We are a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics for the treatment of degenerative diseases and regenerative medicine.
−Removed: The Company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring extracellular vesicles, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent (“ RAAM Products ”).
+Added: 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 ”).
−Removed: Organicell operates an extracellular vesicle processing laboratory in Davie, Florida, and Basalt, Colorado each for the purpose of performing research and development and the manufacturing and processing of the anti-aging and cellular therapy derived products that we sell and distribute to our customers.
+Added: 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.
−Removed: This product contains over 300 growth factors, cytokines, chemokines, and 102 unique microRNAs as well as other exosomes/nanoparticles derived from perinatal tissues.
+Added: The Company recently launched a service platform for its first autologous product called Patient Pure X™ (PPX™).
+Added: 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.
−Removed: The Company is pursuing efforts to complete its already approved clinical studies (as described below) 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.
+Added: 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.
−Removed: New FDA guidance which was announced in November 2017 and which became effective in May 2021 (postponed from November 2020 due to the COVID-19 pandemic) 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 ”).
+Added: 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.
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The efforts include continuing with clinical trials, expanding sales internationally and developing new product offerings and/or designations of products that would not fall under these regulations.
−Removed: In June 2021, the Company announced that it was launching a service platform for its first autologous product called Patient Pure X ™ (“ PPX ™ ”).
−Removed: PPX ™ is a non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood.
−Removed: The Company began to accept minimal orders for this service since October 2021.
+Added: 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.
+Added: 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.
+Added: 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.
Recent Developments Regarding Zofin™ and Other Products
−Removed: In April 2020, the FDA approved an IND application for the Company’s lead product, Zofin™ (IND # 19881), for a Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Organicell™ Flow for the Treatment of Moderate to Severe Acute Respiratory Syndrome (“ SARS ”) Related to COVID-19 Infection vs Placebo.
−Removed: The IRB was approved by the Institute of Regenerative and Cellular Medicine (“ IRCM ”) during June 2020 (approval number:
−Removed: IRCM-2020-254).
−Removed: Enrollment for the clinical trial began in September 2020.
−Removed: A total of ten patients have been enrolled to the study thus far and currently the clinical trial is not enrolling subjects due to the challenges of enrolling the remaining study population.
−Removed: In March 2021, Organicell entered into a Material Cooperative Research and Development Agreement with the Centers for Disease Control and Prevention (the “ CDC ”) to determine the anti-inflammatory and anti-infective effectiveness of Zofin™ in experimental models of influenza infection.
−Removed: Pursuant to the agreement, Organicell will supply the CDC with Zofin™ and using well established in vitro and in vivo experimental models of influenza infection, the CDC will test the anti-infective and anti-inflammatory properties of Zofin™.
−Removed: All the proposed experiments will be performed in the appropriate biosafety levels and approved protocols at the Immunology and Pathogenesis Branch / Influenza Division of the CDC.
−Removed: In April 2021, the Company entered into a similar agreement with Oklahoma State University to evaluate Zofin™ for the treatment of respiratory diseases caused by virus infections of pandemic potential and the FDA approved an IND application for Zofin™, in the treatment of knee osteoarthritis.
−Removed: In June 2021, Organicell announced the results of its expanded access (EA) intermediate size patient population trial (NCT04657406) for treatment of COVID-19 patients with Zofin™, which EA trial had been authorized by the FDA in September 2020.
−Removed: The results of the EA trial indicated that treatment of participants with Zofin™:
−Removed: met endpoints for safety and efficacy in patients with mild to moderate COVID-19;
−Removed: mitigated mild and moderate symptoms;
−Removed: improved pulmonary opacities detected in chest X-rays;
−Removed: improved inflammatory biomarkers.
−Removed: The trial was conducted at United Memorial Medical Center in Houston, Texas.
+Added: Zofin™ Phase I/IIA and IRB Approved Pilot Study Clinical Trial Program
+Added: 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;
+Added: NCT04657406 authorized by the FDA in September 2020).
The study enrolled a total of 11 subjects:
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Two subjects withdrew at day 14 post treatment with Zofin™.
−Removed: As a result, eight subjects completed the day 30 follow-up and are included in the data analysis.
−Removed: The administration of Zofin™ in the trial was well tolerated in all enrolled subjects, with no adverse events.
−Removed: Chest X-ray data demonstrated that 75% of subjects had bilateral opacities caused by COVID-19 infection at day 0 (baseline), prior to treatment with Zofin™ and thirty (30) days after Zofin™ treatment, chest X-ray data showed 83% of treated subjects had normal lung imaging, indicating complete recovery.
−Removed: Upon such time that Organicell enrolls and submits additional patient data from the above-mentioned study, Organicell intends to submit the updated results of the trial to the FDA for approval of an amendment to the Company’s previously approved IND (NCT04384445) to perform a placebo-controlled Phase II clinical trial to confirm safety and efficacy in a randomized fashion.
−Removed: The Company is currently in the process of pursuing the implementation of three other previously approved clinical trials:
−Removed: In July 2021, the Company announced that the FDA had approved an IND application for its lead product, Zofin™, for the treatment of ‘Prolonged COVID-19 Symptoms’ (“ Long Haulers ”).
−Removed: This approved trial design consists of a double blinded, placebo-controlled, randomized phase I/II trial designed to investigate the safety and potential efficacy of Zofin™ in treating COVID-19 Long Haulers.
−Removed: Organicell has secured several sites to date to carry out the trial.
−Removed: The trial, organized and operated through Proxima Clinical Research, a Houston-based CRO, has enrolled a total of 3 participants through January 15, 2023 and the Company expects it can complete full enrolment (30 patients) no later than December 2023.
−Removed: Based on the timing to successfully enroll all patients during 2023, the Company expects to complete the trial during 2024 subject to the Company having sufficient working capital to finance the ongoing costs of the trial, as to all of which no assurance can be given.
−Removed: Patients enrolled in the study will have met prescribed Long Hauler conditions, with subjects experiencing consistent symptoms of a COVID-19 infection for a prolonged period of time, which is greater than 6 weeks and less than 12 months.
−Removed: Enrolled patients will receive 3 doses of Zofin™ in accordance with the study protocol.
−Removed: The trial objectives are to demonstrate the safety and potential efficacy of Zofin™ administered intravenously in subjects experiencing prolonged COVID-19 symptoms.
−Removed: Based on the successful outcome of this trial, the Company intends to immediately submit efficacy data gathered to the FDA to obtain approval for an amendment to its Investigational New Drug (IND) application to begin a Phase II/III trial that will focus on the efficacy of Zofin™ in the treatment of COVID-19 Long Haulers.
−Removed: In January 2021, the Company announced that the FDA had approved an IND application for its lead product, Zofin™, in the treatment of patients diagnosed with chronic obstructive pulmonary disease (“ COPD ”).
−Removed: This approved trial design will be a double blinded, placebo-controlled, phase I/II trial investigating the safety and potential efficacy of intravenous infusion (IV) of Zofin™ for the treatment of COPD.
−Removed: The Company and the CRO are currently working to initiate and complete enrollment in the trial which the Company expects to be completed during 2023, subject to the Company having sufficient working capital to finance the ongoing costs of the trial, as to all of which no assurance can be given.
−Removed: 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.
−Removed: This approved trial design, will be a double blinded, placebo-controlled, phase I/II trial investigating the safety and potential efficacy of Zofin™ for patients suffering with knee osteoarthritis.
−Removed: The Company and the CRO are expected to begin working to initiate the trial once the Company has advanced the Long Hauler and COPD trials to desired levels.
−Removed: The commencement of this trial is subject to the successful negotiation and execution of definitive agreements with the site facility where the study patients will be treated 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.
+Added: As a result, a total of eight subjects completed the study.
+Added: 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).
+Added: 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 ”).
+Added: 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.
+Added: The trial had enrolled a total of 18 of the 30 patients originally contemplated for the trial.
+Added: The Company determined that it acquired sufficient safety data with the 18 enrolled patients and additional patient enrollment was not necessary.
+Added: 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.
+Added: In November 2022, the Company received IRB
+Added: approval (IRCM-2022-317) to conduct a pilot study to evaluate the safety of intravenous infusion and intra-articular injections of
+Added: the Company’s autologous extracellular vesicle product Patient Pure X™ (PPX™) in subjects suffering with
+Added: osteoarthritis of knee.
+Added: The study enrolled a total of 10 patients of which 2 dropped out over six months and a total of six subjects
+Added: completed the study at nine months.
+Added: The study has been completed and the pilot study has been closed as further discussed below.
+Added: In connection with the studies described above, there were no reported therapy-related safety events or significant adverse events.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: These IND’’s include:
+Added: 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.
+Added: Enrollment for the clinical trial began in September 2020.
+Added: 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.
+Added: 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).
+Added: No patients have been enrolled to date.
+Added: 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).
+Added: The trial has yet to commence.
+Added: 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.
+Added: Other Research
+Added: 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.
+Added: The parties are currently working to publish the study results and explore future research objectives.
+Added: 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:
+Added: 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.
+Added: The parties determined that completion of the study would require additional time and funding to complete and the parties elected to terminate the study.
In April 2021, we announced that an initial trial of ten COVID -19 patients in India conducted by CWI India, our Indian partner, generated positive results.
−Removed: The trial had been conducted by CWI India, our Indian partner with whom we had entered a product testing and distribution agreement in February 2021, to collaborate on a study or studies to evaluate the effects of Zofin™ on moderate to severe COVID-19 patients in India.
−Removed: The ten patients in the initial trial were treated at hospitals in Bangalore, Kozhikode and Chennai, and all ten patients recovered from their symptoms and were discharged from the hospital.
−Removed: Based on the initial results of this trial, CWI India has since been seeking to obtain government approval to conduct an expanded trial of up to sixty-five patients with moderate to severe COVID-19, who were to be treated at these hospitals.
−Removed: To date, CWI India has not yet obtained the required approval and it is uncertain if they will ultimately be successful in doing so.
−Removed: The Company currently does not anticipate that this clinical trial will advance any further with CWI India.
+Added: 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.
+Added: Since that time, there has not been any further collaboration on this research and the Company is not actively supporting or pursuing this research.
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.
−Removed: The Company has already shared data with Pakistani regulatory authorities in the country in support of this effort.
−Removed: To date, the Company and the Company’s Pakistani partner for the proposed study have not yet obtained the required approval and the Company is uncertain if they will ultimately be successful in doing so.
−Removed: The Company currently does not anticipate that this clinical trial will advance any further with the Company’s Pakistani partner.
+Added: 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
−Removed: Capital Raise and Corporate Restructuring Transaction
−Removed: On August 19, 2022 (“ Closing ”), the Company consummated a $4.0 million capital raise and corporate restructuring transaction.
−Removed: Stock Purchase Agreements
−Removed: At Closing, the Company entered into stock purchase agreements (each, an “ SPA ” and collectively, the “ SPAs ”) with Skycrest Holdings, LLC (“ Skycrest ”), Greyt Ventures LLC (“ Greyt ”), Beyond 100 FZE (“ Beyond 100 ”) and Smart Co.
−Removed: (“ Smart Co ,” and together with Skycrest, Greyt and Beyond 100, individually, an “ Investor ” and collectively, the “ Investors ”).
−Removed: Skycrest and Greyt are Nevada and Delaware limited liability companies, respectively, which are based in South Florida.
−Removed: Beyond 100 and Smart Co.
−Removed: are Dubai and Singapore corporations, respectively, affiliated with Dr.
−Removed: Bhupendra Kumar Modi, a well-known industrialist and entrepreneur in India and Singapore.
−Removed: Pursuant to the SPAs, the Company issued each Investor 50,000,000 shares of the Company’s common stock (“ Shares ”) at a price of $0.02 per Share ($1,000,000).
−Removed: In addition, under the SPAs with Skycrest and Greyt, the Company issued each of them 50 shares of newly designated Series C Non-Convertible Preferred Stock (the “ Series C Preferred Shares ”).
−Removed: The Series C Preferred Shares vote together with Shares of our common stock as a single class on all matters presented to a vote of stockholders, except as required by law and entitle Skycrest and Greyt to each exercise 25.5% of the total combined voting power of the Company, without regard to the number of shares of common stock outstanding.
−Removed: The Series C Preferred Shares are not convertible into common stock, do not have any dividend rights and do have a nominal liquidation preference.
−Removed: The Series C Preferred Shares also have certain protective provisions, such as requiring the vote of a majority of Series C Preferred Shares to change or amend their rights, powers, privileges, limitations and restrictions.
−Removed: The Series C Preferred Shares are automatically redeemed by the Company for nominal consideration at such time as the holder owns less than 50% of the shares of common stock purchased pursuant to its SPA and shares of common stock issued or issuable upon exercise of the Consulting Warrants (as described below) or in the event the holder transfers or seeks to transfer the Series C Preferred Shares, other than by the laws of descent and distribution.
−Removed: The SPAs with Skycrest and Greyt, also grant them the right, acting jointly, to designate a majority of the nominees to be elected to the Company’s board of directors at each annual meeting of the Company’s stockholders (the “ Designation Right ”).
−Removed: The Designation Right expires at such time as the Preferred Shares are no longer outstanding.
−Removed: As a result of the issuance to Skycrest and Greyt of the Preferred Stock and the granting to them of the Designation Right, a “ Change in Control” of the Company is deemed to have occurred.
−Removed: The SPA with Beyond 100 grants that Investor a right of first refusal for a period of 18 months from Closing with respect to any bona fide offer, or proposal received by the Company from or agreement in principal reach by the Company with a third party to enter into an exclusive arrangement providing for manufacturing, distributing, licensing, and commercializing any of its existing and/or future products and services to be manufactured, licensed and/or distributed by the Company or any of its subsidiaries in India.
−Removed: The SPAs also accord the Investors registration rights under the Securities Act, pursuant to which the Company has agreed to file a registration statement under the Securities Act with the SEC within 180 days of Closing and use its commercially reasonable efforts to cause such registration statement to be declared effective by the SEC within 60 days thereafter.
−Removed: The registration statement will cover the resale of the Shares pursuant to the SPAs, and in the case of Skycrest and Greyt, the Shares issued or issuable upon exercise of the Consulting Warrants.
−Removed: The SPAs also provide the Investors “ piggy-back ” registration rights with respect to their respective Shares.
−Removed: Consulting Agreements
−Removed: At Closing, the Company also entered into 36-month consulting agreements with each of Skycrest and Greyt (each, a “ Consulting Agreement ,” and collectively, the “ Consulting Agreements ”), pursuant to which (a) Skycrest and Greyt will provide certain advisory services to the Company as more fully set forth therein;
−Removed: and (b) Skycrest and Greyt are being compensated for their services by the Company issuing to each of them at closing ten (10) year-warrants to purchase 150,000,000 Shares at an exercise price of $0.02 per Share (the “ Consulting Agreement Warrants ”), which Warrants are exercisable on a “ cashless ” basis.
−Removed: Changes in the Board of Directors
−Removed: At Closing, Albert Mitrani, Dr.
−Removed: Allen Meglin and Michael Carbonara stepped down as directors of the Company.
−Removed: On September 23, 2022, additional directors were appointed to the board, the majority of whom are “ independent ” in accordance with the rules and regulations of the SEC and the Nasdaq Stock Market, LLC.
−Removed: Additional Private Sales of Common Stock
−Removed: In addition to the securities issued in connection with the $4.0 million capital raise and corporate restructuring transaction described above, in August and September 2022, Organicell offered and sold 65,500,000 shares of common stock in four private transactions to four “ accredited investors ” for an aggregate purchase price of $2,620,000 or $0.04 per share.
−Removed: All the above referenced securities were issued and sold pursuant to the exemption from registration afforded by Section 4(a)(2) of the Securities Act and the rules and regulations thereunder.
+Added: Implementation of the Reverse Split
+Added: On November 28, 2023, the Company implemented the Reverse Split.
+Added: The par value of the Company’s common stock was unchanged at $0.001 per share after the Reverse Split.
+Added: 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.
+Added: Proposed Change of Corporate Name and Trading Symbol
+Added: 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.
+Added: 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.
+Added: 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 ”) .
+Added: 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.
+Added: Sale Of Basalt, Colorado Lab Facility
+Added: Effective August 7, 2023, the Company sold our lab facility in Basalt Colorado to a non-affiliated third-party purchaser (“ Purchaser ”).
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
Tysadco Purchase Agreement
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Pursuant to the ELOC Purchase Agreement, Tysadco committed to purchase, subject to certain restrictions and conditions, up to $50,000 worth of the Company’s common stock, over a period of 24 months from the effectiveness of the registration statement registering the resale of shares purchased by Tysadco pursuant to the ELOC Purchase Agreement.
−Removed: which registration statement was declared effective by the SEC on October 24, 2022.
+Added: 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.
−Removed: The proceeds from the share sale are being used for working capital and general corporate purposes.
−Removed: COVID-19 Impact on Economy and Business Environment
−Removed: The adverse public health developments and economic effects of the ongoing COVID-19 outbreak in the United States have adversely affected the demand for our products and services by our customers and from patients of our customers as a result of quarantines, facility closures and social distancing measures put into effect.
−Removed: These restrictions have adversely affected the Company’s sales, results of operations and financial condition.
−Removed: In response to the COVID-19 outbreak, the Company (a) has accelerated its research and development activities;
−Removed: (b) has secured and is continuing to seek additional debt and/or equity financing to support working capital requirements;
−Removed: and (c) continues to take steps to stabilize and increase revenues from the sale of its products.
−Removed: There is no assurance as to when the adverse impact to the United States and worldwide economies resulting from the COVID-19 outbreak will be eliminated, if at all, and whether any new or recurring pandemic outbreaks will occur again in the future causing a similar or worse adverse impact on the United States and worldwide economies or our business.
+Added: The proceeds from the share sale were used for working capital and general corporate purposes.
+Added: 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.
+Added: 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).
+Added: 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.
+Added: The $530,00 Note bears interest at the rate of 12% per annum.
+Added: The $530,000 Note matured on September 6, 2023 and was paid in full.
+Added: Private Offering – Convertible Promissory Notes
+Added: 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.
+Added: Each Unit consists of (a) a $250,000 in principal amount 8% Convertible Promissory Note due September 30, 2026;
+Added: 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.
Corporate Information
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Industry Overview
−Removed: The traditional health care industry in the United States is predominantly controlled by the rules of the Centers for Medicare & Medicaid Services (“ CMS ”) (wwws.cms.gov) and commercial health insurance companies.
−Removed: This control limits patients’ access to alternative medical therapies, that recent medical literature demonstrates highly beneficial outcomes in the field of anti-aging and regenerative medicine.
+Added: 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.
+Added: 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.
−Removed: Because of this close relationship, physicians must follow government and commercial insurers guidelines in order to stay in the plans and receive reimbursement.
−Removed: Physicians are restricted in their ability to expand the nature of the treatments provided beyond industry practices because of legal ramifications and/or lack of knowledge concerning protocol of cutting-edge anti-aging and regenerative medical treatments.
+Added: Because of this close relationship, physicians must follow government and commercial insurers guidelines in order to receive reimbursement for most services.
+Added: 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.
+Added: 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.
−Removed: To address a wide variety of aging issues, safe alternatives to pathologies, including access to other treatments and pharmaceuticals and to achieve beneficial “elective” health treatments, we intend utilize the latest regenerative technologies.
−Removed: These alternative pathways to date have had significant restrictions because of regulations imposed by the FDA, other regulatory bodies and insurers due to lack of randomized controlled studies, yet many published case series demonstrate safety and efficacy.
−Removed: Patients and consumers are looking to safe alternatives compared more traditional medicine, including the following:
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Notwithstanding these current dynamics, patients and consumers are looking to safe alternatives compared to more traditional medicine, including the following:
Cellular/ Tissue based therapies
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Our current business strategy is to achieve the following goals and milestones:
−Removed: Execute on our current strategy to complete existing clinical studies and secure approval to commence additional 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;
+Added: 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;
−Removed: Continue to expand our laboratory facilities to meet expected production, processing and research requirements;
+Added: 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;
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Identify sources of exclusive and superior suppliers of RAAM products and/or raw materials used by us in processing our RAAM products;
−Removed: Identify strategic relationships and acquisition targets that would enhance and/or accelerate the growth of the Company;
−Removed: (a) existing raw material and/or medical device suppliers or owners of IP associated with existing and/or additional desired RAAM products, (b) alliances with Providers that specialized in RAAM products, and/or (c) alliances with marketing and distribution companies of RAAM products;
+Added: 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;
+Added: (b) Providers that specialize in RAAM products;
+Added: and/or (c) companies that market and distribute RAAM products;
Develop and expand operations to provide for growth of our revenues
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marketing and participating in industry trade shows;
−Removed: Increase the number of RAAM product offerings for various modalities using proprietary processing, formulas and administration techniques, including the Company’s new product PPX™;
+Added: 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:
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Common destinations include Thailand, Mexico, Singapore, India, Malaysia, Cuba, Brazil, Argentina, and Costa Rica.
−Removed: If we are able to implement our intended business plan, we believe that we will be well situated to address this increased consumer demand for alternative medical treatments.
+Added: 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),.
+Added: North America is estimated to be the largest market for Regenerative Medicine with 49.1% global market share.
+Added: 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.
+Added: Organicell operates at the crossroads of the biopharmaceutical, regenerative medicine, and cell therapy sectors.
+Added: This growth can be attributed to demographic factors such as increased life expectancy and an aging population.
+Added: 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.
+Added: 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.
−Removed: As of the date of this Annual Report, we had one in-house salesperson who marketed our RAAM products and services.
+Added: 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.
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The table below sets forth a summary of our intellectual property rights.
+Added: Patent Number:
+Added: NG/PT/PCT/2022/6494
+Added: February 20, 2023
+Added: Application Number:
+Added: NG/PT/PCT/2022/6494
+Added: April 10, 2021
Patent Applications:
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Application Number:
−Removed: Not Yet Assigned
April 10, 2021
Application Number:
−Removed: Not Yet Assigned
+Added: 202180041860.8
April 10, 2021
30 unchanged sentences
Application Number:
−Removed: Not available
April 10, 2021
2 unchanged sentences
Application Number:
−Removed: April 10, 2021
−Removed: Application Number:
1-2022-552738
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April 10, 2021
+Added: United Arab Emirates
+Added: Application Number:
+Added: P6002103/2022
+Added: April 10, 2021
Organicell™ has a U.S.
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Organicell Regenerative Medicine, Inc.
−Removed: Organicell ™ has a U.S.
−Removed: Provisional Patent Application on file for its Organicell™ updated line of products and proprietary techniques used for processing perinatal fluid.
−Removed: Provisional Patent Application No.
−Removed: NANOPARTICLE COMPOSITIONS AND METHODS
−Removed: October 14, 2022
−Removed: Maria Ines Mitrani
−Removed: Organicell Regenerative Medicine, Inc.
−Removed: Conversion Filing Deadline :
−Removed: October 14, 2023
Goods/Services :
−Removed: Radiation sterilized 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)
−Removed: Serial Number :
−Removed: Filing Date :
−Removed: November 19, 2020
−Removed: Organicell Regenerative Medicine, Inc.
−Removed: Abandoned on March 21, 2022
−Removed: Goods/Services :
−Removed: Radiation sterilized biologically derived products developed from perinatal tissue material for medical and medical regenerative purposes, namely, biological tissue grafts, implants comprising living tissue, surgical implants comprising living tissue, and biological implants for cushioning tissues and supporting tissue repair and homeostasis (IC 005)
−Removed: Serial Number :
−Removed: Filing Date :
−Removed: November 19, 2020
−Removed: Organicell Regenerative Medicine, Inc.
−Removed: Abandoned on March 21, 2022
−Removed: Goods/Services :
−Removed: Radiation sterilized 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)
−Removed: Serial Number :
−Removed: Filing Date :
−Removed: October 14, 2021
−Removed: Organicell Regenerative Medicine, Inc.
−Removed: Abandoned on January 20, 2023
−Removed: Goods/Services :
−Removed: Radiation sterilized biologically derived products developed from perinatal tissue material for medical and medical regenerative purposes, namely, biological tissue grafts, implants comprising living tissue, surgical implants comprising living tissue, and biological implants for cushioning tissues and supporting tissue repair and homeostasis (IC 005)
−Removed: Serial Number :
−Removed: Filing Date :
−Removed: October 14, 2021
−Removed: Organicell Regenerative Medicine, Inc.
−Removed: Abandoned January 20, 2023
−Removed: Goods/Services :
−Removed: 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)
−Removed: Serial Number :
−Removed: Filing Date :
−Removed: September 9, 2020
−Removed: Organicell Regenerative Medicine, Inc.
−Removed: Registration date :
−Removed: September 13, 2022
−Removed: Goods/Services :
−Removed: 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)
−Removed: Serial Number :
−Removed: Filing Date :
−Removed: September 9, 2020
−Removed: Organicell Regenerative Medicine, Inc.
−Removed: Registration Number:
−Removed: Registration date :
−Removed: August 9, 2022
−Removed: 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);
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Notice of allowance issued May 18, 2021;
−Removed: A third request for extension of time to file a Statement of Use has been granted.
+Added: Non-Final Office Action re specimen issued July 5, 2023;
+Added: Response to Non-Final Office Action filed October 5, 2023;
+Added: Awaiting further examination.
Goods/Services:
4 unchanged sentences
Organicell Regenerative Medicine, Inc.
−Removed: Registration Number:
−Removed: Registration date :
−Removed: February 15, 2022
Goods/Services :
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Organicell Regenerative Medicine, Inc.
−Removed: Registration Number:
−Removed: Registration date :
−Removed: February 22, 2022
PATIENT PURE X - PPX
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January 24, 2020
+Added: ZEO SCIENTIFIX
+Added: Goods/Services :
+Added: manufacturing services, biotechnological products and services, research services, laboratory services, biologics therapeutics, and biologics diagnostics
+Added: Serial Number :
+Added: Filing Date :
+Added: December 11, 2023
Organicell Regenerative Medicine, Inc.
−Removed: Registration Number:
−Removed: Registration date :
−Removed: February 22, 2022
+Added: Awaiting examination
+Added: Composite Mark :
+Added: ZEO SCIENTIFIX (Stylized/Design)
+Added: Goods/Services :
+Added: manufacturing services, biotechnological products and services, research services, laboratory services, biologics therapeutics, and biologics diagnostics
+Added: Serial Number :
+Added: Filing Date :
+Added: December 11, 2023
+Added: Organicell Regenerative Medicine, Inc.
+Added: Awaiting examination
+Added: Goods/Services :
+Added: manufacturing services in the field of biotechnological products, biotechnological products, development of products for others in the field of biotechnology, biotechnology research, scientific laboratory services, therapeutic services featuring biologics, biologics diagnostic testing
+Added: Serial Number :
+Added: Filing Date :
+Added: December 22, 2023
+Added: Organicell Regenerative Medicine, Inc.
+Added: Awaiting examination
+Added: Goods/Services :
+Added: biotechnological products, namely, blood-derived biologics
+Added: Serial Number :
+Added: Filing Date :
+Added: January 4, 2024
+Added: Organicell Regenerative Medicine, Inc.
+Added: 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.
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The regenerative medicine field is highly competitive and subject to rapid technological change and regulation.
−Removed: Companies compete on the basis of product efficacy, pricing, and ease of handling/logistics.
+Added: 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.
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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.
−Removed: 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 (postponed from November 2020 due to the COVID-19 pandemic).
+Added: 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.
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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.
−Removed: As a result of this 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.
+Added: These products vary significantly in terms of pricing, cellular counts, and biological components, including exosomes, extracellular vesicles, micro vesicles, nanoparticles, and bioactive proteins.
+Added: 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.
−Removed: Allogenic competitors are primarily producer-distributor companies which historically included Predictive Biotech, Kimera Labs, MiMedix Group, Inc., Invitrx Therapeutics, Liveyon, BioD (“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.
−Removed: Additionally, there are a variety of accredited blood, bone, and soft tissue banks that we historically competed against, including Utah Cord Bank and Cord for Life.
+Added: 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.
+Added: 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.
−Removed: We also expect to see the growth of many additional autologous equipment manufacturers during 2023, including APEX Biologix LLC.
−Removed: In connection with the new FDA regulations that went into effect in May 2021 described above, the Company believes that several of the largest perinatal product manufacturers in the United States, Predictive Biotech and Utah Cord Bank, have closed their operations.
−Removed: In addition, the FDA has indicated that hundreds of other manufacturers and clinics have already received warning letters of violations of the new FDA regulations, including Vitti Labs LLC.
+Added: 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.
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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.
−Removed: At times when the Company did not manufacture its own products, the products sold were manufactured and processed by third party manufacturers.
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.
+Added: 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.
+Added: The Company’s recently launched autologous product called Patient Pure X™ (PPX™).
+Added: PPX™ is a non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood.
+Added: 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.
−Removed: In addition, the FDA has published some additional draft guidelines related to this industry and the ultimate form of the regulations are not yet known.
Products Regulated as HCT/Ps
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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.
−Removed: Dosage studies are designated as Phase IIA and efficacy studies
−Removed: are designated as Phase IIB.
+Added: 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.
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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.
−Removed: November 2017 FDA Guidelines
−Removed: In November 2017, the FDA released four guidance documents (two final, two draft) 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 ”).
+Added: Guidance Documents
+Added: 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.
−Removed: The Comprehensive regenerative medicine policy framework intends to spur innovation, efficient access to potentially transformative products, while ensuring safety & efficacy.
−Removed: The framework builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products.
−Removed: Further, two of the guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area.
−Removed: The suite of guidance documents also defines a risk-based framework for how the FDA intends to focus its enforcement actions against those products that raise potential significant safety concerns.
−Removed: This modern framework is intended to balance the agency’s commitment to safety with mechanisms to drive further advances in regenerative medicine so innovators can bring new, effective therapies to patients as quickly and safely as possible.
−Removed: The policy also delivers on important provisions of the Act.
−Removed: Final Guidance Documents
−Removed: The two final guidance documents 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.
+Added: 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.
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The FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern.
−Removed: Going forward, the FDA will apply a risk-based approach to enforcement, taking into account how products are being administered as well as the diseases and conditions for which they are being used.
+Added: 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.
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The efforts include continuing with clinical trials, expanding sales internationally and developing new product offerings and/or designations of products that would not fall under these regulations.
−Removed: New Draft Guidance Documents
−Removed: The two draft guidances provide important information to help spur development and access to innovative regenerative therapies.
−Removed: The first draft guidance, which builds off the regenerative medicine provisions in the Act, addresses how the FDA intends to simplify and streamline its application of the regulatory requirements for devices used in the recovery, isolation, and delivery of regenerative medicine advanced therapies, including combination products.
−Removed: The guidance specifies that devices intended for use with a specific RMAT (as defined below0 may, together with the RMAT, be considered to comprise a combination product.
−Removed: The second draft guidance describes the expedited programs that may be available to sponsors of regenerative medicine therapies, including the new Regenerative Medicine Advanced Therapy (“ RMAT ”) designation created by the Cures Act, Priority Review, and Accelerated Approval.
−Removed: In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation – including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, as well as gene therapies that lead to a durable modification of cells or tissues (including genetically modified cells).
Fraud, Abuse and False Claims
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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.
−Removed: Our laboratory and distribution facilities are subject to periodic unannounced inspections by regulatory authorities based on the activities we may be engaged, and may undergo compliance inspections conducted by the FDA and corresponding state and foreign agencies based on our operations.
+Added: 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
−Removed: To date, the Company has obtained certain IND and eIND approvals from the FDA, including applicable IRB approvals which authorized the Company to commence clinical trials or treatments in connection with the use of Zofin™ and related treatment protocols.
−Removed: In connection with the Company’s approved eINDs, the approvals authorize physicians to treat their patients with Zofin ™ under a specified protocol when there is no comparable or satisfactory therapy option available for an individual patient who has a serious or immediately life-threatening disease.
−Removed: These are not formal clinical trials and the Company is not given access to full patient data associated with such treatments.
−Removed: Following FDA’s reporting requirements, the Company submitted an annual report for all of the eINDs to the FDA to formally close each of the eINDs.
−Removed: The annual report consists of a written summary of the results including any adverse effects.
−Removed: For each of the Company’s approved eIND’s described below, the approved protocol consisted of administering three or four individual doses of Zofin™ over an 8-day period and monitoring the patient for a period of 21-days from the date of administering the initial dose.
−Removed: The use of an eIND for “ expanded access ” is primarily to treat patients with the investigational drug and not to answer safety or efficacy questions about the drug.
−Removed: With respect to the Company’s approved INDs and ongoing clinical trials, until such time that the clinical trial is closed and the associated data is reviewed and analyzed by third parties, the Company is not privy to actual patient outcomes and is unable to provide updates on the results of such clinical trials.
−Removed: To date, there has not been a severe adverse event that has been reported to be associated with the use of Zofin ™ .
−Removed: The information provided below represents the Company’s most up to date information regarding results from the Company’s FDA approved and submitted eINDs and approved phase I/II INDs and other trial related activities:
−Removed: For each of the patients that have been treated under the Company’s approved eIND’s described below, the Company had endeavored to obtain initial and follow-up patient information beginning with the initial date that Zofin™ was administered.
−Removed: As stated earlier, the collection of this information was not required by applicable FDA regulations, but the Company desired to obtain such information in an effort to support and improve its ongoing research and development activities.
−Removed: The patient outcome information provided below for each eIND identified is based on information provided by the patient’s treating physicians, has not been audited and/or verified by the Company or by any independent third party for accuracy or completeness and the Company does not make any representations as to the accuracy or completeness of such information.
−Removed: Furthermore, the Company is not making any claims and/or inferences as to any direct or indirect correlation of the reported patient outcomes and the use of Zofin ™ by providing such information.
−Removed: eIND#22370 approved on 05/11/2020 - Treatment for Acute hypoxic respiratory failure with ARDS secondary to COVID-19 infection for single patient.
−Removed: Patient required mechanical ventilation prior to treatment and developed acute metabolic encephalopathy with ICU delirium along with acute kidney injury and anemia.
−Removed: The patient was treated in May 2020.
−Removed: Patient’s respiratory function at 21-days post treatment, transitioned from a 21% t-collar to room air PMV and decannulation on day 26.
−Removed: The physician reported that patient was discharged from hospital after 29-days post treatment.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#22371 approved on 05/11/2020 - Treatment for Acute hypoxic respiratory secondary to bilateral pneumonia secondary to COVID-19 with ARDS for single patient.
−Removed: Patient had also developed acute kidney failure due to sepsis and was placed on hemodialysis.
−Removed: The patient was treated in May 2020.
−Removed: During the course of the treatment, patient’s respiratory function transitioned from CPAP 5 PS 10 30% ventilation to 30% T-Collar ventilation by day 28.
−Removed: The patient’s acute delirium improved.
−Removed: During the observational 21-day period, the physician reported that the patient remained in the step-down unit and required regular hemodialysis treatment due to the kidney injury.
−Removed: The physician reported that the patient passed away 104 days after treatment.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#22897 approved on 05/29/2020 - Treatment for Acute respiratory failure with hypoxia, secondary to COVID-19 with ARDS for single patient.
−Removed: Patient had respiratory impairment due to ARDS and an acute kidney injury that required regular hemodialysis.
−Removed: The patient was treated in June 2020.
−Removed: After receiving the treatment, the patient’s respiratory function improved with a complete decannulation from oxygen therapy by day 4.
−Removed: The patient had a complete recovery of renal function, with decreased creatinine concentration levels, and was removed from hemodialysis by day 17.
−Removed: The physician indicated that the patient was discharged 26-days post treatment initiation.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#25426 approved on 07/24/2020 - Treatment of COVID-19 positive for single patient.
−Removed: The patient was treated in July 2020.
−Removed: The patient was experiencing fatigue, cough, and shortness of breath at rest and upon exertion.
−Removed: At baseline, the patient’s oxygen saturation was 94% with elevated inflammatory biomarkers TNF-a, IL-6, CRP, and D-dimer.
−Removed: Patient reported improvement in fatigue, cough, and shortness of breath by day 21.
−Removed: Furthermore, inflammatory biomarkers IL-6, CRP, and TNF-alpha all decreased into normal range within 21 days.
−Removed: The physician indicated that the patient reported returning to normal activity by day 28.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#25888 approved on 8/01/2020 - Treatment of post COVID-19 complication for single patient.
−Removed: The patient was treated in August 2020.
−Removed: Patient was experiencing shortness of breath, fevers, total malaise, arthropathies vomiting, diarrhea, headaches, and loss of smell.
−Removed: At baseline, bilateral pneumonia with shortness of breath was the primary factor that lead to the long-hauler diagnosis.
−Removed: Blood oxygen saturation level was 95%.
−Removed: The patient began to experience improvements in shortness of breath complications early in the treatment protocol.
−Removed: By the conclusion of the study, the physician indicated that the patient returned to normal with no observation of impairments or respiratory distress.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#26560 approved on 8/17/2020 - Treatment of post-COVID-19 complications for single patient.
−Removed: The patient was treated in August 2020.
−Removed: At baseline, the patient reported prolonged fatigue and shortness of breath.
−Removed: No abnormalities were found in chest x-ray images, oxygen saturation, or inflammatory biomarkers.
−Removed: 20 days post treatment, the physician indicated that the patient continued to experience post-COVID-19 fatigue, shortness of breath, muscle aches, and hair loss.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#26561 approved on 8/17/2020 - Treatment of post-COVID-19 complications for single patient.
−Removed: The patient was treated in August 2020.
−Removed: At baseline, the patient reported prolonged fatigue, shortness of breath, body aches and headaches.
−Removed: Significant improvements in fatigue, mental fog, and shortness of breath with exertion were reported 3 days after the 3 rd dose.
−Removed: The physician indicated that the patient refused to have further follow up 3 days after the 3 rd dose.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#26676 approved on 8/20/2020 - Treatment of respiratory failure due to COVID-19 infection for single patient.
−Removed: The patient was treated in August 2020.
−Removed: Patient was in ICU in severe critical condition prior to initiation of the treatment.
−Removed: The physician indicated that the patient passed away 5 days after initiation of the treatment, having received two of the three doses of Zofin ™ as per the protocol.
−Removed: The single eIND was closed during FDA’s annual reporting
−Removed: eIND#26700 approved on 8/21/2020 - Treatment for ARDS associated with COVID-19 for a single patient.
−Removed: The patient was treated in August 2020.
−Removed: Patient was in ICU in severe critical condition prior to initiation of the treatment.
−Removed: The physician indicated that the patient passed away 7 days after initiation of the treatment, having received two of the three doses of Zofin™ as per the protocol.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#26776 approved on 8/25/2020 - Treatment of COVID-19 positive for single patient.
−Removed: The patient was treated in September 2020.
−Removed: Patient was experiencing significant fatigue, cough, and shortness of breath;
−Removed: inflammatory biomarker CRP was also elevated at baseline.
−Removed: Initial O2 saturation levels fluctuated from 88-95%.
−Removed: Significant improvements were first noted 2 days after the 2nd dose including a decrease in fever and overall improvement in wellbeing.
−Removed: At day 14, the physician reported that the patient returned to work, with a resolution of all reported symptoms.
−Removed: The patients O2 saturation returned to a stable 98% and CRP biomarker levels decreased to normal levels by day 14.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#26777 approved on 8/25/2020 - Treatment of COVID-19 positive for single patient.
−Removed: The patient was treated in September 2020.
−Removed: At baseline, patient was experiencing symptoms of fever, fatigue, cough, and shortness of breath.
−Removed: Patient first reported 25% improvement after the first dose and 95% improvement 2 days after the second dose.
−Removed: At the day 8 time point, the only clinical feature still present was an occasional cough.
−Removed: The physician reported that the patient returned to work 24 hours after the 3rd dose.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#26864 approved on 9/05/2020 - Treatment of COVID-19 positive for single patient.
−Removed: The patient was treated in September 2020.
−Removed: Patient was in ICU in severe critical condition, on ECMO, prior to initiation of the treatment.
−Removed: The patient received 4 doses of Zofin ™ and the physician indicated that the patient remained stable on ECMO 21 days after the 1st dose.
−Removed: The physician reported that the patient passed away 41 days after treatment initiation.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#26821 approved on 9/22/2020 - Treatment of post COVID-19 complications for single patient.
−Removed: The patient was treated in September 2020.
−Removed: At time of initiation of the treatment, the patient reported symptoms to include generalized myalgias, headaches and fatigue.
−Removed: On day 60, the physician indicated that the patient reported marked improvement with arthralgias and achiness but still had complaints of fatigue, headaches and shortness of breath.
−Removed: The single IND was closed during FDA’s annual reporting.
−Removed: eIND#26964 approved on 10/10/2020 - Treatment for ARDS associated with COVID-19 for single patient.
−Removed: The patient was treated in October 2020.
−Removed: Patient was in ICU for 16 days and in severe critical condition receiving 100% FiO2, PC mode of ventilator and PEEP 10 prior to initiation of treatment.
−Removed: The physician reported that the patient passed away 1 day after treatment initiation (only 1 dose of the protocol was administered).
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#26972 approved on 10/14/2020 - Treatment for ARDS associated with COVID-19 for single patient.
−Removed: The patient was treated in October 2020.
−Removed: Patient was in ICU in severe critical condition prior to initiation of the treatment.
−Removed: The physician reported that the patient passed away 13 days after initiation of the first dose and having only received 2 of the 4 doses as per the protocol.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#26978 approved on 10/16/2020 - Treatment for ARDS associated with COVID-19 for single patient.
−Removed: The patient was treated in October 2020.
−Removed: Patient was in ICU suffering with pneumonia and respiratory failure.
−Removed: Initiation of treatment was 6-days post hospital admission and the patient received a total of 4 doses of Zofin™.
−Removed: Physician reported patient was discharged and reported to be in stable condition with complete respiratory improvement.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#27128 approved on 12/04/2020 - Treatment of mild to moderate symptoms of COVID-19 for a single patient.
−Removed: The patient was treated in December 2020.
−Removed: Clinical features prior to infusion included low-grade fever, chills, muscle and joint aches, severe headaches, dry cough, feeling slightly breathless and fatigue.
−Removed: Upon day 13, physician reported the patient had less muscle and joint aches and increased energy.
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: eIND#27165 approved on 12/15/2020 - Treatment of COVID-19 pneumonia and respiratory failure with ARDS for a single patient.
−Removed: The patient was treated in December 2020.
−Removed: Patient had a severely debilitating medical situation following COVID-19.
−Removed: Prior to the use of Zofin™, patient required use of 100% oxygen non-rebreather face mask.
−Removed: The physician reported that the patient passed away 75 days after only receiving the initial dose of the protocol (only 1 dose of Zofin™ was administered, the patient refused the second and third doses at day 4 and 8 as prescribed by the protocol).
−Removed: The single eIND was closed during FDA’s annual reporting.
−Removed: Expanded Access to Zofin ™ (Organicell™ Flow) approved on 09/24/2020 - Treatment of Patients with COVID-19 Outpatient and Inpatient Population.
−Removed: The IRB was approved by the Institute of Regenerative and Cellular Medicine on December 16, 2020 (approval number:
−Removed: IRCM-2020-269).
−Removed: The trial was conducted at United Memorial Medical Center in Houston, Texas.
−Removed: The study enrolled a total of 11 subjects:
−Removed: adults between the age of 35 to 69 who were fighting COVID-19 infection and presented respiratory fatigue with and without exertion, cough, and shortness of breath and met all inclusion/exclusion criteria.
−Removed: One patient withdrew before receiving any doses of Zofin™.
−Removed: Two subjects withdrew at day 14 post treatment with Zofin™.
−Removed: As a result, eight subjects completed the day 30 follow-up and are included in the data analysis.
−Removed: The administration of Zofin™ in the trial was well tolerated in all enrolled subjects, with no adverse events.
−Removed: Chest X-ray data demonstrated that 75% of subjects had bilateral opacities caused by COVID-19 infection at day 0 (baseline), prior to treatment with Zofin™ and thirty (30) days after Zofin™ treatment, chest X-ray data showed 83% of treated subjects had normal lung imaging, indicating complete recovery.
−Removed: Upon such time that Organicell enrolls and submits additional patient data from the above-mentioned study, Organicell intends to submit the updated results of the trial to the FDA for approval of an amendment to the Company’s previously approved IND (NCT04384445) to perform a placebo-controlled Phase II clinical trial to confirm safety and efficacy in a randomized fashion.
−Removed: IND # 19881 approved on 04/30/2020 - A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of OrganicellTM Flow for the Treatment of Moderate to Severe Acute Respiratory Syndrome (SARS) Related to COVID-19 Infection vs Placebo.
−Removed: IRB was approved by the Institute of Regenerative and Cellular Medicine (“IRCM”) on 06/04/2020 (approval number:
−Removed: IRCM-2020-254).
−Removed: The clinical trial is currently in process.
−Removed: A total of ten patients have been enrolled to the study thus far and currently the clinical trial is not enrolling subjects due to the challenges of enrolling the remaining study population.
−Removed: IND #27378 approved on 06/24/21.
−Removed: A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin™ (Organicell™ Flow) for the Treatment of Post COVID-19 Complications “Long Haulers” vs Placebo.
−Removed: The trial, organized and operated through the CRO, has enrolled a total of 3 participants through January 15, 2023 and the Company expects the full enrolment of 30 patients to be completed no later than December 2023.
−Removed: Based on the timing to successfully enroll all patients during 2023, the Company plans to complete the trial during 2024 subject to the Company having sufficient working capital to finance the ongoing costs of the trial, as to all of which no assurance can be given.
−Removed: IND # 23198 approved on 01/27/2021.
−Removed: A Phase I/II Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin™ (Organicell™ Flow) for the Treatment of patients diagnosed with chronic obstructive pulmonary disease (COPD).
−Removed: The Company and the CRO are currently working to initiate and complete enrollment in the trial which the Company expects to be completed during 2023, subject to the Company having sufficient working capital to finance the ongoing costs of the trial, as to all of which no assurance can be given.
−Removed: IND # 23788 approved on 04/06/2021.
−Removed: A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Zofin ™ Infused Intravenously in Patients Suffering with Knee Osteoarthritis vs Placebo.
−Removed: The Company and the CRO are expected to begin working to initiate the trial once the Company has advanced the Long Hauler and COPD trials to desired levels.
−Removed: The commencement of this trial is subject to the successful negotiation and execution of definitive agreements with the site facility where the study patients will be treated and the Company having sufficient working capital to finance the ongoing costs of the trial, as to all of which no assurance can be given.
−Removed: In April 2021, we announced that an initial trial of ten COVID -19 patients in India conducted by CWI India, our Indian partner, generated positive results.
−Removed: The trial had been conducted by CWI India, our Indian partner with whom we had entered a product testing and distribution agreement in February 2021, to collaborate on a study or studies to evaluate the effects of Zofin™ on moderate to severe COVID-19 patients in India.
−Removed: The ten patients in the initial trial were treated at hospitals in Bangalore, Kozhikode and Chennai, and all ten patients recovered from their symptoms and were discharged from the hospital.
−Removed: Based on the initial results of this trial, CWI India has since been seeking to obtain government approval to conduct an expanded trial of up to sixty-five patients with moderate to severe COVID-19, who were to be treated at these hospitals.
−Removed: To date, CWI India has not yet obtained the required approval and it is uncertain if they will ultimately be successful in doing so.
−Removed: The Company currently does not anticipate that this clinical trial will advance any further with CWI India.
−Removed: In May 2021, the Company announced that its Zofin™ therapy has been approved by Pakistani regulators to be used for a treatment of a single COVID-19 patient hospitalized at the Pakistan Institute of Medical Sciences under compassionate grounds.
−Removed: In addition to this compassionate grounds authorization, Organicell received further indications to begin a broader trial of Zofin ™ with up to 60 additional patients suffering from moderate to severe COVID-19.
−Removed: The Company has already shared data with Pakistani regulatory authorities in the country in support of this effort.
−Removed: To date, the Company and the Company’s Pakistani partner for the proposed study have not yet obtained the required approvals and the Company is uncertain if they will ultimately be successful in doing so.
−Removed: The Company currently does not anticipate that this clinical trial will advance any further with the Company’s Pakistani partner.
−Removed: The Company is pursuing efforts to complete all of its approved clinical trials and to obtain approval for and 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.
−Removed: 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.
+Added: 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.
+Added: The Company’s recently launched a service platform for its first autologous product called Patient Pure X™ (PPX™).
+Added: PPX™ is a non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood.
+Added: 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 ”).
+Added: To date, the Company has obtained certain Investigational New Drug (“ IND ”), and 18 emergency IND (“ eIND ”) approvals from the FDA, including applicable Institutional Review Board (“ IRB ”) approvals which authorized the Company to commence clinical trials or treatments in connection with the use of Zofin™ and related treatment protocols.
+Added: In connection with the studies described above, there were no reported therapy-related safety events or significant adverse events.
+Added: 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.
+Added: As a result, the studies and the related sites where the studies were performed have been closed.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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
−Removed: Since May 2019, we have operated laboratory facilities that process or directly handled biomedical materials whereby we receive and/or generate wastes that are required to be disposed.
+Added: 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.
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