MIAMI, Jan. 21, 2020 (GLOBE NEWSWIRE) — Organicell Regenerative Medicine Inc.(OTCPK:BPSR) (the “Company”) is pleased to provide shareholders and the investment community with an update on operations.
Since November 2018, the Company has remained focused on research and development activities and sale and distribution of anti-aging and cellular therapy derived products.
In February 2019, the Company recommenced its efforts to once again operate a perinatal tissue bank processing laboratory in Miami, Florida for the purpose of performing research and development and the manufacturing and processing of anti-aging and cellular therapy derived products. This new laboratory facility became operational in May 2019 and during the same period, the Company began producing products that are now being sold and distributed to its customers.
In addition, the Company has created what it believes is a world class research, medical and scientific advisory team. We believe that our team is one of the most qualified and industry reputable teams assembled to adequately address the current and expected future medical and regulatory challenges facing the Company and overall industry and to provide leadership in the ongoing development of superior quality products for use in the health care industry.
The Company has actively taken steps to assure that it meets compliance with current and anticipated United States Food and Drug Administration (“FDA”) regulations expected to be enforced beginning in November 2020 requiring that the sale of products that fall under Section 351 of the Public Health Services Act pertaining to marketing traditional biologics and human cells, tissues and cellular and tissue based products (“HCT/Ps”) can only be sold pursuant to an approved biologics license application (“BLA”). On July 14, 2019, the Company received Institutional Review Board (“IRB”) approval to proceed with two pilot studies in connection with the Company’s efforts to obtain Investigation New Drug (“IND”) approval from the FDA and commence clinical trials in connection with the use of the Company’s products and related treatment protocols for specific indications. The Company is aggressively pursuing efforts to obtain the aforementioned IND approvals and commence and complete those clinical studies as well as obtaining approval to commence additional studies for other specific indications it has identified that the use of its products will provide more favorable and desired health related benefits for patients seeking alternative treatment options than are currently available.
In an effort to increase sales and mitigate anticipated near future restrictions expected to be imposed by the FDA with respect to the use and distribution of Section 351 designated biologics, the Company is seeking to develop sales and distribution channels outside of the United States. In addition, the Company is focusing its efforts on developing other leading edge product offerings that would not fall within the FDA regulations for requiring a BLA license for U.S.manufacture and sale.
As a result of the Company’s expected future increase in processing requirements and to enable it to perform certain advanced research and development activities, the Company is currently in negotiations to relocate its laboratory facility during the second calendar quarter of 2020 to a larger “ISO 7” classified research and development and processing facility.
The Company has also been actively developing and expanding its sales, marketing and distribution network which it believes that based on the quality of the Company’s existing products, the Company’s commitment to regulatory compliance and superior research and development resources, the Company believes that it will be able to achieve desired growth during 2020.