Revolutionary neurotechnology: FDA approves groundbreaking study for Parkinson's!

Revolutionary neurotechnology: FDA approves groundbreaking study for Parkinson's!

Laimgrubengasse 10, 1060 Wien, Österreich - Newronika, an innovative developer of deep brain stimulation technologies, proudly announces the preservation of an important IDE (Investigational Device Exemption) by the US Food and Drug Administration (FDA). This approval enables the company to start a clinical study in the USA in order to evaluate the security and effectiveness of its adaptive DBS system in patients with movement disorders, especially Parkinson's. Dr. Lorenzo Rossi, CEO of Newronika, refers to this step as milestone, since it shows that their technology addresses urgent demand on the US market, such as APA reported .

growth financing and technological innovativity

In addition to FDA approval, Newronika recently secured financing of over 8.4 million euros in the form of a Series A round. This step was supported by the French risk capital fund omnes and other existing investors such as Innogest and Indaco Venture Partners SGR. Lorenzo Rossi emphasizes that Newronika is at the top of the technological innovation in the field of neurological diseases with the development of a closed system for deep brain stimulation. The funds are used to complete the first clinical study on humans and to maintain the CE marking and the FDA-IDE, such as Omnes Capital executed .

The Adaptive DBS system from Newronika uses real-time feedback from the brain signals of the patients to continuously optimize therapy. According to Prof. Dr. Med. Jens Volkmann, a senior test doctor of the study, enables the approval study to evaluate the advantages of this patient -specific treatment method. The technology could bring considerable progress in the treatment of Parkinson's patients and, according to Rossi, could offer a variety of future applications in various neurological areas.