High-flow portable oxygen concentrator for long-term oxygen therapy

Summary/Abstract: Long-term oxygen therapy (LTOT) is an established treatment for 1.5 million Americans with chronic lung diseases such as chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary hypertension. These patients often rely on oxygen (O2) concentrators. Current state-of-the-art stand-alone O2 concentrators work by drawing in ambient air and filtering out most of the nitrogen—thereby producing concentrated oxygen (85-92% purity) for the patient. Portable oxygen concentrators (POCs) are smaller/lighter units that are battery-powered, lower-flow versions that permit LTOT patients to be mobile. Unfortunately, existing commercial POC options result in significant customer dissatisfaction because of inadequate oxygen flow, excess weight, inadequate battery life, and noisy operation. For many POC users, the limited flow rate and low oxygen concentration fail to meet the minimum specifications of their prescription— leaving them dependent upon and tethered to stationary in-home oxygen units or O2 tanks. Equally unfortunate is the fact that the underlying technology for these commercial POCs is maxed out and stagnant— having gone mostly unchanged for decades. To address these serious drawbacks, Pranions, Inc. is developing a next-generation, high-flow-rate, low-weight POC designed to generate 100% pure oxygen from ambient air as the input. The proprietary basis for this advance is an entirely novel hybrid approach to its physics of operation via an electrochemical core. As envisioned, it will offer higher oxygen flow rates, 100% oxygen purity, quieter operation, and longer duration on full battery charge while being light enough for true portability. In preliminary studies completed by the Pranions R&D team, proof of concept of the device has been established via an initial prototype oxygen-concentrator unit. Consequently, Pranions is proposing a Direct-to-Phase II (D2P2) SBIR project to pursue the key next steps in their POC development and to accelerate their effort to address the needs of millions of LTOT patients—including many who are currently underserved. To move this technology rapidly toward commercial deployment, the expert interdisciplinary Pranions R&D team will pursue three specific aims for the D2P2 work: 1) Scale up the proof-of-concept preliminary electrochemical core; 2) Build a fully functional POC prototype and validate performance metrics against a market control device; and 3) Test prototype for safety re: biocompatibility, electrical, and chemical safety per FDA guidance. This SBIR data obtained will position Pranions for engagement with the private sector for follow-on development, early feasibility studies in human subjects, regulatory approvals, and commercial deployment into what is expected to grow into a $6B POC market globally. Pranions anticipates being able to significantly penetrate this market with its next-generation, cost-competitive POC technology, and to thereby enable substantial improvements in the health, mobility, and quality of life for millions of LTOT patients in the U.S. and worldwide.