Zeo ScientifiX, Inc 8-K, filed Jan 28, 2021
Zeo ScientifiX, Inc. (ZEOX)
About this 8-K
Zeo ScientifiX, Inc filed this 8-K on January 28, 2021.
Items reported
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of report (Date of earliest event reported): January 28, 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 Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) 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 January 28, 2021, Organicell issued a press release in which it announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Zofin™, in the treatment of patients diagnosed with chronic obstructive pulmonary disease (COPD).
A copy of the Company’s press release dated January 28, 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 January 28, 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: January 28, 2021 | ORGANICELL REGENERATIVE MEDICINE, INC. | |
| By: | /s/ Ian Bothwell | |
| Ian
Bothwell Chief Financial Officer | ||
2
Exhibit 99.1
Organicell
Announces FDA Approval Of IND Application for the Use of Zofin™ In
The Treatment Of Chronic Obstructive Pulmonary Disease
(COPD)
PRESS RELEASE
Miami, FL (January 28th, 2021) — Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Zofin™, in the treatment of patients diagnosed with chronic obstructive pulmonary disease (COPD).
This approved trial design will be a double blinded, placebo-controlled, phase I/II trial investigating the safety and potential efficacy of intravenous infusion (IV) of Zofin™ for the treatment of COPD.
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. This product contains over 300 growth factors, cytokines, chemokines, and 102 unique microRNAs as well as other exosomes/nanoparticles derived from perinatal tissues.
According to the Centers for Disease Control and Prevention, “COPD makes breathing difficult for the 16 million Americans who have this disease. Millions more people suffer from COPD but have not been diagnosed and are not being treated.”
“COPD is a chronic, degenerative, inflammatory lung disease with no current cure,” said Dr. Mari Mitrani, Chief Science Officer of Organicell. “We are excited to initiate this FDA approved clinical trial and to further explore the potential of Zofin™ in battling this disease.”
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/.
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.
For further information contact:
Rosh Lowe
Organicell Regenerative Medicine, Inc.
786-290-4400
rlowe@organicell.com
Media Contact:
Jeffrey Freedman
RooneyPartners
646-432-0191
jfreedman@rooneyco.com