#USA #Boston #Chronic Bronchitis #RejuvenAir #CSA Medical

CSA Medical Submits PMA for RejuvenAir® System

CSA Medical, Inc., a pioneering company in the development of interventional pulmonary therapies, recently announced the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its innovative RejuvenAir System. This submission follows encouraging results from the pivotal multicenter clinical trial known as SPRAY-CB, which focused on the efficacy and safety of this treatment for chronic bronchitis, a common complication of chronic obstructive pulmonary disease (COPD).

Positive Results from the SPRAY-CB Trial

The SPRAY-CB trial was designed as a randomized, sham-controlled study, which is critical for validating the efficacy of medical therapies. It successfully met its primary endpoint along with multiple secondary endpoints, all showing statistical significance. This is a significant achievement in a field where patients with chronic bronchitis currently have limited FDA-approved device-based treatment options. CSA Medical's President and CEO, Wendelin Maners, commented on the milestone: "Today marks a major inflection point for RejuvenAir and for patients with chronic bronchitis who currently lack FDA-approved, device-based treatment options."

The positive trial results not only underline the effectiveness of the RejuvenAir device but also highlight its favorable safety profile, reassuring both clinicians and patients about its reliability as a treatment option.

What is the RejuvenAir System?

Unlike traditional treatment approaches, the RejuvenAir System is a unique bronchoscopic device designed to target and treat the diseased airway tissue in patients suffering from chronic bronchitis. This innovation does not leave any implants within the patient's body, facilitating a therapeutic procedure that enhances existing medical management for chronic conditions.

This therapy utilizes Metered CryoSpray (MCS) technology and is aimed at alleviating two major issues associated with chronic bronchitis: chronic cough and dysfunctional mucus production and clearance. By ablating damaged cells within the airways, the system prompts a regenerative healing response that encourages the body to produce new, healthy cells. This mechanism is anticipated to help redefine treatment strategies for pulmonary interventions.

FDA Breakthrough Device Designation

The RejuvenAir System has garnered special recognition from the FDA by receiving the Breakthrough Device Designation. This designation signifies that the device is likely to provide significant benefits over existing treatment options for a large patient population suffering from chronic bronchitis, which affects over 9 million people in the United States alone.

Understanding Chronic Bronchitis

Chronic bronchitis is characterized by a persistent cough coupled with increased mucus production, diagnosed primarily by symptoms lasting three months or more for two consecutive years. Patients may experience chronic inflammation and obstruction due to swelling and excess mucus in the bronchi, leading to significant shortness of breath. This condition presents a considerable healthcare challenge, with millions of Americans living with COPD, the leading cause of chronic bronchitis.

Looking Ahead

With the PMA submission now complete, CSA Medical is poised to work collaboratively with the FDA during the review process. The company is optimistic about advancing the RejuvenAir system towards potential commercialization in the United States, which could represent a groundbreaking step in managing chronic bronchitis and improving the quality of life for millions.

CSA Medical remains dedicated to enhancing the lives of those affected by COPD, marking the RejuvenAir System as a crucial part of its mission. As the review progresses, the hope is that this innovation will soon be accessible to patients in need of effective treatment options for chronic bronchitis.