Own Shares in the Future of

Regenerative Medicine

Cytonics is developing cutting-edge diagnostics and therapeutics for osteoarthritis to disrupt a $180B market

Cytonics' preclinical results indicate signs of safety & efficacy

Cytonics is excited to announce its recent preclinical research results: “The purpose of this pilot preclinical study was to examine whether CYT-108 is a feasible drug candidate for treating osteoarthritis,” comments Cytonics President Joey Bose. Read more here.

The results demonstrated CYT-108, our lead drug candidate, was generally tolerated when injected. Moreover, we also observed slight cartilage-protective effects when CYT-108 was administered into damaged joints.

25% Of adults by year 2030

Over 27M Americans currently suffer from OA, and with the aging population incidence of OA is projected to reach 25% of the adult population in the US by 2030.

Over 27 Million Americans

Over $180 Billion is spent treating OA

An effective treatment for OA would have a tremendous impact on both human well-being and the economic burden of the disease.

Over 6 Million Athletes

Current Therapies Only Address Symptoms

Limited treatment options for OA exist, and the current therapies are all palliative. They address the symptoms but fail to address the root cause: cartilage damage due to the activity of degradative enzymes (proteases) that destroy the arthritic joint.

Treatment Options

  • Non-steroidal Anti-inflammatory
    Drugs (e.g., Advil)
  • Hyaluronic Acid (Essential component of cartilage)
  • Corticosteroids (e.g., Prednisone)

Poor Outcomes

  • Temporary symptomatic relief
  • Treats the symptoms, not the cause
  • Many side effects

An effective treatment for OA would have a tremendous impact on both human well-being and the economic burden of the disease, as over $180B is spent treating OA per year.

Cytonics discovered alpha-2-macroglobulin (A2M) as a potent inhibitor of the cartilage-destroying proteases. A2M is found naturally in the blood. While the natural levels of A2M are too low to lend any therapeutic benefit to damaged joints, Cytonics theorized that delivering high concentrations of A2M directly into the joint space could bind to and inhibit the proteases, slowing and eventually halting the progression of OA.

An effective treatment for OA would have a tremendous impact on both human well-being and the economic burden of the disease, as over $180B is spent treating OA per year.

Cytonics discovered alpha-2-macroglobulin (A2M) as a potent inhibitor of the cartilage-destroying proteases. A2M is found naturally in the blood. While the natural levels of A2M are too low to lend any therapeutic benefit to damaged joints, Cytonics theorized that delivering high concentrations of A2M directly into the joint space could bind to and inhibit the proteases, slowing and eventually halting the progression of OA.

Innovative Delivery System

An effective treatment for OA would have a tremendous impact on both human well-being and the economic burden of the disease, as over $180B is spent treating OA per year.

Cytonics discovered alpha-2-macroglobulin (A2M) as a potent inhibitor of the cartilage-destroying proteases. A2M is found naturally in the blood. While the natural levels of A2M are too low to lend any therapeutic benefit to damaged joints, Cytonics theorized that delivering high concentrations of A2M directly into the joint space could bind to and inhibit the proteases, slowing and eventually halting the progression of OA.

Our Autologous Platelet Integrated Concentration (APIC) system selectively enriches for A2M from a patient’s own blood, delivering high concentrations of the therapeutic A2M to the joint and eliminating all of the damaging molecules.

This is achieved by drawing and centrifuging the patient’s blood, then filtering out all of the proteins that could cause damage to the joint (such as proteases and inflammatory cytokines) and selectively concentrating A2M.

APIC’s successful treatment of over 7,000 patients nationwide led to the development of CYT-108, the synthetic  A2M variant with test data showing a substantial improvement in cartilage protection. See the results here.

Our technology has been proven to slow cartilage degradation, alleviate pain, eventually halt the progression of OA and allow the body’s regenerative mechanisms to heal the damaged tissue.

This success is a testament to the ability of A2M to treat OA.

This observation has been independently verified by a number of academic groups.

Testimonials from Physicians and Patients

See Testimonials

“I was an early investor in Cytonics as the technology is timely in unraveling the etiology of Low back pain. The future will be assaying for specific biomarkers to determine not only the cause of pain but the potential for improvement with certain interventions. As a busy spine surgeon for the last 25 years the direction that Cytonics is proceeding in attempting to minimize clinical failures through their Autologous Platelet Integrated Concentration (APIC) System is breathtaking and timely.”

- Alexander R Vaccaro, MD, PhD, MBA

I have been using Cytonics’ alpha2- macroglobulin kits to treat various joint pains mostly in the knee. This is part of my regenerative medicine practice. I’ve seen remarkable results such that I have suggested that my wife and my son undergo treatments as well as patients. The treatments were remarkably successful in both of them. I am very pleased and I’m looking forward to having this product available more easily off-the-shelf and approved by insurance. I expect a huge demand for it. Thank you.

- Laurence  Rosenfield, MD

Cytonics’ recombinant drug development program is anchored in robust preclinical data indicating that the proteinase inhibitor alpha-2-macroglobulin critically inhibits cartilage breakdown in models of osteoarthritis. Cytonics has developed a lead recombinant drug candidate, a variant of human alpha-2-macroglobulin that possesses a unique and improved bioactivity profile. Cytonics’ strategic efforts are exciting as they target the development of a first biologic therapy for patients suffering from osteoarthritis.”

- Martin Angst, MD

[Dr. Scuderi] took out some of my blood and he put it into the centrifuge and they did what they had to do and then he reinjected the A2M protein back into my knee. Before he did the procedure, I could not bend my knee, I could not walk upstairs. I really couldn't do anything. In fact, I was using a brace on my knee just to give me some support because the whole knee felt like it was going to cave in. A few days after the procedure I was walking and we were walking the dogs and the swelling seemed to have been going down.

- Gail Lynn

I came with Gail when she discovered Dr. Scuderi and what he can do for arthritis. I went for an x-ray. Very simply, he did the same procedure. He took blood from my arm and put it in a centrifuge and got the protein out and injected it in my shoulder. And I’ve been great. We had nothing but success with this protein shot.

- Robert Lynn

- Gail Lynn & Robert Lynn

I partially tore my ACL in a skiing accident in Switzerland. After an unnecessary arthroscopy revealed I was not a candidate for ACL reconstruction, my knee was swollen and stiff for 6 weeks. Then I had a single treatment of Cytonics A2M therapy, APIC. Within 2 days the swelling and stiffness was gone and hasn’t returned 6 months later. I was so impressed with these results that I have been evangelizing for APIC treatment to my doctors and friends ever since.

Even if I need another treatment soon, a couple APIC injections per year with no noticeable side effects and no drugs is closer to a miracle-treatment than I imagined possible before my experience with Cytonics’ product. Joint injuries can be physically and emotionally debilitating, but medical advancements like this make now the best time in history to tear one’s ACL.

- Gabe

“I suffered prolonged pain from a partial tear in my right Achilles tendon. I am very familiar with this pain as I ruptured and had my left Achilles surgically repaired. After almost eight months of therapy and various treatments, Richard Grossman, MD told me about Cytonics and the available A2M treatment. I received my first injection in April of 2018 and within weeks the large nodule in my Achilles had shrunk significantly. While I was feeling much better and able to start playing basketball and tennis again for the first time in ten months, I still felt a little pain. I went back for a 2nd injection in November of 2018 and the pain has been reduced to only minor pain with NO LIMITATIONS. 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

“I was an early investor in Cytonics as the technology is timely in unraveling the etiology of Low back pain. The future will be assaying for specific biomarkers to determine not only the cause of pain but the potential for improvement with certain interventions. As a busy spine surgeon for the last 25 years the direction that Cytonics is proceeding in attempting to minimize clinical failures through their Autologous Platelet Integrated Concentration (APIC) System is breathtaking and timely.”

- Alexander R Vaccaro, MD, PhD, MBA

I have been using Cytonics’ alpha2- macroglobulin kits to treat various joint pains mostly in the knee. This is part of my regenerative medicine practice. I’ve seen remarkable results such that I have suggested that my wife and my son undergo treatments as well as patients. The treatments were remarkably successful in both of them. I am very pleased and I’m looking forward to having this product available more easily off-the-shelf and approved by insurance. I expect a huge demand for it. Thank you.

- Laurence  Rosenfield, MD

Cytonics’ recombinant drug development program is anchored in robust preclinical data indicating that the proteinase inhibitor alpha-2-macroglobulin critically inhibits cartilage breakdown in models of osteoarthritis. Cytonics has developed a lead recombinant drug candidate, a variant of human alpha-2-macroglobulin that possesses a unique and improved bioactivity profile. Cytonics’ strategic efforts are exciting as they target the development of a first biologic therapy for patients suffering from osteoarthritis.”

- Martin Angst, MD

[Dr. Scuderi] took out some of my blood and he put it into the centrifuge and they did what they had to do and then he reinjected the A2M protein back into my knee. Before he did the procedure, I could not bend my knee, I could not walk upstairs. I really couldn't do anything. In fact, I was using a brace on my knee just to give me some support because the whole knee felt like it was going to cave in. A few days after the procedure I was walking and we were walking the dogs and the swelling seemed to have been going down.

- Gail Lynn

I came with Gail when she discovered Dr. Scuderi and what he can do for arthritis. I went for an x-ray. Very simply, he did the same procedure. He took blood from my arm and put it in a centrifuge and got the protein out and injected it in my shoulder. And I’ve been great. We had nothing but success with this protein shot.

- Robert Lynn

- Gail Lynn & Robert Lynn

I partially tore my ACL in a skiing accident in Switzerland. After an unnecessary arthroscopy revealed I was not a candidate for ACL reconstruction, my knee was swollen and stiff for 6 weeks. Then I had a single treatment of Cytonics A2M therapy, APIC. Within 2 days the swelling and stiffness was gone and hasn’t returned 6 months later. I was so impressed with these results that I have been evangelizing for APIC treatment to my doctors and friends ever since.

Even if I need another treatment soon, a couple APIC injections per year with no noticeable side effects and no drugs is closer to a miracle-treatment than I imagined possible before my experience with Cytonics’ product. Joint injuries can be physically and emotionally debilitating, but medical advancements like this make now the best time in history to tear one’s ACL.

- Gabe

“I suffered prolonged pain from a partial tear in my right Achilles tendon. I am very familiar with this pain as I ruptured and had my left Achilles surgically repaired. After almost eight months of therapy and various treatments, Richard Grossman, MD told me about Cytonics and the available A2M treatment. I received my first injection in April of 2018 and within weeks the large nodule in my Achilles had shrunk significantly. While I was feeling much better and able to start playing basketball and tennis again for the first time in ten months, I still felt a little pain. I went back for a 2nd injection in November of 2018 and the pain has been reduced to only minor pain with NO LIMITATIONS. 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

Pre-clinical research on CYT-108: the Data is in, and CYT-108 Works

In an experiment conducted in rodents, administration of CYT-108 directly into the arthritic joint resulted in a substantial improvement in cartilage protection.

CYT-108 was able to significantly reduce the damage to the cartilage and the synovial membrane (the tissue that protects the joint) of rats suffering from post-traumatic osteoarthritis.

CYT-108 is 2-4 times more effective than the naturally occurring, wild-type A2M (wt-A2M) at preventing cartilage degradation and synovial membrane damage

The observation that A2M is a potent inhibitor of cartilage damage has been made independently by a number of academic groups.

Level of Cartilage Damage

Level of Synovial Membrane Damage

Disruptive Product Line

APIC

Our APIC system for concentrating the naturally occurring A2M in the patient’s blood has been approved by the FDA and used to treat over 7,000 patients.

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.

CYT-108

We are currently pursuing pre-clinical studies for our recombinant A2M, CYT-108. We have contracted a research organization, Goodwin Biotechnology, to purify GMP/GLP quantities of CYT-108 for pre-clinical experiments and FDA clinical trials.

The Value of Clinical Success

Risk-Adjusted Discounted Cash Flow Assumptions

  • Discount rate of 30% (this is appropriate for pre-clinical stage biotech)*
  • 1% market capture (very conservative) in the US human orthopedic market only (does not include expansion into other markets).
  • $500 per treatment, avg. 2 treatments per year (based on APIC treatment schedule).
  • Cytonics assumes full development cost of bringing CYT-108 to market and producing and selling the drug upon FDA approval
    • COGS = 15% of revenue (According to a meta-analysis compiled in Biotech Forecasting & Valuation (2016)**. Data was retrieved from company 10-k filings.)
    • SG&A = 34% (According to an analysis of 35 small and mid-cap drug companies in the NASDAQ Biotechnology Index in 2015, reported in Biotech Forecasting & Valuation (2016)**

Why Cytonics?

Historically, Big Pharma’s focus has been on small molecules instead of biologic therapies (like our recombinant A2M – CYT-108). Biologics have taken off in recent years, and Cytonics is at the forefront of this innovation.

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Big Pharma has failed to appreciate the multi-faceted nature of the disease and develop a therapeutic that tackles all of the causal factors.

Big Pharma has failed to develop a treatment for osteoarthritis (OA) because they have adopted a very narrow approach, attempting to imitate the successful discovery of TNF-alpha inhibitors as a treatment for rheumatoid arthritis (RA). Unlike RA, the pathology of OA cannot be distilled down to a single root cause.

Team

See Team Members

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 clinical 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. Carvalho has more than 25 years’ experience developing, manufacturing, and commercializing innovative products in the pharmaceutical and consumer product industries. He served as Vice President of Finance for the Global Oncology business unit of Novartis Pharmaceuticals, where he had financial oversight for the unit’s 20 product launches in a 5 year span. Prior to this role, Mr. Carvalho was the General Manager for Novartis’ US Pharmaceutical manufacturing unit. His other roles at Novartis included CFO Latin America, CFO US Ophthalmics, and Vice President and Controller for Novartis’ US Pharmaceutical Division. Mr. Carvalho has a BBA in Accounting from Iona College (New Rochelle, NY) and is a Certified Public Accountant.

Antonio Carvalho, CPA

CEO and CFO

Mr. Bose has over 10 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 cancers. Mr. Bose worked for two boutique healthcare investment banks/consultancies in the south Florida region, bringing his expertise in translational medicine to the deal diligencing team. As President of Cytonics, his primary responsibilities include coordinating capital raising efforts, initiating clinical trials for the company’s lead drug candidate (CYT-108), filing and maintaining patent protection of intellectual property, and identifying strategic buyers and out-licensing opportunities for the company. He holds a BS in Biomedical Engineering from the University of Virginia (Charlottesville, VA) and an MS in Biomedical Engineering from Johns Hopkins University (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

Keys to Success

Massive Market Potential

For Effective Diagnostics and Orthopedic Pain Relief Therapeutics

$180B market for effective osteoarthritis treatments

Broad Patent Coverage

World-renowned Wilson Sonsini Patent Attorneys

8 issued international patents, 9 pending

Major Breakthrough Discoveries

Fibronectin-Aggrecan Complex biomarker for osteoarthritis

Purified one of the largest recombinant proteins to-date

Track Record of Success

Over 7,000 patients treated with APIC therapy

Successful 510k approval for APIC technology

CE mark designation

Possess Core Competencies to Achieve Milestones

Hogan-Lovells Regulatory Attorneys

Over 100 years’ combined experience in Pharma R&D

Outstanding Team Of MBAs, MDs, And PhDs

Investment Opportunity in Early-Stage Regenerative Medicine.

Cytonics Corporation – Developing First-in-Class Therapies for Osteoarthritis.

We have been receiving a great deal of interest from potential investors such as yourself, and some very insightful questions have been asked during our investor webinars.

What is the key innovation of Cytonics’ technology?

Alpha-2-Macroglobulin (A2M) is a naturally-occurring blood serum protein that has been shown to protect against cartilage breakdown by inhibiting a class of deleterious enzymes (called “proteases”) which degrade the cartilage cushion and cause joint pain/inflammation. A2M inhibits all the inflammatory mediators of the process, eliminating the burden on the immune system and allowing the body to heal itself efficiently. Unfortunately, the levels of naturally occurring A2M are insufficient to completely halt the progression of OA and can only delay the onset of symptoms at best. Cytonics has demonstrated that hyper-concentrating A2M within the joint cavity can halt the progression of OA, allowing the body to heal itself and bring about significant relief to the suffering patient. Cytonics’ Autologous Platelet Integrated Concentration (APIC™) System was developed with the intent of delivering high concentrations of A2M into damaged joints. The APIC™ system utilizes a proprietary filtration process to selectively concentrate A2M and remove inflammatory proteins from a patient’s own blood. Over 7,000 patients have been treated to-date!

When do you see Cytonics being profitable for investors?

Our exit strategy is either acquisition of the company's entire IP portfolio or licensing of the technology to Big Pharma for further development. This typically happens when an experimental drug has Phase 2 results, and we expect to have these results by 2025. The value of the company increases incrementally at each successive Phase of the clinical trial process, and our goal is to maximize shareholder value by demonstrating the clinical success of CYT-108 to Big Pharma.

Why seek funding via the Regulation A+ route instead of Venture Capital?

Regulation A+ is a unique capital raising method because it allows the public to participate in early-stage companies that have the potential to be disruptive. Venture Capital is more inclined to invest in later-stage companies that are less risky, but at a higher price. The beauty of the Reg A+ is that we can offer the public the ability to grow with the company and develop a technology that could truly revolutionize regenerative medicine!

How does your drug development pipeline align with your commercialized technologies?

Our First-in-Class drug development pipeline is predicated on the activity of Alpha-2-Macrglobulin and the success of the APIC treatment. We have engineered a synthetic variant of the A2M molecule (“CYT-108”) that we have shown to be more effective than the naturally occurring A2M found in your bloodstream. We are also able to deliver CYT-108 in high concentrations without the need for the patient’s own blood. If successful, CYT-108 will be the only approved therapy to treat the root cause of osteoarthritis.

How will your patent portfolio prevent duplication of your technologies?

The key innovation of Cytonics' technology is the blocking of certain enzymes from degrading the cartilage in arthritic joints. This is accomplished by CYT-108 binding to these enzymes (proteases) and inhibiting their activity at specific binding sites. We have identified the binding sites to all 3 major classes of proteases that CYT-108 interacts with and inhibits. It would be extremely difficult to replicate this strategy without interacting with some, if not all, of our protected binding sites. This was a very clever way of patenting CYT-108 because it does not just protect a synthetic A2M therapy, it actually protects the mechanism of action of the drug. Additionally, there is a large R&D barrier to entry - Producing and purifying CYT-108 is an extremely difficult process that took us 2 years to optimize (due to the size and physiochemical properties of the molecule). It is possible that another group could create a competing technology, but it highly unlikely that they will be able to do so in a profitable way.

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