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Dipharma’s cGMP Pilot plant, expansion proceeding according to plan

Dipharma Francis S.r.l.

Dipharma Francis S.r.l. (Dipharma), a global CDMO and leading manufacturer of Active Pharmaceutical Ingredients and Intermediates, announced today that the expansion of its cGMP small production pilot plant, at its Italian site in Mereto di Tomba (UD), is proceeding as planned and it will be commissioned by late November this year. The new production line doubles the capacity of the existing pilot plant with a total investment of € 2.7 Million. The plant will be equipped with 2 glass-lined reactors, 2 stainless steel reactors, a Hastelloy C-22 filter dryer with continuous liner discharge and closed system operation; loading of raw material through an isolator and coupling with Split Butterfly valves allow for an extreme containment level. Furthermore, new equipment will increase the capacity of the utilities (scrubber, vacuum pump, chiller, etc.) serving the pilot plant. In addition to this, the new plant will include clean rooms on all the three floors involved in the expansion, with pressure gradient control in rooms and airlocks for personnel and material. This layout allows for the production of HPAPI up to OEB4 and will include a clean room for finishing activities (filter dryer room). The HVAC systems are 100% fresh air. The overall small-scale pilot plant is in full compliance with the highest cGMP standards and it is also equipped with 1 Stainless steel Centrifuge, 1 Stainless steel Tray Vacuum Dryer; it is capable of milling and of producing different batch sizes including: • from 5 kg to 50 kg on the first line • from 5 kg to 25 kg on the second line (HPAPI) “This investment is another important step forward on the strategic path towards the strengthening of our small molecule CDMO offer — said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l. —. The new cGMP pilot plant expansion will enhance our CDMO scale-up capabilities for earlystage drug development and clinical trials, allowing Dipharma to better meet our customers’ needs and expectations by systematically providing integrated, innovative and sustainable service solutions to their challenges”. About the Dipharma Francis group With a turnover of approximately €130 million, Dipharma Group is a global CDMO and a leading manufacturer of APIs and Intermediates, with more than 500 skilled and highly committed employees, 4 cGMP plants, located in the U.S.A. and Italy, plus sales offices in Italy, the U.S.A. and China. The fully equipped R&D Centres develop innovative chemical processes and crystalline forms for the most prominent pharmaceutical companies worldwide. Since 1970, Dipharma has managed to achieve a positive unbroken record of inspections by the main Regulatory Agencies and its cGMP manufacturing sites are equipped to supply quantities from laboratory to industrial scale, covering the entire lifecycle of a pharmaceutical substance. Dipharma has the right size and variety of scale-up capabilities to act as a global player and manage processes efficiently, while offering flexibility and agility to promptly solve any challenge. Experience you can trust. Contact Details Dipharma Francis S.r.l. Paola Clerici +39 02 3822 8320 paola.clerici@dipharma.com Company Website https://www.dipharma.com/

July 12, 2021 09:02 AM Eastern Daylight Time

New Website Created by Quidel Corporation Provides Consumers With Information and Easy-to-Understand Answers Regarding Lyme Disease

Quidel Corporation

Americans looking for information regarding Lyme disease, often referred to as the “epidemic within the pandemic,” now have a new and trusted resource in which to rely with the launch of LymeDiseaseAnswers.com. Created by Quidel Corporation, the website provides consumers with the peace of mind that comes with increased knowledge of the prevalence, causes, warning signs, symptoms and advances in the testing of Lyme disease, which afflicts nearly 480,000 people across the country each year. “Lyme disease can strike anyone of any age, especially those who spend time in wooded or grassy areas or who play sports on grass fields in high-risk areas of the country,” said Cheryl Miller, vice president of new market development for Quidel. “People are rightfully concerned about contracting Lyme disease and want to know how to avoid it, especially now with Americans spending more and more time outdoors as we emerge from the COVID-19 pandemic. We’ve created LymeDiseaseAnswers.com as a consumer-friendly and straight-talk place where people can easily find the information they are seeking.” The new website, created in tandem is Quidel’s strategic and creative partner breakwhitelight, contains answers to frequently asked questions, easy-to-understand infographics showing where Lyme disease is most prevalent and how it is contracted, the latest statistics and clinical research taking place regarding the disease, and links to additional resources on the subject. Also housed on the site is a series of recently produced “Quick Takes”—attention-grabbing educational videos that help consumers and health care professionals alike enhance their knowledge of Lyme disease by providing the information and up-to-the-minute data needed to confront this disease quickly and clearly. Quidel is the diagnostic health care manufacturer behind the industry’s most rapid and reliable in-office test for Lyme disease, the Sofia 2 Lyme FIA test. This test provides a patient as well as his or her physician with indicative results within minutes as opposed to days, which has historically been the norm. Performed in the privacy of a doctor’s office or local clinic, it is also the only test that can get results from a simple finger prick of blood. Given that the vast majority of patients tested are negative, not having to wait days for test results allows physicians and nurse practitioners to more rapidly treat those patients with positive results while more quickly pursuing other diagnosis and treatment for those who test negative. While just launching this month, LymeDiseaseAnswers.com has already been honored for excellence by the renowned MarCom Awards, an international creative competition that recognizes outstanding achievement by marketing and communications professionals, both corporate and agency. LymeDiseaseAnswers.com received MarCom’s highest award—its Platinum Award—while competing against more than 6,500 entries from the United States and several foreign countries. About Quidel Corporation Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of diagnostic solutions at the point of care delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com. Contact Details Jim Yeager +1 818-264-6812 jim@breakwhitelight.com Company Website http://Quidel.com

July 12, 2021 09:00 AM Eastern Daylight Time

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Cyvatar Takes Home Top Prize in 2021 Fortress Awards

Cyvatar

Cyvatar today received more industry accolades as it was named a winner in network security by the Business Intelligence Group for its innovative Cybersecurity-as-a-Service (CSaaS) offering as part of the 2021 Fortress Cybersecurity Awards. The Fortress awards program identifies and rewards the world’s leading companies and products that are working to keep data and electronic assets safe among a growing threat from hackers. “2021 is rapidly becoming the toughest year for cybersecurity professionals and as our reliance on networks continues to accelerate, our identities and data have quickly become global currency, so security is more important than ever,” said Maria Jimenez, chief nominations officer at the Business Intelligence Group. “We are proud to recognize all of our winners and finalists who are on the frontlines of the effort to prepare, defend and respond to this growing threat.” Cyvatar’s proprietary ICARM method guarantees proper installation, configuration, assessment, remediation, and maintenance for every Cyvatar technology solution so that organizations actually achieve better protection and resilience from their investments And because Cyvatar’s method is continuous, it protects against attack vectors that haven’t even surfaced yet. “It’s continued validation of our unique CSaaS model that industry peers recognized Cyvatar again for exceptional leadership and innovation,” said Cyvatar Co-Founder and Chief Product and Strategy Officer Craig Goodwin. “As the first subscription-based CSaaS company to deliver effortless, affordable cybersecurity, we enable our members to protect confidential information with the people, processes, and technology essential to ensure they get value from their security tools, from conception and strategy to implementation and maintenance. No other provider delivers holistic security at price points that work for any size customer and guaranteed value that allows customers to cancel anytime.” Cyvatar CSaaS levels the playing field by democratizing cybersecurity and making the best protection accessible and affordable for every size organization, even if they have no cybersecurity expertise in-house. If your organization needs award-winning cybersecurity, Cyvatar can help. About Cyber Defense Magazine With over 5 Million monthly readers and growing, and thousands of pages of searchable online infosec content, Cyber Defense Magazine is the premier source of IT Security information for B2B and B2G with our sister magazine Cyber Security Magazine for B2C. We are managed and published by and for ethical, honest, passionate information security professionals. Our mission is to share cutting-edge knowledge, real-world stories and awards on the best ideas, products and services in the information technology industry. We deliver electronic magazines every month online for free, and special editions exclusively for the RSA Conferences. CDM is a proud member of the Cyber Defense Media Group. Learn more about us at https://www.cyberdefensemagazine.com and visit https://www.cyberdefensetv.com and https://www.cyberdefenseradio.com to see and hear some of the most informative interviews of many of these winning company executives. Join a webinar at https://www.cyberdefensewebinars.com and realize that infosec knowledge is power. About Cyvatar Cyvatar is committed to effortless cybersecurity for everyone. As the industry’s first subscription-based, cybersecurity-as-a-service (CSaaS) company, it’s our mission to transform the way the security industry builds, sells, and supports cyber solutions. We empower our members to achieve successful outcomes by providing expert advisors, proven technologies, and a strategic process roadmap to guarantee results that map to their business drivers. Our approach is rooted in proprietary ICARM (installation, configuration, assessment, remediation, maintenance) methodology that delivers smarter, measurable security solutions for superior compliance and cyber-attack protection faster and more efficiently, all at a fixed monthly price. And because we’re a subscription, members can cancel anytime. Cyvatar is headquartered in Irvine, California with locations around the world. Begin your journey to security confidence at CYVATAR.AI and follow us on LinkedIn and Twitter. Contact Details Cyvatar KC Higgins +1 303-434-8163 kc@cyvatar.ai Cyber Defense Magazine April Palanca +18338449468 Company Website https://cyvatar.ai/

July 07, 2021 11:51 AM Eastern Daylight Time

Introducing YuCALM®, Natural Calming Chews for Stressed or Anxious Dogs

Lintbells

Lintbells, manufacturer of leading hip and joint supplement for dogs, YuMOVE®, is excited to announce its latest in natural* health products with the launch of YuCALM®. Available on Chewy.com, YuCALM® ONE-A-DAY chews for dogs of all sizes, contains science-backed ingredients to help dogs cope with stress and anxiety. “Many dogs feel anxious on a daily basis or are fearful toward specific triggers such as thunderstorms, fireworks, or new situations like owners returning back to the office,” said John Howie, CEO and co-founder of Lintbells. “By supporting natural calming pathways in the brain, YuCALM® ONE-A-DAY is a safe and effective way to reduce stress and support calm behavior.” Easy to use format. YuCALM® ONE-A-DAY comes in a handy tasty bite dogs love, that makes feeding a breeze. Lemon balm helps dogs feel more relaxed, soothing stress and encouraging calming behavior. L-Theanine offers natural calming properties that support the production of calming compounds such as serotonin. B Vitamins support healthy brain function, reducing excitability and improving concentration. Proprietary blend of natural fish protein hydrolysates helps calming signals locate the right spot in the brain. “We recommend pets be on a daily regimen of YuCALM® approximately four to six weeks in advance of any expected triggering events such as holiday celebrations, major traveling, or family members heading back to school,” adds Howie. “We’re thrilled to offer pet owners a safe and effective solution for their anxious four-legged friends.” Product samples, images, and veterinary and expert interviews available upon request. *Over 90% of ingredients natural. For the full definition please visit yumove.com/natural. About Lintbells Lintbells, the UK's #1 Vet Recommended Dog Joint Supplement company, currently helps more than 1 million dogs across Europe and the United States. In March 2019, Lintbells officially entered the US Market with the introduction of their most popular product abroad, YuMOVE Soft Chews. This joint supplement promotes joint and cartilage health in dogs of all breeds and sizes. Made from all-natural, human-grade, non-GMO ingredients, the secret to YuMOVE Soft Chews' success comes from Lintbells own ActivEaseÂ® Green Lipped Mussel (or GLM). GLM, a superfood derived from the purest sources in New Zealand, is an essential ingredient with extraordinary properties that improves joint function, mobility, and reduces discomfort in our dogs. This unique ingredient, rich with more Omega 3s than any other GLM, is naturally anti-inflammatory, meaning our dog's stiff joints are eased naturally. To learn more, visit www.yumove.com Contact Details The Impetus Agency Jamie Baxter +1 775-322-4022 jamie@theimpetusagency.com Company Website https://yumove.com/

July 07, 2021 06:12 AM Pacific Daylight Time

GROUNDWORK BIOAG EXPANDS LEADERSHIP TEAM FOR GLOBAL GROWTH OF MYCORRHIZAL PLATFORM

Groundwork BioAg

• Former ICL Fertilizers and Chemicals CEO Hanan Dor Joins to Lead Agriculture Business • Co-Founder Dan Grotsky to Lead Expansion of Cannabis and Growth Initiatives Groundwork BioAg ® announced today that the company has expanded its leadership team to directly align with its key growth markets: mainstream agriculture and cannabis, in response to increased demand for its regenerative agriculture products. Former Chief Executive Officer of ICL Fertilizers and Chemicals, a subsidiary of ICL Group LTD, Hanan Dor has joined the company as Chief Commercial Officer, responsible for expanding the agriculture business. He brings more than 35 years of experience leading global business development, marketing and sales for sustainable specialty fertilizer plant nutrition. During his time in leadership roles, ICL tripled its global business and expanded in key commodity agriculture markets, including China and India. Co-Founder Dan Grotsky is named Chief Growth Officer, responsible for expanding the cannabis business and growth initiatives, including sustainability and carbon markets. Since Groundwork BioAg’s inception in 2014, Grotsky led the development of globally recognizable brands, Rootella ® for row, organic and specialty crops, and DYNOMYCO ® for cannabis. His shift in responsibility reflects the company’s goal to build upon this foundation and accelerate its market leadership position in bioagriculture. “We’re thrilled to attract an industry leader like Hanan to our leadership team. Together, I believe Groundwork BioAg is well positioned to continue our rapid growth trajectory,” said Dr. Yossi Kofman, Co-Founder and CEO of Groundwork BioAg. “Along with insights from the specialty fertilizer industry, Hanan shares our passion for mycorrhiza – the queen of biologicals – and understands its central role to building a bio-platform accessible to farmers around the world. Coupled with Dan’s vision for these brands and the dedication of our entire team, I am confident we will deliver upon our goals.” Groundwork BioAg’s mainstream ag business delivered record sales in both the 2019 and 2020 growing seasons and doubled its cannabis business. In May, the company secured new funding to accelerate mass production of its highly concentrated, cost-effective mycorrhizal inoculants and expand its technology platform to support ongoing innovation. In addition to increasing yield, mycorrhizae improve sustainability by reducing dependency on phosphorus fertilizer and improving carbon sequestration in soil. Through distribution partnerships across five continents, Groundwork BioAg is helping farmers improve the efficiency and profitability of major crop production, including corn, soybeans, grains, bio-energy crops, vegetables and cannabis. About Groundwork BioAg Groundwork BioAg, a global bioagriculture company, leverages the natural power of mycorrhizal fungi to improve the productivity, sustainability and profitability of commercial agriculture and expand regenerative agriculture practices. Groundwork BioAg is the first to use innovative techniques to solve challenges inherent in high-volume mycorrhizal inoculant production. We will not rest until every hectare of arable land is protected by mycorrhizae and every farmer benefits from higher crop yields while preserving our soils. For more information, visit www.groundworkbioag.com. Contact Details AgTech PR Jennifer Goldston +1 816-260-0040 jennifer@agtechpr.com Company Website https://www.groundworkbioag.com

July 07, 2021 07:00 AM Eastern Daylight Time

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What You Need to Know About Heart Disease

YourUpdateTV

As the world looks with hope to the light at the end of the COVID-19 tunnel, there lies another ongoing health crisis that, according to the American Heart Association (AHA), kills more Americans than anything else: heart disease. Recently, leading cardiologist and Director of Cardiology at State of the Art Cardiology, Dr. John Osborne, teamed with his patient Mike Hodge on a nationwide satellite media tour to discuss managing cardiovascular risk. A video accompanying the announcement can be found here: https://youtu.be/XKKKCVCofew In the last year, heart disease claimed more than 690,000 lives in the U.S., which is staggeringly more than the reported 345,000 lives lost to COVID-19, according to data from the Centers for Disease Control. While the prevalence of the disease – and incredible amounts of research – would lead many to think the risks and standard practices would be widely known, the overwhelming amount of information and data can actually make it harder to assess risk and treatment options, which can be confusing for physicians and patients alike. For example, many people are unaware that after a failed outcomes study, the FDA revoked the approval of a class of drugs called fenofibrates — such as TriCor ® (fenofibrate) and Trilipix ® (fenofibric acid) — concluding that fenofibrates should not be used in combination with statins for CV risk reduction because the risks outweigh the benefits. As a result, millions of patients at risk of heart attack or stroke may be unknowingly receiving medications that have not been shown to reduce cardiovascular (CV) risk on top of statins. According to Dr. Osborne, patients who are taking a fenofibrate, in addition to a statin, are taking a drug that has not shown CV benefit and instead just exposes them to the potential risks of these medicines which outweigh the benefits. For more information, visit itscleartomenow.com About Dr. John Osborne: Dr. Osborne has been recognized as a Fellow of the American College of Cardiology and a Fellow of the National Lipid Association. His clinical interests include preventive cardiology, metabolic syndrome and diabetes, hypertension, congestive heart failure, cholesterol disorders, coagulation disorders, and cardiovascular genetics. He is the founder and director of State of the Heart Cardiology in Dallas, Texas and is currently the National Director of Cardiology, Preventive Cardiology, and Lipidology for the Low T Centers and HerKare. About YourUpdateTV: YourUpdateTV is a social media video portal for organizations to share their content. It includes separate channels for Health and Wellness, Lifestyle, Media and Entertainment, Money and Finance, Social Responsibility, Sports and Technology. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

July 06, 2021 02:00 PM Eastern Daylight Time

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Motiva launches a ‘life changing’ product, the first-ever clinically proven to help improve Alzheimer’s patients

Fine Hygienic Holding

Motiva Neuro Booster offers higher absorption of six key functional foods New product is clinically proven to improve brain health Worldwide, approximately 44 million people suffer from Alzheimer’s disease and approximately 2.5 million suffer from Multiple Sclerosis (MS) today. With the former expected to rise to 115 million cases by 2050 as well as being the leading cause of institutionalization among the elderly, it remains the only disease on the top 10 list of killers that has no cure, preventative measure, or medication to delay progression. Similarly, MS therapies are noncurative, and except for interferon-based disease-modifying therapies, nearly all are associated with a risk of potentially life-threatening complications. Additionally, MS patients experience a multitude of symptoms and frequent treatment side effects causing significant impairment in all phases of life, including cognition and mood. However, there is hope. The brain, like every other organ in the body, needs essential nutrients to function properly. Dr. John E. Lewis, from the Department of Psychiatry and Behavioural Sciences at the University of Miami Miller School of Medicine, one of the world’s leading experts in nutrition and dietary supplements, has been conducting research on how certain key nutrients can help the brain, with a study on Alzheimer’s patients. His study was a first great step in demonstrating the power of specific nutrients in the face of a serious brain health challenge. As part of the study, each subject took an aloe polymannose multinutrient complex (APMC), a unique blend of nutrients, polysaccharides, phytochemicals, molecules, and elements that are typically uncommon or even missing from the modern diet, for 12 months. The findings at the end of the study were nothing short of remarkable, with the team demonstrating significant and sustained improvements in cognitive function and inflammatory status and a significant increase in the production of stem cells, which may lead to neuro-regeneration, as well as a correlation between cognitive and immune functioning. Unlike research on Alzheimer’s medications, which demonstrate at best only a slowing of disease progress, this product actually showed IMPROVEMENT of cognitive function of Alzheimer’s patients. On learning of this research, Fine Hygienic Holding, behind its Motiva brand of science-based supplements, teamed up with Dr. Lewis to develop the MOTIVA Neuro Booster, a new all-natural product based on the formula that has been clinically proven to improve cognitive function in all, including those with Alzheimer’s. Designed, created, and developed by Dr. Lewis, the MOTIVA Neuro Booster is a powerful combination of six functional foods typically uncommon or even missing from the modern diet, including the very potent acemannan from aloe vera. This unique blend of nutrients, phytochemicals, and polysaccharides, all 100% natural ingredients, gives the product the highest levels of bioavailability and effectiveness. In layman’s terms, MOTIVA Neuro Booster means higher absorption, less dosage, and hence better value for money, a far better value than many prescription medications. Dr. Lewis firmly believes that this dietary supplement is the real deal for brain health, immune support, and overall wellbeing. “I am extremely proud to team-up with a world-class wellness company like Fine Hygienic Holding to bring Motiva Neuro Booster to the world. This is a product that enhances life and can change the trajectory of diseases, such as Alzheimer’s and MS.” The MOTIVA Neuro Booster’s unique blend of ingredients, often lacking in the modern diet, is highly concentrated and comes in an easy-to-digest powder form, enabling it to be easily absorbed by our bodies. The supplement assists focus, maintains memory, and supports overall brain well-being in addition to being clinically proven to support the immune system. MOTIVA is produced in a GMP-CERTIFIED FACILITY in the USA and is the only supplement of its kind to be recommended by the prestigious Medical Wellness Association, based in Houston, Texas, USA. In clinical testing, users of Neuro Booster have reported improved energy, deeper sleep, a happier mood, sharper focus, heightened awareness, and a better sense of overall well-being. What’s not to like about a product that comes from natural ingredients? The Alzheimer’s study’s first published article is on PubMed. The product’s ability to provide enhanced absorption largely comes from BiAloe®, the most bioavailable source of aloe vera polysaccharides known as acemannan. Found in the inner leaf gel of the aloe plant, it is responsible for most of the health benefits associated with aloe vera. Added to that, ingredients such as stabilized rice bran contains more than 200 amino acids, minerals, and vitamins with significant health properties; sunflower lecithin is rich in choline necessary for brain and heart health; and tart cherry, dioscorea, and citric acid offer a host of health benefits for immunity, cholesterol regulation, and enhancement of key cellular processes. Motiva Neuro Booster is being rolled out globally by Fine Hygienic Holding and can be purchased online for global deliveries via our e-commerce website, TheFineShop.com. About Fine Hygienic Holding: Fine Hygienic Holding (FHH), one of the world’s leading wellness groups and the MENA’s leading manufacturer of hygienic products, serves consumers in more than 80 countries around the world. Originally established as a paper manufacturer, FHH has transformed into a wellness company dedicated to enhancing global health and wellbeing. With its commitment to becoming “the shining star of the Arab FMCG business world,” the Group focuses on wellness, sustainability, state-of-the-art production processes, pioneering CSR programs, and award-winning products. The company offers a diverse array of products including sterilized facial tissues, napkins, kitchen towels, toilet paper, baby diapers, adult briefs, jumbo rolls, as well as away-from-home products to accommodate all types of private and public institutions, in addition to innovative personal protective equipment (PPE), long lasting germ protection solutions and natural nutritional supplements. Contact Details Sean Muir sean.m@actionprgroup.com Company Website https://www.finehh.com/

July 05, 2021 09:02 AM Eastern Daylight Time

PCMA v. WEHBI AMICUS BRIEF ADVOCATES FOR STATE REGULATION OF PHARMACY BENEFIT MANAGER INDUSTRY

Alliance for Transparent & Affordable Prescriptions

The Alliance for Transparent and Affordable Prescriptions (ATAP), a coalition of physician and patient advocacy organizations dedicated to exposing the role the pharmacy benefit manager (PBM) industry has on rising prescription drug costs was joined by the Community Oncology Alliance (COA) and American Pharmacies in filing an amicus brief in PCMA v. Wehbi. The case, currently being argued in the 8 th Circuit, Court of Appeals is a challenge to a North Dakota law designed to regulate abusive practices by the PBM industry. The brief prepared by Daniel Geyser of Alexander Dubose & Jefferson LLP on behalf of ATAP, COA and American Pharmacies may be found here. Following a ruling by the United States Supreme Court in Rutledge v. Pharmaceutical Care Management Association ( where ATAP also filed an amicus brief ), many states have begun to explore regulating the PBM industry to lower costs and increase access to therapies. That case resulted in a unanimous 8-0 decision where the Justices agreed that states have the right to impose regulations on PBMs. Despite setbacks in legislatures and the courts, the PBM industry continues to raise challenges to state regulation of their practices and seeks to avoid accountability. ATAP has been an active advocate for patients in a variety of federal and state battles to amplify the voices of patients and physicians – especially as it relates to exposing PBM abuses and their impact on patients’ access to therapies (medications) needed in their treatment. Dr. Robert Levin, ATAP’s President stated, “We see first-hand how the PBM industry drives up costs and interferes with medical care. Doctors, patients, legislators and regulators are all saying, ‘enough is enough’ and fighting back. We appreciate the opportunity to argue on behalf of patients and defend our obligation to them as the Courts once again weigh in on regulating this rogue industry.” “Oncologists remain troubled by the negative impact PBMs have on patient care and role they play in driving up costs,” said Kashyap Patel, MD, president of COA and a practicing medical oncologist at Carolina Blood and Cancer Care Associates in Rock Hill, South Carolina “PBMs are directly responsible for the loss of patient access to affordable, potentially life-saving medications for cancer and other serious diseases. COA is proud to share our voice and support to effort in North Dakota and nationwide to stop PBM abuses.” “PBMs have used their outsized market power to raise community pharmacies costs of operation,” explained Miguel S. Rodriguez, General Counsel at American Pharmacies. “PBMs operate in secrecy and routinely fail to pass along any savings to patients. It is time to shine a light on and regulate this industry.” American Pharmacies is a nation-wide independent pharmacy cooperative that routinely advocates on behalf of independent pharmacies and the patients they serve. ATAP, COA, and American Pharmacies argue in the brief that: “…PBMs engage in harmful practices that impair optimal patient care, distort the free market, and impose serious costs on every major stakeholder in 5 the healthcare industry. States are ideally positioned to attack PBM misconduct; the regulation of healthcare is a traditional state function, and States routinely address market inefficiency and abuse, just as North Dakota did…” “We are optimistic that the Courts will see through the previously hidden profit motives of the PBM industry,” said Dr. Angus Worthing of the American College of Rheumatology, an ATAP member organization. “With each new state law combined with other actions at the federal level, patients, physicians, and policy makers now have the power to effect meaningful change.” “The Courts will surely see, like we all do, that patients are suffering under a system preventing them from obtaining medicine they need – at prices they can afford,” said Dr. Michael Schweitz of the Coalition of State Rheumatology Organizations, an ATAP member organization. “The PBM industry profits significantly off rebates and other schemes while interrupting the provider-patient relationship. It is time to do what is right and allow policymakers to stand up and do the right thing.” “The profit motivations from the PBM industry impact real people in dangerous ways,” Dr. Levin continued. “ATAP members are on the front lines of medical care. We see the struggles and confusion that patients are put through by this completely unnecessary middleman industry. They deserve better – they deserve the truth – not dangerous interference from policies motivated only by profit.” ATAP is working in many states to force the PBM industry to disclose rebate data and encourage transparency and reporting requirements for all entities involved in the prescription drug supply chain – PBMs, insurers, and manufacturers. ### For more information, or to schedule an interview with an ATAP spokesperson please contact Dan Rene at 202-329-8357. Please visit http://www.atapadvocates.com ATAP's mission is to address prescription drugs costs and patient access to affordable treatment by regulating PBM practices and reforming the drug industry through educational outreach and grassroots advocacy initiatives at both the state and federal level. Contact Details Dan Rene +1 202-329-8357 daniel.rene@kglobal.com Company Website http://www.atapadvocates.com

July 02, 2021 08:30 AM Eastern Daylight Time

Vascudyne Announces Successful First Human Use of TRUE Vascular Graft for Hemodialysis Access

Vascudyne

Vascudyne, Inc. announced today the successful first-in-human use of its TRUE™ Vascular Graft in end-stage renal disease patients requiring hemodialysis access. The first clinical procedures were performed by Adrian Ebner, MD, Director of Endovascular and Cardiovascular Surgery at Sanatorio Italiano in Asuncion, Paraguay, as part of an early feasibility study. “We are excited to work with Dr. Ebner and his skilled team at Sanatorio Italiano and are grateful for their commitment to the latest cardiovascular medicine innovations and for the successful first-in-human TRUE Vascular Graft implantation procedures in 5 patients,” said Vascudyne CEO Kem Schankereli. “Until now, hemodialysis patients who are not candidates for autologous fistulas often receive synthetic grafts, like those made with ePTFE,” said Dr. Ebner. “Synthetic grafts have long-term patency issues with infection, intimal hyperplasia, and thrombosis often leading to failure. All this contributes to patient morbidity and mortality and to the high cost of dialysis care.” “Vascudyne’s TRUE Vascular Graft with the potential to regenerate and repair promises to have a major impact on the care of dialysis patients,” added Dr. Ebner. “Improved patency and fewer interventions with a completely biological tissue could significantly reduce the overall cost of dialysis care and improve quality of life for patients.” “The TRUE Vascular Graft handled well and provided excellent flow immediately after implantation,” continued Dr. Ebner. “The device can be felt under the skin which will help with dialysis. Initial follow up showed normal healing and improved flow. There is a tremendous medical need for hemodialysis access solutions, and Vascudyne’s TRUE Vascular Graft has shown very promising initial results.” “It’s immensely rewarding to see this technology become clinical reality by the Vascudyne team,” said Robert Tranquillo, PhD, Distinguished McKnight University Professor, University of Minnesota. “Decades of research in my lab at the University of Minnesota developing and fine tuning the engineered tissue tube technology have come to fruition and now offer a completely biological vascular graft for patients. I am very excited about Vascudyne’s TRUE™ Tissue technology and all the potential benefits it can bring to patients and look forward to providing ongoing support to the team as they broaden the technology’s clinical applications." “Vascudyne is a fast-moving startup with a very successful beginning toward proving clinical relevance,” said Vascudyne General Manager Rick Murphy. “We are a dedicated team of scientists who are committed to innovating solutions with our TRUE Tissue technology for highly demanding medical applications. We are planning additional clinical studies in the next 12 months and will be submitting for market acceptance in the years ahead. We have several more product designs in development and are pursuing ways to accelerate these other programs into the clinical stage. We believe the right material with the correct strategy will help millions of patients across the globe live better lives.” Vascudyne licensed its proprietary TRUE Tissue technology developed by Professor Robert Tranquillo and his colleagues from the University of Minnesota in 2017. The TRUE Vascular Graft is not available for commercial sale. About Vascudyne Headquartered in the heart of Medical Alley in Minnesota, Vascudyne is on a mission to improve patient care with regenerative biomaterials that are inspired by nature. Vascudyne, a privately held company founded in 2014, uses the TRUE™ Tissue technology to develop TRUE to Nature™ biomaterials for soft tissue repair and replacement. For more information, please visit https://www.vascudyne.com/. About TRUE Tissue Technology TRUE™ Tissue is developed from cells isolated from donor tissue and is 100% biological. There are no synthetic materials or chemical fixation used, and implanted tissues are completely cell-derived and acellular. The TRUE Tissue technology can be readily shaped into tubes, sheets, and other geometries making it suitable for many soft tissue applications, is mechanically comparable to native tissues, and is a ready to use, off-the-shelf allograft. Forward Looking Statements This announcement contains forward-looking statements. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements relate to future events or Vascudyne’s clinical development programs, reflect management’s current beliefs and expectations and involve known and unknown risks, uncertainties and other factors that may cause Vascudyne’s actual results, performance or achievements to be materially different. Vascudyne undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. IMAGES Vascudyne TRUE™ Graft First in Human Team Vascudyne TRUE™ Graft Vascudyne TRUE™ Graft Closeup Contact Details Sandy Williams Marketing Director swilliams@vascudyne.com Company Website https://www.vascudyne.com/

July 01, 2021 10:03 AM Eastern Daylight Time

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