REG - Polarean Imaging PLC - FDA grants New Chemical Entity designation

Polarean ImagingAnnouncement

01/02/2023 16:30

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RNS Number : 6398O  Polarean Imaging PLC  01 February 2023

1 February 2023

Polarean Imaging Plc

("Polarean" or the "Company")

 

 FDA grants New Chemical Entity designation for XENOVIEW

 

Polarean Imaging plc (AIM: POLX), the medical imaging technology company,
announces that the U.S. Food and Drug Administration ("FDA") has granted New
Chemical Entity ("NCE") designation for its drug product, XENOVIEW. XENOVIEW,
prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarised contrast agent
indicated for use with magnetic resonance imaging ("MRI") for evaluation of
lung ventilation in adults and paediatric patients aged 12 years and older.
XENOVIEW has not been evaluated for use with lung perfusion imaging. It has
designated a five year market exclusivity period.

 

XENOVIEW expands the opportunity for pulmonary medicine to utilise the first
and only inhaled MRI hyperpolarised contrast agent for novel visualisation of
lung ventilation without the risk of exposing patients to ionising radiation.
The dose of XENOVIEW, created through the Polarean HPX hyperpolarisation
system, is administered in a single 10-15 second breath-hold MRI procedure.

 

More than 30 million Americans suffer from a chronic lung disease and there is
a significant unmet need for non-invasive diagnostic technology. XENOVIEW can
provide pulmonologists, surgeons, and other respiratory specialists with
regional maps of ventilation in their patients' lungs to assist them in
managing their disease.

 

Richard Hullihen, Chief Executive Officer of Polarean said: "FDA designation
of New Chemical Entity represents an achievement of a major milestone for the
Company's technology. As the first ever hyperpolarised noble gas inhaled oral
contrast agent approved, this designation provides the important first mover
protection envisioned under the Hatch Waxman legislation."

 

Enquiries:

 

  Polarean Imaging plc                                         www.polarean.com (http://www.polarean.com/) / www.polarean-ir.com
                                                               (http://www.polarean-ir.com/)
  Richard Hullihen, Chief Executive Officer                    Via Walbrook PR
  Kenneth West, Chairman

  Stifel Nicolaus Europe Limited (NOMAD and Sole Corporate Broker)                     +44 (0)20 7710 7600
  Nicholas Moore / Samira Essebiyea / Kate Hanshaw (Healthcare Investment
 Banking)
  Nick Adams / Nick Harland (Corporate Broking)

  Walbrook PR         Tel: +44 (0)20 7933 8780 or polarean@walbrookpr.com
  Anna Dunphy / Phillip Marriage           Mob: +44 (0)7876 741 001 / +44 (0) 7867 984 082

 

 

About Polarean (www.polarean.com (http://www.polarean.com) )

 

The Company and its wholly owned subsidiary, Polarean, Inc. (together the
"Group") are revenue-generating, medical imaging technology companies
operating in the high-resolution medical imaging space. Polarean aspires to
revolutionize pulmonary medicine by bringing the power and safety of MRI to
the respiratory healthcare community in need of new solutions to evaluate lung
function, diagnose disease, characterize disease progression, and monitor
response to treatment. By researching, developing, and commercializing novel
imaging solutions with a non-invasive and radiation-free functional imaging
platform, Polarean's vision is to help address the global unmet medical needs
of more than 500 million patients worldwide suffering with chronic respiratory
disease. Polarean is a leader in the field of hyperpolarization science and
has successfully developed the first and only hyperpolarized MRI contrast
agent to be approved in the United States. On December 23, 2022, the FDA
granted approval for Polarean's first drug device combination product,
XENOVIEW(TM) (xenon Xe 129 hyperpolarized). (129)Xe MRI is also currently
being studied for visualization and quantification of gas exchange regionally
in the smallest airways of the lungs, across the alveolar tissue membrane, and
into the pulmonary bloodstream for future clinical indications.

 

XENOVIEW(TM) is a trademark of Polarean, Inc.
 
POL-PR-2201

 

 

 

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