Pressure Biosciences Inc (PBIO)

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Hemp's FDA Declassification Opens Door to Massive CBD Market Growth
9:00 am ET January 31, 2019 (PR Newswire) Print
FinancialBuzz.com News Commentary

Cannabis is a family of plants that splits into two categories, marijuana and hemp. However, marijuana contains the psychoactive components of the plant while hemp has more practical uses such as clothing. Due to the effects of marijuana, it is currently more regulated as opposed to hemp. Hemp, being the non-psychoactive derivative of cannabis currently enjoys significantly less Federal regulations around the country, and, due to the current status of hemp, the industry is positioned to see significant growth. According to data compiled by Hemp Business Journal, a division of New Frontier Data, the U.S. hemp industry registered sales of USD 820 Million in 2017 and is expected to reach USD 1.9 Billion by 2022. Additionally, the market is projected to grow at a CAGR of 14.4% during the forecast period. Pressure BioSciences, Inc. (OTC: PBIO), GW Pharmaceuticals plc (NASDAQ: GWPH), Cronos Group Inc. (NASDAQ: CRON), Organigram Holdings Inc. (OTC: OGRMF), Emerald Health Therapeutics, Inc. (OTC: EMHTF)

Within the hemp industry, CBD products held the largest market value in 2017, delivering USD 190 Million in sales. CBD was also recently delisted from its status of a Schedule 1 drug by the U.S. Food and Drug Administration, prompting a robust growth. By 2022, the segment is expected to drive in sales of USD 646 Million and continue to dominate the overall U.S. hemp industry. Hemp-derived products include tinctures, topicals and capsules, which are all being used for both medical and recreational applications due to their relaxing and therapeutic effects. "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. A few years ago almost no one knew what hemp-derived CBD was," said Bethany Gomez, Managing Director at Brightfield Group. "All of a sudden, CBD is everywhere - it is both a trendy new ingredient in drinks, face creams and pet treats and an answer to the prayers of so many people suffering from medical conditions ranging from epilepsy to anxiety and chronic pain."

Pressure BioSciences, Inc. (OTCQB: PBIO) just announced breaking cannabis news earlier this morning that, "a collaboration to advance the development of a new generation of health and wellness nutraceutical products based on processing by PBI's proprietary Ultra Shear Technology (UST(TM)) platform. The Companies believe that nanoemulsions prepared by the UST Platform will have improved quality and effectiveness compared to current emulsions, which will help to facilitate the development of a new generation of improved nutraceutical and other emulsion-based products, such as cosmetics and pharmaceuticals.

PBI is a leader in the development and sale of enabling high pressure-based instruments, consumables, and related services for the life sciences industry. PBI has more than 300 high-pressure instruments installed in over 200 life sciences laboratories worldwide, including in some of the world's leading academic, government, and biopharmaceutical laboratories.

NTFU manufactures and distributes nutritional and dietary supplements focusing on in-house product development and the highest manufacturing standards. All quality control testing and manufacturing processes are in compliance with FDA and cGMP standards. NTFU has developed multiple products for the wellness and nutraceutical markets, including formulas to support energy and focus, sleep, stress, joints, and weight loss.

Edgar J. Ward, President and CEO of NTFU, said, 'We pride ourselves in ensuring that we incorporate the highest level of quality possible in our manufactured products. When we heard that PBI was developing their new, proprietary UST processing platform, and learned of its potential to significantly increase the quality and effectiveness of nutraceutical products, we spoke with PBI and offered to help accelerate its commercial introduction. We are thrilled to be working with such experienced scientific leaders and innovators, in a program that we believe can change lives worldwide for the better.'

Mr. Ward continued, 'We believe PBI's UST platform has the potential to create long-term room temperature stable, water-soluble nanoemulsions of oil-based solutions. Nanoemulsions are known to offer greater stability and bioavailability than the standard macroemulsions used today in nutraceuticals, cosmetics, and other industries. We are excited to have the opportunity to work with a life science industry leader in the optimization of a process that has the potential to bring higher quality not just to our products, but to nutraceutical products worldwide.'

Dr. Bradford A. Young, Chief Commercial Officer of PBI, commented, 'We are pleased to have the opportunity to work with NTFU's scientists and manufacturing personnel in the development of new and improved nutraceutical products utilizing our UST platform. This proprietary technology employs ultra-high pressure and extreme shearing forces to create nano-scale emulsions of oil and water with long-term stability. For many oil-based products, the ability to create very small, nanometer-sized oil droplets that can effectively dissolve in water (nanoemulsions) can improve a product's appearance, sensory and medicinal benefits. There is a large and growing market opportunity for nutraceutical products with proven health and wellness benefits. We believe PBI's UST platform can help manufacturers accelerate growth and success in this market with higher quality, water-soluble, oil-based products with superior dietary absorption and shelf-life.'

Mr. Richard T. Schumacher, President and CEO of PBI, added, 'We are excited to work with Edgar and his NTFU team in the optimization of our UST platform, which we believe will result in the development of new and beneficial health and wellness products. The staff at NTFU has years of experience in manufacturing nutraceutical products in a quality environment. They also have access to both raw materials and finished goods, both of which are needed for optimization. Finally, they have an existing analytical laboratory with state-of-the-art equipment and well-trained chemists who can perform testing on both pre and post-processed materials, which will be invaluable to the optimization process. This collaboration clearly supports both company's strategic objectives: we look forward to an exciting and mutually beneficial relationship with our colleagues at NutraFuels.'

About Pressure BioSciences, Inc. - Pressure BioSciences, Inc. (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 high pressure-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, food science, soil & plant biology, forensics, and counter-bioterror applications. Additionally, we are actively expanding the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired protein disaggregation and refolding technology from BaroFold, Inc. to allow entry into the biologics manufacturing and contract research 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., oils 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 non-thermal technologies.

About NutraFuels, Inc. - NutraFuels, Inc was founded in 2010 and has evolved into a branded and private label developer, distributor and Food and Drug Administration registered (FDA) manufacturer. NTFU's products include a range of nutraceutical, wellness, and CBD products as well as a cosmetics line. NutraFuels' manufacturing process received the Good Manufacturing Processes Standard (GMP) certification. Its products adhere to high manufacturing standards throughout every step of the manufacturing and extraction process. NTFU's product testing and research and development is conducted by four chemists under the direction of NTFU's founder and Chief Executive Officer, Edgar Ward."

GW Pharmaceuticals plc (NASDAQ: GWPH), founded in 1998, is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW Pharmaceuticals plc recently announced positive top-line results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of EPIDIOLEX(R) (cannabidiol or CBD) CV in the treatment of seizures associated with Dravet syndrome, a rare and severe form of childhood-onset epilepsy. In this trial, EPIDIOLEX, when added to the patient's current treatment, achieved the primary endpoint of reduction in convulsive seizures for both dose levels (10 mg/kg per day and 20 mg/kg per day) with high statistical significance compared to placebo. Both EPIDIOLEX doses also demonstrated statistically significant improvements on all key secondary endpoints. "The positive results from this trial follow the recent FDA approval, DEA rescheduling and U.S. launch of EPIDIOLEX for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut Syndrome in patients two years and older. These data show an effective dose range in Dravet syndrome that is consistent with our FDA approved label, and which allows for dosing flexibility to address individual patient needs," stated Justin Gover, GW's Chief Executive Officer. "We are proud to have recently launched EPIDIOLEX, the first FDA-approved plant-derived cannabinoid medicine and are excited about its potential to help the lives of patients and their families."

Cronos Group Inc. (NASDAQ: CRON) is a globally diversified and vertically integrated cannabis company with a presence across five continents. Cronos Group Inc. recently announced that it has entered into a sponsored research agreement with the Technion Research and Development Foundation of the Technion - Israel Institute of Technology ("Technion") to explore the use of cannabinoids and their role in regulating skin health and skin disorders. The preclinical studies will be conducted by Technion over a three-year period and will focus on three skin conditions: acne, psoriasis and skin repair. "We believe that the potential applications of cannabinoids to regulate skin health and treat skin disorders are vast, and we are excited to begin exploring these applications through our partnership with Technion," said Mike Gorenstein, Chief Executive Officer of Cronos Group. "Using rigorous data to develop efficacious topical and transdermal formulations will be key to creating differentiated products that provide quality treatments to our consumers and strengthen our brand portfolio."

Organigram Holdings Inc. (OTCQX: OGRMF) is a TSX Venture Exchange listed company whose wholly owned subsidiary, Organigram Inc., is a licensed producer of cannabis and cannabis-derived products in Canada. Organigram Holdings Inc. announced the Company has entered into an agreement with 1812 Hemp, a New Brunswick based industrial hemp research company to secure supply and support research and development on the genetic improvement of hemp through traditional plant breeding methods. 1812 Hemp is focused on further developing a line of Canadian cultivars (specific varieties of plants cultivated to enhance desirable qualities) of high cannabidiol (CBD) yielding hemp for the Canadian climate. "Maximizing the CBD yield of hemp and cannabis means being able to meet increasing consumer demand for CBD while reducing overall production costs," explains Greg Engel, Chief Executive Officer Organigram. "We are proud to work with other industry-leading companies and researchers to continue to explore the potential of hemp and cannabis plants and the efficiency with which we can deliver CBD to our customers."

Emerald Health Therapeutics, Inc. (OTCQX: EMHTF) is a Licensed Producer under Canada's Access to Cannabis for Medical Purposes Regulations and produces and sells dried cannabis and cannabis oil for medical purposes. Recently, Emerald Health Therapeutics, Inc. agreed to purchase from Emerald Health Hemp Inc. (EHH) CBD-containing hemp biomass for extraction into CBD oil. EHH has established agreements to purchase approximately 500 acres of harvested hemp chaff, plant material consisting mainly of flower and leaf, in Manitoba and Prince Edward Island in 2018, with a plan to expand field operations in 2019. Emerald has signed an agreement with EHH to purchase approximately 500 acres of chaff in 2018 and approximately 1,000 acres in 2019 to 2022, with an option to renew for an additional two-year period. The hemp chaff will be processed via Emerald's exclusive alliance with Factors R&D Technologies Ltd., a division of Factors Group of Nutritional Companies Inc., which has extensive extraction experience and large capacity. "We see non-smoked, non-psychoactive CBD consumption as a major growth opportunity in both the medical and adult-use market in Canada, and our Factors Group alliance uniquely positions us with the largest biomass extraction and softgel encapsulation facility in Canada to produce value-added products to serve this market," said Chris Wagner, Chief Executive Officer of Emerald. "Our intent is to secure significant low-cost cannabinoid supply to serve all our manufacturing and marketing goals and hemp is expected to be our lowest cost source of CBD. We are very pleased with the rapid advancement of our Pure Sunfarms production joint venture with Village Farms and our St. Eustache facility in Quebec. Our collaboration with Emerald Health Hemp now expands our ability to produce CBD products."

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