Healthcare

Addiction Biotech Cannabis Genetics Healthcare Medical Devices Pharmaceutical Science Veterinary
News Release Digital Asset Direct

Hope on the Horizon: Results from MAvERIC-Pilot Show Heartfelt Progress for Patients

RazorPitch CRDL

In a phenomenal year marked by over +180% gains in its stock price, Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) added another feather to its cap last week with the announcement of its Phase II MAvERIC-Pilot study topline results. The Canadian biotechnology company has captured investors’ attention this year with significant milestones achieved, including the advancement of two simultaneous Phase II clinical trials, granting of Orphan Drug Designation by the US FDA for its flagship drug CardiolRx™, and most recently, the announcement of positive topline results from their MAvERIC-Pilot study. These achievements further solidify Cardiol Therapeutics' position as a formidable player in the biotech landscape, offering renewed hope to patients suffering from debilitating rare heart conditions. Last week, Cardiol Therapeutics (NASDAQ: CRDL) (TSX: CRDL) reported 8-week clinical data from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis. The study enrolled 27 adult patients with symptomatic recurrent pericarditis at eight clinical sites across the United States, including the prominent Mayo Clinic, Cleveland Clinic, and Massachusetts General Hospital. Each patient had a high burden of disease, as reflected by both a patient-reported pain score averaging 5.8 out of 10 at baseline and the number of previous episodes of pericarditis (9 patients, or 33%, had 2 previous episodes, 9 patients, or 33%, had 3 such episodes, 4 patients, or 15%, had 4 episodes, and 5 patients, or 19%, had more than 4 episodes). The primary endpoint of the Phase II study is the change in patient-reported pericarditis pain at eight weeks, as measured by an 11-point numeric rating scale (NRS) that has been validated and applied in several clinical trials. NRS is commonly used to assess pain severity by using a scale from 0 to 10, where zero is "no pain" and 10 is "the worst pain imaginable.". Secondary endpoints include the NRS score after 26 weeks of treatment and changes in circulating levels of C-reactive protein (CRP). CRP is a commonly used marker of inflammation in patients with cardiovascular disease. MAvERIC-Pilot topline data revealed several key findings: Efficacy in Pain Reduction: Patients treated with CardiolRx™ experienced a significant reduction in the subjectively perceived pain of the pericarditis. The mean pain score dropped from 5.8 at baseline to 2.1 (64%) after eight-weeks of treatment, marking a decrease of 3.7 points on the 11-point NRS. Reduction in Inflammation: Among patients with elevated baseline CRP (≥1 mg/dL), 80% achieved normalization of CRP levels (≤0.5 mg/dL) at the end of the eight-week treatment period. The average CRP levels were reduced from 5.7 mg/dL to 0.3 mg/dL, indicating a substantial reduction in inflammation. Patient Continuation and Safety: A significantly high percentage of patients (89%) have continued into the extension phase of the study, an 18-week treatment period, suggesting that CardiolRx™ is well-tolerated. The study also confirmed that CardiolRx™ was found to be safe and well tolerated, with no significant adverse effects. David Elsley, President & CEO of Cardiol Therapeutics, expressed optimism about the potential of CardiolRx™ as a non-immunosuppressive therapeutic option for pericarditis. Mr. Elsley highlighted the drug’s comparable efficacy to existing biologic therapies used in third-line treatment of recurrent pericarditis: “ We are delighted to share the exceptional primary endpoint data from the MAvERIC-Pilot study, which demonstrated that oral administration of our small molecule CardiolRx™ led to marked reductions in pericarditis pain and inflammation, and remarkably, these reductions are comparable in magnitude to biologic therapy commonly used in third-line treatment of recurrent pericarditis. Based on the clinically meaningful impact of CardiolRx™ on the key symptom of this debilitating disease, we now anticipate that the totality of the MAvERIC-Pilot data will support advancing to a Phase III trial of CardiolRx™ designed to meet our objective of providing an accessible and non-immunosuppressive therapeutic option for thousands of pericarditis patients. ” Recurrent pericarditis, a persistent inflammation of the pericardium – the protective membrane surrounding the heart – often resurfaces following an initial episode, frequently linked to viral infections. This condition is marked by intense chest pain, shortness of breath, and debilitating fatigue, which results in significant physical limitations and a diminished quality of life for patients. With an estimated 38,000 patients in the U.S. experiencing at least one recurrence annually, and many suffering for years, the need for effective treatments is critical. Approximately 60% of patients with multiple recurrences (>1) still suffer for longer than two years, and one third are still impacted at five years. Moreover, the progressive accumulation of pericardial fluid and subsequent scarring can escalate to a life-threatening constriction of the heart, highlighting an urgent need for advancements in medical treatment and patient care protocols. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and primarily used as a third-line intervention. However, CardiolRx™’s tolerability and side effect profile is expected to be much more favourable than the current treatment – which has risks typical of immunosuppressants. The economic burden is notable, with frequent emergency room visits and hospitalizations driving up healthcare costs. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay, and the cost per stay is estimated to range between $20,000 and $30,000 in the United States. Building on the impressive topline results from the MAvERIC-Pilot study, Cardiol Therapeutics is poised to provide patients with an accessible and non-immunosuppressive treatment option for recurrent pericarditis, potentially surpassing existing therapies. These encouraging outcomes set the stage for a forthcoming Phase III trial, aiming to further validate the efficacy and safety of CardiolRx™, as Cardiol Therapeutics progresses towards commercialization. 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 by Cardiol Therapeutics to assist in the production and distribution of content related to CRDL. 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

June 17, 2024 07:00 AM Eastern Daylight Time

Lisata Therapeutics CEO encouraged by progress on pancreatic cancer trial

Lisata Therapeutics Inc

Lisata Therapeutics Inc. CEO David Mazzo talked with Proactive's Stephen Gunnion about the latest milestone in the company's Phase 1b/2a CENDIFOX trial. Mazzo shared that Lisata has completed patient enrollment for the pancreatic cancer cohorts in the phase 1B/2A clinical trial. This investigator-initiated trial, led by Dr Anup Kasi at The University of Kansas Cancer Center, is evaluating the safety and efficacy of certepetide (formerly LSTA1) in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers. Mazzo highlighted that the trial will enbable the collection of pre- and post-treatment biopsies of tumors. He also mentioned ongoing efforts to complete enrollment in two additional cohorts focusing on colorectal cancer and other tumor types, expecting these to be completed by the end of the year. Expressing his optimism, Mazzo noted the encouraging progress and enthusiasm surrounding the trial, which is drawing patients from the Kansas City area despite competition from other studies. He anticipates that preliminary results will be available by the end of the year, pending the timely processing of biopsies by external laboratories. Visit Proactive's YouTube channel for more videos, and don't forget to give the video a like, subscribe to the channel, and enable notifications for future content. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

June 14, 2024 09:19 AM Eastern Daylight Time

Video

Candel Therapeutics' (NASDAQ: CADL) enLIGHTEN Discovery Platform Aims To Tackle Complexities Of Tumor Microenvironments

Candel Therapeutics

By Jeremy Golden, Benzinga Candel Therapeutics, Inc. (NASDAQ: CADL) is helping pioneer the next generation of viral immunotherapy by leveraging a data-driven approach to create new assets and further the development of existing drug candidates. Candel Therapeutics’ enLIGHTEN Discovery Platform integrates artificial intelligence-selected, therapeutic payloads into programmable vectors for delivery into the tumor microenvironment This tailored approach to discovery and development of new therapeutics has been designed to address the complexity of the tumor microenvironment and the diversity of the tumor response to existing treatments. Using large patient datasets, the enLIGHTEN™ Discovery Platform identifies druggable properties that correlate with clinical outcomes and predicts optimal therapeutic payload combinations in silico. Real-world testing of these predicted payload combinations is used to rapidly evaluate their therapeutic effects. Next, validated multigene payloads are integrated into one of Candel’s programmable viral vectors that are engineered with tunable features to address a specific unmet need in cancer treatment. The enLIGHTEN™ immunotherapy candidates represent a novel class of bespoke immunotherapies with each one tailored for a specific indication, disease stage, or rationally designed therapeutic combination therapy. First Experimental Candidate During the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting and the International Oncolytic Virus Conference in November 2023, Candel presented the first experimental immunotherapy candidate from its discovery platform: Alpha 201-macro-1, an investigational,viral immunotherapy designed to activate innate immune surveillance. Preclinical data demonstrated that programmable, vector-mediated delivery of a novel gene payload designed to interfere with the CD47/SIRPα pathway significantly impede tumor growth when compared to systemic anti-CD47 antibody therapy in a mouse model of breast cancer. Soon afterwards, at the American Association for Cancer Research (AACR) Annual Meeting in April 2024, the company presented late-breaking data from its second immunotherapy candidate based on this platform: a therapeutic able to induce organized lymphocyte aggregates that resemble tertiary lymphoid structures (TLS) within solid tumors. Formation of TLS in tumors correlates with a positive response to immune checkpoint inhibitors and better prognosis. To date, there has not been any drug able to induce therapeutic TLS formation in cancer. The effects of Candel’s new immunotherapy candidate are based on two mechanisms. First, profiling of the biological response to the enLIGHTEN™ programmable vector demonstrated its potential to orchestrate changes in the tumor microenvironment, which bolster effective anti-tumor immune responses to immune checkpoint inhibitor treatment. Second, delivery of two unique payload combinations using this programmable vector resulted in TLS formation associated with monotherapy anti-tumor activity, and enhanced responses in combination with immune checkpoint inhibitor treatment in mouse models of solid tumors. Combining the immunological and oncolytic effects mediated by the viral vector with the biological activity of the transgene payloads results in a unique multimodal therapeutic able to induce the formation of TLS and inhibit the tumor. “With the enLIGHTEN Discovery Platform, we are leveraging our internal expertise and capabilities to design a new class of multimodal therapeutics that can overcome mechanisms of resistance present in the tumor microenvironment and address critical unmet needs for patients with cancer,” said Francesca Barone, M.D. Ph.D., CSO at Candel Therapeutics. “This platform has been designed for collaborations focused on rational combination therapies to induce disease remission in cancer. ” More exciting developments are on the horizon. Candel Therapeutics and the University of Pennsylvania are collaborating in a discovery partnership that will leverage enLIGHTEN™ programmable vectors with therapeutic payloads to potentially overcome barriers to Chimeric antigen receptor (CAR) T-cell therapies. Through the partnership, the University of Pennsylvania researchers – led by the Director of the T-Cell Engineering Lab within Penn’s Center for Cellular Immunotherapies, Neil C. Sheppard, Ph.D. – will explore the ability of Candel’s novel viral immunotherapies to enhance the effects of the university’s CAR T-cell therapies in solid tumor models. Featured photo by National Cancer Institute on Unsplash Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in non-small cell lung cancer (NSCLC) (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent high-grade glioma (HGG). Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. This article includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including the timing and availability of additional data, key data readout milestones, including CAN-3110 in HGG; expectations regarding the potential benefits conferred by Fast Track Designation; expectations regarding the therapeutic benefit of its programs, including the potential for its programs to extend patient survival; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Aljanae Reynolds +1 617-916-5445 areynolds@wheelhouselsa.com Company Website https://www.candeltx.com/

June 14, 2024 08:30 AM Eastern Daylight Time

Image

Roberts & Ryan Inc. expands its internship program in partnership with the Boys and Girls Club of Harlem.

Roberts & Ryan, Inc.

Roberts & Ryan, Inc., America’s first Service-Disabled Veteran-Owned (SDVO) broker-dealer, announced the expansion of its summer internship program, which recently accepted 13 candidates from a diverse pool of students from a variety of schools and backgrounds. The expansion reflects the company’s commitment to supporting veterans and underprivileged youth. “At Roberts & Ryan, we believe that supporting future generations of financial professionals is important to the long-term success of our industry. This year’s internship class was bolstered by our relationship with the Boys & Girls Club of Harlem, who recommended two exceptional candidates, creating more opportunities for diverse talent in the financial services industry,” said Brian Rathjen, President of Roberts & Ryan. Seven interns completed Roberts & Ryan's internship program in 2023, a number the firm nearly doubled in 2024 due to increased student demand. Roberts & Ryan runs two internship cohorts per year to provide students from a variety of backgrounds with real-world experience in the financial services industry. Interns collaborate with experienced professionals on projects that demonstrate a range of services provided by Roberts & Ryan, from secondary equity and fixed income trading to debt and equity capital markets, business development, compliance, and marketing. Roberts & Ryan was recently approved for membership by the New York Stock Exchange, and summer interns have access to its iconic trading floor. "Breaking into the financial services industry can be a challenge, as most entry-level positions require either previous work experience or a professional connection with someone in the industry. We believe that our program provides our interns with both,” said Edward D’Alessandro, Chief Executive Officer of Roberts & Ryan. Roberts & Ryan is committed to increasing access to opportunities in the financial sector by finding high-quality candidates for their internship program. Through the program, interns gain valuable experience, make important connections, and build a talent stack for a successful career in finance. For current undergraduate and graduate students interested in participating in next year’s internship program, please email your resume to info@roberts-ryan.com. About Roberts and Ryan, Inc. Roberts & Ryan, Inc. is a Service-Disabled Veteran Owned (SDVO) broker-dealer with execution capabilities in the capital markets, equities, and fixed-income trading. The firm was founded in 1987 by a United States Marine Corps Vietnam combat veteran and Purple Heart recipient. With over $2 million in committed donations, Roberts & Ryan is active in donating to charitable foundations that make significant positive impacts in the lives of Veterans and their families, primarily focusing on general wellness, mental health, and career transition. To learn more about Roberts & Ryan, please visit www.roberts-ryan.com. Contact Details Michael C. Del Priore +1 646-859-4061 mdelpriore@roberts-ryan.com Company Website https://www.roberts-ryan.com

June 13, 2024 09:00 AM Eastern Daylight Time

Image

Colorectal Cancer Survival Rate After 5 Years Is 90% With Early Detection, Yet Testing Is Inaccessible For Many – Mainz Biomed Wants To Change That

Benzinga

By Meg Flippin, Benzinga Colorectal cancer is a leading cause of death in America, killing 50,000 people each year. But if it's caught early, the survival rate after five years is 90%. Despite those favorable odds, only about four in 10 colorectal cancers are spotted at the early stage. There are several reasons why more people aren’t getting screened for this devastating cancer. Some aren’t aware that regular testing can save their lives, many can’t afford it, while others don’t have access. Colonoscopies done at ten-year intervals and occult blood tests (FITS) performed annually or biannually are the two forms of screenings, but both have disadvantages. Colonoscopies, while very precise, involve an unpleasant procedure and lengthy intestinal cleansing. Occult blood tests are more widely accepted, but they can only provide indirect evidence of disease and often only in later, bleeding stages. https://youtu.be/VOPm4wZMj2k Advanced Screening Equals Early Detection To be effective, cancer screening has to be simple, readily available and affordable, which is where Mainz Biomed (NASDAQ: MYNZ) comes in. The molecular genetics diagnostic company specializing in the early detection of cancer is revolutionizing the colorectal cancer testing industry with ColoAlert, its flagship product. ColoAlert is an early detection screening that spots bleeding and non-bleeding tumors through tumor DNA analysis, offering what the company says is better early detection than fecal occult blood tests. That’s important since almost all colorectal cancers develop from polyps that grow over time. The longer the polyps are present, the higher the risk of them becoming cancerous, which is why early screening has the potential to dramatically impact treatment and prevention. Colorectal cancer originates from the genetic mutation of intestinal cells. These are continuously excreted through the stool and can be examined for tumor DNA using modern genetic diagnostic methods. ColoAlert analyzes samples for the four tumor markers associated with cancer: KRAS-mutation, BRAF-mutation, total amount of human DNA and occult blood. That’s something competing at-home screenings can’t claim to do. By analyzing tumor DNA, Mainz says ColoAlert detects 85% of colorectal cancer cases – often in the very early stages of the disease. That is a key differentiator, given the company says 71% of the diagnoses made are in the later stages of the disease. Market Opportunity Is Broad If ColoAlert proves to be game-changing in terms of getting more people to screen for colorectal cancer, it's a big opportunity for Mainz. As it stands, 37 million people in the U.S. get screened for rectal cancer each year. That could increase to 52 million per year within ten years as the population ages. In the United States there are 112 million people over 50, which is expected to increase to 157 million in the next decade. Of the U.S. population between 50 and 75, about 40% have never been screened. While the common practice is to start the screening at 50, the Food and Drug Administration says screening should start at age 45 and be conducted every three years. If that guidance is followed, it presents an even bigger opportunity for ColoAlert. All told, Mainz pegs the U.S. opportunity at $4 billion and the European market opportunity at $6 billion. ColoAlert is already proving to be more accurate than rivals’ at-home tests, which should drive adoption rates and help Mainz Biomed achieve its goals. A recent multicentric study of 566 patients simultaneously using the occult blood test, M2-PK test and ColoAlert, found ColoAlert, with a sensitivity of 85% and a specificity of 92%, was the most accurate test result among the non-invasive screening methods. The company plans to engage in further testing to validate the effectiveness of its screening over what’s already available in the market. “Combined DNA stool assay represents a reliable assay for detecting colorectal cancer, sufficient to be recommended as a supplement to colonoscopy screening,” the study researchers reported. Making It Easy On top of being accurate, ColoAlert is easy to use, which could be a big driver of adoption. Within five minutes, the sample is collected and packaged and on the way to the lab. Patients receive a kit in the mail that includes instructions, a stool collector and a shipping label to return the kit to their local lab for testing. Patients receive the results in a few days. Unlike the rival ColoGuard, Mainz says ColoAlert requires very small samples to test, which is one of the reasons the company boasts 98% patient satisfaction. Colorectal cancer is the third most commonly diagnosed cancer and a leading cause of cancer death globally, but it doesn’t have to be. Early detection means all the difference, yet far too many people don’t get screened each year. Mainz is hoping ColoAlert will change that, helping to lower incidents of this and other gastrointestinal cancers. To learn more about ColoAlert and the science behind it, click here. Featured photo by National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

June 13, 2024 08:45 AM Eastern Daylight Time

Image

Discover How This Company's Breakthrough Technology Might Be The Key To Transforming Pancreatic Cancer Pain Relief

Benzinga

By Austin DeNoce, Benzinga Pancreatic cancer is notorious for its high mortality rate but also for the severe pain it inflicts on patients. This pain often manifests as significant abdominal and back pain, making it difficult for patients to comfortably sit or lie on their back. The debilitating nature of this pain severely impacts the quality of life of those affected, and it can be particularly challenging to manage. As such, it is a condition primed for innovative solutions to help patients. Pancreatic Pain Management Strategies The pain associated with pancreatic cancer is primarily due to the tumor's proximity to critical nerves and blood vessels. As the tumor grows, it can compress these nerves, leading to intense pain that is challenging to manage. Patients frequently experience persistent and severe abdominal and back pain that can significantly restrict their daily activities and mobility. Emotional distress, anxiety and depression often accompany chronic pain, affecting both patients and their caregivers. The current strategies for managing pancreatic cancer pain are limited and often ineffective. Pain medications, such as opioids, are commonly prescribed but come with significant side effects like constipation, drowsiness and the risk of addiction. Additionally, these medications may lose their effectiveness over time, leading to increased tolerance and necessitating higher doses. Meanwhile, nerve blocks and ablation techniques, while potentially effective, often lack precision and can cause unintended side effects by missing target nerves and damaging surrounding tissues. This imprecision stems from the inability of other technologies to accurately detect weak electrical signals from the peripheral nervous system. However, Autonomix’s catheter-based technology uses a microchip and antenna to precisely detect nerves, which allows for a safe and accurate pain treatment. Approximately 70% to 80% of patients with pancreatic cancer experience pain, with around 44% reporting severe pain as the disease progresses. Breakthrough pain, which occurs despite ongoing pain management, has a high prevalence of 33%-95%, with 50% to 90% of all hospitalized patients experiencing it – further complicating treatment. This unrelenting pain significantly impacts the patient's quality of life, contributing to both physical and emotional distress that demands better management strategies. Autonomix's Approach to Pancreatic Cancer Pain Autonomix Medical (NASDAQ: AMIX) is a medical device company pioneering a groundbreaking technology to revolutionize the diagnosis and treatment of diseases and disorders related to the autonomic nervous system. Their first-in-class technology platform features a catheter-based microchip sensing array that can detect and differentiate neural signals with remarkable sensitivity, up to 3,000 times greater than currently available technologies, according to the company. This innovative technology allows the company to sense the overactive nerves which lead to the intense pain caused by pancreatic cancer. Then Autonomix is able to ablate, or kill, those overactive nerves, effectively turning off the pain signal. By providing a more accurate and targeted approach, Autonomix aims to improve the quality of life for patients suffering from pancreatic cancer pain. First-In-Human Pilot Studies Autonomix recently commenced its first in-human pilot study in pancreatic cancer pain. This marks the first trial ever to evaluate radiofrequency (RF) ablation using a transvascular approach to reduce pain associated with pancreatic cancer. The study involves 25 subjects at a single clinical site, aiming to assess the ablation of relevant nerves and subsequent pain mitigation. Autonomix announced it will release preliminary results from the first five “lead-in” patients in the study on Tuesday, June 18, 2024 and management will host a live webcast at 8:30 AM ET to discuss the results. Click here to register for the webcast. A New Dawn in Pain Management Pancreatic cancer pain is a significant and challenging issue that severely impacts patients' quality of life. Current pain management strategies are often inadequate, underscoring the need for innovative solutions. Autonomix's technology offers a promising alternative, with the potential to provide precise and effective pain relief for patients suffering from pancreatic cancer pain. By targeting a smaller market initially, Autonomix aims to prove the effectiveness of its technology, paving the way for broader applications in the future across conditions where pain is a key symptom. Featured photo by National Cancer Institute 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

June 13, 2024 08:30 AM Eastern Daylight Time

Image

Stupid Cancer Announces CancerCon Live 2024 in Austin, Texas

Stupid Cancer

Stupid Cancer, the leading nonprofit organization dedicated to empowering everyone affected by adolescent and young adult (AYA) cancer, is thrilled to announce that CancerCon Live 2024 will take place in Austin, Texas for the first time ever. This landmark event, scheduled for August 15 - 18, 2024 at the Hyatt Regency Austin, promises to bring together hundreds of young adult cancer patients, survivors, caregivers, and advocates from across the country to share their experiences, gain valuable insights/resources, and build lasting connections. “We look forward to creating an unforgettable experience that empowers young adults affected by cancer and helps them connect with others who truly understand their journey.” says Alison Silberman, CEO of Stupid Cancer. CancerCon Live is the premier annual gathering for the AYA cancer community, offering a unique blend of education, support, and empowerment. This year's event in Austin will feature: Keynote Speakers: Hear from leading voices in the AYA cancer community, including survivors, healthcare professionals, and advocates, sharing their stories and insights on topics ranging from advancements in cancer treatment to survivorship challenges. Workshops and Panels: Participate in interactive sessions on a wide range of topics tailored to the unique needs of AYA cancer patients, survivors, and caregivers, covering mental health, fertility preservation, advocacy, career development, and more. Meet the AYA Community: Dedicated time for attendees to connect with peers, build lasting friendships, and expand their support networks in a supportive and inclusive environment. Exhibit Hall: Explore resources, products, and services from leading organizations committed to supporting the AYA cancer community as well as a few local small businesses. Social Events: Enjoy fun and engaging social activities designed to foster connections and create memorable experiences with some local Austin flavor. Local excursions: Attendees will have the opportunity to explore the city’s unique attractions, including Bat Watching under Congress Bridge and unlimited Skee-Ball at Full Circle Bar, to name a few, all while engaging in meaningful activities that support their personal and collective growth. “Austin’s dynamic and inclusive culture aligns perfectly with our mission to build a strong, supportive community for AYA cancer patients and survivors. We look forward to welcoming everyone to what promises to be our most impactful CancerCon yet,” says Eddie Mouradian, Director of Development. For over a decade, Stupid Cancer has brought together hundreds of patients, survivors, caregivers, advocates, and health professionals at the largest gathering of the AYA community - CancerCon (R). Now gathering both online and off, every CancerCon event is an immersive experience, led by transformative connection and education. The majority of conference attendees are AYA (age 15-39) cancer patients and survivors, but caregivers and health professionals of all ages are also welcome. CancerCon Live is hosted in a different US city each year as we seek to make the event always be within reach of our community at all times. Registration for CancerCon Live 2024 is now open. To register or learn more about the event, please visit cancercon.org. About Stupid Cancer Stupid Cancer’s mission is to help empower everyone affected by adolescent and young adult cancer by ending isolation and building community. Through innovative programming and strategic communications, the organization aims to provide support, resources, education, and a sense of community both online and in-person. For more information, please visit stupidcancer.org. For media inquires, contact: media@stupidcancer.org About Stupid Cancer:Stupid Cancer's mission is to help empower everyone in the adolescent and young adult (AYA) community by ending isolation and building community. Contact Details Alison Silberman +1 646-868-0087 media@stupidcancer.org Company Website https://stupidcancer.org/

June 12, 2024 02:39 PM Eastern Daylight Time

Image

AmeriLife’s HIPE Financial Welcomes Legacy Senior Benefit to Amplify Value Within the Final Expense Marketplace

AmeriLife

HIPE Financial, an ORCA Life company and an affiliate of AmeriLife Group, LLC (“AmeriLife), announced today that it has partnered with Legacy Senior Benefit, a Kentucky-based final expense-specific insurance company with distribution networks throughout the southern U.S. Per the agreement, the terms of the deal were not disclosed. “HIPE is focused on high performance, and we are thrilled to welcome Legacy Senior Benefit to our team,” said David and Lindsey Curry, principals of HIPE Financial. “The final expense market offers significant growth potential, especially given the power of our distribution channels with ORCA Life and AmeriLife. We look forward to continuing consumer awareness, customization, and value-added services for people looking to secure end-of-life expenses.” In 2016, ORCA Life entered the final expense market to address a significant gap by adopting a unique personal and in-home service approach. Since then, this strategy has set ORCA Life and its companies, such as HIPE Financial, apart, enabling its agents to develop deeper connections with their clients and enhance their support to seniors for their end-of-life insurance needs. “David and Lindsey continue to push the bar higher, strengthening our distribution and working to accelerate both business and producer success,” said Glenn Crabtree, founder and president of ORCA Life. “Our partnership with Legacy Senior Benefit is no different. Powered by a servant-leadership approach and value-based service offering, this collaboration has all the hallmarks of high performance, client trust, and care as we continue to achieve industry excellence as a final expense market leader.” Legacy Senior Benefit’s network of agents will continue under the leadership of owner and founder Corey Price. “Legacy Senior Benefit was built through a network of close friends and family,” said Price. “With a solid network of trusted agents, and now powered by one of the strongest distribution channels in the industry, we are ready for this next chapter of growth as we continue to serve our customers with end-of-life planning with trust and dignity.” AmeriLife’s distribution platform offers partners a best-in-class business culture that boasts efficiency, value, and access to professional marketing services to increase productivity and bottom-line revenue. This is particularly beneficial in the final expense sector, where consumers look to provide peace of mind and tailored financial security solutions to meet their end-of-life expenses. “We are thrilled to see our partnership with ORCA Life and HIPE flourish with the addition of Legacy Senior Benefit,” said Scotty Elliott, Chief Distribution Officer of Health for AmeriLife. “This collaboration will expand our holistic distribution capabilities and enhance our ability to serve our beneficiaries more effectively and set new standards in the industry.” ### About ORCA Life ORCA Life’s roots go back to the late ‘90s. Over the last two decades, it has expanded its footprint through grassroots marketing. The company was officially founded in 2016 to fill a glaring void in the final expense industry. It emphasizes an in-home, face-to-face service model, allowing its agents to cultivate meaningful relationships with their clients and better support seniors’ insurance needs for their final days. Today, ORCA Life boasts a growing roster of writing agents throughout and beyond the Midwest and Southeast. We continue to set the standards for client trust, care, and excellence, helping it achieve industry recognition as a final expense market leader. For more information, visit ORCA Life. About HIPE Financial Lindsey and David Curry are dynamic and dedicated to service. Their journey as successful entrepreneurs has led to the foundation of HIPE Financial, which is focused on high performance. Whether the senior market has life, health, and wealth or young professionals seek their next level of performance, HIPE is focused on the solution. For more information, visit HIPE Financial. 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 served through a distribution network of over 300,000 insurance agents and 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 Media Jeff Maldonado media@amerilife.com Partnership Inquiries Patrick Nichols corporatedevelopment@amerilife.com Company Website https://amerilife.com/

June 12, 2024 09:00 AM Eastern Daylight Time

Therma Bright’s Investment Case Just Got Stronger As Approval On Permanent Insurance Codes Gets Closer

TBRIF

Therma Bright (TSXV:THRM) (OTCQB:TBRIF), a developer of a wide range of leading edge, proprietary diagnostic and medical device technologies that address some of today's most important medical and healthcare challenges, appears to be positioned for major growth based on one important upcoming catalyst. For some background, Therma Bright (TSXV:THRM) (OTCQB:TBRIF) sells Venowave, a compact, battery operated peristaltic pump that generates a wave-form motion. When worn below the knee and strapped to the calf, the resulting compression of the calf causes an increased upward volumetric displacement of venous and lymph fluid. The Venowave is FDA approved for 10 indications, including: Management of Post Thrombotic Syndrome, Prevention of Deep Vein Thrombosis (DVT / blood clots), treatment of Chronic Venous Insufficiency, as well as other conditions related to poor circulation in the extremities.It seems that the company is set to receive a newly issued, HCPCS Level II code to identify it’s Venowave device,which will be instrumental in driving revenue growth. HCPCS codes are a set of health care procedure codes used in the United States to standardize the reporting of medical procedures, services and devices. These codes are essential for billing and reimbursement purposes within the Medicare and Medicaid programs, and are also used by other healthcare insurers in the United States, including private insurance companies. Additionally, a preliminary Medicare Payment determination will be made for this new HCPCS code. If the Venowave is purchased outright, Medicare and Medicaid will reimburse $1,199 USD. If the unit is rented to the patient, Medicare and Medicaid will pay $78.05 USD / month for up to 13 months, for a total of $819.55 USD. These are very favourable numbers for Therma Bright when taking into account the manufacturing cost of Venowave. Additionally, private insurers such as blue cross blue shield, UnitedHealth Group, etc., also use these codes as guidelines to determine reimbursement payouts. Why is this so important? Previously, Venowave was placed into the E0676 HCPCS code. E0676 is a miscellaneous code with no set reimbursement, meaning that when Venowave is billed for under this code, Medicare and Medicaid, as well as private insurance companies will default to a $0 reimbursement. While it is possible to submit a package of medical necessity under this code, with a detailed explanation of the patients’ condition and why it should be reimbursed, the reality is that most physicians or prescribing parties will not go through this exercise as they are not reimbursed for the time and trouble it takes. Therma Bright experienced a similar situation with the temporary codes it was approved to sell Venowave under in 2023 – Without the prescribing party submitting a package of medical necessity, Venowave by default will not be paid for. Additionally, these reimbursement issues are a barrier to prescribing parties recommending Venowave, as they are not able to tell their patients if the device will be paid for. Physicians tend to shy away from prescribing devices in these categories, as they could leave their patient with a large unexpected medical bill, reflecting badly on the prescribing party. This new HCPCS code combined with the preliminary payment determination establishes a fixed payout for Venowave across public and private insurers in the United States, eliminating friction in payments as well as hesitancy by the prescribing parties in recommending the device. Therma Bright expects to receive this new HCPCS code and payment determination after the biannual CMS meeting which was held at the end of May, 2024. Venowave differentiates itself from other available compression products in a number of ways. Currently, pneumatic devices and simple products that squeeze the leg make up the majority of the compression market. Inexpensive portable compression devices simply squeeze and release the calf, and do not actively move fluid upwards towards the heart. Sequential compression devices are proven very effective, however they are not portable. Sequential compression devices have tubes attached to an air compressor which inflates chambers in sequence, providing sequential compression. Typically these devices can only be used while lying in bed, on a couch or in a similar position, and do not allow the patient to remain ambulatory. Venowave combines the best of both worlds, providing sequential compression without the use of tubes or wires, allowing the patient to remain completely ambulatory while receiving treatment. Additionally, Venowave is quiet, so patients can continue to receive treatment while they are sleeping or otherwise resting. Currently in the United States an estimated 25 million people are living with some form of Chronic Venous insufficiency. Most go untreated or rely on simple compression stockings for some form of minor relief, as proper treatment via sequential compression devices is too cumbersome and expensive. The issuance of this new HCPCS code and payment determination opens up these patients to the Venowave, a new and portable form of treatment that will not cost them anything out of pocket. This market alone, along with the management of Post Thrombotic Syndrome and prevention of primary thrombosis is potentially huge. Additionally, Therma Bright is working towards securing reimbursement for DVT prevention. While Medicare and Medicaid do not pay for DVT prevention, private insurers do. Therma Bright is confident that the issuance of this new HCPCS code and payment determination will help patients access Venowave for DVT prevention via their private health insurance, which is another huge addressable market in the United States. During the last year, Therma Bright has been meeting with potential distributors across the United States. Many have indicated interest in the Venowave pursuant to a positive outcome with regards to the HCPCS coding. Therma Bright currently has over 2000 Venowave units in inventory, which they expect can be moved right away upon the issuance of the HCPCS code. After these initial 2000 units are sent to distributors, placed on patients, and reimbursement received, Therma Bright conservatively estimates moving 500-1000 units / month. Given the high margin on Venowave, this will fare well for the company. As Venowave is a high margin product, the company is looking at the possibility of setting up a manufacturing operation in either the U.S, Canada or Mexico which would allow it to sell to the VA in the US. This would open up yet another large market for Venowave in the United States. For investors who may be interested in Therma Bright, it is important to note that Venowave isn’t its only product. The company also has respiratory health and consumer health product portfolios. The respiratory health product portfolio features the Digital Cough Test (DCT) app created by Therma Bright (TSXV:THRM) (OTCQB:TBRIF) and AI4LYF. The app uses artificial intelligence to detect multiple respiratory diseases by analyzing a person’s cough sound and has shown a high accuracy rate. The app is currently in the process of securing a 513g FDA clearance, which will allow the company to charge for Remote Therapeutic Monitoring (RTM) and be used for patient reimbursement. The consumer health product portfolio features devices designed for pain relief, cold sore prevention and insect bite relief. 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 expects to be compensated by Therma Brite to assist in the production and distribution of content related to TBRIF. 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

June 12, 2024 06:00 AM Eastern Daylight Time

1 ... 22 23 24 25 26 ... 303