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St John's Innovation Centre
Cowley Road, Cambridge CB4 0WS
United Kingdom
T: +44 1223 703 151
E: info@pneumacare.com
W: www.pneumacare.com
T: +44 1223 703 151
E: info@pneumacare.com
W: www.pneumacare.com
Investor News
July 2013
PneumaCare has been very busy since our last newsletter. This has included appointment of new key management and clinical personnel, initiation of the Company’s first clinical studies, advancement of its regulatory and quality approvals and all important financing activities. In this short newsletter, we aim to give you the highlights of our work and how it is moving the Company forward.
PneumaCare Appoints New CEO
In January 2013, PneumaCare announced that it had appointed a new CEO, Mark Harwood. Mark is a seasoned veteran in the medical device space. In his first six months with PneumaCare, he has made major strides in development of the clinical and commercial program.
Mark is a highly experienced individual with an outstanding commercial track record in the medical device industry. He was previously President and CEO of Arjo Huntleigh in Roselle, US and subsequent to that Vice President of Baxter International Inc. (Global) based in Chicago, IL, US. He then moved on to become President of RF Technologies (North America & EMEA) based in Brookfield WI, US. He has also gained extensive experience outside of the US, as Managing Director for Arjo Med AB, UK & Ireland.
Mark has wide-ranging experience in medical device technology with an outstanding commercial track record and is a strong team builder. Mark also has extensive regulatory and quality experience, which is very relevant to PneumaCare as they are finalising their FDA 510k approval in the US.
"I am very excited to join PneumaCare", said Mark. "PneumaCare represents the very best in innovation for medical imaging and I am looking forward to working with the team, increasing revenue and brand awareness in core markets, providing our Customers and stakeholders an attractive return on investment and to build long term global business relationships with them".
Commercial progress
PneumaCare has been working closely with its first two UK-based distributors, Clement Clarke and Cardiologic, who have placed multiple orders for demo units and for stock. This has included training for a number of their staff.
PneumaCare’s commercial staff, including Eric Stewart and Adrian Zacher, are also focused on appointment of other European and North American distributors. This activity is focused currently on Scandinavia, Netherlands,
July 2013
PneumaCare has been very busy since our last newsletter. This has included appointment of new key management and clinical personnel, initiation of the Company’s first clinical studies, advancement of its regulatory and quality approvals and all important financing activities. In this short newsletter, we aim to give you the highlights of our work and how it is moving the Company forward.
PneumaCare Appoints New CEO
In January 2013, PneumaCare announced that it had appointed a new CEO, Mark Harwood. Mark is a seasoned veteran in the medical device space. In his first six months with PneumaCare, he has made major strides in development of the clinical and commercial program.
Mark is a highly experienced individual with an outstanding commercial track record in the medical device industry. He was previously President and CEO of Arjo Huntleigh in Roselle, US and subsequent to that Vice President of Baxter International Inc. (Global) based in Chicago, IL, US. He then moved on to become President of RF Technologies (North America & EMEA) based in Brookfield WI, US. He has also gained extensive experience outside of the US, as Managing Director for Arjo Med AB, UK & Ireland.
Mark has wide-ranging experience in medical device technology with an outstanding commercial track record and is a strong team builder. Mark also has extensive regulatory and quality experience, which is very relevant to PneumaCare as they are finalising their FDA 510k approval in the US.
"I am very excited to join PneumaCare", said Mark. "PneumaCare represents the very best in innovation for medical imaging and I am looking forward to working with the team, increasing revenue and brand awareness in core markets, providing our Customers and stakeholders an attractive return on investment and to build long term global business relationships with them".
Commercial progress
PneumaCare has been working closely with its first two UK-based distributors, Clement Clarke and Cardiologic, who have placed multiple orders for demo units and for stock. This has included training for a number of their staff.
PneumaCare’s commercial staff, including Eric Stewart and Adrian Zacher, are also focused on appointment of other European and North American distributors. This activity is focused currently on Scandinavia, Netherlands,
Pneumacare Ltd | Investor News
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Heartlands Hospital in Birmingham is
working in conjunction with
PneumaCare using its new Thora-3DITM
product for a major clinical study on pre
and post-operative surgery.
France and the USA. At present we have continued strong interest from
Malaysia and the USA, the latter subject to the Company obtaining its
510k product approvals which will enable marketing not only in USA but
many other countries in Middle East and Asia.
PneumaCare has just released its new sales and marketing literature and will imminently launch its rebranded website to support these initiatives.
Clinical Studies Initiated
In recent months, PneumaCare has been working to develop an aggressive program of clinical studies. The first of these has now been approved and initiated at Birmingham Heartlands Hospital. This study will examine 40 thoracic patients, at various stages of pre- and post- operative surgery. The study at Heartlands Hospital aims to demonstrate the efficacy of the PneumaCare Thora-3DITM instrument to assist in efficient patient management in order to ensure quicker discharge with reduced complications. This study will take about 12 months to complete.
PneumaCare is also in advanced discussions with three additional sites for cinical studies in other related areas including asthma and ventilated patients, and expects to initiate these in Q3 2013.
PneumaCare Appoints New Clinical Manager
Rachel Wilson
Rachel joined PneumaCare in June 2013 to manage the range of clinical studies on which the Company has embarked in the UK and USA. She has unique experience spanning respiratory medical research and commercial development in the medical device industry.
Rachel trained in respiratory measurement at the Royal Brompton Hospital, London and subsequently gained a PhD in Pre-Clinical Medicine at St Georges Hospital Medical School, London under the direction of Professor Paul W. Jones. Her research centered on the ground breaking area of dyspnoea perception and measurement. During this time, she published and presented widely in the field. Moving into the commercial world, she became founding director of a scientific and IT SME, gaining wide ranging commercial experience.
For the past 4 years she has worked as Development Manager for Telehealth with innovative medical device company Docobo Ltd, initiating and managing both commercial partner relationships and a number of pilots with clinical teams across the UK.
"I am very excited to join the PneumaCare team at this exciting stage of the company’s development", said Rachel, new Clinical Manager of the Cambridge-based company." PneumaCare’s highly innovative technology in non-invasive measurement presents a tremendous breakthrough in respiratory measurement. Respiratory measurements are often difficult and distressing for patients to perform, often producing unreliable readings as a result. This technique has the potential to provide a tremendous improvement in patient experience as well as to collect respiratory data until now unavailable by traditional techniques.
PneumaCare has just released its new sales and marketing literature and will imminently launch its rebranded website to support these initiatives.
Clinical Studies Initiated
In recent months, PneumaCare has been working to develop an aggressive program of clinical studies. The first of these has now been approved and initiated at Birmingham Heartlands Hospital. This study will examine 40 thoracic patients, at various stages of pre- and post- operative surgery. The study at Heartlands Hospital aims to demonstrate the efficacy of the PneumaCare Thora-3DITM instrument to assist in efficient patient management in order to ensure quicker discharge with reduced complications. This study will take about 12 months to complete.
PneumaCare is also in advanced discussions with three additional sites for cinical studies in other related areas including asthma and ventilated patients, and expects to initiate these in Q3 2013.
PneumaCare Appoints New Clinical Manager
Rachel Wilson
Rachel joined PneumaCare in June 2013 to manage the range of clinical studies on which the Company has embarked in the UK and USA. She has unique experience spanning respiratory medical research and commercial development in the medical device industry.
Rachel trained in respiratory measurement at the Royal Brompton Hospital, London and subsequently gained a PhD in Pre-Clinical Medicine at St Georges Hospital Medical School, London under the direction of Professor Paul W. Jones. Her research centered on the ground breaking area of dyspnoea perception and measurement. During this time, she published and presented widely in the field. Moving into the commercial world, she became founding director of a scientific and IT SME, gaining wide ranging commercial experience.
For the past 4 years she has worked as Development Manager for Telehealth with innovative medical device company Docobo Ltd, initiating and managing both commercial partner relationships and a number of pilots with clinical teams across the UK.
"I am very excited to join the PneumaCare team at this exciting stage of the company’s development", said Rachel, new Clinical Manager of the Cambridge-based company." PneumaCare’s highly innovative technology in non-invasive measurement presents a tremendous breakthrough in respiratory measurement. Respiratory measurements are often difficult and distressing for patients to perform, often producing unreliable readings as a result. This technique has the potential to provide a tremendous improvement in patient experience as well as to collect respiratory data until now unavailable by traditional techniques.
PneumaCare Ltd | Investor News July 2013
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Personally the role provides me with a unique opportunity to utilize my
respiratory, commercial and medical device industry experience. I am very
much looking forward to working with the team, and their clinical
partners to provide our Customers and stakeholders with the clinical
evidence of the efficacy of the technology across a wide range of
applications".
PneumaCare Appoints Prof. William Denman
as US Chief Medical Officer
William “Pepper” Denman has been appointed earlier in 2013 as PneumaCare’s US Clinical Director. His role will encompass designing clinical trials and implementing them in the USA, and fostering relationships both with key opinion leaders in healthcare and industrial partners.
Pepper Denman was Chief Medical Officer and Vice President of Medical Affairs at Covidien, and then Chief Medical Officer for GE Healthcare. He brings a valuable and none-too-common combination of years of experience as a practising clinician, as well as an in-depth understanding of the medical devices industry.
Dr Denman is currently a Pediatric Anaesthesiologist at the prestigious Massachusetts General Hospital in Boston. He received his medical training in the UK, completing his anaesthesia residency at St Bartholomew’s Hospital in London. He then completed a fellowship at Massachusetts General Hospital, before taking up a position as Chief of Pediatric Anaesthesia at the Floating Hospital for Children in Boston. He returned to Massachusetts General Hospital in 2005 where he is currently on staff. As well as amassing a sound appreciation of medical practices in both the UK and the USA, Dr Denman has authored over 60 papers and conducted trials in both the pharmaceutical and medical devices arena. He is co-leader of an annual mission to Vietnam where he provides anaesthetic services to children undergoing surgery for craniofacial abnormalities.
PneumaCare Appoints Prof. William Denman
as US Chief Medical Officer
William “Pepper” Denman has been appointed earlier in 2013 as PneumaCare’s US Clinical Director. His role will encompass designing clinical trials and implementing them in the USA, and fostering relationships both with key opinion leaders in healthcare and industrial partners.
Pepper Denman was Chief Medical Officer and Vice President of Medical Affairs at Covidien, and then Chief Medical Officer for GE Healthcare. He brings a valuable and none-too-common combination of years of experience as a practising clinician, as well as an in-depth understanding of the medical devices industry.
Dr Denman is currently a Pediatric Anaesthesiologist at the prestigious Massachusetts General Hospital in Boston. He received his medical training in the UK, completing his anaesthesia residency at St Bartholomew’s Hospital in London. He then completed a fellowship at Massachusetts General Hospital, before taking up a position as Chief of Pediatric Anaesthesia at the Floating Hospital for Children in Boston. He returned to Massachusetts General Hospital in 2005 where he is currently on staff. As well as amassing a sound appreciation of medical practices in both the UK and the USA, Dr Denman has authored over 60 papers and conducted trials in both the pharmaceutical and medical devices arena. He is co-leader of an annual mission to Vietnam where he provides anaesthetic services to children undergoing surgery for craniofacial abnormalities.
PneumaCare Ltd | Investor News July 2013
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www.PneumaCare.com
Regulatory News
PneumaCare formally appointed Medical Device Management as its Regulatory advisors for both UK and US matters, including its FDA 510k submissions.
PneumaCare recently passed quality audits by British Standards Institute personnel, and as well a range of technical audits.
PneumaCare has also initiated a range of studies for an additional FDA 510k submission for marketing approval. This study is comparing an FDA approved device, the Respiband (Embletta) with our Thora 3Di product. We are aiming to obtain up to around 200 datasets and submit this for approval to the US authorities in September 2013. This exciting work is progressing very well, and so far the first 50 patient datasets have shown that we can obtain ± 1% agreement with the market leader, using our novel non-invasive 3D imaging technology. This is in line with the Company’s increasing focus on analysis of chest wall movement in health and disease.
Manufacturing and Product Design
PneumaCare is currently streamlining its manufacturing approach which will result in lower cost of goods as we scale up production. The first step has been to sign an agreement with Sofame, based in Le Mans, who are providing a radically new and improved stability stand design for imaging patients who are bedridden.
PneumaCare Attends American Thoracic
Society Meeting in May 2013
PneumaCare made a high profile appearance at the American Thoracic Society meeting in Philadelphia, Pennsylvania, in May 2013. Our exhibition stand was very well attended both by a large number of clinicians to whom we introduced our products and as well by potential distributors and sales agents worldwide. The meeting generated very good sales interest and we are actively following up on the 100+ leads we received.
As always, your comments, feedback and news are welcome. You know how to contact us...
Mark Harwood, CEO Mark.Harwood@pneumacare.com +44 1223 703 151
Dr Bill Mason, Chairman Bill.Mason@pneumacare.com +44 7785 950134
PneumaCare formally appointed Medical Device Management as its Regulatory advisors for both UK and US matters, including its FDA 510k submissions.
PneumaCare recently passed quality audits by British Standards Institute personnel, and as well a range of technical audits.
PneumaCare has also initiated a range of studies for an additional FDA 510k submission for marketing approval. This study is comparing an FDA approved device, the Respiband (Embletta) with our Thora 3Di product. We are aiming to obtain up to around 200 datasets and submit this for approval to the US authorities in September 2013. This exciting work is progressing very well, and so far the first 50 patient datasets have shown that we can obtain ± 1% agreement with the market leader, using our novel non-invasive 3D imaging technology. This is in line with the Company’s increasing focus on analysis of chest wall movement in health and disease.
Manufacturing and Product Design
PneumaCare is currently streamlining its manufacturing approach which will result in lower cost of goods as we scale up production. The first step has been to sign an agreement with Sofame, based in Le Mans, who are providing a radically new and improved stability stand design for imaging patients who are bedridden.
PneumaCare Attends American Thoracic
Society Meeting in May 2013
PneumaCare made a high profile appearance at the American Thoracic Society meeting in Philadelphia, Pennsylvania, in May 2013. Our exhibition stand was very well attended both by a large number of clinicians to whom we introduced our products and as well by potential distributors and sales agents worldwide. The meeting generated very good sales interest and we are actively following up on the 100+ leads we received.
As always, your comments, feedback and news are welcome. You know how to contact us...
Mark Harwood, CEO Mark.Harwood@pneumacare.com +44 1223 703 151
Dr Bill Mason, Chairman Bill.Mason@pneumacare.com +44 7785 950134
PneumaCare Ltd | Investor News July 2013
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