CBD Based Treatments Grow in Popularity as Regulators Soften Stance

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Jun 28, 2019, 09:00 ET

NEW YORK, June 28, 2019 /PRNewswire/ -- With the spread of pharmaceutical therapy, the cannabidiol market is positioned to experience immense growth in the shortcoming years. Cannabidiol, or CBD, is a derivative found within the cannabis plant. While CBD stems from the cannabis plant, it does not offer the same effects that cannabis is commonly associated with. Instead, CBD offers consumers a more relaxing and therapeutic effect as opposed to a psychoactive "high." Typically, legally sold CBD is derived from the hemp plant, which falls within the cannabis family. Compared to its marijuana counterpart, hemp generally contains less than 0.3% THC levels, which cannot cause any cerebral-altering effects. Henceforth, many medical institutions are evaluating the efficacy of CBD and potentially leveraging it for medical applications. Furthermore, current studies have linked CBD to the successful treatment of a number of ailments such as cancer, chronic pain, multiple sclerosis, and epilepsy. Primarily, most studies have returned promising results and as a result, the U.S. Food and Drug Administration ultimately approved Epidiolex, the first ever cannabis-derived drug, in order to treat epilepsy among children. The approval of Epidiolex marked a historic milestone for the cannabis industry because it is the first time a cannabis-based product has been recognized by a U.S. agency since the prohibition era began. The FDA's decision highlights the medical importance that CBD can offer for consumers. However, in order to progress further in the medical cannabis marketplace, the FDA said it requires more large-scale positive clinical trials to fully understand CBD. Nonetheless, more and more countries around the world are beginning to explore opportunities within the CBD industry. Significant economic, political, and legislative shifts across the world are expected to impact the approval of CBD. According to data compiled by Reports and Data, the global CBD market is expected to grow from USD 1.04 Billion in 2018 to USD 16.32 Billion by 2026. Additionally, the market is projected to witness a CAGR of 27.7% during the forecasted period. Pressure BioSciences, Inc. (OTC: PBIO), Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), Charlotte's Web Hldgs Inc. (OTC: CWBHF) (CSE: CWEB), The Green Organic Dutchman Holdings Ltd. (OTC: TGODF) (TSX: TGOD), MariMed, Inc. (OTC: MRMD)

A recent study conducted by Jamie Corroon, the Founder and Medical Director of The Center for Medical Cannabis Education in California, and Joy A. Phillips, Research Assistant Professor at Donald P. Shiley BioScience Center in San Diego State University, concluded that CBD is being used for several diverse medical conditions and noted that the study provides rational data for better understanding the cannabinoid. In their research, the two found that almost 62% of CBD users were using CBD to treat a medical condition. Among the top three conditions, the study uncovered that pain, anxiety, and depression were the most common. Out of the group's respondents, 36% said that CBD helped treat their conditions "very well by itself," while only 4.3% reported, "not very well." In another study, researchers discovered that CBD can treat pain effectively on its own and even when paired with THC. When used alone, CBD is predominantly better suited for inflammatory pain caused by arthritis or injuries. According to Analytical Cannabis, CBD does not directly bind to the receptors found in the endocannabinoid system but rather works to modulate the effects of the endocannabinoids as well as working as CB1 receptor antagonist. Additionally, CBD can help alleviate pain by blocking inflammatory mediators. Furthermore, CBD has also been linked to increasing glycine receptors, which helps suppress pain at the spinal level. The two studies highlight that CBD can be used for both inflammatory and neuropathic pain. In conclusion, many ongoing and concluded studies have praised CBD for its therapeutic benefits. Moreover, researchers are someday hoping that CBD could potentially become a recognized and approved medicinal treatment. "Over the past decade I've covered a wide range of consumer markets, from foods and drinks to telecom, gaming and even cannabis. I have never seen anything like the explosion that we're seeing right now in CBD, even with the bizarre legal gray area where CBD now operates," said Bethany Gomez, Managing Director at Brightfield Group. "CBD is the next healthcare phenomenon. It is so effective for so many conditions, is natural, non-psychoactive and has no known serious side effects."

Pressure BioSciences, Inc. (OTCQB: PBIO) announced yesterday the launch, "of its BaroShear K45 system based on the Company's proprietary Ultra Shear Technology (UST) platform. The BaroShear K45 system is a unique and powerful next generation nanoemulsification system designed to fix one of the most critical problems facing CBD manufacturers today: the extremely poor water solubility of CBD oil.

CBD, a non-psychoactive compound believed to offer powerful health benefits, is extracted from the cannabis plant in an oil. After ingestion, because oils are not well absorbed, most of the CBD is flushed from the body, leaving little of the product to provide its beneficial properties. Because of these solubility issues, many CBD products on the market today contain an inefficient over-abundance of CBD and/or undesirable chemicals to try and improve its solubility in water.

For most oil-based products, the ability to prepare them as nanoemulsions can improve the product's absorption, medicinal benefits, visual appearance, and sensory presentation. Unfortunately, traditional processing methods struggle with this challenge. PBI's patented UST platform uses ultra-high pressure to create extreme shearing forces to make highly stable, homogenized nanoemulsions of materials that normally do not mix, such as CBD Oil and water. To view PBI's UST-processed CBD oil being added to a soft drink, a sports drink, and a beer, please use the following link: PBI UST CBD Video 040219 (https://www.youtube.com/watch?v=gAqFQmsGHcA&feature=youtu.be).

Dr. Nathan Lawrence, Senior Advisor to PBI, said: "The unique concept of the BaroShear K45 system is based on PBI's proprietary UST platform. It was designed for the efficient and affordable manufacture of limited quantity oil-based material into high quality, water-soluble nanoemulsions. The BaroShear K45 system uses a custom-designed, highly responsive ultra-high pressure generating subsystem, matched to our patented BaroIsolator device and NanoGap valve. This allows for the highest effectiveness possible at working pressures up to 45,000 psi. The BaroShear K45 system is ideally suited for processing small amounts (e.g., 50 mL - 2 L) of high value product, such as CBD oil, into nanoemulsions with high yield."

Dr. Bradford A. Young, Chief Commercial Officer of PBI, commented: "Over the past several months, we have spoken with dozens of CBD companies. A common theme has been their desire to develop new and improved delivery methods for CBD and their concern with how best to make stable nanoemulsion mixtures of CBD oil and water. Our new UST platform, the BaroShear K45 system, can help companies make high quality, CBD-based products using physics (e.g. ultra-high pressure) instead of chemistry (e.g. lots of strong detergents). We look forward to helping our customers address the large and growing market for CBD infused foods, beverages, cosmetics and topicals."

The total cannabinoid market is expected to hit$89 billion by 2024 (https://mordorintelligence.com/industry-reports/cannabis-market), with CBD oil-based products being the cornerstone of the non-psychoactive portion of this exploding market. For CBD products commonly consumed orally - including CBD oils in edibles and beverages - absorption is typically below 10% (ERTH 8/28/2018: Water Soluble CBD - The Science of Nanoemulsions and Bioavailability). PBI believes that processing with the UST-based BaroShear K45 system will deliver greatly improved absorption results (potentially as high as 90%) for CBD and other oil-based supplements.

Dr. Keith Warriner, Professor of Food Science at the University of Guelph (Toronto), and a recognized expert in the cannabis industry, commented: 'The data I have reviewed to date on UST-generated nanoemulsions of CBD oil are very impressive. Creating nanoemulsions of CBD oil with full preservation of CBD throughout the process, while not generating impurities, remains a significant challenge in the industry. These data indicate that UST can achieve that goal, thereby offering great promise to the future.'

Richard T. Schumacher, President and CEO of PBI, said: 'The BaroShear K45 system will list for $195,000; we believe that sales of these Systems will become a major revenue-generating part of our business. We will be accepting purchase deposits on pre-sale orders immediately. Based on feedback from potential customers, we believe purchase deposits on instruments from the initial build could start being received by mid-July. We plan to stop accepting purchase deposits on September 30th; however, we will stop earlier if demand exceeds reasonable manufacturing limits.'

Mr. Schumacher continued: 'We are looking forward to working with the early adopters of this exciting technology platform. Early adopters will be the first to use the UST platform in the CBD field, thus giving them a significant head-start over companies who choose to wait or useother methods. They will always be the first to get full access to new instruments, technologies, and applications that can positively impact the UST platform (a commitment to early adopters). They will also have "most favored nation" pricing for subsequent UST platform systems. Finally, because there is much to learn about CBD formulations and their benefits for various factors, we will be offering collaboration opportunities to the first three groups who submit purchase deposits. This is a very exciting time for the entire PBI Team, and for all stakeholders in PBIO.'

About Pressure BioSciences, Inc: Pressure BioSciences, Inc. (OTCQB: PBIO) is a leader in the development and sale of innovative, broadly enabling, pressure-based solutions for the worldwide life sciences industry. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or PCT) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions (e.g., cell lysis, biomolecule extraction). Our primary focus is in the development of PCT-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, soil & plant biology, forensics, and counter-bioterror applications. Additionally, major new market opportunities have emerged in the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired, patented technology from BaroFold, Inc. (the "BaroFold" technology) to allow entry into the bio-pharma contract services sector, and (2) the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology ("UST") platform to (i) create stable nanoemulsions of otherwise immiscible fluids (e.g., CBD Oil and water) and to (ii) prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing technologies."

For our latest "Buzz on the Street" Show featuring Pressure BioSciences, Inc. recent corporate news, please head over to: https://www.youtube.com/watch?v=IHP93mf4ClM

Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) is the leader in pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. Zynerba Pharmaceuticals, Inc. recently announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track Designation for the Company's lead development candidate Zygel™ (ZYN002 CBD gel) for treatment of behavioral symptoms associated with Fragile X Syndrome (FXS). FDA's Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs and can lead to expedited review by FDA in order to get new important drugs to the patient earlier. Zygel (CBD gel) is the first and only pharmaceutically-manufactured CBD formulated as a patent-protected permeation-enhanced clear gel, designed to provide controlled drug delivery into the bloodstream transdermally (i.e. through the skin). Recent studies suggest that FXS and other neuropsychiatric conditions may be associated with a disruption in the endocannabinoid (EC) system. "The FDA's decision to grant Fast Track Designation for Zygel underscores the significance and severity of the unmet medical need that exists for patients living with Fragile X Syndrome and their caregivers," said Armando Anido, Chairman and Chief Executive Officer of Zynerba. "We believe that Zygel has the potential to be the first treatment indicated to directly address the core behavioral symptoms of this syndrome, and we look forward to working closely with the FDA to obtain approval to market Zygel as soon as possible."

Charlotte's Web Hldgs Inc. (OTCQX: CWBHF) (CSE: CWEB) is the market leader in the production and distribution of innovative hemp-based cannabidiol ("CBD") wellness products. Charlotte's Web Holdings, Inc. recently reported its 2018 harvested hemp results. The Company reported more than a 10 times growth in harvested hemp compared to its 2017 grow season. The high-quality 100% U.S.-grown hemp will be processed through proprietary extraction methods to create whole plant hemp extract that will be used in Charlotte's Web products for sale in 2019 and 2020. "Charlotte's Web is one of only a few hemp CBD producers capable of supplying large volumes of high-quality hemp extract from its own supply chain that can meet significantly increasing market demand," said Hess Moallem, President and Chief Executive Officer of Charlotte's Web. "As the category and brand leader, our goal is to increase our market share and with this bountiful harvest we are able to satisfy our customer demands for 2019 and beyond. This incredible harvest ensures we can continue to produce our high-quality human nutrition products without being subject to constantly fluctuating market prices as is common with third-party sourced raw material. This allows us to have better control and predictability over our cost of goods sold and thereby our gross margins. In addition, these harvest levels will allow us to explore opportunities to supply future partners with our proprietary hemp extracts."

The Green Organic Dutchman Holdings Ltd. (OTCQX: TGODF) (TSX: TGOD) is a research & development company licensed under the Access to Cannabis for Medical Purposes Regulations ("ACMPR") to cultivate medical cannabis. The Green Organic Dutchman Holdings Ltd. recently announced that it had signed a definitive agreement to acquire 100% of the issued and outstanding shares of privately-held HemPoland in an immediately accretive cash and share transaction. HemPoland is a leading European manufacturer and marketer of premium organic CBD oils led by Founder and Chief Executive Officer, Maciej Kowalski, one of Europe's most widely recognized CBD experts. This strategic acquisition provides access to HemPoland's vast distribution network, premium Cannabigold brand, state-of-the-art hemp oil extraction technologies, and provides a strategic pathway into the European market for TGOD's medical & recreational products and licensing deals. "HemPoland is a key component to a number of strategic acquisitions and planned partnerships focused on expanding our global distribution network. This acquisition will significantly add to the Company's top and bottom line," said Brian Athaide, Chief Executive Officer of TGOD. "Gaining market share with CBD products now, in the EU, with over 700 locations allows TGOD to establish immediate brand awareness across all verticals including infused beverages. This is an accretive acquisition and gateway to Europe's 750 million people accelerating our plan of becoming the world's largest organic cannabis brand," continued Athaide.

MariMed, Inc. (OTCQB: MRMD) is dedicated to improving health and wellness with the highest quality hemp and cannabis products. MariMed Inc. recently announced that its MariMed Hemp subsidiary will acquire 70% of MediTaurus, LLC, owner of the international Florance™ brand of CBD health and wellness products and extensive intellectual property (IP) relating to cannabis formulations. The Florance™ brand is established in the U.S. and EU with online distributors, wholesalers, pharmacies and physicians. Terms of the transaction were not disclosed. This is the first acquisition for MariMed Hemp, which was formed to optimize MariMed's strategic investment in GenCanna Global, Inc., the Kentucky-based producer of compliant, quality CBD derived from hemp. Bob Fireman, Chief Executive Officer of MariMed Inc., noted, "This transaction is extremely important for MariMed for three reasons: First, from an operational standpoint, the Florance™ brand jump-starts our MariMed Hemp division with an established, premium line of CBD health and wellness products and formulas in the U.S. and the EU, global licensing of MediTaurus IP; and a network of established European relationships. Florance™ provides a ready platform for new product introductions, including diversity of the uses of hemp including food, food supplements and topicals. MariMed will help rapidly scale up production, distribution and licensing partnerships throughout the major U.S. markets where MariMed operates and sells. Second, with MediTaurus and its co-founders, including Dr. Žiburkus, comes a wealth of expertise and research experience into the benefits and function of compounds found in cannabis and hemp. Dr. Žiburkus will be both a trusted advisor and continue his key roles of needed scientific research and balanced education of the medical community on the benefits cannabinoids offer for a variety of health conditions. Finally, MediTaurus is a perfect fit with MariMed's mission, values and corporate culture to unlock and introduce the known and yet-to-be-discovered health benefits of cannabis and hemp."

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