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Complete Response Letter received from FDA

News

Complete Response Letter received from FDA

6 October 2021 - Requirement to address approvability issues identified by FDA ahead of NDA resubmission
Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces that the Company has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) for the New Drug Application (“NDA”) for their drug-device combination product.

The FDA has determined it is unable to approve the NDA in its present form and has provided a list of issues to be addressed by the Company. These issues are mostly technical or manufacturing-related in nature and centre around the Xenon hyperpolariser system. Polarean will work to address the issues identified by the FDA with a view to resubmitting the NDA and securing FDA approval as quickly as possible. Following resubmission of the NDA, it is expected that the FDA review period will take 2-6 months.

Whilst the Company believes that the issues to address in the CRL are attainable, Polarean is disappointed by this unexpected response. The Company will seek additional discussions with the FDA as a matter of urgency and further update the market when material information is received. In the meantime, the Company will continue to collaborate with their current and future research investigators in continued exploration of potential clinical applications of this technology, as they have done to date.

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Article on hyperpolarised xenon

26 May 2021 - Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product for magnetic resonance imaging (MRI), notes the news release on 25 May by the Oxford Biomedical Research Centre concerning a study carried out in longer-term lung damage after COVID-19.

The study was published online in the Journal Radiology (https://pubs.rsna.org/doi/10.1148/radiol.2021210033). This preliminary research determined that hyperpolarised xenon MRI scans had found abnormalities in the lungs of some COVID-19 patients more than three months – and in some cases, nine months – after leaving hospital, when other clinical measurements were normal. Polarean had supplied Oxford University Hospitals Trust with an earlier research model that was used for the study and are working towards providing a new state-of-the-art polariser for further research.

Principal Investigator Prof Fergus Gleeson, Professor of Radiology at the University of Oxford and Consultant Radiologist at Oxford University Hospitals NHS Foundation Trust, said: “Many COVID-19 patients are still experiencing breathlessness several months after being discharged from hospital, despite their CT scans indicating that their lungs are functioning normally. Our follow-up scans using hyperpolarised xenon MRI have found that abnormalities not normally visible on regular scans are indeed present, and these abnormalities are preventing oxygen getting into the bloodstream as it should in all parts of the lungs.”

The full news release can be viewed here


Conference attendances

14 May 2021 - Scientific presentations on hyperpolarised Xenon-129 at upcoming medical conferences
Polarean's investigational drug/device combination product to be prominently featured in presentations across a wide range of lung diseases

Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with an investigational drug-device combination product to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces a number of abstracts and oral presentations highlighting the use of hyperpolarised Xenon-129 ("129Xe") will be made by leading academic researchers at the upcoming American Thoracic Society ("ATS 2021") virtual conference from 14-19 May 2021 and the International Society for Magnetic Resonance in Medicine ("ISMRM 2021") virtual conference from 15-20 May 2021.

23 abstracts related to the use of hyperpolarised 129Xe were accepted for presentation at ATS 2021, consisting of 8 oral presentations and 15 e-poster presentations. Polarean is also supporting ATS 2021 by hosting a virtual exhibit booth.

Additionally, 34 abstracts related to the use of hyperpolarised 129Xe were accepted for presentation at ISMRM 2021, consisting of 7 oral presentations and 27 e-poster presentations. Hyperpolarised 129Xe will also be discussed in a symposium on 17 May and in a sunrise session on 18 May. Furthermore, Polarean is supporting ISMRM 2021 by hosting a virtual exhibit booth. 

Richard Hullihen, Chief Executive Officer of Polarean commented: "We are pleased at the important work being done by leading investigators in the field of functional lung imaging. The data being presented at these key scientific meetings will further add to the body of evidence on hyperpolarised 129Xenon, highlighting several areas of unmet needs in current diagnostic modalities. Research of 129Xe MRI in interstitial lung disease, long-COVID-19, asthma, COPD and interventional pulmonology procedures are among the presentations that will be showcased."

A subset of the abstracts that will be presented during the ATS 2021 and ISMRM conferences are listed below.

 

Lead Author and ATS Abstract Title

Presentation Date

Abstract Number

ATS Notes

Mummy D et al.
Regional Changes in Ventilation Following Bronchodilation in COPD Are Not Associated with Improved Gas Exchange on Xenon-129 MRI

16-May

1052

ORAL PRESENTATION
Session A12: Sunday, May 16, 2021 (3:30-5pm)

Mcintosh M et al.
Response to Benralizumab in Severe Asthma: Oscillometry and MRI Ventilation Defect Improvements in Participants with Abnormal FeNO

18-May

1111

ORAL PRESENTATION
Session C4: Tuesday, May 18, 2021 (8-9:30am)

Eddy RL et al.
Structure-Function Imaging Phenotypes of Asthma Using CT and 129Xe MRI

18-May

1112

ORAL PRESENTATION
Session C4: Tuesday, May 18, 2021 (8-9:30am)

HE M et al.
Probing Early-Stage Pulmonary Pathophysiology in Young Healthy E-cigarettes Users Using Hyperpolarized 129Xe MRI

18-May

1113

ORAL PRESENTATION
Session C4: Tuesday, May 18, 2021 (8-9:30am)

Bdaiwi, AS et al.
In Vivo Lung Morphometry of Lymphangioleiomyomatosis Using Hyperpolarized 129Xe Diffusion MRI

18-May

1114

ORAL PRESENTATION
Session C4: Tuesday, May 18, 2021 (8-9:30am)

Bier E et al.
Hyperpolarized 129Xe Magnetic Resonance Oscillation Imaging in Pulmonary Hypertension

18-May

1115

ORAL PRESENTATION
Session C4: Tuesday, May 18, 2021 (8-9:30am)

Mummy D et al.
Hyperpolarized 129Xe MRI Features Identify Functional Differences That Do Not Correlate with Chest CT in Patients with Idiopathic Pulmonary Fibrosis

18-May

1116

ORAL PRESENTATION
Session C4: Tuesday, May 18, 2021 (8-9:30am)

Plummer JW et al.
129Xe gas-exchange MRI to detect diffusion abnormalities in children following bone-marrow transplantation

18-May

1166

ORAL PRESENTATION
Session C15: Tuesday, May 18, 2021 (3:30-5pm)

Ruppert K et al.
First Experience with Hyperpolarized 129Xe Imaging in a Recovered COVID-19 Patient

May 14-19

1998

E-poster
Session TP031

 

Ranota TK et al.
The Use of Hyper-polarized 129Xe Pulmonary MRI for Study of the Lung Damage in COVID-19 Survivors, Preliminary Results

May 14-19

3835

E-poster
Session TP92

Matheson AM et al.
This Is What COVID-19 Survival Looks Like: 129Xe MRI, Oscillometry and Pulmonary Function Measurements

May 14-19

4453

E-poster
Session TP117

Kooner HK et al.
CT Mucus Score Predicts Benralizumab Response in Severe Asthma

May 14-19

4531

E-poster
Session TP120

Woodward E et al.
Four Years Observation of the Emphysema Progression in Alpha-1 Antitrypsin Deficiency Using 3He/129Xe MRI

May 14-19

4574

E-poster
Session TP121

Hamedani H et al.
Monitoring Patients with Endobronchial Valve Interventions Using a Multifaceted Hyperpolarized (HP) Xenon Lung Function Assessment

May 14-19

4578

E-poster
Session TP121

Bier E et al.
Within-session Repeatability of Pulmonary 129Xe Static and Dynamic Spectroscopy

May 14-19

4589

E-poster
Session TP122

Amzajerdian F et al.
Exploring the Use of Continuous RF Irradiation for Xenon Polarization Transfer Contrast Imaging

May 14-19

4590

E-poster
Session TP122


Lead Author and ISMRM Abstract Title

Presentation Date

Abstract Number

ISMRM Notes

Leewiwatwong S et al.
Deep learning-based thoracic cavity segmentation for hyperpolarized 129Xe MRI

18-May

391

ORAL PRESENTATION
(Session: Machine Learning for Image Analysis)

Mummy D et al.
Regional Changes in Ventilation Following Bronchodilation in COPD Are Not Associated With Improved Gas Exchange on Xenon-129 MRI

19-May

589

ORAL PRESENTATION
(Session: Lung)

Hahn A et al.
Response of Hyperpolarized 129Xe MRI measures of ventilation and gas-exchange to anti-fibrotic treatment in Idiopathic Pulmonary Fibrosis

19-May

591

ORAL PRESENTATION
(Session: Lung)

Hamedani H et al.
Monitoring Patients with Endobronchial Valve Interventions Using a Multifaceted Hyperpolarized Xenon Lung Function Assessment

19-May

592

ORAL PRESENTATION
(Session: Lung)

Marshall H et al.
Hyperpolarised xenon ventilation MRI in difficult asthma; initial experience in a clinical setting

20-May

680

ORAL PRESENTATION
(Session: Latest Advances in Hyperpolarized MRI)

Bier E et al.
Extension of a Diagnostic Model for Pulmonary Hypertension with Hyperpolarized 129Xe Magnetic Resonance Imaging and Spectroscopy

20-May

681

ORAL PRESENTATION
(Session: Latest Advances in Hyperpolarized MRI)

Albert B J et al.
Preclinical Hyperpolarized 129Xe Ventilation Imaging Using 3D Spiral (FLORET) Encoding

20-May

684

ORAL PRESENTATION
(Session: Latest Advances in Hyperpolarized MRI)

Rao M.
Imaging Beyond Perfusion Using 129Xe MRI

17-May

 

MEMBER-INITIATED SYMPOSIUM
(Imaging Beyond Perfusion Using 129Xe MRI)

Woodward E et al.
The Use of the 3He/129Xe MRI Lung Morphometry for a Longitudinal Observation of the Emphysema Progression in AATD Patients

17-May

1269

E-poster
(Session: Novel Contrast Mechanisms)

Grist J et al.
Utilizing hyperpolarised xenon MRI to detect gas transport deficiencies in post-COVID lungs

17-May

1736

E-poster
(Session: MRI in COVID-19)

Ranota T et al.
Feasibility of Single Breath-hold Isotropic Voxel 129Xe MRI in COVID-19 Survivors using a Key-Hole Method

17-May

1739

E-poster
(Session: Role of Advanced Imaging in COVID-19)

Collier G et al.
Imaging lung structure and function in acute COVID-19 patients with 129Xe and 1H MRI

17-May

1746

E-poster
(Session: Role of Advanced Imaging in COVID-19)

Wild J.
Hyperpolarized 129Xe MRI of the Lung

18-May

 

SUNRISE SESSION
(Lung MRI: You Can Do It!)

Lu T et al.
Convolutional Neural Networks for Super-resolution of Hyperpolarized 129Xe MR Images of the Lung

18-May

1968

E-poster
(Session: Machine Learning to Reconstruct Accelerated Scans)

Gandhi D B et al.
Comparison of Respiratory-Gating Weighting Algorithms in Neonatal Pulmonary UTE-MRI

18-May

2273

E-poster
(Session: Pediatrics: Body Topics)

Chan H-F et al.
Comparison of UTE 1H lung MRI with quantitative CT and hyperpolarized 129Xe diffusion-weighted MRI in IPF

19-May

3214

E-poster
(Session: Lung: Disease Assessment)

Eaden J et al.
Correlation of global and regional hyperpolarised 129-Xenon MRI with quantitative CT in patients with idiopathic pulmonary fibrosis

19-May

3216

E-poster
(Session: Lung Disease Assessment)

Bdaiwi A S et al.
Optimizing Acquisition and Analysis for Diffusion Weighted Hyperpolarized 129Xe MRI of Pediatric and Adult Lungs

20-May

3558

E-poster
(Session: Hyperpolarization: Gas)

Astley J et al.
Comparison of 3D convolutional neural networks and loss functions for ventilated lung segmentation using multi-nuclear hyperpolarized gas MRI

20-May

3560

E-poster
(Session: Hyperpolarization: Gas)

Schulte R et al.
Imaging Gas-Exchange Lung Function using Density-Weighted MRSI and Hyperpolarised 129Xe Gas

20-May

3562

E-poster
(Session: Hyperpolarization: Gas)

Pratt R et al.
A 129Xe/1H Switched Frequency High Pass Birdcage Coil for Hyperpolarized 129Xe Gas Lung Imaging in Neonates at 1.5 T

20-May

3563

E-poster
(Session: Hyperpolarization: Gas)

Norquay G et al.
Temporal correlation of alveolar-capillary 129Xe signal dynamics with the cardiac cycle

20-May

3564

E-poster
(Session: Hyperpolarization: Gas)

Amzajerdian F et al.
Feasibility of Xenon Polarization Transfer Contrast Imaging using Continuous RF Irradiation

20-May

3565

E-poster
(Session: Hyperpolarization: Gas)

Hamedani H et al.
Reproducibility Study Measuring Ventilation, Gas Exchange and Surface-to-Volume Using Hyperpolarized Xenon in Free-breathing Human Subjects

20-May

3566

E-poster
(Session: Hyperpolarization: Gas)

Rao M et al.
3D isotropic spectroscopic imaging of hyperpolarized 129Xe in the human brain

20-May

3567

E-poster
(Session: Hyperpolarization: Gas)

Chan H-F et al.
Background field inhomogeneity effects on hyperpolarized 129Xe diffusion-weighted MRI at 1.5T and 3T

20-May

3568

E-poster
(Session: Hyperpolarization: Gas)

Ruppert K et al.
Detection of pulmonary abnormalities in a rabbit thoracic insufficiency syndrome model using hyperpolarized xenon-129 MRI

20-May

3569

E-poster
(Session: Hyperpolarization: Gas)

Ball G et al.
Modelling realistic Rb density and temperature distributions in a high throughput xenon-129 polariser

20-May

3570

E-poster
(Session: Hyperpolarization: Gas)

Lu J et al.
Template-based bias field correction of Hyperpolarized 129Xe Gas Ventilation MRI

20-May

3571

E-poster
(Session: Hyperpolarization: Gas)

Bdaiwi A S et al.
2D and 3D Spiral for Diffusion Weighted MRI with Hyperpolarized 129Xe

20-May

3575

E-poster
(Session: Hyperpolarization: Gas)

Driehuys B et al.
Establishing the Structurally Limited Healthy RBC to Barrier Ratio for 129Xe Gas Exchange MRI

20-May

3791

E-poster
(Session: Hyperpolarization: Gas & Non-Gas)

Bier E et al.
Within-session Repeatability of Pulmonary 129Xe Static and Dynamic Spectroscopy

20-May

3792

E-poster
(Session: Hyperpolarization: Gas & Non-Gas)

Doganay O et al.
Assessment of Gas Exchange Parameters in Healthy and COPD Subjects using Hyperpolarized Xenon-129 MRI and Alveolar Gas-exchange Model

20-May

3793

E-poster
(Session: Hyperpolarization: Gas & Non-Gas)

Loza L et al.
A Comparison of Multi-breath Wash-in/Wash-out and RF-Contrast Hyperpolarized 129Xe Imaging Schemes for Quantifying Fractional Ventilation

20-May

3794

E-poster
(Session: Hyperpolarization: Gas & Non-Gas)

Costa M L et al.
Optimized Magnetization Decay Correction of Hyperpolarized Xe Ventilation Images Using Radial-Keyhole

20-May

3795

E-poster
(Session: Hyperpolarization: Gas & Non-Gas)

Qian Y et al.
Simulating the impact of asymmetric geometries on apparent alveolar septal wall thickness measurements with hyperpolarized xenon-129 MRI

20-May

3796

E-poster
(Session: Hyperpolarization: Gas & Non-Gas)

 




New System Order

10 May 2021 - Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with a proprietary drug-device combination product for the magnetic resonance imaging (MRI) market, announces

that it has received an additional research unit order for a 9820 Xenon Polariser system from the University of British Columbia (“UBC”). This is the second system installation at UBC, following the original order in November 2019 which was initially installed at BC Children’s Hospital (“BC Children’s”) while construction was carried out on its intended original site at St. Paul’s.

As with the original system, this new unit will continue to support UBC’s pulmonary disease research programme using hyperpolarised gas imaging. BC Children’s is a major paediatric research and teaching hospital, and is the most well-known facility in the province for dealing in juvenile health.

Richard Hullihen, CEO of Polarean, said: "We value our long-standing relationship with UBC, a globally recognised research group, and we are excited that they are adding an additional Polariser system to expand their research into the clinical applications of this emerging and much needed technology. We are also pleased to be able to continue to expand our paediatric research cluster, which also includes Cincinnati Children’s Hospital Medical Center and Toronto SickKids Hospital.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.


Scientific presentations on hyperpolarized 129Xenon at upcoming medical meetings

30 July 2020 - Polarean’s investigational drug/device lung diagnostic to be prominently featured.
Multiple hyperpolarized Xenon MRI presentations to be highlighted at two major upcoming scientific conferences

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with a proprietary drug‑device combination diagnostic for the magnetic resonance imaging (MRI) market, announces a number of presentations highlighting the use of hyperpolarized Xenon 129 (“129Xe”) will be made by leading academic researchers at the upcoming American Thoracic Society (“ATS”) virtual conference and the International Society for Magnetic Resonance in Medicine (“ISMRM”) virtual conference. The ATS and ISMRM conferences are taking place between 5-10 August 2020 and 8-14 August 2020, respectively.

Click here to learn more


Meet Polarean at the ATS 2020 Virtual Conference August 5-10

  • Polarean will have a virtual exhibit
  • 9 abstracts related to the use of hyperpolarized xenon will be presened at the conference on Wednesday, August 5:

ATS 2020 Abstract Title and Authors Program Number Session Name
Coleman EM et al. Hyperpolarized 129Xe Identifies Ventilation Responders to Glycopyrrolate/Formoterol Fumarate in Chronic Obstructive Lung Diseasey 523 D28
Bier EA et al. Monitoring Response to Inhaled Prostacyclin Therapy with 129Xenon MR Imaging and Spectroscopy in Patients with Pulmonary Hypertension 593 B56
Neidbalski PJ et al. Hyperpolarized 129Xe MRI of Regional Capillary-Level Cardio-Pulmonary Dynamics Predict Outcomes in IPF Patients 622 A68
Bier EA et al. Noninvasive Diagnosis of Pulmonary Hypertension with Hyperpolarized 129Xe Magnetic Resonance Imaging and Spectroscopy 633 B58
Mummy D et al. Hyperpolarized Xe-129 MRI Measures of Gas Exchange in Non-specific Interstitial Pneumonia 705 D110
Wang Z et al. Spatial Correlation of 129Xenon Gas Exchange MRI with 99mmTc Perfusion Scintigraphy 706 D110
Wang Z et al. Using 129Xenon MR Gas Exchange MRI to Measure the Membrane and Capillary Components of DLCO and KCO 707 D110
Mummy D et al. Hyperpolarized 129Xe MRI is sensitive to therapy response in idiopathic pulmonary fibrosis 713 D110
Shim YM et al. Positive Results from Two Randomized Phase III Trials Assessing Hyperpolarized 129Xenon Gas MRI as a Measure of Regional Lung Function as Compared to Imaging with 133Xenon Scintigraphy 1027 B39

Meet Polarean at the ISMRM & SMRT Virtual Conference 2020 August 8-14

  • Polarean will have a virtual exhibit
  • 6 abstracts related to the use of hyperpolarized xenon will be presented at the conference:

ISMRM 2020 Abstract Title and Authors Program Number Session Name Date
PBier EA et al. Noninvasive Diagnosis of Pulmonary Hypertension with Hyperpolarized 129Xe Magnetic Resonance Imaging and Spectroscopy 2283 Hyperpolarized Gas/Lung MRI August 8-14
Mummy D et al. Hyperpolarized 129Xe MRI Measures of Gas Exchange in Non-specific Interstitial Pneumonia 2291 Thoracic & Breast MRI August 8-14
Niedbalski PJ et al. Imaging Regional Capillary Cardio-Pulmonary Blood Flow Dynamics using Hyperpolarized 129Xe MRI and Keyhole Reconstruction 0432 Thoracic MRI August 11
Rankine L et al. Quantitative dose-dependent changes in regional lung function after radiation therapy detected using xenon-129 gas exchange MRI 0431 Thoracic MRI August 11
Lu J et al. Bias field correction in hyperpolarized 129Xe ventilation imaging 0451 Pulmonary Power August 11
Wang Z et al. A model for interpreting hyperpolarized 129Xe exchange MRI 0443 Pulmonary Power August 11

Polarean Imaging plc Announces Positive Results From Pivotal Phase III Clinical Trials

Durham, N.C. - January 29, 2020 - Both trials met their primary endpoint, showing pre-defined equivalence of hyperpolarized 129Xenon Gas MRI to an approved comparator, 133Xenon Scintigraphy Company plans for NDA submission to FDA in Q3 2020. Polarean's technology could offer clinicians a powerful tool to visualize lung function, overcoming limitations of existing methods of diagnosis and monitoring treatment

Polarean Imaging plc (AIM: POLX), a clinical stage medical imaging technology company developing a proprietary magnetic resonance imaging (MRI) drug-device combination, today announced positive top-line results from two pivotal Phase III clinical trials of the Company's drug-device combination, which uses hyperpolarized 129Xenon gas MRI to visualize and quantify regional lung function.
The drug, 129Xenon, when polarized in Polarean's proprietary system, permits functional, regional and quantitative imaging of the lungs using MRI, without the use of ionizing radiation. 129Xenon is administered as an inhaled gas that is given to patients in a 10-second breath-hold procedure. For patients who participated in the clinical trials, the ventilation in zones of interest was quantified and compared to images, similarly quantified, derived from a different imaging modality.

Click here to learn more


Polarean Imaging Delivers Xenon Polariser To University Of Missouri

'LONDON (Alliance News) - Medical technology company Polarean Imaging PLC on Wednesday said the latest model of its Xenon polariser has been delivered to the radiology department at University of Missouri Health Care.'

The polariser will be used in the radiology department's pulmonary imaging research programme.

"We are excited to deliver the newest version of our polariser to University of Missouri Health Care. We are grateful to Dr. Altes, University of Missouri Health Care, and all the skilled researchers there, for the opportunity to work together and continue our research into the clinical applications of this emerging and much needed technology," said Chief Executive Richard Hullihen.


Polarean Imaging Delivers Xenon Polariser To University of Virginia

'LONDON (Alliance News) - Polarean Imaging PLC said Wednesday the latest model of its Xenon polariser has been delivered to the Department of Radiology & Medical Imaging at the University of Virginia Health System.'

Polarean Imaging will "within a few weeks" begin its Phase III clinical trials with University of Virginia Health System staff.

The recently listed medical technology firm said the University of Virginia Health System has been a "key clinical collaborator".

The Department of Radiology & Medical Imaging now has three Xenon-129 Polarean polarisers, with the newest one being used exclusively for the upcoming clinical trial. Polarean Chief Executive Officer Richard Hullihen said: "We are excited to deliver this newest system, which represents the latest chapter in a relationship dating back to the origins of Polarean. We are grateful to Dr. Mata, University of Virginia Health System, and all the skilled researchers there, for the opportunity to work together, and could not hope to have a more proficient and experienced institution and program with whom to conduct our trials, and to continue our research into the clinical applications of this emerging and much needed technology."


Polarean Technology Used in Severe Asthma Study

'Polarean Imaging plc (AIM: POLX), the medical-imaging technology company, with a proprietary drug-device combination product for the magnetic resonance imaging (MRI) market, notes the publication of a study using Polarean's hyperpolarised gas MRI technology in a study of patients with severe asthma in the April edition of the American Journal of Respiratory and Critical Care Medicine (AJRCCM).'

The study, entitled "Sputum Eosinophilia and Magnetic Resonance Imaging Ventilation Heterogeneity in Severe Asthma" is authored by Svenningsen, Eddy, Lim, Cox, Nair and Parraga and can be obtained from the AJRCCM website.

The study looked at patients with severe asthma and investigated the contributions of both inflammatory and non-inflammatory components of airway disease. A key finding was that MRI scans using hyperpolarized gas were able to identify, for the first time, the airway inflammatory (eosinophilia) and non-inflammatory contributions (smooth muscle dysfunction) to ventilation heterogeneity in patients with severe asthma.

The findings of the study suggest that in patients with severe asthma, inhaled hyperpolarized gas MRI may help discriminate between the different components of severe asthma, enabling more precise and personalised treatment decisions.

Click here to read more


Imaging technique could shed new light on Alzheimer's disease

'No one has looked at these images before. We don't know what we're going to see. So it's very, very exciting'

A new brain imaging technique being examined by a researcher in Thunder Bay, Ont. could help in the search for a treatment for Alzheimer's disease.

Mitch Albert, a researcher at Lakehead University, and the Thunder Bay Regional Research Institute, is receiving over $700,000 from the Weston Brain Institute to fund his three year study of the use of hyperpolarized xenon gas to get a clearer picture of the brain when using an MRI machine.

When patients inhale the gas, and it makes its way to the brain through the bloodstream, the quality of the images is ten times better than those taken using a regular MRI scan, said Albert.

"It's a new window on the brain," he said.

In order to get the hyperpolarized xenon gas to the brain, patients must inhale the gas as they lie in the MRI machine.

The xenon gas (which acts like a general anesthetic at higher concentrations), is harmless, he said, and is exhaled by the patients in a matter of minutes.


Click here to read more


A revolution in lung function diagnostics

'Since lung diseases tend to be complex, imaging is a crucial diagnostic tool. While computed tomography has become the standard modality, which is frequently used outside hospital settings, specialised MRI diagnostics remains the preserve of large university medical centres.'

Until recently, lung MRI was considered a difficult procedure. Now, new methods enable lung function measuring, particularly gas exchange, in the MR scanner. With his team, Professor Frank Wacker, Director of the Institute of Diagnostic and Interventional Radiology at the Medical School Hanover, focuses on this research.
Report: Marcel Rasch

Usually, a general practitioner diagnoses pulmonary hypertension, rather than a hospital-based specialist. The patient is referred to a pneumologist who charts the further course of action, which might include a surgical intervention or balloon pulmonary angioplasty (BAP). Imaging is a pillar of the diagnostic work-up, but CT has turned out to be inadequate to detect so-called web stenosis in the pulmonary vessels. This is where MRI comes in, which today offers local lung function assessment supplementing CT.

A milestone in pulmonary research
‘We are still charting unknown territory,’ Wacker concedes, ‘but the research results are promising.’ He and his team, headed by Professor Jens Vogel-Claussen at the Institute of Diagnostic and Interventional Radiology, are exploring potential uses of MRI in lung function diagnostics. ‘MRI diagnostics now offers a method to not only assess tissue change and morphology but also the function of different lung sections and to quantify blood flow,’ Wacker explains. ‘Beyond knowing how much blood is passing through which lung section we need to assess ventilation and gas exchange.’

The fact that gas exchange can be measured in MRI is nothing short of a revolution in lung function diagnostics. ‘We use hyperpolarised xenon to visualise the gas exchange,’ he explains. In a first step the xenon has to be processed in a polariser for the MRI scanner to achieve high SNR. The Hanover Medical School works closely with the Fraunhofer Institute ITEM in Hanover to show the path of the gas and the speed of diffusion from the alvioli into the blood circulation.

‘Basically we use two gases: fluorine shows the distribution of tidal air. However, this gas does not penetrate the alveoli – which can be an advantage as well as a drawback,’ Wacker points out.


Click here to read more


Polarean Imaging plc. Delivers New High-throughput Hyperpolarizer with 40+% Xenon Polarization - September, 2015

Polarean Imaging plc., a pioneer in hyperpolarized gas technology, announced today that it has delivered and installed its first Model 9820 129Xe Hyperpolarizer at the University of Wisconsin - Madison. The 9820 model consistently produces xenon gas at 35-45% polarization with typical production rates of 1-3 liters per hour.

"In the last three years, Polarean Imaging plc. has improved the xenon polarization levels of its polarizers by a factor of four, commented Dr. Bastiaan Driehuys, Polarean Imaging plc.'s founder and Chief Scientific Officer. "Polarean Imaging plc.'s recently introduced 9820 model includes a 200 Watt narrowed linewidth laser coupled with a larger, redesigned optical cell. In combination, these two components dramatically improve the xenon polarization level and throughput. And, a newly designed higher capacity cryogenic collection system minimizes the polarization loss through the freeze-thaw cycle".

The new 9820 xenon polarizer continues Polarean Imaging plc.'s tradition of modular design, which enables ease of maintenance and upgradability. The company has a number of additional polarization improving upgrades under development, scheduled for introduction in the next 12-18 months.

Polarean Imaging plc.'s technology produces hyperpolarized inert xenon gas, used in conjunction with standard MRI to create high-resolution 3-dimensional functional maps of the human lung. This technique provides a unique and sensitive way to monitor extremely small changes in lung structure and function, and is used in basic and clinical research to study lung physiology and to monitor the efficacy of new drugs.

Higher levels of 129Xe polarization, such as those made possible by the 9820, provide researchers with additional flexibility. They can reduce the amount of xenon to be inhaled, without compromising image quality, and this is especially important in pediatric studies. These advancements let researchers achieve even higher image quality or accelerate their clinical research workflow.

Polarean Imaging plc.'s research equipment is currently in use at leading academic research centers in North America and Europe.

ABOUT POLAREAN®
Polarean Imaging plc.® began operations in 2012, after securing all assets and intellectual property for hyperpolarized gas MRI from GE Healthcare. Located in the Research Triangle Park area of North Carolina, Polarean Imaging plc.® designs and manufactures equipment for production of hyperpolarized xenon or helium gases. When used in conjunction with MRI, these gases offer a fundamentally new and non-invasive functional imaging platform. Current investigational uses include early diagnosis of respiratory diseases as well as monitoring progression and therapeutic response. In addition, xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs as well. Polarean Imaging plc.® hyperpolarization systems are currently sold in the United States and internationally for research and investigational applications only.

Polarean Imaging plc.® Technology
The central equipment required for hyperpolarized gas MRI is a polarizer. Using circularly polarized laser light, the polarizer transforms the inert, stable noble gas isotopes 3He and 129Xe into their hyperpolarized states. This process leaves the gases chemically unchanged, while their nuclei are magnetically aligned. The resulting MRI signal is enhanced by a factor of ◊100,000, making direct imaging of gas molecules possible.

Nearly $550,000 in grants awarded to local businesses - December 03, 2014

RALEIGH — Gov. Pat McCrory and Commerce Secretary Sharon Decker announced Wednesday the 13 recipients of innovation grants through the One North Carolina Small Business Fund.

All but two of these businesses are in Chapel Hill, Durham, Hillsborough or Morrisville.

Federal funders for these grants include the National Institutes of Health, the U.S. Army, the Defense Advanced Research Projects Agency, the National Aeronautics & Space Administration and the Center for Disease Control and Prevention.

The state matches up to half the federal money, with a $50,000 maximum per grant. The budget for this program is $2.5 million for 2015, according to a release from McCrory’s office.

Durham-based BioMarck Pharmaceuticals received $40,466 for its treatment to prevent and reverse Acute Lung Injury and Acute Respiratory Distress Syndromes (ARDS).

Keona Health of Chapel Hill received $50,000 for a call management system for diagnosing issues involving the elderly or persons with dementia.

Dignify Therapeutics LLC of Durham received $50,000 to develop the first drug for bladder control of patients with spinal cord injuries, multiple sclerosis and similar diseases that hamper bladder function.

EpiCypher, Inc. of Durham received $50,000 for developing a new protein process technology for cell research, enabling new detection methodologies for diverse human diseases such as cancer and immunodeficiency disorders.

Indexus Biomedical LLC of Morrisville received $50,000 for a new diagnosis and monitoring test for HIV, available at primary health providers’ offices and enabling earlier HIV detection and treatment.

Polarean Imaging plc. of Durham received $50,000 for a new compact Magnetic Resonance Imaging system providing local medical diagnosis in drug trials.

Triangle BioSystems Inc. of Durham received $49,982 to create wireless and implantable neural microsystems, capable of recording and stimulating the central nervous system, muscle tissues, and others systems.

Asklepios BioPharmaceutical, Inc. of Chapel Hill received $50,000 for conducting preclinical and clinical development of gene transfer therapies to prevent cognitive decline in patients with Alzheimer’s Disease.

HealthSpan Diagnostics, LLC of Chapel Hill received $50,000 to create a new blood test that evaluates kidneys for transplant suitability.

Mycosynthetix Inc. of Hillsborough received $50,000 for development of new fungal therapies to address infections from soil transmitted parasitic worms such as hookworm.

Cell Microsystems of Chapel Hill received $50,000 to explore the feasibility of new technologies for the isolation of single cells for broad applications in health, forensics, and basic research.

Polarean Imaging plc. Unveils New Hyperpolarizer Features, Enables Users to Double Polarization Levels

Polarean Imaging plc., a pioneer in hyperpolarized gas technology, announced today that it has developed new technology to dramatically improve polarization rates. Polarean Imaging plc.'s new technology is now being offered as an upgrade kit to current owners of 9800 series Polarean Xenon Hyperpolarizers, enabling them to consistently reach polarization levels of 20-25%. Additional polarization improvements are underway, to be included in the new 9820 Series of Polarean Hyperpolarizers, available in mid-2015.

Polarean Imaging plc.'s hyperpolarization technology addresses a significant need in pulmonary research and drug development. The technology produces hyperpolarized inert xenon gas, used in conjunction with standard MRI imaging to create high resolution 3-dimensional images of the human lung. This technique is a unique way to monitor extremely small changes in lung structure and lung function, and is used in basic and clinical research to study lung physiology and to monitor the efficacy of new drugs.

Higher levels of polarization provide researchers with additional flexibility. They can reduce the amount of Xenon to be inhaled, without compromising image quality, and this is especially important in pediatric studies. Or, researchers can use the same amount of Xenon and achieve higher image quality.

”We have made significant improvements in our hyperpolarization technology, especially in the downstream recovery of polarized Xenon,” commented Dr. Bastiaan Driehuys, Polarean Imaging plc.'s founder and Chief Scientific Officer. Dr. Driehuys added, ”In addition, Polarean Imaging plc. is developing a new generation of polarizers that not only include these downstream improvements, but also new optical cell designs and a more powerful laser. Together, these improvements will take our polarization and production levels even higher.” Polarean Imaging plc. expects to launch this new line of hyperpolarizers in mid-2015.

Polarean Imaging plc.'s research equipment is currently in use at leading academic research centers in North America and Europe.



ABOUT POLAREAN®
Polarean Imaging plc.® began operations in 2012, after securing all assets and intellectual property for hyperpolarized gas MRI from GE Healthcare. Located in the Research Triangle Park area of North Carolina, Polarean Imaging plc.® designs and manufactures equipment for production of hyperpolarized xenon or helium gases. When used in conjunction with MRI, these gases offer a fundamentally new and non-invasive functional imaging platform. Current investigational uses include early diagnosis of respiratory diseases as well as monitoring progression and therapeutic response. In addition, xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs as well. Polarean® hyperpolarization systems are currently sold in the United States and internationally for research and investigational applications only.

Polarean Imaging plc.® Technology
The central equipment required for hyperpolarized gas MRI is a polarizer. Using circularly polarized laser light, the polarizer transforms the inert, stable noble gas isotopes 3He and 129Xe into their hyperpolarized states. This process leaves the gases chemically unchanged, while their nuclei are magnetically aligned. The resulting MRI signal is enhanced by a factor of ◊100,000, making direct imaging of gas molecules possible.

Additional Pediatric Research Sites Now Using Polarean Imaging plc.'s Hyperpolarized Xenon Imaging Technology - September, 2014

Durham, NC - September, 2014 -Polarean Imaging plc., a pioneer in hyperpolarized gas technology, announced today that The Hospital for Sick Children (SickKids) in Toronto, Ontario and The Cincinnati Children's Hospital Medical Center have both recently acquired Polarean Xenon hyperpolarization systems to conduct clinical research in pediatric lung disease.

Polarean Imaging plc.'s technology addresses a significant need in pulmonary research and drug development. The technology produces hyperpolarized inert xenon gas, used in conjunction with standard MRI imaging to create high resolution 3-dimensional images of the human lung. This technique is a unique way to monitor extremely small changes in lung structure and lung function, and is used in basic and clinical research to study lung physiology and to monitor the efficacy of new drugs.

“Hyperpolarized gas MRI enables us to accurately image the major airways down to the very smallest alveoli”, commented Dr. Giles Santyr, Senior Scientist in Physiology & Experimental Medicine at SickKids. “This equipment will allow us to better study a range of childhood pulmonary conditions without ionizing radiation”, added Dr. Jason Woods, Director of the Center for Pulmonary Imaging Research at Cincinnati Children's Hospital Medical Center. Because Polarean Imaging plc.'s technology does not rely on X-rays, CT scans or radioactive contrast agents, subjects can be scanned repeatedly to monitor small changes in lung function over time without the risk of radiation exposure.

“We are delighted to have these two new sites in the worldwide community of Polarean Imaging plc. customers,” commented Dr. Bastiaan Driehuys, Polarean Imaging plc.'s founder and Chief Scientific Officer. “Each of these institutions is conducting important research in pediatric pulmonary disease and Polarean Imaging plc.'s equipment helps in that effort”.

In addition to these sites in Toronto and Cincinnati, Polarean Imaging plc.'s research equipment is in use at leading academic research centers in North America and Europe.



ABOUT POLAREAN®
Polarean Imaging plc.® began operations in 2012, after securing all assets and intellectual property for hyperpolarized gas MRI from GE Healthcare. Located in the Research Triangle Park area of North Carolina, Polarean Imaging plc.® designs and manufactures equipment for production of hyperpolarized xenon or helium gases. When used in conjunction with MRI, these gases offer a fundamentally new and non-invasive functional imaging platform. Current investigational uses include early diagnosis of respiratory diseases as well as monitoring progression and therapeutic response. In addition, xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs as well. Polarean Imaging plc.® hyperpolarization systems are currently sold in the United States and internationally for research and investigational applications only.

Polarean Imaging plc.® Technology
The central equipment required for hyperpolarized gas MRI is a polarizer. Using circularly polarized laser light, the polarizer transforms the inert, stable noble gas isotopes 3He and 129Xe into their hyperpolarized states. This process leaves the gases chemically unchanged, while their nuclei are magnetically aligned. The resulting MRI signal is enhanced by a factor of ◊100,000, making direct imaging of gas molecules possible.

New MRI Approach Reveals Bronchiectasis’ Key Features Within the Lung - November, 2014

In an abstract presented during American Thoracic Society 2014 International Conference, entitled “Pulmonary Functional Imaging Of Bronchiectasis: A First Look At Ventilation Abnormalities And Their Relationship With Pulmonary Function And Symptoms,” S. Svenningsen and colleagues from the Robarts Research Institute at The University of Western Ontario in Canada presented their clinical evaluation in subjects with a clinical diagnosis of bronchiectasis using 3He MRI ventilation distribution for the first time.

According to the American Lung Foundation, Bronchiectasis is an abnormal stretching and enlarging of the lungs’ airways caused by mucus blockage. The blockage and accompanying infection causes inflammation, leading to the weakening and widening of the passages. The disease can develop at any age, usually beginning during childhood, but symptoms may not appear until much later. It can be congenital or can develop after birth as a result of injury or other diseases, like tuberculosis, pneumonia, and influenza. Some underlying conditions that damage the airways and increase lung infections can cause bronchiectasis such as cystic fibrosis and primary ciliary dyskinesia.

Bronchiectasis cannot be cured. However, with proper treatment, most people can live a normal life. Symptoms include coughing, shortness of breath, abnormal chest sounds, daily production of large amounts of coughed up mucus, chest pain, and clubbing. Early detection is crucial in order to prevent the progression of lung damage. Prevention methods include: vaccinations for measles and pertussis; avoiding toxic fumes, gases, smoke and other substances that can harm the lungs; properly treating lung infections in children; avoiding inhaling small objects, and seeking prompt medical care if any of these occur.

Hyperpolarized gas magnetic resonance imaging (MRI) provides an in-vivo assessment of regional gas distribution in the lung and has the advantage of showing exactly where regional functional abnormalities occur. Previous studies in asthma, chronic obstructive pulmonary disease, and cystic fibrosis have revealed heterogeneously distributed lung function abnormalities that are associated with pulmonary function and symptoms, however, 3He gas distribution has not been evaluated in non-CF bronchiectasis.

In order to evaluate 3He MRI ventilation distribution, subjects with a clinical diagnosis of bronchiectasis were used to test the hypothesized that MRI pulmonary function abnormalities are related to pulmonary function and symptom scores. The team of researchers evaluated 14 (aged 45-85 years) patients using spirometry, plethysmography, the six-minute walk test (6MWT), hyper polarized 3He MRI, high-resolution computed tomography (HRCT), Patient Evaluation Questionnaire (PEQ), and the St. George’s Respiratory Questionnaire (SGRQ).

Using linear regression and Pearson correlations the most novel finding from this study is that MRI heterogeneously distributed ventilation abnormalities are strongly related to worse pulmonary function and symptom scores. This is a pioneering study as this was the first time this method is used in this particular clinical population. The new findings can help physicians to have a better understanding of the key characteristics of Bronchiectasis in diagnosis and treatment.

ABOUT POLAREAN®
Polarean Imaging plc.® began operations in 2012, after securing all assets and intellectual property for hyperpolarized gas MRI from GE Healthcare. Located in the Research Triangle Park area of North Carolina, Polarean Imaging plc.® designs and manufactures equipment for production of hyperpolarized xenon or helium gases. When used in conjunction with MRI, these gases offer a fundamentally new and non-invasive functional imaging platform. Current investigational uses include early diagnosis of respiratory diseases as well as monitoring progression and therapeutic response. In addition, xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs as well. Polarean Imaging plc.® hyperpolarization systems are currently sold in the United States and internationally for research and investigational applications only.

Polarean Imaging plc.® Technology
The central equipment required for hyperpolarized gas MRI is a polarizer. Using circularly polarized laser light, the polarizer transforms the inert, stable noble gas isotopes 3He and 129Xe into their hyperpolarized states. This process leaves the gases chemically unchanged, while their nuclei are magnetically aligned. The resulting MRI signal is enhanced by a factor of ◊100,000, making direct imaging of gas molecules possible.

Polarean Imaging plc. Expands Capabilities in Hyperpolarized Gas Technology - August, 2013
Hyperpolarized Gas MRI: A Unique and Valuable Pulmonary Research Tool

Durham, NC - August, 2013 -a pioneer in hyperpolarized gas technology, announced today that the Canadian Patent Office has allowed two additional patents on the Company’s modular hyperpolarized gas MRI technology. This expands the worldwide patent coverage already provided by Polarean Imaging plc. patent estate of 34 patent families, acquired from GE Healthcare in early 2012. Polarean Imaging plc. manufactures products based on this patented technology for sale worldwide to basic researchers and pharmaceutical companies conducting clinical research.

Polarean Imaging plc.’s technology addresses a significant need in pulmonary research and drug development. The technology produces hyperpolarized inert gas, used in conjunction with standard MRI imaging to create high resolution 3-dimensional images of the human lung. This technique is a unique way to monitor extremely small changes in lung structure and lung function, and is used in basic and clinical research to study lung physiology and to monitor the efficacy of new drugs. Because the technique does not rely on X-rays, CAT scans or radioactive contrast agents, subjects can be scanned repeatedly to monitor small changes in lung structure over time without the risk of radiation exposure.

Since acquiring the technology and beginning commercial operations in 2012, Polarean Imaging plc. has supplied its polarizers to a number of leading researchers in the US and Europe. “We’re pleased to be able to support basic researchers and pharmaceutical companies with our polarizer systems,” says Dr. Bastiaan Driehuys, the company’s founder and Chief Scientific Officer. “They’re built to be flexible and modular, accommodating the varied research needs of our customer base.” The Biomedical Research Imaging Center at University of North Carolina at Chapel Hill is a recent adopter of the technology. Assistant Professor Rosa Tamara Branca has glowing praise for both the system and the Polarean Imaging plc. team. “Installation and training were done in one week and we were able to run our first hyperpolarized xenon gas experiment soon after without any delay,” says Branca.

The commercial supply of xenon and helium hyperpolarizers for pulmonary research is just the beginning for Polarean Imaging plc., because the potential utility for hyperpolarized gas MRI goes far beyond lung disease. Dr. Driehuys continues, “We have always felt that hyperpolarized gas MRI is an enormously powerful research platform. The potential applications are limited only by the imagination of the scientists who use it. We are thrilled to finally be able to expand the access to the scientific and pharmaceutical community, and in doing so, we expect to see not only great progress in imaging lung disease, but novel applications in molecular imaging in other organs too.”

Contact Polarean Imaging plc. to learn more about the applications of hyperpolarized noble gases. www.polarean.com

ABOUT POLAREAN®
Polarean Imaging plc.®, Inc. began operations in 2012, after securing all assets and intellectual property for hyperpolarized gas MRI from GE Healthcare. Located in the Research Triangle Park area of North Carolina, Polarean Imaging plc.® designs and manufactures equipment for production of hyperpolarized xenon or helium gases. When used in conjunction with MRI, these gases offer a fundamentally new and non-invasive functional imaging platform. Current investigational uses include early diagnosis of respiratory diseases as well as monitoring progression and therapeutic response. In addition, xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs as well. Polarean Imaging plc.® hyperpolarization systems are currently sold in the United States and internationally for research and investigational applications only.

Polarean Imaging plc.® Technology
The central equipment required for hyperpolarized gas MRI is a polarizer. Using circularly polarized laser light, the polarizer transforms the inert, stable noble gas isotopes 3He and 129Xe into their hyperpolarized states. This process leaves the gases chemically unchanged, while their nuclei are magnetically aligned. The resulting MRI signal is enhanced by a factor of ◊100,000, making direct imaging of gas molecules possible.