Zeo ScientifiX, Inc.

Overview

Zeo ScientifiX, Inc. (Zeo) is a clinical-stage biopharmaceutical company focused on regenerative medicine and biologics derived from birth tissues. Its RAAM product portfolio centers on Zofin™ (amniotic fluid–derived extracellular vesicles and related components) and PPX™ (an autologous, blood‑derived nanoparticle fraction). Zeo manufactures in FDA‑registered, cGMP facilities and sells to healthcare providers through in‑house and distributor channels. The company is active in contexts created by Florida’s SB 1768 stem cell law.

Key products and capabilities

• Zofin™ (Organicell™ Flow)
  • Derived from amniotic fluid and manufactured to retain naturally occurring extracellular vesicles, proteins, and cell‑secreted nanoparticles (including microRNAs).
  • Presented as an acellular biologic therapy from perinatal sources.
• PPX™ (Patient Pure X)
  • An autologous biologic containing the nanoparticle fraction precipitated from a patient’s peripheral blood.
  • Marketed as a non‑manipulated biologic platform for autologous use.
• Additional product lines
  • Products for topical aesthetic applications that incorporate proprietary ingredients.
  • Rebranding and trademarks around “Day Zero” and related product names (e.g., DAY ZERO, ZEO GROWX, ZEO HAIR GROW, ZEO GROW BOOST, DAY ZERO STEM CELL MATRIX).

Manufacturing, facilities, and operations

• Facilities
  • Extracellular vesicle processing laboratory located in Davie, Florida.
  • Lab operations support R&D and manufacturing of RAAM products for distribution to providers.
• Regulatory approach
  • Products span tissue‑based (HCT/P) and biologics pathways; the company monitors FDA guidance on 361 vs. 351 HCT/P classifications and intends to defend its classification decisions if challenged.
  • Under Florida SB 1768 (effective July 1, 2025), licensed physicians may administer certain non‑FDA‑approved stem cell therapies for orthopedics, wounds, and pain management, subject to cGMP compliance and informed consent. Zeo views SB 1768 as enabling physician adoption, market access, and real‑world data collection to support future FDA submissions.
  • Zeo is pursuing IND/IRB‑approved pathways for current and future trials while also exploring international sales and new product designations to mitigate regulatory risk.

Intellectual property

• Issued U.S. patents:
  • U.S. 12,053,494 — COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF (Zeo/Organicell lineage)
  • U.S. 12,377,121 — COMPOSITIONS COMPRISING NANOPARTICLES, METHOD OF MAKING AND USES THEREOF
  • U.S. 12,213,994 — COMPOSITIONS AND METHODS FOR TREATING PAIN WITH EXTRACELLULAR VESICLES (PPX lineage)
• Additional U.S. and international patent applications and national stage entries related to Organicell products and processing methods (including PPX, XOTIN), with multiple foreign filings and notices of allowance.
• Trademarks and service marks include ZEO SCIENTIFIX, ORGANICELL, PPX, XOTIN, DAY ZERO, ZEO GROWX, ZEO HAIR GROW, ZEO GROW BOOST, DAY XERO, and others.
• Lab and processing methods are covered by specific patent families and ongoing continuation and international filings.

Market, customers, and sales

• Market focus
  • RAAM portfolio targets regenerative medicine and aesthetic applications at the intersection of biopharma, regenerative medicine, and cell therapy.
  • Florida SB 1768 supports direct physician adoption of certain therapies and permits data collection from providers for real‑world safety and outcomes.
  • The company’s strategy reflects global regenerative medicine market growth and interest in both autologous and allogeneic approaches.
• Customers and sales channels
  • Zeo markets to healthcare providers (doctors and clinics) through an in‑house sales team and independent distributors.
  • As of October 31, 2025, Zeo had five in‑house salespeople.
  • Recent initiatives include expansion of the internal sales force and distributor network, turnkey programs for physician adoption, and partnerships with concierge medicine networks and regenerative medicine practices.

Financials and liquidity

• Net losses for fiscal years ended October 31:
  • 2025: net loss of $5,521,000
  • 2024: net loss of $4,705,000
• Accumulated deficits and balance sheet metrics:
  • Accumulated deficits: $67,734,000 (2025) vs. $62,213,000 (2024)
  • Stockholders’ deficit: $1,423,000 (2025) vs. $1,653,000 (2024)
  • Working capital deficit: $1,915,000 (2025) vs. $2,123,000 (2024)
• Financing obligations
  • $250,000 of 8% notes outstanding, payable annually, maturing September 30, 2026, with potential conversion to common stock at noteholders’ option.
• The company reports ongoing operating losses and states a need for additional capital.

2025–2026 strategic and operational activities

• BioXtek, LLC joint venture
  • Binding MOU in February 2025 for development, manufacturing, marketing, and funding collaboration.
  • Disputes arose; BioXtek sought to terminate the MOU in June 2025.
  • Zeo initiated litigation in Broward County in December 2025 (amended January 2026) for breach of contract, fraudulent inducement, and related counts.
• BioLumina acquisition
  • June 25, 2025: Zeo acquired remaining LLC interests in BioLumina, LLC to obtain finished goods inventory and certain trademarks.
• Exotropin agreement and litigation
  • August 2024: sales representative agreement with Exotropin, LLC; initial collaboration product launched November 2024.
  • Agreement terminated for cause on August 15, 2025; subsequent legal actions and countersuits continued through January 2026.
• Strategic partnership with Cytora Therapeutics and Made Scientific (announced January 7, 2026)
  • Multi‑party collaboration to commercialize Cytora’s allogeneic stem cell therapy in the U.S. under SB 1768 pathways.
  • Cytora to provide manufacturing rights; Made Scientific to act as exclusive U.S. CDMO for starting tissue cell banks and drug product; Zeo to be exclusive U.S. commercial partner for market access, distribution, and site management.
  • Definitive agreements are in process, with aims to advance FDA Phase 2b trials and pursue an approved license.

Governance and public company matters

• Reporting and controls
  • The company is subject to periodic reporting under the Exchange Act and incurs audit and legal fees associated with financial reporting.
  • Zeo identified material weaknesses in internal controls over financial reporting as of October 31, 2025 (including limited segregation of duties, IT access controls, and reliance on less experienced staff and consultants) and is undertaking remediation efforts.
• Ownership and board control
  • Two stockholders (Ian T. Bothwell and Greyt Ventures LLC) hold Series C Preferred Shares representing 51% of combined voting power, enabling control over director elections and other matters.
  • The board may issue up to 10,000,000 shares of preferred stock, which could affect common stock voting power or dilution.
• Market considerations
  • The company has low historical trading volume and faces potential for volatile trading and dilution risk from existing or future equity issuances.
  • No dividends are anticipated; the company is focused on growth and capital investment.

Headquarters and personnel

• Headquarters
  • Davie, Florida facility at Nova Southeastern University Center for Collaborative Research.
  • Approximately 1,200 square feet under a month‑to‑month license; annual base license fee of $20,230.
  • Corporate website: www.zeoscientifix.com
• Staffing
  • 20 full‑time employees and 0 part‑time employees (as of October 31, 2025).
  • Two consultants supporting regulatory, marketing, administrative, and distribution activities.
  • Use of independent contractors for sales and administration as needed.
  • Employment agreements assign company ownership of work product and related IP rights.
  • No collective bargaining agreements.

Summary

Zeo ScientifiX develops birth‑tissue‑derived biologics (Zofin) and autologous nanoparticle therapies (PPX) for regenerative medicine and aesthetics, with manufacturing and R&D operations in Florida. The company sells through providers and distributors, uses Florida’s SB 1768 framework to expand physician adoption and collect real‑world data, and pursues FDA/IND pathways for broader approval. Zeo holds multiple U.S. patents and international filings covering its technologies and trademarks, and it continues to manage several strategic initiatives, partnerships, and legal matters while addressing ongoing operating losses and liquidity needs.