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CEO Roby Zomer discusses Argent BioPharma's future in pharmaceuticals

Argent BioPharma Ltd

Argent BioPharma managing director and CEO Roby Zomer speaks to Proactive's Stephen Gunnion following the company's rebranding from MGC Pharmaceuticals, alongside a comprehensive restructuring. Zomer explained the shift marks a refined focus on the pharmaceutical sector, discarding previous activities not aligned with pure pharmaceutical processes. Zomer highlighted the company’s advancement in drug discovery, particularly through a multidisciplinary approach and modern technologies such as nanotechnology and mRNA modulation. These innovations are targeted at addressing unmet medical needs. The company has developed notable products including CannEpil and CimetrA. CannEpil targets refractory epilepsy and has shown efficacy in controlling seizures without reported adverse events. CimetrA, developed during the COVID-19 pandemic, is designed to alleviate COVID-19 symptoms and prevent cytokine storms, with potential applications in treating other autoimmune diseases. Both drugs are now being prescribed in key markets including the United States and Europe. Zomer expressed optimism about the future, emphasizing ongoing research and progress in obtaining regulatory approvals. The focus will remain on enhancing early patient access schemes, which are expected to significantly impact revenue. Over the next 24 months, Argent BioPharma plans to introduce more innovative treatments to the market. Contact Details Proactive UK Proactive UK +44 20 7989 0813 UKEditorial@proactiveinvestors.com

May 01, 2024 10:07 AM Eastern Daylight Time

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Immunic Phase 2 EMPhASIS trial data highlighted in peer-reviewed neurology journal

Immunic Inc

Immunic Inc (NASDAQ:IMUX) CEO Dr Daniel Vitt joined Proactive's Stephen Gunnion with news of the publication of extended data from the Phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting multiple sclerosis (RRMS) in the peer-reviewed journal, Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology. Vitt noted that the EMPhASIS trial demonstrated a notable reduction in gadolinium-enhancing lesions by 78% and 74% in two high-dose groups compared with the placebo. These results also correlate with improvements in serum neurofilament light chain levels, consistent with recent interim phase 2 clinical data from the ongoing CALLIPER trial in progressive MS, indicating ongoing progress in the field. Vitt highlighted the study's contribution to understanding the neuroprotective and anti-inflammatory effects of the treatment under investigation. The drug's potential impact on the treatment landscape of MS, particularly its role in addressing disease progression independent of relapse activity, was emphasized. Immunic is also conducting the CALLIPER trial in progressive MS, with key results expected by April 2025. Additionally, the phase 3 ENSURE trials are actively enrolling, with projected readouts in 2026. Dr Vitt expressed optimism about the drug's unique profile, combining safety and effectiveness in potentially altering the management of all forms of MS. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 01, 2024 10:02 AM Eastern Daylight Time

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Poolbeg Pharma and Silk Road Therapeutics announce strategic collaboration on novel orphan drug

Poolbeg Pharma PLC

Poolbeg Pharma PLC CEO Jeremy Skillington and Tim Coté CEO of Silk Road Therapeutics join Proactive's Stephen Gunnion with details of an exclusive 12-month option agreement with Silk Road Therapeutics for Poolbeg to acquire a novel topical drug aimed at treating oral ulcers in patients with Behçet's disease, a rare and debilitating condition. Skillington said the move is aligned with Poolbeg's strategic focus on rare and orphan diseases. Coté, with an extensive background in orphan drug approvals from his time at the FDA, highlighted the potential of the drug given its unique formulation and unmet need in the market. He explained the severe impact of Behçet's disease, underscoring the innovative potential of their topical treatment in improving the quality of life for those affected. Both CEO expressed optimism about their collaboration's potential to fast-track this novel treatment to market, leveraging Poolbeg’s and Silk Road's combined expertise. Furthermore, Skillington provided insights into Poolbeg’s financial health and strategic developments over the past year, mentioning a robust cash position of £12.2 million at the end of 2023. He emphasised the company's disciplined capital allocation and the expansion of its intellectual property portfolio. Looking ahead, Skillington outlined Poolbeg's focus on progressing its pipeline, particularly ongoing projects like POLB001 in the oncology sector, addressing cytokine release syndrome—a critical side effect in cancer immunotherapies. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 01, 2024 09:51 AM Eastern Daylight Time

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3 Trends In Healthcare Guided By AI And The Companies Behind The Innovation

Cardio Diagnostics Holdings, Inc

By Jeremy Golden, Benzinga Artificial intelligence (AI) is on the cusp of transforming nearly every single industry. When it comes to healthcare, several trends have emerged. As doctors and scientists continue to innovate, the market for AI in healthcare is expanding. The AI healthcare market appears poised for growth, with a market size of $22 billion in 2023 – a number that’s expected to accelerate at a CAGR of 36.4% from 2024-2030. The market for AI in healthcare is expected to reach $187.95 billion by 2030, demonstrating the transformative shift it’s brought to the healthcare industry. AI-focused healthcare companies are driving this progress. Here is how three healthcare companies are harnessing AI’s capabilities, using technology to drive innovation, target treatments and increase access to healthcare. Driving Innovation The rapidly growing field of AI in healthcare is already coming to life at places like the Mayo Clinic, where several AI-powered medical and surgical improvements have validated new approaches to clinical care in cardiovascular medicine, neurology, oncology, radiology and other fields of medicine. AI is replacing repetitive, manual processes – such as patient data analysis – that slow down healthcare professionals. Moving forward, this new technology will drive innovation, executives at Moderna (NASDAQ: MRNA) said after inking a partnership with OpenAI, the company behind ChatGPT, in April. The move gave about 3,000 Moderna employees access to ChatGPT Enterprise, built on OpenAI’s most advanced language model, GPT-4, the Wall Street Journal reports. Moderna anticipates the integration of AI could lead to the introduction of 15 new products by 2029, the Cambridge, Mass., company said. Moderna CEO Stéphane Bancel envisions employees using ChatGPT at least 20 times a day to “reinvent all of Moderna's business processes,” leading to greater overall efficiency. Here’s one example. When developing medicines, researchers study the biological and genetic variations that cause diseases to develop. Utilizing AI to dissect medical data sets like lab results can help scientists fill in the missing pieces. AI can assist them in figuring out the root cause of the disease, helping get much-needed treatments to patients faster. AI can lift success rates to up to 50% while reducing a drug’s time-to-market, a recent Moderna study by Harvard University’s Digital Data Design Institute found. AI is already transforming Moderna and enhancing its value-creation process. The company’s position in AI-powered innovation is leading to more efficiency and scalability across the value chain due in large part to an AI-centric culture. As of October 2023, nearly 65% of Moderna employees were active AI users. They have used the tool in multiple specific functions, from customized support to meaningful improvements in workflow efficiency and efficacy. Moderna has plans to integrate AI into all aspects of the drug development life cycle. To that end, the company has launched the Moderna AI Academy to accelerate training on AI throughout the organization. Targeted Treatments In addition to advancing drug discovery, artificial intelligence is also helping treatments reach patients faster. The past decade has seen an explosion in the amount of health data available to doctors. Organizing and analyzing this much data in a timely manner, however, can be a complex and time-consuming task for the human mind, no matter how capable or intelligent the person. That’s where AI comes in. AI is enabling researchers to develop more targeted medicines, driving progress in the field of precision medicine. This trend was part of a presentation delivered by executives at Johnson & Johnson (NYSE: JNJ), who hosted a panel discussion about AI’s role in transforming healthcare at this year’s South by Southwest conference. They touched on many topics, from AI applications in drug discovery to its ability to assist doctors during clinical trials. When it comes to running clinical trials, one of the biggest challenges is quickly and efficiently recruiting and enrolling patients who meet the selection criteria. By applying AI technology to the early stages of a clinical trial, Johnson & Johnson researchers can use large anonymized datasets to identify and locate clinical research sites with patients who could potentially benefit from the Johnson & Johnson medicines that are being studied. From there, the clinical trial operations team can work to determine the likelihood of enrolling the newly identified sites into their trials. “Historically, many clinical trials have largely taken place at major academic medical centers, but we know that not all patients have access to these centers,” said Nicole Turner, Senior Director of Global Development, Data Science & Digital Health and R&D at Janssen Pharmaceuticals. “Our goal is to leverage the power of AI to bring trials to more patients, rather than waiting for patients to come to us.” According to The Wall Street Journal, Johnson & Johnson continues to make investments – to the tune of hundreds of millions of dollars – in AI and data science. The company has hired about 6,000 data science and digital experts and opened a new research facility near San Francisco, and company executives say AI will power the company’s drug discovery work and strengthen its pharmaceuticals business in the future. Increasing Access Across the country, there is a need for more accessible and systemic healthcare solutions. One company is responding by using AI to combat cardiovascular diseases globally while committing to health equity and access. AI algorithms can effectively handle and analyze extensive medical data, including DNA biomarkers such as epigenetic and genetic information. As such, the shift to digital health and AI-driven diagnostics could also have widespread impacts on the cardiovascular detection, care and management industry, helping increase access to healthcare in a timely manner across the board – especially helping underserved communities in the process. Cardio Diagnostics (NASDAQ: CDIO), an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention and detection more precise, was formed to improve patient outcomes by developing and commercializing clinical tests that leverage AI-driven technology to combat cardiovascular disease. The company is behind PrecisionCHD TM, the first integrated genetic-epigenetic test for the detection of coronary heart disease (CHD), the most common type of heart disease and the cause of most heart attacks. With the introduction of PrecisionCHD, clinicians are armed with a powerful, scalable and non-invasive alternative that comes in the form of a blood-based test that uses AI, along with personalized genetic and epigenetic information, to sensitively detect the presence of CHD and use the information for more personalized patient management. Cardio Diagnostics has also developed Epi+Gen CHD TM, a powerful test that predicts the three-year risk for a CHD event, mainly a heart attack. Powered by AI-driven integrated genetics-epigenetics, the tool enables more effective decision-making and earlier interventions. Traditional diagnostic methods for CHD, often inaccessible due to the need for specialized infrastructure, can be invasive and sometimes require exposure to ionizing radiation. Additionally, some of the tests are not sensitive to all forms of CHD and can be very costly, resulting in millions of Americans left without adequate and potentially lifesaving cardiac care. Thanks to AI, PrecisionCHD has armed clinicians with a powerful, scalable and non-invasive alternative that comes in the form of a blood-based test. For rural communities where access to specialized medical facilities is limited, the implications of this advancement are particularly relevant. With only a simple blood draw needed to complete a test, PrecisionCHD offers patients in underserved areas access to state-of-the-art cardiac assessments. PrecisionCHD can be administered in primary care or telemedicine settings, significantly reducing the need for patients to travel to distant specialized clinics. This level of availability, marking a step forward toward mitigating healthcare disparities, would not be possible without AI. Featured photo by CDC on Unsplash. Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine (“Core Technology”) for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. For more information, please visit www.cardiodiagnosticsinc.com. Certain statements and information included in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, the words or phrases “will”, "will likely result," "expected to," "will continue," "anticipated," "estimate," "projected," "intend," “goal,” or similar expressions are intended to identify "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of the Company. Such uncertainties and risks include but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, dependence on management, dilution to stockholders, lack of capital, the effects of rapid growth upon the Company and the ability of management to effectively respond to the growth and demand for products and services of the Company, newly developing technologies, the Company’s ability to compete, regulatory matters, protection of technology, the effects of competition and the ability of the Company to obtain future financing. An extensive list of factors that can affect future results are discussed in the Current Report on Form 10-K for the period ended December 31, 2022 and Form 10-Q for the period ended March 31, 2023, under the heading “Risk Factors” in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission. Such factors could materially adversely affect the Company's financial performance and could cause the Company's actual results for future periods to differ materially from any opinions or statements expressed within this press release. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Gene Mannheimer - Investor Relations +1 855-226-9991 investors@cardiodiagnosticsinc.com Company Website https://cardiodiagnosticsinc.com/

May 01, 2024 08:30 AM Eastern Daylight Time

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Nevis Brands Expands Major Distribution with Exclusive Licensing Agreement in Mississippi

Nevis Brands

Nevis Brands CEO John Kueber joined Steve Darling from Proactive to announce the company has announced a significant expansion in Major's distribution through an exclusive licensing agreement with Stash House for production and distribution in Mississippi. Under this agreement, Stash House will have exclusive rights to produce and distribute the full lineup of Major products in the state. The Major lineup includes dose-able 100mg THC beverages available in flavors such as Blueberry, Fruit Punch, and Blackberry Lemonade. Known for delivering the effects of cannabis within a short timeframe of 10-20 minutes after consumption, Major has gained popularity since its initial launch in Washington State in 2019, with over 5 million bottles sold to date. Kueber highlighted Mississippi's recent legalization of cannabis for medical use in January 2023, which has led to the licensing of over 400 dispensaries in the state. This agreement marks Major's entry into its 10th state for production, further expanding its reach across the United States. Currently available in Washington, Oregon, Arizona, Ohio, Colorado, Nevada, California, and Missouri, Major is also preparing for production in Michigan, signaling the brand's continued growth and market penetration. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

April 30, 2024 12:12 PM Eastern Daylight Time

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Cloud DX Reports Significant Revenue and Profit Growth in 2023

Cloud DX

Cloud DX CEO Robert Kaul joined Steve Darling from Proactive to discuss the company's impressive performance in its 2023 full-year results. Notably, Cloud DX reported a substantial 55.4% increase in revenue, reaching $1.8 million. A key driver of this growth was the remarkable surge in subscription revenue, which soared by nearly 70%, surpassing the overall revenue increase. This shift towards subscription revenue, characterized by high margins exceeding 90%, has significantly bolstered profitability, with gross profit doubling to $1.2 million, reflecting a remarkable 112% increase. The company's stellar performance is further underscored by its operational efficiency, as evidenced by a noteworthy $1.3 million reduction in operating expenses. This reduction was achieved through strategic staff cost management, executed without compromising on customer service quality. As a result, Cloud DX achieved a more than 20% decrease in operating loss, setting a positive trajectory towards profitability and positive cash flow in the coming quarters. Looking ahead, Cloud DX is well positioned to solidify its presence in the remote patient monitoring market in Canada. The company boasts the largest share of provincial contracts and maintains robust partnerships with major industry players such as Medtronic and Teladoc Health. Moreover, Cloud DX's successful early conversion of convertible debt at a premium underscores its strong financial management and commitment to enhancing shareholder value. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

April 30, 2024 12:04 PM Eastern Daylight Time

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Hemogenyx Pharmaceuticals outlines significant progress with HEMO-CAR-T in 2023

HemoGenyx Pharmaceuticals

Hemogenyx Pharmaceuticals PLC CEO Dr Vladislav Sandler tells Proactive's Stephen Gunnion that 2023 was a significant year for the company, marked by notable progress with its HEMO-CAR-T product candidate. The key achievement for the year was the submission of a new Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to commence a phase one clinical trial for the treatment of relapsed refractory acute myeloid leukemia. However, the process faced a setback due to issues with lentivirus purity, resulting in a clinical hold. After re-manufacturing the lentivirus, Hemogenyx successfully addressed the FDA's concerns and received approval to proceed with the clinical trials. Furthermore, Sandler reported a successful fundraising which will support the upcoming clinical studies. The company also entered a service agreement with Prevail Infoworks for the clinical trials. In addition to its advancements in HEMO-CAR-T, Hemogenyx continued developing other programs, such as its proprietary Chimeric Bait Receptor (CBR) platform, showing promise in treating non-Hodgkin lymphoma and exploring applications in solid rare tumors. For 2024, the primary focus remains on advancing these clinical trials, particularly the phase one studies, with an immediate goal to initiate patient treatment. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

April 29, 2024 11:52 AM Eastern Daylight Time

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Immunic CEO Dr Daniel Vitt marks International Day of Immunology with discussion on its crucial role

Immunic Inc

Immunic Inc CEO Dr Daniel Vitt joins Proactive's Stephen Gunnion on the International Day of Immunology to discuss the broad and crucial role of immunology in human health. Vitt said immunology encompasses immune responses against pathogens like viruses, including the coronavirus, and also plays a significant role in combating cancer. He highlighted the importance of the immune system in managing and preventing autoimmune diseases, where the body mistakenly attacks its own cells, leading to various conditions. Focusing on Immunic's efforts, Vitt detailed their drug development pipeline, particularly in addressing chronic inflammatory and autoimmune diseases such as multiple sclerosis, ulcerative colitis, Crohn's disease, and celiac disease. He spotlighted multiple sclerosis, with ongoing phase three studies in its relapsing form and a phase two study, named the CALLIPER trial, for its progressive form. The latter holds particular promise as it targets an area with currently no available treatments. For celiac disease, Vitt reported promising results from a phase one B proof-of-concept study that showed positive data across various metrics, including histology and biomarker levels. Plans are underway for further phase two studies in celiac disease and potentially other indications. Vitt also shared his personal journey from chemistry to immunology, driven by the potential to develop drugs that address significant medical needs. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

April 29, 2024 11:11 AM Eastern Daylight Time

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New Standard of Care? IceCure Submits Final ICE3 Data To FDA, Minimally Invasive Cryoablation Shows Similar 5-year Recurrence Outcomes To Surgery With Hormone Therapy

Benzinga

By Meg Flippin, Benzinga IceCure Medical Ltd. (NASDAQ: ICCM), the Israeli medical device developer of ProSense®, an advanced liquid-nitrogen-based cryoablation therapy that destroys tumors (benign and cancerous) by freezing them, is one step closer to getting U.S. Food and Drug Administration approval to market ProSense® to treat patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. IceCure just reported final clinical trial results of 100% patient and physician satisfaction with the minimally invasive procedure. At the 5-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense® cryoablation, followed by hormone therapy, were estimated to be free from local recurrence Earlier in April, the company submitted its final data to the FDA which included five-year follow-up data from its ICE3 study, a sub-analysis of the ICE3 results compared to studies that evaluated the risk of recurrence in patients with low-risk Luminal A breast cancer who were treated with lumpectomy surgery and received hormone therapy and real-world data from the use of ProSense® globally, including post-market commercial use as well as data from independent third-party studies. ProSense®, which received the FDA's Breakthrough Device Designation, is already cleared for use in the U.S. for several other indications, including treating benign tumors of the breast and tumors in the kidney and liver. Positive Topline Results IceCure’s ICE3 study was the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors. The five-year recurrence-free rates from the study, which evaluated IceCure's minimally invasive 20-to-40-minute outpatient cryoablation procedure, were in line with expectations and showed similar outcomes to lumpectomy, the current standard of care for early-stage breast cancer patients, which is breast surgery that requires an operating room and hospital stay. In the ICE3 study, 96.39% of patients (187 out of 194 patients) were local recurrence-free with no significant device-related adverse events or complications reported. A comparison of this result from the ICE3 study shows similar outcomes in five-year recurrence rates compared to patients in other studies who were treated with lumpectomy followed by hormone therapy. The LUMINA study reported a 97.7% recurrence-free rate at five-year follow-up and the PRISMA meta-study, which included Lumina, reported a 97.19% recurrence-free rate at five-year follow-up. ICE3 results are also in line with data from real-world use of ProSense® by third parties in territories where IceCure's cryoablation system is used to treat early-stage breast cancer. In the final ICE3 analysis, no significant device-related adverse events or complications were reported, and all patients and physicians reported satisfaction with the ProSense® procedure, the company said. That means 100% of physicians and patients were happy with the treatments they received. Dr. Richard Fine, ICE3’s lead investigator, presented final data from the ICE3 study at the American Society of Breast Surgeons 25th Annual Meeting, where he commented, "Cryoablation is a safe, minimally invasive ablative procedure with acceptably low five-year same breast recurrence similar to that of lumpectomy for similar patient populations, with the benefit of being an office-based, nonsurgical treatment. Further study within a clinical trial or registry is needed to confirm cryoablation as a viable alternative to surgical excision in the appropriately selected patients.” Dr. Fine’s presentation, which received the conference’s Scientific Impact Award, was well received by breast surgeons who are constantly looking for treatments that are minimally invasive and effective. A New Way To Treat An Old Problem What makes cryoablation so attractive to freeze and destroy tumors is that it is minimally invasive, has little pain associated with it and thanks to an ultrasound or computerized tomography can accurately destroy diseased tissue within the tumor zone. Cryoablation also costs less than a lumpectomy and reduces the risk of follow-up surgery. With a lumpectomy, the re-excision rate is between 14-21%. IceCure’s ProSense® has the potential to become a new standard of care treatment for women with early-stage T1 invasive breast cancer, marking a major improvement to the care available today. Some researchers have even called cryoablation the “ ultimate esthetic solution for breast cancer ” because it reduces the need for pre-emptive or corrective surgical procedures to maintain or restore breast volume, contour and symmetry. "Initial reimbursement codes are already in place and our U.S. marketing and commercial team is ready, as we await the FDA's response. Driven by favorable healthcare economics combined with patient satisfaction and demand, we expect rapid adoption pending FDA granting the DeNovo Classification Request for Marketing Approval," stated IceCure CEO Eyal Shamir. With Reimbursement In Place, IceCure Is Ready To Go With the final data submitted, IceCure is ready to go once the FDA gives it the green light. The company received what it said was the first Medicare coverage approval of a cryoablation procedure for breast cancer. The Centers for Medicare & Medicaid Services (CMS) set the reimbursement payment at about $3,400 for the facility alone. Additional coverage, including payment for the physician, is expected upon establishment of the permanent CPT Category I code, which is conditioned on factors including the company's receipt of FDA marketing authorization of ProSense® for breast cancer. Having that reimbursement should enhance the usage of the ProSense® system. Nearly 300,000 women are diagnosed with invasive breast cancer yearly, and the majority have to undergo invasive treatments and deal with follow-up surgeries in the quest to live cancer-free. IceCure is changing that by freezing tumors to destroy them. IceCure seems poised to do exactly what it set out to do: provide women with an alternative minimally invasive treatment option. Featured photo by Angiola Harry 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 is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

April 29, 2024 08:20 AM Eastern Daylight Time

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