FDA Authorized Emergency Compassionate Use Investigational New Drug Applications for Treatment of COVID-19 at Landmark Hospitals

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First Patients at Landmark Hospitals Treated with Organicell Flow through “Emergency Single Patient Compassionate Use” Designation

“The data collected from the patients receiving Compassionate Use treatments will guide us to interventions that modulate COVID-19 immune response in the lungs and reduce systemic organ damage," said William K. Kapp III, MD, founder and chairman of Landmark Hospitals.

Landmark Hospitals, an innovative system of six long-term acute care hospitals across the Southeast, today announced it is providing Organicell Flow, an allogenic biologic product derived from amniotic fluid, to patients with advanced COVID-19 conditions under the FDA-approved Compassionate Use pathway.

Two patients at Landmark Hospital of Athens, GA were treated last week with the first doses of the regimen. Intravenous infusions of Organicell Flow were administered safely to these two patients and they are clinically stable.

The standard treatment of COVID-19 includes oxygen therapy, mechanical ventilation, and medications to maintain the patient’s blood pressure. William K. Kapp III, MD, Founder and Chairman of Landmark Hospitals explains, “COVID-19 patients can experience immune activation and the appearance of cytokine storm syndrome (CSS) which causes damage to lungs and other organs and can lead to death. Landmark Hospitals obtained Compassionate Use approval to administer Organicell Flow because previously collected research showed it may have therapeutic potential in the reduction of the cytokine activation cycle, which will impact COVID-19 infection severity.”

Organicell Flow is manufactured by Organicell Regenerative Medicine Inc. and is a novel treatment derived from human amniotic fluid (HAF) that is voluntarily donated during planned Caesarean section surgeries. The product contains over 300 growth factors, cytokines, and chemokines as well as hyaluronic acid and exosomes.

There is currently no specific antiviral therapy available for patients with COVID-19. The FDA-approved Compassionate Use pathway allows for the immediate use of this experimental biologic. “The data collected from the patients receiving Compassionate Use treatments will guide us to interventions that modulate COVID-19 immune response in the lungs and reduce systemic organ damage. Landmark Hospitals strives to identify innovative treatment options for COVID-19 that result in the best patient recovery outcomes,” states Dr. Kapp.

About Landmark Hospitals:
Landmark provides solutions for patients who face a hospital discharge, yet still require acute medical care. These patients require a higher level of care for a longer period than the average hospital offers, but they are not yet ready to transfer to a sub-acute care facility. Landmark brings exciting new technologies and experienced management for the primary task of providing patients with the best medical care available as they continue their journey toward healing.
For more information regarding Landmark Hospitals, visit https://www.landmarkhospitals.com.

About Organicell Regenerative Medicine, Inc:
Organicell Regenerative Medicine, Inc. is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative diseases. The company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Mari Mitrani, Chief Scientific Officer. To learn more, please visit https://organicell.com/.

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