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The Potential Of Ketamir-2: A Safer Treatment For Mental Health Disorders And Neuropathic Pain, IND Filing Expected By Year-End

Benzinga

By Meg Flippin, Benzinga Treating mental health is constantly evolving, bringing new therapies and hope to people battling depression, treatment-resistant depression (TRD), post-traumatic stress disorder (PTSD) and other neuropsychiatric conditions. Not all therapies work for everyone, but sometimes an exciting treatment emerges. Ketamine, originally developed as an anesthetic, falls into that category. In recent years, it has been repurposed as a rapid-acting antidepressant, particularly for patients who have not responded to conventional treatments. While often effective, ketamine’s widespread use has been limited by its side effects and low oral bioavailability. Traditional ketamine requires intravenous or intranasal administration, which can be inconvenient and impractical for at-home treatment. Additionally, ketamine’s interaction with multiple receptor sites in the brain can lead to unwanted side effects such as dissociation, hallucinations and, in some cases, psychotic symptoms. Tweaking Ketamine But that doesn’t mean ketamine has to be written off as a new treatment for mental health. It just needs to be tweaked. That’s where MIRA Pharmaceuticals (NASDAQ: MIRA) and Ketamir-2 come in. A pre-clinical-stage pharmaceutical company, MIRA is refining this treatment with its oral ketamine analog, Ketamir-2. MIRA Pharmaceuticals says Ketamir-2 is a groundbreaking compound that has the potential to revolutionize the way mental health disorders and neuropathic pain are treated, offering a safer and more effective alternative to traditional therapies. The company is on track to file an Investigational New Drug (IND) application by the end of the year, marking what it says is a significant milestone in bringing Ketamir-2 closer to clinical trials. Ketamir-2 is designed to overcome the challenges of existing ketamine treatments by creating an agent that is more targeted. Ketamir-2 selectively inhibits the NMDA receptor at the PCP-binding site with 30 to 50 times lower affinity than traditional ketamine. This selective inhibition can reduce the risk of dissociation and hallucinations, providing a cleaner, safer therapeutic experience for patients. Preclinical studies have so far found that Ketamir-2 offers a superior safety profile compared to traditional ketamine. MIRA Pharmaceuticals said one of the most significant findings is that Ketamir-2 does not induce hyper-locomotor activity – a behavior associated with psychotic symptoms – making it a potentially safer option for patients. Better Oral Absorption Could Be Game-changing Another discovery MIRA Pharmaceuticals reports, is Ketamir-2’s non-substrate status for P-glycoprotein (P-gp), a membrane protein that typically limits drug entry into the brain. This means that Ketamir-2 can more effectively cross the blood-brain barrier, leading to better oral absorption and higher efficacy at lower doses. This feature is particularly important for patients seeking convenient, at-home treatment options. On top of all that, MIRA Pharmaceuticals says Ketamir-2’s principal metabolite, Nor-Ketamir, boasts nearly 100% oral bioavailability and sustained plasma residence. This means that once Ketamir-2 is administered orally, it is efficiently metabolized into Nor-Ketamir, which remains in the bloodstream longer, providing extended therapeutic effects. The development of Ketamir-2 Pamoate, a new salt form, further enhances these benefits by ensuring higher plasma and brain levels with a longer half-life, reports the company. Treating Chronic Pain Too Beyond depression and mental health issues, MIRA Pharmaceuticals said studies are ongoing to assess Ketamir-2’s effectiveness in treating neuropathic pain, a chronic and debilitating condition that has an estimated prevalence of 6.9% to 10% worldwide. The dual potential of Ketamir-2 to address both mental health disorders and neuropathic pain could represent a significant advancement in patient care, offering a versatile and effective treatment option. The potential of Ketamir-2 and Nor-Ketamir to offer effective, at-home treatment options for mental health disorders and neuropathic pain could prove to be a game-changer. The convenience of oral administration, combined with the drug’s safety and efficacy, could significantly improve patient adherence to treatment and overall outcomes. Further, the company says toxicology studies have validated Ketamir-2’s safety profile, with no observed toxicity at very high doses in animal models. Ketamine holds a lot of promise in treating mental health but the side effects are limiting adoption. Ketamir-2 could change that by addressing the limitations of traditional ketamine and offering a safer, more effective alternative. If the preclinical trials are any indication, Ketamir-2 could provide hope for many sufferers. For more information about MIRA Pharmaceuticals and its novel compounds, visit MIRA Pharmaceuticals. Featured photo by nikko macaspac 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

August 27, 2024 08:50 AM Eastern Daylight Time

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Minerva Surgical Launches Next Generation Symphion Fluid Management Accessory with Fluid Deficit Readout

Minerva Surgical, Inc.

Minerva Surgical, a manufacturer and distributor of minimally invasive gynecologic surgical technologies, today announced the launch of the Symphion Fluid Deficit Readout, an optional accessory that provides fluid deficit volume readings during operative hysteroscopy procedures. Operative hysteroscopy is a surgical procedure that requires precise fluid management to prevent complications. The Symphion Fluid Deficit Readout, which is intended for use with the Symphion Operative Hysteroscopy System, automatically calculates the fluid deficit during the procedure by measuring the weight of the saline bag throughout the procedure in real time and converting the weight measurement into fluid volume readings. Additional key features of the Symphion Fluid Deficit Readout include a fluid deficit accuracy within +/- 50mL, a user-friendly interface with an intuitive display for easy operation, and a compact design that allows for quick set up with the Symphion controller. “Continuous innovation with a focus on enhancing patient safety has always been the primary objective for Minerva Surgical. The Symphion Operative Hysteroscopy System is intended to volumetrically limit a patient’s exposure to fluid so the risk of fluid absorption and overload can be avoided. With the introduction of the Symphion Fluid Deficit Readout, the system has a new layer of procedural safety to complement the unprecedented precision during uterine cavity tissue resection.”, states Minerva Surgical Chief Medical Officer Eugene Skalnyi, M.D. Along with the Symphion Fluid Deficit Readout, Minerva Surgical is launching a compatible, next generation of Fluid Management Accessory called INFINITY. Together, the Symphion line extensions are the newest additions to the Minerva Surgical portfolio of minimally invasive technologies. The company is committed to advancing gynecologic surgery and providing solutions that enhance outcomes. About Minerva Surgical, Inc. Minerva Surgical is a technology enabled medical device company focused on developing, manufacturing, distributing, and commercializing minimally invasive solutions to meet the distinct pelvic healthcare needs of women. The Company has established a broad product line of minimally invasive alternatives to hysterectomy, which include solutions to detect and address common causes of Abnormal Uterine Bleeding (AUB). The Minerva Surgical pelvic health solutions can be used in a variety of medical treatment settings and aim to address the drawbacks associated with alternative treatment methods and to preserve the anatomy by avoiding unnecessary hysterectomies. For more information about the innovative medical devices of Minerva Surgical, please visit www.MinervaSurgical.com. Contact Details Kevin Tracey +1 855-646-7874 kevin.tracey@minervasurgical.com Company Website https://minervasurgical.com/

August 26, 2024 10:00 AM Eastern Daylight Time

AmeriLife’s Senior Market Advisors Welcomes Parker Marketing Insurance to Expand Presence in the Medicare Advantage and Final Expense Markets

AmeriLife

Senior Market Advisors (SMA), a fast-growing field marketing organization (FMO) in the insurance space and an affiliate of AmeriLife Group, LLC (“AmeriLife”), announced today that it has completed its acquisition of Parker Marketing Insurance (“PMI”). Per the agreement, terms of the deal were not disclosed. “Daniel [Parker] and his team represent the kind of customer-focused care that we promote in every interaction our affiliated agents and agencies have with their clients,” said Joshua Borders, CEO of Senior Market Advisors. “This partnership represents our shared values in meeting people where they are in their health insurance journey and helping them safeguard their assets for some of life’s unexpected events.” Inspired by his experiences and what he learned from his father, Parker established his first insurance agency in 2016, focused on replicating a successful final expense business into the Medicare Advantage market. This pivotal decision led to PMI’s Legacy Chassis—a primary brokerage model that benefits agents through a tiered lump sum model, enhancing recruitment efforts. “AmeriLife’s distribution platform offers robust layers of professionalism to ensure success for PMI’s agents and customers,” said Daniel Parker, owner and president of Parker Marketing Insurance. “This partnership will fuel my long-term vision, allowing me to continue my life’s work for the people I serve, enabling continued growth, and enhancing agent success emphasized by the power and unity of AmeriLife’s core values that prioritize the needs and success of others.” PMI’s growing, nationwide agent network—specifically, across the southeast in Mississippi, Georgia, and Florida—is a testament to its focus and dedication to talent acquisition and best-in-class training protocols, which have developed some of the region’s top producers. AmeriLife provides partners with a business environment and distribution network characterized by efficiency, value, and access to teams of dedicated professionals working together to enhance their platform with productivity and profitability. This proves especially advantageous for companies like PMI focused on the Medicare and final expense sectors, where consumers search for peace of mind and customized solutions to address their healthcare needs and end-of-life expenses. "Seeing our collaboration with Senior Market Advisors flourish through the years, and now with the inclusion of Parker Marketing Insurance, is exciting," added Scotty Elliott, Chief Distribution Officer of Health for AmeriLife. "This expansion highlights the robust nature of our expanding Health Distribution network, enabling us to assist more beneficiaries and establish new benchmarks in top-tier customer service within the industry." ### About Parker Marketing Insurance Parker Marketing Insurance helps people navigate the complex world of insurance, focusing on Medicare Advantage, Medicare Supplement, Medicare Part D, Dental & Vision Insurance, Hospital Indemnity, and Final Expense. Based in Meridian, MS, Parker Marketing Insurance is staffed by proven insurance professionals committed to providing consumers with highly personalized service. For more information, visit www.pmiagents.com. About Senior Market Advisors Senior Market Advisors (SMA) has been people over profits since 2007, by hard work and a commitment to “doing right” by the consumer. We have certainly knocked on our fair share of doors. We know the grit and determination involved in becoming a career agent. As a result, we are a fast-growing FMO, doubling our business each year for the past five years. For more information, visit us online at www.SeniorMarketAdvisors.com. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For over 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers through a distribution network of over 300,000 insurance agents, financial professionals, and over 100 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com and follow AmeriLife on Facebook and LinkedIn. Contact Details AmeriLife Jeff Maldonado media@amerilife.com Partnership Inquiries Patrick Nichols corporatedevelopment@amerilife.com Company Website https://amerilife.com/

August 26, 2024 09:00 AM Eastern Daylight Time

Theriva Biologics Receives Rare Pediatric Drug Designation From FDA For Treatment Of Retinoblastoma

Benzinga

By Kyle Anthony, Benzinga The growing prevalence of cancer is not limited to adults; it is also afflicting children. An estimated 15,780 children between birth and 19 years of age are diagnosed with cancer each year in the U.S., according to the American Childhood Cancer Organization. Approximately 1 in 285 children in the U.S. will be diagnosed with cancer before their 20th birthday. Globally, there are more than 300,000 children diagnosed with cancer each year, and the rate of childhood cancer is slowly rising; cancer cases increased to 177 per million in 2019 from 165 per million in 2003. Recently, Theriva Biologics (AMEX: TOVX), the clinical-stage immuno-oncology company developing therapies for difficult-to-treat cancers, was granted Rare Pediatric Drug Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for VCN-01 for the treatment of retinoblastoma; the most common type of eye cancer in children. Retinoblastoma Presents Significant Treatment Challenges Retinoblastoma is a tumor that originates in the retina and accounts for approximately 2% of all childhood cancers. Some 200 to 300 children are diagnosed each year in the U.S., and the cancer is most common among infants and young children. The average age of a child when diagnosed is two years of age. Approximately three out of four children with retinoblastoma have a tumor in only one eye (known as unilateral retinoblastoma). When both eyes are affected it is known as bilateral retinoblastoma. Although the chances of developing retinoblastoma are statistically low, the challenge of preserving life while preventing the loss of an eye, blindness, and other severe consequences that diminish both lifespan and quality of life remains significant. Furthermore, in low-resource countries, children with retinoblastoma face a higher risk of losing their eyes and succumbing to metastatic disease. Recently, market research and industry consulting firm Spherical Insights assessed the global retinoblastoma treatment market size to be $2.5 billion in 2023; and it is expected to grow to $3.8 billion by 2033. Rare Pediatric Drug Designation For VCN-01 As the name suggests, the Rare Pediatric Drug Designation is a special status given to drugs explicitly developed for treating rare diseases that affect children. This designation is part of a broader effort to encourage the development of medications for conditions not commonly addressed due to the small number of patients, particularly in the pediatric population. For Theriva Biologics, this designation comes with a key incentive: if a Biologics License Application for VCN-01 for the treatment of retinoblastoma is approved by the FDA, Theriva says it may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed to receive a priority review for any subsequent marketing application or may be transferred or sold. PRVs have previously been sold by different companies for around $100M. “The FDA’s decision to grant rare pediatric drug designation to VCN-01 highlights the urgent need for new treatment options for pediatric patients with retinoblastoma. We are encouraged by this important step forward and, in parallel, continue to work closely with leading physicians and regulatory agencies to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma,” said Steven A. Shallcross, CEO of Theriva Biologics. “Most recently, results from the investigator-sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma were determined to be positive by the study Monitoring Committee. Data from this study will further inform our clinical development pathway in this area of high unmet need,” he said. With VCN-01 receiving RPDD from the U.S. FDA, this milestone speaks to the drug's efficacy and long-run potential. As such, the social benefit that Theriva Biologics provides could continue to grow and have increased industry resonance. Featured photo by Ani Kolleshi 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

August 26, 2024 08:45 AM Eastern Daylight Time

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Poster Presentations, Upcoming Human Trials, Recently Secured Funding And More: Glucotrack’s Plans To Transform The Continuous Glucose Monitoring Market

Benzinga

By Meg Flippin, Benzinga Managing diabetes has gotten an overhaul thanks to continuous glucose monitoring devices (CGM). Glucotrack Inc. (NASDAQ: GCTK), the Rutherford, New Jersey medical technology company that makes a continuous blood glucose monitoring (CBGM) device, is seeking to position itself to transform the glucose monitoring market. It is doing so through what it says is a game-changing medical technology that overcomes the challenges of the existing devices on the market, including the lack of real-time accuracy, the need for frequent sensor changes and concerns regarding comfort and wearability. Glucotrack’s implantable Continuous Blood Glucose Monitor (CBGM) measures glucose in the blood, something no other known competitor is offering to date. By measuring glucose in the blood instead of glucose in interstitial fluids – which is what most other devices measure – users get an accurate, real-time reading. Plus, Glucotrack’s implant can last up to three years, compared to less than one year for many of the continuous glucose monitoring (CGM) devices on the market. Patients don’t have to worry about sticking an adhesive to their body or be concerned about it falling off during physical activity, whether it's swimming or hot yoga. The CBGM, which also requires minimal calibration, eliminates the hassle and discomfort of a wearable that requires frequent replacement, the company said. Making The Rounds Glucotrack has been busy getting the word out about the potential of its CBGM. In June, it presented two posters at the American Diabetes Association (ADA) 84th Scientific Sessions discussing preclinical animal studies and a sensor longevity simulation modeling for its CBGM. The ADA Scientific Sessions is one of the premier diabetes conferences which provides a platform for the latest advancements in diabetes research, prevention and care. This annual meeting provides researchers and healthcare professionals with the opportunity to share ideas and learn about cutting-edge technologies and breakthroughs in diabetes research and diabetes-related conditions. Glucotrack also presented an emerging science industry poster at the Association of Diabetes Care and Education Specialists annual conference, which took place from Aug. 9 to 12. The poster presented market research data on the acceptance of the company’s CBGM concept among people with type 1 and type 2 diabetes. It highlighted that out of 757 respondents with type 1 and type 2 diabetes using a variety of insulin regimens, there was a positive sentiment towards the CBGM concept, with over 50% of potential users open to adopting the product. In other words, the CBGM concept could be a viable alternative to existing products on the market. PreClinical Trials In The Bag Glucotrack’s data so far seems to back up its claims, including its recent 90-day preclinical study demonstrating the sustained accuracy of its CBGM. The second long-term preclinical study for its CBGM showed a Mean Absolute Relative Difference (MARD) of 4.7% at day 90, which is considered highly accurate for a continuous glucose monitor, reports Glucotrack. MARD is a key metric used to assess the accuracy of glucose monitoring devices, measuring the average difference between the CBGM device’s measurement and a reference measurement, most often obtained via capillary blood glucose. Lower values indicate better performance, said Glucotrack. The company said the 90-day preclinical study, which included a larger number of animal subjects and a longer duration than the initial 60-day study announced earlier this year, further validates the CBGM’s sustained accuracy and performance. “We are again very pleased with the performance of our sensor during a long-term preclinical study and look forward to moving into human clinical trials,” stated Paul Goode, PhD, president and CEO of Glucotrack. “Our CBGM’s ability to continuously measure blood glucose for 3 years with accuracy, minimal calibration and without a wearable device represents a significant advancement in glucose monitoring. We believe this technology has the potential to greatly improve the quality of life for people with diabetes by providing a more convenient and discreet monitoring solution,” he said. Cashing In All of these developments seem to have brought Glucotrack investment money; in July, the company secured $4 million in funding from its leading shareholder to support its upcoming first in-human clinical trial. It also helps the company that it has a deep leadership bench and board with years of experience. Take Goode, for starters. He has decades of experience developing innovative medical technologies in the implantables and glucose monitoring space for big-name medical technology companies, including DexCom Inc. (NASDAQ: DXCM), a global continuous glucose monitoring company. Goode is a named inventor on over 150 issued patents, including over 100 relating to Dexcom’s continuous glucose sensing technology. Meanwhile, Mark Tapsak, Ph.D., VP of Sensor Technology, has held senior positions at diabetes management companies, including as senior scientist at DexCom. Further, the bench just got deeper with the appointment of Andy Balo – a former DexCom executive – to the board. Balo brings decades of regulatory, clinical and quality experience in the medical technology industry. In 2002, he joined DexCom as part of the original executive team where he remained for the next 22 years, playing a key role in shaping the company’s future. During his tenure, he was responsible for numerous glucose monitoring regulatory submissions and clinical trials worldwide, and coordinated quality activities across multiple manufacturing facilities. With a forecasted CAGR of 10.3% over 2024-2034, the continuous glucose monitoring market could be poised to take off, and Glucotrack wants to play a role in expanding options for patients with its technology. With preclinical trials already being in the bag, and human trials up next - the company feels its commitment to that goal is progressing steadily toward fruition. Featured photo by Mykenzie Johnson 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

August 26, 2024 08:30 AM Eastern Daylight Time

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RedHill's Opaganib Shows Diabetes And Obesity Potential With Positive In Vivo Results

Benzinga

By Meg Flippin, Benzinga A potential, previously unexplored pathway for fighting diabetes and obesity-related disorders may have been unveiled by RedHill Biopharma (NASDAQ: RDHL), a specialty biopharmaceutical company, and its partner Apogee Biotechnology Corp., who are busy developing what may be an interesting new approach in the obesity and diabetes market. The company is testing opaganib in a range of metabolic disease models designed to show its potential to prevent and treat type 2 diabetes and other obesity-related diseases and recently received positive in vivo results. The positive results of early trials are good news for RedHill Biopharma given the global obesity-diabetes drug market opportunity is huge, projected to reach $100 billion by 2030. It’s being driven largely by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk’s (NYSE: NVO) Ozempic and Wegovy (semaglutide), Eli Lilly’s (NYSE: LLY) Trulicity (dulaglutide) and Mounjaro (tirzepatide) and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim’s Jardiance (Empagliflozin), reports RedHill. If RedHill is right about opaganib, it could join those ranks. “Sphingolipid metabolism is implicated in insulin resistance, β-cell disruption, adipocyte function, inflammation and immune regulation, vascular complications and energy metabolism – all significant components of obesity, diabetes and their associated complications,” said Charles D. Smith, Ph.D. Founder and CEO of Apogee Biotechnology Corp., Redhill’s partner who led the testing of opaganib for the treatment and prevention of type 2 diabetes and other obesity-related disorders. “Opaganib’s ability to modulate multiple signaling pathways through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells provides a strong rationale for evaluation of opaganib in obesity-related disorders.” Opaganib Slows Weight Gain Earlier this week RedHill announced that in vivo studies conducted by RedHill’s partner, Apogee, yielded positive results. The studies looked at the impact opaganib had on weight gain and glucose tolerance in a high-fat diet (HFD) model. They demonstrated opaganib suppressed HFD-induced body weight gain, loss of glucose tolerance and fat deposition. Additionally, opaganib reduced weight gain and restored glucose tolerance in an already obese HFD model, suggesting its potential for treating, not just preventing, obesity-related disorders, reports RedHill Biopharma. “Sphingolipid metabolism is a key pathway in many diseases, including obesity, but has not been adequately examined as a therapeutic target for human therapy,” said Dr. Mark Levitt, Chief Scientific Officer at RedHill. “Opaganib, which acts as a sphingosine competitor, is the first clinical drug to target three key enzymes in this pathway.” With multiple U.S. government collaborations ongoing, opaganib, RedHill Biopharma’s first-in-class new chemical entity with anti-inflammatory, anti-cancer and antiviral activity, is a host-directed, potentially broad-acting, orally administered small molecule drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection. More Than Fighting Diabetes But it’s not just in fighting diabetes and obesity-related disorders where RedHill is making progress. Adding to its commercialization by RedHill in the U.S., the company just launched Talicia (omeprazole magnesium, amoxicillin and rifabutin) in the United Arab Emirates (UAE) – making it available by prescription to treat adults with Helicobacter pylori ( H. pylori ) infection. Talicia is the first approved low-dose rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori. The commercial launch of Talicia in the UAE triggers RedHill’s eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales. Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In a pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). “As one of the strongest risk factors for gastric cancer, H. pylori is a major public health concern,” said Rick Scruggs, President & Chief Commercial Officer at RedHill. “With 41% of the UAE population infected by H. pylori and the alarming failure rates of clarithromycin-based therapies, there is a significant medical need for a highly effective first-line H. pylori therapy. Our efforts to make Talicia available to patients in more countries continue as we work to explore additional opportunities with existing and potential partners.” From preventing diabetes and obesity-related diseases to fighting H. pylori, RedHill Biopharma seems to be making strides with its key drug compounds. Early testing shows promise, potentially making this a company worth watching. To learn more about RedHill Biopharma’s pipeline, click here. Featured photo by Diana Polekhina 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

August 23, 2024 08:30 AM Eastern Daylight Time

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News Release

Sector Spotlight: Top 4 Basket of Diagnostic Stocks (EXAS, GH, ILMN, LUDG)

LUDG EXAS GH ILMN

Big diagnostic companies soared during the pandemic thanks in part to mandated government testing, but once the at-home kits arrived and insurance companies were forced to foot the bill, diagnostic companies with COVID-19 revenues collapsed. Many diagnostic companies got caught in the downdraft because they thought the testing gravy train was going to continue and ramped up capacity instead of diversifying. The opportunity in the sector comes from diagnostic companies that chose to reinvent themselves by developing early cancer screening tests. During the pandemic, regular cancer screenings were put off to conserve medical resources toward COVID. Since the pandemic is over, it's worth reexamining beat-up diagnostic companies that were able to adapt and are now on the upswing. The top diagnostic stock to put on your radar is Exact Sciences (NASDAQ: EXAS). Most investors will recognize their at-home cancer screening kit is called cologuard which tests for colon cancer. Those primetime commercials you’ve likely heard mean they’ve established their brand along with a national audience. Testing volume dropped measurably during the pandemic as early cancer screening was pushed aside, but now their testing volumes are ramping back up and helping chew through the testing backlog created by the pandemic. It has taken a couple of years for EXAS testing volumes to return to pre-pandemic levels. In Q2 2024 the company had a record 1.0 million screenings and got back on its growth trajectory, helped by an expansion of cancer indications that include breast, prostate, and colon cancer. It also started its pipeline expansion into precision oncology. EXAS also made a move into a blood-based multi-cancer space when they purchased Thrive Early Detection Corp. for $2.15 billion. This purchase turned into a business vertical that not only does a deeper dive into the hereditary nature of the cancer but also profiles the tumor in such a way that it assists in the optimization of treatment regimens. The company has $2.6 billion in trailing revenues and a current market cap of $10.3 billion and is an overall leader in the diagnostic sector with solid earnings and a balance sheet for risk averse shareholders looking for a solid return from a company that consistently beats expectations. Guardant Health Inc. (NASDAQ: GH) has the first FDA-approved primary screening blood test for colorectal cancer (CRC). The test is called Shield and it is covered under the Medicare reimbursement program. Shield has a sensitivity of 83% and a 90% specificity (false positives) for advanced neoplasia (polyps that could turn cancerous). The company has $600 million in trailing revenues and a current market cap of $4.0 billion. They call it a non-invasive test, but you still have to get pricked. Another way to play the diagnostic market is to look at the top industry suppliers. llumina Inc. (NASDAQ: ILMN) is a medtech company that makes genetic testing equipment that enables the large-scale analysis of genetic variations. The company manufactures next-generation sequencing (NGS) platforms, microarrays, and bioinformatics software. Their machines are used in genomics research, clinical applications, and molecular diagnostics, which means their customers are research centers, pharma companies, academic institutions, and clinical research organizations. The company recently spun off their diagnostics business called Grail Inc. (NASDAQ: GRAL) which is an early cancer screening company for people that are not symptomatic, enabling a proactive approach to diagnosing cancer earlier. ILMN funded GRAL with a one-time cash payment of $923 million. The company's leading product is a multi-cancer early detection blood test called Galleri. The test screens for 50+ types of cancer by reading the DNA sequence. The backbone of the testing technology is from the Illumina platform and over 20,000 participants in large clinical trial studies. The test kits cost around $1100 each, and they are awaiting FDA approval for the test. Investors looking for a little more alpha should look at this diagnostic testing company disruptor and its game changing technology. Ludwig Enterprises Inc. (OTCMKTS: LUDG) is an exceptional OTC company in the diagnostic screening sector, boasting mRNA testing technology that has the potential to revolutionize the multibillion-dollar diagnostic screening industry with its less invasive tests. CEO Marvin S. Hausman MD stated, “mRNA is the language that interprets DNA and is the future of medicine.” Although the company currently has no revenue, it is gearing up for an exciting product launch in October, coinciding with Breast Cancer Awareness Month, which is expected to kickstart its revenue stream. To spearhead its viral marketing campaign, the company has enlisted a seasoned veteran. LUDG’s Lab Developed Test (LDT) will initially target breast cancer screening, but the technology can be easily adapted to other inflammatory-driven cancers. These LDTs are processed at the Genetics Institute of America, a CLIA lab, which allows for quicker product launches as they do not require FDA approval. The company has developed a unique cancer screening approach by measuring mRNA at the nucleotide level. Their test uses AI algorithms to create a personalized inflammatory index, comparing it to a database of over 3,200 mRNA samples collected from 40+ clinical centers over five years. This method, particularly for breast cancer, boasts a 97% test sensitivity, indicating when further evaluation is needed. The LUDG test kits will cost $249 and will follow proven successful direct-to-consumer viral marketing strategies driven by targeted machine learning algorithmic technologies. The CEO of LUDG Hausman has come out of retirement to lead this technology to commercialization. He is a Medical Doctor, Immunologist, and board certified Urological Surgeon. Investors in LUDG will have an experienced CEO at the helm with a proven track record of successful exits. One of his most notable exits was when he sold his NYSE company Medco Research to King Pharmaceuticals, which was ultimately acquired by Pfizer (NYSE: PFE). LUDG’s Revealia breast cancer test is very much like the EXAS Cologuard test. As investors move back into diagnostic stocks, these 4 represent a diversified basket every investor should put on their radar. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated to assist in the production and distribution of content related to LUDG. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Inc Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website http://razorpitch.com

August 23, 2024 06:00 AM Eastern Daylight Time

Navigate your Investment Roadmap with Select Sector SPDR ETFs

Select Sector SPDR

In an era where market dynamics shift as swiftly as the winds, Select Sector SPDR ETFs remain a beacon for investors aiming to harness the potential of sector-specific investments. Tailored to meet the diverse needs of both individual and institutional investors, these ETFs chart a course for strategic portfolio management by distilling the vast S&P 500 into accessible segments. Focused Investment Across Diverse Sectors Select Sector SPDR ETFs stand out by offering a focused approach to investing, breaking down the broad landscape of the S&P 500 into key sectors. This segmentation allows investors to pinpoint their investments according to specific economic areas, aligning their portfolios with their investment goals, risk assessments, and market perspectives. Below is a glimpse into the diverse holdings that form the core of the Select Sector SPDR ETFs: Communication Services Select Sector SPDR Fund (XLC): Zooms in on the telecommunications and media sectors, capturing the pulse of digital communication. Consumer Discretionary Select Sector SPDR Fund (XLY): Targets the vibrant consumer goods and services sector, from retail giants to entertainment behemoths. Consumer Staples Select Sector SPDR Fund (XLP): Focuses on essential consumer goods and services, providing stability in fluctuating markets. Energy Select Sector SPDR Fund (XLE): Powers through with a dedicated look at the energy sector, from fossil fuels to renewable resources. Financials Select Sector SPDR Fund (XLF): Encompasses the robust banking, investment, and insurance industries, the backbone of economic infrastructure. Health Care Select Sector SPDR Fund (XLV): Centers on the pharmaceuticals, healthcare equipment, and services sectors, addressing global health needs. Industrials Select Sector SPDR Fund (XLI): Broadens the horizon with manufacturing, construction, and logistics firms. Materials Select Sector SPDR Fund (XLB): Covers the foundational chemicals, construction materials, and packaging industries. Real Estate Select Sector SPDR Fund (XLRE): Opens doors to commercial real estate services and REITs. Technology Select Sector SPDR Fund (XLK): Accelerates into the information technology and electronics sectors, powering innovation and connectivity. Utilities Select Sector SPDR Fund (XLU): Illuminates the path with utility companies, ensuring the flow of essential services. A Path for Strategic Investment By offering a lens through which to invest in specific sectors, Select Sector SPDR ETFs enable investors to steer their portfolios with confidence and clarity. The ETFs’ commitment to transparency and strategic focus empowers investors to adapt and thrive amidst the ebb and flow of market conditions. In the evolving landscape of the financial markets, Select Sector SPDR ETFs stand as a testament to the power of targeted investment. Through detailed sector analysis and dedicated portfolio exposure, these ETFs offer a distinguished pathway for those seeking to refine their investment strategies with sector-specific allocations. About Select Sector SPDR ETFs Select Sector SPDR ETFs are a series of exchange-traded funds designed to provide investors with an effective way to engage in sector-specific investment strategies. By segmenting the S&P 500 into distinct sectors, Select Sector SPDR ETFs furnish investors with the tools necessary for targeted and strategic investment decisions. DISCLAIMER: This is a work of research and should not be taken as investment or financial advice. Therefore, Select Sector SPDRs or the publisher is not liable for any decision made based on the publication. About the Company: Select Sector SPDR ETFs offer flexibility and customization opportunities. Many investors have similar outlooks, but no two are exactly alike. Select Sector SPDR ETFs let investors select the sectors that best meet their investment goals. DISCLOSURES The S&P 500 Index is an unmanaged index of 500 common stocks that is generally considered representative of the U.S. stock market. The index is heavily weighted toward stocks with large market capitalizations and represents approximately two-thirds of the total market value of all domestic common stocks. The S&P 500 Index figures do not reflect any fees, expenses or taxes. An investor should consider investment objectives, risks, fees and expenses before investing. One may not invest directly in an index. Transparent ETFs provide daily disclosure of portfolio holdings and weightings All ETFs are subject to risk, including loss of principal. Sector ETF products are also subject to sector risk and nondiversification risk, which generally will result in greater price fluctuations than the overall market. Diversification does not eliminate risk. An investor should consider investment objectives, risks, charges and expenses carefully before investing. To obtain a prospectus, which contains this and other information, call 1-866-SECTOR-ETF (732-8673) or visit www.sectorspdrs.com. Read the prospectus carefully before investing. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is distributor for the Select Sector SPDR Trust. Media Contact: Company: Select Sector SPDRs Contact: Dan Dolan* Address: 1290 Broadway, Suite 1000, Denver, CO 80203 Country: United States Email: dan.dolan@sectorspdrs.com Website: https://www.sectorspdrs.com/ *Dan Dolan is a Registered Representative of ALPS Portfolio Solutions Distributor, Inc. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is the distributor for the Select Sector SPDR Trust. SEL007734 EXP 10/31/24 Contact Details Dan Dolan +1 203-935-8103 dan.dolan@sectorspdrs.com Company Website https://www.sectorspdrs.com/

August 22, 2024 05:00 AM Eastern Daylight Time

Continuous Blood Glucose Monitoring Can Materially Improve The Quality Of Life For People With Diabetes – Glucotrack Wants To Make It Easier

Benzinga

By Meg Flippin, Benzinga You can’t wing it when it comes to diabetes. Everything you eat and drink, the amount of physical activity you engage in and the medicines you take must be monitored closely. Keeping your blood glucose level within its target range is vital in preventing other medical issues. But managing diabetes can be cumbersome and intrusive. The main way of tracking glucose in your blood is via a glucose meter which requires you to prick your finger several times a day to get a sample of your blood. These meters provide blood glucose readings – which is considered the most accurate form of glucose monitoring – however testing must be done often and even then users can miss highs and lows in their glucose and the direction in which their glucose is changing. This type of monitoring is also a constant reminder of the disease. A More Modern Approach Continuous glucose monitoring (CGM) offers a better alternative. With it, your glucose level is monitored automatically through a device worn on the body 24 hours a day. It enables you to review your glucose levels to make well-informed decisions and adjust your behavior on a continual basis. These devices also enable people with diabetes to review how their glucose levels change over hours, days, weeks and months. Using a CGM device can help patients better manage glucose levels, reduce the number of low glucose events and decrease or eliminate the number of finger pricks. If your glucose rises or drops beyond a certain threshold, you’ll be alerted. The convenience is a big reason why the market for CGM devices is large and growing. In 2024 it is forecast to hit $16.2 billion and reach $44.6 billion by 2034, growing at a CAGR of 10.3%. Driving the demand is a need among patients to find a more convenient way to manage this chronic disease. After all, life doesn’t have to stop just because you have been diagnosed with diabetes. Diabetes is a disease that's growing in the U.S. and around the globe, impacting people of all ages. The total number of people around the globe who suffer from diabetes is projected to reach 643 million by 2030 and soar to 783 million by 2045. While adults are the most likely to be diagnosed with diabetes, it impacts children as well at a growing rate. Not Every CGM Device Is The Same But when it comes to CGM, not all devices are created equally. The duration that the monitoring lasts, the placement of the device, the type of glucose being tested and how often data is received differ from one manufacturer to the next. Take DexCom Inc. (NASDAQ: DXCM) for starters. Its CGM device consists of sensors worn under the skin that must be reapplied every 10 to 15 days, depending on the system, and which monitor glucose data every five minutes. The results are accurate but they measure interstitial glucose, which can lag 10 to 15 minutes behind blood glucose, so there is a delay versus blood glucose readings. Meanwhile, FreeStyle Libre by Abbott Laboratories (NYSE: ABT) is a CGM device that also monitors glucose from interstitial fluids just underneath the skin rather than glucose in the blood. It uses a sensor that is worn on the back of the arm and measures glucose every minute versus every five minutes. The sensor has to be reapplied every 14 or 15 days, depending on the system. Eversense, a CGM device made by Senseonics Holdings Inc. (NYSE: SENS), is another type that works by implanting a small sensor under your skin, along with a transmitter worn on top of the skin. It measures the glucose in interstitial fluids every five minutes and the sensor works for up to 180 days before it needs to be swapped out. While all these devices are much easier to use than multiple finger pricks a day, they do require some intervention after a period of time and don’t measure glucose in the blood. And, they each require an on-body wearable, so there is the possibility of skin irritation and sensors falling off early or during physical activities like swimming or hot yoga. Additionally, having a wearable on the body reduces the amount of discretion that some people with diabetes desire. A Potentially Better Way Glucotrack, Inc. (NASDAQ: GCTK) is different. The Rutherford, New Jersey, medical technology company focused on the design, development and commercialization of novel technologies for people with diabetes has developed a Continuous Blood Glucose Monitor (CBGM) that aims to overcome the challenges of today’s CGM, including delays due to the interstitial lag, the need for frequent sensor changes and concerns regarding comfort and wearability. Unlike the others on the market, Glucotrack's device measures glucose in the blood. Because Glucotrack’s implantable CBGM measures glucose in the blood, it doesn’t have the lag time associated with subcutaneous sensors that measure glucose in interstitial fluid. The ability to directly measure blood glucose in real-time and on a continuous basis enables a less burdensome approach to glucose monitoring for extended periods of time. Additionally, with no on body wearable, the CBGM offers increased discretion to the user, making it potentially less intrusive to daily living. What’s more, Glucotrack’s implant can last up to three years, compared to months for the other CGM devices on the market. Patients don’t have to worry about sticking an adhesive to their body or be concerned about it falling off during physical activity. And, with minimal calibration required, the CBGM eliminates the hassle and discomfort of a wearable that requires frequent replacement. Monitoring glucose and thus living with diabetes can become easier with Glucotrack. Proof Through Studies Glucotrack has data to back up its claim. It recently completed a second long-term preclinical study for its CBGM device, which showed a Mean Absolute Relative Difference (MARD) of 4.7% at day 90, which is considered highly accurate for a continuous glucose monitor, the company reports. MARD is a key metric used to assess the accuracy of glucose monitoring devices, measuring the average difference between the CBGM device’s measurement and a reference measurement, most often obtained via capillary blood glucose. Lower values indicate better performance, said Glucotrack. The company said the 90-day preclinical study, which included a larger number of animal subjects and a longer duration than the initial 60-day study announced earlier this year, further validates the CBGM sustained accuracy and performance. “We are again very pleased with the performance of our sensor during a long-term preclinical study and look forward to moving into human clinical trials” stated Paul Goode, Ph.D., president and CEO of Glucotrack. “Our CBGM’s ability to continuously measure blood glucose for three years with accuracy, minimal calibration and without a wearable represents a significant advancement in glucose monitoring. We believe this technology has the potential to greatly improve the quality of life for people with diabetes by providing a more convenient and discreet monitoring solution.” The company presented preclinical animal data and longevity data at the 84th Scientific Sessions of the American Diabetes Association (ADA) held Jun. 21-24, 2024 in Orlando, Florida. The company also provided market research data showing acceptability of the CBGM with a large number of people with diabetes at the Association of Diabetes Care and Education Specialists (ADCES) 2024 Annual Conference held Aug. 9-12, 2024, in New Orleans, Louisiana. Diabetes is a chronic disease that’s poised to impact hundreds of millions of people around the globe. Managing the disease today is cumbersome and intrusive, even with the technological advances that the current generation of CGM devices have brought. Glucotrack wants to change that and believes its device is the answer. If preclinical test results are any indication, the company may be on to something that could be life-transforming for people with diabetes. Featured photo by Sweet Life 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

August 21, 2024 08:30 AM Eastern Daylight Time

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