8-K
Zeo ScientifiX, Inc. (ZEOX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
Pursuant to Section 13 or 15(d) of The SecuritiesExchange Act of 1934
Date of report (Date of earliest event reported): June 15, 2021
ORGANICELL REGENERATIVE MEDICINE, INC.
(Exact name of registrant as specified in its charter)
| Nevada | 000-55008 | 47-4180540 |
|---|---|---|
| (State or Other Jurisdiction | (Commission File Number) | (IRS Employer |
| of Incorporation) | Identification No.) | |
| 4045 Sheridan Avenue, Suite 239, Miami, FL | 33140 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: (888) 963-7881
_________________________________________________
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities<br>Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange<br>Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b)<br>under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c)<br>under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each Class | Trading Symbol | Name of each exchange on which registered |
|---|---|---|
| None | N/A | N/A |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
As used in this Current Report on Form 8-K, and unless otherwise indicated, the terms “the Registrant”, “the Company,” “Organicell,” “we,” “us” and “our” refer to Organicell Regenerative Medicine, Inc.
| Item 8.01 | Other Events. |
|---|
On June 15, 2021, Organicell issued a press release in which it announced the outcome of their expanded access (EA) intermediate size patient population trial (NCT04657406).
A copy of the Company’s press release dated June 15, 2021 is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits |
|---|
(d) Exhibits
| Exhibit No | Description |
|---|---|
| 99.1 | Press Release, dated June 15, 2021 |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: June 15, 2021 | ORGANICELL REGENERATIVE MEDICINE, INC. | |
|---|---|---|
| By: | /s/ Ian Bothwell | |
| Ian Bothwell<br><br>Chief Financial Officer |
2
Exhibit 99.1
Organicell AnnouncesPositive Results Of Their Expanded Access Trial For The Treatment Of Mild to Moderate COVID-19 Using Zofin^TM^
Miami, FL (June 15th, 2021) - Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced the outcome of their expanded access (EA) intermediate size patient population trial (NCT04657406) which:
| ● | Met endpoints for safety and efficacy in patients with mild to moderate COVID-19 |
|---|---|
| ● | Mitigated mild and moderate symptoms |
| --- | --- |
| ● | Improved pulmonary opacities detected in chest X-rays |
| --- | --- |
| ● | Improved inflammatory biomarkers |
| --- | --- |
The trial was conducted at United Memorial Medical Center (UMMC) in Houston, TX. The administration of Zofin^TM^ was well tolerated in all enrolled subjects, with no adverse events. Chest X-ray data demonstrated that 75% of subjects had bilateral opacities caused by COVID-19 infection at day 0 (baseline), prior to Zofin^TM^ treatment. Thirty days after Zofin^TM^ treatment, chest X-ray data showed 83% of treated subjects had normal lung imaging, indicating complete recovery. There was also a significant decrease in biomarker levels like CRP, IL-6, and TNF-α at day 14, 21, and 30 when compared to the respective control with p-values less than p < 0.05, p < 0.01 and p < 0.001, respectively. Organicell intends to submit results for scientific peer review and publication.
Organicell will immediately submit this data to the FDA for a requested amendment to their approved IND (NCT04384445) to perform a placebo-controlled Phase 2 clinical trial to confirm safety and efficacy in a randomized fashion.
“There are only a few evidence-based treatments for acute COVID-19 that are appropriate for use in the outpatient setting. We are extremely pleased by the outcome of this analysis, which provides strong evidence that Zofin^TM^ may be an effective treatment for patients who are at high risk of progressing to severe COVID-19, hospitalization, or both if no treatment is given,” said Vincent Friedewald, MD, FACC, FACP, Primary Investigator at UMMC, Houston, TX.
“The study results mark an important step in our journey to bring forward a biological drug capable of helping end this devastating pandemic,” said Mari Mitrani, M.D. Ph.D., Chief Science Officer of Organicell.
ABOUT ZOFIN^TM^
Zofin^TM^ 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. This product contains over 300 growth factors, cytokines, and chemokines as well as extracellular vesicles/nanoparticles derived from perinatal tissues. Zofin™ is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin™ for the treatment of moderate to SARS related to COVID-19 infection.
ABOUT ORGANICELL REGENERATIVE MEDICINE, INC.
Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR) 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/.
ABOUT UNITED MEMORIAL MEDICAL CENTER (UMMC)
UMMC Hospital was established to fill the need for quality emergency and surgical care in the community of Spring, Texas. We are a complete surgical facility with an Emergency Room to provide care for those unexpected medical emergency needs using innovative techniques and the latest methods of treatment. We operate by the Hippocratic Oath to the best of our ability. Our doctors remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon’s knife or the chemist’s drug. To learn more, please visit https://ummc.care
FORWARD-LOOKING STATEMENTS
Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as “will,” “believes,” “expects,” “potential” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties, including the risk factors discussed in the Company’s periodic reports that are filed with the SEC and available on the SEC’s website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.
Media Contact:
Jeanene Timberlake
Rooney Partners
646-770-8858
jtimberlake@rooneyco.com