Periodic Reporting for period 2 - alphadbs (Adpative DBS)
Berichtszeitraum: 2024-03-01 bis 2025-02-28
There are 10 million Parkinson’s patients worldwide. Deep brain stimulation (DBS) is an established advanced treatment for Parkinson Disease. DBS delivers mild electric pulses to patients' brains using technology like cardiac pacemakers and delivers continuous electrical stimulation with fixed parameters, irrespective of real-time brain activity. With current DBS technology patients spend 20-30% of the day with symptoms and side effects. This is because the amount of treatment a patient needs fluctuates throughout the day. Moreover, managing current DBS therapy requires frequent patient visits to the neurologist.
Newronika’s innovation is the development of an adaptive or close loop DBS system called AlphaDBS that continuously measures brain signals and automatically adjusts therapeutic stimulation intensity to the patient’s needs. The system can operate in conventional open loop and adaptive mode. The system also includes a remote monitoring feature allowing the neurologist to track patients’ brain signals and DBS system status via a cloud-based database.
The technology can be applied to other psychiatric and neurodegenerative diseases.
Newronika’s innovation is the development of an adaptive or close loop DBS system called AlphaDBS that continuously measures brain signals and automatically adjusts therapeutic stimulation intensity to the patient’s needs. The system can operate in conventional open loop and adaptive mode. The system also includes a remote monitoring feature allowing the neurologist to track patients’ brain signals and DBS system status via a cloud-based database.
The technology can be applied to other psychiatric and neurodegenerative diseases.
During the project, the AlphaDBS System underwent significant evolution, in line with the predefined product development strategy and in response to evidence emerging from the clinical study and user feedback. In particular, the device has been upgraded both in terms of electronics and software to allow the implementation of advanced features and to make the investigational device more usable and suitable for manufacturing.
In addition, the project achieved significant milestones in the clinical validation and regulatory approval of the AlphaDBS System, in particular:
1. the European Study titled “A double-blind crossover study to evaluate the safety and efficacy of adaptive Deep Brain Stimulation delivered through the AlphaDBS System in patients with Parkinson’s Disease”, was completed and provided the clinical data necessary to obtain CE marking under the MDR for both conventional (cDBS) and adaptive (aDBS) stimulation modes.
2. The regulatory and ethical approvals for the international ADVENT study: “A Prospective, Multi-center, Randomized, Double-blind, Cross-Over Clinical Trial to Compare the Safety and Effectiveness of Adaptive versus Conventional Stimulation in Levodopa-Responsive Parkinson’s Disease Treated with Bilateral Deep Brain Stimulation of the Subthalamic Nucleus”, were obtained. This trial is designed to support market approval in the United States.
3. CE mark certification for the AlphaDBS System under the European Medical Device Regulation (MDR).
These achievements were instrumental in securing the first tranche of our Series B equity financing round, through which we raised approximately €13 million.
In addition, the project achieved significant milestones in the clinical validation and regulatory approval of the AlphaDBS System, in particular:
1. the European Study titled “A double-blind crossover study to evaluate the safety and efficacy of adaptive Deep Brain Stimulation delivered through the AlphaDBS System in patients with Parkinson’s Disease”, was completed and provided the clinical data necessary to obtain CE marking under the MDR for both conventional (cDBS) and adaptive (aDBS) stimulation modes.
2. The regulatory and ethical approvals for the international ADVENT study: “A Prospective, Multi-center, Randomized, Double-blind, Cross-Over Clinical Trial to Compare the Safety and Effectiveness of Adaptive versus Conventional Stimulation in Levodopa-Responsive Parkinson’s Disease Treated with Bilateral Deep Brain Stimulation of the Subthalamic Nucleus”, were obtained. This trial is designed to support market approval in the United States.
3. CE mark certification for the AlphaDBS System under the European Medical Device Regulation (MDR).
These achievements were instrumental in securing the first tranche of our Series B equity financing round, through which we raised approximately €13 million.
Although the European study was not designed to assess the superiority of adaptive DBS, preliminary results indicate that aDBS was at least as effective as cDBS in managing motor symptoms, and in most cases, resulted in clinically meaningful improvements.
The most striking result of the clinical study is a marked patient preference for aDBS (around 86%). In the large majority of cases such preference (selected when the patient was not aware of the type of stimulation received), corresponded to the improvement observed in the patient reported motor symptoms or to the one observed in clinical scales (or both).
In addition, anecdotal reports from patients themselves or from their caregivers highlighted improvements in clinical domains that were not fully assessed in the patient diaries or clinical scales (e.g. speech and gait).
The AlphaDBS system available for clinical use, due to its peculiar and innovative technical characteristics, has gained attention and will be soon commercialized in few research-intensive clinical centers in Europe.
The upcoming International study will address some aspects related to the applicability of the technology in different geographies, characterized by different DBS-patients' management practices and routines.
The most striking result of the clinical study is a marked patient preference for aDBS (around 86%). In the large majority of cases such preference (selected when the patient was not aware of the type of stimulation received), corresponded to the improvement observed in the patient reported motor symptoms or to the one observed in clinical scales (or both).
In addition, anecdotal reports from patients themselves or from their caregivers highlighted improvements in clinical domains that were not fully assessed in the patient diaries or clinical scales (e.g. speech and gait).
The AlphaDBS system available for clinical use, due to its peculiar and innovative technical characteristics, has gained attention and will be soon commercialized in few research-intensive clinical centers in Europe.
The upcoming International study will address some aspects related to the applicability of the technology in different geographies, characterized by different DBS-patients' management practices and routines.