REG - Polarean Imaging PLC - Company Update

Polarean ImagingAnnouncement

13/02/2023 07:00

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RNS Number : 6982P  Polarean Imaging PLC  13 February 2023

Polarean Imaging Plc

("Polarean" or the "Company")

 

 Company Update

 

Company to focus on commercial sales of XENOVIEW(TM) (xenon Xe 129
hyperpolarised), the first and only FDA approved hyperpolarised MRI contrast
agent, and pursue corporate partnering opportunities to drive shareholder
value

 

Polarean Imaging plc (AIM: POLX), the medical imaging technology company,
announces that following the approval by the U.S. Food and Drug Administration
("FDA")  for its drug device combination product, XENOVIEW, it intends to
pursue a dual strategy of using its current cash resources to maximize
commercial sales of XENOVIEW, whilst also pursuing collaborations with
pharmaceutical companies, magnetic resonance imaging ("MRI") companies,
Contract Research Organizations ("CRO") and other strategic partners to fund
the future commercial applications of the Company's technology.

 

Financial Update

The Company finished 2022 with approximately $16M in cash, which is expected
to fund the company until May 2024.

 

Commercial Strategy

The Company will focus primarily on securing new installations in leading
Centers of Excellence in academic medicine institutions specializing in
Pulmonary and Radiology diagnostics and therapeutics distributed across North
America.  A key part of this strategy is to leverage its existing
enthusiastic user base of Key Opinion Leaders and institutions expanding
exposure and education in the use of Hyperpolarised noble gas imaging in
medicine and research.  The Company anticipates converting 9 research sites
to FDA approved configuration and clinical use, selling 75 to 100 Xenoview Gas
Blend cylinders and 15 to 20 Polarizer systems over the next 24 months.  In
addition, the Company will continue to develop a plan for seeking regulatory
approval of the next indications for the Xenoview technology.

 

Future Financing

Based on the current cash balance, the Company will need additional cash
resources to achieve the 24 month commercial targets and to pursue the
development of the next indications and their approvals, and advanced R&D
for future products.  The Company is exploring a broad range of options to
provide further financing, including, but not limited to, equity raises and
strategic partnering.

 

Corporate Partnering

The Company will focus Business Development activities with respiratory drug
and radiology contrast agent manufacturers, pulmonary drug clinical trial
CROs, and MRI system manufacturers to monetize their use of our technology to
leverage their commercial activities.  In addition, the Company will continue
in its dialog with the FDA to finalize its plans for seeking regulatory
approval for the next indications of its Xenoview technology.

 

Richard Hullihen, Chief Executive Officer of Polarean said: "Having achieved
regulatory approval for our first indication, we now need to demonstrate the
establishment of commercial traction and clinical adoption beyond our existing
global research base according to our consistently stated objectives. We will
do that within our existing resources, and strategic sources of non-dilutive
financing, and return to markets for future financing to expand clinical
indications and geographic territories on an ROI basis if and when
appropriate."

 

Enquiries:

 

  Polarean Imaging plc                                         www.polarean.com / 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)

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.

 

 

About Xenoview

 

Indication

Xenoview, prepared from the xenon Xe 129 Gas Blend, is a hyperpolarised
contrast agent for use with magnetic imaging (MRI) for evaluation of lung
ventilation in adults and paediatric patients aged 12 years and older.

 

Limitations of Use

Xenoview has not been evaluated for use with lung perfusion imaging.

Important Safety Information

 

Contraindications

None.

 

WARNINGS AND PRECAUTIONS

Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen
administered simultaneously with XENOVIEW inhalation can cause degradation of
image quality.  For patients on supplemental oxygen, withhold oxygen
inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen
inhalation immediately following the imaging breath hold.

 

Risk of Transient Hypoxia:  Inhalation of an anoxic gas such as XENOVIEW may
cause transient hypoxemia in susceptible patients.  Monitor all patients for
oxygen saturation and symptoms of hypoxemia and treat as clinically indicated.

 

ADVERSE REACTIONS

Adverse Reactions in Adult Patients:  The adverse reactions (> one
patient) in efficacy trials were oropharyngeal pain, headache, and dizziness.

 

Adverse Reactions in Pediatric Patients:  In published literature in
paediatric patients aged 6 to 18 years, the following transient adverse
reactions were reported:  blood oxygen desaturation, heart rate elevation,
numbness, tingling, dizziness, and euphoria.   In at least one published
study of paediatric patients aged 6 to 18 years, transient decrease in SpO2%
and transient increase in heart rate were reported following hyperpolarised
xenon Xe 129 administration.  XENOVIEW is not approved for use in paediatric
patients less than 12 years of age.

 

See full U.S. Prescribing Information at www.xenoview.net

 

XENOVIEW has received marketing approval in the United States and not in other
countries.

 

XENOVIEW(TM) is a trademark of Polarean, Inc.
 

 

 

 
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