Respiratory-Pacing Device Found Beneficial in Heart Failure

Outcomes of two studies presented at the Heart Failure Society of America suggest a promising non-invasive device-based treatment approach

Heart failure patients witnessed a significant improvement in disease symptoms and markers of the underlying pathology using an experimental non-invasive treatment device, inTone™, according to two studies presented this week at the 2003 Heart Failure Society of America annual conference in Las Vegas.

“We have long known about the beneficial effects of respiratory-pacing on the cardiovascular system,” Said Dr. Gianfranco Parati, Professor of Medicine and Director of the Second Cardiology Unit, S.Luca Hospital, Istituto Auxologico Italiano, Milan, Italy and an investigator of one of the studies. “Having a device which delivers such a therapy in the comfort of the patients’ home is very promising. With just 15-minutes session twice a day, we have seen in our pilot study that patients’ ejection fraction (EF), pulmonary artery pressure (PAP) and performance at the 6-minutes walk test improved significantly. In addition, we have seen a significant improvement in patients’ quality of life (QOL) as reflected by a formal QOL questionnaire and by patients attesting to their ability to climb stairs, carry groceries and breathe easier throughout the day and night. Personally, I was most impressed by the fact that patients were reluctant to return the devices at the end of the study.”

“Since the FDA clearance of our first therapeutic device, RESPeRATE® to lower blood pressure, we are constantly perusing additional applications for our Low-Frequency Respiratory-Pacing technology” said Erez Gavish, CEO of InterCure, inTone’s & RESPeRATE’s manufacturer. “We are encouraged by the promising outcomes of these first two heart failure studies and are looking forward to study inTone further in a pivotal trial setting in the near future.”

For reprints of the abstracts and posters as well as additional information about inTone or RESPeRATE see www.intercure.com/publications or call Tom Kirwan at (201) 720-7750, ext. 7136.

About InterCure Ltd. & RESPeRATE™

InterCure (www.intercure.com) is a medical device company pioneering the application of respiratory-pacing technology for the treatment of hypertension and heart failure. Following six successful clinical trials, RESPeRATE™ (www.resperate.com), InterCure’s first product, became the only FDA-cleared, non-drug medical device indicated for the adjunctive treatment of hypertension. InterCure heart failure product, InTone™ has successfully completed phase 2a efficacy clinical trials and is expected to be launched after it completes the regulatory approval process.