Sick babies require simple solutions. For nearly two decades, inhaled Nitric Oxide (NO) has been a life-saving intervention for hundreds of thousands of patients in Europe and the US, especially hospitalized infants with acute pulmonary hypertension. However, there have been no major innovations away from the first-generation tank-based delivery paradigm established in the early 1990s. This lack of innovation has limited access to NO to developed markets with infrastructure to transport, maintain, return and refill tanks of compressed gas. Third Pole has launched by developing a simple, convenient, economical, and lightweight device capable of generating nitric oxide from air on-demand, on-site potentially providing an alternative to storing and moving NO in large compressed gas cylinders.
In the decades since the US Food and Drug Administration (FDA) approved inhaled NO for the treatment of hypoxic respiratory failure (HRF) in term or near-term infants, the medical field has sought to refine the system by which NO is stored and delivered in tanks. While the industry has incrementally improved on the system over the years, the use of tanks themselves has limited access. Third Pole sought an entirely alternative approach that kept what was necessary—nitric oxide for inhalation—and removed what was not necessary—tanks.
We are building a robust pipeline of innovations in heart and lung medicine. Our novel approach of creating NO on demand has the promise to create new markets by enabling the worldwide use of inhaled NO in settings outside of acute care. A more convenient and portable technology could bring Third Pole’s product to more settings, including community hospitals and other facilities outside of level III units in apex institutions and regional perinatal centers. On-demand iNO could potentially make it available in more hospitals, and a number of developmental benefits can be disrupted if the parents are unable to be consistently present with the patient due to distance of a tertiary facility.
JLABS has provided invaluable assistance in bringing our idea to market, including the residence at M2D2 which has provided technical equipment, and access to a community of some of the best medical and engineering minds in the world around Lowell. In addition to this, they have provided access to mentorship and coaching from Johnson & Johnson Innovation experts. These resources come at a critical moment, as we are currently developing clinic-ready inhaled NO therapy delivery systems and are embarking on the process of review by regulatory agencies to be able to provide the solution to patients.
Meet the Team:
David Zapol, Founder & CEO & Warren Zapol, Scientific Advisory Board Chairman
Left to right: Philip E. Silkoff, CMO; Warren Zapol, Scientific Advisory Board Chairman; Wolfgang Scholz, Head of Product Marketing; Greg Hall, VP Product Development