February 2, 2025 – Regenity Biosciences announced the enrollment of the first patient in its clinical study for a new, first-of-its-kind device-drug combination product to improve outcomes for sinus surgery.
ENHANCE is a prospective, single-arm, multicenter trial designed to investigate the safety and performance of Regenity’s steroid-eluting nasal dressing, in patients that have undergoneendoscopic sinus surgery (ESS) for chronic sinusitis1.
This product introduces a new category of nasal dressings offering localized, controlled delivery of a commonly used steroid, mometasone furoate, directly to the sinus tissue. Inserted by the physician, the device gradually dissolves while delivering a corticosteroid with anti-inflammatory properties directly to the sinus lining.
“This study is designed to confirm the safety of a steroid-eluting nasal dressing, while we collect data to understand the potential benefit for patients with chronic sinusitis, a condition that seriously impacts quality of life,” said Peggy Hansen, General Manager, Contract Development and Manufacturing & Senior Vice President, Regulatory, Quality and Clinical Affair. “We are very excited to initiate this ‘First In Human’ study given its potential to offer a new treatment alternative to the limited and costly options we have in managing recurrent symptoms.”
This new enhanced nasal dressing product is based on Regenity’s proprietary, resorbable poly-urethane technology, a platform with a proven track-record of more than 20 years ofsafety and performance. The benchmarked nasal dressing products are owned and commercialized by a market-leading medical device company and have been used in more than 5 million sinunasal surgical procedures around the world.
“We are excited to introduce an advanced innovation for the treatment of chronic sinusitis via the efficient delivery of active pharmaceutical components [APIs] where they are needed most. We believe this inaugural API-preloaded nasal dressing for chronic sinusitis surgery can provide an overall benefit to post-operative outcomes as patient-administered nasal corticosteroids have limited distribution, and response to treatment is historically variable,” said Shawn McCarthy, Chief Executive Officer of Regenity Biosciences. “This transformational technology is a demonstration of our commitment to making a material difference in the lives of patients around the world.
About Chronic Sinusitis
Chronic sinusitis is a condition in which patients’ sinuses become swollen and inflamed, leading to difficulty breathing, facial pain or headache, and reduced sense of smell and taste. The condition is common, affecting as many as 30 million people in the U.S.,2 and greatly impacts quality of life. Chronic sinusitis often requires a complex combination of surgical and medical treatments. Each year, 500,000 patients undergo sinus surgery to treat the condition.3 Although sinus surgery is effective, the majority of patients experience recurrent symptoms within the first year; as many as 25 percent then undergo revision surgery due to recurrent obstruction of the sinus cavity.4
About Regenity’s nasal dressing device
The device is a steroid-eluting nasal dressing. The design conforms to the sinus anatomy, and effectively delivers anti-inflammatory medication as is gradually dissolves during the post-operative course.
References
1ClinicalTrials.gov ID: NCT06642116
2Caulley et al. Direct costs of adult chronic rhinosinusitis by using 4 methods of estimation: results of the US Medical Expenditure Panel Survey. J Allergy Clin Immunol, 2015
3 Bhattacharyya. Influence of polyps on outcomes after endoscopic sinus. Laryngoscope, 2007
4 Shaitkin et al, Laryngoscope, 2003