Race for the emerging medical device market: Breathing Labs LLC in dispute

Pursed Lip Breathing (PLB) is a breathing technique that is helping COPD and asthma patients to breathe easier, and has been later proposed to be used by general public in order to make their breathing more efficient. Today Pursed Lip Breathing is recommended by American Lung Association, American Thoracic Society, The Ohio State University Medical Center, University of Minnesota Medical Center, University of Iowa Children's Hospital, University of Michigan, Vanderbilt University Medical Center, UTMB, The University of Texas, Cleveland Clinic, and others.

Figure 1: Patented PLB device by Breathing Labs named BREATHING+

Breathing Labs, who describe themselves as a company that makes breathing exercises fun, has been selling its Breathing Games gaming headset called PLB device, commercially under the name BREATHING+, since 2012 (see Figure 1 for a photo of their products’ backplate with PLB device engravings).

Recently however, Dr. George M. Zlupko has started advertising PLB device that consists of a plastic tube in which a patient supposedly blows (see Figure 2).

Figure 2: PLB device as marketed by Dr. George M. Zlupko

Breathing Labs claims Dr. George M. Zlupko is making major miscommunication regarding Pursed Lip Breathing consequently misinforming and thus harming general public. The major issue is that Pursed Lip Breathing is essentially performed without external device, external device can be used to provide feedback and monitoring of Pursed Lip Breathing exercises (such as in example of Breathing Labs’ BREATHING+ device). Essentially the device by Dr. George M. Zlupko is not allowing people to perform Pursed Lip Breathing as they have to keep their products in their mouth, unabling them to create positive expiratory end pressure (PEEP) with their pursed lips.

According to Breathing Labs, BREATHING+ has many advantages over the device listed above :

-    The Advantage of Breathing Labs’ solution is in the fact that it is not required to use tubes or pipes to achieve resistance during exhalation as users eventually learn to provide such a resistance by exhaling through pursed lips - helping them achieve more efficient ventilation at any time, with or without external devices. Users eventually learn to implement exhalation through pursed lips into their daily routine and thus change their breathing behavior without raising dependence on technology or drugs.
-    Advantage of BREATHING+ headset is that blowing air into the BREATHING+ mouthpiece does not require a physical contact with user’s mouth or lips, therefore it eliminates possibilities of infection.
-    Additionally Breathing games provide biofeedback functionality resulting in an enhanced motivation which leads to a more efficient learning process that keeps kids entertained and motivated as they practice.
-    Additionally Breathing Games provide a clinical backend with historical charts and statistics that make supervision of user’s exercise implementation possible on a larger scale with an option to intervene early in the process in case of user’s non-compliance.

Pursed Lip Breathing has been first identified as a beneficial breathing technique in early 60s, since then there were 50+ clinical trials performed and over 100+ references in media regarding its benefits. The question is if regulatory agencies will do their work to prevent miscommunication regarding this breathing technique that according to Breathing Labs should remain free for humans to use and learn from.

Correspondence:
CEO at Breathing Labs, Ljubljana, Slovenia: Dr. Matevz Leskovsek, PhD
Email: [email protected]

Source:
https://www.breathinglabs.com/