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Psycheceutical Bioscience, Inc. Named a 2023 Top 10 Biotech Startup by Life Sciences Review

As Psycheceutical prepares to begin clinical trials for its novel NeuroDirect™ ketamine topical to treat PTSD, the company is named to Life Science Review's yearly Top Biotech Start-Up List

MIAMI — April 13, 2023 —Psycheceutical Bioscience, Inc. (“Psycheceutical” or the “Company”) (OTC PINK: BWVI), a bioscience company dedicated to developing cutting-edge technologies for the next generation of mental health treatments, was named in Life Sciences Review’s Top 10 Biotech Startups for 2023. Psycheceutical earned recognition for its significant progress in developing innovative patented delivery technologies that are intended to increase the safety and efficacy of psychedelic compounds.

According to Life Sciences Review, “Psycheceutical’s combination of innovative technologies and neurological experience helps to differentiate them in the bioscience market. Targeted drug delivery to the brain can both enhance compound efficacy and mitigate side effects. Psycheceutical achieves this with two patented technologies, the NeuroDirect™ topical delivery system and Janus particles. Psycheceutical’s focus on delivery technology upholds enormous potential.”

“We are proud to receive this distinction from Life Sciences Review and are honored to join the list of so many exciting biotech startups,” said Psycheceutical CEO Chad Harman. “This type of award drives us to move as rapidly as possible into clinical phase testing and development so that more people can access the profound benefits of psychedelic medicine, with non-intimidating and cost-effective treatment options.”

The company’s novel NeuroDirect™ ketamine topical cream to treat PTSD has already shown positive pre-clinical results. Data from a recently published study in Drug Development and Delivery Journal supports the potential of NeuroDirect ketamine topical cream as an improved treatment for PTSD. In the study of 100 patients who didn’t respond to traditional therapies, more than 80% trying NeuroDirect ketamine topical found it effective at treating their PTSD symptoms. “Discernible improvement[s] in anxiety, depression, paranoia and unrealistic fear, focusing issues, cloudy thinking, neuro­pathic pain, and other such symptoms were noted within 8-10 minutes of topical drug application. No psychogenic effects, such as hallucinations or dissociative phenomena, were experienced by any patient. To the contrary, patients indicated their thought processes were clearer, more focused, and that they were more keenly aware of surroundings.”

Psycheceutical’s unique delivery method for psychedelic compounds has caught the attention of industry trailblazers like Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS). “I’ve been working in psychedelics for more than 40 years, and it’s rare for me to come across something unique like the NeuroDirect topical cream that is currently being developed by Psycheceutical with the goal of delivering a psychedelic compound without a psychedelic experience or negative side effects,” noted Doblin.” Psycheceutical recently announced plans to begin clinical trials in Q2 in Australia for its NeuroDirect ketamine topical cream as a treatment for PTSD. “I’m curious to learn about the results of Psycheceutical’s upcoming clinical trials in Australia and to further evaluate this potential treatment. I look forward to reviewing more research data,” said Doblin. “Sometimes the biggest breakthroughs are right under our noses.”

NeuroDirect™ for Non-Systemic Delivery
Psycheceutical’s NeuroDirect™ non-systemic delivery technology is protected by several patents and pending applications, and is designed to deliver neuro-active compounds directly into the nerve tissue via topical application at the back of the neck. This delivery system is intended to enable immediate and sustained delivery, safe dosage control, and consistent results, while avoiding the systemic side effects of psychedelic compounds such as hallucinations, nausea and vomiting. NeuroDirect™ is designed to be administered through telehealth or at home instead of a clinical setting, greatly lowering the cost of care for each patient, ensuring that these life-saving treatments are cheap and available to anyone suffering from mental health disorders or central nervous system diseases. 

About Psycheceutical Bioscience, Inc. 
Psycheceutical Bioscience, Inc. is seeking to develop cutting-edge delivery technologies to support and advance the safe and effective delivery of psychedelic pharmaceutical medicines. Powered by a team of FDA drug development veterans, biotechnology experts, and the top minds in the psychedelic space, Psycheceutical is on a mission to develop, improve and commercialize its precision dosing technologies to provide affordable, life-saving treatments to anyone suffering from mental health disorders or central nervous system diseases. Learn more at Psycheceutical.com.

Forward-Looking Statements:
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These uncertainties include, but are not limited to, (i) general market growth for and acceptance of psychedelic-inspired medicines, (ii) capital and credit availability and market volatility, (iii) general economic conditions, (iv) governmental approvals and compliance with regulations, (v) product research and development and clinical trial risks, (vi) incorrect underlying assumptions, and (vii) our future business development, results of operations, and financial condition. These statements generally can be identified using forward-looking words such as “will,” “may,” “should,” “could,” “intend,” “estimate,” “plan,” “anticipate,” “expect,” “believe,” “potential” or “continue,” or the negative thereof or similar variations. All information provided in this press release is as of the date of this press release, and we undertake no duty to update such information, except as required under applicable law.

Media Relations: Contact Psycheceutical, Inc.

Psycheceutical Bioscience, Inc. Announces Observational Research Results for NeuroDirect™ Ketamine Topical Cream in Treating PTSD

  • A pre-clinical observational study published in Drug Development & Delivery found that more than 80% of patients experienced relief within minutes of applying NeuroDirect™ ketamine topical cream
  • Patients indicated their thought processes were clearer and more focused, and were more keenly aware of surroundings

Miami, FL — March 21, 2023 — Psycheceutical Bioscience, Inc. (“Psycheceutical” or the “Company”) (OTC PINK: BWVI), a bioscience company dedicated to developing cutting-edge technologies for the next generation of mental health treatments, today announced the publication of pre-clinical observational data that supports the potential of its NeuroDirect™ ketamine topical cream as a treatment for PTSD. The study was published in the March 2023 issue of Drug Development & Delivery.

The preliminary observational data indicates that the non-systemic topical cream could be more effective at treating PTSD symptoms than cur­rent ketamine treatment options, which utilize systemic delivery methods. Additionally, the study supports the Company’s belief that the topical cream approach would be more cost-effective than current ketamine therapy options.

“Administering ketamine with NeuroDirect drug delivery technology has shown observational promise in addressing undesirable side effects and providing therapeutic benefits,” said Dr. Ronald Aung-Din, Clinical Advisor for Psycheceutical and inventor of the NeuroDirect™ delivery system. “We believe this technology has the potential to play a significant role in developing new life-saving treatments for PTSD and other mental health conditions by safely dosing psychedelic compounds.”

Observational data was collected in a non-clinical setting from an outpa­tient Neurology and Neuropsychiatry prac­tice, examining 100 patients with intractable depression, anxiety, and other symptoms commonly associated with PTSD. Sub­jects were patients with long-term symptoms related to PTSD who had each tried numerous previous other treatments. The patient group was comprised of 61 females and 39 males, and the patients’ ages ranged from 12 to 90 years.

Objective measures like the Hamilton Depression Scale and EEG tracings documented the patients’ responses. Family members and other observers also noted additional benefits from the treatment.

The innovative, non-systemic delivery method is being designed to deliver compounds across the blood-brain barrier while bypassing the GI tract and liver. Patients indicated relief of PTSD symptoms within minutes after using NeuroDirect keta­mine applied as a topical cream on the back of the neck.

  • Eight patients had NeuroDirect keta­mine applied during EEG recording. All exhibited EEG improvement 3-5 minutes after treatment.
  • Within 8-10 minutes of topical drug application, patients noted discernible improvement in anxiety, depression, paranoia and unrealistic fear, focusing issues, cloudy thinking, neuro­pathic pain, and other such symptoms.
  • Six patients studied before and after treat­ment with ketamine exhibited a reduction in HAM-D scores of 40, 22, 13, 11, and 7 points 15 minutes after ketamine application.

Psychogenic effects, such as hallucinations or dissociative phenomena, were not expressed as having been experienced by any patient–all patients reported feeling clear-headed, more focused, and more aware of their surroundings.

“NeuroDirect ketamine has the potential to be a life-altering treatment option that will provide profound benefits and relief to patients suffering from PTSD,” said Chad Harman, CEO of Psycheceutical. “The observational data shows us that this novel delivery method could improve how psychedelic pharmaceutical drugs are developed, studied, and administered. We are committed to bringing NeuroDirect ketamine through the formal steps needed to achieve the needed regulatory approvals to be able to make this revolutionary medicine available.”

NeuroDirect™ for Non-Systemic Delivery
Psycheceutical’s NeuroDirect™ non-systemic delivery technology is designed to deliver neuro-active compounds directly into the nerve tissue via topical application at the back of the neck. This delivery system is intended to enable immediate and sustained delivery, safe dosage control, and consistent results, while avoiding the systemic side effects of psychedelic compounds such as hallucinations, nausea, and dizziness. NeuroDirect™ is designed to be administered at home instead of a clinical setting, greatly lowering the cost of care for both insurance companies and patients, increasing access to these life-saving treatments for anyone suffering from mental health disorders or central nervous system diseases.

About Psycheceutical Bioscience, Inc. 
Psycheceutical Bioscience, Inc. is developing cutting-edge technologies to advance the safe and effective delivery of psychedelic pharmaceutical medicines. Powered by a team of FDA drug development veterans, biotechnology experts, and the top minds in the psychedelic industry, Psycheceutical is on a mission to commercialize its precision dosing technologies to provide affordable, life-saving treatments to anyone suffering from mental health disorders or central nervous system diseases. Learn more at Psycheceutical.com.

Forward-Looking Statements:
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These uncertainties include, but are not limited to, (i) general market growth for and acceptance of psychedelic-inspired medicines, (ii) capital and credit availability and market volatility, (iii) general economic conditions, (iv) governmental approvals and compliance with regulations, (v) product research and development and clinical trial risks, (vi) incorrect underlying assumptions, (vii) FDA determinations regarding how that recognize and classify one or more our clinical trials and (vii) our future business development, results of operations, and financial condition. These statements generally can be identified using forward-looking words such as “will,” “may,” “should,” “could,” “intend,” “estimate,” “plan,” “anticipate,” “expect,” “believe,” “potential” or “continue,” or the negative thereof or similar variations. All information provided in this press release is as of the date of this press release, and we undertake no duty to update such information, except as required under applicable law.

Media Relations: Contact Psycheceutical, Inc.

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