AffloVest has received marketing approvals via CE Mark, Health Canada, and Australian TGA, according to a press release from developer and manufacturer International Biophysics Corp. The approvals will allow International Biophysics to market and sell the vest in the markets of CanadaAustralia and New Zealand, as well as many countries globally who use the CE mark.

AffloVest is the first completely self-contained, battery operated, portable high frequency chest wall oscillation (HFCWO) device that provides critical prescriptive airway clearance therapy for people with cystic fibrosis, bronchiectasis, and other respiratory diseases.

“Gaining these approvals is an exciting achievement for us. We are very happy to now be able to provide this innovative technology to patients in our neighboring Canada, as well as AustraliaNew Zealand and the rest of the world.  We have also completed expanding our internal salesforce to now allow us nationwide sales and product support coverage here in the USA,” said H. David Shockley, Jr., CEO of International Biophysics.

In a new patient clinical paper released last month, 12 patients saw average FVC, FEV1, and FEF25-75% increase 15.22%, 17.41%, and 11.21% respectively, according to International Biophysics.

In a previous 5 patient study in 2015 treatment with the AffloVest contributed to improved lung function scores compared to previous air bladder technology scores. Average FVC, FEV1, and FEF 25-75% increased 9.5%, 11.5%, and 21.3% respectively with the AffloVest.

In addition, International Biophysics is introducing the new AffloVest Pro, a special infection control enhanced hospital version, which is disposable and gives healthcare professionals greater oscillation airway clearance therapy control to target specific parts of the lungs.