International Biophysics Corporation, AffloVest's developer, manufacturer and seller, has received CE mark, Health Canada, and Australian TGA approval for the AffloVest.
This will allow International Biophysics to market and sell the vest in the markets of Canada, Australia and New Zealand as well as many countries globally who use the CE mark.
AffloVest is the first completely self-contained, battery operated, portable HFCWO High Frequency Chest Wall Oscillation device that provides critical prescriptive airway clearance therapy for people with Cystic Fibrosis, Bronchiectasis and other respiratory diseases.
H. David Shockley, Jr., International Biophysics’ CEO, "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 Australia, New 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."
Shockley adds, "We’ve recently moved manufacturing of the AffloVest back on-shore to International Biophysics’ facility in Austin, Texas.
"This innovative product is now "Made in the USA". This internal on-shore manufacturing will add permanent manufacturing and engineering jobs here, and increase our ability to remain competitive globally while meeting the growing customer demand for the AffloVest both here and internationally."
International Biophysics’s new "Made in the USA" product features several innovations from its previous design including a better overall tailored fit, a "more fashionable" denim color, an electronic digital programmable controller with compliance monitoring, longer battery life, and more sizes.
International Biophysics is also 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.
In a new patient clinical paper released last month, 12 patients saw average FVC, FEV1, and FEF 25-75% increase 15.22%, 17.41%, and 11.21% respectively. 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. Shockley, "The AffloVest technology is affecting lives for the better. The proof is in the data."