Zeo ScientifiX, Inc. 10-K

Item 1. Business. Overview 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 are derived from perinatal sources and manufactured to retain the naturally occurring extracellular vesicles, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent and an autologous non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood (“ RAAM Products ”). Our RAAM Products and related services are principally used in the health care industry administered through doctors and clinics (“ Providers ”). Organicell operates an extracellular vesicle processing laboratory in Davie, Florida for the purpose of performing research and development and the manufacturing and processing of the anti-aging and cellular therapy derived products that we sell and distribute to our customers. 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 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. 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. 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 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. During the year ended October 31, 2023, the Company invested $100,000 in cash (representing a 10% equity interest at the time of the investment) in a privately held formulator of skin care products (“ Formulator ”) in an effort to accelerate the Company’s development of expertise with respect to the skincare industry and to expand the use of its proprietary products in future formulations for a variety of topical use applications. The Company has partnered with the Formulator in a supply arrangement with a non-affiliated third-party whereby the Company will receive proceeds from the sale of its products to the third party. In addition, we have also entered into a sales representation agreement with the Formulator pursuant to which we will receive commissions on sales made by the Formulator to customers that were introduced by the Company to the Formulator. 1 Recent Developments Regarding Zofin™ and Other Products Zofin™ Phase I/IIA and IRB Approved Pilot Study Clinical Trial Program In June 2021, Organicell announced the results of its expanded access (“EA”) intermediate size patient population trial for treatment of COVID-19 patients with Zofin™ (IND # 19881-EA; NCT04657406 authorized by the FDA in September 2020). The study enrolled a total of 11 subjects: adults between the age of 35 to 69 who were fighting COVID-19 infection and presented respiratory fatigue with and without exertion, cough, and shortness of breath and met all inclusion/exclusion criteria. One patient withdrew before receiving any doses of Zofin™. Two subjects withdrew at day 14 post treatment with Zofin™. As a result, a total of eight subjects completed the study. The Company has decided that it will not enroll future patients from the above-mentioned study and has since closed the clinical trial (see below). In July 2021, the Company announced that the FDA had approved an IND application for its lead product, Zofin™ (IND #27378), for the treatment of ‘Prolonged COVID-19 Symptoms’ (“ Long Haulers ”). This approved trial design consisted of a double blinded, placebo-controlled, randomized phase I/II trial designed to investigate the safety and potential efficacy of Zofin™ in treating COVID-19 Long Haulers. The trial had enrolled a total of 18 of the 30 patients originally contemplated for the trial. The Company determined that it acquired sufficient safety data with the 18 enrolled patients and additional patient enrollment was not necessary. As further discussed below, the Company provided FDA with a summary safety report on the 18 subjects and the related sites have since closed the clinical trial. In November 2022, the Company received IRB approval (IRCM-2022-317) to conduct a pilot study to evaluate the safety of intravenous infusion and intra-articular injections of the Company’s autologous extracellular vesicle product Patient Pure X™ (PPX™) in subjects suffering with osteoarthritis of knee. The study enrolled a total of 10 patients of which 2 dropped out over six months and a total of six subjects completed the study at nine months. The study has been completed and the pilot study has been closed as further discussed below. In connection with the studies described above, there were no reported therapy-related safety events or significant adverse events. Based on the results of the above studies, the Company has determined that there was sufficient Phase I safety data obtained from the existing enrolled patients using Zofin™ and/or autologous extracellular vesicles and accordingly there was no longer any benefit from continued enrollment to obtain additional patient Phase 1 safety related data among the above studies. The Company is seeking to commence one or more Phase II studies in 2024, subject to obtaining approval of new or amended IND’s from the FDA and available working capital. In connection with the Company’s other previous research initiatives, the Company is reviewing which indications to pursue for Phase II efficacy related research and whether any of the existing approved and open IND’s should be modified, terminated and/or replaced. These IND’’s include: a. In April 2020, the FDA approved an IND application for the Company’s lead product, Zofin™ (IND # 19881), for a Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Organicell™ Flow for the Treatment of Moderate to Severe Acute Respiratory Syndrome (“ SARS ”) Related to COVID-19 Infection vs Placebo. Enrollment for the clinical trial began in September 2020. A total of ten patients had been enrolled in the study thus far and currently the clinical trial is not enrolling subjects due to the challenges of enrolling the remaining study population. b. In January 2021, the Company announced that the FDA had approved an IND application for its lead product, Zofin™, in the treatment of patients diagnosed with chronic obstructive pulmonary disease (IND # 23198 approved on 01/27/2021). No patients have been enrolled to date. c. In April 2021, the Company announced that the FDA had approved the IND application for its lead product, Zofin™, in the treatment of knee osteoarthritis (IND # 23788 approved on 04/06/2021). The trial has yet to commence. The ability for the Company to initiate any Phase II studies are subject to many uncertainties, including FDA approval of the respective IND applications and the Company having sufficient working capital to finance the ongoing costs of the trial, as to all of which no assurance can be given. 2 Other Research In April 2021, the Company entered into an agreement with Oklahoma State University to evaluate Zofin™ for the treatment of respiratory diseases caused by virus infections of pandemic potential. The parties are currently working to publish the study results and explore future research objectives. As a result of the above and the Company’s ongoing evaluation of the design and objectives of our previously approved clinical trials, as well as changes in clinical developments regarding the treatment of COVID-19 since the initial IND’s described above were submitted, the Company has completed or determined that it would no longer be actively pursuing the previously disclosed research initiatives described below: a. In March 2021, Organicell entered into a Material Cooperative Research and Development Agreement with the Centers for Disease Control and Prevention (the “ CDC ”) to determine the anti-inflammatory and anti-infective effectiveness of Zofin™ in experimental models of influenza infection. The parties determined that completion of the study would require additional time and funding to complete and the parties elected to terminate the study. b. In April 2021, we announced that an initial trial of ten COVID -19 patients in India conducted by CWI India, our Indian partner, generated positive results. The trial had been conducted by CWI India with whom we had entered a product testing and distribution agreement in February 2021, to collaborate on a study or studies to evaluate the effects of Zofin™ on moderate to severe COVID-19 patients in India. Since that time, there has not been any further collaboration on this research and the Company is not actively supporting or pursuing this research. c. In May 2021, the Company announced that its Zofin™ therapy has been approved by Pakistani regulators to be used for a treatment of a named COVID-19 patient hospitalized at the Pakistan Institute of Medical Sciences on compassionate grounds. In addition to this compassionate grounds authorization, Organicell received further indications from the Pakistani regulators to begin a broader trial of Zofin™ with up to 60 additional patients suffering from moderate to severe COVID-19. Since that time, there has not been any further collaboration on this research and the Company is not actively supporting or pursuing this research. Recent Corporate Developments Implementation of the Reverse Split On November 28, 2023, the Company implemented the Reverse Split. The par value of the Company’s common stock was unchanged at $0.001 per share after the Reverse Split. As a result, on the effective date of the Reverse Split, the stated capital on the Company’s balance sheet attributable to the Company’s common stock was reduced proportionately based on the reverse stock split ratio of one-for-200 and the additional paid-in capital account was credited with the amount by which the stated capital was reduced. Proposed Change of Corporate Name and Trading Symbol On December 8, 2023, our board of directors and our stockholders holding a majority of the Company’s voting power, approved resolutions authorizing the Company to amend its Articles of Incorporation to change the name (“ Name Change ”) of the Company from Organicell Regenerative Medicine, Inc. to “Zeo ScientifiX, Inc.” and to change the Company’s stock trading symbol from OCEL to “ZEOX” (“Ticker Symbol Change”) to align with the Name Change. Implementation and effectiveness of the Name Change and Ticker Symbol Change will be subject to Organicell’s compliance with applicable regulatory requirements of the SEC and the Financial Industry Regulatory Authority (“ FINRA ”) . In connection with the Name Change and Ticker Symbol Change, the Company has filed an Issuer Company- Related Action Notification with FINRA to effectuate the Name Change and Ticker Symbol Change, which is currently being reviewed by FINRA. 3 Sale Of Basalt, Colorado Lab Facility Effective August 7, 2023, the Company sold our lab facility in Basalt Colorado to a non-affiliated third-party purchaser (“ Purchaser ”). The transaction included the assignment of the premises lease for the Basalt Lab facility and the lease for certain laboratory equipment and the sale of all leasehold improvements associated with the Basalt Lab and inventory. The purchase price paid by Purchaser was $1,250,000 plus the assumption by Purchaser of all remaining financial and other obligations under the leases for the Basalt Lab premises and certain laboratory equipment. In addition, Organicell and Purchaser entered into a distribution agreement, pursuant to which Purchaser became a non-exclusive distributor of Organicell’s products and a commission agreement, pursuant to which Organicell may be entitled to certain payments from Purchaser in connection with transactions by it with specified third parties. As a result of the Basalt Lab sale, the Company currently performs all of it administrative, research, processing and sales and distribution activities from its Fort Lauderdale laboratory location. Financings Tysadco Purchase Agreement On September 1, 2022, the Company entered into a Purchase Agreement (the “ ELOC Purchase Agreement ”) with Tysadco Partners LLC, a Delaware limited company (“ Tysadco ”) and a Registration Rights Agreement with Tysadco. Pursuant to the ELOC Purchase Agreement, Tysadco committed to purchase, subject to certain restrictions and conditions, up to $50,000 worth of the Company’s common stock, over a period of 24 months from the effectiveness of the registration statement registering the resale of shares purchased by Tysadco pursuant to the ELOC Purchase Agreement. which registration statement was declared effective by the SEC on October 24, 2022 (“ ELOC Registration ”). Pursuant to the ELOC Purchase Agreement, on December 2, 2022, the Company submitted a put request to Tysadco to purchase 22,282 registered shares at a purchase price (as calculated pursuant to the ELOC Purchase Agreement) of $4.49, for a total of $100,000. On December 5, 2022, Tysadco funded the put request and the Company issued the 22,282 shares to Tysadco. The proceeds from the share sale were used for working capital and general corporate purposes. Due to overall market conditions, the Company determined that it would not seek to obtain additional financing through the ELOC Purchase Agreement and the ELOC Registration is now no longer effective. SPA 23 On March 6, 2023, the Company entered into a Securities Purchase Agreement (“ SPA 23 ”) with AJB Capital, pursuant to which we sold a Promissory Note in the principal amount of $530,000 (“$ 530,000 Note ”) to AJB in a private transaction for a purchase price of $519,400 (giving effect to original issue discount of $10,600). In connection with the sale of the $530,000 Note, the Company also paid AJB Capital’s legal fees and due diligence costs of $15,000, resulting in net proceeds to the Company of $504,400, which was used for working capital and other general corporate purposes. The $530,00 Note bears interest at the rate of 12% per annum. The $530,000 Note matured on September 6, 2023 and was paid in full. Private Offering – Convertible Promissory Notes During August and September 2023, the Company sold 2.9 Units (“ Unit s”) to 4 investors in a private offering at a purchase price of $250,000 per Unit for an aggregate purchase price of $725,000. Each Unit consists of (a) a $250,000 in principal amount 8% Convertible Promissory Note due September 30, 2026; and (b) 7,813 common stock purchase warrants, each entitling the holder to purchase one share of our common stock at an exercise price of $20.00 for a period of five years from the date of issuance. 4 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, and assumed its current name of “ Organicell Regenerative Medicine, Inc. ,” by amendment to its Articles of Incorporation on June 20, 2018. Our executive offices are located at 3321 College Avenue, Suite 246, Davie, FL 33134 and our telephone number is (888) 963-7881. Our corporate website is www.organicell.com . Information appearing on our website is not part of this Annual Report. 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 ○ Adipose-derived stromal vascular fraction ○ Bone marrow-derived stem cell therapies ○ Peripheral blood derived therapies ( i.e., platelet rich plasma); ○ Placental-based therapies Ø 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 5 ● Anti-Aging ○ Supplements Ø Vitamin Ø Mineral Ø Medical foods ○ Weight control ○ 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 Ø Central and South America Ø Caribbean Ø Europe ● Consulting directly with physicians knowledgeable in providing regenerative medical services ● Unlicensed life coaches 6 Current Business Strategy 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; ● 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; ● 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 Organicell brand from: marketing and participating in industry trade shows; 7 ○ 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; and ● Developing and providing educational support to Providers regarding our products and regulatory concerns; ● Secure additional working capital ○ Fund shortfalls in working capital to fund ongoing expenses and required payments to vendors and creditors until revenues are stabilized; ○ 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 our strategy to develop and expand our revenues for the sales and distribution of RAAM related products described above; ○ Hire additional personnel to support our growth and planned expansion; and ○ Enhance our CRM, e-commerce and ERP capabilities to facilitate marketing, sales and distribution functionality and accounting for our operations. ● Enhance Company Corporate Governance ○ Continue to develop and expand the Company’s internal control policies; and ○ 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. 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 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. 8 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. Organicell 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. 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. 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. 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. 9 Intellectual Property The table below sets forth a summary of our intellectual property rights. Patents: Country: Nigeria Patent Number: NG/PT/PCT/2022/6494 Issue Date: February 20, 2023 Application Number: NG/PT/PCT/2022/6494 Filing Date: April 10, 2021 Patent Applications: Organicell™ has two U.S. Patent Applications on file for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid. U.S. Patent Application No. 17/226,587 Titled : COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF Filed : April 9, 2021 Inventor : Maria Ines Mitrani Applicant : Organicell Regenerative Medicine, Inc. Assignment : MARIA INES MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC. (Assignee) Recorded : April 9, 2021 Real/Frame : 055878 / 0801 & 055878 / 0900 U.S. Patent Application No. 17/990,522 ( Continuation of 17/226,587) Titled : COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF Filed : November 18, 2022 Inventor : Maria Ines Mitrani Applicant : Organicell Regenerative Medicine, Inc. Assignment : MARIA INES MITRANI (Assignor), ORGANICELL REGENERATIVE MEDICINE, INC. (Assignee) Recorded : April 9, 2021 Real/Frame : 055878 / 0801 & 055878 / 0900 Organicell™ has twenty-five Ex-US Patent Applications on file for its Organicell™ line of products and the proprietary techniques used for processing perinatal fluid. 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: Australia Application Number: 2021253889 Filing Date: April 10, 2021 10 Country: Brazil Application Number: BR112022020441-8 Filing Date: April 10, 2021 Country: Canada Application Number: 3179925 Filing Date: April 10, 2021 Country: China Application Number: 202180041860.8 Filing Date: April 10, 2021 Country: Colombia Application Number: NC2022/0015966 Filing Date: April 10, 2021 Country: Costa Rica Application Number: 2022-570 Filing Date: April 10, 2021 Country: Ecuador Application Number: SENADI-2022-86300 Filing Date: April 10, 2021 Country: Europe Application Number: 21784900.9 Filing Date: April 10, 2021 Country: Indonesia Application Number: P00202212337 Filing Date: April 10, 2021 Country: Israel Application Number: 297195 Filing Date: April 10, 2021 Country: India Application Number: 202217062549 Filing Date: April 10, 2021 Country: Japan Application Number: 2022-562119 Filing Date: April 10, 2021 Country: Republic of Korea Application Number: 10-2022-7039360 Filing Date: April 10, 2021 Country: Saint Lucia Application Number: Not available Filing Date: April 10, 2021 11 Country: Mexico Application Number: MX/a/2022/012692 Filing Date: April 10, 2021 Country: Malaysia Application Number: PI2022005623 Filing Date: April 10, 2021 Country: New Zealand Application Number: 793562 Filing Date: April 10, 2021 Country: Panama Application Number: 94165-01 Filing Date: April 10, 2021 Country: Philippines Application Number: 1-2022-552738 Filing Date: April 10, 2021 Country: Qatar Application Number: QA/202210/0000698 Filing Date: April 10, 2021 Country: Saudi Arabia Application Number: 522440872 Filing Date: April 10, 2021 Country: Singapore Application Number: 11202253965C Filing Date: April 10, 2021 Country: Thailand Application Number: 2201006618 Filing Date: April 10, 2021 Country: Vietnam Application Number: 1-2022-06884 Filing Date: April 10, 2021 Country: South Africa Application Number: 2022/11630 Filing Date: April 10, 2021 Country: Jordan Application Number: PCT/JO/2022/259 Filing Date: April 10, 2021 Country: United Arab Emirates Application Number: P6002103/2022 Filing Date: April 10, 2021 12 Organicell™ 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. U.S. Patent Application No. 18/063,227 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. Organicell™ has an International Patent Application on file for its Organicell™ PPX product and the proprietary techniques used in the administration of blood-derived exosomes to treat pain 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. 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) Serial Number : 90050511 Filing Date : July 13, 2020 Owner : Organicell Regenerative Medicine, Inc. Status : Notice of allowance issued May 18, 2021; Non-Final Office Action re specimen issued July 5, 2023; Response to Non-Final Office Action filed October 5, 2023; Awaiting further examination. 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) Serial Number : 88903989 Filing Date : May 6, 2020 Owner : Organicell Regenerative Medicine, Inc. 13 Word Mark : ORGANICELL Goods/Services : Non-medicated anti-aging serum; non-medicated skin serums; all of the aforementioned goods are made in whole or in substantial part of organic ingredients (IC 003) Serial Number : 87311045 Filing Date : January 23, 2017 Status : Registered Owner : Organicell Regenerative Medicine, Inc. Registration Number: 5289671 Registration Date: September 19, 2017 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) Serial Number : 88771931 Filing Date : January 24, 2020 Owner : Organicell Regenerative Medicine, Inc. 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) Serial Number : 88771934 Filing Date : January 24, 2020 Word Mark : ZEO SCIENTIFIX Goods/Services : manufacturing services, biotechnological products and services, research services, laboratory services, biologics therapeutics, and biologics diagnostics Serial Number : 98307890 Filing Date : December 11, 2023 Owner : Organicell Regenerative Medicine, Inc. Status : Awaiting examination Composite Mark : ZEO SCIENTIFIX (Stylized/Design) Goods/Services : manufacturing services, biotechnological products and services, research services, laboratory services, biologics therapeutics, and biologics diagnostics Serial Number : 98307906 Filing Date : December 11, 2023 Owner : Organicell Regenerative Medicine, Inc. Status : Awaiting examination 14 Word Mark : HEALTHY X Goods/Services : manufacturing services in the field of biotechnological products, biotechnological products, development of products for others in the field of biotechnology, biotechnology research, scientific laboratory services, therapeutic services featuring biologics, biologics diagnostic testing Serial Number : 98327846 Filing Date : December 22, 2023 Owner : Organicell Regenerative Medicine, Inc. Status : Awaiting examination Word Mark : PPX Goods/Services : biotechnological products, namely, blood-derived biologics Serial Number : 98341677 Filing Date : January 4, 2024 Owner : Organicell Regenerative Medicine, Inc. Status : Awaiting examination 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. 15 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™. 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. 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. 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. 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. 16 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 recently launched 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: ● Be minimally manipulated, no structural change, or be mixed with anything; ● Be intended for homologous use, essentially used for the same purpose that it was used in the donor; ● Its manufacture must not involve combination with another article, except for water, crystalloids or a sterilizing, preserving or storage agent; and ● It must not be dependent upon the metabolic activity of living cells for its primary function. 17 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: ● Completion of preclinical laboratory tests, animal studies and formulations studies under the FDA’s good laboratory practices regulations; ● 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; ● 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; ● 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; ● Satisfactory completion of an FDA Advisory Committee review; and ● 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: ● 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. ● 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. ● 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. 18 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. 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. 19 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. 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: 20 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. 21 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. 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. 22 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. 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 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 ”). 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 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. 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. 23 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 January 28, 2024, we have 23 full-time employees and no part-time employees. We also engaged 6 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.