Treatment-Resistant Depression — A Side-Effect-Free Therapy
ScudoMind delivers clinically-evidenced Negative Air Ion therapy through a consumer-grade wearable — enabling patients to treat at home, without drugs, clinic visits, or side effects.
A Global Crisis With No Good Solutions
People worldwide living with depression
WHO, 2023
Don't seek or adhere to treatment
Due to side effects and stigma
Annual economic burden in Europe alone
Including healthcare and lost productivity
Existing non-invasive treatments — ECT, TMS, esketamine — require frequent clinic visits, cost up to $25,000 per patient per treatment course, and still carry side effects. Chronic and treatment-resistant depression remains one of the most underserved conditions in modern medicine. Millions go untreated.
A New Category of Treatment
Patent Pending
Wearable. Non-Invasive.
Self-administered at home, work, or on-the-go. The ScudoMind device delivers therapeutic doses of Negative Air Ions via natural breathing — and resembles a consumer headphone.
Clinically Evidenced.
A landmark randomized controlled trial demonstrates 50% remission rates and 51.1% reduced depression scores in 5 weeks. No reported side effects across all trials.
Clinic-Connected.
An AI-driven clinic dashboard enables remote monitoring, treatment personalization, and progress tracking — letting clinicians manage dozens of patients with minimal staff.
Treatment core protocol: daily ~1 hour of precise therapeutic-dose inhaled Negative Air Ions (NAI)
Five Neuropathways. One Mechanism.
NAI therapy engages multiple biological systems simultaneously — explaining why results appear faster and more comprehensively than conventional approaches.
Neuroendocrine Regulation
Attenuates HPA axis hyperactivity by reducing stress-induced corticosterone elevation.
Normalizes the stress response — a core physiological dysfunction in depression.
Autonomic Nervous System
Enhances parasympathetic tone (increased HRV) and modulates sympatho-vagal balance via vagal nerve and hypothalamic pathways.
Reduces physiological hyperarousal and promotes somatic recovery and relaxation.
Neurotransmitter Modulation
Modulates serotonin (5-HT) levels and accelerates enzymatic oxidation via superoxide pathways.
Modulates monoaminergic signaling systems central to mood regulation.
Immunomodulation & Antioxidative
Rebalances Th1/Th2 cytokine profiles, downregulates pro-inflammatory cytokines and Reactive Oxygen Species (ROS) pathways.
Targets the inflammatory hypothesis of depression by reducing neuroinflammation and oxidative stress.
Emotional & Cognitive Processing
Increases positive emotional processing, improves vigilance and memory for positive stimuli, and enhances cognitive performance.
Mimics early cognitive shifts seen with conventional antidepressants, reversing negative cognitive bias.
Results based on multiple small-scale trials including a landmark randomized controlled trial (Goel et al., 2005).
Full scientific detail →Faster. Safer. More Affordable.
ScudoMind is the only treatment in its class that delivers competitive efficacy without side effects, clinic visits, or prohibitive costs.
| Treatment | Treatment Setting | Response Rate | Remission Rate | Time to Response | Side Effects | Reimbursement Cost |
|---|---|---|---|---|---|---|
| ScudoMind | Daily · Home or On-the-Go | 51% | 50% | 5 weeks | None reported | €2,750 |
| ECT | Clinic · 3×/week | ~54% | 31–47% | 6–8 weeks | Cognitive & memory loss | €13,500–€23,000 |
| TMS | Clinic · 5×/week | ~50% | 31–37% | 4–6 weeks | Headache | €5,500–€13,500 |
| Neuromodulation Wearable | Daily at home · 2×/day | 50–60% | Up to 50% | 8–16 weeks | Very mild | €3,600 |
| Esketamine | Clinic · 1–2×/week | ~50% | 30–50% | 4–12 weeks | Dissociation, hypertension | €5,500–€18,000 |
Data sourced from published clinical trials and peer-reviewed literature. Individual results may vary. ScudoMind data based on Goel et al., 2005 RCT.
A Large, Underserved Market with No Adequate Solution
Total Addressable Market
Adults with Major Depressive Disorder in the EU (Fischer et al., 2023)
Serviceable Available Market
Chronic / treatment-resistant depressed adults in the EU (20% of MDD)
Serviceable Obtainable Market
5% of EU TRD population — first 5 years
€260M projected 5-year revenue
at 80%+ gross margins · ~€900 net revenue per patient · EU + US + Asia-Pacific
Regulatory path: Pursuing CE Mark (MDR) via phased clinical programme: Study 1A (n=20, open-label device validation) followed by Study 1B (n=40, double-blind sham-controlled RCT). Phase 2 pivotal multi-site RCT (n=200, ≥3 EU countries) designed during grant period.
A Scalable B2B2C Model Built for Clinical Adoption
ScudoMind sells to clinics and hospitals, who deliver treatment to patients. Multiple revenue streams accumulate to ~$1,000 per patient at ~90% gross margins.
Revenue Streams
- Clinic Dashboard€4,550 / year
- Device per Patient€365
- Core Treatment Protocol€455 / 5 weeks
- Post-Treatment (Optional)€45 / week
Clinical Delivery
Enables clinic partners to manage dozens of patients remotely with minimal staff. ScudoMind retains ~€900 net revenue per treated patient at 80%+ gross margins.
Insurance Reimbursement
$3,000 / patient
Target insurance reimbursement of €2,750 per patient — well below competing alternatives (€5,500–€23,000).
Patient Experience
- ✓Wearable device access
- ✓5-week treatment protocol
- ✓Optional relapse prevention
Built by People Who Know This Problem
Benny Shoham
CEO & Founder
Serial entrepreneur and inventor who built three companies across BioTech, Renewable Energy (BrightView), and Sustainable Nutrition (GreenOnyx). ScudoMind is his third startup, born from a personal encounter with depression. Decades of experience taking hardware products from concept through manufacturing.
- —Electronic Engineering degree, Technion
- —Executive MBA
- —25 patents across hardware and deep-tech domains
- —Deep expertise in IP strategy, fundraising, and company scaling
- —Markets: BioTech, Renewable Energy, Sustainable Nutrition, Enterprise SW, Semiconductors
Dr. Shahak Yariv
Chief Medical Officer
Psychiatrist specialising in treatment-resistant depression. Former Head of the Neuromodulation and Advanced Treatments for Depression Unit, Emek Medical Center (Technion-affiliated). Currently serves as medical advisor steering FDA approval and clinical research for medical device companies. Based in The Hague, Netherlands.
- —M.D./Ph.D. in Neurobiology — Weizmann Institute & Technion
- —Former Head, Neuromodulation & Advanced Treatments Unit, Emek Medical Center
- —Brain Stimulation Fellowship, CAMH Toronto
- —Hands-on experience with ECT, TMS, tDCS, esketamine & psychotherapy
- —FDA approval process & clinical research advisor
Michal Kedar-Datel
VP Clinical Affairs
Over 20 years leading clinical operations, regulatory affairs, and quality assurance in the medical device industry, with specific expertise in mental health and innovative depression treatments. Track record spanning the full product lifecycle from early feasibility through pivotal RCTs to market entry.
- —20+ years in medical device clinical ops, regulatory affairs & QA
- —Successfully led FDA PMA and De Novo clearance programmes
- —Completed pivotal trials ahead of schedule under challenging conditions
- —Built clinical infrastructures from scratch to ISO 13485 compliance
- —Experienced integrating internal teams with KOLs and CROs
Shai Rubanenko Shalgi
COO & AI Lead
Operations executive with extensive experience leading large-scale, multi-stakeholder programmes across government, technology, and international organisations. Led national-scale digital transformation initiatives implementing AI and automation solutions at EY Advisory.
- —MSc European Studies, LSE
- —M.A. Human Rights, Hebrew University
- —AI Development and Automation Course graduate, Hebrew University
- —Led national-scale digital transformation at EY Advisory
- —Experience across government, technology, and international organisations
Seed Round Open
Seeking $2M SAFE for 12–18 months operational runway, reaching three key de-risking milestones.
Device Development & CE Mark Engineering
Finalise product specs, deliver units meeting Medical Device Class I and CE material and radiation safety criteria, manufacture units for first clinical trial.
First Clinical Validation
Study 1A: 20-patient open-label device validation. Study 1B: 40-patient double-blind sham-controlled RCT using MADRS to assess efficacy, usability, and side effect profile.
Multi-Site RCT Readiness & Round A
Site screening and onboarding across ≥3 EU countries, protocol and software readiness, manufacturing partnerships, and Round A investor engagement.
Reach out directly to the founding team.
Connect with Benny · info@scudo.health