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Polarean Imaging Ltd.'s technology is for research use only

Company Profile

Polarean is a clinical-stage company with a core technology that is a drug-device combination product that enables the visualisation of hyperpolarised 129Xe ("HPX") using MRI technology to help diagnose lung disease earlier, identify the type of intervention likely to benefit a patient, and to monitor the efficacy of treatment. It is currently being used at a number of research sites on a pre-FDA clearance basis to facilitate the research and evaluation of lung function, to assist in making improved disease progression assessment and to clearly visualise the effectiveness of several therapeutics which are under development.

The key element of the Group's technology is hyperpolarised Xenon, and the Company sells the 129Xe gas, the instrument to polarise the gas and an auxiliary device that provides quality assurance for each dose of 129Xe generated.

Implementing the Group's technology in a clinical setting is straightforward: prior to the MRI scan a patient breathes in a small amount of inert HPX to provide an extremely strong MRI signal. This transforms the MRI from a technology that is not applicable to the lungs into one that is able to provide multiple images of the lung structure and function in one 10-20 second breath-hold. HPX MRI overcomes the limitations of traditional pulmonary function testing as HPX MRI:

  • is more accurate and reproducible than spirometry and other traditional pulmonary function tests, enabling the detection and mapping of small and localised changes in lung ventilation and gas exchange over time;
  • provides regional information about lung disease without exposure to ionising radiation or radioactivity; and
  • assesses ventilation and gas exchange in the smallest airways, where disease often begins.

The Group's technology works in conjunction with traditional MRI, transforming it into a powerful diagnostic modality for the lung. The Group's approach is to take 129Xe, an inert gas, and hyperpolarise the nucleus to create an MRI signal which is approximately 100,000 times stronger than a conventional MRI signal.

Hyperpolarisation of the 129Xe is accomplished by placing a non-radioactive isotope of Xenon (129Xe) into a beam of circularly polarised laser light in the presence of very small concentration of the alkali metal Rubidium, which acts as a physical catalyst in the hyperpolarisation process. The result is 129Xe whose nuclear magnetic spin is highly aligned but not chemically or biologically different than unpolarised 129Xe, an inert gas. This hyperpolarised state persists for around 2 hours allowing ample time to administer the HPX to the patient.
The Group's products include:

  • the 129Xe gas, blended and made under GMP at high purity, to be polarised within the polariser;
  • the polariser itself, of which the latest model, the Polarean 9820 Xenon Hyperpolariser, has been designed to deliver up to 3 litres of HPX per hour (approximately 5-10 doses) of which each dose is to be used within 30 minutes of its production in order to retain sufficient polarisation to create a strong image;
  • the dose delivery inhalation bag, made of HPX-compatible impermeable plastic materials and a mouthpiece for ease of inhalation; and
  • the Polarean 2881 Polarisation Measurement Station, which provides a calibrated measurement of the polarisation of hyperpolarised gas within the dose delivery inhalation bag.

The Group currently designs and builds the polariser equipment and has relationships with GMP gas producers to supply the Group with high purity 129Xe.

In order to take advantage of the Group's current products, an MRI machine is required to be outfitted with hardware and software capable of operating at 129Xe frequency to detect the HPX signal. In addition, the patient will need to wear a 129Xe RF chest coil to allow for detecting the HPX MR signal in the lungs. Approximately 35,000 MRI machines are currently in use worldwide and technically many of these can be easily adapted to be used with 129Xe frequency. The Group's products can be placed near the MRI scanner for ease of radiology workflow and, following the m2m Merger, the Group has continued to explore ways to further integrate the Group's existing technology with the coils which had previously been the focus of m2m.

 

Page last updated: 29 March 2018