Breaking Boundaries in Osteoarthritis Care

Unveiling Cytonics: A Biotech Powerhouse Revolutionizing Osteoarthritis Care. 

Since 2006, we have been developing diagnostics and therapeutics for Osteoarthritis (OA), a debilitating joint disease that affects over 365M people worldwide and for which there are no effective treatments. Our breakthrough FACT™ biomarker test has guided thousands of patients to effective treatments by linking joint pain to cartilage damage, allowing physicians and patients to determine their best course of therapy . In 2015 we transformed the OA treatment game with our Autologous Protease Inhibitor Concentrate™ therapy (or “APIC™” for short). APIC™ leverages the therapeutic activity of a naturally occurring blood protein called Alpha-2-Macroglobulin (“A2M”) by selectively concentrating the A2M protein from patients’ own blood (autologous means obtained from self), then injecting the A2M concentrate directly into their arthritic joints. APIC™ has successfully treated over 8,000 patients to-date, and is clinical proof that our core A2M technology is a potent solution for OA.

Now, we are redefining regenerative medicine once again with the development of CYT-108, a genetically engineered variant of the naturally occurring A2M protein that we believe will be the ultimate solution to OA. Preclinical studies of CYT-108 have established its superior efficacy compared to natural A2M in addressing the root molecular causes of Osteoarthritis. If approved by the FDA, CYT-108 will be the first and only disease-modifying treatment that will address a $240 billion global market currently occupied by inferior, temporary, palliative treatments that merely mask the pain and inflammation caused by the disease. We believe we’re positioned to completely change the OA treatment landscape with CYT-108 by treating the root cause of the disease, resulting in cartilage repair, reduced pain and inflammation, and bringing lasting relief.

Pioneering a Breakthrough Solution for Joint Health and Cartilage Damage

Osteoarthritis (OA) afflicts over 365 million worldwide and is a massive burden to the global economy, yet current treatments only mask symptoms and do not bring lasting relief. Patients yearn for a solution that targets the root cause of cartilage damage, eliminating pain and restoring joint function for life. Cytonics  is on a mission to rewrite the script for OA by leveraging the power of Alpha-2-Macroglobulin (A2M), a naturally-occurring blood serum protein that plays a critical role in blood clotting. Via that same mechanism of action, it also has the remarkable ability to shield against cartilage deterioration by blocking very specific catabolic enzymes called “proteases”. By counteracting these destructive protease  enzymes, which accumulate in OA-afflicted joints and “chew” up the cartilage tissue, A2M prevents cartilage degradation and reduces joint inflammation and associated pain. A2M's comprehensive suppression of inflammatory triggers not only eases the immune system's load but also facilitates the body's autonomous healing. Although native A2M levels in the joints are too low to halt OA progression, Cytonics has demonstrated that delivering highly-concentrated A2M processed from patients’ blood directly into the joint effectively arrests the disease, providing substantial long-term and robust relief for suffering patients. 

This led to the development of our first-generation A2M therapy, called the “Autologous Protease Inhibitor Concentrate™” therapy (“APIC™”), which has successfully treated over 8,000 patients nationwide and has recently been shown effective in treating race horses. The royalty stream from APIC™ sales is a great source of non-dilutive funding for our company, but the most important feature of the therapy is that it is a testament to A2M’s ability to potently treat Osteoarthritis.

But why stop there?

Introducing CYT-108: the “super A2M” 

Emboldened by APIC™’s  clinical and commercial success, we embarked on a mission to create a “super A2M” that would overcome the limitations of relying on the naturally occurring A2M —namely, the amount of A2M varies significantly from patient-to-patient, and the therapy requires equipment and time to administer, reducing its global scalability. Named “CYT-108,” this super A2M is a genetically-engineered variant of the naturally occurring protein that can be synthesized in a lab, produced on an industrial scale, distributed globally, and made “off-the-shelf” for ease of administration. After 5 years’ of intensive and thorough experimentation, we have completed the critical preclinical experiments (data below) that allow us to proceed into a first-in-human Phase 1 clinical trial of CYT-108. We stand at this critical juncture with unbridled enthusiasm and confidence that we will demonstrate superior efficacy (up to 4x more potent than the natural A2M) and (most importantly) safety in our clinical trial participants. APIC™ has proven that A2M is an effective OA treatment. Now, we just have to prove that CYT-108 will perform even better.

Intra-articular injection of our recombinant A2M variant, CYT-108, results in reduced cartilage degradation and reduced joint membrane inflammation in subjects suffering from post-traumatic Osteoarthritis. Histopathological grading (modified OARSI scoring system) of the joint tissues reveals that treatment with  CYT-108 results in a 57% reduction in cartilage damage and a 60% reduction in joint membrane inflammation, as measured by an independent pathologist. These results indicate that CYT-108 is therapeutically active against joint tissue damage, not only protecting cartilage but reducing inflammation in arthritic joints. Taken together with the toxicology and immunogenicity data (not shown), this preliminary preclinical data indicates that CYT-108 may be a viable treatment for Osteoarthritis. Error bars +/- SEM.

Cytonics presents a unique investment opportunity fueled by cutting-edge biotechnology innovation and dual revenue streams. Through exclusive agreements with two independent manufacturers (one operating in the human market and the other in the veterinary space) we have secured over $4M in license acquisition fees and royalties through 2029, with guaranteed royalty minimums of $400,000 annually, providing stable and non-dilutive capital to fund our research and development of CYT-108. We're at the forefront of innovation with our genetically-engineered A2M variant,  the development of which is significantly de-risked by the proven success of our APIC™ treatment. 

Driven by an accomplished and seasoned team of medical doctors and PhDs, we have emerged as pioneers in regenerative medicine and have solidified our position as leaders in the industry. Dr. Gaetano Scuderi, Founder and Chairman, discovered the therapeutic potential of A2M while conducting research at Stanford Medical School before he founded Cytonics in 2006, and he brings extensive medical expertise (over 30 years as a practicing orthopedic surgeon) and academic distinction (over 45 published papers in the field of regenerative medicine) with him. Guided by Dr. Lewis Hanna, Chief Scientific Officer and former Director of R&D at Alexion, Cytonics’s research and development of CYT-108 is poised to reach its pinnacle with a successful first-in-human Phase 1 clinical trial. By integrating over 15 years’ experience as both a biomedical researcher and healthcare investment banker, Joey Bose, President & CEO, is  leading the charge through this exciting path of biotechnology R&D.

Our team is dedicated to developing the cure for Osteoarthritis once and for all, and it is with this dogged passion that we will bring relief to millions of suffering patients and give them their lives back.

Patently Impressive, Proven and Promising

The OA market is enormous. Drawing parallels from the success of rheumatoid arthritis (RA) treatments (TNF-alpha inhibitors, like Abbvie’s Humira, one of the best selling drugs of all-time) we estimate the market for a “true” disease-modifying OA treatment to be ~$240B ($40B is spent on TNF-alpha drugs x 6-fold more OA patients than RA| Source). Cytonics entered the arena with the intent of developing a universally effective solution for OA, the analog to TNF-alpha inhibitors which have effectively eradicated RA. Our Founder, Dr. Gaetano Scuderi (a fourth-degree black belt in jujitsu and respected instructor in the BJJ and MMA community), testifies to A2M's effectiveness in extending his athletic career into his 60’s (as does Royce Gracie, decorated UFC and MMA veteran), and endorsements from training partners and an expanding patient population of athletes and the elderly (and everyone in between!)  reinforce the potential of Cytonics' core technology to heal joints and transform lives.

*These testimonials may not be representative of the experience of other customers and are not a guarantee of future performance or success.

Cytonics showcases an extensive IP portfolio with 22 issued US and international patents (protecting all three of our technologies - FACT™, APIC™, and CYT-108) that solidify our competitive edge. Johnson & Johnson Development Corp. holds a significant stake (12%) in Cytonics, validating our potential and providing an avenue for acquisition once an exit is sought. Notably, many of our early investors are orthopedic surgeons, physicians, and patients who've experienced the impact of APIC™ first hand. Over 8,000 patients have had their lives changed by our APIC™ therapy, which provides critical validation of the positive preclinical data that backs CYT-108's safety and efficacy in treating Osteoarthritis. With a track record of successful funding, including over $20M raised from Family Offices, orthopedic surgeons, and equity crowdfunding (most recently  $7 million+ raised on SeedInvest), Cytonics is ready to bring on new investors to advance CYT-108 out of the laboratory and into FDA Phase 1 clinical trials. This is a pivotal juncture in our corporate trajectory, and we welcome you to join us as we transform into a clinical-stage company and cross over a substantial valuation inflection point. 

Join the Regenerative Medicine Revolution

With a dynamic blend of groundbreaking innovation, strategic partnerships, and proven traction, Cytonics is on the brink of transforming the Osteoarthritis treatment landscape. This paradigm shift will be accomplished by targeting the root causes of OA through the cartilage-protecting power of a naturally occurring blood protein called A2M. We're not just masking symptoms – we're rewriting the script for a pain-free future. Backed by an impressive base of sophisticated investors, track record of industry-advancing research, and a history of successful funding, Cytonics is positioned to disrupt the OA market and redefine the standard of care. Seize this opportunity to be part of a journey that's reshaping the landscape of regenerative medicine, bringing hope back to millions of people.

Invest today and become a driving force behind the transformation of millions of lives.