Synedgen has developed Synazal®, an innovative sinus irrigation product that mechanically clears mucus and breaks up sinus biofilms.
Millions of Americans suffer from sinus infections. [1] This common infection costs $11 billion each year and is one of the leading causes of antibiotic over-prescriptions. [2-3] Patients with cystic fibrosis especially suffer from sinus infections, which can become lifelong conditions if they develop resistance to treatment.
Sinus health is critical to pulmonary health. In patients with cystic fibrosis, pulmonary infections can be seeded by bacteria that form reservoirs in the sinus passages. Yet, common treatments like antibiotics and anti-inflammatory agents are often ineffective, leading to nearly 600,000 surgeries in the U.S. each year. [4]
Synazal reduces sinus inflammation and infection to provide patients with gentle relief. Synazal is the first therapeutically precise nasal irrigation technology developed to complement sinusitis standard-of-care. This irrigation product is formulated as a non-cytotoxic, non-hemolytic, non-sensitizing, biocompatible solution.
In collaboration with the University of Washington (Seattle, WA), Synazal was tested over a two-week period by chronic sinusitis sufferers with and without cystic fibrosis. In this study, Synazal:
- Was very well tolerated
- Significantly improved nasal endoscopy scores
- Reduced mucus levels
- Reduced pathogen carriage
- Did not affect the sense of smell
In addition to being a gentle, non-irritating sinus rinse, Synazal is also being developed for care following mechanical sinus interventions or sinus surgery. Synazal is expected to enter the FDA 510(k) pathway in 2019.
- https://www.cdc.gov/nchs/fastats/sinuses.htm
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5498318/
- https://www.nejm.org/doi/full/10.1056/NEJMcp1601749
- Laryngoscope. 2010 Mar;120(3):635-8.