Third Pole Therapeutics has completed a study evaluating its portable inhaled nitric oxide delivery system, eNOfit, demonstrating its safety and practicality when treating pulmonary hypertension accompanying interstitial lung disease (PH-ILD).
The early-feasibility study (NCT05867914) has validated the safety and practical use of the device, which will now be investigated in a larger, randomised safety and efficacy studies. The study was performed under an investigational device exemption (IDE) granted by the US Food and Drug Administration (FDA).
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eNOfit is a compact, portable nitric oxide generator and delivery system for the ambulatory treatment of patients with PH-ILD. The condition, characterised by elevated blood pressure stemming from underlying lung disease, presents symptoms such as shortness of breath, fatigue, chest discomfort, and decreased exercise tolerance.
The wearable device produces nitric oxide through a combination of electricity and air. When inhaled, the gas serves as a recommended therapy for various hypertension conditions by dilating blood vessels and reducing pressure. While inhaled nitric oxide has demonstrated effectiveness in clinical settings, Third Pole aims to demonstrate its benefit in patients beyond the hospital environment.
In December 2022, Third Pole secured $32m in Series B financing, adding to the $25m raised through venture financing in January 2022. The completion of this study will trigger the final funding of the US-based company’s Series B investment round, according to Third Pole’s CEO Bill Athenson.
In the announcement accompanying the completion, Athenson said: “The successful completion of our EFS which validated the safe and practical use of our eNOfit system, enables us to confidently move into larger randomised placebo-controlled safety and efficacy studies.”
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By GlobalDataIn July 2023, nitric oxide therapy medical device company NOxBOX issued an urgent Class I recall of its NOxBOXi nitric oxide system, following reports of misalignment of the check valve in the device’s manifold, an error that could cause the manifold to break letting nitric oxide or oxygen leak out.
This failure could interrupt nitric oxide therapy causing a desaturation of blood oxygen levels and increased pressure on the pulmonary artery. No reported deaths or injuries were caused by the issue.
