Safety Information

SAFETY INFORMATION

Is D’OXYVA safe for my patients (humans and pets)?

Circularity Healthcare operates a state-of-the-art supply chain and quality management system (QMS) for manufacturing. Circularity has certificates of registration for IS EN ISO13485:2012 (European Union) and ISO13485:2003 under CMDCAS (Canada), which it has been implementing since 2013.

D’OXYVA is a CE-marked medical device (Class I, low risk) for delivery of medications via the skin. Circularity is seeking approval from the U.S. FDA and other countries for delivery of medical gases such as medical carbon dioxide (USP UN1013) via a novel, patented, non-invasive transdermal route with D’OXYVA to treat various widespread conditions.

Medical carbon dioxide is manufactured and delivered under applicable standards per each country’s regulatory requirements. In the United States, the Food and Drug Administration has cleared the use of medical carbon dioxide through inhalation for humans but not yet through transdermal delivery with D’OXYVA. Transportation of medical carbon dioxide via any postal or courier service requires a certification for handling dangerous goods (HAZMAT) by the U.S. Department of Transportation (DOT).

Possible risks of and adverse reactions to the D’OXYVA device and water vapor with high CO2 concentration (not yet recorded):

  • Hypersensitivity
  • Hypercapnia
  • Transient hypotension FZ©
  • Orthostatic intolerance
  • Facial flushing
Until our research community performs further studies, we do not recommend the use of the D’OXYVA medical device for:
  • Severe hypertension
  • New cardiac infarctions
  • Aortic and mitral valve stenosis
  • Severe congenital heart failure
  • Cor pulmonale
  • Bronchopulmonary diseases accompanied by hypercapnia
  • Acute inflammatory vascular diseases