Corporate News

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with a proprietary drug‑device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces the appointment of Dr. Marcella (“Marcie”) Ruddy as a Non-Executive Director with immediate effect.

Dr. Ruddy has over 15 years of experience in the development of respiratory and other therapeutic compounds across all stages of clinical development from translational through post approval. She has held multiple senior management positions over her career to date, including Merck & Co., Inc., Alnylam Pharmaceuticals, Inc, Regeneron Pharmaceuticals, Inc and at Tectonic Therapeutic where she has been employed as Chief Medical Officer since July 2021.

Dr. Ruddy is a board-certified pulmonologist who prior to entry into drug development, held a staff position in the Pulmonary Unit at Massachusetts General Hospital/Harvard Medical School where she founded and directed the Adult Cystic Fibrosis Programme. Earlier in her career, she completed her Internal Medicine Residency and Pulmonary Critical Care Fellowship training at Harvard Medical School and associated medical centres.

Dr. Ruddy holds an AB (Bachelor of Arts) from Princeton University and an MD (Doctor of Medicine) from Washington University, St Louis.

Additional Information

The following information is disclosed pursuant to Rule 17 and Schedule Two paragraph (g) of the AIM Rules for Companies in relation to Marcella Kuhlman Ruddy, aged 60:

Dr. Ruddy will be appointed to the Board on the same basis as regards voting and term of appointment as the Company's existing Non-Executive Directors. She will be subject to the same requirements as contained in the Articles of Association of the Company for such appointment to be approved at the next Annual General Meeting of the Company and will be subject to the same requirements for retirement by rotation as the other Directors.

500,000 Share Options have been granted to Dr. Ruddy. The Share Options will be exercisable at a price of 61p and will vest 25% on 25 August 2023 with the remaining Share Options vesting in equal portions on the last day of each calendar month over the period of 36 months starting on 30 September 2023.

Notifications have been made in accordance with the requirements of the UK Market Abuse Regulation in respect of the PDMR and further details can be found by following this link:  https://www.polarean-ir.com/content/investors/shareholder-information

Save as disclosed above there are no additional disclosures to be made in accordance with Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies.

Richard Hullihen, CEO of Polarean, said: “Marcie is a recognised leader in the clinical development with experience across a broad range of indications, including respiratory therapeutics. Her broad expertise in all stages of drug development as well as her demonstrated capability in building and leading clinical development teams will be invaluable to us and we look forward to her guidance and specific insights into the industry. She has a wealth of experience and knowledge and I believe Polarean will greatly benefit having her on the Board.”

Market Abuse Regulation Disclosure

Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR") until the release of this announcement.

Enquiries:

About Polarean (www.polarean.com)

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 membrane, 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. The Group received a complete response letter on 5 October 2021. On 30 March 2022, the Company filed the resubmission of its NDA with the US FDA and has received a PDUFA date of Sept 30, 2022.

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. 

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with a proprietary drug‑device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces the appointment of Dr. Marcella (“Marcie”) Ruddy as a Non-Executive Director with immediate effect.

Dr. Ruddy has over 15 years of experience in the development of respiratory and other therapeutic compounds across all stages of clinical development from translational through post approval. She has held multiple senior management positions over her career to date, including Merck & Co., Inc., Alnylam Pharmaceuticals, Inc, Regeneron Pharmaceuticals, Inc and at Tectonic Therapeutic where she has been employed as Chief Medical Officer since July 2021.

Dr. Ruddy is a board-certified pulmonologist who prior to entry into drug development, held a staff position in the Pulmonary Unit at Massachusetts General Hospital/Harvard Medical School where she founded and directed the Adult Cystic Fibrosis Programme. Earlier in her career, she completed her Internal Medicine Residency and Pulmonary Critical Care Fellowship training at Harvard Medical School and associated medical centres.

Dr. Ruddy holds an AB (Bachelor of Arts) from Princeton University and an MD (Doctor of Medicine) from Washington University, St Louis.

Additional Information

The following information is disclosed pursuant to Rule 17 and Schedule Two paragraph (g) of the AIM Rules for Companies in relation to Marcella Kuhlman Ruddy, aged 60:

Dr. Ruddy will be appointed to the Board on the same basis as regards voting and term of appointment as the Company's existing Non-Executive Directors. She will be subject to the same requirements as contained in the Articles of Association of the Company for such appointment to be approved at the next Annual General Meeting of the Company and will be subject to the same requirements for retirement by rotation as the other Directors.

500,000 Share Options have been granted to Dr. Ruddy. The Share Options will be exercisable at a price of 61p and will vest 25% on 25 August 2023 with the remaining Share Options vesting in equal portions on the last day of each calendar month over the period of 36 months starting on 30 September 2023.

Notifications have been made in accordance with the requirements of the UK Market Abuse Regulation in respect of the PDMR and further details can be found by following this link:  https://www.polarean-ir.com/content/investors/shareholder-information

Save as disclosed above there are no additional disclosures to be made in accordance with Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies.

Richard Hullihen, CEO of Polarean, said: “Marcie is a recognised leader in the clinical development with experience across a broad range of indications, including respiratory therapeutics. Her broad expertise in all stages of drug development as well as her demonstrated capability in building and leading clinical development teams will be invaluable to us and we look forward to her guidance and specific insights into the industry. She has a wealth of experience and knowledge and I believe Polarean will greatly benefit having her on the Board.”

Market Abuse Regulation Disclosure

Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR") until the release of this announcement.

Enquiries:

About Polarean (www.polarean.com)

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 membrane, 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. The Group received a complete response letter on 5 October 2021. On 30 March 2022, the Company filed the resubmission of its NDA with the US FDA and has received a PDUFA date of Sept 30, 2022.

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. 

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with a proprietary drug‑device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces the appointment of Dr. Marcella (“Marcie”) Ruddy as a Non-Executive Director with immediate effect.

Dr. Ruddy has over 15 years of experience in the development of respiratory and other therapeutic compounds across all stages of clinical development from translational through post approval. She has held multiple senior management positions over her career to date, including Merck & Co., Inc., Alnylam Pharmaceuticals, Inc, Regeneron Pharmaceuticals, Inc and at Tectonic Therapeutic where she has been employed as Chief Medical Officer since July 2021.

Dr. Ruddy is a board-certified pulmonologist who prior to entry into drug development, held a staff position in the Pulmonary Unit at Massachusetts General Hospital/Harvard Medical School where she founded and directed the Adult Cystic Fibrosis Programme. Earlier in her career, she completed her Internal Medicine Residency and Pulmonary Critical Care Fellowship training at Harvard Medical School and associated medical centres.

Dr. Ruddy holds an AB (Bachelor of Arts) from Princeton University and an MD (Doctor of Medicine) from Washington University, St Louis.

Additional Information

The following information is disclosed pursuant to Rule 17 and Schedule Two paragraph (g) of the AIM Rules for Companies in relation to Marcella Kuhlman Ruddy, aged 60:

Dr. Ruddy will be appointed to the Board on the same basis as regards voting and term of appointment as the Company's existing Non-Executive Directors. She will be subject to the same requirements as contained in the Articles of Association of the Company for such appointment to be approved at the next Annual General Meeting of the Company and will be subject to the same requirements for retirement by rotation as the other Directors.

500,000 Share Options have been granted to Dr. Ruddy. The Share Options will be exercisable at a price of 61p and will vest 25% on 25 August 2023 with the remaining Share Options vesting in equal portions on the last day of each calendar month over the period of 36 months starting on 30 September 2023.

Notifications have been made in accordance with the requirements of the UK Market Abuse Regulation in respect of the PDMR and further details can be found by following this link:  https://www.polarean-ir.com/content/investors/shareholder-information

Save as disclosed above there are no additional disclosures to be made in accordance with Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies.

Richard Hullihen, CEO of Polarean, said: “Marcie is a recognised leader in the clinical development with experience across a broad range of indications, including respiratory therapeutics. Her broad expertise in all stages of drug development as well as her demonstrated capability in building and leading clinical development teams will be invaluable to us and we look forward to her guidance and specific insights into the industry. She has a wealth of experience and knowledge and I believe Polarean will greatly benefit having her on the Board.”

Market Abuse Regulation Disclosure

Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR") until the release of this announcement.

Enquiries:

About Polarean (www.polarean.com)

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 membrane, 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. The Group received a complete response letter on 5 October 2021. On 30 March 2022, the Company filed the resubmission of its NDA with the US FDA and has received a PDUFA date of Sept 30, 2022.

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. 

2020

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with a proprietary drug‑device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces the appointment of Dr. Marcella (“Marcie”) Ruddy as a Non-Executive Director with immediate effect.

Dr. Ruddy has over 15 years of experience in the development of respiratory and other therapeutic compounds across all stages of clinical development from translational through post approval. She has held multiple senior management positions over her career to date, including Merck & Co., Inc., Alnylam Pharmaceuticals, Inc, Regeneron Pharmaceuticals, Inc and at Tectonic Therapeutic where she has been employed as Chief Medical Officer since July 2021.

Dr. Ruddy is a board-certified pulmonologist who prior to entry into drug development, held a staff position in the Pulmonary Unit at Massachusetts General Hospital/Harvard Medical School where she founded and directed the Adult Cystic Fibrosis Programme. Earlier in her career, she completed her Internal Medicine Residency and Pulmonary Critical Care Fellowship training at Harvard Medical School and associated medical centres.

Dr. Ruddy holds an AB (Bachelor of Arts) from Princeton University and an MD (Doctor of Medicine) from Washington University, St Louis.

Additional Information

The following information is disclosed pursuant to Rule 17 and Schedule Two paragraph (g) of the AIM Rules for Companies in relation to Marcella Kuhlman Ruddy, aged 60:

Dr. Ruddy will be appointed to the Board on the same basis as regards voting and term of appointment as the Company's existing Non-Executive Directors. She will be subject to the same requirements as contained in the Articles of Association of the Company for such appointment to be approved at the next Annual General Meeting of the Company and will be subject to the same requirements for retirement by rotation as the other Directors.

500,000 Share Options have been granted to Dr. Ruddy. The Share Options will be exercisable at a price of 61p and will vest 25% on 25 August 2023 with the remaining Share Options vesting in equal portions on the last day of each calendar month over the period of 36 months starting on 30 September 2023.

Notifications have been made in accordance with the requirements of the UK Market Abuse Regulation in respect of the PDMR and further details can be found by following this link:  https://www.polarean-ir.com/content/investors/shareholder-information

Save as disclosed above there are no additional disclosures to be made in accordance with Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies.

Richard Hullihen, CEO of Polarean, said: “Marcie is a recognised leader in the clinical development with experience across a broad range of indications, including respiratory therapeutics. Her broad expertise in all stages of drug development as well as her demonstrated capability in building and leading clinical development teams will be invaluable to us and we look forward to her guidance and specific insights into the industry. She has a wealth of experience and knowledge and I believe Polarean will greatly benefit having her on the Board.”

Market Abuse Regulation Disclosure

Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR") until the release of this announcement.

Enquiries:

About Polarean (www.polarean.com)

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 membrane, 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. The Group received a complete response letter on 5 October 2021. On 30 March 2022, the Company filed the resubmission of its NDA with the US FDA and has received a PDUFA date of Sept 30, 2022.

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. 

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with a proprietary drug‑device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces the appointment of Dr. Marcella (“Marcie”) Ruddy as a Non-Executive Director with immediate effect.

Dr. Ruddy has over 15 years of experience in the development of respiratory and other therapeutic compounds across all stages of clinical development from translational through post approval. She has held multiple senior management positions over her career to date, including Merck & Co., Inc., Alnylam Pharmaceuticals, Inc, Regeneron Pharmaceuticals, Inc and at Tectonic Therapeutic where she has been employed as Chief Medical Officer since July 2021.

Dr. Ruddy is a board-certified pulmonologist who prior to entry into drug development, held a staff position in the Pulmonary Unit at Massachusetts General Hospital/Harvard Medical School where she founded and directed the Adult Cystic Fibrosis Programme. Earlier in her career, she completed her Internal Medicine Residency and Pulmonary Critical Care Fellowship training at Harvard Medical School and associated medical centres.

Dr. Ruddy holds an AB (Bachelor of Arts) from Princeton University and an MD (Doctor of Medicine) from Washington University, St Louis.

Additional Information

The following information is disclosed pursuant to Rule 17 and Schedule Two paragraph (g) of the AIM Rules for Companies in relation to Marcella Kuhlman Ruddy, aged 60:

Dr. Ruddy will be appointed to the Board on the same basis as regards voting and term of appointment as the Company's existing Non-Executive Directors. She will be subject to the same requirements as contained in the Articles of Association of the Company for such appointment to be approved at the next Annual General Meeting of the Company and will be subject to the same requirements for retirement by rotation as the other Directors.

500,000 Share Options have been granted to Dr. Ruddy. The Share Options will be exercisable at a price of 61p and will vest 25% on 25 August 2023 with the remaining Share Options vesting in equal portions on the last day of each calendar month over the period of 36 months starting on 30 September 2023.

Notifications have been made in accordance with the requirements of the UK Market Abuse Regulation in respect of the PDMR and further details can be found by following this link:  https://www.polarean-ir.com/content/investors/shareholder-information

Save as disclosed above there are no additional disclosures to be made in accordance with Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies.

Richard Hullihen, CEO of Polarean, said: “Marcie is a recognised leader in the clinical development with experience across a broad range of indications, including respiratory therapeutics. Her broad expertise in all stages of drug development as well as her demonstrated capability in building and leading clinical development teams will be invaluable to us and we look forward to her guidance and specific insights into the industry. She has a wealth of experience and knowledge and I believe Polarean will greatly benefit having her on the Board.”

Market Abuse Regulation Disclosure

Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR") until the release of this announcement.

Enquiries:

About Polarean (www.polarean.com)

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 membrane, 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. The Group received a complete response letter on 5 October 2021. On 30 March 2022, the Company filed the resubmission of its NDA with the US FDA and has received a PDUFA date of Sept 30, 2022.

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. 

Polarean Imaging plc (AIM: POLX), the medical‑imaging technology company, with a proprietary drug‑device combination product using hyperpolarised xenon-129 gas to enhance magnetic resonance imaging (MRI) in pulmonary medicine, announces the appointment of Dr. Marcella (“Marcie”) Ruddy as a Non-Executive Director with immediate effect.

Dr. Ruddy has over 15 years of experience in the development of respiratory and other therapeutic compounds across all stages of clinical development from translational through post approval. She has held multiple senior management positions over her career to date, including Merck & Co., Inc., Alnylam Pharmaceuticals, Inc, Regeneron Pharmaceuticals, Inc and at Tectonic Therapeutic where she has been employed as Chief Medical Officer since July 2021.

Dr. Ruddy is a board-certified pulmonologist who prior to entry into drug development, held a staff position in the Pulmonary Unit at Massachusetts General Hospital/Harvard Medical School where she founded and directed the Adult Cystic Fibrosis Programme. Earlier in her career, she completed her Internal Medicine Residency and Pulmonary Critical Care Fellowship training at Harvard Medical School and associated medical centres.

Dr. Ruddy holds an AB (Bachelor of Arts) from Princeton University and an MD (Doctor of Medicine) from Washington University, St Louis.

Additional Information

The following information is disclosed pursuant to Rule 17 and Schedule Two paragraph (g) of the AIM Rules for Companies in relation to Marcella Kuhlman Ruddy, aged 60:

Dr. Ruddy will be appointed to the Board on the same basis as regards voting and term of appointment as the Company's existing Non-Executive Directors. She will be subject to the same requirements as contained in the Articles of Association of the Company for such appointment to be approved at the next Annual General Meeting of the Company and will be subject to the same requirements for retirement by rotation as the other Directors.

500,000 Share Options have been granted to Dr. Ruddy. The Share Options will be exercisable at a price of 61p and will vest 25% on 25 August 2023 with the remaining Share Options vesting in equal portions on the last day of each calendar month over the period of 36 months starting on 30 September 2023.

Notifications have been made in accordance with the requirements of the UK Market Abuse Regulation in respect of the PDMR and further details can be found by following this link:  https://www.polarean-ir.com/content/investors/shareholder-information

Save as disclosed above there are no additional disclosures to be made in accordance with Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies.

Richard Hullihen, CEO of Polarean, said: “Marcie is a recognised leader in the clinical development with experience across a broad range of indications, including respiratory therapeutics. Her broad expertise in all stages of drug development as well as her demonstrated capability in building and leading clinical development teams will be invaluable to us and we look forward to her guidance and specific insights into the industry. She has a wealth of experience and knowledge and I believe Polarean will greatly benefit having her on the Board.”

Market Abuse Regulation Disclosure

Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR") until the release of this announcement.

Enquiries:

About Polarean (www.polarean.com)

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 membrane, 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. The Group received a complete response letter on 5 October 2021. On 30 March 2022, the Company filed the resubmission of its NDA with the US FDA and has received a PDUFA date of Sept 30, 2022.

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.