Inhaled nitric oxide (iNO) relaxes blood vessels in the lungs and is an important and life-saving treatment for pulmonary hypertension. Current iNO delivery solutions are estimated to cost $2,800 per day and rely on compressed gas delivery which limits accessibility and applicability of this technology worldwide.
Dr. Warren Zapol and team, led by his son David Zapol, have launched the company Third Pole with technology licensed from Massachusetts General Hospital (MGH) with the goal of developing next generation life-saving therapies capable of serving new cardio-pulmonary markets. Their initial product leverages an iridium spark electrode, calcium hydroxide scavenger, and filter to deliver continuous inhaled nitric oxide (NO) generated from readily available ambient air. The technology could be integrated with standard ventilators, inhalers, or implantable devices, enabling the use of iNO for pulmonary hypertension and other diseases in ways never before seen.
Medgadget had the privilege of interviewing Dr. Zapol, Chairman of the Third Pole Scientific Advisory Board, Director of the Anesthesia Center for Critical Care Research at MGH, and Reginald Jenney Professor of Anesthesia at Harvard Medical School.
William Kethman, MD, Medgadget: What inspired you to develop a portable on-demand iNO source?
Dr. Warren Zapol, Third Pole: I was flying from Boston to Los Angeles to visit a colleague, Lou Ignarro, who won the Nobel Prize for the discovery of NO’s biological role, when I read about NOX in smog and read about how NASA flies chase planes through lightning and can measure nitric oxide. This formed the core of the idea. It’s made all around us by electrical discharge in air. In follow-up lab work and testing over several years, it became clear that this unique technology to safely generate NO for inhalation using iridum-electrodes to make clean discharge could also be portable, and bring NO to the rest of the world.
Medgadget: Where you do see this technology being most transformative? Do you think it will unlock therapy for other diseases or patients populations? If so, which?
Dr. Zapol: Nitric oxide has been used for 1M patients in 27 years. This is the tip of the iceberg. Third Pole’s technology could be accessible to facilities that could not accommodate tank-based NO and facilities that already offer tank based iNO could have more convenient access. The technology has the potential to be transformative in so many ways.
In developed countries, a more convenient and portable technology could bring Third Pole’s product to more settings outside of level III units in apex institutions and regional perinatal centers. I’d like to see iNO in community hospitals. If our technology were to make it one day possible for newborns born in a community hospital to start iNO therapy without delay or transfer, it could potentially prevent escalation to ECMO. Data has demonstrated that ECMO-eligible infants whose iNO treatment started at >24 hours of age were more likely to respond to iNO. Moreover, having your baby being transferred potentially hours away from your home can induce increased levels of distress in parents of a NICU baby. There are also 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. Touch is critical for growth, development, communication, and healing.
I always tell people I speak with- “Don’t forget the babies in Uganda.” Our technology can extend iNO therapy to a greater degree in emerging markets that lack the with infrastructure to transport, maintain, return and refill tanks of a gaseous pharmaceutical and reliably move around costly fleets of compressed gas cylinders.
Beyond that, there is a lot of exciting research into the potential uses of nitric oxide, and Third Pole’s convenient technology could make them more feasible. We will see iNO extend into the ambulatory market, used by people with COPD or other heart and lung diseases at home. Our work points to the need for new PDE inhibitors or pathway modulators to be developed as cardiopulmonary therapies.
Medgadget: What regulatory pathway does Third Pole anticipate for clearance of the technology?
Dr. Zapol: We will seek device approval as an iridium-electrode NO generator. Because our iridium-based, filtered and scavenged system makes clean NO, we expect physicians to use our device with the same indications for which tank-based iNO is approved: hypoxic respiratory failure in neonates in the US and additional acute cardiopulmonary conditions in Europe. We will later conduct trials of our technology and seek approval for ambulatory use.
Medgadget: What are some of the challenges you are anticipating as you commercialize the technology?
Dr. Zapol: As stated above, there are many hospitals both in developed and emerging countries that have never used iNO. For many people the cell phone is the only phone they know. For many hospitals electrically generated iNO will be their introduction to iNO.
Link: Third Pole…