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Research and Development of Cannabis for Medical Markets Bolsters its Credibility

NEW YORK, March 7, 2019 /CNW/ -- There has been a growing focus on medical cannabis for treatment in the last 20 years. Various studies conducted have noted that cannabis can effectively aid in the treatment of chronic and degenerative diseases. While medical cannabis still remains illegal in most countries, some are moving to adopt it. Countries such as Canada, Colombia, Czech Republic, Chile, the Netherlands, and Spain all allow cannabis for medicinal use. The acceleration of the medical sector is primarily being driven by the rising number of life-threatening diseases. Healthcare facilities are adding credibility to cannabis since it is more often being used as an alternative medication. Specifically, cannabis can be used to replace medication used for insomnia, anxiety, antidepressants, seizures and nausea. As research and development of cannabis continuously improve, medical cannabis is set to see widespread adoption by governments all over the world. According to data compiled by Zion Market Research, the global medical marijuana market was valued at approximately USD 11.81 Billion in 2017 and is expected to generate revenue of approximately USD 40.90 Billion by 2024. Furthermore, the market segment is expected to exhibit a CAGR of 19.4% between 2018 and 2024. Pressure BioSciences, Inc. (OTC:PBIO - News), Aurora Cannabis Inc. (NYSE:ACB - News) (TSX:ACB.TO - News), Youngevity International, Inc. (NASDAQ:YGYI - News), Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE - News), The Alkaline Water Company Inc. (NASDAQ:WTER - News) (TSX-V:WTER.V - News)

The expansion of the cannabis industry has led certain investment firms to back the marketplace as well. Piper Jaffray is among the handful who foresee a bright future for the industry. Piper Jaffray analyst Michael Lavery recently met with pain specialists to determine the impact of medical cannabis and concluded that the U.S. market is in dire need of a replacement to prescription opioids, according to Benzinga. Lavery highlighted that consumers prefer cannabis over traditional drugs to avoid the latter's side effects. Consumers are using cannabis-based products such as vapors, strains, and oils for their therapeutic benefits. However, due to the strict regulations regarding cannabis' THC derivative, CBD is more commonly being used because of its non-psychoactive effects. Looking forward, Lavery expects cannabis to be federally legal in the U.S. within the next few years. "We do believe the long-term growth opportunities are significant — both from transitioning illicit trade to legal sales, medical sales, and from transitioning sales in health & wellness categories to CBD-infused products," Lavery said in a note to clients. "While timing of further changes is difficult to predict, the pace of further legalization appears to be accelerating."

Pressure BioSciences, Inc. (OTCQB:PBIO - News) announced earlier last month that, "analytical testing on hemp-derived CBD oil processed via PBI's Ultra Shear Technology™ (UST™) platform has confirmed that UST processing uniquely achieves the challenging criteria for creating highly-effective "nanoemulsions" of CBD oil in water, without loss or modification of CBD throughout the entire UST process (> 99% recovery).

The ultimate goal in mixing oil-based nutritional and therapeutic products like CBD oil into water, for effective oral or topical delivery and absorption, is to reduce the size of the oil drops to such a level that they seemingly 'vanish' into the water (become "water soluble"). These exceedingly small, nanometer-scale droplets are so tiny that it becomes very easy for the human (or other animal) body to absorb the oil-based nutrients or drugs (like CBD) directly from the inner surface of the oil droplet. Traditional processing methods struggle mightily with this challenge, but PBI's proprietary UST platform uses ultra-high pressure to create extreme shearing forces to make nanometer-scale droplets of fluids that become highly-stable, homogenized "nanoemulsions" of materials that normally do not mix (e.g., CBD oil and water).

Dr. Vera Gross, Director of Applications Development at PBI, explained: 'We asked an independent, university-affiliated laboratory to determine the size of oil droplets achieved in UST-processed CBD oil, using a universally-accepted sizing method called DLS. Their analytical results revealed that the UST- processed oil drops were reduced to approximately 65 nm in size, well into the 20-200 nm range targeted for truly effective nanoemulsion delivery and absorption of nutrients and therapeutics, such as CBD (Nano- and Microscale Drug Delivery Systems, 2017).'

Dr. Gross continued: 'It was critically important to also demonstrate that CBD from hemp-derived CBD oil was not lost or modified during UST processing. For this we enlisted the help of scientists at NutraFuels, Inc. (OTCQB:NTFU - News), which has an FDA-inspected, highly-qualified analytical testing laboratory with state-of-the-art equipment and well-trained chemists with years of experience in laboratory testing.'

Mr. Cooper Dodd, R&D Scientist at NTFU, said: 'Using a powerful laboratory method called HPLC to measure the concentrations of CBD and potential impurities, we determined that no appreciable amount of CBD was lost during the UST process. These results compare well to our standard processing method of ultrasonication, which can carry a risk of measurable loss of CBD, and sometimes creates the appearance of impurities if not performed properly. While there is more work to be done, as a nutraceutical manufacturer with products already on the market, we see these results as a robust leap towards better optimization of our CBD-enhanced products.'

Dr. Keith Warriner, Professor of Food Science at the University of Guelph (Toronto), and a recognized expert in the cannabis industry, commented: 'The data released today 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.'

Professor Warriner continued: 'Not only does the UST process appear capable of achieving stability of emulsions, but the controlled heating that also occurs may offer a valid alternative to thermal and non-thermal pasteurization methods to reduce the risk of harmful microbes in products such as edibles and topicals. I believe that CBD-infused topicals and similar products will prove more popular with users than edibles. However, to be successful, it is imperative that topicals be highly stable, safe, bioavailable, and readily absorbent nanoemulsions. After consideration of the data released today, the UST process appears to be a leading candidate to fill that important need.'

Dr. Bradford A. Young, Chief Commercial Officer of PBI, summarized: 'We were delighted to release a short video last week showing the ability of our new UST platform to make visually clear and stable mixtures of CBD oil and water. The scientific data released today have further validated the achievement of creating high quality, nanoemulsion mixtures of oil and water using our UST platform. In particular, these data specifically show that CBD levels are preserved all the way through UST processing to the finished product. We are very excited by these results and believe our proprietary Ultra Shear Technology can help a diverse variety of customers to develop a vast array of new and beneficial products spanning multiple large markets, including CBD and nutraceuticals, cosmetics and topicals, food and beverages, drug delivery and more.'"

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=LyYRDpYRhAA

Aurora Cannabis Inc. (NYSE:ACB - News) (TSX:ACB.TO - News), headquartered in Edmonton, Alberta, Canada with funded capacity in excess of 500,000 kg per annum and sales and operations in 21 countries across five continents, is one of the world's largest and leading cannabis companies. Aurora Cannabis Inc. recently announced that - further to its October 17, 2018 announcement that it had received a sales license from Health Canada permitting the sale of cannabis softgel capsules - the Company has commenced shipments for both the Canadian medical and adult-use markets. Aurora expects to commence exports to international markets in early 2019. At scale, the Company anticipates that softgel production at its state-of-the-art Aurora Vie facility in Quebec will reach at least 1.4 million capsules per week. Aurora intends to make this high-volume, high-margin, smoke-free, product available to all of its domestic and international target markets over time where legally possible. For the medical market, Aurora is launching three product types: Aurora Indica Softgels: 8-10 mg/pill of THC; Aurora Sativa Softgels: 8-10 mg/pill of THC; Aurora CBD Softgels: 8-10 mg/pill of CBD. Additional product types and potencies will be made available in the coming months including softgel capsules that contain 5mg THC, 20mg CBD and 1:1 (5gm CBD and 5mg THC), plus softgels that employ a range of functional carrier oils. "Softgels are a high-volume, high-margin product for both the medical and adult-use markets that are in strong demand, and Aurora is one of few companies making these products available to patients and consumers alike," said Terry Booth, Chief Executive Officer of Aurora. "There is a strong momentum towards smoke-free, consistent dosage delivery technologies, and our softgels are a very familiar form factor that satisfy patient and consumer needs. We are delighted to have a preferred partnership with Capcium, whose technology is performing above our initial expectations, delivering high volumes of pharma-grade products."

Youngevity International, Inc. (NASDAQ:YGYI - News), is a leading omni-direct lifestyle company offering a hybrid of the direct selling business model, that also offers e-commerce and the power of social selling. Youngevity International, Inc. recently announced the expansion of its HEMPFX line with the launch of two new hemp-derived cannabidiol products: HempFX™ Hydration™ – Sleep and HempFX™ Hydration™ – Pure. Both products are expected to be available in November of this year. These tablet-based products will be used with Youngevity's Y-DR8+ proprietary, portable water bottle system designed to help provide great tasting water and reduce chemicals found in tap water. The Y-DR8 filter features (ACC) activated carbon cloth and is portable to fit today's "On the go lifestyle." The cannabidiol tablets will be housed above the water line and consumed as the water flows over the tablets. HempFX™ Hydration™ – Sleep combines melatonin with organic, full spectrum, hemp-derived cannabidiol oil in a proprietary beverage enhancement tablet. Hemp Hydration Sleep is formulated to help sleep patterns to provide a restful night's sleep with the health benefits of CBD. Also available in tablet form, HempFX™ Hydration™ – Pure is added to water and quickly dissolves as it is consumed. It contains 25 mg of organic, full spectrum, hemp-derived cannabidiol oil per tablet. Hemp Hydration Pure is formulated to provide daily CBD for people of all ages who want organic, full spectrum CBD. "This bottle system is intended to provide people with a revolutionary point-of-use water system for great tasting, water and enables consumers to customize tap water based upon their health and wellness needs. It is a beverage technology that we expect will have broad consumer appeal and we are extremely excited to combine this technology with the benefits hemp-based CBD," stated Rick Anson, Vice President of Innovation and Emerging Markets of Youngevity.

Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE - News) 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. Patent and Trademark Office has issued US Patent No. 10,213,390, titled "Treatment of Fragile X Syndrome with Cannabidiol" which includes claims directed to methods of treating Fragile X Syndrome by administering a therapeutically effective amount of synthetic or purified cannabidiol. This new patent, which expires in 2038, is part of an expanding intellectual property portfolio covering the Company's cannabidiol (CBD) product candidate, ZYN002 Transdermal CBD gel. The issuance of this patent comes as enrollment progresses in CONNECT-FX, a pivotal, multi-national, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of ZYN002 in three through 17-year old FXS patients with full mutation of the FMR1 gene. The primary endpoint is the change from baseline to the end of the treatment period in the Aberrant Behavior Checklist-Community FXS Specific (ABC-CFXS) Social Avoidance subscale. Clinical investigative sites are enrolling patients in the United States, Australia, and New Zealand. Patients who have completed the double-blind phase are now enrolling into the 12-month open label phase. The Company expects to report top line data in the second half of 2019.

The Alkaline Water Company Inc. (NASDAQ:WTER - News) (TSX-V:WTER.V - News) is a leading producer of premium bottled alkaline drinking water sold under the brand name Alkaline88®. The Alkaline Water Company Inc. recently announced that, following the passage of the Agriculture Improvement Act of 2018 (Farm Bill), the Company is well-positioned to capitalize on the opportunity to be one of the first national U.S. beverage companies to bring the true water-soluble, full-spectrum features of bioactive cannabidiol (CBD) molecules from hemp plants to U.S. consumers through its A88 Infused Beverage Division, Inc. (A88 Infused). "We are very excited that Congress has passed legislation redefining hemp to include extracts, cannabinoids and derivatives, which will permanently remove hemp from the Controlled Substances Act (CSA)," said Ricky Wright, President and Chief Executive Officer of The Alkaline Water Company. "This is a significant step forward for consumers who are looking to access CBD and CBD-infused products. As local and state legislatures, as well as the U.S. Food and Drug Administration (FDA), finalize their regulations for hemp, we are well-positioned to launch our great tasting Alkaline88® infused with natural hemp-extract formulations to become a dominant brand in this beverage category."

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