New Study Shows Monaghan Medical's Drug-Free Aerobika Device Reduces Acute Drug Usage and Costs Following COPD Exacerbations

Real-world study presented at CHEST 2016 Annual Meeting in Los Angeles. End Quote

(1888PressRelease) October 29, 2016 - Syracuse, NY, USA - Monaghan Medical Corporation (MMC) today announced that a new study presented to the American College of Chest Physicians (CHEST) shows MMC's Aerobika® (http://www.trudellmed.com/products/aerobika) device is effective in reducing drug use for treatment of Chronic Obstructive Pulmonary Disease (COPD).

COPD is a major source of morbidity and mortality in the United States.(i) The Center for Disease Control estimates that COPD medical visits, hospital admissions and lost time costs 36 billion dollars annually.(ii) The recommended course of treatment for acute COPD exacerbations includes antibiotics and oral corticosteroids (OCS).(iii)

The study results revealed today at the CHEST Annual Meeting in Los Angeles, show that those study patients who used the Aerobika® device experienced a significant reduction (57% and 89% reduction, respectively) in the use of antibiotics and OCS in the hospital setting compared to those study patients who did not use the Aerobika® device in addition to the regular COPD medication treatment. These findings are part of a larger 6-month retrospective study that demonstrated a 28% reduction in exacerbations in as little as 30 days of treatment, when used as an add-on to usual COPD medications.

COPD exacerbations can be caused by viral or bacterial infections, in fact pulmonary infections are associated with 50% of COPD hospital admissions(iv) and higher mortality rates.(v) Overproduction of mucous leads to increased rates of infection and inflammation contributing significantly to morbidity and mortality in COPD.(vi)

This study showed for patients in the Aerobika® device cohort, antibiotics were used 57% less and oral corticosteroids were used 89% less than for the cohort without the Aerobika® device within 6 months' post-exacerbation. The decreased need for short-term drug therapies including antibiotics and OCS, may have reflected better disease control with those patients who used the non-drug device. Additionally, patients in the Aerobika® device cohort exhibited significantly lower costs throughout the study period with an average reduction of $6,347 USD and $9,936 USD per patient at 30 days and 6 months respectively for all in-patient and out-patient hospital costs.

"One of our major goals in developing the Aerobika® device was to safely improve patient outcomes," said Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development at Monaghan Medical. "These real-world findings are encouraging as we continue to conduct additional studies to further demonstrate the impact of our device in this high risk patient population."

The projected cost of COPD in the U.S. by 2020 has been calculated at $49 billion.(vii) Since COPD exacerbations account for the greatest proportion of burden on healthcare systems,(viii) and readmissions are unwanted and expensive, the simplest way to reduce hospital admissions for COPD is to reduce exacerbations.(ix)

About the Aerobika® device study: A 6-month retrospective cohort study of the US hospital Charge Detail Master (CDM) claims database, conducted between September 2013 and August 2015. This real-word study involved 810 COPD patients with a diagnosis of chronic bronchitis, 405 receiving treatment with the Aerobika® device and 405 propensity score matched controls. The primary outcome was the proportion of patients with moderate-to-severe and severe exacerbations at 30 days. Secondary measures included resource utilization and costs associated with exacerbations.

About The Aerobika® Device
The Aerobika® device is hand-held, easy-to-use, and drug-free. When the patient exhales through the device, intermittent resistance creates positive pressure and oscillations simultaneously, which expands the airways, helps expel the mucus to the upper airways where it can be coughed out and may also aid in improved drug deposition. The Aerobika® device is available in Canada, Mexico, and select European countries including the UK and Germany through Trudell Medical International and in the US via Monaghan Medical Corporation. (http://www.trudellmed.com/products/aerobika)

About Monaghan Medical Corporation (MMC, USA)
MMC offers leading aerosol drug delivery devices and respiratory management products including AeroEclipse® II BAN, AeroChamber Plus® aVHC and the Aerobika® device exclusively in the United States. MMC's strength lies in product development around core capabilities in mechanical design complimented by collaboration with a state-of-the-art aerosol research laboratory. MMC focuses on developing cost-efficient, outcome-based solutions for its customers. (http://www.monaghanmed.com)

For clinical inquiries, please contact:
Dominic P. Coppolo, MBA, RRT, FAARC
Vice President of Clinical Strategy and Development
Monaghan Medical Corporation
1-800-343-9071

COPD Facts in USA(x)
- More than 15 million people report being diagnosed with COPD but millions more may not have been diagnosed
- COPD accounts for 10.3 million medical visits and 1.5 million hospital admissions
- 23 percent of hospitalized patients are re-hospitalized within 30 days
- For COPD exacerbations, Medicare healthcare expenditures for re-hospitalization are the third highest
- The total cost of COPD hospitalizations is estimated at $36 billion per year

i Ford ES, et al. Chest 2013;144(1):284-305.
ii Ford ES, et al. Chest. 2015 Jan;147(1):31-45.
iii Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2015.
iv Tesfaigzi Y et al. Clinical and Applied Immunology Reviews 2006;6(1):21-36
v Burgel PR, Martin C. European Respiratory Review 2010;19(116):94-96.
vi Hogg JC et al. The Nature of Small-Airway Obstruction in Chronic Obstructive Pulmonary Disease The New England Journal of Medicine 2004;350(26):2645-2653
vii Ford ES, et al. Chest. 2015 Jan;147(1):31-45.
viii Khakban A, et al. Am J Respir Crit Care Med. 2016
ix Mittmann et al. Respir Med. (http://www.ncbi.nlm.nih.gov/pubmed/18086519) 2008 Mar;102(3):413-21.
x Ford ES, et al, Chest. 2015 Jan;147(1):31-45.

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