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First U.S. Patients Treated in PneumRx Inc. RENEW Pivotal Study for Treatment of Severe Emphysema


2/25/2013 11:16:11 AM

MOUNTAIN VIEW, Calif., Feb. 25, 2013 /PRNewswire/ -- PneumRx, Inc., a leader in interventional pulmonology, announced the first U.S. patients treated with PneumRx's Lung Volume Reduction Coils (LVRCs) for severe emphysema. Dr. Charlie Strange, of the Medical University of South Carolina, and Dr. Frank Sciurba, of the University of Pittsburgh and UPMC, treated the first US patients in the FDA-approved RENEW Study. The RePneu® LVRC, a minimally invasive medical implant designed to treat the symptoms of severe emphysema, is intended to improve lung function, exercise ability and quality of life for this underserved patient population.

(Logo: http://photos.prnewswire.com/prnh/20120514/SF06703LOGO)

Dr. Sciurba stated that "There is no cure for severe emphysema, and patients have very few options available to relieve their symptoms. I believe the LVRC is a potentially life-changing treatment option for many patients with severe emphysema." Dr. Strange, the Principal Investigator for the RENEW Study, added"Having attended LVRC procedures in Europe and seen the benefits of this innovative treatment for emphysema patients, I am thrilled to be able to offer our patients the option of participating in the RENEW Study."

Although the LVRC is undergoing clinical evaluation in the United States, it has been used in Europe since 2008. The technology is routinely available to treat patients in Germany, and was the only emphysema treatment method selected in 2012 by the French Ministry of Health to undergo a multi-center cost-effectiveness study in France. Unlike Lung Volume Reduction Surgery or other minimally invasive devices designed to treat emphysema, the RePneu LVRC is intended to treat a broad range of emphysema patients, including those with heterogeneous and homogeneous disease, in both upper and lower lobes, and it performs independently of collateral ventilation, a common condition in emphysema patients.

The RENEW Study began enrolling patients in the European sites, which are experienced in the technique, late last year. Up to 315 patients in over 25 medical centers across North America, plus centers in the Netherlands, UK and Germany, will participate in the RENEW Study. "Bringing relief to the millions of emphysema sufferers was a significant motivation in founding PneumRx, so it is particularly meaningful to me that we have begun treating people with this debilitating disease here at home. We look forward to submitting the pivotal trial results in support of a PMA application and eventually offering the benefits of LVRC treatment to patients throughout the U.S." stated Erin McGurk, President and CEO of PneumRx.

Qualifying patients must have been clinically diagnosed with severe emphysema and be experiencing increasing difficulty with simple daily tasks. Patients must have stopped smoking for at least eight weeks and must have completed a pulmonary rehabilitation program prior to enrollment.

Although the RePneu LVRC is investigational in the United States and not yet approved for commercial use by the FDA, the device has a CE Mark and has been used in Europe for the treatment of severe emphysema since 2008.

For more information about the RePneu LVRC and the RENEW study, visit www.pneumrx.com or http://www.clinicaltrials.gov/ct2/show/NCT01608490?term=RENEW&rank=1

About Advanced Emphysema

Over three million[1] Americans suffer from advanced emphysema, a chronic, debilitating disease most commonly brought on by years of smoking. Emphysema causes irreversible damage to delicate lung tissue, leading to shortness of breath and even feelings of suffocation that result in reduced quality of life. Emphysema is medically characterized by reduced lung function, increased lung volume and loss of the lung's natural elastic properties, which makes breathing very difficult.

Emphysema is medically characterized by reduced lung function and increased lung volume, which makes breathing very difficult. As the disease progresses and the lung's natural elastic properties are destroyed, excess air is trapped in the lungs, making it difficult for the person to exhale. This process is known as hyperinflation and is responsible for the feeling of being "short of breath." The RePneu LVRC works by compressing the hyperinflated lung tissue to reduce volume, while helping to restore the lung's natural elastic recoil. The LVRC also helps hold open the lung's airways, preventing airway collapse that causes air trapping and hyperinflation. Implanting the LVRC involves a minimally invasive, non-surgical procedure, and most patients are able to return home the following day.

As the disease progresses and lung tissue is destroyed, excess air is trapped in the lungs making it difficult for the person to exhale. This process is known as hyperinflation and responsible for the feeling of being "short of breath." Patients with severe emphysema experience shortness of breath nearly all the time, even when resting, and suffer from continuous fatigue, chronic coughing, wheezing and frequent respiratory infections. Patients are also at higher risk for lung infection, inflammation and other respiratory conditions, as well as serious other systemic conditions such as diabetes[2] and heart disease.[3]

As there is no cure for emphysema, the goal of current treatment methods such as drug therapy (inhaled steroids, bronchodilators and antibiotics), supplemental oxygen, and pulmonary rehabilitation (breathing exercises) is to relieve symptoms and teach people how to live with the disease. Eventually, the disease will exhaust these treatment methods, leaving the patient with very few options for symptom relief.[4]

About PneumRx Inc.

PneumRx, Inc. is a Mountain View, CA based medical device start-up focused on developing minimally-invasive solutions for unmet medical needs in pulmonary medicine. The flagship product, the RePneu® Lung Volume Reduction Coil, is designed to reduce lung volume and restore elastic recoil to improve lung function, exercise capacity, and quality of life for patients with emphysema. Made from shape-memory Nitinol, the RePneu Coil is designed to compress hyperinflated tissue and tether small airways to prevent airway collapse without blocking or inducing fibrosis, a key advantage over other endoscopic techniques. The RePneu LVRC is limited to investigational use in the U.S.A. Read more at www.pneumrx.com.

[1] National Emphysema Foundation, via http://www.emphysemafoundation.org/about-us.html

[2] Emma H Baker MD and Derek Bell MD. Blood glucose: of emerging importance in COPD exacerbations. Thorax 2009;64:830-832.

[3] Kaiser Permanente Medical Care Program. COPD and Incident Cardiovascular Disease Hospitalizations and Mortality. Chest 2005: 128: 2068-075

[4] Centers for Disease Control and Prevention. Chronic Obstructive Pulmonary Disease Surveillance United States, 1971-2000. Morbidity and Mortality Weekly Report. August 2, 2002; 51(SS06):1-16.

SOURCE PneumRx, Inc.



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