At CSA Medical, we are advancing our core technology to find options for treating diseases that may benefit from a rejuvenative healing solution.
Chronic Bronchitis is one such disease. By spraying liquid nitrogen in a circumferential pattern within the airway, we believe we can destroy the mucus producing goblet cells and reduce inflammation within the bronchi. With the destruction of these unwanted cells in a non-scarring way, the body can begin the rapid process of regrowth of new healthy cells in its place.
This product is currently under clinical investigations and is not commercially available.
Chronic Bronchitis disease
Chronic Bronchitis is a subset of Chronic Obstructive Pulmonary Disease (COPD).
Bronchitis is inflammation of the bronchial airways. A chronic bronchitis diagnosis is defined by cough with productive sputum of three months duration for two consecutive years. In addition to a chronic inflammation, cough and increased production of mucus, chronic bronchitis may or may not present with obstruction/partially blocked airways due to swelling and excess mucus in the bronchi, or shortness of breath (dyspnea).
Prevalence (US, Europe, Canada)
In the United States of America, there are an estimated 12.7 – 14.7 million Americans with COPD1, and in 2011 approximately 10 million Americans sought medical attention for chronic bronchitis2. In Europe, there are approximately 23 million people with COPD3, and approximately 14.3 million people with COPD in Germany, France, Belgium, Austria, Netherlands, Spain, Italy, UK and Ireland4.
The population of chronic bronchitis patients is relatively steady, growing at approximately 1% per year5. There is no cure for chronic bronchitis.
The standard of care for chronic bronchitis patients is pharmaceuticals, many of which are designed to address dyspnea associated with inflammation – LABA (long acting beta agonists) and ICS (Inhaled corticosteroids); and/or cough. Physicians may prescribe bronchodilators to patients as a way to provide relief during sudden breathing problems, such as acute bronchospasm.
Patients often seek emergent medical attention when they are experiencing exacerbations, either through a physician office visit or in the emergency department (ED). Patients with moderate exacerbations are often treated with an oral corticosteroid (OCS) medication to reduce swelling in the airways. Patients with severe exacerbations are often hospitalized for supportive oxygen therapy until their exacerbation is reduced.
RejuvenAir® technology and development status
The RejuvenAir® System is designed to deliver Metered Cryosprays™ to distinct locations throughout a patient’s lung. The system consists of a catheter and console with pressure and temperature controls that enable the delivery of liquid nitrogen to meet a predetermined amount of cooling energy for each metered cryospray delivered.
The user interface provides guidance to the physician as to the treatable airways for this procedure and controls the metered cryospray that will be delivered based on the location the physician is treating.
The RejuvenAir® System is currently under clinical investigations and is not commercially available.
LOBECTOMY-EU Clinical Study (NCT02106143)
|Design||This is a prospective, open label, single arm, multi-center clinical trial|
|Study Phase||Feasibility (First in Man)|
|Study Goals||Demonstrate the feasibility and safety of delivery of a specific cryospray therapy dose using the RejuvenAir® System. To understand the histologic outcome of the treatment area in the airway in humans.|
|Patient Population||Patients scheduled within 60 days for a planned lobectomy or pneumonectomy.|
|Countries Participating||The Netherlands and Ireland. Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT02106143?term=NCT02106143&rank=1|
|Results||Results of the study will be presented at the American Thoracic Society (ATS) conference in San Francisco on Wednesday, May 18, 2016.|
Lobectomy Histology-CAN Clinical Study (NCT02483052)
|Design||This is a prospective, open label, single-center, clinical trial|
|Study Phase||Feasibility (First in Man)|
|Study Goals||To demonstrate the safety of the RejuvenAir® System and to determine the delayed histological effects of the RejuvenAir® System treatment in the human airway.|
|Patient Population||Subjects scheduled for lobectomy within 2- 90 days from date of study treatment.|
|Countries Participating||Canada. Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT02483052?term=NCT02483052&rank=1|
|Results||Results of the study will be presented at the World Congress of Bronchology and Interventional Pulmonology (WCBIP) World Conference in Florence, Italy on Wednesday, May 11, 2016.|
Feasibility-EU Clinical Study (NCT02483637)
|Design||This is a prospective, open label, multi-center, single arm clinical trial|
|Study Goals||To evaluate the safety of the RejuvenAir® Cryospray Therapy to treat symptomatic chronic bronchitis patients with airflow restrictions and to evaluate the feasibility of planned liquid nitrogen cryospray treatment.|
|Patient Population||Subjects age 40-75 with known diagnosis of chronic bronchitis who despite being on optimal medication have daily symptoms of cough and sputum.|
|Countries Participating||United Kingdom and The Netherlands. Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT02483637?term=NCT02483637&rank=1|
|Results||Preliminary results will be presented at the European Respiratory Society (ERS) meeting in London, England on Tuesday September 5, 2016.|
1American Lung Association, Trends in COPD: Morbidity and Mortality, Table 3.
2American Lung Association, Trends in COPD: Morbidity and Mortality, Table 3.
3Health at a Glance: Europe (2012 and 2014 reports) http://www.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-europe-2012_9789264183896-en
4European COPD Coalition http://www.copdcoalition.eu/about-copd/prevalence
5American Lung Association, Trends in COPD: Morbidity and Mortality, Table 3.