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Former Senior Advisor To Obama Joins Forces With Innovative Biotech To Catch Cancer Early

Benzinga

By Johnny Rice, Benzinga Petra Smeltzer Starke, Brand Ambassador for Mainz Biomed (NASDAQ: MYNZ), was recently interviewed by Benzinga. Mainz creates clinical laboratory tests that save costs and lives by enabling early detection and prevention of disease. The company reports that patients with cancers and other conditions are living longer and enjoying better health because of medical innovations like the tests Mainz creates. Petra Smeltzer Starke is the new face of Mainz. As a former senior advisor to President Obama and a rectal cancer survivor, Mainz believes she is uniquely suited to help spread the word about early detection and help save lives. Watch the full interview here: Featured photo by Louis Reed 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

October 07, 2024 08:20 AM Eastern Daylight Time

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UNOS applauds introduction of the Organ Donation Referral Improvement Act

United Network for Organ Sharing

The United Network for Organ Sharing (UNOS) today applauded the introduction of the bipartisan Organ Donation Referral Improvement Act by U.S. Reps. Rob Wittman, Jennifer McClellan, Mariannette Miller-Meeks and Jim Costa. The bipartisan legislation aims to optimize the deceased organ donor referral process by identifying and recommending best practices for software tools used by hospitals and organ procurement organizations. This will help to maximize potential organ donation while reducing the burden on busy hospital staff and will ultimately improve patient access to transplants. “We are pleased to see this important legislation introduced,” said Maureen McBride, Ph.D. CEO of UNOS. “By leveraging technology, we can streamline the organ donor referral process to increase organs available for transplant and save more lives. UNOS is committed to working with Congress and the entire organ donation and transplant community to advance the Organ Donation Referral Improvement Act and ensure a safe and efficient organ donation and transplant system for all. Thank you, Representatives Wittman, McClellan, Miller-Meeks and Costa for your leadership on this critical issue.” UNOS calls upon the U.S. House Committee on Energy and Commerce to quickly take up this important legislation. About UNOS United Network for Organ Sharing (UNOS) is the mission-driven non-profit serving as the nation’s transplant system under contract with the federal government. We lead the network of transplant hospitals, organ procurement organizations, and thousands of volunteers who are dedicated to honoring the gifts of life entrusted to us and to making lifesaving transplants possible for patients in need. Working together, we leverage data and advances in science and technology to continuously strengthen the system, increase the number of organs recovered and the number of transplants performed, and ensure patients across the nation have equitable access to transplant. Contact Details United Network for Organ Sharing Anne Paschke anne.paschke@unos.org Company Website https://unos.org

October 04, 2024 02:00 PM Eastern Daylight Time

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Expanding Continuous Glucose Monitoring Options: How Glucotrack Is Helping Usher In The Next Generation Of Diabetes Care Technology

Benzinga

By Josh Enomoto, Benzinga Introduced in the late 1990s, continuous glucose monitoring (CGM) revolutionized diabetes care. Prior to CGM, home blood glucose monitoring (BGM) methodologies – which involve patients using a lancet to prick their fingers and apply a drop of blood to a test strip – represented the norm. Still, even with the rise of CGM, several challenges remain. That’s what Glucotrack Inc. (NASDAQ: GCTK) is looking to address. In particular, while current CGM solutions have improved quality of life via informed decision-making, several obstacles – including discomfort and inconvenience – have left many patients as well as medical professionals wanting. Glucotrack aims to fill the opportunity gaps in the CGM industry by directly addressing the pain points of the contemporary standard of care. Most importantly, Glucotrack’s mainline innovation – known as the Continuous Blood Glucose Monitor (CBGM) – focuses on the patient. Diabetes affects 38 million people in the U.S. alone, according to the CDC, and it's the eighth leading cause of death, contributing to serious complications like kidney disease, blindness and cardiovascular risk. With such a vast population facing the daily burden of managing their blood sugar, innovations like Glucotrack’s real-time monitoring system could be essential to improving quality of life and healthcare outcomes. Assessing The Current State Of CGM Technology According to a publication posted by the National Library of Medicine, the U.S. Food and Drug Administration (FDA) approved the first “professional” CGM in 1999. Since that time, there have been several major advancements in the technology. However, commercially available CGMs tend to measure glucose in interstitial fluid and not directly from blood. And, until relatively recently, all CGM devices required calibration via blood glucose measurements extracted from the fingerstick process. Generally, the calibration process is used to improve system accuracy by comparing it to a blood glucose measurement from a fingerstick. Even with the latest advancements, several challenges and inconveniences remain. Among the most vexing for patients is a lack of a platform that addresses all major concerns. Instead, sufferers of diabetes must compromise across a range of different sets of pros and cons. Abbott Laboratories (NYSE: ABT) has established a strong presence in diabetes management with its CGM system, FreeStyle Libre. Libre offers accurate and continuous glucose monitoring, but the platform also requires frequent sensor changes (every 14-15 days, depending on the model) and the use of a wearable. Dexcom (NASDAQ: DXCM) is also among the leaders in CGM technology, offering accurate and continuous glucose tracking. However, reports indicate the company’s platform falls short in terms of the adhesive patch potentially not properly sticking to the patient’s skin at all times. Senseonics Holdings Inc. (AMEX: SENS) has gained in popularity thanks to its product Eversense, an implantable CGM with a sensor life of up to six months, with the FDA recently clearing use for one year. While an enticing proposition, the system requires frequent calibration and patients still need to wear a transmitter over the skin. Medtronic PLC (NYSE: MDT) represents another of the innovative powerhouses in diabetes care, with its CGM integrated into a broader diabetes management ecosystem. Nevertheless, the underlying platform still requires regular calibration and the use of wearables. In contrast, Glucotrack seeks to address these shortcomings of contemporary CGM devices. One of the most distinct advantages of the company’s solution is a much longer sensor life. Moreover, it does away with wearables while providing real-time blood glucose monitoring. Key Advantages Of The Glucotrack System As mentioned earlier, sensor life represents a core struggle of many diabetes patients managing their condition. On one end of the scale, Abbott’s FreeStyle Libre, Dexcom systems and Medtronic systems offer a relatively pain-free sensor application process. However, the sensor requires replacement after 7-15 days, depending on the model. On the other hand, Senseonic offers a sensor life of up to half a year, with one-year recently approved by the FDA. This system is implantable, but still requires the need for a wearable transmitter, which impacts the patient’s quality of life. Furthermore, according to internal market research performed by Glucotrack, 73% of endocrinologists favor devices with a sensor life of three years. As shared in an earlier Benzinga article, the key advantage of the Glucotrack system is that the underlying implantable CBGM features a sensor that can last up to three years. That’s a significant improvement over many more popular options, thus reducing the frequency and hassle of updating prescriptions and ordering supplies. Speaking of organic benefits, Glucotrack’s device eliminates the need for wearables. This advantage automatically resolves common concerns tied to continuous glucose monitoring, including adhesive skin irritation, sensor detachment during activities and the burden of managing supplies and copayments. Another important attribute of the Glucotrack system is its real-time blood glucose measurement capabilities. Such measurements may provide much more accurate readings because the use of blood dramatically cuts the lag time present in traditional interstitial glucose monitors. Significantly, real-time measurements may potentially facilitate improved safety. Thanks to the quicker testing data, patients may be able to respond more quickly to urgent matters, such as low or high blood sugar events. This attribute may potentially reduce the risk of severe complications like diabetic ketoacidosis or hypoglycemic coma. A core advantage that Glucotrack claims is CBGM’s broad interest among healthcare professionals. The company recently conducted proof of concept research among 100 endocrinologists and 50 primary care providers (PCPs), which yielded much data, including the following statistics: Finding the implantable CBGM concept an intriguing and innovative one, 42% of endocrinologists expressed willingness to adopt the platform following approval and at a sensor life of only two years. Even more so than endocrinologists, PCPs have vocally expressed eagerness to try the implantable CBGM, with 68% willing to adopt the system at a sensor life of only two years. Individual PCPs reported that Glucotrack’s device can be a “game changer for diabetics,” along with labeling the concept itself as “genius.” Finally, Glucotrack offers an intuitive interface, requiring minimal calibration and thus reducing the daily burdens that patients must follow. Rising Need For CGM Innovation According to Lancet’s global burden studies, chronic conditions represented the root of 74% of all deaths across the world. That’s a noticeable rise from 67% of deaths in 2010, reflecting the rising prevalence of chronic diseases, of which diabetes is one. As such, the rise of diabetes – particularly type 2 and prediabetes – represents a significant area of concern. However, for Glucotrack, the main focus is on insulin-using people with diabetes, as these patients require continuous monitoring due to insulin therapy. With this population segment also growing, finding advanced solutions to address their unique challenges becomes even more critical. It’s not just about the inconveniences of frequent sensor changes and the irritation and discomfort involved in everyday utilization of standard CGM devices. It’s often also limiting the ability to participate in some activities such as swimming or hot yoga due to concerns about the wearable falling off. By facilitating a long-lasting alternative, Glucotrack’s CBGM makes glucose monitoring less intrusive and potentially more accessible. Most significantly, the accuracy behind real-time glucose measurements reported by the company may potentially improve quality of life and in some acute situations save it. Empowering Diabetes Care With Real-Time Solutions In an ever-growing diabetes landscape, Glucotrack’s advancements in continuous glucose monitoring offer a potential solution to the persistent challenges faced by insulin-using people with diabetes. By addressing key pain points such as short sensor life, the discomfort of wearables and the hassle of frequent replacements, Glucotrack potentially positions itself as a transformative force in diabetes care. Additionally, with its reported real-time, accurate blood glucose measurements, long-lasting sensor and lack of an intrusive wearable, the CBGM system not only improves day-to-day management but also has the potential to prevent life-threatening complications. As the need for better diabetes care intensifies, Glucotrack is looking to offer a brighter, healthier future for millions of people managing this chronic disease. Featured photo by Brooke Cagle 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

October 04, 2024 08:30 AM Eastern Daylight Time

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Holiday Gift Guide: Add These Luxury Cannabis Items to Your Shopping List

MJ Attaché

Cannabis is legal in 38 states and counting for medical use. Almost 40% of women over the age of 21 currently consume cannabis, and men are nearly twice as likely to use cannabis than women. Odds are, your holiday gift-giving list includes an herbalist who would cherish an easy and elegant addition to their self-care ritual. “Whether the cannabis connoisseur on your holiday giving list uses cannabis medicinally or recreationally, MJ Attaché gift options elevate the experience and simplify the lives of discerning herbal enthusiasts,” explains MJ Attaché founder Christy Fuicelli. “Not only are our attachés statement pieces for self-care rituals, but they’re discreet, lockable and customizable to suit individual consumption needs.” New-to-market, MJ Attaché luxury holiday gift options for cannabis enthusiasts The Anthony Bag - $2,150.00 The Anthony bag combines style and sophistication for the discerning herbalist. Built by Italian artisans with the finest materials, this attaché dispels outdated stereotypes and elevates self-care rituals with patent-pending technology. It is the first on the market to provide a subtle, smell-disguising, practical and elegant solution to suit a cannabis enthusiast’s lifestyle. Available in five colors, The Anthony contains a removable rolling tray and magnetic accessories for customizable storage of your cannabis and accouterments. Retractable Vape Pen Holder - $150.00 Give the gift of ease, and the herbalist on your list will never lose another vape pen. Made in Italy of metal, leather and elastic, this accessory ensures the safekeeping and easy access of a favorite pen. The branded snap hook clips to bags or clothing, and the monogrammed retractable piece allows for use without removal. Fits most batteries up to.5″ in diameter. Retractable Lighter Holder - $175.00 Place this holder under the tree, and your favorite cannabis enthusiast’s lighter will always be at hand. Like the pen holder, this lighter holder is made in Italy of metal and leather. It is engineered to ensure a lighter’s safekeeping and easy access. The accessory’s branded snap hook clips to clothing or bags for accessibility, and the monogrammed retractable piece allows for use without removal. Fits classic BIC lighter. “Our vape pen and lighter holders keep your cannabis accessories safe and right where you need them. The Anthony is a luxury storage solution for all your cannabis needs—making it the perfect gift for a sophisticated herbal enthusiast,” says Fuicelli. “In addition to beauty and refinement, The Anthony is equally functional in that the components can be customized to meet individual needs. For example, edibles, flower and prerolls can be stored in the provided smell-proof jars and locked in The Anthony bag for safekeeping and transport this holiday season,” Fuicelli explains. The Anthony bag makes cannabis self-care rituals easy and elegant Discreet, smell-disguising design you can take anywhere Patent-pending modular elements include smell-proof jars for edibles and flower, lighter holder and glass holder Removable rolling tray for ease of use and clean-up Zipper lock eliminates need for difficult-to-open childproof containers "The Anthony bag not only keeps all my sesh products nicely organized for on-the-go, but it also turns heads. All my colleagues are shocked to find out its purpose!" says Arend Richard, The Anthony bag purchaser and founder of Cirrus Social Club in Denver. Find holiday luxury at MJAttache.com. Connect on Facebook and Instagram for the latest updates and deals. # # # About MJ Attaché Launched in April 2024, MJ Attaché is a designer and developer of high-quality, handmade Italian leather bags and accessories for the cannabis connoisseur. The luxury brand, with its moniker “MJ” (short for Mary Jane—an alias for marijuana), was founded by entrepreneur Christy Fuicelli, a stylish herbalist. Realizing a void in the marketplace, Fuicelli created MJ Attaché to cache and carry her cannabis in a discreet manner reflective of the luxury she enjoyed in other personal products. Fuicelli spent years designing beautifully crafted bags that embody elevated style, sophistication, high quality and fine craftsmanship. Appealing to men and women alike, MJ Attaché products bring ease and style to the cannabis industry and challenge outdated stigmas. Contact Details MJ Attaché Katie Converse for MJ Attaché info@mjattache.com Company Website https://mjattache.com/

October 03, 2024 01:00 PM Mountain Daylight Time

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PathAI Announces Collaboration with the Crohn’s & Colitis Foundation to Advance Novel IBD Research and Development

PathAI

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced a partnership with the Crohn’s & Colitis Foundation. The collaboration will empower academic and biopharmaceutical researchers to unlock insights into inflammatory bowel disease (IBD) through the unique combination of quantitative histopathology data and well-characterized multi-modal clinical and molecular data. Quantitative histopathology data will be derived from the deployment of PathAI's IBD Explore ™ and AIM-HI UC ™ algorithm products 1 on digitized histology images from the Crohn’s and Colitis Foundation’s IBD Plexus ​Ⓡ dataset. The parties will also pursue collaborative research using their complementary assets aimed at advancing the field of IBD research.​ Despite the current array of treatment options in ulcerative colitis and Crohn’s disease, remission rates in induction trials are still less than 50%, revealing a therapeutic ceiling in the treatment of both diseases and potential challenges that need to be addressed 2-5. PathAI’s IBD Explore algorithm utilizes AI-powered histopathology analysis to provide detailed insights into the tissue’s inflammatory microenvironment. IBD Explore has the potential to lead to the discovery of novel biomarkers 6,7, disease subtypes, and treatment targets. Meanwhile, AIM-HI UC is the only AI-powered Geboes scoring tool that provides automated subgrade-level scores to accurately and reproducibly measure histological stage and improvement for ulcerative colitis research and clinical trials. “We are thrilled to collaborate with the Crohn’s & Colitis Foundation, the leading nonprofit organization in the IBD space, as a preferred partner to meaningfully advance our understanding of IBD through this unique combination of datasets,” said Andy Beck, MD, PhD, co-founder and CEO of PathAI. “By partnering with PathAI, we aim to uncover valuable insights from well-characterized pathology images, enhancing our understanding of IBD at the microscopic level and paving the way for novel biomarkers, refined disease subtypes, and potential therapeutic targets,” said Angela Dobes, SVP IBD Plexus, Crohn’s & Colitis Foundation. By combining IBD Plexus’ deeply curated multimodal data, including its large-scale digitized pathology archive, with advanced AI analysis by PathAI, this collaboration aims to enhance researchers’ understanding of the histological factors of IBD to drive novel discoveries that improve quality of life for the millions of Americans living with these diseases. For more information on licensing a joint dataset from PathAI and the Crohn’s and Colitis Foundation, please reach out to bd@pathai.com. Register for a free demo of PathAI’s algorithm products here. Footnotes IBD Explore and AIM-HI UC are For Research Use Only. Not for use in diagnostic procedures. Danese S. et al. Unmet medical needs in ulcerative colitis: an expert group consensus. Dig. Dis. 2019;37(4):266–283. doi: 10.1159/000496739. https://www.ncbi.nlm.nih.gov/pubmed/30726845 Colombel J.F. et al. Discrepancies between patient-reported outcomes, and endoscopic and histological appearance in UC. Gut. 2017;66(12):2063–2068. doi: 10.1136/gutjnl-2016-312307. https://www.ncbi.nlm.nih.gov/pubmed/27590995 Colombel J.F. et al. Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet. 2017;390(10114):2779–2789. doi: 10.1016/S0140-6736(17)32641-7. Alsoud D. et al. Breaking the therapeutic ceiling in drug development in ulcerative colitis. Lancet Gastroenterol Hepatol. 2021;6(7):589–595. doi: 10.1016/S2468-1253(21)00065-0. Shamshoian et al. 2024. United European Gastroenterology Week. ePoster PP0375. Griffin et al. 2024. European Crohn’s and Colitis Organisation. P008. About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and laboratory use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of pathology samples, with the potential to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI is headquartered in Boston, MA. For more information, please visit www.pathai.com. About the Crohn’s & Colitis Foundation The Crohn’s & Colitis Foundation is the leading nonprofit organization focused on both research and patient support for inflammatory bowel disease (IBD), with the mission of curing Crohn’s disease and ulcerative colitis and improving the quality of life for the millions of people living with IBD. The Foundation’s work is dramatically accelerating the research process, while also providing extensive educational and support resources for patients and their families, medical professionals, and the public. To learn more about the IBD Plexus program, visit www.crohnscolitisfoundation.org/research/plexus. Contact Details SVM Public Relations and Marketing Communications +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

October 03, 2024 10:00 AM Eastern Daylight Time

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This Company Is Taking An Innovative, Non-Opioid Approach To Pain Management For Pancreatic Cancer

Autonomix Medical, Inc.

By Austin DeNoce, Benzinga Pancreatic cancer is one of the most aggressive and painful forms of cancer, often leaving patients with limited options for effective pain management. Traditional treatments like opioids and nerve blocks offer only temporary relief, and their side effects can further diminish the quality of life. This underscores the urgent need for innovative solutions that can provide sustainable pain relief for those battling this debilitating disease. Autonomix Medical (NASDAQ: AMIX) is working to address this critical gap with a novel, non-opioid approach designed to significantly reduce pain in pancreatic cancer patients. The company recently shared promising preliminary data from its ongoing human clinical trial, showcasing the potential of its precision nerve-targeted treatment. This minimally invasive method aims to deliver lasting pain relief, offering hope to patients who have struggled to find effective alternatives to around-the-clock opioids. “We are encouraged by the significant, sustained pain reduction demonstrated from the lead-in patients in our ongoing first-in-human trial. These are very sick individuals, who up until this point primarily relied on opioids to help mitigate their pain, which our baseline data shows were not effective,” said Autonomix CEO Brad Hauser. Overview Of Preliminary Results In early September, Autonomix announced positive outcomes from its proof-of-concept trial. The results indicated that 60% of patients in the initial cohort experienced a substantial reduction in pain. Using the Visual Analog Scale (VAS), patients reported a dramatic drop in pain scores from an average of 8.0 to just 1.33 within 4 to 6 weeks post-procedure — an 83% reduction. Significantly, patients in the responder group felt pain relief as early as one day after the procedure, highlighting the potential for rapid and meaningful impact. The trial also identified a key factor that may factor in treatment success: the access point used during the procedure. Patients treated through femoral access showed significant improvements, while those with brachial access did not. These findings suggest that the method of delivery may play a crucial role in optimizing outcomes. Innovative Technology Behind The Treatment Autonomix reports that its groundbreaking technology employs a catheter-based microchip sensing array capable of detecting and differentiating nerve signals with extraordinary precision – up to 3,000 times greater than existing methods. The company says this advanced platform not only identifies overactive nerve signals but also targets them with radiofrequency (RF) ablation, providing precise pain relief without the common drawbacks of conventional treatments. Looking Ahead: Expanding The Possibilities The trial is expected to complete patient enrollment by the end of 2024, with plans to incorporate additional biomarkers to refine the correlation between nerve ablation and pain relief. The success of this trial could pave the way for a new standard in pain management, extending beyond pancreatic cancer to other conditions characterized by severe nerve-related pain. A Potential Game-Changer, Non-Opioid Approach In Pain Therapy Autonomix Medical could be poised to help revolutionize pain management, not only for pancreatic cancer patients but for a broader range of chronic pain conditions. As their technology evolves and clinical trials progress, the company says its approach could transform the landscape of pain therapy, offering hope and improved quality of life to countless individuals. By developing cutting-edge solutions, Autonomix is not just addressing a critical unmet need but also potentially setting the stage for a new era in precision pain management. With the potential to impact a significant segment of the multi-billion-dollar pain management market, this breakthrough could mark a turning point in the way we treat pain in complex medical conditions. Featured photo by Ousa Chea from Unsplash. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.We are initially developing our technology for pancreatic cancer pain, a condition that can cause debilitating pain and needs an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum. Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the completion of patient enrollment in the trial and the Company’s ability to successfully meet the milestones set forth in this press release on a timely basis, if at all. Such forward-looking statements can be identified by the use of words such as ‘should,’ ‘may,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘forecasts,’ ‘expects,’ ‘plans,’ and ‘proposes.’Although Autonomix Medical, Inc. (or Autonomix) believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering circular filed with the U.S. Securities and Exchange Commission (“SEC”) on January 26, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details JTC Team, LLC autonomix@jtcir.com Company Website https://autonomix.com/

October 03, 2024 08:35 AM Eastern Daylight Time

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Breakthrough Therapies And Novel Treatments - This Biopharma Is Out To Change The Game

Benzinga

By Johnny Rice, Benzinga Erez Aminov, CEO & Chairman of the Board, and Dr. Itzchak Angel, Chief Scientific Advisor for MIRA Pharmaceuticals (NASDAQ: MIRA), were recently interviewed by Benzinga. MIRA is a pre-clinical biopharma focused on developing treatments for neurologic and neuropsychiatric disorders. It holds exclusive rights to Ketamir-2, an oral ketamine analog being studied for neuropathic pain, treatment-resistant depression, major depressive disorder with suicidal ideation and PTSD. The company’s other primary asset, MIRA-55, is a novel pharmaceutical marijuana analog that could provide enhanced therapeutic effects over THC. Watch the full interview here: Featured photo by Jeremy Bishop 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

October 03, 2024 08:25 AM Eastern Daylight Time

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Psilocybin's Potentially Revolutionary Ability To Treat Depression Hinges On FDA Approval – AJNA BioSciences Is Standardizing Raw Materials To Meet Guidelines

Benzinga

By Anthony Termini, Benzinga Results of research conducted at Emory University, the University of Wisconsin-Madison and UC Berkeley estimate that more than five million Americans suffering from depression could benefit from psilocybin-assisted therapy. This first-of-its-kind peer-reviewed study is scheduled to be published in the scientific journal Psychedelics on September 24, 2024. How Psilocybin Can Deliver Rapid And Sustained Antidepressant Effects This latest research report is not the first to look into the use of psilocybin to treat depression. There is a body of research showing that it can potentially deliver quick and continuous antidepressant effects. For example, results of randomized clinical trials have been published in the Journal of the American Medical Association and by the University of California San Francisco. In fact, psilocybin’s therapeutic properties had been researched as early as the 1950s by Swiss drugmaker Sandoz Group (OTC: SDZNY) as part of specific psychiatric studies. A Pioneering Drug Development Company Focused On Botanical Therapies All of this seems to support the work of AJNA BioSciences, based in Littleton, Colorado. The company could be strategically poised to lead and create value in this emerging category of pharmaceuticals. AJNA is currently developing a full-spectrum psilocybin “novel antidepressant.” AJNA believes that a standardized botanical medicine made from psilocybin will be in high demand. It reports that in 2020, doctors prescribed nearly $19 billion worth of drugs to treat depression. Researchers have estimated that the market for psychedelic drugs will grow annually by more than 12% through at least 2027. AJNA believes it can capture a high single-digit percentage of that market. What is significant about AJNA’s drug development work is that it is standardizing botanical materials to meet strict FDA guidelines. AJNA reports that it is the first biotech company working with botanicals under a DEA Schedule-1 license. AJNA is developing a daily-use anti-depression treatment through what it intends to be a fully characterized and FDA-approved formulation. AJNA has advanced the development of two prescription drug candidates: its CBD-based Autism Spectrum Disorder drug is anticipating a phase 2 trial in late 2024, and its psilocybin-based antidepressant drug has a phase 1 trial scheduled for early 2025. The company’s research team, led by scientists from Harvard, Johns Hopkins and New York University, is conducting clinical trials in the same manner as large drug manufacturers. However, AJNA is working to transform the pharmaceutical industry by pioneering a new regulatory pathway to produce drugs from plants. Why AJNA Is Focused On FDA Approvals Authors of the research to be published by Emory University, the University of Wisconsin-Madison and UC Berkeley say that their “projections are highly contingent on…precise FDA approval parameters.” In other words, how broadly or narrowly the FDA defines this new class of drugs. AJNA seems to have anticipated some of this. It reports that it has distinguished itself as one of the leaders in the evolving field of botanical drug development and has paid strict attention to how the FDA is defining the pathways for botanical drugs to get approved. Joel Stanley, AJNA’s CEO, says that FDA approval is a critical component of bringing new drugs to market. Federal law requires that a manufacturer show that the drugs they produce are safe and effective. Stanley also notes that without the FDA’s stamp of approval, a drug is unlikely to be considered for reimbursement by health insurance carriers. For botanical drugs to be an accepted component of a physician’s and patient’s routine treatment options, they must be approved by the FDA. AJNA is committed to producing natural botanical drugs that have undergone rigorous laboratory and clinical scrutiny to demonstrate that they deliver “nature, backed by science.” AJNA is currently raising capital in a crowdfunding round through Wefunder. Stanley says that “by investing in AJNA, you’re helping to change the healthcare paradigm to include optionality that none of us have ever had.” With less than a week before the current financing/investment opportunity closes, interested investors can find more information on the Wefunder website. Featured photo by Monika Schröder on Pixabay. 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

October 02, 2024 08:25 AM Eastern Daylight Time

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Market Alert: Silexion Therapeutics (NASDAQ: SLXN) Sees Record Volumes Following Breakthrough Preclinical Data for SIL-204

Global Markets News

Shares of Silexion Therapeutics (NASDAQ:SLXN) are seeing significatnly today after the company announced promising new preclinical data for its next-generation siRNA candidate, SIL-204. The stock saw a significant initial of price spike of over 50% in pre-market activity as investors responded to the latest developments in Silexion's RNA interference (RNAi) platform, which targets KRAS-driven cancers. As of now, volume is at record highs, currently standing at over 50 million shares today. The company revealed that SIL-204, an extended-release microparticle formulation, demonstrated substantial tumor reduction and necrosis in mouse models of pancreatic cancer bearing the KRAS G12D mutation—one of the most common mutations found in pancreatic cancer patients. This latest data builds on a string of recent successes for Silexion, including its September 24 announcement of results from the Phase 2 trial for its first-generation product, LODER™, which showed significant improvements in tumor resectability among non-resectable pancreatic cancer patients. Alongside the new preclinical results, Silexion has recently reported plans to begin toxicology studies for SIL-204 in preparation for Phase 2/3 clinical trials expected to commence in the first half of 2026. The company is also expanding the application of its siRNA technology to colorectal cancer models, reflecting its broader ambitions to target multiple KRAS-driven cancers, which are notoriously difficult to treat with conventional therapies. While stock price has pulled back since premarket, The spike in Silexion’s market activity as marked by these record high volumes (according to market data) may highlight the growing market interest in the company’s novel approach to tackling cancers with high unmet medical needs, particularly its focus on KRAS mutations, which are common across a variety of aggressive cancers, including pancreatic and colorectal cancer. Silexion’s continued momentum in the precision oncology space potentially positions it as a leading player in the development of next-generation RNAi therapies. With its promising pipeline and recent positive developments, the company seems to be gaining attention as it advances toward clinical trials that could offer new hope for patients battling some of the deadliest cancers. Click here to read Silexion's full announcement *** This update is for informational purposes only and is not intended to serve as financial, investment or any form of professional advice, recommendation or endorsement. Please review the full documentation detailing financial compensation disclosures and disclaimers the article is subject to. [https://justpaste.it/ab9dn/pdf]. Global Markets News Network is a commercial digital brand compensated to provide coverage of news and developments related to innovative companies as detailed in the full documentation and it is thus subject to conflicts of interest. Contact Details News Coverage ronald@futuremarketsresearch.com

October 01, 2024 11:47 AM Eastern Daylight Time

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