Cytonics has developed a novel biologic solution for osteoarthritis, the debilitating joint disease which affects over 30M Americans1 and 600M people worldwide2. Now is the opportunity to invest in our first-in-class biopharmaceutical as we prepare for Phase 1 human clinical trials.
$23,000,000
$490
$490
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Osteoarthritis (OA) is the most common joint disease characterized by the erosion of protective cartilage tissue within joints. Often thought of as a disease of the elderly, OA is also prevalent among athletes. To date, the joint pain and inflammation associated with OA is merely managed, and there are no effective therapies that target the root cause of the disease to reverse its progression and restore the damaged cartilage. Over $240B is spent on palliative treatments (pain killers, corticosteroids, and hyaluronic acid injections) that bring temporary symptomatic relief. This must change.
*Market size computed based on 6x prevalence of OA compared to rheumatoid arthritis and global sale of TNF-alpha inhibitors.
Osteoarthritis is a degenerative joint disease defined by the breakdown of the protective cartilage tissue that provides support within articular joints. This breakdown is caused by a cascade of molecular mechanisms that result in the hyper-activity of a class of enzymes called “proteases.” These proteases act like molecular “Pacmen,” chewing up the cartilage tissue, rendering the joint brittle, inflamed, immobile, and painful. OA can affect any joint, from the knees, ankles, toes, shoulders, elbows, wrists, fingers, and hips, to the vertebrae within the spine.
Cytonics has developed breakthrough OA treatments based on a naturally occurring blood protein called “Alpha-2-macroglobulin” (A2M). A2M is a potent, broad-spectrum protease inhibitor that is able to inhibit the proteases involved in cartilage degradation in arthritic joints.
Osteoarthritis is caused by hyperactive proteases, a class of catabolic enzymes that chew away at the cartilage matrix. A successful treatment must address these root molecular forces to reverse the cartilage damage caused by the disease
The Autologous Protease Inhibitor Concentrate (APIC) therapy
The company’s first-generation, FDA-approved OA treatment utilizes the A2M found in patients’ own blood. This device employs a proprietary filtration system to selectively concentrate the A2M protein while removing inflammatory proteins from blood serum.
This A2M “super-concentrate” is injected into patients’ arthritis joints.
Cytonics is currently working on a second-generation novel biopharmaceutical drug product – a genetically engineered variant of the A2M protein that has been intelligently designed to enhance the potency and activity of the natural A2M molecule.
Cytonics has proven that CYT-108 is significantly more potent than the natural A2M protein in preclinical experiments and has demonstrated that CYT-108 is safe to administer and prevents damage to cartilage (and other joint tissues) associated with osteoarthritis.
Cytonics is preparing for a first-in-human Phase 1 clinical trial anticipated to start in early Q1 2023. The company is currently conducting their final preclinical study to submit to the FDA in an Investigational New Drug (IND) application in Q3 2021.
Preliminary preclinical data demonstrates CYT-108’s efficacy in preserving the cartilage and surrounding tissues (e.g., synovial membrane) in a large animal model of post-traumatic osteoarthritis. Regular treatments of CYT-108 (or placebo saline solution) were injected into the damaged joints along a 12-week treatment window. Pieces of the cartilage and surrounding tissues were examined to measure the cartilage-protective effects of CYT-108 and its ability to encourage joint remodeling/healing. In summary, the administration of CYT-108 into the joint restored the damage caused by osteoarthritis to the cartilage and synovial membranes by ~60%. Read more here.
Since our last raise (2021), we have accomplished all of our milestones in pursuit of advancing CYT-108 into FDA human clinical trials. These accomplishments include manufacturing GMP-grade CYT-108 protein for our final preclinical study (“IND-enabling toxicology study”) and an imminent Phase 1 clinical trial (planned for Q1 2023). Now, we are calling on investors to help fund our first-in-human Phase 1 clinical trial and advance CYT-108 one step closer to FDA approval.
Once approved by the FDA, CYT-108 will be the first and only OA therapy on the market that targets the root molecular cause of the disease. CYT-108 will not only alleviate the joint pain and inflammation associated with osteoarthritis, but it will reverse the cartilage damage and progression of OA, providing patients with a long-term and effective therapy solution.
Invest in our next growth phase as we prepare for Phase 1 human clinical trials.
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).
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.
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.
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.
Cytonics is disrupting the field of regenerative medicine with their innovative biologic therapies for osteoarthritis. Returning Reg A+ investors that make another investment will receive perks equivalent to one tier above their investment amount. Learn more about the investor perks below.
Invest in our next growth phase as we prepare for Phase 1 human clinical trials.
Download the investor deck and learn more about how Cytonics is advancing treatments for osteoarthritis.
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