Sinaptica Therapeutics

What Sinaptica Therapeutics does

Sinaptica Therapeutics is a clinical-stage medical device company developing the SinaptiStim System, a non-invasive, personalized, closed-loop neuromodulation therapy for Alzheimer's disease. The system combines repetitive transcranial magnetic stimulation (rTMS) with electroencephalography (EEG) and MRI-guided neuronavigation to deliver precision electromagnetic stimulation targeting the Default Mode Network (DMN), specifically the precuneus region central to episodic memory. Its proprietary MAINTAIN algorithm personalizes treatment by measuring each patient's TMS-EEG response patterns and generating individualized stimulation protocols via cloud-based spatiotemporal analysis. The company is pre-revenue, with the SinaptiStim System classified as an investigational device not yet approved by the FDA or any other regulator.

Founded in 2022 and headquartered in Cambridge, Massachusetts, Sinaptica operates with R&D partnerships in Rome, Italy (Santa Lucia Foundation) and Boston, Massachusetts (Massachusetts General Hospital and Harvard Medical School). The company's scientific co-founders, Giacomo Koch and Emiliano Santarnecchi, bring decades of academic expertise in non-invasive brain stimulation. Phase 2 trial results published in Brain (2022) and Alzheimer's Research & Therapy (April 2025) reported 44% slowing of Alzheimer's progression over 12 months and 82%+ slowing at 6 months across four gold-standard cognitive and functional endpoints, with no serious adverse events reported.

Sinaptica's intended business model centers on medical device sales and recurring treatment sessions delivered through healthcare institutions, with the therapy administered in weekly 20-minute (first-generation) or 6-minute (second-generation) clinical sessions. The company received FDA Breakthrough Device Designation in October 2022 and is preparing for a pivotal randomized controlled trial. Current revenue is zero; the company is funded by venture investors including Time Zero Capital, Sony Innovation Fund, Wilson Sonsini Ventures, HealthTech Capital, and non-dilutive sources including CABHI, BrightFocus Foundation, the Alzheimer's Drug Discovery Foundation, and the Italian Ministry of Health.

Name

Sinaptica Therapeutics

Legal name

Sinaptica Therapeutics, Inc.

Website

https://sinapticatx.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

11–50 employees

Short description

Sinaptica Therapeutics is a clinical-stage medical device company developing the SinaptiStim System, a non-invasive personalized closed-loop rTMS-EEG neuromodulation therapy targeting the Default Mode Network to slow cognitive and functional decline in Alzheimer's disease patients.

Ownership category

akta.pro rank

Product category

Neuromodulation Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Scientific Research and Development Services (5417)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS) (HLAHAEAK)

akta.pro secondary industry

Digital Rehabilitation & Physical Therapy Therapeutics (HLACANAJ)

Keywords

• Neuromodulation therapy
• Alzheimer's treatment
• Transcranial magnetic stimulation
• Brain stimulation devices
• Precision neurology

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Medical Device Sales: Pre-revenue clinical-stage company. The SinaptiStim™ System is an investigational device not yet approved for commercial sale. Revenue will likely come from device sales and treatment sessions once regulatory approval is obtained.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Sinaptica Therapeutics develops the SinaptiStim™ System, an investigational personalized closed-loop neuromodulation therapy for Alzheimer's disease. The system combines non-invasive repetitive transcranial magnetic stimulation (rTMS) with EEG and MRI-guided neuronavigation, governed by the proprietary MAINTAIN™ AI-derived personalization algorithm, to deliver precision electromagnetic stimulation of the Default Mode Network (precuneus). Treatment is administered in clinical sessions (weekly 20-minute sessions for first-generation; 6-minute sessions for second-generation) following initial MRI and calibration, and is being advanced through clinical trials toward FDA approval.

Product overview

Sinaptica Therapeutics offers the SinaptiStim™ System, an investigational personalized neuromodulation therapy for Alzheimer's disease. The system integrates rTMS-EEG technology with proprietary AI-driven personalization algorithms to deliver precision neurostimulation targeting the Default Mode Network (DMN). Treatment involves initial MRI and calibration sessions, followed by an induction phase of daily 20-minute (first-generation) or 6-minute (second-generation) sessions, then weekly maintenance sessions. The company is advancing toward pivotal trials following FDA Breakthrough Device Designation granted in 2022.

Differentiator

Problem solved

Functional benefit

Products and services

• SinaptiStim™ System (SinaptiStim–AD System) Personalized closed-loop neuromodulation therapy for Alzheimer's disease combining non-invasive repetitive transcranial magnetic stimulation (rTMS) with EEG and MRI-guided neuronavigation. Each patient's prescription is calibrated using the proprietary MAINTAIN™ AI-derived algorithm, which analyzes single-pulse TMS-EEG propagation in spatiotemporal domains and returns a patient-specific stimulation protocol targeting the Default Mode Network (precuneus) to enhance neuroplasticity. Delivered in clinical settings following initial MRI and calibration sessions, with weekly maintenance sessions. Investigational; not yet approved for commercial sale in any geography.
• Second-Generation SinaptiStim™ Precision Neuromodulation System Next-generation iteration of the SinaptiStim platform offering the same personalized closed-loop rTMS-EEG-DMN neuromodulation therapy with reduced per-session treatment time (from 20 to 6 minutes), designed to improve clinical workflow and patient throughput in preparation for pivotal trials and commercialization. Investigational; not yet approved for commercial sale.

Quantifiable outcome

• 44% slowing of Alzheimer's progression over 12 months (1.09 point CDR-SB separation)
• +5 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature5 records

Partnerships

Three partnerships are on record, tiered core, strategic and minor.

• BaycrestcoreStrategic or Co-development Partner · 11 December 2025Baycrest treats over 10,000 patients annually and partnered with Sinaptica through the CABHI funding arrangement. Baycrest provides clinical collaboration and validation support for the neuromodulation therapy development.
• Nexstim PlcstrategicTechnology or Integration · 15 June 2024Nexstim announced a planned Alzheimer's collaboration with Sinaptica Therapeutics. Nexstim is a company specializing in navigated TMS (nTMS) technology. This collaboration aims to leverage Nexstim's hardware capabilities for Sinaptica's neuromodulation therapy development.
• StartUp HealthminorOthers · 22 May 2024Sinaptica was selected for StartUp Health's Alzheimer's Moonshot, an investment and support program for companies working on breakthrough innovations in Alzheimer's disease.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• MagVenture: Danish manufacturer of TMS systems used in research, depression treatment, and clinical neuroscience. Closely comparable on TMS device technology, FDA-cleared depression indication, and clinical delivery model; competes on the same device-installation economics in neurology and psychiatry clinics.
• Nexstim: Finnish medical technology company specializing in navigated TMS (nTMS) systems for both therapeutic (depression, chronic pain) and diagnostic (pre-surgical mapping) applications. Direct comparison: Sinaptica's announced 2024 collaboration with Nexstim establishes it as a hardware partner, and both companies use MRI-navigated TMS as their core platform.
• Brainsway: Israeli medical device company commercializing Deep TMS systems for depression, OCD, smoking cessation, and ADHD. Comparable on modality (non-invasive brain stimulation, FDA-cleared device) and clinical delivery (in-clinic sessions). Less direct overlap on indication but operates in the same neurostimulation device category with similar clinical and reimbursement dynamics.
• Neuronetics: Commercial-stage neuromodulation company developing transcranial magnetic stimulation (TMS) systems (NeuroStar) primarily for treatment-resistant depression. Directly comparable on modality (TMS), regulatory pathway (FDA-cleared device), and clinical-delivery model (in-clinic sessions), with overlapping executive expertise (Sinaptica VP R&D Greg Harper previously at Neuronetics).
• Cognito Therapeutics: Clinical-stage company developing non-invasive gamma frequency neuromodulation for Alzheimer's disease. Most directly comparable peer on indication (Alzheimer's), modality (non-invasive neurostimulation), stage (clinical with pivotal plans), and FDA pathway (Breakthrough Device Designation). Represents the closest head-to-head competitor in the Alzheimer's neuromodulation space.
• Magstim: UK-based manufacturer of TMS equipment used in research and clinical applications including depression and neuroscience. Directly comparable as a TMS device manufacturer serving the same modality market, though Magstim is more research-focused while Sinaptica is therapeutic.
• Functional Neuromodulation: Earlier-stage company pursuing deep brain stimulation (DBS) of the fornix for Alzheimer's disease — direct indication overlap with Sinaptica. Sinaptica's Chief Clinical & Strategy Officer Lisa Fosdick previously led Functional Neuromodulation through two FDA trials and CE mark. Closest direct peer on indication (Alzheimer's neuromodulation).

Emerging players

• Neurosoft Bioelectronics: Developer of TMS devices and clinical applications for neurological conditions. Comparable on core modality (TMS) and target customer base (neurology clinics); smaller player with overlapping R&D focus on non-invasive brain stimulation.
• Soterix Medical: Developer of non-invasive neuromodulation and neurostimulation technologies including transcranial direct current stimulation (tDCS) and high-definition tDCS for clinical and research use. Comparable on non-invasive neuromodulation modality and clinical applications, though primarily uses electrical rather than magnetic stimulation.

Broad incumbents

• Boston Scientific Neuromodulation: Large incumbent neuromodulation business (spinal cord stimulation, deep brain stimulation, vagus nerve stimulation) within Boston Scientific. Comparable on category (neurostimulation devices for CNS disorders) but operates across multiple indications with implantable technologies; Sinaptica CEO Ken Mariash previously led the neuromodulation division's Cosman RF ablation business.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/SinapticaTX
• LinkedInlinkedin.com/company/sinaptica-therapeutics

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds3 records

Investors3 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sinaptica Therapeutics