Relief For Osteoarthritis
Over 30 million people are treated for back pain every year in the US, and osteoarthritis (OA) is the leading culprit affecting over 27 million people. Back pain is the #1 cause of missed work, reduced productivity, and healthcare expenditure in our country. Joint pain and OA account for millions of doctor office visits each year, and are rapidly rising as the average life expectancy increases. In all, osteoarthritis burdens our nation with human suffering, reduced quality of life, reduced economic output, and excessive medical expenses.
Cytonics’ flagship product was the Fibronectin-Aggrecan Complex Test (FACT™), which detects the presence of the Fibronectin-Aggrecan Complex (FAC) in samples of patients’ joint fluid. A positive readout on the test indicates that the patient’s pain is caused by cartilage degradation due to overactive enzymes that “chew” up the cartilaginous matrix. The ability to pinpoint the source of joint pain is crucial to both the physician and patient, as it directs the course of treatment and has a significant effect on the patient’s outcome. Leveraging our in-depth knowledge of the pain cascade and cartilage breakdown, we developed an autologous therapy (deemed “APIC™”) based upon a naturally-occurring blood protein, Alpha-2-Macroglobulin (A2M), which has been shown to protect cartilage. Over 6,000 patients have been treated to-date, including physicians, professional athletes (including UFC Hall-of-Fame and Jiu-Jitsu expert, Royce Gracie!), and the elderly. Cytonics’ mission is to rid the world of pain, suffering, and reduced quality of life caused by osteoarthritis. Supported by hundreds of physicians nationwide, we are a leader in the field of regenerative medicine and are positioned to disrupt the space with our innovative biologic therapies for osteoarthritis
Cytonics offers the FACT™ diagnostic test to assist physicians with your treatment plan. The amount for which you are responsible will vary depending on your healthcare provider. Cytonics will bill for the FACT™ diagnostic test as the provider of the lab service. Depending on your healthcare plan, you may have financial responsibility for any applicable co-payments, co-insurance, or deductible for the test.
Cytonics’ Autologous Platelet Integrated Concentrate (APIC™) A2M therapy is the only autologous A2M treatment to submit and win an Investigational New Drug (IND) approval. Based on our in-depth knowledge of the pain cascade and discovery of FAC, we developed the APIC™ treatment with the intent of halting cartilage damage at its source. The APIC™ system utilizes a unique process to concentrate plasma proteins from a patient’s own blood and is superior to common Platelet Rich Plasma (PRP) treatments because it removes all of the “junk” (inflammatory cytokines) and retains the therapeutic A2M molecule. Over 6,000 patients have been treated to-date, including physicians, professional athletes (including UFC Hall-of-Fame and Jiu-Jitsu expert, Royce Gracie!), and the elderly.
The FACT™ is an enzyme-linked immunosorbent sandwich assay (ELISA) that measures the presence of the Fibronectin-Aggrecan Complex fluid specimen taken the joints of patients. The presence of this complex has been shown in clinical studies to be associated with inflammation due to cartilage damage. Reference: “Identification of a Complex between Fibronectin and Aggrecan G3 Domain in Synovial Fluid of Patients with Painful Meniscal Pathology,” Clinical Biochemistry 43 (2010) 808-814, Scuderi, et al.
Physicians commonly use MRI imaging to identify orthopedic abnormalities. Unfortunately, non-invasive MRI imaging has limitations. Many patients may have “normal” looking anatomy, even though degenerative enzymes may be at work causing pain and slowly destroying their joint or disc. Additionally, patients often have non-painful abnormalities that have the same appearance as painful conditions. This makes it difficult for surgeons to diagnose the source of pain and make decisions regarding treatment. The limitations of MRI may lead to misdiagnosis, ineffective surgery, and other inappropriate treatments. The FACT™ overcomes the limitations of MRI by identifying the molecular source of pain.
A small fluid sample taken from the disc or joint space.
The FACT™ Diagnostic Test allows physicians to pinpoint the source of joint pain, and determine whether cartilage degradation is the culprit. Joint replacement surgeries are all too common, many of which are unnecessary, costly to the patient, and overcomplicated. By identifying cartilage degradation as the source of joint pain, the physician is equipped to determine the best course of treatment and improve patient outcome.
Cytonics offers the FACT™ diagnostic test to assist physicians with your treatment plan. The amount for which you are responsible will vary depending on your healthcare provider. Cytonics will bill for the FACTTM diagnostic test as the provider of the lab service. Depending on your healthcare plan, you may have financial responsibility for any applicable co-payments, co-insurance, or deductible for the test.
The “Patient Authorization” section of the Test Request Form must be signed by the patient. This authorization serves as consent for the specimen collection.
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Cytonics has received over $15M in funding to-date, including $1.8M in grants from the National Institute of Health and a $4M investment from Synthes (a Johnson and Johnson company). We are seeking to raise $19M by conducting a public offering under Regulation A. Proceeds will be used to advance our lead drug candidate, Cyt-108, into FDA clinical trials and fund ongoing business operations.
Cytonics Corporation is offering securities under Regulation A through SI Securities, LLC (“SI Securities”). The Company has filed a Form C with the Securities and Exchange Commission in connection with its offering, a copy of which may be obtained at: https://seedinvest.com/cytonics