Nexstim Plc announced that it has successfully negotiated and signed a Letter of Intent (LOI) to exclusively collaborate with Sinaptica Therapeutics Inc. (?Sinaptica?) to develop, manufacture and supply Sinaptica?s patented precision neuromodulation system custom-based upon the Nexstim NBS 6 system with its advanced TMS-EEG and precision neuronavigation capabilities, in the field of Alzheimer?s Disease (AD). According to the LOI, the Sinaptica system will have a proprietary workflow, integrate a third-party EEG device, and connect to Sinaptica?s proprietary MAINTAIN? cloud-based personalization engine among other modifications.

The planned partnership contemplates a worldwide, 10-year exclusive arrangement (renewable in 3-year increments). In the first phase, Nexstim would provide R&D resources to develop the integrated system, designed to meet the needs for Sinaptica?s Phase 3 pivotal clinical trial, estimated to commence in 2025. Nexstim would manufacture and deliver at least 20 Sinaptica precision neuromodulation systems and provide certain maintenance services for clinical trials.

The estimated total value of the first phase of the partnership is approximately EUR 6 million for the first two years of the agreement after signing of the definitive agreements. The financial structure of the agreement consists of an upfront exclusivity signing fee, milestone-based development project, and clinical system sales. The clinical trial systems would also generate recurring revenue for Nexstim during the trial period, based on hardware and software service & support, as well as consumables.

The LOI is non-binding, and the closing of this transaction is subject to finalization and approval of the definitive agreements. Sinaptica and its scientific co-founders have worked over a decade to optimize their brain stimulation therapy using TMS-EEG-based ML-derived algorithms to customize neuromodulation targeting the Default Mode Network (DMN) in the brain via stimulation of the precuneus, which the company refers to as ?nDMN? therapy.

Their scientific co-founders' work has resulted in unprecedented clinical outcomes in two Phase 2 studies in mild/moderate Alzheimer?s patients, one of which is published in the Oxford journal Brain and earned the company Breakthrough device designation by the FDA. Sinaptica now intends to run a pivotal Phase 3 trial to achieve FDA clearance in the U.S., aiming to be the first TMS-based system in the market to treat Alzheimer?s, and the only to offer closed-loop personalization via its patented TMS-EEG personalization software, which it calls ?MAINTAIN??. Through Sinaptica?s investment in the referenced Pivotal Study and eventual de novo FDA clearance, the Company will be creating a new market for the integrated use of TMS, EEG and neuronavigation technology and a new therapeutic option for patients with AD.

Following a successful Pivotal trial, the parties are planning to collaborate exclusively to develop a commercial system in a further R&D project, and for Nexstim to manufacture and supply Sinaptica with the commercial systems and support Sinaptica?s commercialization in the field of the diagnosis and treatment of Alzheimer?s disease, worldwide.