Through our product pipeline we are investing in the future of Myocardial Perfusion Imaging (MPI) by developing RUBY-FILL® a sophisticated technology comprising a82Sr/82Rb generator and an Elution System. The system will provide a solution of Rubidium-82 Chloride (Rubidium Chloride Rb 82 Injection) for intravenous infusion in patients with suspected coronary artery disease. Rb-82, a short-lived positron emitter, is used to assess myocardial perfusion and to quantify regional blood flow in the myocardium.

RUBY-FILL® Rubidium 82 Generator

RUBY-FILL® Rb-82 GENERATOR

The RUBY-FILL® Generator contains an accelerator produced Strontium-82, which decays to Rubidium-82. When the generator is eluted with saline it produces a sterile, non-pyrogenic solution of Rb-82 Chloride.

Due to the short half-life (75 s) of Rb-82, the use of an elution system is required for delivery of the Rb-82 Chloride into a patient for the purposes of performing Myocardial Perfusion Imaging with PET.  PET imaging with Rb-82 Chloride may be performed under rest and/or stress conditions.

Rubidium Elution System

The Rubidium Elution System has been exclusively designed to be used with the RUBY-FILL® generator and to deliver accurate doses of Rb-82 Chloride to patients.

ELUTION SYSTEM

Product Approval Status

Canada

RUBY-FILL® is the only 82Sr/82Rb generator approved for use by Health Canada. In Canada, the approval process requires that the generator and the elution system be approved separately. Physicians need both the elution system and generator to administer the radiotracer in order to perform the imaging procedure. The elution system is not yet approved for use in Canada. Therefore despite the fact that RUBY-FILL® Rubidium 82 Generator is approved for use,  the Rb-82 system (generator and elution system) can  only be used under approved research protocols at this time.

United States

RUBY-FILL®  is approved by the USFDA.

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Rest of World
We are seeking approval of the JDI Rb-82 System in multiple countries.