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Researchers aim to Build Credibility for CBD Products Following Shift in Regulations

NEW YORK, July 11, 2019 /PRNewswire/ -- The cost of medical expenses can pile up very quickly for some. According to a survey conducted by Eventbrite, an average American spends approximately USD 199 each month on self-medication. In total, a typical American can spend upwards of USD 143,280 in their lifetime to treat themselves. Self-medicating is considered purchasing an over-the-counter (OTC) drug to treat a simple condition like headaches or a common cold. However, often times, medical attention is required for more severe cases. Certain therapies and treatments can cost thousands of dollars, potentially even hundreds of thousands depending on the severity of the condition. For instance, treatment of epilepsy (VNS therapy) in the U.S. can cost as much as USD 20,000, which includes implants and a surgical procedure. However, the cost of the surgery can vary throughout parts of the U.S. and can increase over time, according to the Epilepsy Foundation of Greater Chicago. Due to the rising costs of medical treatments, researchers and medical institutions have sought out alternatives to offer consumers cheaper options. Notably, cannabis has become a popular alternative within the healthcare marketplace, as specifically, CBD or cannabidiol is being leveraged across global markets because of its therapeutic benefits. Researchers have discovered that CBD can effectively be used to treat a variety of medical conditions, including cancer, arthritis, multiple sclerosis, and even epilepsy. Remarkably, the U.S. Food and Drug Administration approved the first-ever cannabis-based drug in 2018, Epidiolex, which is used to treat Dravet syndrome and Lennox-Gastaut syndrome, a form of epilepsy common among children. However, the FDA explicitly stated that more positive and large-scale clinical trials are required before the agency can approve more cannabis-based treatments. And as a result, scientists and researchers are now undergoing vigorous trials to uncover the efficacy of CBD. According to data compiled by Acumen Research and Consulting, the global cannabidiol market is projected to reach a market value of USD 22 Billion by 2026. Additionally, the market is expected to grow at a CAGR of 33% over the forecast period from 2019 to 2026. Pressure BioSciences, Inc. (OTC: PBIO), Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), Neptune Wellness Solutions Inc. (NASDAQ: NEPT) (TSX: NEPT), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), iAnthus Capital Holdings, Inc. (OTC: ITHUF) (CSE: IAN)

While CBD is being used for a variety of medical conditions, it has become well-known as a potential alternative to opioids. According to a study published in the American Journal of Psychiatry, researchers discovered that CBD helped reduce opioid cravings and anxiety in participants. The study included 42 men and women who had a history of heroin abuse. For the study, the participants either received an oral CBD solution or a placebo. Afterward, the participants were shown videos that contained neutral and drug-related cues. Neutral cues included relaxing scenes such as nature, while the drug-related cues showcased IV drug use and heroin-related items like syringes and powders. Furthermore, CBD can also be used to treat addictions to other opioid products such as oxycontin and vicodin. Oxycontin and vicodin are commonly prescribed painkillers for patients that may break a bone or are undergoing cancer therapy. The major side effect of opioids is an addiction, which has caused an epidemic in many regions around the world. As a result, medical institutions are looking to use CBD as a replacement to end or limit the opioid crisis. "Our findings indicate that CBD holds significant promise for treating individuals with heroin use disorder," said Yasmin Hurd, the Ward-Coleman Chair of Translational Neuroscience and the Director of the Addiction Institute at Mount Sinai. "A successful non-opioid medication would add significantly to the existing addiction medication toolbox to help reduce the growing death toll, enormous health care costs, and treatment limitations imposed by stringent government regulations amid this persistent opioid epidemic."

Pressure BioSciences, Inc. (OTCQB: PBIO) announced earlier last month 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. Patent and Trademark Office has issued US Patent No. 10,314,792, titled "Treatment of Autism Spectrum Disorder with Cannabidiol" which includes claims directed to methods of treating autism spectrum disorder by administering a therapeutically effective amount of synthetic cannabidiol. This new patent, which expires in 2038, is part of an expanding intellectual property portfolio covering the Company's cannabidiol (CBD) product candidate, Zygel™ (ZYN002 transdermal CBD gel). This patent follows the previously announced issuance of 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. The issuance of this patent comes as enrollment progresses in the open-label Phase 2 BRIGHT study evaluating the safety, tolerability and efficacy of Zygel for the treatment of children and adolescents with Autism Spectrum Disorder (ASD). The efficacy assessments include the Aberrant Behavior Checklist, Parent Rated Anxiety Scale – Autism Spectrum Disorder, Autism Impact Measure, and Clinical Global Impression-Severity and Improvement. The Company expects to report top line data in the first half of 2020.

Neptune Wellness Solutions Inc. (NASDAQ: NEPT) (TSX: NEPT) specializes in the extraction, purification and formulation of health and wellness products. Neptune Wellness Solutions Inc. recently announced that its Solutions Business had begun offering turnkey product development solutions with hemp-derived ingredients to business customers in the United States. A U.S.-based supply chain of licensed hemp extract producers has been established, and initial purchase orders are now being processed. Neptune boasts long-standing experience in the management of custom and white label turnkey product development solutions comprising a diverse array of product forms including softgels, liquids, topicals, emulsions, and water-dispersible powders. Branded ingredients and products that have contributed to Neptune's success, such as MaxSimil® and ECSentialsTM formulations, could potentially be used in unique combinations with hemp ingredients, particularly as the U.S. regulatory framework around hemp extracts and cannabidiol (CBD) evolves. "The U.S. market for hemp is developing rapidly and represents a significant opportunity for the consumer products industry. Neptune is now offering products and services to American brands that want to create a unique hemp-based portfolio, with products made exclusively in the U.S. for the U.S.," said Jim Hamilton, President and Chief Executive Officer of Neptune.

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento Therapeutics, Inc. recently announced that it had established a new business unit to focus on the market potential for its innovative water-soluble cannabidiol (CBD) formulation technology. Cannabidiol (CBD) has been under consideration within the pharmaceutical side of Sorrento for its interesting pharmacological properties and potential clinical benefits in multiple central nervous system, autoimmune or inflammatory disease and pain related indications. "Without distracting from our pharmaceutical business, we have the ability to leverage another Sorrento innovative technology – this time from our formulation experts – and make it available to the broader consumer market," stated Dr. Henry Ji, Chief Executive Officer and Chairman of Sorrento Therapeutics. "Longer-term, we may consider spinning off our CBD consumer business into an independently operated company if appropriate, while our research and clinical development team continues to explore the potential pharmaceutical applications of cannabidiol (CBD) for the medical markets."

iAnthus Capital Holdings, Inc. (OTCQX: ITHUF) (CSE: IAN) owns and operates best-in-class licensed cannabis cultivation, processing and dispensary facilities throughout the United States, providing investors diversified exposure to the U.S. regulated cannabis industry. iAnthus Capital Holdings, Inc. recently announced that its U.S. subsidiary had closed the previously announced acquisition of CBD For Life, a top-ranked, national CBD brand in the U.S. CBD For Life's currently available product lineup includes CBD-infused topicals, tinctures, and sprays geared toward health and wellness as well as lotions, creams, and hair products targeting beauty and skincare. CBD For Life plans to leverage the iAnthus platform to launch additional product lines in the second half of 2019, including a luxury skincare line and an adult product line. Furthermore, iAnthus plans to expand CBD For Life's existing wholesale and retail platform to give more consumers access to its growing range of products—including international distribution planned for Q4 2019. "CBD is one of the fastest growing segments of the consumer products industry," said Hadley Ford, Chief Executive Officer of iAnthus. "We look forward to integrating CBD For Life's award-winning products into the iAnthus platform, and we're excited about the opportunity to reach a larger customer base nationwide via this acquisition. iAnthus continues to define its positioning amongst its multi-state operator peer group with the addition of national CBD platform." 

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