Periodic Reporting for period 2 - Biventricular Epicardial Augmentation Technology (A revolutionary technology platform for providing life-saving treatment for end-stage heart failure patients)
Période du rapport: 2024-01-01 au 2024-12-31
Worldwide, there are more than 800.000 patients suffering from advanced heart failure that would profit from receiving a durable mechanical circulatory support (MCS) device. Yet in the US and Europe, less than 3% of these patients receive any one of the possible treatment strategies per year, i.e.: (a) heart transplantations per year (the current gold standard treatment), due to a chronic organ donor shortage or (b)durable MCS devices. These devices, also referred to as “blood pumps”, are employed restrictively, due to the complications associated with such therapies. Such blood pumps have continuous contact with blood, which can cause blood clotting – thus increase the risk of stroke, and ischemia. To counter this effect, patients are treated with anti-clotting medication, which in turn increases their risk of bleeding. Thus, patients that receive these devices as treatment face potentially severe complications.
reBEAT is a novel, durable MCS device that is developed and manufactured by AdjuCor in Munich, Germany. reBEAT comprises an Implant that can be implanted minimal invasively around a patient’s heart and is connected to an electro-pneumatic Drive Unit that can be carried by the patient. The main differentiation of reBEAT to currently available durable MCS technologies, is that it completely avoids blood contact. Furthermore and contrary to currently available technologies, it can deliver pulsatile support and support one or both sides of the heart.
The objective of this EIC project was to enable the reBEAT technology to reach its final pre-market clinical study and achieve certain key market entry preparatory steps. AdjuCor started with the reBEAT technology development in 2012. Since then, AdjuCor’s multi-disciplinary team was able to achieve key milestones in its development, in vitro and pre-clinical in-vivo tests and regulatory requirements for maturing the technology to reach a sufficient TRL level to qualify for EIC Accelerator funding.
To reach this objective, AdjuCor has been focusing on pre-market activities of preparing for market entry (WP1), performing long-term testing required for different system components, for patient use and for usability (WP2), management of grant (WP3), production of reBEAT systems required for clinical testing and optimization of manufacturing capabilities (WP4) and execution on the world’s, first-in-human study of a device of this kind (WP5).
reBEAT is a novel, durable MCS device that is developed and manufactured by AdjuCor in Munich, Germany. reBEAT comprises an Implant that can be implanted minimal invasively around a patient’s heart and is connected to an electro-pneumatic Drive Unit that can be carried by the patient. The main differentiation of reBEAT to currently available durable MCS technologies, is that it completely avoids blood contact. Furthermore and contrary to currently available technologies, it can deliver pulsatile support and support one or both sides of the heart.
The objective of this EIC project was to enable the reBEAT technology to reach its final pre-market clinical study and achieve certain key market entry preparatory steps. AdjuCor started with the reBEAT technology development in 2012. Since then, AdjuCor’s multi-disciplinary team was able to achieve key milestones in its development, in vitro and pre-clinical in-vivo tests and regulatory requirements for maturing the technology to reach a sufficient TRL level to qualify for EIC Accelerator funding.
To reach this objective, AdjuCor has been focusing on pre-market activities of preparing for market entry (WP1), performing long-term testing required for different system components, for patient use and for usability (WP2), management of grant (WP3), production of reBEAT systems required for clinical testing and optimization of manufacturing capabilities (WP4) and execution on the world’s, first-in-human study of a device of this kind (WP5).
As with the previous reporting period, progress have been made in all of the proposed work packages (WP). The main achievements were the evaluation of study endpoints of first phase of the FIH acute feasibility trial, showing superior safety and encouraging performance results. Parallel to this, all steps involved in the extended portion of the FIH acute feasibility trial were completed, including design and manufacturing optimizations to the Drive Unit and Implant as an iteration to deliver the long-term reBEAT system. It also included completing testing and manufacturing for getting regulatory approval for the extended portion of the FIH acute feasibility, user training and regulatory submission. In order to increase enrolment speed and to achieve further visibility and cooperation from key opinion leaders, AdjuCor also included of a third study centre, i.e. Rigshospitalet (Copenhagen, DK), by getting regulatory approval from the Danish Medical Authority.
Translational insights (including superior safety results) from the first phase of the FIH acute feasibility trial enabled an extended phase of the trial for fine-tuning this novel technology for mechanical support of the heart. No previous technology comprising a sleeve surrounding the heart, squeezing it in synchrony with the natural heart rhythms has been able to reach this advanced level of clinical evidence for a device that supports. It also trumps any insights that are possible with pre-clinical (animal) models – and thereby also enable its long-term application and ultimately commercialization.
The results of first phase of the FIH acute feasibility trial showed that all primary safety and performance endpoints were met, with positive outcomes also for other exploratory endpoints, including implantation duration and echocardiographic compatibility. This is essential foundation that needed to be laid to enter into the longer-term clinical trials.
Finally, since AdjuCor applied for the “grant first” modality of the EIC accelerator program, a strong emphasis was placed on fundraising activities to secure the foreseen follow-on investment in order to reach market approval for reBEAT. Apart from focus on preparing and approaching new private investors, AdjuCor also successfully completed a due diligence process with the European Investment Bank and demonstrated sufficient progress to secure term sheet from the EIC Fund for a €10 million mirroring investment.
The results of first phase of the FIH acute feasibility trial showed that all primary safety and performance endpoints were met, with positive outcomes also for other exploratory endpoints, including implantation duration and echocardiographic compatibility. This is essential foundation that needed to be laid to enter into the longer-term clinical trials.
Finally, since AdjuCor applied for the “grant first” modality of the EIC accelerator program, a strong emphasis was placed on fundraising activities to secure the foreseen follow-on investment in order to reach market approval for reBEAT. Apart from focus on preparing and approaching new private investors, AdjuCor also successfully completed a due diligence process with the European Investment Bank and demonstrated sufficient progress to secure term sheet from the EIC Fund for a €10 million mirroring investment.