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Medicus Pharma says U.S. FDA has provided comments on Phase 2 Clinical Protocol of SKNJCT-003

Medicus Pharma

Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma joined Steve Darling from Proactive to share significant updates regarding the company's interaction with the U.S Food and Drug Administration (FDA). Medicus Pharma has received comments from the FDA, pertaining to its recent study findings and regulatory submissions. The FDA's feedback regarding the study results is considered exploratory, with specific requests directed towards providing additional data from clinical studies to support the doses of 100μg and 200μg of micro-array needles containing doxorubicin. Additionally, the FDA has requested an updated investigator brochure, incorporating insights from the clinical studies SKNJCT-001 and SKNJCT-002, focusing particularly on adverse events and dose-limiting toxicities at each dose level. Dr. Bokhari conveyed to Proactive that the SKNJCT-001 study successfully met its primary objective of assessing safety and tolerability. The investigational product, D-MNA, demonstrated favorable safety profiles across all dose levels among the thirteen participants enrolled in the study. This encouraging outcome underscores the potential of D-MNA as a safe and well-tolerated therapeutic option. In response to the FDA's requests, Medicus Pharma is committed to making a comprehensive submission in the second quarter of 2024. This submission will include the requested data and an updated investigator brochure, meticulously incorporating insights from the SKNJCT-001 and SKNJCT-002 studies. Furthermore, the submission will encompass Chemistry, Manufacturing, and Controls (CMC) stability data, ensuring a comprehensive and robust dossier. Dr. Bokhari reiterated Medicus Pharma's dedication to adhering to regulatory guidelines and fostering transparent communication with regulatory authorities. By addressing the FDA's queries and providing comprehensive data, the company aims to facilitate the regulatory review process and advance the development of D-MNA towards potential regulatory approval. In summary, Medicus Pharma remains steadfast in its commitment to advancing innovative therapies while upholding the highest standards of safety and efficacy. The company's proactive engagement with regulatory agencies reflects its dedication to bringing impactful treatments to patients in need. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

March 28, 2024 08:21 AM Eastern Daylight Time

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NeuroOnes’s Innovative Electrode Brain Monitoring Seeks To Provide Insights Into Neurological Disorders

Benzinga

by Meg Flippin, Benzinga When it comes to diseases of the brain, epilepsy is among the more common ones, affecting roughly 50 million people globally. This condition arises from various factors that disrupt normal brain activity, such as strokes, brain tumors, traumatic brain injuries, and infections of the central nervous system, with the annual cost of managing epilepsy approximately $28 billion. Current treatments, despite the availability of over 20 antiepileptic drugs (AEDs), fall short of effectively managing the condition for all patients. Approximately 36% of individuals with epilepsy experience uncontrolled seizures, which could have a significant impact on their quality of life and mortality. For many, the only solution is surgery. Better Outcomes With Electrodes NeuroOne Medical Technologies Corp. (NASDAQ: NMTC) is hoping to achieve better outcomes for patients suffering from neurological disorders with its high-definition, minimally invasive thin film electrodes used for intracranial monitoring. The electrodes are implanted inside the skull to record brain activity and the company says they may someday be able to treat diseases like epilepsy. NeuroOne’s Evo® Cortical Electrode portfolio consists of various configurations of strips and grid electrodes made with polyimide thin film, which reduce trauma to the brain. They are a less invasive implant because the material is flexible, thin and light. They can monitor brain activity for less than 30 days. NeuroOne’s Evo® sEEG Electrode technology enables the recording and monitoring of brain activity for less than 30 days. With the technology, the company says doctors can identify the right foci zones to determine the best treatment for patients. The company has said its technology provides new options for surgical placement and potentially smaller incisions, as well as for lower inflammation compared to the bulky electrodes currently on the market, while also enabling the pairing of diagnostic and therapeutics in one offering. With proven placement accuracy and enhanced signal quality, physicians can capture the vital data they need to support more confident diagnoses, according to NeuroOne. Thanks to NeuroOne’s partnership with Zimmer Biomet Holdings Inc. (NYSE: ZBH), the company’s technology is already being used in the marketplace. Zimmer Biomet, which is the exclusive worldwide distribution partner for the NeuroOne Evo Cortical and sEEG electrode product lines, uses it for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. That segment of the business is growing, and the company expects its revenue to increase with the addition of new accounts by Zimmer Biomet. Making Strides With Regulators More recently, NeuroOne received U.S. Food and Drug Administration 510(k) clearance to market its OneRF™ Ablation System, a stereoelectroencephalogram (sEEG)-guided tool that surgeons can use to record electrical activity and ablate nervous tissue under temperature-controlled environments. That, along with the electrodes, has the potential to revolutionize diagnoses and treatment of brain diseases, NueroOne says. Following 510(k) clearance, NeuroOne just announced that it has initiated a limited commercial launch of its OneRF™ Ablation System, which has FDA 510(k) clearance for creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures. "The FDA clearance of NeuroOne's OneRF system will provide neurosurgeons with an important new tool in the surgical management of epilepsy, with the ability to provide ablative therapy using already implanted depth electrodes used for diagnosing the epileptic focus as part of stereoEEG,” Robert E. Gross, MD, PhD, chair of the Department of Neurosurgery at New Jersey Medical School and Robert Wood Johnson Medical School, said in a press release. “This may lead to improved outcomes for patients with potential for fewer interventions and an improved therapeutic window." In another recent press release, NeuroOne CEO Dave Rosa commented that the company expects “to start shipping systems this week to centers participating in our limited launch with cases already scheduled starting in April. We believe physicians and patients will benefit from our technology given it may reduce hospital stays, number of surgeries, and adverse events, while offering significant clinical benefits including temperature control to enhance patient safety. Looking ahead, we plan to leverage the system for other targeted ablation indications by submitting additional FDA 510(k) applications.” Pinpointing Where Seizures Occur The company’s electrodes may help pinpoint the exact location in the brain where seizures originate, which today proves difficult to do. Epileptic seizures are caused by excessive electrical discharges in a group of brain cells. Since different parts of the brain can be the site of such discharges, getting them under control is hard. After all, seizures can vary from the briefest lapses of attention or muscle jerks to severe and prolonged convulsions. They can also vary in frequency from less than one per year to several a day. Armed with more precise information from NeuroOne’s technology, medical professionals can provide patients with more accurate diagnoses and determine the best course of treatment for patients with epilepsy, according to the company. That will be welcome news to sufferers around the world. As it stands, the risk of premature death among epilepsy patients is up to three times higher than non-suffers. Currently, NeuroOne is focused on improving epilepsy diagnoses, but in the future, the focus could shift to treating seizures. For example, the company says its electrodes could be used to deliver electrical stimulation to suppress seizure activity. If they are able to achieve this, it could be game-changing for patients. It is important to note that further clinical trials are needed to determine if its electrodes can be used in the treatment of epilepsy. Epilepsy affects millions of people, costing billions of dollars annually. As it stands, more than one-third of sufferers don’t get the relief they so desperately need. NeuroOne is determined to revolutionize the landscape of neurological disorders and is making strides thanks to its unwavering dedication to developing groundbreaking products for the medical community. Featured photo by Natasha Connell on Unsplash Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

March 28, 2024 08:15 AM Eastern Daylight Time

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BenevolentAI advances novel ulcerative colitis treatment through Phase 1a trial

BenevolentAI

BenevolentAI (OTC:BAIVF) chief scientific officer Dr Anne Phelan joins Proactive's Stephen Gunnion with positive safety data from the Phase 1a, first-in-human, clinical study of BEN-8744 in healthy volunteers. Phelan explained that BEN-8744 is a potent, selective PD10 inhibitor, uniquely designed to be peripherally restricted to mitigate CNS-mediated side effects associated with previous PD10 inhibitors. This design aims to ensure safety and tolerability, a primary goal in this phase of clinical research. She said the study successfully met its objectives, proving the hypothesis that peripheral restriction could eliminate adverse side effects, although it was not positioned to assess therapeutic value directly. Phelan further detailed the study's methodology, highlighting its role in estimating the pharmacologically relevant exposure and understanding the drug's exposure profile, which is critical for determining the efficacious dose for future patient trials. The interview also shed light on BenevolentAI's innovative platform that integrates diverse data types, including genomics and transcriptomics, through advanced AI and machine learning models. This platform identified PDE10 inhibition as a novel approach for treating ulcerative colitis, despite the lack of direct literature linking PDE10 to the condition, demonstrating the company's proprietary method in target discovery. Looking ahead, Phelan mentioned ongoing Biomarker Qualification studies and extended toxicology studies to pave the way for phase 1b and phase 2 studies, with an emphasis on ensuring longer dosing durations are safe for patients. This step is pivotal for moving BEN-8744 towards clinical efficacy trials, underlining BenevolentAI's commitment to advancing drug development through AI-enabled insights. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

March 28, 2024 08:12 AM Eastern Daylight Time

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BioHarvest Sciences adds key hires as company looks to ramp up CDMO Services Business Unit

BioHarvest Sciences Inc

BioHarvest Sciences CEO Ilan Sobel joined Steve Darling from Proactive to announce two key appointments in the areas of business development and science to lead important initiatives within the company's newly launched CDMO Services Business Unit. Sobel introduced Matt Zrebiec as the Vice President of Business Development, tasked with driving the sourcing and closing of new deals for the CDMO Business Unit. Zrebiec brings with him 23 years of experience in the branded specialty, biotech, generics, and CDMO pharmaceutical sector, positioning him well to contribute to BioHarvest's growth and success in this area. In addition, Sobel announced the appointment of Professor Itay Mayrose as Senior Artificial Intelligence Scientist, who will lead development initiatives within the CDMO Business Unit. Professor Mayrose is a globally recognized expert in plant computational genomics, known for his multidisciplinary approach that combines computer science with biological research. He has been instrumental in pioneering the use of artificial intelligence in genome editing and evolutionary studies, leading to groundbreaking discoveries published in prestigious scientific journals such as Nature, Science, and others. These appointments signal BioHarvest's commitment to driving innovation and excellence within its CDMO Services Business Unit, leveraging the expertise of seasoned professionals like Zrebiec and Professor Mayrose to advance the company's strategic objectives and deliver value to its stakeholders. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

March 27, 2024 11:26 AM Eastern Daylight Time

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Nevis Brands releases financial numbers seeing a 44% increase in quarterly revenue

Nevis Brands

Nevis Brands CEO John Kueber joined Steve Darling from Proactive to announce the company's financial results for fiscal year 2023 and the fourth quarter ending November 30, 2023. Nevis Brands reported revenues of $671,000 for the year, with Cost of Goods Sold amounting to $278,604. For the fourth quarter alone, Nevis generated revenues of $395,876, primarily derived from royalties received from Licensees in five states, while Cost of Goods Sold stood at $134,223. Kueber expressed satisfaction with the conclusion of the fiscal year, highlighting the significant expenses and charges incurred during the transition from Pascal Biosciences Inc., the company's previous business entity. Notably, Nevis Brands achieved growth in revenues and managed to reduce costs of goods sold in the fourth quarter, signalling positive momentum in its operations. Furthermore, Kueber emphasized the company's ongoing efforts to expand its revenue streams, particularly in states where Nevis is currently operating. He expressed excitement about the additional revenues expected from licensees that have been secured but have yet to contribute to revenues. Notably, revenues for the fourth quarter did not include contributions from Nevada and California, both of which are now revenue-generating states. Additionally, Michigan and Missouri are anticipated to contribute to revenues in 2024, further bolstering Nevis Brands' financial performance. Looking ahead, Nevis Brands sees significant growth opportunities for its major brand, not only through expansion into new markets but also through the introduction of new products. Kueber emphasized the potential for diversification beyond beverages into other edible products, underscoring the company's commitment to innovation and market expansion. In summary, Nevis Brands' financial results for fiscal year 2023 and the fourth quarter reflect steady progress and positive momentum in its operations. With a strategic focus on revenue growth and product diversification, the company is well-positioned to capitalize on emerging opportunities in the cannabis market and deliver value to its shareholders. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

March 27, 2024 10:21 AM Eastern Daylight Time

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ExpressGene Revolutionizes At-Home Genetic Testing, Competing Head-to-Head with Industry Giants

ExpressGene Lab

In an unprecedented move, ExpressGene Laboratory headquartered in Miami, Florida announces its entry into the competitive landscape of the American laboratory industry, standing tall among giants such as Quest Diagnostics, LabCorp, and Clinical Pathology Laboratories. With its innovative approach to genetic testing, ExpressGene is not just joining the ranks but is set to redefine them by offering direct-to-consumer at-home testing services that break away from traditional models. ExpressGene's groundbreaking service model allows individuals to access comprehensive genetic testing from the comfort of their homes, eliminating the need for a doctor's prescription. This consumer-centric approach is designed to empower individuals with critical health insights without the barriers of conventional lab testing procedures. Breaking the Mold with At-Home Testing At the core of ExpressGene's offerings is the simple cheek swab test, an easy, non-invasive method that makes genetic testing accessible to everyone. This method paves the way for a wide array of tests, including but not limited to: Cancer Screening: Early detection and risk assessment for various cancers. Paternity Testing: Quick and confidential answers. Ancestry Discovery: A deep dive into genetic heritage and lineage. Health and Wellness: Insights into genetic predispositions affecting health. Pharmacogenomics: Understanding how genes affect a person’s response to drugs. Neurogenetic Disorders: Screening for genetic markers associated with neurological conditions. A New Era of Genetic Testing ExpressGene is not just offering tests; it's offering a new way of understanding oneself through genetics. "Our goal is to democratize genetic testing, making it as easy as ordering a book online. We believe that everyone should have the opportunity to access crucial health information that can make a difference in their lives," -ExpressGene Team. With the launch of its direct-to-consumer platform, ExpressGene is challenging the status quo and inviting consumers to take control of their health in ways previously unimaginable. The company's commitment to privacy, accuracy, and affordability positions it as a formidable contender in the laboratory services industry. ExpressGene's launch into the direct-to-consumer genetic testing market is more than just an announcement; it's a call to action for individuals to take an active role in their health and well-being through accessible, innovative genetic testing solutions. For more information about ExpressGene and to explore our testing services, visit www.expressgene.me About ExpressGene ExpressGene is at the forefront of molecular diagnostics, offering a comprehensive suite of genetic testing services designed to provide insightful and actionable health information. Our state-of-the-art laboratory is equipped with advanced technology to ensure accuracy and reliability across all tests, including pharmacogenomics, cancer risk assessment, neurogenetic disorders, and prenatal screenings. At ExpressGene, we are committed to making genetic testing accessible and understandable, empowering individuals and healthcare providers to make informed decisions about health and treatment strategies. Our team of expert geneticists, pathologists, and laboratory technicians work diligently to uphold the highest standards of quality and confidentiality. With a patient-centric approach, we strive to deliver not just results, but also the support and resources needed to navigate genetic health. ExpressGene is proud to be an accredited facility by the College of American Pathologists (CAP), reflecting our dedication to excellence in laboratory services. For more information about our services or to request a testing kit, please visit our website or contact us directly. Our customer service team is available to answer any questions and assist with your genetic testing needs. At ExpressGene, your health is our priority, and we are dedicated to providing you with the highest level of service and care. For Press Inquires: AlphaBull PR (800) 530-0412 www.Pubcowire.com Contact Details Express Gene Molecular Diagnostics Laboratory Customer Service +1 786-250-3419 info@expressgene.us Company Website https://www.expressgene.me

March 27, 2024 09:53 AM Eastern Daylight Time

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Ondine Biomedical achieves milestone with NHS trust's adoption of Steriwave

Ondine Biomedical Inc

Ondine Biomedical Inc Vice President of Sales & Marketing Matt Ross joined Proactive's Stephen Gunnion after the company sealed its first commercial deal with an NHS trust, starting with the Pontefract and Pinderfields hospitals. This follows a successful 500-patient elective hip and knee surgical quality initiative at Pontefract, leading to its adoption across the two hospitals. The company aims to develop a business case with York health economics group and Mid Yorkshire for broader NHS adoption, based on the successful outcomes and health economics work. Ross also highlighted Ondine's commercial momentum, including the deployment of Steriwave in eight new healthcare facilities and a growing international presence, now spanning 22 facilities in Canada and expanding in the UK and Spain. The success is attributed partly to Steriwave's effectiveness in reducing the need for antibiotics, as demonstrated in a UK study, and its alignment with antimicrobial resistance efforts. Ondine plans to continue expanding in European markets, capitalize on its success in Canada, and explore potential in the United States through FDA phase three trials. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

March 27, 2024 09:44 AM Eastern Daylight Time

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Timothy Applegate Elected as Board Chair Elect for National Contract Management Association

National Contract Management Association

The National Contract Management Association (NCMA), dedicated to advancing the contract management profession, proudly announces the appointment of Timothy Applegate as its Board Chair for Program Year 2026, that begins July 1, 2025. A retired Colonel in the United States Air Force, Mr. Applegate brings over 36 years of acquisition and contracting expertise to the role. Mr. Applegate is currently a distinguished member of the Senior Executive Service and Director of the Acquisition Management and Integration Center at Headquarters Air Combat Command (ACC), where he is responsible for overseeing a total acquisition portfolio exceeding $20 billion. A devoted member of NCMA since 1992, an NCMA Certified Professional Contract Manager™ (CPCM™) certificant, Board Member (2018- 2021 and 2023-2024), and Board Advisor (2021-2022), Mr. Applegate is a dedicated and long-standing champion of NCMA and the role it plays in the advancement of the contract management profession. "It is a privilege to serve alongside such esteemed colleagues and I look forward to working with the NCMA's dedicated members and partners,” said Mr. Applegate. Kraig Conrad, CEO of NCMA, added, "Tim's wealth of experience and expertise is truly invaluable to meet our strategic objectives. Over the past six years, he has been instrumental in fostering the growth and evolution of our association through his dedicated service. I am eager to collaborate with him to advance our Common Language Initiative and expand our partnerships to elevate the profession with international standards.” With Mr. Applegate assuming the role of Board Chair-Elect, NCMA is poised to further enhance its programs and standards, ensuring that practitioners receive unparalleled support and opportunities for professional development and certification. The entire NCMA community eagerly looks forward to the transformative leadership that Mr. Applegate will bring to the organization. The National Contract Management Association (NCMA) – www.ncmahq.org – has grown as a professional society whose mission is to collaborate towards a globally recognized contract management profession that strengthens its nexus with related acquisition communities. Serving approximately 20,000 members in both the public and private sectors, NCMA propels the growth, advancement, and impact of practitioners through a steadfast commitment to serve through the open exchange of ideas in neutral forums. Contact Details National Contract Management Assocation Holly DeHesa +1 281-865-3296 holly.dehesa@ncmahq.org Company Website https://www.ncmahq.org

March 26, 2024 06:25 PM Eastern Daylight Time

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Adin Avertising Technology Announces AI-Based Approach to Digital Media Planning - Adin.Ai

Spark Metro PR

In an era marked by challenges in transparency and efficiency, Adin.Ai disrupts the traditional media planning sector by emerging as a beacon of innovation, transforming the landscape of media planning through its AI-based advertising intelligence platform. With unparalleled precision and strategy, Adin.Ai revolutionizes planning processes across TV and digital platforms. The Visionary Team Behind Adin.Ai's Success At the helm of Adin.Ai's ground-breaking platform is an esteemed team of industry pioneers, led by the renowned entrepreneur Serhat Gurcu, a five-time honoree on the Fortune 40 Under 40 list. Partnering with Gurcu is Prof. Altan Cakır, a luminary in data science and artificial intelligence. Together with other esteemed founding partners, including visionary 2 CTOs, a PhD holder, a rising star female co-founder in media, and another female co-founder who is one of the Fast Company Female Founders for 3 years in a row, Adin.Ai stands poised at the forefront of the industry. Innovative Technology Drives Enhanced Transparency Adin.Ai's integration of AI and blockchain technology ensures an unprecedented level of transactional transparency. Through Adin.trust, each transaction is securely recorded, instilling advertisers with the confidence needed to invest in their media planning strategies. Industry Recognition and Collaborative Ventures Fast Company's recognition of Adin.Ai on both its Most Innovative Companies and Startup 100 lists underscores the company's impact. Additionally, AWS lauds Adin.Ai's proactive adoption of emerging cloud and AI technologies, particularly its utilization of generative AI, a testament to Adin.Ai's commitment to staying at the forefront of technological advancements. The collaboration between Adin.Ai and AWS engineers has resulted in a unique amalgamation of different AWS modules, harmoniously working together to enhance Adin.Ai's capabilities. With AWS's validation of its technology and an upcoming collaboration with KPMG, Adin.Ai is primed to further its influence on global media transparency. Stellar Financial Performance Foreshadows Success In its Proof of Concept (POC) year, Adin.Ai generated an impressive revenue of 300K USD, setting a robust foundation for its future endeavors. Subsequently, in its first official year, the company achieved an Annual Recurring Revenue (ARR) of 2.4M USD, alongside a Monthly Recurring Revenue (MRR) of 200K USD. Notably, 70% of this revenue was generated in Turkey, a testament to Adin.Ai's resilience amid currency fluctuations. Additionally, the company reported 11 M USD Billings in its first year, indicating strong growth and market demand for its innovative solutions. Explosive Growth in Competitive Markets Adin.Ai's strategic focus on expansion across Europe and the UK has yielded exceptional results, with a staggering 700% growth compared to the previous year. This exponential growth underscores Adin.Ai's strong business model and the burgeoning demand for innovative AI solutions in media planning. Rapid Expansion and Global Ambitions With its remarkable revenue achievements and unprecedented growth rate, Adin.Ai is poised to emerge as the preeminent interface for advertisers worldwide. The company's sights are set on further expansion and solidifying its status as a USA-established company, with Istanbul serving as the operational hub for the Europe, UK, and EMEA region, and London as the headquarters for Europe. This strategic positioning, coupled with global acclaim, sets new benchmarks for excellence in the industry. Adin.Ai is strategically positioned to shape the future of advertising, where AI-based decisions redefine the landscape. Client Success Stories Adin.Ai's transformative impact is evident through the success stories of its clients. A FINTECH company from Spain achieved a remarkable 30% reduction in Cost Per Acquisition, while the largest private bank in Turkey witnessed a substantial 70% increase in Viewability. Additionally, a fashion company from the UK experienced a significant 64% boost in Return on Ad Spend (ROAS), and a gaming company from the Netherlands successfully mitigated display ad fraud by 52%. These results underscore Adin.Ai's commitment to driving tangible outcomes for its clients across diverse industries. Adin.Ai as the AI-Based Digital Advertising Platform for Enterprise Advertisers: Maximize Ad Return up to 5X; Minimize Effort up to 100X. With Adin.Ai, advertisers gain access to a cutting-edge platform that maximizes ad returns up to 5 times while minimizing effort up to 100 times. Our revolutionary AI-driven approach to digital media planning empowers advertisers to achieve unparalleled success in their campaigns. For further insights into Adin.Ai's journey and services, visit www.adin.ai Founders of the Company: Serhat Gürcü: LinkedIn Profile Prof. Altan Çakır: LinkedIn Profile Selin Ergin: LinkedIn Profile Halil Faruk Deniz: LinkedIn Profile Özgün Akın: LinkedIn Profile Seden Gürcü: LinkedIn Profile SOURCE: Adin.Ai Contact Details Adin.ai Seden Gurcu +90 533 476 96 49 Seden@adin.ai Company Website https://adin.ai/

March 26, 2024 11:08 AM Eastern Daylight Time

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