What changed in this filing

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Item 1. Business

2026-01-29 compared with 2025-01-29 · 252 added, 106 removed, 364 unchanged (50% of the section changed)

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.

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 ”).

The Company has a portfolio of proprietary products derived from ethically sourced birth tissue, including mesenchymal stem cells, stem cell and amniotic fluid derived exosomes and Whartons Jelly matrix.

The Company’s principal product is Zofin™, a product derived from amniotic fluid and manufactured to retain the naturally occurring extracellular vesicles, proteins and cell secreted nanoparticles.

ZEO also manufactures Patient Pure X™ (“ PPX™ ”), a proprietary autologous biologic containing a nanoparticle fraction that is precipitated from a patient’s own peripheral blood.

ZEO’s products are all manufactured in FDA-registered, cGMP-compliant laboratory facilities.

Our portfolio of products (“ RAAM Products ”) and related services are principally used in the health care industry administered through doctors and clinics (“ Providers ”).

The state of Florida enacted a new “stem cell therapy” law, effective July 1, 2025 (“ SB 1768 ”).

The legislation authorizes licensed physicians to administer non-FDA-approved stem cell and other human tissue-derived therapies for orthopedic, wound care, and pain management indications.

It mandates compliance with cGMP and prohibits the use of stem cells derived from aborted fetuses, promoting ethically sourced materials such as adult stem cells and umbilical cord blood.

SB 1768 also requires informed patient consent and disclosure that treatments are not FDA-approved.

Zeo expects that SB 1768 will create substantial new demand for current and future stem cell therapy products by:

(i) meeting existing physician and patient interest in regenerative therapies, (ii) increasing awareness of the availability and potential efficacy of stem cell therapy treatments, and (iii) attracting medical tourists who previously sought stem cell therapy treatments abroad but can now access comparable procedures in Florida under higher regulatory standards and at lower cost.

Accordingly, the Company has begun to pursue clinical research and commercial sales strategies that are compliant with SB 1768.

By enabling physicians to adopt Zeo’s products for approved indications in Florida, the Company anticipates significant revenue growth and faster advancement of its clinical trial objectives at reduced cost.

ZEO expects to further distinguish itself through leadership in research, quality, safety, and regulatory compliance for biologics.

The new law also allows Zeo to collect real-world safety and outcome data from providers—data that previously could only be obtained through FDA Investigational New Drug (IND) applications or Institutional Review Board (IRB)-approved studies.

Access to this data is expected to lower risks associated with the Company’s future FDA submissions for product approvals.

While prioritizing the anticipated growth of Florida’s stem cell market, Zeo continues to advance its research programs, including clinical studies, product development, and ongoing quality and compliance initiatives.

The Company recently launched an IRB-approved clinical study titled “Open-Label Prospective Longitudinal Clinical Trial to Evaluate the Safety and Potential Efficacy of PPX™ in Patients Suffering from Musculoskeletal Joint Pathologies Using Real-World Data to Monitor Patient Outcomes.” The study will enroll up to 350 patients, with five clinics already participating and seven patients enrolled to date.

In addition to the Company’s efforts to develop, manufacture and market products that are compliant with SB 1768, 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.

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.

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.

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.

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Current FDA guidance requires 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 ”).

We have not obtained any opinion or ruling regarding the Company’s operations and whether the processing, sales and distribution of the products we currently produce would be subject to the FDA’s previously announced intended enforcement policies regarding HCT/P’s.

However, we do not believe that our products fall within these guidelines and intend to vigorously defend against any adverse interpretation by the FDA on the classification of our products that may be deemed as falling under this defined regulation, if any.

We have not obtained any opinion or ruling regarding the Company’s operations and whether the processing, sales and distribution of the products we currently supply and/or produce would be subject to the FDA’s previously announced intended enforcement policies regarding HCT/P’s or fall within SB 1768 that permits the use and sale of certain stem cell therapies and products that would otherwise be restricted under current FDA regulations.

However, we believe that our products are compliant and fall within the respective guidelines and intend to vigorously defend against any adverse interpretation by the FDA and/or the state of Florida on the classification of our products that may be deemed as not being compliant under currently defined regulations, if any.

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.

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.

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).

During November 2024, the Company received a capital call notice from Exotropin (“ November Capital Call ”).

The Company has yet committed to participating in the November Capital Call.

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.

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.

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.

During November 2024, the Company announced that it was launching the first planned collaborative product with Exotropin;

“ZEO HAIR GROW™ Powered By Exotropin™”

Fiscal 2025 Developments

Bio Xt ek Joint Venture

On February 4, 2025, the Company entered into a Binding Memorandum of Understanding (the “ Binding MOU ”) with BioXtek, LLC, a Florida limited liability company (“ BioXtek ”) setting forth the terms of a joint development, manufacturing, marketing and funding arrangement to be entered into by the Company and BioXtek in various phases (the “ BioXtek Joint Venture ”).

BioXtek is a privately-held Florida-based company engaged in the development, manufacturing and marketing of biologic regenerative therapeutics.

The Company and BioXtek failed to execute and deliver the required series of definitive agreements documenting the BioXtek Joint Venture, including the mutual agreement to modify certain terms as set forth in the Binding MOU with respect to the Company relocating its operations to BioXtek’s Pompano Beach, Florida manufacturing facility and the structure of how the parties will collaborate in future clinical trials and the sale of products that were intended to be sold pursuant to the BioXtek Joint Venture.

In June 2025, BioXtek sought to terminate the Binding MOU and the BioXtek Joint Venture for alleged breaches by the Company, which the Company contested.

As the Company and BioXtek were not able to amicably resolve the dispute, on December 17, 2025, the Company commenced an action against BioXtek in Broward County Circuit Court (and an amended Complaint on January 5, 2026), asserting claims for breach of contract and implied covenant, fraudulent inducement, violation of the Florida Deceptive Unfair Trade Practices Act, equitable accounting, and declaratory judgment.

BioLumina Acquisition

On June 25, 2025, the Company acquired all the outstanding limited liability company interests of BioLumina, LLC (“ BIO ”), a Delaware limited liability company, from its members.

BioLumina was engaged in the sale and distribution of topical aesthetic products.

The Company acquired BIO for the purpose of obtaining the finished goods inventory on hand and certain trademarks applications that were pending review and approval.

Exotropin Sales Representative Agreement

In August 2024, the Company entered into a sales representative agreement (the “ Sales Agreement ”) with Exotropin, LLC (“ Exotropin ”), a privately held formulator of skin care products, in which the Company had previously made a minority investment.

The investment in Exotropin was made with and the Sales Agreement was entered into with Exotropin with a view to collaborating on the development of products for the aesthetics market combining Exotropin’s skin care expertise and the Company’s proprietary technology.

In November 2024, The Company announced the launch of its initial collaborative product with Exotropin.

On August 15, 2025, the Company terminated the Sales Agreement for cause.

Exotropin filed a complaint against the Company

for declaratory judgment on August 29, 2025, concerning the Sales Agreement, seeking declarations related to termination and the survival/enforceability

of certain restrictive and other clauses.

On November 6, 2025, the Company moved to dismiss Exotropin’s complaint and to strike

the jury demand pursuant to the agreement’s jury waiver.

The Company filed counterclaims on November 17, 2025, alleging, among other

things, unjust enrichment tied to diverted sales, tortious interference with business relationships, and seeking imposition of a constructive

trust, as well as recovery of attorneys’ fees and costs, with rights reserved to amend and supplement.

On January 7, 2026, Exotropin

filed a First Amended Complaint adding claims for breach of contract and breach of fiduciary duty and seeking injunctive and monetary

Strategic Partnership with Cytora and Made Scientific

On January 7, 2026, the Company announced that it had entered into a comprehensive strategic partnership with Cytora Therapeutics Ltd.

(“ Cytora ”), a clinical-stage biotechnology company based in Israel developing allogeneic stem cell therapies and Made Scientific, Inc.

(“ Made Scientific ”), a leading U.S.-based cell therapy contract development and manufacturing organization (“ CDMO ”), seeking to advance and commercialize Cytora’s novel allogeneic, off- the- shelf, human oral mucosal stem cell therapy in the United States.

The partnership objectives will be the commercialization of the Cytora novel therapeutic through available avenues that have opened up under SB 1768 for the treatment of wound care, pain, and orthopedic conditions and the parallel commencement of U.S.

FDA Phase 2b clinical trials for the therapeutic towards the goal of obtaining an approved FDA license.

Under this multi-party collaboration, Cytora will provide the right to manufacture Cytora’s product, while continuing clinical and regulatory development, Made Scientific will serve as the exclusive U.S.

manufacturing partner, cGMP manufacture, and quality control release testing of starting tissue-derived cell banks and final drug product from its state-of-the-art Princeton, New Jersey facility, and Zeo will serve as the exclusive U.S.

commercial partner, providing market access, distribution infrastructure, and clinical site management.

The parties are currently in the process of

preparing the various definitive agreements associated with the collaboration.

Corporate Information

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Cellular/ Tissue based therapies

Mesenchymal stromal/stem cells (MSCs)

Hematopoietic stem cells (HSCs)

Adipose-derived stromal vascular fraction

Bone marrow-derived stem cell therapies

Peripheral blood derived therapies ( i.e., platelet rich plasma);

Placental-based therapies

Bone marrow concentrates

Peripheral blood derived therapies (i.e., platelet rich plasma, PPX)

Perinatal derived -based therapies (amniotic membrane, placental tissue, extracellular vesicles, umbilical cord tissue or blood)

Technology documented since 1910 for safety and efficacy, tissue processed from human amniotic membrane and fluid, donated by consenting mothers delivering a full-term healthy baby by scheduled Caesarean section, avoiding any ethical or moral concerns, proven safety record, case series documented success in a multitude of systemic and local pathologies

Growth factor, cytokine therapies

Secretome based therapies, Growth factor, cytokine therapies

Medical foods

Weight control

Topical lotions and creams for the largest organ the skin

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Our current business strategy is to achieve the following goals and milestones:

Execute on our current strategy to complete existing clinical studies and secure approval to commence larger Phase II studies for other specific indications that we identify that the use of our products will provide more favorable and desired health related benefits for patients seeking alternative treatment options than are currently available;

Perform clinical based studies associated with the use of our products (independently and/or in conjunction with Providers, Manufacturers, Government Agencies and Educational Institutions) and seek accelerated approval where available for each product application in accordance with the 21st Century Cures Act (“ Cures Act ”) and/or through the granting of an FDA-approved biologics application (“ BLA ”) to allow products to be lawfully marketed and/or sold in the United States;

Assure the Company maintains compliance with existing and the anticipated changes to FDA regulations, including the guidance related to the use and sale of tissue-based products (“ HCT/Ps ”) which was published in November 2017 and took effect in May 2021 (postponed from November 2020 due to the COVID-19 pandemic), as well as readiness to respond to ongoing future changes to regulations impacting our products;

Expand our laboratory facilities to meet expected production, processing and research requirements;

Engage high profile and industry recognized medical advisors, researchers and/or scientists to help identify and develop new and emerging technologies concerning biologics and to assure our Products remain cutting edge and competitive to products offered by other companies;

Perform ongoing research and data gathering to support publishing peer-reviewed outcomes and additional support for safety and efficacy of ZEO’s products.

ZEO intends to achieve this through:

Continued IND and IRB related clinical trials with large clinics and institutions,

The ability to advance clinical research by leveraging data collected from providers that treat specific indications from biologics legally sold in Florida under SB 1768 (and potentially other states in the future that adopt similar legislation) which previously could only previously be done through an FDA approved IND or IRB.

Collecting safety and outcome data in real time will ultimately reduce the costs (time and $$) and risks to pursue a desired FDA approval for an indication(s),

Seek accelerated approval and reimbursement where available for each product application in accordance with existing regulatory guidelines, including 21st Century Cures Act (“ Cures Act ”) and/or through the granting of an FDA-approved biologics application (“ BLA ”).

Identify and consummate strategic relationships and acquisition targets that would enhance and/or accelerate the growth of the Company such as (a) existing raw material and/or medical device suppliers or owners of advanced and proven intellectual property associated with manufacturing and/or supplying existing and/or additional desired RAAM products;

(b) Providers that specialize in RAAM products;

and/or (c) companies that market and distribute RAAM products.

Development / supply of new products and services to support Providers;

Expand current products to target specific indications that comply with SB 1768 (Pain, Wound Care, Orthopedics),

Identify alternative products and services to (a) offset any potential decline in revenues resulting from FDA limitations on the sales and distribution of our existing products currently being sold and distributed and/or future expected FDA restrictions on RAAM products;

and (b) provide our Providers with alternative product and treatment options to remain competitive with the market and our Providers to meet the needs and demands of their patients.

Increase sales of our products that are compliant with FDA regulations and/or SB 1768 which became effective July 1, 2025 (“SB 1768”);

Expand w-2 sales force,

Continue to grow independent national and regional sales organizations (1099) to market and distribute the Company’s products,

Partnership with concierge medicine and large practice groups and regenerative medicine focused practices,

Scaling physician adoption nationwide through turnkey integration programs,

Building strategic partnerships with universities, hospitals, biotech firms, and global distribution networks,

Expand sales into the Medical Aesthetic market

Continue efforts to strengthen market awareness of the Company, our portfolio of product offerings that are derived from various birth tissue sources and levels of concentration and the Company’s superior safety, quality and compliance surrounding its operations and biologic product offerings.

These initiatives include:

Rebranding of our product line to Day Zero™

Website redesign

Digital Marketing

Webinars, seminars, curated events

Assure the Company maintains compliance with existing and the anticipated changes to FDA regulations, including the guidance related to the use and sale of tissue-based products (“ HCT/Ps ”) which was published in November 2017 and took effect in May 2021, as well as readiness to respond to ongoing future changes to regulations impacting our products.

Engage high profile and industry recognized medical advisors, researchers and/or scientists to serve as ambassadors to the Company, to help identify and develop new and emerging technologies concerning biologics, and to assure our Products remain cutting edge and competitive to products offered by other companies.

Identify sources of exclusive and superior suppliers of RAAM products and/or raw materials used by us in processing our RAAM products.

Identify strategic relationships and acquisition targets that would enhance and/or accelerate the growth of the Company with third parties such as (a) existing raw material and/or medical device suppliers or owners of IP associated with existing and/or additional desired RAAM products;

(b) Providers that specialize in RAAM products;

and/or (c) companies that market and distribute RAAM products;

Develop and expand operations to provide for growth of our revenues

Expand our sales market and network of Providers within and outside of the United States to increase revenues for RAAM related products through:

Hiring additional in-house sales personnel;

Selectively engaging independent distributors;

Marketing private label products to distributors;

Increasing market recognition for our brands from:

marketing and participating in industry trade shows;

Increase the number of RAAM product offerings for various modalities using proprietary processing, formulas and administration techniques, and

Extend our referral network of Providers based on:

Superior product offerings;

Demonstrating a realistic and executable regulatory roadmap to assure Company and product compliance with current and anticipated FDA regulations;

Developing and providing educational support to Providers regarding our products and regulatory concerns;

Secure additional working capital;

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Fund ongoing costs to complete current pipeline of clinical trials as well as future clinical trials

Fund capital expenditures associated with maintaining compliance of our facilities and products;

Fund capital expenditures associated with meeting expected production, processing and research requirements and maintaining compliance of our facilities and products

Fund our strategy to develop and expand our revenues for the sales and distribution of RAAM related products described above;

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Continue to develop and expand the Company’s internal control policies;

Continue to explore previously announced plans to uplist the Company to Nasdaq for the purpose of enhancing interest and investment opportunities for the Company once the Company is able to demonstrate compliance with initial listing requirements, including minimum share price and stockholder’s equity thresholds.

Continue to explore previously announced plans to uplist the Company to a nationally recognized exchange for the purpose of enhancing interest and investment opportunities for the Company once the Company is able to demonstrate compliance with initial listing requirements, including minimum share price and stockholder’s equity thresholds.

Market Overview

The population of the United States and the developed world is getting older and living longer.

According to a United States Consensus Bureau’s report, “ An Aging World:

2015 ,” America’s 65-and-over population is projected to nearly double over the next three decades, ballooning from 48 million to 88 million by 2050 and that worldwide, the 65-and-over population will more than double to 1.6 billion by 2050.

According to the report, in 2015, 14.9% of the U.S.

population was 65 or over and the United States was the 48th oldest country out of 228 countries and areas in the world in 2015.

Baby boomers began reaching age 65 in 2011 and by 2050 the older share of the U.S.

population will increase to 22.1%.

The world average age of death has increased by 35 years since 1970, with declines in death rates in all age groups, including those aged 60 and older (Source:

Institute for Health Metrics and Evaluation, 2013;

Mathers et al., 2015).

The population of the United States and many other developed economies is aging due to increased life expectancy and sustained declines in fertility rates.

According to the U.S.

Census Bureau, the number of individuals aged 65 years and older in the United States reached approximately 61.2 million in 2024, representing about 18.0% of the total U.S.

The proportion of older adults has increased steadily over time, reflecting long-term demographic shifts in population age structure.

Demographic projections indicate that population aging in the United States is expected to continue over the coming decades.

Research published by the Population Reference Bureau projects that the number of Americans aged 65 and older will rise to approximately 82 million by 2050, at which point this age group is expected to represent approximately 23% of the total U.S.

These changes are driven in part by the aging of the post-World War II baby-boom generation, all of whom will be at least 65 years old by 2030.

Similar trends are occurring globally.

According to population projections published by the United Nations, the number of people aged 65 years and older worldwide is expected to more than double, increasing from approximately 761 million in 2021 to about 1.6 billion by 2050.

Population aging is occurring across both developed and many emerging economies as longevity increases and birth rates decline.

These demographic trends are expected to influence labor force participation, consumer behavior, healthcare utilization, public expenditures, and overall economic growth patterns in the United States and globally.

As a result, population aging represents a significant structural factor shaping long-term market conditions across multiple sectors.

The world average age of death has increased by 35 years since 1970, with declines in death rates in all age groups, including those aged 60 and older according to the Institute for Health Metrics and Evaluation, 2013.

The leading causes of death are shifting, in part because of increasing longevity.

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In addition, growth is expected to be supported by macroeconomic factors including (anticipated) more favorable regulatory conditions and growing investor interest in the aforementioned three subsectors.

If we are able to fully implement our intended business plan, we believe that we will be well situated to address this increased consumer demand for alternative medical treatments.

Florida Stem Cell Therapy Law – SB 1768

Effective July 1, 2025, the state of Florida enacted a new “stem cell therapy” law, SB 1768, which authorizes licensed physicians to administer certain stem cell therapies that have not been approved by the U.S.

Food and Drug Administration (“FDA”) for use in the treatment of orthopedic conditions, wound care, and pain management, provided specific statutory requirements are met.

The law mandates adherence by suppliers to FDA’s current good manufacturing practices (cGMP) for stem cell products and explicitly prohibits the use of stem cells derived from aborted fetuses , encouraging ethically sourced cells like adult stem cells and umbilical cord blood.

The law also imposes certain requirements of physicians, including obtaining patient consent and notices warning that the treatments are not FDA approved.

Several other U.S.

states have implemented laws expanding access to non-FDA-approved stem cell therapies, including Texas, Mississippi, North Carolina, Nevada and Utah and the expectation is that more states will adopt similar provisions in the near future.

The Company expects that SB 1768 will drive significant new demand from (i) the medical tourism population which are no longer required to be treated outside the United States to obtain stem cell treatments (more costly and less reliable), (ii) increased physician and patient demand resulting from increased awareness and education of the availability and benefits of stem cell treatments that may be more efficacious than existing standard of care options and (iii) Florida physicians seeking options to stay relevant and increase their practice revenues.

SB 1768 provides the Company with new legal pathways to market and sell its products, including its newly offered stem cell products.

By allowing for physicians to adopt and use the Company’s products, the Company believes that it will be able to significantly grow revenues and accelerate its clinical trial objectives and at significantly lower costs.

The Company has historically been constrained from achieving its desired objectives to grow revenues and obtain funding to advance clinical trials due to FDA constraints and the resulting physician, patient and investor uncertainty over the sale of biologics which could restrict the providers’ ability and desire to use biologic products and the costs, time and overall risks associated with performing clinical trials and ultimately obtaining FDA approval.

Under SB 1768, the Company:

is now able to legally sell its biologics in Florida (and potentially other states in the future that adopt similar legislation), including newly offered and highly sought after Stem Cells, and

is now able to educate providers and market its products, which will allow ZEO to distinguish itself among its competitors as a global leader in research, quality, safety and regulatory compliance for biologics, and

has the ability to advance clinical research by leveraging data collected from providers that treat specific indications which previously could only be done through an FDA approved IND or IRB.

Zeo believes that collecting safety and outcome data in real time will ultimately reduce the costs (time and $$) and risks to pursue a desired FDA approval for an indication(s).

If we are able to fully implement our intended business plan with respect to stem cell therapy products, we believe that we will be well situated to address this increased consumer demand for alternative medical treatments.

Marketing and Sales

Currently, we market our RAAM products and services to a network of Providers through in-house, contracted sales personnel and/or from independent distributors.

As of the date of this Annual Report, we had two in-house salespersons who marketed our RAAM products and services.

As of the date of this Annual Report, we had five in-house salespersons who marketed our RAAM products and services.

In addition, we had arrangements with several independent distributors that were marketing and distributing our products.

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Issued Patents:

ZEO ScientifiX™ has one issued U.S.

Patent for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid.

Patent Application No.

ZEO ScientifiX™ has two issued U.S.

Patents for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid.

COMPOSITIONS COMPRISING

NANOPARTICLES, METHOD OF MAKING AND USES THEREOF

Application No.

17/990,522 (Continuation of 17/226,587)

COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF

November 18, 2022

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March 17, 2023

Patent Applications:

ZEO ScientifiX™ has one U.S.

Patent Application on file for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid.

Patent Application No.

ORGANICELL REGENERATIVE MEDICINE, INC.

(Assignor), ZEO SCIENTIFIX, INC.

July 28, 2025

COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF

Application No.

April 9, 2021

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Organicell Regenerative Medicine, Inc.

August 5, 2025

MARIA INES MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC.

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055878/0801 & 055878/0900

ORGANICELL REGENERATIVE MEDICINE, INC.

(Assignor), ZEO SCIENTIFIX, INC.

June 26, 2025

ZEO ScientifiX™ has one issued U.S.

Patent for its Organicell™ PPX product and the proprietary techniques used in the administration of blood-derived exosomes to treat

COMPOSITIONS AND METHODS FOR TREATING PAIN WITH EXTRACELLULAR VESICLES

Application No.

December 8, 2022

Maria Ines Mitrani, Michael Bellio, and Albert Mitrani

Organicell Regenerative Medicine, Inc.

February 4, 2025

MARIA INES MITRANI (Assignor), MICHAEL BELLIO (Assignor),

ALBERT MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC.

April 19, 2023

ORGANICELL REGENERATIVE MEDICINE, INC.

(Assignor), ZEO SCIENTIFIX, INC.

December 10, 2024

Patent Applications:

ZEO ScientifiX™ has one U.S.

Patent Application on file for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid.

Patent Application No.

18/981,124 (Continuation of 17/226,587)

COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF

December 13, 2024

Maria Ines Mitrani

Zeo ScientifiX, Inc.

MARIA INES MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC.

July 24, 2025

ORGANICELL REGENERATIVE MEDICINE, INC.

(Assignor), ZEO SCIENTIFIX, INC.

July 28, 2025

ZEO ScientifiX™ has one 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.

Patent Application No.

19/045,385 (Continuation of 18/063,227)

COMPOSITIONS AND METHODS FOR TREATING PAIN WITH EXTRACELLULAR VESICLES

February 4, 2025

Maria Ines Mitrani, Michael Bellio, and Albert Mitrani

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.

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Application Number:

Filing Date :

April 10, 2021

Application Number :

Filing Date :

April 10, 2021

Application Number :

202180041860.8

Filing Date :

April 10, 2021

Application Number :

Filing Date :

April 10, 2021

Application Number :

Filing Date :

April 10, 2021

Application Number :

Filing Date :

April 10, 2021

Application Number :

MX/a/2022/012692

Filing Date :

April 10, 2021

Application Number:

Filing Date :

April 10, 2021

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.

Patent Application No.

COMPOSITIONS AND METHODS FOR TREATING PAIN WITH EXTRACELLULAR VESICLES

Application Number:

December 8, 2022

Maria Ines Mitrani, Michael Bellio, and Albert Mitrani

Organicell Regenerative Medicine, Inc.

MARIA INES MITRANI (Assignor), MICHAEL BELLIO (Assignor), ALBERT MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC.

April 19, 2023

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.

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Organicell Regenerative Medicine, Inc.

MARIA INES MITRANI (Assignor), MICHAEL BELLIO (Assignor), ALBERT MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC.

MARIA INES MITRANI (Assignor), MICHAEL BELLIO (Assignor),

ALBERT MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC.

Goods/Services :

4 unchanged sentences

July 13, 2020

Zeo ScientifiX, Inc.

Organicell Regenerative Medicine, Inc.

(Assignor), Zeo ScientifiX, Inc.

December 10, 2024

Goods/Services:

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Filing Date :

Zeo ScientifiX, Inc.

Organicell Regenerative Medicine, Inc.

(Assignor), Zeo ScientifiX, Inc.

December 10, 2024

PATIENT PURE X - PPX

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January 24, 2020

Zeo ScientifiX, Inc.

Organicell Regenerative Medicine, Inc.

(Assignor), Zeo ScientifiX, Inc.

December 10, 2024

PATIENT PURE X - PPX

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January 24, 2020

Zeo ScientifiX, Inc.

Organicell Regenerative Medicine, Inc.

(Assignor), Zeo ScientifiX, Inc.

December 10, 2024

Goods/Services :

3 unchanged sentences

September 9, 2020

Zeo ScientifiX, Inc.

Organicell Regenerative Medicine, Inc.

(Assignor), Zeo ScientifiX, Inc.

December 10, 2024

Goods/Services :

3 unchanged sentences

September 9, 2020

Zeo ScientifiX, Inc.

Organicell Regenerative Medicine, Inc.

(Assignor), Zeo ScientifiX, Inc.

December 10, 2024

Goods/Services :

Biotechnological products, namely, blood-derived biologics being plasma extract containing concentrated nanoparticles derived from whole human blood (IC 005)

Registration Number :

Filing Date :

January 4, 2024

Zeo ScientifiX, Inc.

Organicell Regenerative Medicine, Inc.

(Assignor), Zeo ScientifiX, Inc.

December 10, 2024

ZEO SCIENTIFIX

7 unchanged sentences

December 11, 2023

Zeo ScientifiX, Inc.

Notice of Allowance Issued August 12, 2025

Organicell Regenerative Medicine, Inc.

Non-Final Action Issued November 18, 2024

(Assignor), Zeo ScientifiX, Inc.

December 10, 2024

Composite Mark :

8 unchanged sentences

December 11, 2023

Organicell Regenerative Medicine, Inc.

Non-Final Action Issued November 18, 2024

Goods/Services :

Biotechnological products, namely, blood-derived biologics being plasma extract containing concentrated nanoparticles derived from whole human blood (IC 005)

Serial Number :

Filing Date :

January 4, 2024

Zeo ScientifiX, Inc.

Notice of Allowance Issued August 12, 2025

Organicell Regenerative Medicine, Inc.

Published for Opposition December 10, 2024

(Assignor), Zeo ScientifiX, Inc.

December 10, 2024

Goods/Services :

Hair growth serum

Hair growth serum in the nature of a system comprised of hair growth stimulants for follicle stimulation (IC 005)

Serial Number :

2 unchanged sentences

Zeo ScientifiX, Inc.

Notice of Allowance Issued December 9, 2025

ZEO HAIR GROW

Goods/Services :

Hair growth serum

Hair growth serum in the nature of a system comprised of hair growth stimulants for follicle stimulation (IC 005)

Serial Number :

2 unchanged sentences

Zeo ScientifiX, Inc.

Notice of Allowance Issued December 9, 2025

ZEO GROW BOOST

Goods/Services :

Hair growth serum

Hair growth serum in the nature of a system comprised of hair growth stimulants for follicle stimulation (IC 005)

Serial Number :

2 unchanged sentences

Zeo ScientifiX, Inc.

Notice of Allowance Issued December 9, 2025

Goods/Services :

Biologically derived products developed from perinatal tissue material for skincare aesthetic purposes (IC 001);

Biologically derived products developed from perinatal tissue material for medical, regenerative and aesthetic purposes (IC 005)

Serial Number :

Filing Date :

Zeo ScientifiX, Inc.

Non-Final Office Action Issued October 10, 2025

Goods/Services :

Biologically derived products developed from perinatal tissue material for skincare aesthetic purposes (IC 001);

Biologically derived products developed from perinatal tissue material for medical, regenerative and aesthetic purposes (IC 005)

Serial Number :

Filing Date :

Zeo ScientifiX, Inc.

Non-Final Office Action Issued October 10, 2025

DAY ZERO STEM CELL MATRIX

Goods/Services :

Conditioned media derived from processing of stem cells (IC 005)

Serial Number :

Filing Date :

August 13, 2025

Zeo ScientifiX, Inc.

Non-Final Office Action Issued October 10, 2025

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.

24 unchanged sentences

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.

Allogenic competitors are primarily producer-distributor companies which historically included Kimera Labs, Frontier Biologics, Platinum Biologics, Benev Company Inc., Exocel Bio, Re-gen Active Lab, Neobiosis, MiMedix Group, Inc., Invitrx Therapeutics, 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.

Additionally, there are a variety of accredited blood, bone, and soft tissue banks that we historically competed against.

18 unchanged sentences

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.

The Company’s recently launched autologous product called Patient Pure X™ (PPX™).

The Company’s autologous product called Patient Pure X™ (PPX™).

PPX™ is a non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood.

93 unchanged sentences

We have incorporated the principles of the AdvaMed Code in our standard operating procedures, sales force training programs, and relationships with health care professionals.

Florida Stem Cell Therapy Law – SB 1768

Effective July 1, 2025, the state of Florida enacted SB 1768, which authorizes licensed physicians to administer certain stem cell therapies that have not been approved by the FDA for use in the treatment of orthopedic conditions, wound care, and pain management, provided specific statutory requirements are met.

The law mandates adherence by suppliers to cGMP for stem cell products and explicitly prohibits the use of stem cells derived from aborted fetuses , encouraging ethically sourced cells like adult stem cells and umbilical cord blood.

The law also imposes certain requirements of physicians, including obtaining patient consent and notices warning that the treatments are not FDA approved.

Several other U.S.

Key provisions of SB 1768 include:

Authorization for licensed Florida physicians to perform specified stem cell therapies that are not FDA-approved, subject to compliance with Florida law and applicable standards for the collection, processing, storage, and use of human cells, tissues, or cellular or tissue-based products.

Requirements that stem cells be sourced from facilities registered with the FDA and accredited/certified by specified organizations, and that physicians adhere to current good manufacturing practices (cGMP).

Mandatory informed consent from patients — including disclosure that therapies are not FDA-approved — and statutory notice/disclaimer requirements for advertising and patient communications.

Prohibitions on the use of stem cells derived from aborted fetuses or embryos and criminal/disciplinary penalties for noncompliance under Florida law.

Manufacturing (Processing)

We intend on becoming a registered establishment, accredited by the American Association of Tissue Banks (“ AATB ”) for the storage and distribution of tissue products that we purchase directly or indirectly from third party manufacturers.

We also intend to seek American Association Blood Banks (“ AABB ”) accreditation in connection with certain of our products that we intend to store, process and/or distribute.

Our laboratory and distribution facilities are subject to periodic unannounced inspections by regulatory authorities based on the activities in which we may be engaged, and may undergo compliance inspections conducted by the FDA and corresponding state and foreign agencies based on our operations.

We intend to seek American Association Blood Banks (“ AABB ”) or AATB accreditation in connection with the storage of products we intend to distribute.

FDA Compliance Steps

7 unchanged sentences

As a result, the studies and the related sites where the studies were performed have been closed.

In addition, the Company is reviewing the benefit from continued efforts to commence and/or complete additional Phase I safety related trials as well as which indications should be pursued for Phase II efficacy related research and whether any of the existing approved and open IND’s should be modified, terminated and/or replaced.

In addition, the Company is reviewing whether any of the existing approved and open IND’s should be modified, terminated and/or replaced.

The ability for the Company to initiate any future 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.

12 unchanged sentences

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.

What changed 10-K

Item 1. Business