Organicell Regenerative Medicine, Inc. announced that it has secured its first site to carry out the Organicell Phase I/II Multicenter, Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Zofin™ Infused Intravenous (IV) in Patients Experiencing Prolonged COVID-19 Symptoms (Long-Haulers) vs. Placebo. The site and principal investigator that will conduct the trial is Dr. Ryan Klein of NewportNativeMD in Newport Beach, California.

The trial, organized and operated through Proxima Clinical Research, a Houston-based contract research organization, is anticipated to enroll over a 12-month period with the full enrollment of 30 patients expected to be completed no later than February 2023. Based on the timing to successfully enroll all patients, Organicell plans to complete the trial no later than August 2023. Patients enrolled in the study will have met prescribed Long Hauler conditions, with subjects experiencing consistent symptoms of a COVID-19 infection for a prolonged period of time, which is greater than 6 weeks and less than 12 months.

Enrolled patients will receive 3 doses of Zofin™ in accordance with the study protocol. The trial objectives are to demonstrate the safety and potential efficacy of Zofin™ administered intravenously in subjects experiencing prolonged COVID-19 symptoms. Based on the successful outcome of this trial, the Company intends to immediately submit efficacy data gathered to the FDA to obtain approval for an amendment to its Investigational New Drug (IND) application to begin a Phase II/III trial that will focus on the efficacy of Zofin™ in the treatment of COVID-19 Long Haulers. Zofin™ is an acellular, biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs without the addition or combination of any other substance or diluent.

The product contains over 300 growth factors, cytokines, chemokines, and 102 unique microRNAs as well as other exosomes/nanoparticles derived from perinatal tissues. These microRNA are the keys to Zofin's therapeutic effect. Packaged with exosomes, which are messengers that carry proteins and nucleic acids that bind like a lock and key to the cell's RNA, directing its behavior, Zofin may direct the cells to repair themselves.

Zofin™ is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. Zofin™ contains over 300 growth factors, cytokines, and chemokines as well as extracellular vesicles/nanoparticles.