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Cigar Association Urges OMB to Reject FDA's Proposed Flavored Cigar Ban

Cigar Association of America

The Cigar Association of America (CAA) said that it asked the Office of Management and Budget (OMB) during a November 6 meeting to withdraw the Food and Drug Administration (FDA) Flavored Cigar Product Standard (FCPS) banning flavors in cigars, which it said would cost the industry nearly $4 billion in sales—up to 47 percent of industry sales—and destroy 16,000 jobs. CAA president David Ozgo stated, “We presented evidence to OMB that FDA’s proposed flavored cigar ban dramatically fails to meet the criteria necessary for such a ban under the Tobacco Control Act, offering little or no public health benefit while having a devastating economic impact on the industry.” Ozgo noted, “FDA claims the product standard will reduce youth usage of cigars and that prohibiting flavored cigars will address health disparities in minority adult subpopulations. CAA showed OMB government data demonstrating that neither of these claims is true.” FDA Ignores Science on Health Effects & Clear Economic Impact In order for FDA to impose a flavored cigar ban through a FCPS, the law requires that the Agency consider: whether the potential product standard is appropriate for the public health, taking into consideration scientific evidence concerning the risks and benefits to the population as a whole; the increased or decreased likelihood that existing users of tobacco products will stop using such products; and, the increased or decreased likelihood that those who do not use tobacco products will start using such products.   “FDA’s Flavored Cigar Product Standard fails on all three accounts,” Ozgo charged, “Youth usage rates of cigars, and of flavored cigars in particular, are at all-time lows and these low rates reflect a stable and sustained trend.”   The 2022 National Youth Tobacco Survey (“NYTS”) showed past 30‐day youth cigar use at 1.85% and past 30‐day youth flavored cigar use at 0.83%. The recently released 2023 NYTS data showed past 30‐day youth cigar use has declined to 1.6%. While the flavored cigar use data has not yet been released, it is expected to follow the trend at under 1% of use.  Other government surveys reflect similar trends. In fact, the most recent Population Assessment of Tobacco and Health Survey (PATH) showed that past 30-day youth usage of cigars was only 0.70% and past 30-day youth usage of flavored cigars was just 0.14%. In addition to unsupported youth usage claims, CAA demonstrated FDA failed to show that adult subpopulation health disparities are associated with flavored cigar use or that banning flavored cigars would remedy these disparities among Black, Non-Hispanic Americans. CAA did so despite the fact that FDA is required by law to base its decisions not on subpopulation impacts but on impacts to the population as a whole. 1 (See note 1) “FDA’s claims aside, there is simply not a pattern of use of these products that raises a concern of public health that can justify eliminating an entire category of products, while depriving adult consumers of the right to choose these products” he said.  While the public health case is non-existent, FDA’s proposal would have dramatically negative economic consequences. A recent study by the Policy Navigation Group showed the flavored cigar ban would reduce retail sales by nearly $4 billion, up to 47 percent of industry sales, causing some 16,000 people to lose their jobs. FDA Recently Lost in Court After Ignoring Scientific Evidence CAA and other industry groups recently convinced a court to reject the Agency’s effort to regulate “premium” cigars. More particularly, the judge in the case ruled against the FDA, citing the Agency for ignoring the scientific evidence. The proposed FCPS similarly ignores scientific evidence. Ozgo stated, “Just as it did in 2016 and 2019, we urge OMB to again reject FDA’s flavored cigar proposal. There is little or no public health benefit from the proposed FCPS, but huge negative economic consequences will result. This is as bad as public policy gets. Ultimately, FDA’s proposal is a solution in search of a problem.” CAA is a national trade association representing manufacturers, distributors, importers, suppliers, and all channels of retailers in the cigar industry, and traces its roots back to the 1890s. 1 The most recent PATH data (Wave 6), collected in 2021, reports that, in the overall adult population, Black, Non‐Hispanic use of flavored cigars had fallen to 1.86% from 3.22% in Wave 5 (collected in 2019). Further, in the young adult population (18–25‐year‐olds) the past 30‐day prevalence rate had fallen to 0.76% in Wave 6 from 1.57% in Wave 5. Contact Details Frank Coleman +1 202-223-8204 fcoleman@cigarassociation.com

November 08, 2023 12:30 PM Eastern Standard Time

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Hydrogen Utopia International confident in demand surge for medical cannabis

Hydrogen Utopia International PLC

Hydrogen Utopia International PLC (LSE:HUI, OTCQB:HUIPF) CEO Aleksandra Binkowska and Howard White, Executive Director of the same company and 100% owner of Ohrid Organics speak to Proactive's Thomas Warner about HUI's recent step into the medical cannabis sector through an investment in North Macedonia-focused grower Ohrid Organics. Binkowska explains that her passion for establishing a waste plastic-to-hydrogen facility is behind the decision to partner with Ohrid Organics, emphasising the importance of HUI becoming financially self-sufficient. The shift in strategy is the result of slower than expected progress in garnering governmental grants and a reluctance to ask the market for fresh funding. Howard White shares his journey as an established investor in waste-to-energy and gives an overview of developments at Ohrid Organics' King Field facility. He expresses confidence in the future of the site and says that he sees the liberalisation of medical cannabis legislation, particularly in conflict-afflicted areas as a potentially lucrative opportunity. Ohrid Organics highlights on its website that North Macedonia has the lowest cost per gram for cannabis production in Europe. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

November 08, 2023 09:11 AM Eastern Standard Time

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HKBU-led research discovers therapeutic potential of hyodeoxycholic acid for non-alcoholic fatty liver disease

Hong Kong Baptist University

HONG KONG SAR - Media OutReach - 8 November 2023 - A research led by Hong Kong Baptist University (HKBU) has discovered that hyodeoxycholic acid (HDCA), a bile acid generated in human intestine, can reduce fat accumulation and inflammation in the liver, demonstrating its strong therapeutic potential for non-alcoholic fatty liver disease (NAFLD). The research also found that HDCA's intervention in NAFLD works by reshaping the population of beneficial gut bacteria, which affects the metabolic interactions between the gut and the liver. The result highlighted the critical role of gut health in liver disease. The research findings have been published in the renowned scientific journal Cell Metabolism. HKBU researchers will coordinate a phase I and II clinical trial in the Mainland to evaluate the safety and efficacy of HDCA for patients with fatty liver disease and type 2 diabetes. 32% of adults suffer from NAFLD NAFLD is a leading cause of chronic liver disease, characterised by the build-up of excessive fat in liver cells that is not caused by alcohol consumption. Its global prevalence has been increasing over time. A meta-analysis in 2022 estimated that 32% of the adult population is affected by NAFLD. Some people with NAFLD can develop non-alcoholic steatohepatitis, which is marked by liver inflammation and may progress to cirrhosis and liver failure. Currently, there are no therapeutic drugs available for sale on the market for non-alcoholic steatohepatitis. A research led by Professor Jia Wei, Acting Dean and Chair Professor in Chinese Medicine and Systems Biology of the School of Chinese Medicine at HKBU, discovered that HDCA offers promising potential as a pharmaceutical intervention for NAFLD. "Our research is a significant stride forward in understanding the pathophysiology of NAFLD, and it offers a potential new avenue for therapeutic intervention," he said. Therapeutic effects of HDCA Professor Jia's team found that individuals with NAFLD have lower levels of HDCA compared to those without NAFLD. In a cohort consisting of 178 patients with NAFLD and 73 healthy individuals, hyocholic acid species, including HDCA and its major metabolite glycohyodeoxycholic acid, comprises 0.5% of the bile acids in NAFLD patients, which is significantly lower than the 2% in healthy individuals. This observation led the team to explore HDCA's potential therapeutic role. A series of controlled experiments were conducted to evaluate the therapeutic effect of HDCA. The team orally fed HDCA to mouse models with NAFLD for eight weeks. The results showed that HDCA markedly reduced excessive lipid droplets, and improved hepatic inflammation, oral glucose tolerance (i.e. the blood glucose level after oral intake of glucose), and insulin sensitivity (i.e. the sensitivity of the body to the effects of insulin which helps the glucose to enter into the cells for use) compared to the control group. The results revealed that HDCA alleviated NAFLD conditions and the risk factors of NAFLD such as type 2 diabetes and insulin resistance. Interestingly, the researchers found that HDCA did not exert its therapeutic effects on NAFLD by directly targeting liver cells. They evaluated the potential direct effect of HDCA on lipid accumulation in a mouse model. The results showed that lipid accumulation was barely affected by the HDCA. They hypothesised that HDCA induced gut microbiota alterations, which might contribute to the alleviation of NAFLD. HDCA reshapes gut microbiota The researchers observed that HDCA could improve the population of beneficial gut bacteria. Parabacteroides distasonis (P. distasonis), a member of the core microbiome in the human gut, sharply increased in the mouse model fed with high-fat food and administered with HDCA, compared with the control group fed with high-fat food only. The results revealed that HDCA provided a favorable environment for the thriving of P. distasonis, which regulates fatty acid metabolism as well as the hepatic bile acid synthesis pathways. "The study underscores the crucial role of the gut-liver metabolic axis in disease management. We hope that the research findings on HDCA and the clinical trial to be conducted in the Mainland will provide more insights into the treatment of fatty liver disease and non-alcoholic steatohepatitis," said Professor Jia. Professor Jia has also led a research project investigating the molecular connections between metabolic-associated fatty liver disease and type 2 diabetes mellitus, with a specific focus on host-gut microbiota interactions. The project has been awarded over HK$7.2 million in research funding from the Theme-based Research Scheme (13th round) under the Research Grants Council. Contact Details Christina Wu christinawu@hkbu.edu.hk

November 08, 2023 09:00 AM Eastern Standard Time

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NuggMD Launches Its Leading Marijuana Telemedicine Service in Florida

NuggMD

NuggMD, the nation's largest medical marijuana telemedicine platform, has launched its industry-leading service in Florida, with an initial focus on the metro areas of Miami, Tampa, Orlando, and Fort Myers. Since its founding in 2015, NuggMD has connected over 1,000,000 patients to their medical marijuana physicians in 27 states. Florida's medical cannabis law requires an in-person examination for the initial patient assessment, but the biannual follow-up evaluations can now be conducted via telehealth due to a recent change in the law. “We are thrilled to bring our life-changing telehealth services to Florida. The state’s 210-day renewal mandate poses real barriers for the state's medical cannabis patients. While we hope their legislature will do more to ease access in the near future, especially in light of likely cannabis rescheduling, we're happy that lawmakers chose to ease that burden by making telehealth a permanent option for renewal,” said Alex Milligan, NuggMD co-founder and CMO. "Our initial focus is in these four metro areas because that's where we saw the most demand," said Kam Babazade, NuggMD co-founder and COO. "We've already received a surprisingly robust response, and are planning to expand this new hybrid service to several more states in the near future. Meanwhile, we look forward to expanding our service to the rest of Florida in the coming weeks to help ease the increased regulatory burdens these patients face.” "We've helped to divert over a million medical cannabis patients from the black market now," said Collin Mann, NuggMD co-founder and CEO. "States must ease access to legal cannabis and reduce patient costs if they want to keep these patients away from dangerous black market products. This was a wise move on Florida's part, and we're doing our part too. With the addition of Florida, over 240 million Americans now have access to our platform where they can receive candid guidance from knowledgeable, fully licensed practitioners." It costs just $179 for the initial in-person evaluation and an additional $159 for follow-up telehealth appointments at seven months. Medical cannabis certifications must be renewed with the state every year. NuggMD's platform is available from 8 am to 10 pm seven days a week. No appointment is needed, and patients who don't qualify for their state's medical cannabis program won't be charged for their evaluation. About NuggMD NuggMD is the nation's leading medical marijuana technology platform, serving patients in California, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Vermont, Virginia, Washington, and West Virginia. They've connected over 1,000,000 patients face-to-face with their new medical marijuana doctors via their state-of-the-art telemedicine platform. They believe every human being has the right to explore the benefits of medical cannabis and are fully committed to helping each patient explore every option in their journey to wellness. For further information, visit NuggMD.com/Florida. Contact Details Andrew Graham +1 646-385-0189 andrew.g@getnugg.com Company Website http://www.nuggmd.com

November 07, 2023 03:47 PM Eastern Standard Time

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Futura Medical continues global expansion with Latin America announcement

Futura Medical PLC

Futura Medical PLC (AIM:FUM, OTC:FAMDF) CEO James Barder speaks to Thomas Warner from Proactive London after the pharmaceutical company announced another milestone in its global expansion efforts. Barder shares the news that the Futura has reached an agreement to expand its presence in Latin America. Initially, Futura Medical had been working with key markets in Mexico and Brazil, and their agreement with local partner M8 Pharmaceuticals confirmed their interest in expanding to the rest of Latin America. The deal follows others in markets around the world. Barder mentions that the company has received regulatory approval in Mexico and is preparing for its launch there, and they anticipate several more launches in the coming months. The company remains on track to execute up to 10 launches between now and the end of April. He acknowledges the frustration among shareholders due to the declining share price in recent months. He attributed this decline, in part, to macroeconomic factors and interest rate uncertainty. While the company is actively exploring ways to address this issue, Barder emphasises that the primary focus remains on product commercialisation and expansion. Despite the share price challenges, Barder says that Futura Medical maintains a robust balance sheet and is fully funded to support its ongoing growth initiatives. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

November 07, 2023 11:53 AM Eastern Standard Time

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Big and Growing Need for Senior Care: Empowering Family Caregivers to Get the Supportand Guidance They Deserve

YourUpdateTV

November marks National Family Caregivers Month, a time to bring attention to the challenges faced by those caring for aging parents. Recently, Tatyana Zlotsky, President of A Place for Mom (APFM), conducted a satellite media tour to share vital insights and tips for family caregivers navigating the world of senior care. A video accompanying this announcement is available at: https://youtu.be/dUjQA6H_26Y There is a big and growing need for senior care, as the number of seniors is rapidly increasing and is projected to reach over 80 million by 2040. Today, 41 million Americans are unpaid caregivers for seniors, most often the adult daughter or son of their aging parents. As the senior population grows, family caregivers face serious challenges. A Place for Mom issued its new State of Caregiving Survey, showing that an overwhelming majority or caregivers are physically, mentally, and financially at risk. 82% have had to make sacrifices to provide adequate care. Nearly all (96%) reported being emotionally drained, with more than half feeling this way often or all the time. And 75% who were employed prior to assuming the caregiver role said they have less time to focus on work or have had to quit their jobs altogether to provide care. “These findings reveal some of the hard truths being faced by caregivers as they struggle to care for their aging parents and loved ones,” said Zlotsky. “Navigating the process of finding the most suitable senior care is not easy. There are three important things to consider – care needs, costs, and lifestyle.” First is care needs. Zlotsky shared that as seniors face a variety of physical and mental challenges, they require more and more assistance with their Activities of Daily Living. A Place for Mom finds that nearly all seniors they work with need some daily support, and more than 40% need extra help associated with dementia. The second is costs. “Families need help to better understand senior living costs in their area and options on how to pay,” said Zlotsky. At A Place for Mom, two-thirds of the families they work with have shared that they do not feel prepared when it comes to senior care costs and need help to better understand options and how to pay. “Lastly, families want to find a place where their parents will feel right at home -- a warm environment that helps them experience joy and feel a sense of community,” said Zlotsky. “This is where amenities and activities play an important role in helping mom or dad with the transition.” A Place for Mom has a team of senior living advisors who help caregivers navigate this journey end to end, all at no cost to families. “We start with a simple but very important question: tell us about your mom, dad, aunt, or uncle,” said Zlotsky. The expert advisors then gather critical information ranging from mobility, medication, and bathing assistance to mom’s favorite meals and activities. They then match those needs with preferred options and budget in order to make personalized recommendations for home care or senior living options to best assist the family. For senior living specifically, A Place of Mom also serves as a concierge to help families set up tours, understand feedback, and support the moving process. Special benefits and resources for veterans and their families: There are more than 8 million veteran seniors in the U.S. And at A Place for Mom – the veteran community is critically important. In fact, more than 30% of the families A Place for Mom helps are veteran families. “Veterans and their spouses may qualify for the VA Aid & Attendance benefit to help pay for senior care,” said Zlotsky. However, A Place for Mom’s survey revealed that more than two-thirds of veteran families don’t know how to access this monetary benefit or even understand it. A Place for Mom expert advisors are knowledgeable about VA benefits for senior care and help families understand what benefits are available. Their advisors’ expertise has helped families secure more than $8 million in financial aid annually. To expand their impact and help more veteran seniors and their families, A Place for Mom is joining forces with USAA, the leading veterans organization for financial resources, with over 13M members. Visit aplaceformom.com to learn more about A Place for Mom’s services and connect with a local expert advisor. About Tatyana Zlotsky Tatyana Zlotsky is the President of A Place for Mom, Inc., the leading online platform connecting families searching for senior care with a team of expert, local advisors providing insight-driven, personalized solutions. In this role, Tatyana leads the sales and marketing teams and is responsible for delivering on the company’s mission to enable caregivers to make the best senior living decisions. Since joining, Tatyana has served in various leadership roles at A Place for Mom and has successfully helped to transform the brand and overall family experience, which helps over 300K families per year. Tatyana joined A Place for Mom from American Express, where she spent nine years driving digital transformation as the VP/GM of Acquisition and Digital Innovation and was responsible for driving revenue growth in the U.S. Small Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

November 07, 2023 10:42 AM Eastern Standard Time

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Kadimastem and iTolerance Submit Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) Meeting Request with FDA for Potential Cure for Type 1 Diabetes

Kadimastem Ltd.

Kadimastem Ltd. (TASE:KDST), a clinical cell therapy company developing a cell therapy treatment for ALS and a potential cure for diabetes and its diabetic product development partner, the American company iTolerance Inc., have asked the FDA for a preliminary meeting (INTERACT) regarding the companies’ joint diabetes treatment in development, iTOL-102, which does not require continuous suppression of the immune system. The companies signed a collaboration agreement several months ago to co-develop cell technology as a potential cure for diabetes without the need for chronic immunosuppression and received a total grant of about US$1 million from the international BIRD fund. This is the first of a three-step process, with the goal of designing and commencing an FDA-approved clinical study of iTOL-102. The second step would be to submit a pre-IND application based on the feedback from the INTERACT meeting, followed by an IND application to begin clinical trials at locations worldwide. In May 2023, the companies announced their research collaboration agreement to co-develop and commercialize a breakthrough and innovative regenerative technology to cure diabetes without the need for chronic immunosuppression and received a grant in the aggregate amount of US$1m (with a budget of about US$2 million) from the Binational Israel-U.S. Industrial R&D (BIRD) Foundation. As part of the agreement, the companies are considering expanding their cooperation and advancing the development of iTOL-102 which combines Kadimastem’s advanced cell product for the treatment of diabetes called IsletRx, and iTolerance’s iTOL-100 immunomodulatory technology. The purpose of the meeting would be to present the iTOL-102 development program and specifically discuss the chemistry, manufacturing and control (CMC) program, the definitive proof of concept study design in light of preliminary data, and general plans for non-clinical safety and clinical development. The parties intend to continue the development of the product and are even considering expanding the cooperation, for the benefit of product development, including through the establishment of a joint company in the United States. IsletRx is comprised of clinical-grade clusters of human pancreatic islet like cells (ILCs) with the ability to secrete insulin. IsletRx cells can detect the sugar levels in the body and produce the required amounts of insulin and glucagon, iTolerance will provide its platform technology (iTOL-100) intended to enable the transplantation of allogeneic cells without tissue matching and without the need for chronic treatments that suppress the immune system of the transplant recipient (immunosuppression). Kadimastem Chief Executive Officer Asaf Shiloni added, “The INTERACT meeting is an important step forward for this development program. We are dedicated to advancing this program and providing diabetic patients with a potential solution to live without the need for insulin injections.” Dr. Anthony Japour, Chief Executive Officer of iTolerance, commented, “We are pleased with the continued progress of our research collaboration with Kadimastem and look forward to meeting with the FDA. We believe that this collaboration has the potential to provide a much-needed, innovative cure for patients with Type 1 Diabetes and look forward to building on our continued momentum.” At Kadimastem we envision being a global leader in cell therapy.Our passion and commitment keep us moving forward, to develop innovative regenerative therapies for incurable diseases. Our goal is to treat millions of patients around the world with that technology. 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 Kadimastem’s or iTolerance’s control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the companies' activity, as well as developments in the general environment and external factors affecting the companies' activity. The companies’ results and achievements in the future may differ materially from any presented herein and the companies make no undertaking to update or revise such projection or estimate and do not undertake to update this document. This document does not constitute a proposal to purchase the companies' securities or an invitation to receive such offers. Investment in securities in general and in the companies in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future. Contact Details Kadimastem Sarah Bazak +972 73-797-1613 s.bazak@kadimastem.com iTolerance Media Contact Susan Roberts +1 202-779-0929 sr@roberts-communications.com Company Website https://www.kadimastem.com/

November 07, 2023 07:00 AM Eastern Standard Time

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Faron Pharmaceuticals initiates second phase of BEXMAB study

Faron Pharmaceuticals Oy

Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF) chief executive Dr Markku Jalkanen speaks to Thomas Warner from Proactive London after the clinical-stage biopharmaceutical company announced it has initiated Phase 2 of its BEXMAB Study of Bexmarilimab in HMA-failed myelodysplastic syndrome (MDS). MDS is a group of bone marrow disorders that results in an inability to produce enough healthy blood cells. Jalkanen starts by giving a brief summary of the company's hope for the BEXMAB study, before going on to reveal more information about its second phase. He highlights the significant advantage to Faron of the relatively small size of the next phase of the study, which saves the company money at a time when many of its competitors are suffering financially - something he describes as a "a big relief for all of us." He concludes by giving an overview of the company's financial position, highlighting the €7.1 million raised in late October in a share offering. He adds that "very intense" discussions with potential partners are ongoing. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

November 06, 2023 12:36 PM Eastern Standard Time

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Ondine Biomedical’s Steriwave platform seeing strong adoption

Ondine Biomedical Inc

Ondine Biomedical Inc president and chief technology officer Nicolas Loebel and Matt Ross, vice president of Sales and Marketing joined Steve Darling from Proactive to share exciting news regarding the expansion of Ondine's Steriwave nasal photodisinfection technology within the healthcare sector. Alberta Health Services has confirmed its decision to expand the use of Steriwave nasal photo-disinfection following promising data from its pilot introduction at the Mazankowski Alberta Heart Institute. The pilot project demonstrated significant reductions in surgical site infections following cardiac surgery. Ross provided more details about the successful pilot project and shared that the Royal Alexandra Hospital in Edmonton is set to implement Steriwave nasal photo-disinfection before performing 3,000 orthopedic surgeries over the next year. The interest from hospitals across Canada and internationally has been increasing, leading to faster adoption of the platform. Loebel also highlighted the latest data from Vancouver General Hospital and UBC Hospital, which showed a remarkable 66.5% reduction in spine surgery infection rates with the pre-surgical use of Steriwave. These findings were presented at the IP2023 Annual conference in Liverpool in October and have been accepted for publication in the Canadian Journal of Surgery. Contact Details Proactive Canada +1 604-688-8158 na-editorial@proactiveinvestors.com

November 06, 2023 03:00 AM Eastern Standard Time

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