"We entered 2025 with strong execution across our clinical, commercial, and operational priorities, maintaining the momentum established in 2024," said Ofer Gonen, Chief Executive Officer of MediWound. "The VALUE Phase III study for EscharEx remains on schedule, and our additional collaboration with Kerecis marks a significant milestone—bringing nearly all leading global wound care companies into our clinical research programs. Meanwhile, NexoBrid continues to gain global traction, as we advance strategic m ...

CUPERTINO, Calif., May 20, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) ("Reviva" or the "Company"), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will participate in the following upcoming investor conferences. Benchmark Healthcare House Call Virtual I ...

Tivic Health Systems (TIVC) Q1 2025 Earnings Call May 15, 2025 04:30 PM ET Company Participants Jennifer Ernst - Co-Founder, CEO & DirectorLisa Wolf - Interim CFOMichael Handley - COO & President of the Biopharma Division Operator Welcome to the Trivik Health First Quarter twenty twenty five Financial Results and Operational Update Conference Call. This call has been pre recorded and the questions you have submitted in advance will be answered following the prepared remarks. This call is being webcast and t ...

Tivic Health Systems (TIVC) Q1 2025 Earnings Call May 15, 2025 04:30 PM ET Speaker0 Welcome to the Trivik Health First Quarter twenty twenty five Financial Results and Operational Update Conference Call. This call has been pre recorded and the questions you have submitted in advance will be answered following the prepared remarks. This call is being webcast and the replay will be available on the IR section of the company's website for three months. Before we begin, let me remind you that during today's cal ...

Core Viewpoint - BrainStorm Cell Therapeutics Inc. is making significant progress in the development of its NurOwn® therapy for ALS, with plans for a Phase 3b trial aimed at confirming efficacy in early-stage ALS patients and supporting a new Biologics License Application (BLA) [2][4]. Financial Results - As of March 31, 2025, the company reported cash, cash equivalents, and restricted cash of approximately $1.8 million [4]. - Research and development expenditures for Q1 2025 were $1.3 million, an increase from $1.0 million in Q1 2024 [4]. - General and administrative expenses for Q1 2025 were approximately $1.8 million, compared to $1.5 million in Q1 2024 [4]. - The net loss for Q1 2025 was approximately $2.9 million, an improvement from a net loss of approximately $3.4 million in Q1 2024 [4][14]. - Net loss per share for Q1 2025 was $0.45, compared to $0.75 for Q1 2024 [4][14]. Corporate Updates - The company submitted an IND amendment for NurOwn to the FDA, which is a critical step for the upcoming Phase 3b trial [4]. - The Phase 3b trial, named ENDURANCE, is designed to enroll approximately 200 early-stage ALS participants and will assess changes in ALSFRS-R scores [4]. - NurOwn data was selected for presentation at the ISCT 2025 Meeting, highlighting the impact of the UNC13A genotype on clinical outcomes for ALS patients [4]. - Insights on biomarkers related to NurOwn treatment were presented at the 2025 ALS Drug Development Summit [4]. About NurOwn® - NurOwn® is an investigational therapy utilizing autologous MSC-NTF cells, which are derived from bone marrow and designed to deliver neurotrophic factors to slow or stabilize neurodegenerative diseases [6][8]. - The therapy has received Orphan Drug designation from both the FDA and EMA, and a Phase 3 trial has been completed [8]. Company Overview - BrainStorm Cell Therapeutics Inc. focuses on developing autologous adult stem cell therapies for neurodegenerative diseases, with its proprietary NurOwn® platform aimed at modulating neuroinflammation and promoting neuroprotection [7].

Industry Overview - The medical instruments industry is experiencing a transformative phase driven by the rapid adoption of generative artificial intelligence (genAI) and digital therapeutics, which are expected to significantly impact the healthcare sector [1] - Since early 2023, there has been mass adoption of AI and the Internet of Medical Things in digital healthcare options across hospitals and healthcare settings [1] Generative AI Impact - GenAI is demonstrating its capabilities in various healthcare fields, including administrative tasks, technological discovery, and clinical trials, by analyzing complex genetic and molecular data [2] - The technology is anticipated to enhance predictive treatment options and smart hospital systems [2] Investment Opportunities - It is advisable to invest in stocks from the Zacks-defined Medical Instrument industry that have a favorable Zacks Rank, with five selected stocks showing double-digit returns amid market volatility [3][4] Selected Stocks - **DexCom Inc. (DXCM)**: Benefiting from strong performance in the Sensor segment, with expected revenue and earnings growth rates of 14.3% and 23.2% respectively for the current year [7][8] - **IDEXX Laboratories Inc. (IDXX)**: Demonstrating robust strategic execution with expected revenue and earnings growth rates of 5.8% and 14% respectively for the current year [9][11] - **NeuroPace Inc. (NPCE)**: Focused on developing a brain-responsive neuromodulation system for treating drug-resistant focal epilepsy, with expected revenue and earnings growth rates of 18.1% and 15.1% respectively for the current year [12][13] - **Fresenius Medical Care AG (FMS)**: Benefiting from strong organic growth and operational improvements, with expected revenue and earnings growth rates of 1.6% and 28.3% respectively for the current year [14][15] - **ClearPoint Neuro Inc. (CLPT)**: Specializing in minimally invasive surgical procedures in the brain, with expected revenue and earnings growth rates of 24.1% and 11.4% respectively for the current year [16][17]

SAN DIEGO, May 15, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that it will host a virtual research and development (R&D) day on Thursday, May 22, 2025, from 10:00 to 11:30 AM ET. To register, click here. Frederick G. Hayden, MD, FACP, is a Stuart S. Richardson Professor Emeritus of Clinical Virology and Professor Emeritus of Medicine at the ...

SAN DIEGO, May 15, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that it will host a virtual research and development (R&D) day on Thursday, May 22, 2025, from 10:00 to 11:30 AM ET. To register, click here. The event will feature key opinion leaders (KOLs) Fred Hayden, MD, FACP (University of Virginia School of Medicine) and Rick Bright, PhD ( ...

Core Viewpoint - BrainStorm Cell Therapeutics Inc. has rescheduled the release of its financial results for Q1 2025 and an investor conference call, indicating ongoing engagement with investors and stakeholders [1][2]. Company Overview - BrainStorm Cell Therapeutics Inc. is a leading developer of adult stem cell therapies targeting neurodegenerative diseases, utilizing its proprietary NurOwn® platform to produce neurotrophic factor-secreting cells [5]. - The company's lead investigational therapy, NurOwn®, has received Orphan Drug designation from both the FDA and EMA, and a Phase 3 trial for ALS has been completed [6]. Upcoming Events - The financial results will be released post-market on May 15, 2025, and the investor conference call is scheduled for May 19, 2025, at 8:30 a.m. Eastern Time [1][2]. - Participants are encouraged to submit questions in advance, with specific contact details provided for access to the conference call [3]. Clinical Development - BrainStorm has completed a Phase 2 trial of MSC-NTF cells in progressive multiple sclerosis, supported by a grant from the National MS Society [6]. - The company is advancing an allogeneic exosome-based platform for delivering therapeutic proteins and nucleic acids, with a foundational patent recently allowed by the U.S. Patent and Trademark Office [6].

- On track to report preliminary data from Phase 1 monotherapy expansion cohorts of MICVO for 2L/3L R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy in second half of 2025, and 2L/3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy in first half of 2026 - On track to report preliminary data from Phase 1 trial of MICVO in combination with pembrolizumab targeting multiple tumor types including 1L/2L HNSCC patients in second h ...