Business Wire07.20.21
CARMAT, designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announced the first implant of its Aeson bioprosthetic artificial heart in a commercial setting.
This implant of the Aeson artificial heart was performed by the team headed by heart surgeon Dr. Ciro Maiello at the Azienda Ospedaliera dei Colli hospital in Naples, one of the hospitals with the greatest experience in the field of artificial hearts in Italy.
This implant represents the first sale ever recorded by CARMAT since it was created in 2008. It is a major milestone that opens-up a new chapter in the company’s development.
In accordance with its strategy, in 2021, CARMAT intends to focus its Aeson artificial heart marketing efforts on Germany, and address one or two other EU countries, including Italy, in a more opportunistic way.
Since it obtained CE marking for its artificial heart as a bridge to transplant in December 2020, the Company has initiated very active and constructive talks, from a scientific and medical as well as contractual perspectives, notably with the twenty most active German hospitals in the field of mechanical assistance.
These discussions have confirmed both the extent of the patient population which could benefit from the Aeson heart and the medical community’s keen interest in a therapy understood to be truly innovative and providing patients with unique benefits.
This assessment has been confirmed by the cardiac surgery teams at Duke University Hospital in the United States, who recently estimated1 the number of new cases of heart failure in that country at 100,000 per year, with only 3,000 to 4,000 of these patients currently able to benefit from a heart transplant, concluding that a substantial portion of the remaining 96,000 patients could potentially benefit from CARMAT’s solution.
At this stage, 5 German hospitals have already been trained by CARMAT and are currently screening patients for an implant. A number of patient files are currently being analyzed by these hospitals with the support of CARMAT, whose teams will remain mobilized throughout the summer to ensure the continuity of the commercial launch of the Aeson artificial heart.
The company expects around a dozen medical centers to be trained and commercially active by the end of 2021, primarily in Germany.
CARMAT will provide a comprehensive update on its schedule and main strategic objectives when it publishes its half-year results on September 15, 2021.
The terms of this communication will be specified at a later date.
Prof. Marisa De Feo, Director of the Department of General Cardiac Surgery and Transplantation at Azienda Ospedaliera dei Colli, declared: “We are pleased to be the first center in the world to implant the Aeson total artificial heart in a commercial setting. The surgery has been performed by Dr. Ciro Maiello and Dr. Cristiano Amarelli without any particular difficulty thanks to the excellent preparation and cooperation between our department and the specialists from CARMAT. The patient is recovering well and, thanks to the combination of the main features of the device—pulsatility, hemocompatibility and self regulation—we believe that he will experience a rapid transition to outpatient management. I would also like to take the opportunity to thank the entire Department of Cardiac Surgery and the Azienda Ospedaliera dei Colli for continuing innovating in the domain of transplantation and mechanical assistance, and the Campania Region for supporting our program.”
Stéphane Piat, CEO of CARMAT, added: “The first commercial implant of the Aeson heart is a major milestone in CARMAT’s history. It paves the way for a large number of patients to gradually access our therapy, and is the culmination of many years of work for our teams and our partners. The feedback we are receiving, both within the framework of our clinical trials, notably very recently in the United States, and in our discussions with European hospitals as part of Aeson’s commercialization, makes us very confident that our Aeson artificial heart is a ‘game changer’ and offers unique benefits to patients, compared to all existing therapies. I would like to thank the teams at the Naples hospital for their trust and commitment, and can assure you that our teams are as mobilized as ever to enable other patients, notably in Germany, to benefit from our therapy in the coming weeks.”
Reference
1 Virtual press conference held by Duke University Hospital on July 15, 2021, following the first implantation of the Aeson heart in the United States within the framework of the EFS (Early Feasibility Study).
This implant of the Aeson artificial heart was performed by the team headed by heart surgeon Dr. Ciro Maiello at the Azienda Ospedaliera dei Colli hospital in Naples, one of the hospitals with the greatest experience in the field of artificial hearts in Italy.
This implant represents the first sale ever recorded by CARMAT since it was created in 2008. It is a major milestone that opens-up a new chapter in the company’s development.
In accordance with its strategy, in 2021, CARMAT intends to focus its Aeson artificial heart marketing efforts on Germany, and address one or two other EU countries, including Italy, in a more opportunistic way.
Since it obtained CE marking for its artificial heart as a bridge to transplant in December 2020, the Company has initiated very active and constructive talks, from a scientific and medical as well as contractual perspectives, notably with the twenty most active German hospitals in the field of mechanical assistance.
These discussions have confirmed both the extent of the patient population which could benefit from the Aeson heart and the medical community’s keen interest in a therapy understood to be truly innovative and providing patients with unique benefits.
This assessment has been confirmed by the cardiac surgery teams at Duke University Hospital in the United States, who recently estimated1 the number of new cases of heart failure in that country at 100,000 per year, with only 3,000 to 4,000 of these patients currently able to benefit from a heart transplant, concluding that a substantial portion of the remaining 96,000 patients could potentially benefit from CARMAT’s solution.
At this stage, 5 German hospitals have already been trained by CARMAT and are currently screening patients for an implant. A number of patient files are currently being analyzed by these hospitals with the support of CARMAT, whose teams will remain mobilized throughout the summer to ensure the continuity of the commercial launch of the Aeson artificial heart.
The company expects around a dozen medical centers to be trained and commercially active by the end of 2021, primarily in Germany.
CARMAT will provide a comprehensive update on its schedule and main strategic objectives when it publishes its half-year results on September 15, 2021.
The terms of this communication will be specified at a later date.
Prof. Marisa De Feo, Director of the Department of General Cardiac Surgery and Transplantation at Azienda Ospedaliera dei Colli, declared: “We are pleased to be the first center in the world to implant the Aeson total artificial heart in a commercial setting. The surgery has been performed by Dr. Ciro Maiello and Dr. Cristiano Amarelli without any particular difficulty thanks to the excellent preparation and cooperation between our department and the specialists from CARMAT. The patient is recovering well and, thanks to the combination of the main features of the device—pulsatility, hemocompatibility and self regulation—we believe that he will experience a rapid transition to outpatient management. I would also like to take the opportunity to thank the entire Department of Cardiac Surgery and the Azienda Ospedaliera dei Colli for continuing innovating in the domain of transplantation and mechanical assistance, and the Campania Region for supporting our program.”
Stéphane Piat, CEO of CARMAT, added: “The first commercial implant of the Aeson heart is a major milestone in CARMAT’s history. It paves the way for a large number of patients to gradually access our therapy, and is the culmination of many years of work for our teams and our partners. The feedback we are receiving, both within the framework of our clinical trials, notably very recently in the United States, and in our discussions with European hospitals as part of Aeson’s commercialization, makes us very confident that our Aeson artificial heart is a ‘game changer’ and offers unique benefits to patients, compared to all existing therapies. I would like to thank the teams at the Naples hospital for their trust and commitment, and can assure you that our teams are as mobilized as ever to enable other patients, notably in Germany, to benefit from our therapy in the coming weeks.”
Reference
1 Virtual press conference held by Duke University Hospital on July 15, 2021, following the first implantation of the Aeson heart in the United States within the framework of the EFS (Early Feasibility Study).
