Beyond Air has entered into an agreement with Getz Healthcare to commercialize its LungFit PH device in certain countries across the Asia-Pacific region, pending regulatory approvals. LungFit® PH was approved by the U.S. Food and Drug Administration (FDA) in June 2022 to treat term and near-term neonates with hypoxic respiratory failure (often referred to as persistent pulmonary hypertension of the newborn or PPHN) (prescription use only).
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 Asia-Pacific 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.
“This partnership with Getz Healthcare expands the reach of Beyond Air’s innovative technology into key growth markets outside of the United States,” stated Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We are excited to work with such a strong partner which is well positioned to maximize the potential for LungFit PH in the Asia-Pacific region.”
James Simkins, CEO of Getz Healthcare, commented, “We are thrilled to announce our partnership with Beyond Air, a pivotal step forward in Getz Healthcare’s unwavering commitment to deliver impactful healthcare solutions to the Asia-Pacific region. Together, we will be pioneering innovative approaches in the delivery and access to nitric oxide therapy.”
With the mission of bringing meaningful healthcare solutions to the people of Asia Pacific, Singapore-Headquartered Getz Healthcare serves 7,500 customers and works with more than 450 business partners worldwide. It has 23 offices and distribution centers spread across Australia, Hong Kong, Malaysia, New Zealand, Pakistan, Philippines, Taiwan, Thailand, and Vietnam.