Cytonics | The Future of Regenerative Medicine

Final Day for Early Investor Perks

A Breakthrough Therapy for Osteoarthritis

Osteoarthritis Affects 600M People. We’re Making a First-In-Class Therapy.

Our most recent funding round has closed. Thank you to everyone who invested.

View Offering Circular

Valuation Cap:

$23,000,000

Min. Investment:

$490

Min. Investment:

$490

Security Type

SAFE

Valuation Cap:

$23,000,000

Min. Investment:

$490

Round Size:

$4,300,000

Security Type

SAFE

Problem

Over $240B³ Is Spent On Inferior Treatments*

Osteoarthritis (OA) is a degenerative disease that destroys the protective cartilage within joints, severely hindering mobility and causing debilitating pain. OA affects over 600M people worldwide and is anticipated to afflict 25% of US adults by 2030. Unfortunately, there is no cure for OA and patients are left with painkillers and corticosteroids to bring about temporary, symptomatic relief. There is an enormous need for a treatment that actually treats the root cause of osteoarthritis, undoing the cartilage damage caused by the disease instead of merely masking the symptoms.

Solution

We’re Developing A Revolutionary Treatment for OA

Our new drug, “CYT-108,” has been proven to protect against cartilage damage in preclinical studies by targeting the root cause of osteoarthritis. Now, we are ready to begin our first-in-human Phase 1 clinical trial for CYT-108 as a treatment for osteoarthritis. Once approved by the FDA, CYT-108 will be the first and only OA treatment that attacks the disease at its molecular source instead of just treating the symptoms.

CYT-108 Development is De-Risked

Cytonics has already successfully commercialized a therapy for osteoarthritis. This FDA-approved medical device (the Autologous Protease Inhibitor Concentrate therapy, or “APIC”) leverages the cartilage-protecting properties of a naturally occurring blood protein, called alpha-2-macroglobulin (A2M), by purifying the A2M from a patient’s own blood and injecting it into their arthritic joints.

The clinical and commercial success of our first-generation APIC therapy is a testament to A2M’s ability to treat osteoarthritis. But why stop there?

Cytonics’ next-generation treatment for OA, “CYT-108”, is a genetically modified, synthetic variant of the natural A2M protein that has been engineered to increase its potency and cartilage-restoring abilities.
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‍The logic is simple: We already know that A2M works as a treatment for OA… and now we have developed a superior, patented version. Essentially, we have “improved on Nature’s design.”

CYT-108 Will Be A Game Changer

Why make a new OA treatment when we already have one? Simple. While our APIC therapy has treated over 8,000 patients to date, it’s costly and involves drawing and processing patients’ blood.
CYT-108 overcomes these challenges and offers major benefits for patients:

CYT-108 can be produced on an industrial scale, which means the product can be sold globally and is more cost effective

CYT-108 is highly concentrated and extremely potent, so patients are no longer limited by the amount of A2M that their body can produce naturally.

CYT-108 will be available “off the shelf” for immediate injection, so patients won’t need to spend hours in a doctor’s office

CYT-108 is more likely to be covered by insurance since it is a biopharmaceutical and not a medical device

Testimonials From Physicians, Patients, And Investors

“Breathtaking and timely.”

- Alexander R Vaccaro, MD, PhD, MBA

“I expect a huge demand for it.”

- Laurence Rosenfield, MD

“Cytonics’ strategic efforts are exciting as they target the development of a first biologic therapy for patients suffering from osteoarthritis.”

- Martin Angst, MD

“Before he did the procedure, I could not bend my knee [...] after the procedure I was walking.”

- Gail Lynn & Robert Lynn

“I was so impressed with these results that I have been evangelizing for APIC treatment to my doctors and friends ever since.”

- Gabe

“The A2M therapy has given me my sports and mobility life back and I have recommended this treatment to all of my friends.”

- Daryle Bobb

Cytonics Is Pioneering Breakthrough Treatments For Osteoarthritis

Invest in our next growth phase as we prepare for Phase 1 human clinical trials.

Pipeline

Development Pipeline

In addition to the FDA-approved APIC therapy and novel CYT-108 biopharmaceutical under development, we also have an OA biomarker test in the market and are pursuing FDA approval for a modified APIC device called the “APIC Mini” (a more cost-effective solution for smaller joints).

BIOPHARMACEUTICALS

IND (Drug) Pathway to FDA Approval

CYT-108

We have completed preclinical studies for our genetically modified A2M variant, “CYT-108,” and are ready for our first-in-human Phase 1 clinical trial. Our Contract Manufacturing Organization, Goodwin Biotechnology, has purified our GMP-grade CYT-108 for human clinical studies.

MEDICAL DEVICES

510(K) Pathway to FDA Approval

APIC

Our Autologous Protease Inhibitor Concentrate (APIC) therapy works by concentrating the naturally occurring, therapeutic A2M protein found in the bloodstream and delivering this purified A2M into arthritic joints. APIC is FDA approved and has been used to treat over 8,000 patients to date. We have licensed the manufacturing and distribution rights to 3rd parties in the human and veterinary markets. It is also being used to treat race horses with outstanding success!

APIC Mini

We have developed a smaller, less expensive APIC system dubbed “APIC Mini” to provide physicians with a solution for treating small joints (such as fingers) that do not require as much volume. The APIC Mini also has the potential for veterinary applications.

FACT Diagnostic

The Fibronectin-Aggrecan Test (“FACT”) is a diagnostic to measure the level of cartilage damage in arthritic joints. This diagnostic is sold alongside the APIC therapy.

DIAGNOSTICS

Clinical Laboratory Test

Milestones

Company Milestones

Find out what’s happened since our last raise here

Johnson & Johnson Development Corp. is a large shareholder.

Over 8,000 patients successfully treated with the APIC therapy.

$22 million raised from institutions and individuals.

Awarded $1.8M in NIH grants to pursue OA treatments.

IP Portfolio includes 22 issued US and international patents with 5 patents pending.

CYT-108 has demonstrated positive preclinical safety and efficacy data.

Roadmap

Good Manufacturing Practices (GMP)

is a standard developed by the FDA to ensure the quality of the drug and reproducibility of the manufacturing process. GMP certification requires rigorous testing of the process and final drug product, and GMP-certified material is needed to conduct human clinical trials.

An Investigational New Drug Application (IND)

is filed with the FDA prior to initiating Phase 1 human trials. The IND contains all preclinical data supporting the safety and efficacy of the drug in animals, details of the manufacturing process, and a description of the drug product itself. An IND must be filed and approved by the FDA (90 days) before conducting human clinical studies.

FDA pre-IND Submission for Osteoarthritis

Pre-IND application provides opportunity for dialogue with FDA prior to conducting Phase 1 clinical study for Osteoarthritis. This is critical to designing an effective, efficient human clinical trial

FDA pre-IND
Meeting for Osteoarthritis

FDA will provide feedback on preclinical data and guidance on GLP preclinical and Phase 1 human clinical trials for Osteoarthritis

FDA pre-IND Submission for COVID

Submission of COVID-19 preclinical study proposal and Phase 1 human trial protocol for review and feedback prior to conducting any studies

FDA pre-IND
Meeting for COVID

FDA will provide feedback on proposed preclinical and Phase 1 human trials for CYT-108 as a treatment for COVID. FDA will also discuss Emergency Use Authorization to expedite the drug approval process for COVID drugs

GLP Preclinical Study for Osteoarthritis

Repeat the large animal preclinical study under GLP conditions, as per the FDA’s recommendation in the pre-IND meeting (4) for Osteoarthritis held on September 25 (Q3 2020)

Preclinical COVID-19 Study

Preclinical study to assess the safety and efficacy of CYT-108 as a therapeutic for COVID-19. Levels of SARS-CoV-2 virus and inflammatory cytokines in the blood and lungs will be measured

Reg A Capital Raise Complete

Reg A+ issuance of preferred equity complete. Potential NASDAQ listing following close. Funds will be used to complete drug development, pursue Phase 1 human clinical trials for CYT-108 as a treatment for osteoarthritis, and preclinical studies to assess the safety and efficacy of CYT-108 as a treatment for COVID-19

IND Filing for Osteoarthritis Phase 1 Clinical Study

Phase 1 Trial Begins

Phase 1 human clinical study commences upon FDA acceptance of IND filing. Establishing safety is the primary goal. Efficacy will be scored by measuring a reduction in patient-reported pain

Team

Gaetano Scuderi, MD is the Founder of Cytonics Corporation. Dr. Scuderi is a fellowship-trained (UCSD, San Diego, CA) spine surgeon who has practiced medicine since 1993. He was also appointed to Clinical Assistant Professor in the Department of Orthopedic Surgery of Stanford University. He graduated medical school from State University of New York (Buffalo, NY) and completed his Residency at University of Miami School of Medicine (Miami, FL). Dr. Scuderi has published over 45 scientific articles and has lectured world-wide. Dr. Scuderi currently practices orthopedic surgery in Jupiter, FL.

In addition to his practice and his role with Cytonics, Dr. Scuderi is a 4th degree black-belt in Jiu Jitsu and the founder/principle instructor of Scuderi Self Defense (Jupiter, FL). Dr. Scuderi’s love for this martial art is only surpassed by his passion for helping the sick and elderly reclaim their mobility and quality of life.

Gaetano Scuderi, MD

Founder and Chairman of the Board

Mr. Bose has over 15 years’ experience in biotechnology research development and healthcare investment banking. He began his career as a systems biology researcher at the University of Virginia and Johns Hopkins University, advancing the field of proteomics and elucidating the molecular drivers of various cancers. Mr. Bose then worked for two boutique healthcare investment banks in the South Florida region, bringing his expertise to the healthcare deal diligencing team. As CEO & President of Cytonics, Mr. Bose coordinates capital raising efforts, manages the company’s preclinical and clinical trials for lead drug candidate “CYT-108”, oversees the Freedom to Operate patent prosecution strategy, and develops relationships with potential strategic partners. He holds a BS in Biomedical Engineering from the University of Virginia (Charlottesville, VA) and an MS in Biomedical Engineering from Johns Hopkins University School of Medicine (Baltimore, MD).

Joey Bose, MS

President

Dr. Hanna has served as Chief Scientific Officer of Cytonics since February 2008. Dr. Hanna has over 28 years’ experience in pharmaceutical research and development, specializing in the development of recombinant protein therapies. He has extensive knowledge of protein folding, purification, formulation, large-scale production, quality, and the regulatory requirements to obtain FDA new drug approval. Until 2004, Dr. Hanna was the Director of Process Development at Alexion Pharmaceutical, and prior to that he was a Group Leader at Bristol-Myers Squibb Pharmaceutical Research Institute. He also served a Principal Research Scientist at R.W. Johnson Pharmaceutical Research Institute (Raritan, NJ) for 7 years. Dr. Hanna received his BS degree from Cairo University (Giza, Egypt), received his PhD from City University of New York (New York City, NY), and completed a postdoctoral fellowship at Cornell University (Ithaca, NY).

Lewis Hanna, PhD

Chief Scientific Officer

Cytonics recently welcomed Tracy Goeken, MD to the company's Board of Directors. As a member of the Board, Dr. Goeken will help drive the company's direction and manage clinical trials. Dr. Goeken brings over 15 years' of expertise in the biopharmaceutical industry and currently serves as the Chief Medical Officer for Linical Americas, a contract research organization that provides the full spectrum of drug development services.
‍
Prior to Linical, Dr. Goeken held positions at The Methodist Hospital Research Institute in Houston, Texas, Pharm-Olam International, Nuron Biotech, and Somahlution. During his tenure as Vice President of Clinical and Medical affairs at Nuron Biotech Inc., the company secured $80mm in financing for the commercialization and expansion of its vaccine Meningitec.

Tracy Goeken, MD

Board Member

Phil LoGrasso, Ph.D. joined the company’s growing Board of Directors in December of 2020. Dr. LoGrasso’s expertise in the biotechnology industry includes experience as a Program Director at the National Institute of Health (NIH), Research Fellow in drug discovery and development at Merck and Avera Pharmaceuticals, and as a senior analyst at GQG Partners (a $56B global hedge fund). Phil has spent almost three decades actively involved in forming relationships with Big Pharma, venture-backed biotech companies, academic researchers at the NIH, and biotech-focused hedge funds.

Mr. Ramseier is the President, co-founder and an equity member of BCI LifeSciences LLC. He has over forty years of origination and operations experience, building and commercializing new technologies. He was a Founder of The Sage Group, and has held senior level executive and board of directors positions with a number of companies in the life sciences industry, including: OncoTherapeutics, ImmuneTech Pharmaceuticals, Inc. (later Dura Pharmaceuticals), the Healthcare Industries Practice of Booz, Allen & Hamilton, G.D. Searle, and Pfizer Laboratories. Mr. Ramseier received his M.B.A. (with distinction) from the Amos Tuck School of Business Administration, Dartmouth College and his B.S. in Chemistry from Washington & Lee University.

Gordon Ramseier

Board Member

Gaetano Scuderi, MD is the Founder of Cytonics Corporation. Dr. Scuderi is a fellowship-trained (UCSD, San Diego, CA) spine surgeon who has practiced medicine since 1993. He was also appointed to Clinical Assistant Professor in the Department of Orthopedic Surgery of Stanford University. He graduated medical school from State University of New York (Buffalo, NY) and completed his Residency at University of Miami School of Medicine (Miami, FL). Dr. Scuderi has published over 45 scientific articles and has lectured world-wide. Dr. Scuderi currently practices orthopedic surgery in Jupiter, FL.

In addition to his practice and his role with Cytonics, Dr. Scuderi is a 4th degree black-belt in Jiu Jitsu and the founder/principle instructor of Scuderi Self Defense (Jupiter, FL). Dr. Scuderi’s love for this martial art is only surpassed by his passion for helping the sick and elderly reclaim their mobility and quality of life.

Gaetano Scuderi, MD

Founder and Chairman of the Board

Mr. Bose has over 15 years’ experience in biotechnology research development and healthcare investment banking. He began his career as a systems biology researcher at the University of Virginia and Johns Hopkins University, advancing the field of proteomics and elucidating the molecular drivers of various cancers. Mr. Bose then worked for two boutique healthcare investment banks in the South Florida region, bringing his expertise to the healthcare deal diligencing team. As CEO & President of Cytonics, Mr. Bose coordinates capital raising efforts, manages the company’s preclinical and clinical trials for lead drug candidate “CYT-108”, oversees the Freedom to Operate patent prosecution strategy, and develops relationships with potential strategic partners. He holds a BS in Biomedical Engineering from the University of Virginia (Charlottesville, VA) and an MS in Biomedical Engineering from Johns Hopkins University School of Medicine (Baltimore, MD).

Joey Bose, MS

President

Dr. Hanna has served as Chief Scientific Officer of Cytonics since February 2008. Dr. Hanna has over 28 years’ experience in pharmaceutical research and development, specializing in the development of recombinant protein therapies. He has extensive knowledge of protein folding, purification, formulation, large-scale production, quality, and the regulatory requirements to obtain FDA new drug approval. Until 2004, Dr. Hanna was the Director of Process Development at Alexion Pharmaceutical, and prior to that he was a Group Leader at Bristol-Myers Squibb Pharmaceutical Research Institute. He also served a Principal Research Scientist at R.W. Johnson Pharmaceutical Research Institute (Raritan, NJ) for 7 years. Dr. Hanna received his BS degree from Cairo University (Giza, Egypt), received his PhD from City University of New York (New York City, NY), and completed a postdoctoral fellowship at Cornell University (Ithaca, NY).

Lewis Hanna, PhD

Chief Scientific Officer

Cytonics recently welcomed Tracy Goeken, MD to the company's Board of Directors. As a member of the Board, Dr. Goeken will help drive the company's direction and manage clinical trials. Dr. Goeken brings over 15 years' of expertise in the biopharmaceutical industry and currently serves as the Chief Medical Officer for Linical Americas, a contract research organization that provides the full spectrum of drug development services.
‍
Prior to Linical, Dr. Goeken held positions at The Methodist Hospital Research Institute in Houston, Texas, Pharm-Olam International, Nuron Biotech, and Somahlution. During his tenure as Vice President of Clinical and Medical affairs at Nuron Biotech Inc., the company secured $80mm in financing for the commercialization and expansion of its vaccine Meningitec.

Tracy Goeken, MD

Board Member

Phil LoGrasso, Ph.D. joined the company’s growing Board of Directors in December of 2020. Dr. LoGrasso’s expertise in the biotechnology industry includes experience as a Program Director at the National Institute of Health (NIH), Research Fellow in drug discovery and development at Merck and Avera Pharmaceuticals, and as a senior analyst at GQG Partners (a $56B global hedge fund). Phil has spent almost three decades actively involved in forming relationships with Big Pharma, venture-backed biotech companies, academic researchers at the NIH, and biotech-focused hedge funds.

Phil LoGrasso, Ph.D

Board Member

Mr. Ramseier is the President, co-founder and an equity member of BCI LifeSciences LLC. He has over forty years of origination and operations experience, building and commercializing new technologies. He was a Founder of The Sage Group, and has held senior level executive and board of directors positions with a number of companies in the life sciences industry, including: OncoTherapeutics, ImmuneTech Pharmaceuticals, Inc. (later Dura Pharmaceuticals), the Healthcare Industries Practice of Booz, Allen & Hamilton, G.D. Searle, and Pfizer Laboratories. Mr. Ramseier received his M.B.A. (with distinction) from the Amos Tuck School of Business Administration, Dartmouth College and his B.S. in Chemistry from Washington & Lee University.

Gordon Ramseier

Board Member

Investor Perks

Limited Time Investor Perks

Cytonics is disrupting the field of regenerative medicine with their innovative biologic therapies for osteoarthritis. Returning investors that make another investment will receive perks equivalent to one tier above their investment amount. Learn more about the investor perks below.

Premier

Tier 1

Invest $15,000 to $29,999

Complimentary consultation with a qualified physician (regional availability may differ)
Participation in scheduled quarterly calls with Cytonics’ senior management

Tier 2

Invest $30,000 to $74,999

All of the above
Complimentary APIC kit (sent to a qualified physician, regional availability may differ)

Insider

Tier 3

Invest $75,000 to $149,999

All of the above
Paid airfare to visit our research facilities and a dinner with Cytonics’ senior management
Complimentary consult with Gaetano Scuderi, MD and APIC treatment

Tier 4

Invest $150,000 to $249,999

All of the above
Complimentary flight (for two) to Jupiter, FL for a weekend stay at the Jupiter Beach Resort
Plus invitation to annual updates (dinners, calls) with Cytonics’ senior management

Elite

Tier 5

Invest Invest $250,000 or more

All of the above
Plus an active role in CYT-108 development, plus complimentary admission to industry conferences that Cytonics attends (such as the American Academy of Orthopedic Surgeons Annual Meeting)

Cytonics Is Pioneering Breakthrough Treatments For Osteoarthritis

We are currently preparing for Phase 1 human clinical trials.