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348: Richard Hullihen of Polarean Imaging is happy with progress ahead of FDA approval date

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Manage episode 302752286 series 2936804
İçerik jruss88 and Vox Markets Podcast tarafından sağlanmıştır. Bölümler, grafikler ve podcast açıklamaları dahil tüm podcast içeriği doğrudan jruss88 and Vox Markets Podcast veya podcast platform ortağı tarafından yüklenir ve sağlanır. Birinin telif hakkıyla korunan çalışmanızı izniniz olmadan kullandığını düşünüyorsanız burada https://tr.player.fm/legal özetlenen süreci takip edebilirsiniz.
Richard Hullihen, CEO of Polarean Imaging #POLX says he's happy with the company's progress just ahead of their FDA approval date on 5th October and describes their technology as unique.
About Polarean
The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue-generating, investigational drug-device combination companies operating in the high-resolution medical imaging research space.
The Group develops equipment that enables existing MRI systems to achieve an improved level of pulmonary function imaging and specialises in the use of hyperpolarised Xenon gas (129Xe) as an imaging agent to visualise ventilation. 129Xe gas is currently being studied for visualisation of gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue barrier, and into the pulmonary bloodstream.
In October 2020, the Group submitted a New Drug Application ("NDA") to the FDA for hyperpolarised 129Xe used to evaluate pulmonary function and to visualise the lung using MRI. In December 2020, the Group received confirmation of acceptance of its NDA by the FDA, with a target PDUFA action date of 5 October 2021.
The Group operates in an area of significant unmet medical need and the Group's technology provides a novel investigational diagnostic approach, offering a non-invasive and radiation-free functional imaging platform. The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.
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1848 bölüm

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iconPaylaş
 
Manage episode 302752286 series 2936804
İçerik jruss88 and Vox Markets Podcast tarafından sağlanmıştır. Bölümler, grafikler ve podcast açıklamaları dahil tüm podcast içeriği doğrudan jruss88 and Vox Markets Podcast veya podcast platform ortağı tarafından yüklenir ve sağlanır. Birinin telif hakkıyla korunan çalışmanızı izniniz olmadan kullandığını düşünüyorsanız burada https://tr.player.fm/legal özetlenen süreci takip edebilirsiniz.
Richard Hullihen, CEO of Polarean Imaging #POLX says he's happy with the company's progress just ahead of their FDA approval date on 5th October and describes their technology as unique.
About Polarean
The Company and its wholly owned subsidiary, Polarean, Inc. (together the "Group") are revenue-generating, investigational drug-device combination companies operating in the high-resolution medical imaging research space.
The Group develops equipment that enables existing MRI systems to achieve an improved level of pulmonary function imaging and specialises in the use of hyperpolarised Xenon gas (129Xe) as an imaging agent to visualise ventilation. 129Xe gas is currently being studied for visualisation of gas exchange regionally in the smallest airways of the lungs, across the alveolar tissue barrier, and into the pulmonary bloodstream.
In October 2020, the Group submitted a New Drug Application ("NDA") to the FDA for hyperpolarised 129Xe used to evaluate pulmonary function and to visualise the lung using MRI. In December 2020, the Group received confirmation of acceptance of its NDA by the FDA, with a target PDUFA action date of 5 October 2021.
The Group operates in an area of significant unmet medical need and the Group's technology provides a novel investigational diagnostic approach, offering a non-invasive and radiation-free functional imaging platform. The annual burden of pulmonary disease in the US is estimated to be over US$150 billion.
  continue reading

1848 bölüm

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