Ironstone Product Development Receives Investigational Testing Authorization From Health Canada for Its Oxygen Delivery System Designed for COVID-19 Patients

Ironstone Product Development (IPD) announced today that it has received Investigational Testing Approval (ITA) from Health Canada for its oxygen delivery system, Revoxa™. Receipt of the ITA allows the medical device company to initiate a first-in-human clinical trial of the Revoxa™ technology, set to begin in January 2021 in the ICU at Kingston Health Sciences Centre (KHSC). The technology provides more effective oxygen delivery to hypoxic patients, including those with COVID-19, while reducing the amount of oxygen required by more than 75%.
The Revoxa™ technology, developed internally by IPD, delivers oxygen to hypoxic patients requiring respiratory support. The technology safely recycles gas exhaled by the patient, removes carbon dioxide (CO2), and injects oxygen as needed. In addition to reducing the amount of oxygen consumed through its intelligent sensors and algorithms, the Revoxa™ technology greatly minimizes the amount of aerosolization from COVID-19 patients as compared to other high-flow oxygen systems, potentially reducing infection transmission.
“We’re extremely excited to evaluate IPD’s Revoxa™ system at KHSC,” says David Maslove, a Clinician Scientist and Intensivist at KHSC and principal investigator for the clinical study. “This technology has been designed to improve oxygen delivery while also reducing oxygen consumption. This stands to address a pressing problem as ICU facilities and resources become increasingly overburdened. Delivering high concentrations of oxygen more easily and non-invasively may be helpful in improving patient outcomes and making efficient use of hospital resources.”
“It’s an exciting day for IPD,” said Joel Ironstone, CEO of IPD. “The product was developed based on a need articulated by our clinician partners. Our team has worked tirelessly to develop a solution that could both improve outcomes and reduce usage of precious healthcare resources during this and future pandemics.”
This first-in-human study is expected to last two to four months and demonstrate the safety and efficacy of the product as well as measure the reduction in oxygen consumption as compared to standard therapy.
Advisory services and research and development funding was provided by the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP). The clinical evaluation of the device is taking place as part of OBIO’s Early Adopter Health Network (EAHN™).
About Ironstone Product Development:
Ironstone Product Development (IPD) is Canada’s only full-service medical device consultancy, offering regulatory affairs consulting, clinical trial design, and turnkey product development. IPD’s team of engineers, clinicians, and regulatory experts have developed life-saving devices, authored many ISO 13485 compliant quality management systems, and successfully secured FDA, CE Mark (Europe), TGA (Australia), SFDA (China), KFDA (Korea), and TPD (Canada) approval for Class I, II, and III devices in neurology, critical care, imaging, women’s health, and anesthesia. IPD has contributed to more than a dozen ventilators and COVID-19 diagnostic tests in Canada and around the world. For more information, visit www.ironstonepd.com. 
For more information: Joel IronstonePresident, Ironstone Product Developmentjoel@ironstonepd.com
Source: Ironstone Product Development