International Biophysics Corp., the company that developed, manufactures, and commercialize the AffloVest, recently received CE mark (CE stands for Conformité Européne, which literally means European Conformity), as well as Health Canada and Australian Therapeutic Goods Administration approval for AffloVest.
The decision will allow the company to market and sell the vest in Canada, Australia, and New Zealand, as well as in all the countries that use the CE mark.
“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,” said International Biophysics CEO H. David Shockley Jr. in a press release. “We have also completed expanding our internal sales force to now allow us nationwide sales and product support coverage here in the USA.”
AffloVest is the first self-contained, battery-operated, portable high frequency chest wall oscillation (HFCWO) device that provides critical airway clearance therapy for people suffering from respiratory conditions such as bronchiectasis or cystic fibrosis.
The CE Mark, along with the Canada and Australia approvals, came after a new study revealed that 12 cystic fibrosis patients using the AffloVest experienced an improvement in lung function in terms of average forced vital capacity (FVC) by 15.22 percent, normal forced expiratory volume at 1 second (FEV1) by 17.41 percent, and forced expiratory flow (FEF) 25 to 75 percent increase of 11.21 percent.
In a 2015 study, five cystic fibrosis patients receiving AffloVest treatment were reported to have improved lung function scores compared to patients using air bladder technology. FVC, FEV1, and FEF 25 to 75 percent increased on average 9.5 percent, 11.5 percent, and 21.3 percent, respectively, with the use of the AffloVest.
“The AffloVest technology is affecting lives for the better. The proof is in the data,” Shockley said.
International Biophysics is also introducing the new AffloVest Pro – a special infection control enhanced hospital version that is disposable and allows healthcare professionals to better control oscillation airway clearance therapy, targeting specific parts of the lungs.
The company also decided to make AffloVest a “Made in the USA” product with several new features, including a better overall fit, a fashion-forward denim color, an electronic digital programmable controller with compliance monitoring, as well as longer battery life and more available sizes.
“We’ve recently moved manufacturing of the AffloVest back on-shore to International Biophysics’ facility in Austin, Texas,” Shockley said. “This innovative product is now ‘Made in the USA.’ This internal 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.”