11 September 2023 | News
The partnership provides access to hospitals in Australia, New Zealand, Thailand, Philippines, Taiwan, Hong Kong, Malaysia, Pakistan, Singapore and Vietnam
US-based Beyond Air has entered into an agreement with Singapore headquartered Getz Healthcare to commercialise the LungFit PH device in certain countries across the Asia-Pacific (APAC) region, pending regulatory approvals.
Under the terms of the agreement, Getz Healthcare will make a milestone payment to Beyond Air following CE mark certification of LungFit PH in the European Union. CE mark certification in Europe provides a pathway to approval in certain countries across the APAC region. In addition, Beyond Air will receive ongoing royalty payments based on net sales of LungFit PH.
The partnership provides access to hospitals in Australia, New Zealand, Thailand, Philippines, Taiwan, Hong Kong, Malaysia, Pakistan, Singapore and Vietnam. Getz Healthcare will manage the logistics, sales, service, and maintenance process in each of these countries where they have extensive experience with medical device distribution and hospital sales.
Also, Getz Healthcare’s regulatory team will handle local product registration in addition to customer service and support. Beyond Air will provide the LungFit PH device and all accessories on a cost-plus basis, as well as providing other support services in areas such as marketing.
Beyond Air’s LungFit PH is a cylinder-free, phasic flow generator and delivery system that has received premarket approval (PMA) from the US Food and Drug Administration (FDA). The device is ventilator compatible and can generate nitric oxide (NO) from ambient air on demand for delivery to the lungs at concentrations ranging from 1 ppm to 80 ppm. LungFit PH could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. LungFit PH is the first and only FDA approved system with patented ioniser technology that generates nitric oxide using room air, enabling the delivery of unlimited, on-demand nitric oxide regardless of dose and flow.