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Microdose Psychedelics Molecular Masterclass: LSD Conference Set to Explore The Potential Of LSD

Biotech experts, top LSD researchers, science specialists, influencers, and medical professionals are invited to attend the virtual LSD Conference being held on February 17, 2022. The agenda of the conference will include discussions, keynotes, and insights from world-class speakers focused on the research regarding therapeutic benefits and potential of LSD. The conference is organized by Microdose, a premier organization engaged in creating, offering and distributing the most compelling content on the finance, industry news, science, and the latest breakthroughs and events of the psychedelic industry. This is the biggest platform offering exposure to professionals, companies, and individuals about the events of the psychedelic industry. The title sponsor of the virtual event is MindBio Therapeutics, a clinical-stage drug development company engaged in the research of microdosing and the medicinal benefits of psychedelic medicines in treating debilitating mental illnesses. This 2-day virtual event will explore the scope and potential of LSD along with discussing the latest innovations in drug development, clinical safety and care, the laws and regulations, science and research, culture and creativity, as well as business trends. This LSD event offers a phenomenal platform and a huge breadth of audience. The attendees can interact with industry influencers and organizations who will discuss the future potential of LSD in different sectors. They will learn the varied uses of LSD and its potential non-psychedelic uses, its role in healing debilitating mental conditions, drug development and safety, clinical applications, and its creative effects, to name a few. This conference is a great networking medium where businesses and professionals can connect to build relationships and explore the latest innovations in psychedelic science. The major points of discussion at the conference include:
  • Therapeutic Use of LSD in Psychiatry
  • Posology and Tolerance to Regression
  • Safety and Efficacy of Lysergic Acid Diethylamide Assisted Psychotherapy
  • LSD Microdosing
  • Effect of Lysergic Acid Diethylamide (“LSD”) on Learning
  • The Effects of LSD on Creativity
Attendees buying tickets to the event can attend the sessions, live presentations, group discussions as well as avail networking opportunities in one-to-one meetings with dedicated companies. Also, they will have lifetime access to the live recordings and will be added to the My content section of the website of every ticketholder’s account within 5 business days following the event. For more information visit https://ibn.fm/xE23e.

Flora Growth Corp. (NASDAQ: FLGC) Seeks EUA to Test Cannabis Product Against COVID Virus, Building on Early Study Results as it Names New Chief Strategy Officer

  • Recent research efforts have targeted the potential of cannabis compounds to combat COVID-19 infection as the worldwide pandemic presses forward into its third year
  • Perhaps most notable among the early-stage research efforts is a study by Oregon State University that found high doses of two specific cannabinoids bound to spike proteins such as COVID’S SARS-CoV-2 and inhibited their potential for infection
  • Cannabis cultivator and brand builder Flora Growth Corp. has filed a provisional patent application for a cannabinoid-based formula that it is simultaneously seeking approval from Colombia’s food and drug regulatory authority for a study and potential clinical trial in fighting COVID
  • Flora Growth hopes to fast-track the product for potential commercialization as a therapeutic for combating the virus
  • Flora also recently named James Choe, the founder of its cannabis technology acquisition Vessel, as Flora’s new chief strategy officer to help establish the company’s direction in the coming years
A number of recent studies have signaled the possibility that cannabis derivative products may be beneficial in preventing COVID infections or combatting them once they have caused sickness. The baseline studies have generated enough excitement that cannabis cultivator and worldwide cannabidiol (“CBD”) brand builder Flora Growth (NASDAQ: FLGC) is asking Colombia’s food and drug regulatory agency to approve the company’s plans for more rigorous research into a patent-pending, cannabinoid-based product to fight viruses such as COVID’s SARS-CoV-2. “At Flora Growth we believe in following the research, and there have been several promising studies published in just the last few months on the application of cannabinoids in certain treatments. We are excited for our Flora Pharma researchers to build upon this progress and generate new data for how cannabis could help consumers around the world, leveraging this natural, botanical alternative,” Flora Growth President and CEO Luis Merchan stated in the company’s Feb. 2 announcement (https://ibn.fm/bsSPn). Flora Growth is asking Colombia’s regulatory Instituto Nacional de Vigilancia de Medicamentos y Alimentos (“INVIMA”) to provide guidelines for researching cannabis products’ effects on the SARS-CoV-2 virus under emergency use authorization protocols that let Flora pursue the fastest path to market for a product that would serve as an immune system-enhancing preventative therapeutic. The potential for cannabis compounds found in non-psychoactive hemp to act in a COVID prevention capacity was announced by Oregon State University researchers in late January after they found that high doses of cannabigerolic acid, or CBGA, and cannabidiolic acid, or CBDA, prevented infection of human epithelial cells by “a pseudovirus expressing the SARS-CoV-2 spike protein” and prevented entry of live SARS-CoV-2 into cells (https://ibn.fm/OMS0t). The study’s authors note that the compounds are orally bioavailable and have a long history of safe human use. The compounds worked by binding to spike proteins found on the virus and preventing it from following a process it uses to infect people, although the study didn’t go so far as to give the supplements to people and compare their effectiveness in patients to those who wouldn’t receive the substances (https://ibn.fm/WoG7d). A Reuters report on the development noted similar research that found small doses of highly purified CBD did not keep the coronavirus from infecting cells in test tubes, but rather acted soon after the virus entered the cells, blocking it from making copies of itself. The researchers also found small doses of cannabis compounds tetrahydrocannabinol (“THC”), cannabidivarin (“CBDV”), cannabichromene (“CBC”) and cannabigerol (“CBG”) — as well as CBDA — did not keep the virus out of cells or prevent it from replicating, and that THC actually prevented the CBD from working. The high doses of CBDA and CBGA used in the OSU study “were non-toxic to cells. (But) it is not clear yet that similarly high doses would be safe for humans,” study author Richard van Breemen told Reuters (https://ibn.fm/jadgD). Flora’s research division, Flora Pharma, has filed a provisional patent application on a cannabinoid-based formula and with INVIMA’s backing would take the product through clinical trials that would exceed the early-stage research done by the other entities, the company states. Flora Pharma is based at the company’s Cosechemos cultivation facility in central Colombia, and approval would mark the first emergency use authorization granted by INVIMA for cannabinoid therapies against COVID. “I have worked on various aspects of SARS-CoV-2 research for the last two years, with a focus on cannabinoid therapeutics more broadly,” Flora Pharma managing scientist Dr. Annabelle Manalo-Morgan stated. “I believe the Flora team is best positioned to formulate, test and ultimately bring to the market this kind of novel product offering.” As Flora Growth establishes its direction for the coming years, the company named James Choe, the founder and CEO of premium cannabis consumption facilitator Vessel, as Flora’s chief strategy officer (https://ibn.fm/ZW0Yr). Flora acquired Vessel’s sustainable technology and accessories late last year (https://ibn.fm/yfx8A). For more information, visit the company’s website at www.FloraGrowth.com. NOTE TO INVESTORS: The latest news and updates relating to FLGC are available in the company’s newsroom at https://ibn.fm/FLGC

Nemaura Medical Inc.’s (NASDAQ: NMRD) CEO Dr. Faz Chowdhury Addresses Growing CGM Demand at H.C. Wainwright BioConnect Conference

  • NMRD CEO Dr. Faz Chowdhury presented at H.C. Wainwright BioConnect Conference held January 10-13, 2022
  • Presentation revealed growing need for CGM devices, diabetes market estimated at $150 billion
  • NMRD’s sugarBEAT(R) devices measure glucose at the skin surface, non-invasive, easy to use
  • NMRD recently commenced product shipments in lieu of an order for 5,000 CGM devices and 200,000 sensors to UK licensing partner MySugarWatch Limited
  • NMRD recently announced launch of Miboko metabolic health program targeted at global employers and insurers
Dr. Faz Chowdhury, CEO of Nemaura Medical (NASDAQ: NMRD), recently presented at the H.C. Wainwright BioConnect Conference on January 10-13, 2022, where he discussed the growing diabetes problem and how Continuous Glucose Monitoring (“CGM”) devices can help patients manage symptoms and reverse the disease (https://ibn.fm/HPL7B). Nemaura is a medical technology company that develops affordable, non-invasive wearable diagnostic devices and digital tools for chronic disease management. The company is currently commercializing its sugarBEAT(R) and proBEAT(TM) non-invasive and flexible wearable glucose monitoring devices that provide insights to help diabetic and pre-diabetic people better prevent, manage, and reverse the onset of the disease. During his presentation, Dr. Chowdhury revealed that there are over 463 million diabetes patients worldwide amid a growing market estimated at $150 billion. NMRD’s vision is to lead the industry in the prevention, management, and reversal of diabetes with low-cost, flexible, and user-friendly devices and health coaching programs. Unlike traditional glucose monitoring methods, NMRD’s sugarBEAT(R) devices are non-invasive and use a well-established glucose oxidase enzyme methodology to convert glucose at the skin’s surface to an electric current signal. Low energy Bluetooth connectivity then sends this information to the complimentary phone app every five minutes, where it’s converted to a glucose value that is presented to the user. With these insights, users can make critical lifestyle decisions to help prevent or manage symptoms. The company is currently commercializing sugarBEAT(R) and in December 2021 commenced shipments in lieu of an order for 5,000 CGM devices and 200,000 sensors to MySugarWatch Limited, its UK licensing partner. MySugarWatch Limited plans to market the devices to nearly 5 million diabetics and 13.6 million at-risk people in the UK with a subscription model that includes a coaching and management service (https://ibn.fm/tOTMu). In addition, NMRD launched Beta trials of Miboko, a new metabolic health program targeted at global employers and insurers (https://ibn.fm/Yd5xE) as well as the direct to consumer market. In 2011, NMRD initially created a single platform technology that measures blood markers at the skin’s surface and has since adapted the technology to develop non-invasive glucose-monitoring wearable devices. With a unique position at the intersection of both diabetes and weight loss markets, Nemaura is positioned favorably with its proprietary technology in the rapidly growing medical wearable device industry. For more information, visit the company’s website at www.NemauraMedical.com. NOTE TO INVESTORS: The latest news and updates relating to NMRD are available in the company’s newsroom at https://ibn.fm/NMRD

Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) Receives IRB Approval for Kernel Flow Feasibility Study

  • Institution Review Board gives green light to study designed around Kernel’s quantitative neuroimaging technology
  • Kernel Flow device provides ability to measure longitudinal brain activity before, during and after a psychedelic experience
  • CYBN CEO says results from study will further support company’s mission to develop psychedelics into therapeutics
Cybin (NEO: CYBN) (NYSE American: CYBN), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics(TM), has received approval to move forward on a key feasibility study designed to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics (https://ibn.fm/f0HXk). The approval, granted by the Institution Review Board (“IRB”), gives a green light to a Cybin-sponsored study designed around Kernel’s quantitative neuroimaging technology, Kernel Flow. “By leveraging the Kernel Flow technology, we may have the ability to measure longitudinal brain activity before, during and after a psychedelic experience, and collect quantitative data as opposed to subjective patient reporting,” said Cybin CEO Doug Drysdale. “We believe the results of this study will lead to future studies that will test the effectiveness of psychedelic treatments and will further support our mission to develop psychedelics into therapeutics.” Early last year, Cybin partnered with Kernel to leverage Kernel’s proprietary Kernel Flow device for psychedelic-based studies and clinical trials (https://ibn.fm/rRZbn). The first-of-its-kind device uses quantitative neuroimaging technology to measure brain activity in real time using a wearable helmet during psychedelic treatments. In June 2021, Cybin announced it would be sponsoring a feasibility study of the Kernel Flow technology and ketamine. As part of that sponsorship, Cybin has the rights to any innovations that are discovered or developed through its independent analysis of the study findings. The study received U.S. Food and Drug Administration Investigational New Drug (“IND”) authorization in October 2021, and enrollment is expected to begin in the coming weeks. “We still have much to learn about what is occurring in the brain during a psychedelic experience,” said Drysdale. “This first-of-its-kind, Cybin-sponsored study using the Kernel Flow device aims to expand our physiological understanding of psychedelic pharmacotherapy. We are excited to be part of this pioneering journey with our partners at Kernel.” Kernel Flow uses pulsed light instead of continuous wave light to increase measured brain information. In contrast with electroencephalography (“EEG”) electrodes that usually require gel on the head or functional magnetic resonance imaging (“fMRI”) studies that require lying in a scanner, the Flow device is a wearable helmet with potential for wide use in neuroscientific or physiological studies of brain activity during psychedelic use. To date, direct neuroimaging research of psychedelic effects is rare and has never been attempted with a wearable device. Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists to create safe and effective therapeutics for a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The company is focused on progressing psychedelics to therapeutics by engineering proprietary drug-discovery platforms, innovative drug-delivery systems, novel formulation approaches and treatment regimens for mental health disorders. For more information, visit the company’s website at www.Cybin.com. NOTE TO INVESTORS: The latest news and updates relating to CYBN are available in the company’s newsroom at https://ibn.fm/CYBN

Physics, Cost, Favor FuelPositive Corp.’s (TSX.V: NHHH) (OTCQB: NHHHF) Vision of Using Green Ammonia as a Vector for Hydrogen; Company Provides Corporate Update

  • Ammonia is less expensive to transport long-distance via seaborne vessels than liquid hydrogen
  • Ammonia has a lower boil-off rate and higher volumetric energy density than liquid hydrogen; additionally, an ammonia carrier requires less capital investment than a liquid hydrogen transportation vessel
  • FuelPositive holds that green ammonia is a perfect substitute for transporting and storing hydrogen because of existing infrastructure
  • The company recently provided a corporate update in which it detailed the progress of the building of the first demonstration systems for its green ammonia production technology
While the hydrogen economy envisions a decarbonized future where green hydrogen is used to power transportation vessels, a Recharge special report observes that physics and cost back ammonia as a more economic option for long-distance seaborne transportation than liquid hydrogen (“LH2”) (https://nnw.fm/7nHPX). (https://ibn.fm/UJnL4). These findings dovetail perfectly with part of the vision Canadian growth-stage technology company FuelPositive (TSX.V: NHHH) (OTCQB: NHHHF) has for its modular, scalable, and portable green ammonia production technology. The system, designed to produce green ammonia from water, air, and renewable electricity, is touted as a solution to the hydrogen transportation conundrum. According to FuelPositive, green ammonia, which is hydrogen dense and is much easier to store and transport using existing infrastructure, is the perfect vector for hydrogen. As a liquid, hydrogen needs cryogenic temperatures of -253°C, while as a gas, it has to be kept at extremely high pressure. At the same time, it is explosive when it escapes and combines with air (https://nnw.fm/tcwkB). (https://ibn.fm/5oJkB). These characteristics mean that long-distance hydrogen transportation may not be entirely practical. These sentiments are shared by Leigh Collins, the Recharge special report’s author, who notes that because the volumetric density of liquid ammonia is 59% higher than LH2, “it would theoretically take more than three shipments of LH2 to transport the same amount of energy as two shipments of liquid ammonia,” assuming same-sized vessels. Further, Recharge established that a 160,000m3 cargo (a standard LNG vessel size) of liquid hydrogen would cost about $200 per MWh to produce, in terms of the energy it contains, compared to just under $88/MWh of liquid ammonia. In addition, LH2 transportation would result in a $270.5 million annual loss from boil-off compared to $4.1 million when liquid ammonia is transported. With LH2 requiring colder cryogenic temperatures of -253°C to remain as a liquid, compared to liquid ammonia’s -33°C, the Recharge article notes that the latter’s lower annual losses “could be due to the fact that existing ammonia carriers are often fully refrigerated to keep the ammonia in its liquid state – something that isn’t possible with far colder LH2.” The article further points out that the capital cost of a vessel carrying 160,000 cubic meters of LH2 would be higher than one holding the same volume of liquid ammonia. “Taking all these elements into account, it is clear that ammonia would be far less expensive to transport by sea than liquid hydrogen,” Collins writes. FuelPositive’s system is even more advantageous as it uses less energy than conventional (“grey”) ammonia production, which involves the energy-intensive and extremely dirty Haber-Bosch process. In addition, it is 100% carbon-free. Meanwhile, FuelPositive recently announced it had filed its annual audited financial statements and provided a corporate update (https://nnw.fm/4UHU7). (https://ibn.fm/aDEdA). In its update, contained in a NetworkNewsAudio presentation, the company noted that the building of the first demonstration systems for the green ammonia production technology was progressing according to plan and that it expects to commence validating the system in the first half of the year. The validation is anticipated to prove the rate and purity of the produced green ammonia. The company has also selected a farm in Manitoba, Canada, to serve as the first demonstration pilot project. FuelPositive will deploy the first prototype in this location later this summer. Finally, FuelPositive announced advisory appointments as well as the fact that it has identified the Kitchener-Waterloo area as the location for its head office. For more information, visit the company’s website at www.FuelPositive.com. NOTE TO INVESTORS: The latest news and updates relating to NHHHF are available in the company’s newsroom at https://nnw.fm/NHHHF https://ibn.fm/NHHHF

Lexaria Bioscience Corp. (NASDAQ: LEXX) Technology Shows Promise in Improving Performance, Speed of ED Drugs

  • Health and wellness drug bio-effectiveness innovator Lexaria Bioscience is advancing human testing of its patented DehydraTECH(TM) technology for the potential treatment of high blood pressure and heart disease
  • Lexaria also recently announced that DehydraTECH boosted the speed and effectiveness of sildenafil in laboratory rats for the potential treatment of erectile dysfunction (“ED”)
  • The company’s statement notes that DehydraTECH-processed sildenafil “delivered 74% more sildenafil into the bloodstream on average than the concentration-matched, generic control formulation”
  • ED affects some 30 million men in the United States and is expected to affect about 322 million men worldwide by 2025
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, has made a case for increasing the rapidity and effectiveness of medication absorption through Lexaria’s patented DehydraTECH(TM) technology. Recent clinical studies have shown the potential for improved bio-effectiveness of nicotine and cannabidiol (“CBD”) when processed with DehydraTECH for the potential treatment of conditions such as high blood pressure and arterial stiffness, for example. In a Feb. 2 news release, the company announced it has also observed successes when administering DehydraTECH-processed sildenafil to lab rats to study the potential of Lexaria technology in improving the treatment of erectile dysfunction. Viagra, the most widely known sildenafil product in the world, “is moderately bioavailable orally at roughly 40%, but many people find it slow to act,” Lexaria’s news release states (https://ibn.fm/M6FGU). The company’s PDE5-A21-1 animal study found DehydraTECH-processed sildenafil “delivered 74% more sildenafil into the bloodstream on average than the concentration-matched, generic control formulation.” The study suggests sildenafil may take effect much more quickly when processed with DehydraTECH than without it. Seven minutes after the animals received their doses, the DehydraTECH-sildenafil formulation reached an average blood level higher than the generic sildenafil control formulation reached at any point during the study, the company states. The landmark Massachusetts Male Aging Study completed in 1994 reported that 52 percent of men experience some form of erectile dysfunction (“ED”), while other more recent studies have found that about 30 million men in the United States may be affected, with about 322 million men worldwide expected to be affected by 2025 (https://ibn.fm/wotN5). Lexaria’s study could be a boon for Viagra or its generic pharmaceutical competitors in responding to the market for ED solutions that are faster and more effective than current options. The company noted that despite a clear trend toward faster and higher overall delivery of sildenafil into the bloodstream, the improvements in delivery rate did not achieve statistical significance so further investigation with a larger number of animals may be needed. In the meantime, human clinical studies evaluating DehydraTECH’s potential for treating hypertension in combination with CBD are ongoing. In December, the U.S Food and Drug Administration (“FDA”)-registered Independent Review Board (“IRB”) approved the protocols for HYPER-H21-4, which is tentatively expected to begin dosing by April to measure 24-hour ambulatory blood pressure (the primary outcome), blood biomarkers (including lipids such as cholesterol), sleep disorders and perceived stress (https://ibn.fm/PI9QR). These markers will provide information on DehydraTECH-CBD’s impact on chronic heart disease, following on the positive results of the blood pressure studies. For more information, visit the company’s website at www.LexariaBioscience.com. NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://ibn.fm/LEXX

Delic Holdings Corp.’s (CSE: DELC) (OTCQB: DELCF) Delic Labs to Present Latest Results and Insights from Its Extensive Experimental Studies on Cannabis Extraction at the Emerald Conference on February 28

  • Delic Lab’s President and Chief Science Officer, Dr. Markus Roggen, will present at the upcoming Emerald Conference on February 28
  • Delic Labs is a federally licensed research laboratory operating as part of the Delic Holdings ecosystem
  • The laboratory focuses on extraction optimization, analytical testing, and chemical product and process development and is likely to continue supporting the cannabis industry with the latest technology and services as the cannabis market and cannabis extraction spaces mature
Delic Holdings (CSE: DELC) (OTCQB: DELCF) recently announced that Dr. Markus Roggen – the President and Chief Science Officer of Delic Labs, a federally licensed cannabis and psilocybin research laboratory operating as part of Delic’s ecosystem of wellness brands – will present at the 7th Annual Emerald Conference on Monday, February 28, 2022, at 12.45 pm PT (https://ibn.fm/LR1qm). The conference will be held at Loews Coronado Bay Resort in San Diego (https://ibn.fm/uSg9C). Dr. Roggen’s presentation entitled “Artificial Intelligence for Craft Cannabis Products” will offer a unique opportunity for Delic Labs to report the latest results and insights from its comprehensive experimental studies. “Focusing solely on extraction yields for cannabis extraction operations is an imprecise way to think about production,” commented Dr. Roggen. “Quality of extract, cost of extraction, and loss in post-processing should all be considered. Our laboratory undertook extensive experimental studies on the extraction behavior of various solvents, and we’re excited to present our latest results and insights from developing and utilizing our extraction optimization AI.” As a research laboratory, Delic Labs focuses on extraction optimization, analytical testing, and chemical product and process development. In addition, the lab supports the psychedelic and cannabis industry with metabolomic identification, formulation research, process design and optimization, and high precision chemical analytics. Delic Labs also plans to develop a suite of novel compounds and delivery methods for the industry. Dr. Roggen will be one of the more than 20 industry-leading speakers at the two-day event to be held at the Loews Coronado Bay Resort in San Diego (https://ibn.fm/EzvsZ). Considered the original, longest-running interdisciplinary cannabis science event, the Emerald Conference is expected to connect the scientific community through presentations, exhibitions, and networking opportunities. Organizers have worked to ensure that this year’s conference will feature the latest research and emerging trends, issues, and opportunities. Little wonder, then, that Delic Labs is set to showcase results from its groundbreaking research on AI. Through research, Delic Labs is innovating and subsequently pushing the boundaries of what is expected from cannabis extraction processes. And with multiple countries and states looking to legalize cannabis use in 2022, joining scores of trailblazers that have already decriminalized the substance, Dr. Roggen’s presentation and the results and insights he is set to share could not have come at a better time. According to a Prohibition Partners report (https://ibn.fm/Q9LFt), the cannabis extraction space is set to evolve rapidly and become highly competitive as the global cannabis market matures and regulatory frameworks are established. “The ability and willingness of companies to leverage the latest technology and services in the cannabis extraction sector will mean the difference between their success, or failure, in the space,” the report reads. Through its innovative approach to conducting research and the resulting discoveries, Delic Labs appears poised to continue supporting the cannabis industry with advanced technology and services as the cannabis market matures, providing the necessary innovation for companies to remain competitive and successful. Since its founding in 2018, Delic has progressively built a robust ecosystem targeting psychedelic wellness. Its portfolio of brands currently includes the largest chain of ketamine clinics in the United States (Ketamine Wellness Centers), media platforms (Delic Radio and Reality Sandwich), a psychedelic wellness event (Meet Delic) and Delic Labs. For more information, visit the company’s website at www.DelicCorp.com. NOTE TO INVESTORS: The latest news and updates relating to DELCF are available in the company’s newsroom at https://ibn.fm/DELCF

Kaival Brands Innovations Group Inc. (NASDAQ: KAVL) Benefits from Court Decision Permitting Bidi Vapors to Resume Sales

  • On February 1, 2022, Kaival Brands’ product partner, Bidi Vapors LLC was granted a judicial stay on the marketing denial order issued by the US FDA, enabling the company to resume sale of their products within the US market
  • The legal action comes after the FDA moved to oust over 946,000 vaping products from the market through the issuance of blanket MDO’s whilst approving only 3 over the course of a year-long review
  • Bidi Vapor LLC sought to contest the MDO, arguing that their near-285,000-page PMTA filing contained robust and reliable scientific data touting the benefits of their flavored BIDI(R) stick products relative to tobacco-flavored ENDS
  • The company’s management believe the judicial stay will lead to a marked improvement in overall sales, with Bidi Vapor’s former distributors likely to resume prior orders
Following months of legal inertia, on February 1, 2022, the Eleventh Circuit Court of Appeals granted Bidi Vapor LLC a judicial stay on their marketing denial order (“MDO”) which was issued by the Food and Drug Administration (“FDA”) (https://ibn.fm/B65bR). In effect, the legal decision enables Bidi Vapor to continue marketing and selling their product while lawsuits remain active. Kaival Brands Innovations Group (NASDAQ: KAVL), a company dedicated towards fostering and incubating companies into mature, dominant brands and global distributor for Bidi Vapor LLC, hailed the decision which followed on from the FDA’s decision to deny and oust thousands of products from the marketplace through its new premarket tobacco product application (“PMTA”) process. Originally conceived to determine whether a given product was “appropriate for the protection of public health” – an ambiguous concept understood to symbolize a given product’s likelihood to help adult smokers transition to safer alternatives, the FDA had set a deadline of September 2020 for vape companies to submit PMTA applications to support their respective products’ health bonafides. However, a year later and having only authorized a single vaping product and two tobacco-flavored cartridges in the interim, the FDA issued a near blanket denial decision, turning down thousands of applications from small- to medium-sized companies whilst simultaneously, delaying making decisions on companies with the largest market shares. Following their original receipt of the FDA PMTA request in 2018, Bidi Vapor embarked on a near-two-year effort to assemble its PMTAs at a total cost of around $6.6 million. The company would go on to file 285,000 pages of information, “including health risk and toxicological data, marketing restrictions, and scientific literature reviews,” and “demonstrated [the] products provide substantial benefits in terms of lower relative health risks [compared with smoking]”, ahead of the deadline. However, the efforts were apparently, largely in vain. The FDA, which had previously explicitly stated in writing that there were no requirements for a company to carry out clinical studies to support their PMTA or evaluate substitute products within their filing, allegedly went on to issue a MDO to any company which had failed to include at least two specific long-term studies within their PMTA application. In a subsequent lawsuit filed by Bidi Vapor against the FDA, the plaintiff went on to argue, “Indeed, [the] FDA never said Bidi must compare the cessation benefits of its non-tobacco flavoured products to its tobacco flavoured product and [that] the absence of such a study would, without any scientific review, automatically result in an MDO.” The Eleventh Court of Appeals has now granted judicial stays to three other manufacturers in addition to Bidi Vapor LLC, including the likes of Diamond Vapor, Johnny Cooper, and Vapor Unlimited – with all four companies permitted to market their products freely in the United States in lieu of a final court verdict. Meanwhile, the majority of the over 946 thousand flavored e-cigarette products subject to the original FDA-issued MDOs continue to languish out of the market nearly six months removed from the FDA’s decision whilst awaiting further court-ordered resolutions over the coming weeks and months (https://ibn.fm/reb4W). Bidi Vapor and Kaival Brands expressed their satisfaction with the court order and reiterated their belief that the decision would result in a significant improvement in the companies’ sales effort. “We expect this judicial stay will result in a rebounding of BIDI(R) Stick sales,” said Niraj Patel, president and CEO of both Kaival Brands and Bidi Vapor. “Many wholesale and retail partners had discontinued or slowed purchases of the BIDI(R) Stick, until we heard back from the courts on the likelihood of our merits case succeeding,” Patel said. “This is what our wholesale and retail partners have been waiting for.” For more information, visit the company’s website at www.KaivalBrands.com. NOTE TO INVESTORS: The latest news and updates relating to KAVL are available in the company’s newsroom at http://ibn.fm/KAVL

The Alternative Products Expo To Offer Important Networking Opportunities

The Alternative Products Expo presented by 3Chi arrives in Fort Lauderdale March 11-13 to feature the scope and potential of all innovative products and services of the alternative products ecosystem. Organized by ZJ Events, the event group is committed to bringing the industry’s best alternative products traders, vendors, and enthusiasts under one roof, while offering a fun and exciting experience. Having conducted its CBD shows in the top cities of America, ZJ Events is all set to host an exciting new event in Fort Lauderdale, The Alternative Products Expo. The alternative product category includes herbal products, mood enhancers, cannabis derivatives, vape products, energy boosters, and dietary supplements, to name. Products in the alternative category comprise products that are disrupting the traditional products; they are either substitutes for better-known products or there are no substitutes for them in the mainstream category. Exhibitors can showcase their products at dedicated booths and opt for sponsorships to conduct advertising to drive traffic to their booths wherein they impart extensive information regarding their products and services. There will also be several show specials to offer discounts on wholesale pricing for store owners. The products/services can be exhibited under the following Industry types: Accessories (Glass, Rolling papers, etc), cannabis and cannabis derivatives such as CBD, hemp, delta8, and more, dietary supplements, functional beverages, herbal products, kratom, mushrooms, nicotine replacements, nootropic, psychedelics, service providers, vape, and others. Thought leaders at the event will discuss vital topics and share valuable information about the latest market trends of the growing alternative product ecosystem. The conference offers a huge arena for joint venture collaborations and gives attendees direct access to connect with worldwide cannabis industry leaders who share their vision about the future scope of these products. The Alternative Products Expo includes keynotes, discussions, and workshops from eminent industry personas who will share important insights and education about the latest trends in the alternative products ecosystem. This event is a suitable platform for new businesses and traders to explore and discover long-term business opportunities in this niche. The influential speaking faculty includes an impressive line-up of industry thinkers, professionals, and executives who have immense knowledge and experience in the alternative products field which they will share with the attendees of the conference. With the growing inclination towards the alternative products category, vendors, and new businesses can connect with established traders and build long-term ties that are beneficial for the success of their company. For more information, please visit https://altproexpo.com/.

Eat Well Investment Group Inc. (CSE: EWG) (OTC: EWGFF) Marks Another Key Milestone in its 2022 Accelerated Distribution Plan Following Expansion Into HEB Grocery Stores

  • Eat Well Group’s majority-owned portfolio company, Amara, will now be available in 200 HEB grocery stores in the United States
  • This move strengthens the company’s retail shelf footprint and adds to the growing number of brick and mortar stores stocking Amara products, including Walmart Canada, Whole Foods, Loblaws, and Sprouts Farmers’ Market
  • Amara’s management is optimistic that this milestone will be integral to the company strengthening its brand and increasing its sales going forward
At the beginning of the year, Eat Well Investment Group (CSE: EWG) (OTC: EWGFF) announced its Amara Organic Foods’ expanded distribution to Walmart Canada and Walmart’s growing e-commerce platform. Amara, Eat Well Group’s majority-owned portfolio company, is currently one of the fastest-growing baby food brands in the United States, with other products in its portfolio including Tropical Mango, Peas, Carrots, and Corn. In what marks a significant move in the company’s accelerated distribution plan for the 2022 financial year, Eat Well Group announced that Amara products would now be available at HEB grocery stores all over the United States (https://ibn.fm/uBcIp). While appearing on The Power Play by The Market Herald, Marc Aneed, the Chief Executive Officer (“CEO”) of Eat Well Group, noted that this expansion opens the company to over 200 locations in one of the largest independently owned food retailers in America. Jessica Sturzenegger, the Founder and CEO of Amara, expressed her optimism with this new deal, citing how it would bring products closer to consumers. “We’re thrilled to be expanding our retail shelf footprint with one of our key retailers, HEB,” she noted. “It’s a true testament to Amara’s strong growth in the category and the changing customer. Customers are increasingly thinking about the food they eat, and Amara’s truly the only baby food that can bring all the benefits of fresh with the convenience of shelf stable,” she added (https://ibn.fm/6XHGq). The distribution to HEB adds to Eat Well Group and Amara’s strong retail footprint, given that its products can now be found on Walmart Canada, Whole Foods, Loblaws, and Sprouts Farmers’ Market stores across North America. As a result, Amara’s management is optimistic that this move will strengthen its brand and increase sales going forward. For more information, visit the company’s website at www.EatWellGroup.com. NOTE TO INVESTORS: The latest news and updates relating to EWGFF are available in the company’s newsroom at https://ibn.fm/EWGFF

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