Belluscura shares jumped on Thursday morning after the portable oxygen manufacturer said they could now target additional markets after securing ISO 13485 certification.
The certification of their portable oxygen enrichment technology is a recognition of the high-quality standard of Belluscura’s units and allow them to be distributed in the European under the CE mark and the UK using the CA mark.
Receiving the certification enables them to distribute global and effectively double the size of their target market. The US currently accounts for around 45% of global demand.
Belluscura shares were 3.5% higher at 58.5p at the time of writing.
“This is a hugely significant step for the Group, as ISO 13485 certification will enable the company to begin the process to start distributing its products globally. Our existing market in the US represents approximately 45% of the Portable Oxygen Concentrator market, so this certification more than doubles the available market opportunity for the Group,” said Robert Rauker, CEO of Belluscura.
“The certification shows the dedication of our team to not only developing a quality product, but to being a leading manufacturer of portable oxygen concentrators. Compliance with this standard will enable Belluscura’s commercial development by proving to new customers that the Company adheres to the highest standards of quality management excellence.
“It will, therefore, contribute to our growth as we expand production of our X-PLOR® device and the Nomad Biometric™ App, as well as the DISCOV-R™, which we expect to launch in Q1 2023 as the world’s first ambulatory dual flow portable oxygen concentrator.”
