivalents, and short-term investments totaled $5.1 million as of June 30, 2025, with net cash used in operating activities of $3.4 million for the three months ended June 30, 2025, resulting in a 23% decrease quarter-over-quarter. Management Commentary "In the quarter, we continued to engage in positive and productive discussions with the FDA on the 12-lead ECG synthesis software submission for arrhythmia assessment and we continue to anticipate clearance by the end of the year. As we have discussed, that clearance, together with our foundational clearance, will form the basis for our commercial launch," said Robert Eno, Chief Executive Officer, HeartBeam. "We continue to make significant progress with commercial readiness plans, which is positioning us for a successful launch following 510(k) clearance of our 12-lead synthesis software. "Additionally, we are seeing a marked increase in interest from industry partners as we get closer to our 12-lead ECG synthesis clearance and commercialization. We believe these players understand that HeartBeam's technology is transformative and is an ideal platform in the form of a cable free ECG that produces a synthesized 12-lead ECG output. There are multiple ways for partners to get involved in the HeartBeam ecosystem, including data and AI, companion products and services, and complementary diagnostics and treatments. "Our vision for the near future is to bring additional capabilities of a synthesized 12-lead ECG into patients' hands outside of the healthcare setting. One of the most important trends in medicine today is the movement of medical grade devices from the hospital and clinic to the patient. Accurate, connected, medical grade technologies have been shown to expand access, reduce healthcare costs and enable personalized medicine. Within cardiac diseases there is a major gap and a huge opportunity. Cardiac diseases are the leading cause of death worldwide and most cardiac events, whether arrhythmias or ischemia, happen outside of the healthcare setting. Diagnosing these events is crucial for patients and for the healthcare system and we believe that as we implement our vision, our technology will be well positioned to accomplish this," concluded Eno. Second Quarter 2025 Financial Results Research and development expenses for the second quarter of 2025 were $3.3 million, compared to $2.8 million for the second quarter of 2024. General and administrative expenses for the second quarter of 2025 were $1.7 million compared to $2.2 million for the second quarter of 2024. Net loss for the second quarter of 2025 was $5.0 million, compared to a net loss of $5.0 million for the second quarter of 2024. Net cash used in operating activities was $7.9 million for the six months ended June 30, 2025, as compared to $7.0 million for the six months ended June 30, 2024. Cash, cash equivalents, and short-term investments totaled $5.1 million as of June 30, 2025, with net cash used in operating activities of $3.4 million during the period. Second Quarter 2025 Results Conference Call HeartBeam CEO Robert Eno and CFO Tim Cruickshank will host the conference call, followed by a question-and-answer period. The conference call will be accompanied by a presentation, which can be viewed during the webcast or accessed via the investor relations section of the Company's website here. To access the call, please use the following information: Date: Wednesday, August 13, 2025 Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time) Dial-in: 1-844-826-3035 International Dial-in: 1-412-317-5195 Conference Code: 10201583 Webcast: HeartBeam Second Quarter 2025 Earnings Conference Call A telephone replay will be available approximately three hours after the call and will run through November 13, 2025, by dialing 1-844-512-2921 from the U.S., or 1-412-317-6671 from international locations, and entering replay pin number: 10201583. The replay can also be viewed through the webcast link above and the presentation utilized during the call will be available in the Company's investor relations section here. About HeartBeam, Inc. HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024. The 12-Lead ECG synthesis software is under FDA review. The Company holds over 20 issued patents related to technology enablement. For additional information, visit Forward-Looking Statements All statements in this release that are not based on historical fact are "forward-looking statements." While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our Forms 10-K, 10-Q and other reports filed with the SEC and available at We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. Cleared Indications for Use The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional. For full safety information, see the full Instructions for Use or Clinician Portal Manual. HEARTBEAM, INC. Condensed Balance Sheets (Unaudited) (In thousands, except share data) June 30, 2025 December 31, 2024 Assets Current Assets: Cash and cash equivalents $ 3,256 $ 2,377 Short-term investments (Note 3) 1,797 — Prepaid expenses and other current assets 308 393 Total Current Assets 5,361 2,770 Property and equipment, net 564 450 Other assets 56 56 Total Assets $ 5,981 $ 3,276 Liabilities and Stockholders' Equity Current Liabilities: Accounts payable (includes related party $0 and $5, respectively) $ 814 $ 531 Accrued expenses (includes related party $5 and $0, respectively) 985 1,091 Total Current Liabilities 1,799 1,622 Total Liabilities 1,799 1,622 Commitments (Note 7) Stockholders' Equity Preferred stock - $0.0001 par value; 10,000,000 authorized; 0 shares outstanding at June 30, 2025 and December 31, 2024 — Common stock - $0.0001 par value 100,000,000 shares authorized; 34,020,340 and 26,960,901 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively 4 3 Additional paid in capital 70,909 57,924 Accumulated deficit (66,731 ) (56,273 ) Total Stockholders' Equity 4,182 1,654 Total Liabilities and Stockholders' Equity $ 5,981 $ 3,276 HEARTBEAM, INC. Condensed Statements of Operations (Unaudited) (In thousands, except share and per share data) Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Operating Expenses: General and administrative $ 1,711 $ 2,246 $ 3,720 $ 4,602 Research and development 3,326 2,844 6,818 5,272 Total operating expenses 5,037 5,090 10,538 9,874 Loss from operations (5,037 ) (5,090 ) (10,538 ) (9,874 ) Other Income and (Expense) Interest income 63 134 80 312 Total other income 63 134 80 312 Loss before provision for income taxes (4,974 ) (4,956 ) (10,458 ) (9,562 ) Income tax provision — — — — Net Loss $ (4,974 ) $ (4,956 ) $ (10,458 ) $ (9,562 ) Net loss per share, basic and diluted $ (0.15 ) $ (0.19 ) $ (0.32 ) $ (0.36 ) Weighted average common shares outstanding, basic and diluted 33,834,950 26,566,832 32,184,025 26,538,863 HEARTBEAM, INC. Condensed Statements of Cash Flows (Unaudited) (In thousands) Six months ended June 30, 2025 2024 Cash Flows From Operating Activities Net loss $ (10,458 ) $ (9,562 ) Adjustments to reconcile net loss to net cash used in operating activities Depreciation 15 — Stock based compensation expense 2,286 2,247 Changes in operating assets and liabilities: Prepaid expenses and other current assets 85 92 Accounts payable and accrued expenses 150 210 Net cash used in operating activities (7,922 ) (7,013 ) Cash Flows From Investing Activities Purchase of property and equipment (102 ) (98 ) Purchase of short-term investments (3,760 ) — Maturities of short-term investments 1,963 — Net cash used in investing activities (1,899 ) (98 ) Cash Flows From Financing Activities Proceeds from sale of equity, net of issuance costs 10,250 — Proceeds from sale of equity under ATM, net of issuance costs 450 76 Proceeds from exercise of stock options — 8 Net cash provided by financing activities 10,700 84 Net increase (decrease) in cash and restricted cash 879 (7,027 ) Cash, cash equivalents and restricted cash – Beginning of period 2,433 16,239 Cash, cash equivalents and restricted cash – Ending of period $ 3,312 $ 9,212 Reconciliation of cash, cash equivalents and restricted cash: Cash and cash equivalents $ 3,256 $ 9,157 Restricted cash (included in other assets) 56 55 Total cash, cash equivalents and restricted cash $ 3,312 $ 9,212 Supplemental Disclosures of Cash Flow Information: Purchase of property and equipment in accounts payable $ 27 $ 16 Taxes paid $ — $ — View source version on Contacts Investor Relations Contact: Chris Tyson Executive Vice PresidentMZ North AmericaDirect: 949-491-8235BEAT@ Media Contact: media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
