Breaks Categories: News

MondayJun 16, 2025 9:00 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) VALID-ECG Study Confirms Diagnostic Accuracy of Synthesized 12-Lead ECG

HeartBeam’s credit card-sized device demonstrated 93.4% diagnostic agreement with standard ECGs VALID-ECG study results presented at Heart Rhythm Society conference Company eyes U.S. commercialization pending FDA clearance HeartBeam (NASDAQ: BEAT) announced its synthesized 12-lead ECG met clinical endpoints in the VALID-ECG pivotal study, achieving 93.4% diagnostic agreement with standard ECGs for arrhythmia assessment. The findings, presented by Dr. Thomas Deering of Piedmont Heart Institute at the Heart Rhythm Society’s annual meeting in San Diego, validate HeartBeam’s compact, patient-friendly ECG technology. The study compared ECG intervals and amplitudes between HeartBeam’s synthesized output and simultaneously collected standard ECGs in 198 patients across…

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FridayJun 13, 2025 2:52 pm

BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Reported Q1 2025 Results, Advanced Toward Commercialization Following VALID-ECG Study Success

HeartBeam (NASDAQ: BEAT) reported financial results and operational highlights for the first quarter of 2025, marking significant progress toward commercialization of its 12-lead ECG synthesis software. The company successfully met clinical endpoints in its VALID-ECG pivotal study, demonstrating a 93.4% diagnostic agreement with standard ECGs, and engaged in productive discussions with the FDA on its 510(k) submission. During the quarter, HeartBeam entered a strategic collaboration with AccurKardia to integrate its FDA-cleared AccurECG(TM) software into HeartBeam’s compact, cable-free cardiac device. The partnership was expected to accelerate product development and improve access to rapid arrhythmia diagnosis. The company also expanded its intellectual…

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ThursdayJun 12, 2025 10:36 am

BioMedNewsBreaks — Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Highlights Growth and SEPA Funding Ahead of BIO 2025 CEO Participation

Scinai Immunotherapeutics (NASDAQ: SCNI) announced that CEO Amir Reichman will participate in the BIO International Convention 2025, taking place June 16–19 in Boston. The company will present recent strategic, operational, and financial milestones, including its rapid CDMO business growth and progress on its nanobody pipeline. Scinai recently secured $1.38 million in funding via its Standby Equity Purchase Agreement with Yorkville Advisors, boosting capital without warrants or additional dilution. The company reaffirmed 2025 CDMO revenue guidance of $2 million and targets breakeven in 2026. To view the full press release, visit https://ibn.fm/saChe About Scinai Immunotherapeutics Ltd. Scinai is a biopharmaceutical company…

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ThursdayJun 12, 2025 9:10 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) and HOPE Therapeutics to Present at H.C. Wainwright Neuro Perspectives Conference

NRx Pharmaceuticals (NASDAQ: NRXP) and its wholly owned subsidiary HOPE Therapeutics, Inc. announced participation in the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference, set for June 16–17, 2025. Dr. Jonathan Javitt, Founder, Chairman and CEO of NRx and Co-CEO of HOPE, will deliver a corporate presentation highlighting recent developments, available on demand to registered attendees starting at 7 a.m. ET on June 16. The company will also conduct one-on-one investor meetings during the event. To view the full press release, visit https://ibn.fm/7jYZu About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA…

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WednesdayJun 11, 2025 9:20 am

BioMedNewsBreaks – Intelligent Bio Solutions Inc. (NASDAQ: INBS) Expands U.S. Forensic Market Presence Through SMARTOX Partnership

Intelligent Bio Solutions (NASDAQ: INBS) reported continued growth in the U.S. Forensic Use Only Market through its strategic alliance with SMARTOX, a Texas-based leader in drug and alcohol screening services. SMARTOX has deployed over 50 INBS Intelligent Fingerprinting Drug Screening Readers and conducted more than 7,000 tests to date—including over 1,500 in 2024—demonstrating rising demand for INBS' rapid, non-invasive testing solution. The technology offers a fingerprint sweat-based alternative to urine and saliva tests, improving efficiency, dignity, and ease of use across corrections, rehabilitation, and drug court environments. INBS is also pursuing FDA clearance for its codeine opiate test, with plans…

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MondayJun 09, 2025 1:32 pm

BioMedNewsBreaks — Panna Sharma, Lantern Pharma CEO, Says FDA’s Elsa AI Rollout Underscores Urgency to Modernize

Panna Sharma, CEO of Lantern Pharma, commented on the U.S. Food and Drug Administration’s launch of its new AI tool in PharmaVoice, stating: “The timeline is aggressive, especially given that the scope and rigor of the initial pilot testing wasn’t fully showcased, but this reflects the urgency FDA feels.” His remarks highlight the rapid pace at which the agency is moving to integrate artificial intelligence into its regulatory infrastructure. The FDA officially announced the agency-wide deployment of Elsa, a generative AI tool designed to assist staff in reviewing clinical protocols, summarizing adverse events, comparing drug labels, and identifying inspection targets.…

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MondayJun 09, 2025 9:00 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Secures U.S. Patent for Abuse-Deterrent Transdermal Technology

Nutriband (NASDAQ: NTRB) has been granted U.S. patent No. 12,318,492 for its "Abuse and Misuse Deterrent Transdermal Systems," further strengthening domestic protection for its Aversa(TM) technology. The patent, issued June 3, 2025, enhances the company’s intellectual property portfolio for abuse-deterrent transdermal products designed to curb misuse, diversion, and accidental exposure. Aversa(TM) is currently in development as part of Nutriband’s lead product, Aversa Fentanyl, which aims to be the first abuse-deterrent fentanyl patch on the market, with peak U.S. sales potential projected between $80 million and $200 million. To view the full article, visit https://ibn.fm/9bBiW About Nutriband Inc. Nutriband is primarily…

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FridayJun 06, 2025 11:34 am

BioMedNewsBreaks — FDA Accelerates Launch of AI Tool Elsa, Raising Questions on Transparency and Oversight 

The U.S. Food and Drug Administration (“FDA”) has fast-tracked the rollout of its AI tool, Elsa, originally planned for June 30, with Commissioner Dr. Marty Makary touting the launch as both “ahead of schedule and under budget.” Elsa is already streamlining workflows across the agency, reducing multiday review tasks to minutes, and handling administrative functions such as safety profile assessments, label comparisons, and protocol reviews. The tool is housed in a secure GovCloud environment and was not trained on industry-submitted data, according to Makary. Still, the launch has raised questions about transparency, validation, and long-term oversight. Some FDA staff reportedly…

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ThursdayJun 05, 2025 1:38 pm

BioMedNewsBreaks — Calidi Biotherapeutics Inc. (NYSE American: CLDI) Unveils Promising Data on CLD-401 at ASCO 2025

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage biotechnology company pioneering the development of systemic oncolytic targeted immunotherapies with the ability to deliver genetic payloads. The company unveiled promising new data on its lead RedTail platform candidate, CLD-401, at the American Society of Clinical Oncology (“ASCO”) Annual Meeting. The announcement reads, “Calidi has previously demonstrated its pioneering efforts in developing an enveloped form of its proprietary oncolytic virus that is significantly more resistant to immune clearance than non-enveloped forms, allowing for systemic delivery and efficacy in syngeneic tumor-bearing pre-clinical models. Calidi has further advanced this technology with CLD-401, its first…

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ThursdayJun 05, 2025 1:16 pm

BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Files ANDA for Preservative-Free IV Ketamine, Targets Expanding $750M Market 

NRx Pharmaceuticals (NASDAQ: NRXP), has submitted an Abbreviated New Drug Application (ANDA) to the FDA for NRX-100, its preservative-free intravenous ketamine formulation aimed at approved indications such as anesthesia and pain management. With the U.S. ketamine market valued at $750 million and global demand projected to reach $3.35 billion by 2034, the company is seeking priority review amid an ongoing national shortage. NRx also plans to petition the FDA to mandate preservative-free ketamine formulations, citing safety concerns over benzethonium chloride. This filing complements its broader strategy to expand ketamine’s label to include treatment for suicidal depression, backed by clinical data…

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