We are a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics for the treatment of degenerative diseases and regenerative medicine.
−Removed: The Company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring extracellular vesicles, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent and an autologous non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood (“ RAAM Products ”).
+Added: The Company’s proprietary products, including Zofin™, are derived from perinatal sources and manufactured to retain the naturally occurring extracellular vesicles, proteins and cell secreted nanoparticles and Patient Pure X™ (“ PPX™ ”), an autologous biologic containing a nanoparticle fraction that is precipitated from a patient’s own peripheral blood (“ RAAM Products ”).
Our RAAM Products and related services are principally used in the health care industry administered through doctors and clinics (“ Providers ”).
−Removed: Organicell operates an extracellular vesicle processing laboratory in Davie, Florida for the purpose of performing research and development and the manufacturing and processing of the anti-aging and cellular therapy derived products that we sell and distribute to our customers.
−Removed: The Company’s leading product, Zofin™ (also known as Organicell™ Flow), 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.
−Removed: The Company recently launched a service platform for its first autologous product called Patient Pure X™ (PPX™).
−Removed: PPX™ is a non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood.
−Removed: To date, the Company has obtained certain Investigational New Drug (“ IND ”), and 18 emergency IND (“ eIND ”) approvals from the FDA, including applicable Institutional Review Board (“ IRB ”) approvals which authorized the Company to commence clinical trials or treatments in connection with the use of Zofin™ and related treatment protocols.
+Added: ZEO operates an extracellular vesicle processing laboratory in Davie, Florida for the purpose of performing research and development and the manufacturing and processing of the anti-aging and cellular therapy derived products that we sell and distribute to our customers.
+Added: The Company has recently developed and begun to distribute additional products that incorporate its proprietary ingredients for products to be used in topical aesthetic applications and is actively exploring further development of additional products to be used in other topical aesthetic applications.
+Added: To date, the Company has obtained certain Investigational New Drug (“ IND ”), emergency IND (“ eIND ”) approvals from the FDA, including applicable Institutional Review Board (“ IRB ”) approvals which authorized the Company to commence clinical trials or treatments in connection with the use of Zofin™ and related treatment protocols.
The Company is pursuing efforts to complete its already approved 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.
5 unchanged sentences
The efforts include continuing with clinical trials, expanding sales internationally and developing new product offerings and/or designations of products that would not fall under these regulations.
−Removed: During the year ended October 31, 2023, the Company invested $100,000 in cash (representing a 10% equity interest at the time of the investment) in a privately held formulator of skin care products (“ Formulator ”) in an effort to accelerate the Company’s development of expertise with respect to the skincare industry and to expand the use of its proprietary products in future formulations for a variety of topical use applications.
−Removed: The Company has partnered with the Formulator in a supply arrangement with a non-affiliated third-party whereby the Company will receive proceeds from the sale of its products to the third party.
−Removed: In addition, we have also entered into a sales representation agreement with the Formulator pursuant to which we will receive commissions on sales made by the Formulator to customers that were introduced by the Company to the Formulator.
−Removed: Recent Developments Regarding Zofin™ and Other Products
−Removed: Zofin™ Phase I/IIA and IRB Approved Pilot Study Clinical Trial Program
−Removed: In June 2021, Organicell announced the results of its expanded access (“EA”) intermediate size patient population trial for treatment of COVID-19 patients with Zofin™ (IND # 19881-EA;
−Removed: NCT04657406 authorized by the FDA in September 2020).
−Removed: The study enrolled a total of 11 subjects:
−Removed: adults between the age of 35 to 69 who were fighting COVID-19 infection and presented respiratory fatigue with and without exertion, cough, and shortness of breath and met all inclusion/exclusion criteria.
−Removed: One patient withdrew before receiving any doses of Zofin™.
−Removed: Two subjects withdrew at day 14 post treatment with Zofin™.
−Removed: As a result, a total of eight subjects completed the study.
−Removed: The Company has decided that it will not enroll future patients from the above-mentioned study and has since closed the clinical trial (see below).
−Removed: In July 2021, the Company announced that the FDA had approved an IND application for its lead product, Zofin™ (IND #27378), for the treatment of ‘Prolonged COVID-19 Symptoms’ (“ Long Haulers ”).
−Removed: This approved trial design consisted of a double blinded, placebo-controlled, randomized phase I/II trial designed to investigate the safety and potential efficacy of Zofin™ in treating COVID-19 Long Haulers.
−Removed: The trial had enrolled a total of 18 of the 30 patients originally contemplated for the trial.
−Removed: The Company determined that it acquired sufficient safety data with the 18 enrolled patients and additional patient enrollment was not necessary.
−Removed: As further discussed below, the Company provided FDA with a summary safety report on the 18 subjects and the related sites have since closed the clinical trial.
−Removed: In November 2022, the Company received IRB
−Removed: approval (IRCM-2022-317) to conduct a pilot study to evaluate the safety of intravenous infusion and intra-articular injections of
−Removed: the Company’s autologous extracellular vesicle product Patient Pure X™ (PPX™) in subjects suffering with
−Removed: osteoarthritis of knee.
−Removed: The study enrolled a total of 10 patients of which 2 dropped out over six months and a total of six subjects
−Removed: completed the study at nine months.
−Removed: The study has been completed and the pilot study has been closed as further discussed below.
−Removed: In connection with the studies described above, there were no reported therapy-related safety events or significant adverse events.
−Removed: Based on the results of the above studies, the Company has determined that there was sufficient Phase I safety data obtained from the existing enrolled patients using Zofin™ and/or autologous extracellular vesicles and accordingly there was no longer any benefit from continued enrollment to obtain additional patient Phase 1 safety related data among the above studies.
−Removed: The Company is seeking to commence one or more Phase II studies in 2024, subject to obtaining approval of new or amended IND’s from the FDA and available working capital.
−Removed: In connection with the Company’s other previous research initiatives, the Company is reviewing which indications to pursue for Phase II efficacy related research and whether any of the existing approved and open IND’s should be modified, terminated and/or replaced.
−Removed: These IND’’s include:
−Removed: In April 2020, the FDA approved an IND application for the Company’s lead product, Zofin™ (IND # 19881), for a Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Organicell™ Flow for the Treatment of Moderate to Severe Acute Respiratory Syndrome (“ SARS ”) Related to COVID-19 Infection vs Placebo.
−Removed: Enrollment for the clinical trial began in September 2020.
−Removed: A total of ten patients had been enrolled in the study thus far and currently the clinical trial is not enrolling subjects due to the challenges of enrolling the remaining study population.
−Removed: In January 2021, the Company announced that the FDA had approved an IND application for its lead product, Zofin™, in the treatment of patients diagnosed with chronic obstructive pulmonary disease (IND # 23198 approved on 01/27/2021).
−Removed: No patients have been enrolled to date.
−Removed: In April 2021, the Company announced that the FDA had approved the IND application for its lead product, Zofin™, in the treatment of knee osteoarthritis (IND # 23788 approved on 04/06/2021).
−Removed: The trial has yet to commence.
−Removed: The ability for the Company to initiate any Phase II studies are subject to many uncertainties, including FDA approval of the respective IND applications and the Company having sufficient working capital to finance the ongoing costs of the trial, as to all of which no assurance can be given.
−Removed: Other Research
−Removed: In April 2021, the Company entered into an agreement with Oklahoma State University to evaluate Zofin™ for the treatment of respiratory diseases caused by virus infections of pandemic potential.
−Removed: The parties are currently working to publish the study results and explore future research objectives.
−Removed: As a result of the above and the Company’s ongoing evaluation of the design and objectives of our previously approved clinical trials, as well as changes in clinical developments regarding the treatment of COVID-19 since the initial IND’s described above were submitted, the Company has completed or determined that it would no longer be actively pursuing the previously disclosed research initiatives described below:
−Removed: In March 2021, Organicell entered into a Material Cooperative Research and Development Agreement with the Centers for Disease Control and Prevention (the “ CDC ”) to determine the anti-inflammatory and anti-infective effectiveness of Zofin™ in experimental models of influenza infection.
−Removed: The parties determined that completion of the study would require additional time and funding to complete and the parties elected to terminate the study.
−Removed: In April 2021, we announced that an initial trial of ten COVID -19 patients in India conducted by CWI India, our Indian partner, generated positive results.
−Removed: The trial had been conducted by CWI India with whom we had entered a product testing and distribution agreement in February 2021, to collaborate on a study or studies to evaluate the effects of Zofin™ on moderate to severe COVID-19 patients in India.
−Removed: Since that time, there has not been any further collaboration on this research and the Company is not actively supporting or pursuing this research.
−Removed: In May 2021, the Company announced that its Zofin™ therapy has been approved by Pakistani regulators to be used for a treatment of a named COVID-19 patient hospitalized at the Pakistan Institute of Medical Sciences on compassionate grounds.
−Removed: In addition to this compassionate grounds authorization, Organicell received further indications from the Pakistani regulators to begin a broader trial of Zofin™ with up to 60 additional patients suffering from moderate to severe COVID-19.
−Removed: Since that time, there has not been any further collaboration on this research and the Company is not actively supporting or pursuing this research.
−Removed: Recent Corporate Developments
−Removed: Implementation of the Reverse Split
−Removed: On November 28, 2023, the Company implemented the Reverse Split.
−Removed: The par value of the Company’s common stock was unchanged at $0.001 per share after the Reverse Split.
−Removed: As a result, on the effective date of the Reverse Split, the stated capital on the Company’s balance sheet attributable to the Company’s common stock was reduced proportionately based on the reverse stock split ratio of one-for-200 and the additional paid-in capital account was credited with the amount by which the stated capital was reduced.
−Removed: Proposed Change of Corporate Name and Trading Symbol
−Removed: On December 8, 2023, our board of directors and our stockholders holding a majority of the Company’s voting power, approved resolutions authorizing the Company to amend its Articles of Incorporation to change the name (“ Name Change ”) of the Company from Organicell Regenerative Medicine, Inc.
−Removed: to “Zeo ScientifiX, Inc.” and to change the Company’s stock trading symbol from OCEL to “ZEOX” (“Ticker Symbol Change”) to align with the Name Change.
−Removed: Implementation and effectiveness of the Name Change and Ticker Symbol Change will be subject to Organicell’s compliance with applicable regulatory requirements of the SEC and the Financial Industry Regulatory Authority (“ FINRA ”) .
−Removed: In connection with the Name Change and Ticker Symbol Change, the Company has filed an Issuer Company- Related Action Notification with FINRA to effectuate the Name Change and Ticker Symbol Change, which is currently being reviewed by FINRA.
−Removed: Sale Of Basalt, Colorado Lab Facility
−Removed: Effective August 7, 2023, the Company sold our lab facility in Basalt Colorado to a non-affiliated third-party purchaser (“ Purchaser ”).
−Removed: The transaction included the assignment of the premises lease for the Basalt Lab facility and the lease for certain laboratory equipment and the sale of all leasehold improvements associated with the Basalt Lab and inventory.
−Removed: The purchase price paid by Purchaser was $1,250,000 plus the assumption by Purchaser of all remaining financial and other obligations under the leases for the Basalt Lab premises and certain laboratory equipment.
−Removed: In addition, Organicell and Purchaser entered into a distribution agreement, pursuant to which Purchaser became a non-exclusive distributor of Organicell’s products and a commission agreement, pursuant to which Organicell may be entitled to certain payments from Purchaser in connection with transactions by it with specified third parties.
−Removed: As a result of the Basalt Lab sale, the Company currently performs all of it administrative, research, processing and sales and distribution activities from its Fort Lauderdale laboratory location.
−Removed: Tysadco Purchase Agreement
−Removed: On September 1, 2022, the Company entered into a Purchase Agreement (the “ ELOC Purchase Agreement ”) with Tysadco Partners LLC, a Delaware limited company (“ Tysadco ”) and a Registration Rights Agreement with Tysadco.
−Removed: Pursuant to the ELOC Purchase Agreement, Tysadco committed to purchase, subject to certain restrictions and conditions, up to $50,000 worth of the Company’s common stock, over a period of 24 months from the effectiveness of the registration statement registering the resale of shares purchased by Tysadco pursuant to the ELOC Purchase Agreement.
−Removed: which registration statement was declared effective by the SEC on October 24, 2022 (“ ELOC Registration ”).
−Removed: Pursuant to the ELOC Purchase Agreement, on December 2, 2022, the Company submitted a put request to Tysadco to purchase 22,282 registered shares at a purchase price (as calculated pursuant to the ELOC Purchase Agreement) of $4.49, for a total of $100,000.
−Removed: On December 5, 2022, Tysadco funded the put request and the Company issued the 22,282 shares to Tysadco.
−Removed: The proceeds from the share sale were used for working capital and general corporate purposes.
−Removed: Due to overall market conditions, the Company determined that it would not seek to obtain additional financing through the ELOC Purchase Agreement and the ELOC Registration is now no longer effective.
−Removed: On March 6, 2023, the Company entered into a Securities Purchase Agreement (“ SPA 23 ”) with AJB Capital, pursuant to which we sold a Promissory Note in the principal amount of $530,000 (“$ 530,000 Note ”) to AJB in a private transaction for a purchase price of $519,400 (giving effect to original issue discount of $10,600).
−Removed: In connection with the sale of the $530,000 Note, the Company also paid AJB Capital’s legal fees and due diligence costs of $15,000, resulting in net proceeds to the Company of $504,400, which was used for working capital and other general corporate purposes.
−Removed: The $530,00 Note bears interest at the rate of 12% per annum.
−Removed: The $530,000 Note matured on September 6, 2023 and was paid in full.
−Removed: Private Offering – Convertible Promissory Notes
−Removed: During August and September 2023, the Company sold 2.9 Units (“ Unit s”) to 4 investors in a private offering at a purchase price of $250,000 per Unit for an aggregate purchase price of $725,000.
−Removed: Each Unit consists of (a) a $250,000 in principal amount 8% Convertible Promissory Note due September 30, 2026;
−Removed: and (b) 7,813 common stock purchase warrants, each entitling the holder to purchase one share of our common stock at an exercise price of $20.00 for a period of five years from the date of issuance.
+Added: In March 2003 and July 2024, the Company invested $100,000 and $45,000, respectively, in Exotropin, LLC (“ Exotropin ”) a privately held formulator of skin care products in exchange for a minority equity interest (approximately 8.9% as of October 31, 2024).
+Added: During November 2024, the Company received a capital call notice from Exotropin (“ November Capital Call ”).
+Added: The Company has yet committed to participating in the November Capital Call.
+Added: If the Company does not elect to participate, its interest in Exotropin would be reduced to approximately 5.6% based on all other members fulling participating in the November Capital Call.
+Added: The investment in Exotropin was made in an effort to accelerate the Company’s development of expertise with respect to the skincare industry and to expand the use of its proprietary products in future formulations for a variety of topical use applications.
+Added: In addition, we have also entered into a sales representation agreement with Exotropin pursuant to which we will receive commissions on sales made by Exotropin to customers that were introduced by the Company to Exotropin.
+Added: During November 2024, the Company announced that it was launching the first planned collaborative product with Exotropin;
+Added: “ZEO HAIR GROW™ Powered By Exotropin™”
Corporate Information
1 unchanged sentence
,” changed its name to “ Biotech Products Services and Research, Inc.
−Removed: ” effective November 4, 2015, and assumed its current name of “ Organicell Regenerative Medicine, Inc.
−Removed: ,” by amendment to its Articles of Incorporation on June 20, 2018.
−Removed: Our executive offices are located at 3321 College Avenue, Suite 246, Davie, FL 33134 and our telephone number is (888) 963-7881.
−Removed: Our corporate website is www.organicell.com .
+Added: ” effective November 4, 2015, to “ Organicell Regenerative Medicine, Inc.
+Added: ” effective June 20, 2018 and assumed its current name of “ Zeo ScientifiX, Inc.
+Added: ” effective February 20, 2024.
+Added: Our executive offices are located at 3321 College Avenue, Suite 246, Davie, Florida and our telephone number is (888) 963-7881.
+Added: Our corporate website is www.zeoscientifix.com .
Information appearing on our website is not part of this Annual Report.
49 unchanged sentences
Marketing private label products to distributors;
−Removed: Increasing market recognition for our Organicell brand from:
+Added: Increasing market recognition for our brands from:
marketing and participating in industry trade shows;
36 unchanged sentences
Although the market is highly concentrated in North America (specifically the U.S.), international demand for approved gene, cell, and RNA therapies remains sizable, with over 107 therapies now approved for clinical use globally.
−Removed: Organicell operates at the crossroads of the biopharmaceutical, regenerative medicine, and cell therapy sectors.
+Added: ZEO operates at the crossroads of the biopharmaceutical, regenerative medicine, and cell therapy sectors.
This growth can be attributed to demographic factors such as increased life expectancy and an aging population.
14 unchanged sentences
The table below sets forth a summary of our intellectual property rights.
−Removed: Patent Number:
−Removed: NG/PT/PCT/2022/6494
−Removed: February 20, 2023
−Removed: Application Number:
−Removed: NG/PT/PCT/2022/6494
−Removed: April 10, 2021
−Removed: Patent Applications:
−Removed: Organicell™ has two U.S.
−Removed: Patent Applications on file for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid.
+Added: Issued Patents:
+Added: ZEO ScientifiX™ has one issued U.S.
+Added: Patent for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid.
Patent Application No.
+Added: 17/990,522 ( Continuation of 17/226,587)
COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF
−Removed: April 9, 2021
+Added: November 18, 2022
Maria Ines Mitrani
Organicell Regenerative Medicine, Inc.
+Added: August 6, 2024
MARIA INES MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC.
−Removed: April 9, 2021
−Removed: 055878 / 0801 & 055878 / 0900
+Added: March 17, 2023
+Added: Patent Applications:
+Added: ZEO ScientifiX™ has one U.S.
+Added: Patent Application on file for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid.
Patent Application No.
−Removed: 17/990,522 ( Continuation of 17/226,587)
COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF
−Removed: November 18, 2022
+Added: April 9, 2021
Maria Ines Mitrani
3 unchanged sentences
055878 / 0801 & 055878 / 0900
−Removed: Organicell™ has twenty-five Ex-US Patent Applications on file for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid.
+Added: ZEO ScientifiX™ has eight Ex-US Patent Applications on file for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid.
These Applications are national stage entries of:
7 unchanged sentences
Application Number :
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: BR112022020441-8
+Added: Filing Date :
April 10, 2021
Application Number :
+Added: Filing Date :
April 10, 2021
1 unchanged sentence
202180041860.8
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: NC2022/0015966
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: SENADI-2022-86300
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
+Added: Filing Date :
April 10, 2021
Application Number :
+Added: Filing Date :
April 10, 2021
−Removed: Republic of Korea
Application Number :
−Removed: 10-2022-7039360
+Added: Filing Date :
April 10, 2021
Application Number :
−Removed: Not available
+Added: Filing Date :
April 10, 2021
1 unchanged sentence
MX/a/2022/012692
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: 1-2022-552738
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: QA/202210/0000698
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
−Removed: PCT/JO/2022/259
+Added: Filing Date :
April 10, 2021
−Removed: United Arab Emirates
Application Number :
−Removed: P6002103/2022
+Added: Filing Date :
April 10, 2021
−Removed: Organicell™ has a U.S.
+Added: ZEO ScientifiX™ has a U.S.
Patent Application on file for its Organicell™ PPX product and the proprietary techniques used in the administration of blood-derived exosomes to treat pain.
4 unchanged sentences
Organicell Regenerative Medicine, Inc.
−Removed: Organicell™ has an International Patent Application on file for its Organicell™ PPX product and the proprietary techniques used in the administration of blood-derived exosomes to treat pain
+Added: MARIA INES MITRANI (Assignor), MICHAEL BELLIO (Assignor), ALBERT MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC.
+Added: April 19, 2023
+Added: ZEO ScientifiX™ has an International Patent Application on file for its Organicell™ PPX product and the proprietary techniques used in the administration of blood-derived exosomes to treat pain
International Patent Application No.
4 unchanged sentences
Organicell Regenerative Medicine, Inc.
+Added: MARIA INES MITRANI (Assignor), MICHAEL BELLIO (Assignor), ALBERT MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC.
Goods/Services :
1 unchanged sentence
Biologically derived products developed from perinatal tissue material for medical and medical regenerative purposes, namely, biological tissue grafts, implants comprising living tissue, surgical implants comprising living tissue, and biological implants for cushioning tissues and supporting tissue repair and homeostasis (IC 005)
−Removed: Serial Number :
+Added: Registration Number :
Filing Date :
1 unchanged sentence
Organicell Regenerative Medicine, Inc.
−Removed: Notice of allowance issued May 18, 2021;
−Removed: Non-Final Office Action re specimen issued July 5, 2023;
−Removed: Response to Non-Final Office Action filed October 5, 2023;
−Removed: Awaiting further examination.
Goods/Services :
1 unchanged sentence
Biologically derived products developed from perinatal tissue material for medical and medical regenerative purposes, namely, biological tissue grafts, implants comprising living tissue, surgical implants comprising living tissue, and biological implants for cushioning tissues and supporting tissue repair and homeostasis (IC 005)
−Removed: Serial Number :
−Removed: Filing Date :
−Removed: Organicell Regenerative Medicine, Inc.
−Removed: Goods/Services :
−Removed: Non-medicated anti-aging serum;
−Removed: non-medicated skin serums;
−Removed: all of the aforementioned goods are made in whole or in substantial part of organic ingredients (IC 003)
−Removed: Serial Number :
+Added: Registration Number:
Filing Date :
−Removed: January 23, 2017
Organicell Regenerative Medicine, Inc.
−Removed: Registration Number:
−Removed: Registration Date:
−Removed: September 19, 2017
PATIENT PURE X - PPX
1 unchanged sentence
plasma extracts for medical use, namely, plasma extract containing purified and concentrated exosomes derived from whole human blood (IC 005)
−Removed: Serial Number :
+Added: Registration Number:
Filing Date :
4 unchanged sentences
plasma processing services for others, namely, extracting purified and concentrated exosomes based on whole blood harvested from patients for use by hospitals, clinics, or other organizations or persons involved in delivering healthcare services to patients (IC 040)
−Removed: Serial Number :
+Added: Registration Number:
Filing Date :
January 24, 2020
+Added: Organicell Regenerative Medicine, Inc.
+Added: Goods/Services :
+Added: Biologically derived nanoparticles, namely, exosomes and extracellular vesicles, developed from perinatal tissue for medical and medical regenerative purposes, namely, biological tissue grafts, implants comprising living tissue, surgical implants comprising living tissue, and biological implants for cushioning tissues and supporting tissue repair and homeostasis (IC 005)
+Added: Registration Number :
+Added: Filing Date :
+Added: September 9, 2020
+Added: Organicell Regenerative Medicine, Inc.
+Added: Goods/Services :
+Added: Biologically derived nanoparticles, namely, exosomes and extracellular vesicles, developed from perinatal tissue material for aesthetic purposes, other than for medical or veterinary purposes (IC 001)
+Added: Registration Number :
+Added: Filing Date :
+Added: September 9, 2020
+Added: Organicell Regenerative Medicine, Inc.
ZEO SCIENTIFIX
Goods/Services :
−Removed: manufacturing services, biotechnological products and services, research services, laboratory services, biologics therapeutics, and biologics diagnostics
+Added: Manufacturing services for others in the field of regenerative medicine (IC 040);
+Added: Scientific research services for others in the field of regenerative medicine;
+Added: Scientific laboratory services;
+Added: Design of biotechnological products being regenerative medicine products (IC 042)
Serial Number :
2 unchanged sentences
Organicell Regenerative Medicine, Inc.
−Removed: Awaiting examination
+Added: Non-Final Action Issued November 18, 2024
Composite Mark :
1 unchanged sentence
Goods/Services :
−Removed: manufacturing services, biotechnological products and services, research services, laboratory services, biologics therapeutics, and biologics diagnostics
+Added: Manufacturing services for others in the field of regenerative medicine (IC 040);
+Added: Scientific research services for others in the field of regenerative medicine;
+Added: Scientific laboratory services;
+Added: Design of biotechnological products being regenerative medicine products (IC 042)
Serial Number :
2 unchanged sentences
Organicell Regenerative Medicine, Inc.
−Removed: Awaiting examination
+Added: Non-Final Action Issued November 18, 2024
Goods/Services :
−Removed: manufacturing services in the field of biotechnological products, biotechnological products, development of products for others in the field of biotechnology, biotechnology research, scientific laboratory services, therapeutic services featuring biologics, biologics diagnostic testing
+Added: Biotechnological products, namely, blood-derived biologics being plasma extract containing concentrated nanoparticles derived from whole human blood (IC 005)
Serial Number :
Filing Date :
−Removed: December 22, 2023
+Added: January 4, 2024
Organicell Regenerative Medicine, Inc.
−Removed: Awaiting examination
+Added: Published for Opposition December 10, 2024
Goods/Services :
−Removed: biotechnological products, namely, blood-derived biologics
+Added: Hair growth serum
Serial Number :
Filing Date :
−Removed: January 4, 2024
−Removed: Organicell Regenerative Medicine, Inc.
−Removed: Awaiting examination
+Added: December 3, 2024
+Added: Zeo ScientifiX, Inc.
+Added: ZEO HAIR GROW
+Added: Goods/Services :
+Added: Hair growth serum
+Added: Serial Number :
+Added: Filing Date :
+Added: December 4, 2024
+Added: Zeo ScientifiX, Inc.
+Added: ZEO GROW BOOST
+Added: Goods/Services :
+Added: Hair growth serum
+Added: Serial Number :
+Added: Filing Date :
+Added: December 4, 2024
+Added: Zeo ScientifiX, Inc.
Pursuant to our employment agreements with our executives, all work product that is created, prepared, produced, authored, edited, amended, conceived or reduced to practice by each executive individually or jointly with others during the period of their employment by the Company and relating in any way to the business or contemplated business, research or development of the Company (regardless of when or where the Work Product is prepared or whose equipment or other resources is used in preparing the same), as well as any and all rights in and to copyrights, trade secrets, trademarks (and related goodwill), patents and other intellectual property rights therein arising in any jurisdiction throughout the world and all related rights of priority under international conventions with respect thereto, including all pending and future applications and registrations thereof, and continuations, divisions, continuations-in-part, reissues, extensions and renewals thereof (collectively, “ Intellectual Property Rights ”), the sole and exclusive property of the Company.
14 unchanged sentences
Notwithstanding the foregoing, we are undertaking efforts on an ongoing basis to mitigate any potential risks associated with an adverse ruling by the FDA and the subsequent limitations on our ability to continue to generate revenues from the sale of our products in the United States until the Company obtains the required licenses.
−Removed: The efforts include continuing with clinical trials both domestically and internationally, expanding sales internationally and developing new product offerings and/or designations of products that would not fall under these regulations, including the Company’s recent launching of PPX™.
+Added: The efforts include continuing with clinical trials both domestically and internationally, expanding sales internationally and developing new product offerings and/or designations of products that would not fall under these regulations, including the Company’s recent launching of PPX™ and the recent development and distribution of additional products that incorporate its proprietary ingredients for products to be used in topical aesthetic applications.
We intend to perform clinical trials for our RAAM Products for the purpose of obtaining biologics license status from the FDA to provide us with advantages over our competitors, including acceleration for acceptance of our products in traditional insurance plans, compliance with FDA regulations and/or to provide our customers with superior education and support of the benefits of our products.
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These products are the fastest growing sector of regenerative medicine due to their compliant regulatory position with the FDA.
+Added: In addition, many companies have emerged with products that are being targeted for aesthetic and/or topical use, which in some instances have less regulatory restrictions for the use of the products.
Allogenic competitors are primarily producer-distributor companies which historically included Kimera Labs, Frontier Biologics, Benev Company Inc., Exocel Bio, Re-gen Active Lab, Neobiosis, MiMedix Group, Inc., Invitrx Therapeutics, Liveyon Labs, DermaSciences, Signature Biologics, Direct Biologics and Vitti Labs LLC, as well as a number of distributors who sell white-labeled products from those producer-distributor entities.
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To date, the Company has not received any warning letters or correspondence from the FDA indicating that our products were not in compliance with the current FDA regulations.
+Added: The aesthetic market consists of numerous products aimed at skin rejuvenation, anti-aging, and overall dermatologic health.
+Added: These include advanced serums, creams, and other over-the-counter formulations that incorporate cutting-edge ingredients like peptides, growth factors, and nanoparticles.
+Added: While these products are generally marketed as non-invasive and appeal directly to consumers and are often sold as “topical” and/or “cosmetics”, they compete indirectly with medical aesthetic procedures by offering lower-cost alternatives for achieving similar cosmetic improvements.
+Added: This segment consists of many competitors, many of which have significantly greater resources than the Company to develop, research and market their products.
As stated previously, the demand for RAAM products is very high and expected to grow with the growing baby boomer generation getting older, the increase in patients desiring to seek health care options outside of traditional therapies, the growing trend in the desire of individuals to remain active longer in life and the ongoing rise in health care costs which RAAM products may provide a more efficient and economical alternative for certain conditions.
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Environmental Protection Agency and similar state agencies.
−Removed: As of January 28, 2024, we have 23 full-time employees and no part-time employees.
+Added: As of October 31, 2024, we had 20 full-time employees and no part-time employees.
We also engaged 2 other consultants that assisted with various regulatory, marketing, administrative activities and distribution services.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.