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The World Prestigious Diabetes Research Institute, University of Miami, Announces Kadimastem's Joint Project as Breakthrough Transplantation Approach for the Treatment of Type 1 Diabetes

Kadimastem

Kadimastem Ltd. (TASE: KDST), announces positive results of its leading diabetes product jointly developed with iTolerance Inc. The results were presented at the 84th scientific conference of the American Diabetes Association (ADA), in a late-breaking session. The product was evaluated by at the DRI, The Fast Track Center for Testing at the DRI Cell Transplant Center where it was designated to be a “novel combination of tolerance-inducing agent and human stem cell-derived islets demonstrates functional insulin release and disease reversal in a model of diabetes.” Link to quote. The recognition of the scientific progress of the treatment, which combines immune modulator microgel material (a substance that eliminates the need for chronic systemic immune suppression) and insulin-producing islet cells derived from human stem cells, as an innovative treatment intended for the treatment of type 1 diabetes, was given by the world's largest diabetes research institute at the University of Miami (Florida) School of Medicine (DRI). The experts at DRI presented product compatibility, safety and efficacy to the conference attendees, concluding that combination of the engineered iTOL-100 microgel material developed by iTolerance and the pancreatic cells - IsletRx developed by Kadimastem - can effectively restore normoglycemia (a state of glycemic balance like that of a healthy person) in a diabetes animal model. Dr. Giacomo Lanzoni, PhD, program leader at the DRI, stated, "Our observations highlight the transformative potential of combining stem cell-derived islets with an immunomodulatory microgel. This approach could enable transplantation across the allogeneic barrier, offering a scalable and sustainable solution for T1D, and could enhance the safety and long-term efficacy of islet cell transplantation.” Dr. Camillo Ricordi, MD, Director of the Cell Transplant Center and Director Emeritus at the Diabetes Research Institute, commented: “The Fast Track Center for Testing at the DRI Cell Transplant Center continues to serve as a key shared resource to validate emerging technologies towards a cure for diabetes. We hope to continue to be of assistance towards the identification of reliable and potentially unlimited stem cell-derived islet sources for transplantation, which may one day be able to replace the limited availability of pancreas-derived islets from multiorgan donors, when life-long recipient immunosuppression will no longer be required.” The study's key findings indicate that this combination therapy reverses diabetes and preserves the functional integrity of the transplanted stem cell-derived islets. Key Highlights: -IsletRx, a preparation of Human Stem Cell-Derived Islets developed by Kadimastem, Ltd., is a scalable and virtually unlimited source of insulin-producing cells, and could address the critical shortage of donor islets for transplantation. -iTOL-100, an immunomodulatory microgel developed by iTolerance, Inc., designed to eliminate the need for chronic systemic immunosuppression and shown to induce local immune acceptance of transplanted islets, was found to be compatible with stem cell-derived islets. -Implantation in a Retrievable Site: The transplantation procedure is performed in a retrievable site, ensuring the possibility of graft retrieval through a minimally invasive surgery, if needed. -Successful Reversal of Diabetes: The study reports reversal of disease in a chemically induced model of diabetes, with comparable efficacy of IsletRx in the presence or absence of iTOL-100, indicating a lack of toxicity from the microgel. Additional Comments: Prof. Michel Revel, Chief Scientist of Kadimastem: "Our collaboration with iTolerance opens an innovative and world-first avenue for transplanting pancreatic island cells into diabetics without the need for full suppression of the immune system, which is required today in organ transplants. Prof. Revel emphasized, "Our company produces high-quality pancreatic islet cells. The joint data collected by us prove the possibility of combining our cells with the material that locally prevents the rejection of the implant developed by our project partner iTolerance. The successfully completed an Interact meeting with the FDA, and the two companies are moving together to the pre-IND submission stage." Dr. Anthony Japour, CEO of iTolerance, Inc., commented, “iTolerance is pleased to co-sponsor the project at the Diabetes Research Institute toward a functional cure of T1D through the combination of human stem cell-derived insulin producing islet cells together with our iTOL-100 proprietary immunomodulator. Removing the need for life-long toxic immunosuppressive agents in islet transplantation is a common goal among those working toward a cure for T1D through transplantation without immunosuppression.” About Kadimastem Kadimastem is a clinical stage cell therapy company, developing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications. IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST). Social Media: LinkedIn, Twitter, Facebook About iTolerance, Inc. iTolerance is an early-stage privately-held regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com. About the Diabetes Research Institute (DRI) The Diabetes Research Institute at the University of Miami Miller School of Medicine is a recognized world leader in cure-focused research. The DRI is committed to developing and rapidly applying innovative strategies to restore natural insulin production and normalize blood sugar levels without imposing other risks. For more information, please visit https://diabetesresearch.org/ Kadimastem (TASE:KDST) is a clinical stage biotechnology company, with a unique platform for cell therapy that enables the production of off-the-shelf cell-based products for the treatment of unmet medical needs. Kadimastem was founded in 2009 based on patent protected technology that was developed at Prof. Michel Revel’s laboratory at the Weizmann Institute of Science. Forward Looking Statement This document may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future. Contact Details Kadimastem Ltd. Asaf Shiloni CEO +972 73-797-1613 s.bazak@kadimastem.com iTolerance Inc. Susan Roberts +1 202-779-0929 sr@roberts-communications.com Company Website https://www.kadimastem.com/

June 23, 2024 07:00 AM Eastern Daylight Time

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Mainz Biomed’s ColoAlert Potentially Puts It On A Similar Track As Big Name Cancer Screening Stocks

Benzinga

By Meg Flippin, Benzinga When it comes to screening for colorectal cancer, Mainz Biomed NV (NASDAQ: MYNZ) and Exact Sciences Corp. (NASDAQ: EXAS) have a lot in common. Both are overhauling the screening market for a cancer that kills 50,000 people each year. And both are doing it without an invasive test that requires hours of uncomfortable prep. Exact Sciences, which makes Cologuard and Mainz Biomed, which makes ColoAlert, are trailblazing with their at-home cancer screening tests. Cologuard in the U.S. and ColoAlert in Europe. Take ColoAlert for starters. It spots bleeding and non-bleeding tumors through tumor DNA analysis, offering what the company says is a 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. Caught early, the survival rate after five years is 90% for colorectal cancer. Exact Sciences’ Cologuard looks for colorectal neoplasia-associated DNA markers and for the presence of occult hemoglobin in human stool. It, too, says its screening technology is better at detecting colorectal cancer than blood tests. Similar But Different The companies both boast high accuracy rates and customer satisfaction. But that is where the similarities end. Exact Sciences dwarfs Mainz Biomed in size and sales, sporting a market cap of $7 billion to Mainz Biomed’s $12.6 million as of this writing. Exact Sciences stock, which trades at around $42 a share, has already had a runup, while Mainz Biomed, which is under $1.00 a share, is just starting out. That might not be forever, which could position Mainz to follow a similar trajectory to Exact Sciences and other diagnostics companies specializing in the detection of early-stage cancers. Exact Sciences launched Cologuard in 2014, becoming the first DNA test for colorectal cancer in the U.S. Since then, it has expanded into other cancers and its stock and business have taken off. Mainz has been in the market since 2018 and sales have been growing at double digits since then. Revenue for ColoAlert increased 69% year-over-year in 2023 and more growth is expected this year and beyond. ColoAlert Coming To The U.S. Mainz Biomed has already made a name for itself in Europe and is gearing up to bring ColoAlert to the U.S. ColoAlert is currently under evaluation by the Food and Drug Administration for use in the U.S. as part of its ReconAAsense clinical study of about 15,000 subjects from 150 sites across the United States. The results of the study, which is pivotal for FDA approval, are expected next year. Once approved, MYNZ says it plans to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country. If it does get the nod from the FDA, it could prove to be a catalyst for the company’s growth. It shouldn’t prove difficult given ColoAlert’s accuracy and ease of use. The company says ColoAlert detects 85% of colorectal cancer cases, often in the very early stages of the disease. 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. Big Opportunity On The Horizon Then there is the market opportunity. 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 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. Colorectal cancer is deadly but it doesn’t have to be. Companies like Exact Sciences and Mainz Biomed are turning the market on its head with their at-home screening tests. While Exact Sciences dwarfs Mainz in size, Mainz has a lot of potential, especially if it gets approval to sell its test in the U.S. With that coming down the pike, Mainz is a story worth keeping an eye on. 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 21, 2024 08:45 AM Eastern Daylight Time

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“One Of The Most Significant Developments In Rapid In Vitro Diagnostics Since Its Invention” Says Gemina Labs CEO About Company’s Revolutionary Technology

Benzinga

By Meg Flippin, Benzinga Gemina Laboratories (CNSX: GLAB), the biosensor and diagnostic company focused on rapid testing for respiratory and other pathogens that affect human health and wellness, is making waves in the diagnostics sector thanks to its cutting-edge, next-gen technology. Under the leadership of CEO Brian Firth, formerly COO of Swiss Precision Diagnostics and makers of the Clear Blue Pregnancy Test, Gemina Laboratories says it is poised to transform the landscape of rapid testing for respiratory diseases and beyond. It’s a big market opportunity, given chronic respiratory disease was the third-leading cause of death in 2019. Rapid testing for it and other pathogens can reduce the spread of life-threatening illnesses and help people get treated faster. Breakthrough In Point-Of-Care Diagnostics Gemina Labs specializes in the development of unique binding technologies for the Point-of-Care (PoC) diagnostic industry. Utilizing their proprietary chemistry, Gemina's innovations reduce production costs and improve the accuracy and the useability of diagnostic tests. The company’s "game-changing" chemistry is not only reserved for its own products. Gemina Labs is also licensing it to other producers to incorporate into their lateral flow technologies. "Our chemistry is one of the most significant developments in rapid in vitro diagnostics since its invention. It reduces production costs and improves accuracy," says Firth. Expanding Horizons And Industry Impact Gemina Labs is in growth mode, pursuing its vision to make affordable, rapid and lab-accurate PoC diagnostics available worldwide. The company’s cutting-edge technology and R&D capabilities have drawn significant attention from leading biochemists, healthcare professionals, academics and business leaders globally, including a big global diagnostics company. Gemina Labs just signed a licensing agreement with what it says is one of the leading players in the $106 billion global in vitro diagnostics market. Gemina says the agreement marks a major validation of its technology after a year of extensive scrutiny and evaluation by the diagnostics company. "This is an outstanding first for Gemina," said Firth. "We are now targeting similar licensing deals with strategic partners across the life sciences and medical device sectors to enable next-generation diagnostics with our unique suite of proprietary technologies." Financial And Commercial Implications The new partnership looks poised to have significant financial implications for both Gemina and the broader diagnostics market, thanks to Gemina’s ability to reduce the antibody requirements in lateral flow. As it stands, Gemina says the antibodies used in lateral flow cost up to $1,500 per mg. Gemina’s technology can potentially reduce that by 75%, translating into $3 billion in annual savings for the lateral flow diagnostics sector. That, says Firth, is a convincing commercial opportunity for partners. "Our diagnostic technology asset has passed rigorous testing by one of the best teams in the industry, resulting in this long-term relationship. We have previously reported how one of our technology breakthroughs saves up to 75% of antibodies used on lateral flow tests," Firth said. Future Prospects Looking ahead, Gemina Labs is strategically positioning itself for further growth through additional licensing deals and partnerships. The company’s goal is to continue expanding access to rapid, accurate diagnostics – making a positive difference in the medical, healthcare, wellness and occupational health sectors. Gemina Labs isn’t your run-of-the-mill diagnostics company. It sees itself as a transformative force with the potential to revolutionize how rapid diagnostics are developed and deployed globally. Investors and industry stakeholders may want to keep an eye on this potential rising star. Featured photo by Anastasiia Chepinska 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 21, 2024 08:45 AM Eastern Daylight Time

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Dentalplans.com Addressing The Gap In Dental Care Accessibility Through Affordable Dental Plans

DentalPlans.com

By Mangeet Kaur Bouns Dental care is a crucial aspect of personal health and hygiene, profoundly influencing a person’s ability to eat, speak and maintain overall well-being. Poor oral hygiene is linked to numerous health issues, including cardiovascular disease, respiratory infections, diabetes and adverse pregnancy outcomes. In addition to physical health, poor dental health can affect mental and emotional well-being, leading to issues such as low self-esteem and social anxiety. Despite the critical importance of oral health, access to quality dental care remains a significant challenge. Many people face barriers such as high costs and lack of insurance coverage, which prevent them from receiving the dental care they need. DentalPlans.com, the largest online marketplace for dental savings plans and dental insurance, seeks to address this gap by making dental care more accessible and affordable for everyone. The company’s mission is to achieve dental care equality in America – ensuring everyone has an equal opportunity to access quality dental care. High Costs Prevent Access To Essential Dental Care Oral health is a vital yet frequently overlooked component of general health. Regular dental check-ups and cleanings can mitigate common oral diseases such as tooth decay, bad breath, dry mouth, periodontitis and oral cancer. Despite this, many people in the U.S. do not visit the dentist at least once a year, as health experts recommend. In 2022, nearly 14% of children and adolescents in the U.S. experienced oral health problems. This statistic underscores the importance of early and regular dental visits to prevent long-term health issues. The deficit in dental coverage is immense. Nearly 69 million U.S. adults did not have dental insurance or access to routine oral health care in 2023, according to a survey by the nonprofit CareQuest Institute for Oral Health. Additionally, millions more lost dental insurance last year when states began to unwind Medicaid coverage for people who signed up during the COVID-19 pandemic. This loss of coverage means that many people who need dental care choose to wait until minor problems turn into larger, sometimes life-threatening, issues. For those who rely on programs such as Medicaid or federally qualified community health centers, getting timely dental appointments is often a struggle. Only one in three U.S. dentists agree to take Medicaid patients, and even fewer see a substantial number of them. These statistics illustrate the urgent need for more affordable dental care solutions, which DentalPlans.com aims to provide through affordable, flexible dental savings plans. DentalPlans.com: Pioneering Affordable Dental Care For 25 Years This year, DentalPlans.com celebrates its 25th anniversary. Founded in Florida over two decades ago, the company has since become a national leader, having helped over a million people access quality dental care through direct-to-consumer dental savings plans and dental insurance plans. By offering dental savings plans – an affordable alternative to traditional dental insurance – DentalPlans.com is helping consumers afford the care they need without sacrificing quality. Dental savings plans operate similarly to membership programs at warehouse stores. Plan members pay a low annual fee to join and then receive reduced rates on almost all dental services, including major procedures like crowns, braces, implants and dentures. These plans provide a cost-effective solution for individuals who may not have dental insurance through their employers or those on Medicare, which does not cover regular dental care. Plans From Top Healthcare Brands Understanding that each individual’s dental needs are unique, DentalPlans.com is committed to ensuring everyone finds the most suitable and cost-effective dental plan for their specific needs. The company has introduced an innovative online quiz that asks a few questions and provides personalized plan recommendations within minutes. All plans are from top healthcare brands, including Cigna, Aetna, Careington, Humana and more. By partnering with such brands, DentalPlans.com has over 25 high-quality plans for users to choose from. And with an extensive network of over 140,000 dentists nationwide, plan members can use their plan to save on their dental care no matter where they’re located. Committed To Promoting Oral Health And Overall Well-Being The company’s journey from a start-up of two entrepreneurs to an online leader in dental care access exemplifies the transformative power of innovation and commitment to social impact. By continuously seeking new ways to make dental care more accessible and affordable, DentalPlans.com plays a pivotal role in oral health outcomes for millions of Americans. DentalPlans.com’s mission to make quality dental care accessible and affordable for everyone remains at the forefront of its operations as it celebrates its 25th anniversary. By offering dental savings plans and working to eliminate financial barriers to dental care, DentalPlans.com continues to push society closer to true dental care equality. The company's ongoing efforts ensure that cost is no longer a barrier to essential oral health care, promoting a healthier future for all. Feeling lost among countless dental plans? DentalPlans.com offers a straightforward, hassle-free way to choose the right plan for you, so you can save money on the dental care you need. Featured photo by Lesly Juarez on Unsplash. DentalPlans.com, founded in 1999, is a leading online marketplace for dental savings plans in the U.S., helping more than a million people to affordably access quality healthcare services. Our mission is to empower consumers with the tools, information, and services that they need to live happier, healthier lives. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Discount Health Program consumer & provider surveys indicate average savings of 50%. Savings may vary by provider, location and plan. Sample savings are based on zip code 43614, actual costs and savings may vary by service and geographical area. Contact Details Matthew Wong matthew.wong@wpromote.com Company Website https://www.dentalplans.com/

June 20, 2024 08:30 AM Eastern Daylight Time

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Expert Tips to Support and Celebrate Aging Pets

YourUpdateTV

Many pet owners struggle with the reality of their furry friends aging. Dr. Stacey Bone, veterinarian and senior pet advocate with Hill’s Pet Nutrition recently talked about the importance of embracing, not fearing, this natural process and how proper nutrition and care can help pets live bold in their older years. A video accompanying this announcement is available at: https://youtu.be/nhs96_Yu3Uc According to a 2019 study by The American Animal Hospital Association, 80% of pet owners do not realize the age at which their pet is considered a senior pet – which is typically age 7. Just like humans, pets’ biology changes as they age, but getting older doesn't have to make life any less exciting. Pet parents fear aging, because “getting old” is associated with slowing down and losing the spirit and vibrancy that makes their pets special. The fear associated with owning a senior pet can potentially lead to inadequate care for senior pets, resulting in health issues and decreased quality of life. There are attainable ways to support your senior pet’s changing needs. Knowing how to best care for your pet – from tailored nutrition for senior pets to regular veterinary care - can help pet parents continue to experience a full life together.   Tailored Nutrition for Senior Pets Hill’s Pet Nutrition is raising awareness of the unique nutritional needs of senior pets and how important it is to switch to a food designed specifically for seniors, such as Hill’s Science Diet Senior Vitality. The right nutrition can help senior pets live life to the fullest, so it is important to transition your pet to a senior pet food that meets his or her needs. Hill’s Science Diet Senior Vitality is made for older pets’ changing biology, including balanced minerals for heart and kidney health, omega-6 fatty acids and vitamin E for healthy skin and coat, and easy-to-digest ingredients to support digestion. Hill’s Science Diet Senior Vitality improves senior pets’ everyday ability to get up and go. It features nutrition that can help support the brain function, interaction and overall energy and vitality of your senior pet. In a clinical study, pet parents observed increased affection and stamina in as little as 28 days when their pets ate Senior Vitality dry dog food. The best food for aging pets is one formulated to keep up with their changing nutritional requirements. Talk with your veterinarian to ensure your dog or cat is getting the right nutrition at each lifestage.   Encouraging Senior Pet Adoption There are many animals in shelters across the nation who need homes, and some of the most overlooked pets include seniors. Hill’s Pet Nutrition is encouraging people to consider opening their hearts and homes to a senior pet in a shelter. Senior pets tend to spend the longest time at shelters and are often viewed as unadoptable based on the misperception that they likely have behavioral issues. In reality, many of these animals were companions to elderly people who passed away or moved to an assisted living facility. Only 25% of senior pets get adopted, compared to a 60% adoption rate for younger pets, according to the ASPCA. Puppies and kittens are cute, but they also need a ton of extra attention and training. On the other hand, senior pets are overflowing with love and their laid-back personalities make them perfect for lots of different homes. Along with expert care from shelter staff, quality nutrition can play a vital role in helping shelter pets be healthy, happy and more adoptable. That’s why Hill’s Food, Shelter & Love program provides science-led nutrition to hundreds of shelters across North America, helping more than 14 million pets find new homes since 2002. For more information, visit hillspet.com and search ‘Senior Care’ to learn more about care and nutrition for senior pets. About Dr. Stacey Bone: Dr. Stacey Bone brings over 16 years of expertise to his role as a small animal veterinarian, where he currently serves both as a relief veterinarian and as a senior brand manager at Hill's Pet Nutrition. Within Hill's, he is part of the Prescription Diet marketing team, driving the company's strategic vision in the U.S. market. With a heartfelt commitment to geriatric pet care, Dr. Bone focuses on areas critical to the health of senior pets, including advanced nutrition, comprehensive disease management, and the importance of preventive care. That passion led him to found a company dedicated to creating products that address the unique issues of senior pets. His work is characterized by a deep understanding of veterinary science, coupled with genuine care for his animal patients. Dr. Bone is an advocate for educating pet parents about the impactful role that nutrition plays in senior pet health: “Most pet parents do not like to acknowledge that their pet is getting older, but celebrating aging, rather than fearing it, can help those animals live long, full lives. In partnership with your veterinarian, it is important to transition your pet to a senior pet food that meets his or her needs. Providing age-appropriate nutrition supports overall energy and mobility and can help pets live life to the fullest.” Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 18, 2024 04:30 PM Eastern Daylight Time

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Shedding Light on Cystic Fibrosis

YourUpdateTV

Cystic fibrosis (CF) is a rare, progressive, and genetic disease that currently affects about 40,000 people in the United States. CF is the result of a defective gene, inherited from each parent, and the disease can impact people of all races and ethnicities. Recently, KC White, Board Chair of the Cystic Fibrosis Foundation, participated in a nationwide satellite media tour to discuss the disease, her personal journey, and how the Foundation is helping progress care and treatment options. A video accompanying this announcement is available at: https://youtu.be/8wj8u0JEqLU CF is a life-shortening disease that prevents our bodies from clearing mucus. This can lead to lung infections, poor nutrition, lung disease, and a host of unique challenges that can impact every aspect of a person’s life. When it was first discovered, it was considered a fatal pediatric disease. But due to transformative advancements in treatments and high-quality care, the life-expectancy for someone born with CF today is 56. While that number is climbing there is still a long way to go and unfortunately, not all people with CF equally benefit from this progress. KC White was elected chair of the Cystic Fibrosis Foundation’s Board of Trustees in 2022 after serving on the Board since 2005. Diagnosed with cystic fibrosis at age 3, White has been a committed volunteer and inspiring advocate for the Foundation since childhood and is the first person with CF to serve as board chair. When she was diagnosed, she wasn’t expected to live past high school age, but her family refused to accept that fate, which prompted their dedication to the Foundation’s work. Because of recent treatments known as modulators, about 90% of the CF population (including KC) experienced an incredible transformation in their health. With this though, comes navigating unplanned challenges including careers, finances, family, and more. In addition to fueling the research, particularly in genetic therapies, that will lead to transformative treatments for the entire CF population, the CF Foundation works to support the CF community in all aspects of their lives through support programs and fostering connection opportunities. The CF Foundation is committed to finding a cure and providing all people with CF the opportunity to lead long, fulfilling lives. The Foundation is aggressively funding research and drug development, advancing high-quality, specialized care, and partnering with and advocating for the CF community. For more information, visit CFF.ORG About KC White KC White was elected chair of the Cystic Fibrosis Foundation’s Board of Trustees in 2022 after serving on the Board since 2005. Diagnosed with cystic fibrosis at age 3, White has been a committed volunteer and inspiring advocate for the Foundation since childhood, speaking at her first Foundation event when she was only 9 years old. She is the first person with CF to serve as board chair. White received her Master of Applied Positive Psychology from the University of Pennsylvania in 2022 and currently serves as an assistant instructor in the program. She is also the Head Varsity Women’s Lacrosse coach for the Chagrin Falls, Ohio, Tigers. She and her husband, Justin, have one son, Mac. About the Cystic Fibrosis Foundation The Cystic Fibrosis Foundation is a donor-supported nonprofit organization leading the relentless pursuit of a cure for cystic fibrosis. The Foundation is committed to providing all people with CF the opportunity to lead long, fulfilling lives by funding research and drug development, advancing high-quality, specialized care, and partnering with and advocating for the CF community. The Foundation funds more CF research than any other organization, and nearly every CF drug available today was made possible because of Foundation support. The organization supports and accredits a national network of over 130 CF care centers recognized by the National Institutes of Health as a model of care for a chronic disease. Also, the Foundation manages support programs and fosters connection opportunities for the CF community. Based in Bethesda, Md., the Foundation’s impact is made possible by the work of nearly 70 local chapters across the country. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 17, 2024 01:46 PM Eastern Daylight Time

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Valeo Pharma hits record 2nd quarter revenue as demand for Asthma products continues to rise

Valeo Pharma Inc.

Valeo Pharma CEO Steve Saviuk joined Steve Darling from Proactive to discuss the company's financial results for the second quarter, which saw record-breaking revenue for the period. The company reported revenues of $14.1 million for Q2, an increase from the $13.6 million recorded in the same quarter of 2023. This represents a growth of 4%. The revenue increase was primarily driven by a boost in sales due to promotional activities in the respiratory segment, Allerject, and sustained growth from other core products such as Redesca and Simbrinza. However, Saviuk emphasized that these top-line numbers do not fully capture the extent of the company's progress. Despite the overall growth, the company faced revenue softness in several of its non-core brands and encountered short-term structural delays in Ontario that impacted Redesca. These challenges somewhat masked the robust performance of Valeo's asthma franchise, which saw a 52% increase in Q2 revenues compared to the same quarter the previous year. Specifically, total prescriptions for Enerzair and Atectura for the 12 months ending April 30, 2024, surpassed 88,000, marking a significant 96% increase over the 12-month period ending April 30, 2023. In addition to discussing revenue figures, Saviuk announced that Valeo Pharma is undertaking a comprehensive restructuring of its commercial field operations. This initiative aims to improve profit margins, reduce operating expenses, align the company's commercial infrastructure with current market dynamics, and accelerate its journey towards profitability. These cost reduction measures are expected to decrease operating expenses by more than $5 million annually. Combined with previously implemented cost-saving strategies, Valeo anticipates that total cost savings will exceed $7 million. Contact Details Proactive +1 347-449-0879 na-editorial@proactiveinvestors.com

June 17, 2024 12:58 PM Eastern Daylight Time

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Hoffman Financial Group Joins Forces with AmeriLife’s Brookstone Capital Management

AmeriLife

Brookstone Capital Management (“Brookstone”), a leading, SEC-Registered Investment Advisory (RIA) firm and affiliate of AmeriLife Group, LLC (“AmeriLife”), announced today that it has partnered with Hoffman Financial Group, a nationally recognized financial planning firm based in Atlanta. Per the agreement, terms of the deal were not disclosed. “We’re excited to partner with the Hoffman team. This collaboration will only strengthen both organizations and continue to provide best-in-class solutions for them and all the clients they serve,” said Dean Zayed, CEO of Brookstone Capital Management. “Additionally, this partnership underscores Brookstone’s ongoing investment and commitment to our advisors and our goal to be the leader at the intersection of insurance and securities.” “Hoffman Financial Group is a premier financial services firm – Chris and his team have created something special that we are excited to be a part of,” added Darryl Ronconi, president of Brookstone Capital Management. “With a broader relationship with Brookstone and AmeriLife, our goal is to help continue to accelerate their significant growth by providing them with even more resources and support.” Founded in 2011, Hoffman Financial Group is a comprehensive financial and retirement planning firm with one goal in mind: to be the go-to financial advisor for individuals wanting to retire. The firm offers a completely hands-on approach to retirement planning and a full suite of wealth management offerings, including investment management, 401(k) and IRA rollovers, tax planning, and more through its eight investment advisor representatives. Hoffman Financial Group has applied this high-touch approach to unique offerings such as Her Wealth Her Way ®, designed specifically to help women retire with comfort, confidence, and class. Hoffman Financial Group is also incredibly active in the media, bringing its expertise on money management to viewers of The Financial Edge on Atlanta’s CBS 46 and ABC’s Good Morning America Weekend every Sunday morning, and to listeners of Money Unleashed on Atlanta’s 95.5 WSB every Sunday afternoon. Additionally, the firm is an Official Partner of the University of Georgia Bulldogs ® and, most recently, was named Official Financial Advisor of former Bulldog and NFL player Brock Bowers, partnerships that have cemented Hoffman Financial Group as a leading financial services company alongside two distinguished names in collegiate sports. “I couldn’t be more excited to partner and expand our relationship with Brookstone,” said Chris Hoffman, founder of Hoffman Financial Group. “They are the best partner to take us to the next level. The entire team is thrilled about the opportunity of aligning Hoffman Financial Group with the extensive resources and talent that they offer.” Now, as part of the AmeriLife family of companies, Hoffman Financial Group will enjoy broad access to best-in-class platforms, tools, resources, and an expansive product portfolio to move quickly into new markets, accelerate production, and drive the firm’s growth for years to come. “Chris Hoffman has built a powerhouse brand and business that is reshaping retirement planning for America’s retirees,” said Mike Vietri, Chief Distribution Officer for AmeriLife Wealth Group. “We’re incredibly excited for Hoffman Financial Group to join forces with Brookstone as part of AmeriLife Wealth Group, and look forward to integrating their unique approach, expertise, and leadership into our fast-growing distribution platform.” ### About Hoffman Financial Group Hoffman Financial Group is a leading financial planning firm based in Atlanta, Ga. With a personalized approach coupled with highest standards of financial advisory services, the firm specializes in principal protection, income planning, wealth accumulation, legacy planning, and more. For more information, visit HoffmanCorporation.com. About Brookstone Capital Management Founded in 2006, Brookstone Capital Management (BCM) is an SEC-Registered Investment Advisory firm with over $9.5B in Assets Under Management (AUM), providing fee-based investment management services through its network of more than 750 financial advisors and firms. Brookstone is an innovator and industry leader and empowers independent financial advisors of all sizes to scale their business by providing access to a Turnkey Asset Management Platform (TAMP) along with a dedicated team to support every aspect of an advisor’s practice. Visit BrookstoneCM.com for more information. 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 a 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 more than 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 advisors and 120 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 17, 2024 09:00 AM Eastern Daylight Time

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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

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