Cytonics Corporation believes that access and reimbursement issues should not hinder your ability to offer quantitative, objective diagnostic tools to your patients.
We understand that the billing and reimbursement process can be challenging, so we’ve taken steps to simplify it for you and your patients. Cytonics will bill for the test, as the provider of service, so your office will not be required to bill or collect for the FACT™ assay.
On behalf of your patients, FACT™ is billed using procedure codes (CPT® codes) that generally have established coverage policies. Cytonics will work hard to obtain payer coverage for the FACT™ diagnostic test, including pursuing appeals as necessary.
Depending on the terms of the healthcare plan, patients may have financial responsibility for payment of any applicable co-payments, co-insurance, or deductible for the test.
Finding The Cause Of Pain
Physicians commonly use MRI imaging to identify orthopedic abnormalities. However, MRI has limitations. Many patients have “normal” looking anatomy following a traumatic injury even though degenerative enzymes may be at work causing pain and slowly destroying their joint.
Additionally, patients often have non-painful abnormalities that are indistinguishable from painful conditions. This makes it difficult for surgeons to diagnosis the source of pain and to make decisions on the best course of treatment. The limitations of MRI often lead to misdiagnosis and ineffective treatment, leaving patients to continue to suffer in pain following treatment, despite the best intentions of their physicians.
Research has shown that an inflammatory cascade of proteins causes back and joint pain. Our FACT™ assay detects a unique bio-marker (FAC) in this cascade allowing physicians to identify and treat the source of pain.
How Cytonics Can Help
In addition to the FACT™ assay, Cytonics is developing the next generation in autologous treatments for osteoarthritis, back, and joint pain. Based on Cytonics’ in-depth knowledge of the pain cascade and our discovery of FAC, we have developed a method to concentrate on proteins that inhibit cartilage degeneration and that prevent the formation of FAC.
Our APIC™ System utilizes a unique centrifugation and filtration process to concentrate platelets, growth factors, and protease inhibitors from a patient’s own blood. The platelet-rich, leukocyte-poor APIC™ has been shown to slow the progression of osteoarthritis in preclinical models.
Through the discovery of a unique “pain protein” that can identify the source of musculoskeletal pain, Cytonics developed the Fibronectin-Aggrecan Complex Test (FACT™), a diagnostic molecular biomarker test to identify symptomatic intervertebral discs or painful joint abnormalities. FACT™ is used to measure the presence of the Fibronectin-Aggrecan Complex (FAC) in a fluid specimen taken from patients with joint or disc pain. The FAC is a unique molecular complex that has been reported in peer-reviewed publications to be associated with painful inflammation.
What is FACT™?
(FIBRONECTIN-AGGRECAN COMPLEX TEST)
FACT™ is a novel antibody test that was developed as an optimized assay to detect the Fibronectin-Aggrecan Complex in samples of patients’ joint fluid. The test is a heterogeneous sandwich ELISA utilizing anti-fibronectin antibody immobilized on solid support and anti-aggrecan-G3 as a detection antibody.
FACT™ measures the presence of the Fibronectin-Aggrecan Complex in a fluid specimen taken from patients that experience joint and back pain. It can be used by physicians for testing synovial fluid from any joint or from intradiscal fluid obtained by Molecular Discography. Your FACT™ score can help your physician determine what is going on below the surface, beyond those signs and symptoms you and your doctor can see and feel.
Physicians commonly use MRI imaging to identify orthopedic abnormalities. However, MRI has limitations. Many patients have “normal” looking anatomy following a traumatic injury even though degenerative enzymes may be at work causing pain and slowly destroying their joint. Additionally, patients often have non-painful abnormalities that are indistinguishable from painful conditions on an MRI image. The limitations of MRI often lead to misdiagnosis and ineffective treatment, leaving patients to continue to suffer from joint pain following treatment despite the best intentions of their physicians.
WHY SHOULD YOUR PATIENT GET FACT™?
FACT™ assesses a cartilage breakdown product present in painful disc diseases and painful joint abnormalities. The test can be used for Molecular Discography and Joint Diagnostics. FAC is a unique molecular complex that is specific for painful inflammation of the spine and articular cartilage. The results of FAC can assist physicians in determining their next course of treatment, used to predict functional outcomes from spinal intervention, and can differentiate between painful joint abnormalities in which inflammatory and degenerative molecules degrade the articular cartilage.
FACT™ FOR MOLECULAR DISCOGRAPHY
Identifying symptomatic intervertebral discs remains a challenge in orthopedic medicine. Landmark studies have demonstrated that MRI alone cannot reliably distinguish a disc causing symptoms from one that is not, even when correlated with patient history and physical examination. Studies have demonstrated a high rate of degenerative changes to the lumbar spine identified by MRI asymptomatic volunteers. Identifying which disc causes symptoms in any one patient is highly subjective, requiring careful correlation with patient history and physical examination. This can create reimbursement challenges for indicated procedures when different interpretations of the findings conflict.
The Fibronectin-Aggrecan Complex (FAC) is the single best molecular biomarker to predict functional outcome from spinal intervention. FAC is a unique molecular complex that is specific for painful inflammation of the spine and articular cartilage. FACT™ has been developed for Molecular Discography in which inflammatory and degenerative molecules in the disc space can be sampled and assessed in the laboratory. A significant body of scientific evidence supports the superior efficacy of FACT™ for Molecular Discography in improving benefit/risk ratios than provocative discography. The technique of Molecular Discography has been developed through meticulous research and clinical trials. Each phase of the sample collection, chemical treatment, shipping, and storage is essential to detect molecular biomarkers successfully.
The use of traditional provocative discography can have potential benefits, but also has received variable reports regarding efficacy, and risks vs. benefits ratio. In traditional provocative discography, a needle is inserted into one disc at a time in an attempt to produce concordant pain that reproduces a patient’s daily back pain. Despite its potential benefits and numerous practitioners, provocative discography has received variable reports regarding efficacy, and risk vs. benefits concern. This uncertainty creates increasingly difficult reimbursement challenges for provocative discography alone. The development of FACT™ for Molecular Discography enables more robust reimbursement for evidence-based medicine.
FACT™ FOR JOINT DIAGNOSTIC
The differentiation between symptomatic and asymptomatic cartilaginous abnormalities identified by MRI remains a significant challenge. Studies have shown that MRI alone cannot reliably distinguish a joint abnormality causing symptoms from one that is not, even when correlated with patient history and physical examination.
Despite its potential benefits and numerous practitioners, arthroscopy can have variable outcomes and in some cases, the risks exceed the benefits for the patient. This uncertainty creates reimbursement challenges for arthroscopy, and the absence of a reliable diagnostic method that has high efficacy and optimal risk/benefit ratio for patients with joint pain remains a significant unmet medical need. This was the inspiration for the development of FACT™ for joint diagnostics.
What does the fac score mean?
The FACT™ score provides valuable information to doctors and complements their clinical assessment. It can assist in discussions about the next course of treatment and management of pain. To obtain their patient’s FACT™ score, physicians are granted access to a HIPPA compliant database where all of the patient information and scoring is accessible. A determination as to the severity of the cartilage damage is provided in the report using a threshold (“Positive Range”).
The Autologous Platelet Integrated Concentration (APIC™) system is indicated for the rapid preparation and filtration of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient’s point of care. The APIC™ system consists of a centrifuge, a pump, and a disposable processing kit for the preparation of an A2M-enriched platelet-rich plasma formulation. The disposable processing kit contains 3 centrifuge tubes, one sterile filter, one concentration bag, connection tubing, one waste bag, and other sterile and non-sterile, single-use, disposable accessories that aid in blood collection, preparation and administration of the PRP. The disposable processing kit must be used in conjunction with the APIC™ System centrifuge and pump.
The APIC™ System separates and concentrates A2M from a volume of a patient’s own blood. The patient’s blood is drawn via IV catheter into syringes that are preloaded with anticoagulant citrate dextrose solution A (“ACD-A”). The ACD-A is provided separately and not as part of the disposable processing kit. The blood is then transferred to centrifugation tubes and centrifuged for 4 minutes. The plasma above the buffy coat is transferred to the concentration bag by use of a sterile syringe. The pump circulates the plasma through a filter for 20 minutes, removing the inflammatory cytokines and selectively enriching for the therapeutic A2M. Upon completion of the filtration cycle, the filtered concentrate is drawn from the concentration bag into a syringe and provided for mixing as needed for clinical administration.
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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