Organicell Regenerative Medicine

What Organicell Regenerative Medicine does

Organicell Regenerative Medicine is a clinical-stage biotechnology company developing exosome-based therapeutics, with its lead asset Zofin™ currently in Phase I/II clinical evaluation. Founded in 2014 and headquartered in Miami, Florida, the company is publicly traded on the OTCQB market and operates with 11–50 employees. Zofin™ is an intravenously administered, acellular, sterile, injectable extracellular vesicle product derived from human perinatal sources, positioned as a regenerative therapy for inflammatory and degenerative conditions.

The company has positioned Zofin™ across three indications: COVID-19 Long Haulers, Chronic Obstructive Pulmonary Disease (COPD), and osteoarthritis. The multi-indication strategy attempts to leverage the platform's anti-inflammatory and regenerative properties across distinct patient populations, though this breadth also stretches limited capital and operational bandwidth. Trials are at early-stage (Phase I/II), and no product has been approved or commercialized.

Organicell is pre-revenue with no disclosed product sales, licensing income, or commercial partnerships. Its business model is conventional clinical-stage biotech: raise capital, advance candidates through FDA-regulated trials, and either commercialize directly upon approval or out-license to a larger partner. To date the company has raised approximately $4.5 million in aggregate across a $500K SEC-exempt offering in August 2021 and a $4M financing in July 2022. Public listing status on OTCQB provides access to equity capital markets but also exposes the company to heightened governance and disclosure scrutiny.

Name

Organicell Regenerative Medicine

Legal name

Organicell Regenerative Medicine, Inc.

Website

https://organicell.com

Company type

Public

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Organicell Regenerative Medicine is a clinical-stage biotechnology company developing Zofin™, an exosome-based therapeutic in Phase I/II trials for COVID-19 Long Haulers, COPD, and osteoarthritis. The pre-revenue public company is based in Miami, Florida.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Biologics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Regenerative Immunology & Inflammation Modulation (pro-regenerative biologics) (HLAAAGAL)

akta.pro secondary industries

Stem Cell–Based Regenerative Therapies (HLAAAGAA), Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE), Cartilage, Bone & Musculoskeletal Regeneration (HLAAAGAH)

Keywords

• Regenerative medicine
• Exosome therapeutics
• Biologic drug products
• Clinical-stage biotechnology
• Cell-based therapies

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Pre-commercial / Clinical Stage Revenue: Organicell is a clinical-stage biotechnology company focused on developing cell and exosome-based therapeutics. As a pre-revenue company in the clinical trial phase, it has not yet commercialized products. Revenue generation is contingent on successful completion of clinical trials and regulatory approval.

Core offering

Organicell Regenerative Medicine is a clinical-stage biotechnology company developing and commercializing proprietary cell and exosome-based biologic therapeutics. Its lead product candidate, Zofin™, is a human cell-derived, minimally manipulated biologic therapeutic composed of over 300 growth factors, exosomes, and anti-inflammatory cytokines intended to treat inflammatory and degenerative conditions such as COVID-19 Long Haulers, COPD, and osteoarthritis.

Product overview

Organicell Regenerative Medicine is a clinical-stage biotechnology company developing cell and exosome-based therapeutics. The company's primary product candidate is Zofin™, an exosome-based therapeutic currently in Phase I/II clinical trials for COVID-19 Long Haulers, COPD, and osteoarthritis. The company operates as a single-product-focused biotech firm rather than a multi-product platform company.

Differentiator

Problem solved

Functional benefit

Products and services

• Zofin™

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Scale indicators3 records

Recent moves4 records

Expansion highlights3 records

Direct peers

• Athersys: Clinical-stage cell therapy company (MultiStem) developing regenerative treatments for stroke, ARDS, and inflammatory conditions — comparable in modality (multipotent adult progenitor cells) and indication strategy.
• Kimera Labs: Developer and supplier of exosome-based and birth-tissue-derived regenerative products, including for orthopedic and inflammatory indications — competes in the same exosome therapeutic category as Zofin™.
• Aethlon Medical: Clinical-stage company developing exosome-related therapeutics and diagnostics, including Hemopurifier and exosome science — overlapping exosome/extracellular vesicle focus with Organicell.
• Capricor Therapeutics: Clinical-stage biotech developing cell-derived and exosome-based therapeutics (e.g., CAP-1002, exosome program) for inflammatory and degenerative conditions — directly comparable modality and indication overlap with Zofin™.
• Direct Biologics: Developer of exosome-based regenerative medicine products targeting inflammatory and orthopedic indications, including osteoarthritis — a near-direct competitor to Organicell's Zofin™ pipeline.
• Evox Therapeutics: UK-based biotech engineering exosome-based therapeutics for rare diseases and inflammatory conditions — operates in the same exosome therapeutic modality as Organicell with a similar preclinical-to-early-clinical stage profile.
• Pluristem Therapeutics: Clinical-stage company developing placenta-derived cell therapy products for inflammatory and ischemic conditions — directly comparable as a small-cap, cell-based regenerative medicine developer.

Broad incumbents

• Mesoblast: Commercial-stage regenerative medicine company with allogeneic cell therapies (remestemcel-L) targeting inflammatory conditions such as GVHD and heart failure — broader incumbent in the cell-based regenerative medicine space.
• United Therapeutics: Large public biotech with a regenerative medicine and cell therapy platform (e.g., Tyvaso DPI, prior lung cell programs) — broader incumbent operating in pulmonary and inflammatory disease adjacent to Zofin™'s COPD indication.

Emerging players

• Codiak BioSciences: Was a leading engineered-exosome therapeutic developer (engEx platform) targeting inflammatory and oncology indications — directly comparable exosome engineering modality, though now operating in a restructured form.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat2 records

Key risks6 records

Key highlights4 records

Customer concentration

• Xx.com/organicellTM

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds2 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Organicell Regenerative Medicine