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.
