Chronic Rhinosinusitis (CRS)
Chronic sinusitis is common and debilitating
Chronic sinusitis is an infectious disease characterized by severe inflammation of the sinus cavities, the hollow spaces around the cheek bones and eyes that warm, moisten, and filter air. Allergies, infections, or physical defects trigger an initial inflammatory response, leading to blockage of the nasal passageway and the accumulation of mucus and pathogens in the sinuses. In this state, the sinuses are left susceptible to chronic infection.
Symptoms of chronic sinusitis include severe facial pain, nasal congestion, swelling, and headaches. This can last for more than 8 weeks and can occur up to four times a year. It is estimated that more than 13 million persons in the United States live with chronic sinusitis and experience a significant impact on their quality of life.
Chronic sinusitis patients are typically first treated with medications such as nasal steroids, decongestants, antihistamines, saline solutions and antibiotics. Although treatment with these medications is often successful, patients can experience side effects with long term use. It is estimated that more than 20% of the 13 million US patients treated with medication for chronic sinusitis fail to respond, leaving approximately 2.6 million patients looking to surgery as an alternative treatment.
Summary of U.S. CRS Market Statistics
- Sinusitis is one of the most prevalent of human diseases, second only to periodontal disease. Both conditions involve biofilm infections and undesirable host inflammatory responses. About 1 in 7, or 13% of the US population (35mm) are affected by the chronic form of the disease (CRS).
- 20% of chronic sinusitis patients are unresponsive to medical therapy and therefore represent potential sinus surgery candidates. Cost per procedure can range up to $35,000 per patient.
- Surgical failure rates range between 10-40%; failure rate of further revision surgeries is about 23%. This directly points to the need for an effective alternative approach.
- 40% of CRS patients have polyps. 70% of polyps return post-surgery.
- 40% of all patients with successful sinus surgeries continue to require some form of ongoing medical therapy and monitoring by the ENT specialist. Annual medical care costs are only reduced by 40% after surgery.
- More than 500,000 CRS patients are unresponsive to both sinus surgery and all pharmacological intervention, and this patient base is growing at 10-15% CAGR. This refractory pool represents 34% of an ENT’s patient base.
- Less than 4% of CRS patients undertake surgeries annually. Minimally invasive therapies such as sinuplasty (FEDS) cause more patients to opt for endoscopic sinus procedures. Excellent growth opportunity for effective therapies that avoid removal of sinus tissue and bones via direct to patient marketing.
Patients who continue to remain uncontrolled on pharmacological interventions are referred to an ENT specialist for surgery, on the general consideration that a multi-drug resistant infection and/or mucociliary clearance defect exists that is responsible for the refractory disease. Approximately 500,000 of these patients undergo a sinus surgery procedure, representing a penetration rate of less than 4% of the entire CRS market. Due to the development of newer minimally invasive endoscopic approaches, the market has experienced a significant annual growth rate from 257,000 procedures in 2006 to over 550,000 in 2011 (CAGR of 13.5%). Nevertheless, in a significant fraction of these cases (up to 25%), surgical intervention still fails to bring lasting relief. Over time, the extant pool of refractory chronic rhinosinusitis patients has grown to exceed 500,000 patients in the US alone.
There is a significant unmet need to adequately treat this large and growing pool of refractory patients. Additionally, there is a big opportunity for ENTs to surgically treatment more than 4% of the CRS patient population by combining an effective anti-infection and anti-inflammation treatment to their current surgical protocols. A combination therapy would appeal to more patients as the inclusion of Photodisinfection would yield higher success rates and less tissue and bone removal. More sinuplasty procedures would be justified, driven by the inclusion of Photodisinfection’s antimicrobial efficacy once sinus cavities were unblocked by the sinuplasty. The minimally invasive nature of Photodisinfection would appeal to the patient and the patient’s referring general practitioner, who generally opt for less aggressive approaches.