OTC: ZEOX

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.

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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. The ability of the Company to succeed in these efforts is subject to among other things, the Company having sufficient available working capital to fund the substantial costs of completing clinical trials, which the Company currently does not have, and ultimately, obtaining approval from the FDA.

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 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.

Fiscal 2025 Developments

BioXtek 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.

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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
relief.

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

The Company was incorporated in the state of Nevada on August 9, 2011, under the name “Bespoke Tricycles Inc.,” changed its name to “Biotech Products Services and Research, Inc.” effective November 4, 2015, to “Organicell Regenerative Medicine, Inc.” effective June 20, 2018 and assumed its current name of “Zeo ScientifiX, Inc.” effective February 20, 2024.

Our executive offices are located at 3321 College Avenue, Suite 246, Davie, Florida and our telephone number is (888) 963-7881. Our corporate website is www.zeoscientifix.com.. Information appearing on our website is not part of this Annual Report.

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Industry Overview

The traditional health care industry in the United States is predominantly controlled by the rules of the Centers for Medicare & Medicaid Services (“CMS”) (www.cms.gov) and commercial health insurance companies with respect to payor coverage for medical diagnostics and therapies. This control of coverage currently limits patients’ access to alternative medical therapies, although emerging medical research demonstrates highly beneficial outcomes in the field of anti-aging and regenerative medicine. Traditional allopathic medicine of health care provided to patients in the United States relies on government and commercial health insurance for payment of the costs associated with their day-to-day health care. Because of this close relationship, physicians must follow government and commercial insurers guidelines in order to receive reimbursement for most services. In addition, physicians may be hesitant to adopt new treatments because of perceived legal ramifications and/or lack of knowledge concerning recent research supporting the use of cutting-edge anti-aging and regenerative medical treatments. In addition, many physicians provide alternative therapies that are not yet covered by payors in a “private-pay” or concierge medicine model.

Despite the above, anecdotal and medical literature has shown an increased demand by patients for access to alternative medical therapies and treatments. Patients are seeking these alternatives to traditional allopathic medicine, due to the adverse events associated with traditional pharmaceuticals, risks associated with surgeries, and that traditional medicine and insurers are not addressing wellness or preventive medicine sufficiently. To address a wide variety of common and debilitating conditions related to aging, the Company is developing safer alternatives to traditional therapies, leveraging the latest regenerative technologies. As described above, these alternative therapies face significant restrictions because of regulations imposed by the FDA, other regulatory bodies and insurers due to lack of a sufficient body of randomized controlled studies. Nonetheless, many published case series and some randomized trials demonstrate the safety and efficacy of regenerative therapies, and payor coverage may expand as the body of supportive research grows. Notwithstanding these current dynamics, patients and consumers are looking to safe alternatives compared to more traditional medicine, including the following:

●
Cellular/ Tissue based therapies

○
Mesenchymal stromal/stem cells (MSCs)

○
Hematopoietic stem cells (HSCs)

○
Adipose-derived stromal vascular fraction

○
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

○
Secretome based therapies, Growth factor, cytokine therapies

●
Anti-Aging

○
Supplements

■
Vitamin

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■
Mineral

■
Medical foods

○
Peptides

○
Topical lotions and creams for the largest organ the skin

●
Nontraditional medical alternatives

○
Acupuncture

○
Naturopathic

○
Chiropractic

●
Self-directed

○
Meditation

○
Yoga

○
Tai Chi

Currently, patients who desire alternative treatments rely on the following options:

●
Medical Tourism

○
In United States

○
Off-shore United States

■
Central and South America

■
Caribbean

■
Europe

●
Consulting directly with physicians knowledgeable in providing regenerative medical services

●
Unlicensed life coaches

Current Business Strategy

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

1.
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:

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

b.
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),

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c.
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”).

2.
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.

3.
Development / supply of new products and services to support Providers;

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

b.
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.

4.
Increase sales of our products that are compliant with FDA regulations and/or SB 1768 which became effective July 1, 2025 (“SB 1768”);

a.
Expand w-2 sales force,

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

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

d.
Scaling physician adoption nationwide through turnkey integration programs,

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

f.
Expand sales into the Medical Aesthetic market

5.
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:

a.
Rebranding of our product line to Day Zero™

b.
Website redesign

c.
Digital Marketing

d.
Webinars, seminars, curated events

6.
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.

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7.
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.

8.
Identify sources of exclusive and superior suppliers of RAAM products and/or raw materials used by us in processing our RAAM products.

9.
Secure additional working capital;

a.
Fund shortfalls in working capital to fund ongoing expenses and required payments to vendors and creditors until revenues are stabilized

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

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

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

e.
Hire additional personnel to support our growth and planned expansion; and

f.
Enhance our CRM, e-commerce and ERP capabilities to facilitate marketing, sales and distribution functionality and accounting for our operations

10.
Enhance Company Corporate Governance;

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

b.
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 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. population. 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. population. 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.

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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. Between 1990 and 2013, the number of deaths from non-communicable diseases (“NCDs”) has increased by 42%; and the largest increases in the proportion of global deaths took place among the population aged 80 and over. An estimated 42.8% of deaths worldwide occur in the population aged 70 and over, with 22.9% in the population aged 80 and over.

Also, according to the Centers for Disease Control (the “CDC”), “Medical Tourism” (a term commonly used to describe people traveling outside their home country for medical treatment) is a worldwide, multibillion-dollar phenomenon that is expected to grow substantially in the next 5–10 years. Studies have estimated that hundreds of thousands of medical tourists travel from the United States annually and that patients pursue medical care abroad for a variety of reasons, including a desire to receive a procedure or therapy not available in their country of residence. Common categories of procedures that US travelers pursue during medical tourism trips include orthopedic surgery, cosmetic surgery, cardiology (cardiac surgery), oncologic care, and dentistry. Common destinations include Thailand, Mexico, Singapore, India, Malaysia, Cuba, Brazil, Argentina, and Costa Rica.

According to Precedence Research, the global regenerative treatment market value, in which cell therapy operates, is expected to grow to ~$174.72 billion by 2032 with a projected growth rate of 22.8% annually (2023-2032). North America is estimated to be the largest market for Regenerative Medicine with 49.1% global market share. 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. 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. 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.

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.

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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:

1.
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

2.
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

3.
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 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. We intend in the future to expand our in-house sales force and independent distributors as our working capital improves, our product line expands and as volumes increase. We also intend to develop and offer ongoing training seminars to provide the best possible information on the latest advances on anti-aging, and regenerative medicine to Providers.

Raw Materials and Sources of Supply

We acquire the raw materials and supplies for our RAAM research and development and the manufacturing of our RAAM placental-related products from unaffiliated third-party laboratories pursuant to supply arrangements.

In the event any one or more of our current suppliers are unwilling or unable to sell us required raw materials and/or products, for any reason, we may not be able to provide replacement products to our customers, or if other supply arrangements can be made, the replacement products and terms may not be as favorable.

Customers

Our RAAM business is not dependent on any one or more customers, especially as our customer and distribution network expands. Our customer base is increasingly broad based and throughout the United States and worldwide.

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Intellectual Property

The table below sets forth a summary of our intellectual property rights.

Issued Patents:

ZEO ScientifiX™ has two issued U.S. Patents for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid.

U.S. Patent No. 12,053,494

Titled: COMPOSITIONS COMPRISING
NANOPARTICLES, METHOD OF MAKING AND USES THEREOF

Application No.: 17/990,522 (Continuation of 17/226,587)

Filed: November 18, 2022

Inventor: Maria Ines Mitrani

Applicant: Organicell Regenerative Medicine, Inc.

Issue Date: August 6, 2024

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

Recorded: March 17, 2023

Reel/Frame: 063014/0851

Assignment: ORGANICELL REGENERATIVE MEDICINE, INC. (Assignor), ZEO SCIENTIFIX, INC. (Assignee)

Recorded: July 28, 2025

Reel/Frame: 072287/0052

U.S. Patent No. 12,377,121

Titled: COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF

Application No.: 17/226,587

Filed: April 9, 2021

Inventor: Maria Ines Mitrani

Applicant: Organicell Regenerative Medicine, Inc.

Issue Date: August 5, 2025

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

Recorded: April 9, 2021

Reel/Frame: 055878/0801 & 055878/0900

Assignment: ORGANICELL REGENERATIVE MEDICINE, INC. (Assignor), ZEO SCIENTIFIX, INC. (Assignee)

Recorded: June 26, 2025

Reel/Frame: 071757/0113

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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
pain.

U.S. Patent No. 12,213,994

Titled: COMPOSITIONS AND METHODS FOR TREATING PAIN WITH EXTRACELLULAR VESICLES

Application No.: 18/063,227

Filed: December 8, 2022

Inventors: Maria Ines Mitrani, Michael Bellio, and Albert Mitrani

Applicant: Organicell Regenerative Medicine, Inc.

Issue Date: February 4, 2025

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

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

Recorded: April 19, 2023

Reel/Frame: 063370/0572

Assignment: ORGANICELL REGENERATIVE MEDICINE, INC. (Assignor), ZEO SCIENTIFIX, INC. (Assignee)

Recorded: December 10, 2024

Reel/Frame: 069585/0596

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.

U.S. Patent Application No. 18/981,124 (Continuation of 17/226,587)

Titled: COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF

Filed: December 13, 2024

Inventor: Maria Ines Mitrani

Applicant: Zeo ScientifiX, Inc.

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

Recorded: July 24, 2025

Reel/Frame: 071826/0850

Assignment: ORGANICELL REGENERATIVE MEDICINE, INC. (Assignor), ZEO SCIENTIFIX, INC. (Assignee)

Recorded: July 28, 2025

Reel/Frame: 072287/0052

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.

U.S. Patent Application No. 19/045,385 (Continuation of 18/063,227)

Titled: COMPOSITIONS AND METHODS FOR TREATING PAIN WITH EXTRACELLULAR VESICLES

Filed: February 4, 2025

Inventors: Maria Ines Mitrani, Michael Bellio, and Albert Mitrani

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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:

International Patent Application No. PCT/IB2021/052982

Titled: COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF

Filed: April 10, 2021

Inventor: Maria Ines Mitrani

Applicant: Organicell Regenerative Medicine, Inc.

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

Country: Mexico

Application Number: MX/a/2022/012692

Filing Date: April 10, 2021

Country: Panama

Application Number: 94165-01

Filing Date: April 10, 2021

Country: Canada

Application Number: 3242248

Filing Date: December 8, 2022

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. PCT/US2022/081146

Titled: COMPOSITIONS AND METHODS FOR TREATING PAIN WITH EXTRACELLULAR VESICLES

Filed: December 8, 2022

Inventors: Maria Ines Mitrani, Michael Bellio, and Albert Mitrani

Applicant: Organicell Regenerative Medicine, Inc.

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

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

Trademarks:

Word Mark: ZOFIN

Goods/Services: Biologically derived products developed from perinatal tissue material in the nature of cultured biological tissue and non-cultured biological tissue, for aesthetic purposes, other than for medical or veterinary purposes (IC 001); 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)

Registration Number: 7,469,132

Filing Date: July 13, 2020

Owner: Zeo ScientifiX, Inc.

Assignment: Organicell Regenerative Medicine, Inc. (Assignor), Zeo ScientifiX, Inc. (Assignee)

Recorded: December 10, 2024

Reel/Frame: 8675/0758

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Word Mark: ORGANICELL

Goods/Services: Biologically derived products developed from perinatal tissue material in the nature of cultured biological tissue and non-cultured biological tissue, for aesthetic purposes, other than for medical or veterinary purposes (IC 001); 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)

Registration Number: 6,647,223

Filing Date: May 6, 2020

Owner: Zeo ScientifiX, Inc.

Assignment: Organicell Regenerative Medicine, Inc. (Assignor), Zeo ScientifiX, Inc. (Assignee)

Recorded: December 10, 2024

Reel/Frame: 8675/0758

Word Mark: PATIENT PURE X - PPX

Goods/Services: plasma extracts for medical use, namely, plasma extract containing purified and concentrated exosomes derived from whole human blood (IC 005)

Registration Number: 6,654,296

Filing Date: January 24, 2020

Owner: Zeo ScientifiX, Inc.

Assignment: Organicell Regenerative Medicine, Inc. (Assignor), Zeo ScientifiX, Inc. (Assignee)

Recorded: December 10, 2024

Reel/Frame: 8675/0758

Word Mark: PATIENT PURE X - PPX

Goods/Services: 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)

Registration Number: 6,654,297

Filing Date: January 24, 2020

Owner: Zeo ScientifiX, Inc.

Assignment: Organicell Regenerative Medicine, Inc. (Assignor), Zeo ScientifiX, Inc. (Assignee)

Recorded: December 10, 2024

Reel/Frame: 8675/0758

Word Mark: XOTIN

Goods/Services: 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)

Registration Number: 6,815,780

Filing Date: September 9, 2020

Owner: Zeo ScientifiX, Inc.

Assignment: Organicell Regenerative Medicine, Inc. (Assignor), Zeo ScientifiX, Inc. (Assignee)

Recorded: December 10, 2024

Reel/Frame: 8675/0758

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Word Mark: XOTIN

Goods/Services: 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)

Registration Number: 6,847,416

Filing Date: September 9, 2020

Owner: Zeo ScientifiX, Inc.

Assignment: Organicell Regenerative Medicine, Inc. (Assignor), Zeo ScientifiX, Inc. (Assignee)

Recorded: December 10, 2024

Reel/Frame: 8675/0758

Word Mark: PPX

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

Registration Number: 7,667,270

Filing Date: January 4, 2024

Owner: Zeo ScientifiX, Inc.

Assignment: Organicell Regenerative Medicine, Inc. (Assignor), Zeo ScientifiX, Inc. (Assignee)

Recorded: December 10, 2024

Reel/Frame: 8675/0758

Word Mark: ZEO SCIENTIFIX

Goods/Services: Manufacturing services for others in the field of regenerative medicine (IC 040); Scientific research services for others in the field of regenerative medicine; Scientific laboratory services; Design of biotechnological products being regenerative medicine products (IC 042)

Serial Number: 98307890

Filing Date: December 11, 2023

Owner: Zeo ScientifiX, Inc.

Status: Notice of Allowance Issued August 12, 2025

Assignment: Organicell Regenerative Medicine, Inc. (Assignor), Zeo ScientifiX, Inc. (Assignee)

Recorded: December 10, 2024

Reel/Frame: 8675/0758

Composite Mark: ZEO SCIENTIFIX (Stylized/Design)

Goods/Services: Manufacturing services for others in the field of regenerative medicine (IC 040); Scientific research services for others in the field of regenerative medicine; Scientific laboratory services; Design of biotechnological products being regenerative medicine products (IC 042)

Serial Number: 98307906

Filing Date: December 11, 2023

Owner: Zeo ScientifiX, Inc.

Status: Notice of Allowance Issued August 12, 2025

Assignment: Organicell Regenerative Medicine, Inc. (Assignor), Zeo ScientifiX, Inc. (Assignee)

Recorded: December 10, 2024

Reel/Frame: 8675/0758

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Word Mark: ZEO GROWX

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

Serial Number: 98883075

Filing Date: December 3, 2024

Owner: Zeo ScientifiX, Inc.

Status: Notice of Allowance Issued December 9, 2025

Word Mark: ZEO HAIR GROW

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

Serial Number: 98884330

Filing Date: December 4, 2024

Owner: Zeo ScientifiX, Inc.

Status: Notice of Allowance Issued December 9, 2025

Word Mark: ZEO GROW BOOST

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

Serial Number: 98884343

Filing Date: December 4, 2024

Owner: Zeo ScientifiX, Inc.

Status: Notice of Allowance Issued December 9, 2025

Word Mark: DAY ZERO

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: 99199389

Filing Date: May 23, 2025

Owner: Zeo ScientifiX, Inc.

Status: Non-Final Office Action Issued October 10, 2025

Word Mark: DAY XERO

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: 99199359

Filing Date: May 23, 2025

Owner: Zeo ScientifiX, Inc.

Status: Non-Final Office Action Issued October 10, 2025

Word Mark: DAY ZERO STEM CELL MATRIX

Goods/Services: Conditioned media derived from processing of stem cells (IC 005)

Serial Number: 99334949

Filing Date: August 13, 2025

Owner: Zeo ScientifiX, Inc.

Status: Non-Final Office Action Issued October 10, 2025

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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. All of the Work Product consisting of copyrightable subject matter shall be deemed “work made for hire” as defined in 17 U.S.C. § 101 and such copyrights are therefore owned by the Company or if not applicable, deemed to be irrevocably assigned to the Company, for no additional consideration. The Intellectual Property Rights in any “Pre-existing Materials” included contained in the Work Product shall be retained by the executive but the executive shall be deemed to have granted to the Company an irrevocable, worldwide, unlimited, royalty-free license to use, publish, reproduce, display, distribute copies of, and prepare derivative works based upon, such Pre-Existing Materials and derivative works thereof. The Company may not assign, transfer and sublicense such rights to others without executive’s consent, other than to a wholly owned subsidiary of the Company. The executive shall provide written notice to the Company’s Chief Executive Officer therein notifying the Company new intellectual property including the Pre-Existing Materials.

Competition

The regenerative medicine field is highly competitive and subject to rapid technological change and regulation. Companies compete on the basis of regulatory compliance, product efficacy, pricing, and ease of handling/logistics. A critically important factor for growth in the US market is third-party reimbursement, which is difficult to obtain, and the process can be time-consuming and expensive. We expect that it will take some time before RAAM products will be widely accepted under health insurance coverage. In addition, growth of this industry is expected to expand as additional research and development into the benefits of regenerative products and specific products becomes more widely accepted as a result of FDA mandated or optional clinical trials are performed by industry stakeholders.

As stated previously, companies competing in the industry must now meet the new and more stringent regulatory deadlines imposed by the FDA in connection with regulation of RAAM products that went into effect in May 2021. As a result of these concerns, the Company and our competitors are expected to need to pursue research and development efforts, submit IND applications for FDA approval to commence clinical trials for RAAM products and ultimately obtaining a biologic license for their products to be sold, to assure that their respective operations and products remain compliant with FDA regulations and there is no adverse impact to future operations.

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. 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 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.

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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. Initially we are positioning ourselves as a cash-based health care alternative for consumers that can provide higher levels of improvement, that is not available from traditional allopathic medicine at this time.

The Company competes in multiple areas of clinical treatment where regenerative biomaterials may be employed to modulate inflammation, enhance healing and reduce scar tissue formation: advanced wound care treatment, including spine, orthopedic, sports medicine, and surgical as well as regenerative and aesthetics applications.

The primary competitive products in this space and which are now subject to being classified as an HCT/P product that must meet current regulatory guidelines and require IND approvals, clinical trials, and ultimately biologic license are allogenic products derived from perinatal sources or blood/bone sources including placental powders, placental frozen tissues or liquids, cord blood derived products, and Wharton’s jelly derived products. These products vary significantly in terms of pricing, cellular counts, and biological components, including exosomes, extracellular vesicles, micro vesicles, nanoparticles, and bioactive proteins. As a result of the increased regulatory oversight of HCT/P’s, competitors have begun shifting their product portfolios to autologous solutions including serums derived from blood, bone marrow, and adipose tissue. These products are the fastest growing sector of regenerative medicine due to their compliant regulatory position with the FDA. 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, 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. Currently one of the largest companies in the autologous segment is Regenexx.

In connection with the new FDA regulations that went into effect in May 2021 described above, the Company believes that several perinatal product manufacturers in the United States have closed their operations and that hundreds of other manufacturers and clinics have already received warning letters of violations of the new FDA regulations. 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.

The aesthetic market consists of numerous products aimed at skin rejuvenation, anti-aging, and overall dermatologic health. These include advanced serums, creams, and other over-the-counter formulations that incorporate cutting-edge ingredients like peptides, growth factors, and nanoparticles. 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. 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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Government Regulation

General

The Company’s operations are subject to FDA regulations in connection with the sales and distribution of its RAAM products. In addition, the Company relies on supply agreements with birth tissue recovery companies, supply manufacturers and/or third-party distributors for the supply of RAAM products and/or the Company’s intended objectives to conduct research and development and clinical trials of RAAM products, all of whom are required to comply with FDA regulations. We anticipate these regulations will be heavily enforced and subject to more restrictive regulations by the FDA in the future. A summary of the current FDA regulations is set forth below.

FDA Premarket Clearance and Approval Requirements

Tissue Products

Currently the products that are sold by the Company are derived from human tissue that is purchased by the Company and processed directly in the Company’s laboratory facilities. As discussed below, some tissue-based products are regulated solely under Section 361 of the Public Health Service Act as human cells, tissues and cellular and tissue-based products, or HCT/Ps, which do not require premarket clearance or approval by the FDA. Other tissue products are regulated as biologics and, in order to be lawfully marketed in the United States, require an FDA-approved BLA.

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 autologous product called Patient Pure X™ (PPX™). PPX™ is a non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood.

The Company also supplies products to third party manufacturers that are used as ingredients in formulations or use in conjunction with topical products or topical procedures.

The FDA is continually changing and formulating new guidelines for this industry.

Products Regulated as HCT/Ps

The FDA has specific regulations governing human cells, tissues and cellular and tissue-based products, or HCT/Ps. An HCT/P is a product containing or consisting of human cells or tissue intended for transplantation into a human patient. HCT/Ps that meet the criteria for regulation solely under Section 361 of the Public Health Service Act (so-called “361 HCT/Ps”) are not subject to approval requirements and they are subject to post-market regulatory requirements.

To be a 361 HCT/P, a product generally should meet following criteria:

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Be minimally manipulated, no structural change, or be mixed with anything;

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Be intended for homologous use, essentially used for the same purpose that it was used in the donor;

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Its manufacture must not involve combination with another article, except for water, crystalloids or a sterilizing, preserving or storage agent; and

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It must not be dependent upon the metabolic activity of living cells for its primary function.

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Products Regulated as Biologics- The BLA Pathway

The typical steps for obtaining FDA approval of a BLA to market a biologic product in the U.S. include:

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Completion of preclinical laboratory tests, animal studies and formulations studies under the FDA’s good laboratory practices regulations;

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Submission to the FDA of an Investigational New Drug Application (“IND”) for human clinical testing, which must become effective before human clinical trials may begin and which must include independent Institutional Review Board (“IRB”) approval at each clinical site before the trials may be initiated;

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Performance of adequate and well-controlled clinical trials in accordance with Good Clinical Practices to establish the safety and efficacy of the product for each indication;

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Submission to the FDA of a Biologics License Application for marketing the product, which includes, among other things, reports of the outcomes and full data sets of the clinical trials, and proposed labeling and packaging for the product;

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Satisfactory completion of an FDA Advisory Committee review; and

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Satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with Current Good Manufacturing Practices (“cGMP”) regulations.

Generally, clinical trials are conducted in three phases:

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Phase I trials typically involve a small number of healthy volunteers and are designed to provide information about the product safety.

●

Phase II trials are conducted in a larger but limited group of patients afflicted with a specific diagnosis in order to determine preliminary efficacy, and to identify possible adverse effects.

○
Dosage studies are designated as Phase IIA and efficacy studies are designated as Phase IIB.

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Phase III clinical trials are generally large-scale, multi-center, comparative trials conducted with patients who have a specific condition in order to provide statistically valid proof of efficacy, as well as safety and potency.

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In some cases, the FDA will require Phase IV, or post-marketing trials, to collect additional data after a product is on the market.

The process of obtaining an approved BLA requires the expenditure of substantial time, effort and financial resources and may take years to complete.

FDA Post-Market Regulation

Tissue processors are required to register as an establishment with the FDA. 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. Once we are registered, we will be required to comply with regulations, including those regulations regarding storage, controls, access, labeling, record keeping, security, processes, compliance with established Good Tissue Practices, and documentation associated with the sale of our products by our customers to their patients. Our facilities will be subject to periodic inspections to assess our records and determination of our compliance with the regulations.

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Products covered by a BLA, 510(k) clearance, or a PMA are subject to numerous additional regulatory requirements, which include, among others, compliance with cGMP, which imposes certain procedural, substantive and record keeping requirements, labeling regulations, the FDA’s general prohibition against promoting products for unapproved or “off-label” uses, and additional adverse event reporting.

Other Regulation Specific to Tissue Products

The AATB, has issued operating standards for tissue banking, whether manufacturing and/or storing products as a distributor of manufactured products by third parties. Compliance with these standards is a requirement in order to become a licensed tissue bank.

21st Century Cures Act

In December 2016, President Obama signed the 21st Century Cures Act (the “Cures Act”) into law. The Cures Act includes many provisions that aim to speed up the process of bringing new drugs and devices to market. One of the Cures Act’s most significant amendments to the Federal Food, Drug and Cosmetic Act allows the FDA to grant accelerated approval to regenerative medicine products, while also providing the agency with wide discretion on creating new approaches to regenerative medicine. This legislative development is the result of increased pressure from patients and other stakeholders to move regenerative medicine advancements more quickly from the lab into the clinic.

Specifically, the new accelerated approval pathway authorized by the Cures Act allows certain regenerative medicine products to be designated as “regenerative advanced therapy” and become eligible for priority review by FDA. To qualify for this pathway, the product must be aimed at a serious disease and have the potential to deal with currently unmet medical needs. It must also meet the Cures Act’s new definition of a regenerative advanced therapy, which is defined as “cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act.” This broad definition would seem to encompass the majority of regenerative medicine products known to be currently in the development stages.

As with the existing accelerated approval pathway for drugs and biologics, this new regulatory pathway would allow a regenerative medicine product to be approved for marketing based on surrogate or intermediate clinical trial endpoints rather than longer term clinical outcomes. The use of such endpoints can decrease the number, duration, and complexity of clinical trials that are needed to prove a longer-term outcome. Subsequently, a sponsor would have to conduct confirmatory clinical trials to ensure that the surrogate or intermediate endpoint was in fact predictive of patients’ clinical response to the product, otherwise the accelerated approval could be withdrawn.

The Cures Act also requires the FDA to work with the National Institute of Standards and Technology (“NIST”) and other stakeholders to develop standards and consensus definitions for regenerative medicine products. Such standards are expected to play a large role in advancing this nascent industry by allowing companies to rely on FDA-recognized standards, rather than creating and validating their own as is the case today.

The Cures Act attempts to create a research network and a public-private partnership to assist developers in generating definitive evidence about whether their proposed therapies indeed provide clinical benefits that are hoped for. The Cures Act also requires the FDA to track and report the number and type of applications filed for regenerative medicine products, including the number of products approved through the new accelerated approval pathway. The law also includes provisions that require the FDA to publish guidance on how it will design and implement an approval process for regenerative medicine devices.

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Guidance Documents

In November 2017, the FDA released two final guidance documents in an effort to implement a “comprehensive policy framework” for existing laws and regulations governing regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). These guidance documents build upon the previous regulatory framework for these products, which was completed in 2005. A guidance document cannot alter a regulation, but can clarify how the FDA intends to enforce the regulation.

The two guidance documents below clarify the FDA’s interpretation of the risk-based criteria manufacturers use to determine whether a product is subject to the FDA’s premarket review.

The first guidance provides greater clarity around when cell and tissue-based products would be exempted from the established regulations if they are removed from and implanted into the same individual within the same surgical procedure and remain in their original form. The second final guidance helps stakeholders better understand how existing regulatory criteria apply to their products by clarifying how the agency interprets the existing regulatory definitions “minimal manipulation” and “homologous use.” As this field advances, the FDA has noted that there are a growing number of regenerative medicine products subject to FDA premarket authorization. These guidance documents will help explain how the FDA will provide a risk-based framework for its oversight. The policy framework defines how the FDA intends to take action against unsafe products while facilitating continued innovation of promising technologies.

To accomplish this goal, the guidance document has clarified the FDA’s view of “minimal manipulation” and “homologous use.” These are two concepts that are defined in current regulation to establish the legal threshold for when a product is subject to the FDA’s premarket approval requirements. By further clarifying these terms in the final guidance, the FDA is applying a modern framework for its oversight.

FDA regulations at 21 C.F.R. Part 1271, previous draft guidance documents, and untitled letters establish the agency’s approach to regulating HCT/Ps. Some HCT/Ps are exempt from premarket approval and are subject to regulation solely under section 361 of the Public Health Service Act (“PHS Act”) (so-called “361 HCT/Ps”) whereas others require premarket approval (i.e., as a drug, device, or biologic) (so-called “351 HCT/Ps”). Both 361 HCT/Ps and 351 HCT/Ps are subject to FDA requirements (at Part 1271) for registration and listing, donor-eligibility, current good tissue practices, and other requirements intended to prevent transmission of communicable diseases. Those that are the subject of the “same surgical procedure” exception – are exempt from both premarket approval requirements and the requirements of Part 1271. This regime is outlined in a flow chart, which is one of the few new features of the final guidance documents and is presented below:

Enforcement Discretion

In order to allow manufacturers of products time to comply with the requirements, the FDA announced that it intended (originally through November 2020 and extended to May 2021 because of the COVID-19 pandemic) to exercise enforcement discretion for certain products that are subject to the FDA’s premarket review under the existing regulations, but are not currently meeting these requirements. The FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern. Going forward, the FDA will apply a risk-based approach to enforcement, taking into account how products are being manufactured, marketed and administered as well as the diseases and conditions for which they are being used. This risk-based approach allows product manufacturers time to engage with the FDA, as to determine if they need to submit a marketing authorization application and, if so, submit their application to the FDA for approval.

The FDA’s enforcement discretion policy for IND and premarket approval requirements does not apply to products that have been associated with reported safety concerns or have the potential to cause significant safety concerns to patients. The FDA has stepped up its oversight of cellular and related products in recent years and has issued compliance actions, including numerous warning and untitled letters, and pursued litigation for serious violations of the law, including some involving patient harm.

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The FDA has indicated it intends to focus enforcement actions on “products with higher risk,” taking into account factors such as non-autologous (allogeneic) use, the route of administration, the site of administration, and whether the product is intended for homologous or non-homologous use. For example, HCT/Ps administered via intravenous injection or infusion, aerosol inhalation, intraocular injection, or injection or infusion into the central nervous system, will be prioritized over HCT/Ps administered by intradermal, subcutaneous, or intra-articular injection. Similarly, HCT/Ps intended for non-homologous use, particularly those intended to treat serious or life-threatening conditions, “are more likely to raise significant safety concerns than HCT/Ps intended for homologous use.”

The Company believes that the new regulatory restrictions being implemented by the FDA are intended to assure that all parties involved in the chain of gathering, processing, distributing and/or administrating RAAM related products have met the required standards to assure that the manufacturing, marketing the administration of the RAAM regulated products are not misleading and are performed in a safe and ethical manner and in accordance with the “objective intent” of the manufacturer.

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. 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.

Fraud, Abuse and False Claims

We are directly and indirectly subject to various federal and state laws governing relationships with healthcare providers and pertaining to healthcare fraud and abuse, including anti-kickback laws. In particular, the federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing, arranging for or recommending a good or service for which payment may be made in whole or part under federal healthcare programs, such as the Medicare and Medicaid programs. (See 42 U.S.C. § 1320a-7b). Penalties for violations include criminal penalties and civil sanctions such as fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal healthcare programs. The Anti-Kickback Statute is broad and prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry. In implementing the statute, the Office of Inspector General of the U.S. Department of Health and Human Services (“OIG”) has issued a series of regulations, known as the “safe harbors.” These safe harbors set forth provisions that, if all their applicable requirements are met, will assure healthcare providers and other parties that they will not be prosecuted under the Anti-Kickback Statute.

AdvaMed has established guidelines and protocols for medical device manufacturers in their relationships with healthcare professionals on matters including research and development, product training and education, grants and charitable contributions, support of third-party educational conferences, and consulting arrangements. Adoption of the AdvaMed Code by a medical device manufacturer is voluntary, and while the OIG and other federal and state healthcare regulatory agencies encourage its adoption and may look to the AdvaMed Code, they do not view adoption of the AdvaMed Code as proof of compliance with applicable laws. We have incorporated the principles of the AdvaMed Code in our standard operating procedures, sales force training programs, and relationships with health care professionals.

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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. 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.

Key provisions of SB 1768 include:

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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.

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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.

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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.

FDA Compliance Steps

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 a service platform for its first autologous product called Patient Pure X™ (PPX™). PPX™ is a non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood.

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”).

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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. In connection with the studies described above, there were no reported therapy-related safety events or significant adverse events.

Based on the results from the clinical trials or treatments in connection with the use of Zofin™ and PPX™ and related treatment protocols performed to date, the Company has determined that there was sufficient Phase I safety data obtained from the existing enrolled patients using Zofin™ and/or PPX™ and accordingly there was no longer any benefit from continued enrollment to obtain additional patient Phase 1 safety related data among the above studies. As a result, the studies and the related sites where the studies were performed have been closed.

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.

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. 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.

Environmental Laws

Our laboratory facilities process or directly handled biomedical materials whereby we receive and/or generate wastes that are required to be disposed. We contract with third parties for the transport, treatment, and disposal of the waste that we obtain and at all times plan on being compliant with applicable laws and regulations promulgated by the Resource Conservation and Recovery Act, the U.S. Environmental Protection Agency and similar state agencies.

Employees

As of October 31, 2025, 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. From time to time, the Company engages independent contractors for sales and administration activities. There are no collective bargaining agreements.

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