Liberate Medical, LLC is a medical device company, based in Louisville, KY, whose mission is to improve the quality and reduce the cost of care for patients with Chronic Obstructive Pulmonary Disease (COPD).
COPD is a chronic respiratory disease that is the third leading cause of death in the U.S. Despite current treatment options, many COPD patients cannot properly empty their lungs during activities of daily living, for example walking up the stairs. This causes the lungs to hyperinflate, which can lead to dyspnea (shortness of breath) and is the beginning of an unforgiving downward cycle that degrades quality of life, results in hospitalizations and often ends with death. The total direct cost of COPD in the US is estimated to be $34 billion, with hospitalizations accounting for the majority of these costs.
Liberate’s solution, SecondBreath, is a patent-pending device that applies surface electrical stimulation to the abdominal muscles during exhalation to enhance lung emptying and rapidly reduce hyperinflation. Clinical testing showed that SecondBreath clinically, and statistically, significantly reduces static hyperinflation and breathlessness during exercise. The SecondBreath technology is incorporated into a belt that patients can wear underneath their clothes and will be used in combination with current treatment options, e.g. bronchodilators, to provide a solution for the currently unmet medical need of hyperinflation.
SecondBreath will be prescribed to patients by physicians or nurse practitioners and will be sold through a durable medical equipment distributor or a specialized medical equipment retail store. The revenue model is an upfront device cost plus recurring revenue from disposables and the initial target market is the 4 million COPD patients that suffer from activity limitation. Out of the $15 billion total COPD market, which is growing at 4.6% per year, this represents an addressable market in the U.S. of $2.2 billion.
Over the next 24 months, Liberate Medical will prepare SecondBreath for manufacture, complete confirmatory clinical testing and obtain FDA 510(k) regulatory approval. Following regulatory approval, Liberate will complete post-market health economics pilot studies to demonstrate that regular use of SecondBreath can lead to reduced hospitalizations in COPD. Liberate Medical’s business strategy is to be acquired by an existing stimulator manufacturer or a COPD medical device company.