Heme Photonics LLC is a medical device start-up company established on 18 April 2018. The company aims to develop a novel method for the treatment of carbon monoxide (CO) poisoning and enable its introduction into medical practice. This ground-breaking approach represents the first major clinical development for this life-threatening problem since 1950, when hyperbaric oxygen (HBO) was first demonstrated to accelerate the elimination of CO in humans.
A practical approach capable of saving lives was postulated that is applicable in the setting of an emergency room. This innovative therapeutic intervention requires a minimally invasive procedure that is often performed in emergency rooms by either emergency medicine physicians or anesthesiologists.
The initial strategy for the company is centered on securing both Phase I and Phase II SBIR grant funding from the NIH. The end-objective of the Phase I program is to construct a fully operational reaction chamber.
Upon successful construction and testing of the reaction chamber, the company plans to proceed directly to the Phase II program. The goal of the Phase II program is to conduct and complete the animal experiments necessary in meeting all critical regulatory requirements satisfactory to the FDA.
Considering the lack of conclusive clinical evidence demonstrating efficacy of HBO therapy, the trend over the last several years has been that some HBO centers are no longer accepting patients suffering from CO poisoning for treatment. Another compounding issue includes the clinical challenge of transferring critically ill and medically unstable patients from an emergency room to an HBO center, where the vast majority of patients receive HBO on an outpatient basis for other than acute conditions.
Once this life-saving medical device can be manufactured in sufficient numbers, the most likely scenario is that its initial deployment will be to all Level I Trauma Centers to be then followed by all Level II Trauma Centers. Following acceptable clinical validation, it is expected that this novel method of treatment will become the new standard of care over HBO for patients severely poisoned with CO.
