LUMEN Materna Clinical Overview
Pregnancy-Specific Nervous System Support Technology
Quick Facts
Technical Platform
Market Gap Analysis
Underserved Population
Despite pregnancy representing one of the most significant nervous system transformations in human physiology, no wearable biofeedback device has been designed specifically for maternal use. Existing devices (Apollo Neuro, Muse, etc.) serve general adult populations and lack pregnancy-specific calibrations.
Clinical Need
Pregnant individuals experience prenatal stress
Prenatal anxiety linked to adverse birth outcomes
Non-pharmaceutical interventions increasingly sought
Demand for objective prenatal stress monitoring
Current Limitations
Available solutions include:
- Generic stress-reduction apps: No biofeedback, no physiological adaptation
- Adapted adult wearables: Not calibrated for maternal physiology
- Clinical-only monitoring: Expensive, not accessible for home use
LUMEN Materna addresses these limitations with pregnancy-specific technology.
Trimester-Specific Technology
Three distinct devices designed for the unique physiological needs of each trimester
SPARK: First Trimester Stabilization
Weeks 1-13 • Addressing early pregnancy challenges
Target Symptoms
- Nausea/hyperemesis support (P6 acupressure)
- Hormonal adaptation stress
- Early pregnancy anxiety
- Temperature dysregulation
Technology Platform
Physiological Rationale
P6 (Nei Guan) acupressure point stimulation has demonstrated efficacy in nausea reduction in multiple clinical studies. Combined with low-frequency PEMF shown to support autonomic balance, SPARK addresses first trimester's unique challenges with evidence-based, non-pharmaceutical interventions.
Safety Profile
- No electromagnetic exposure above background levels
- PEMF levels 10x below FDA safety guidelines
- Medical-grade biocompatible materials
- Appropriate for early pregnancy use
Safety Profile & Regulatory Pathway
Electromagnetic Safety
Material Safety
- Medical-grade silicone - ISO 10993 biocompatibility
- Hypoallergenic metals - Copper, rose gold, platinum coatings
- No latex, phthalates, or BPA - Pregnancy-safe materials only
Clinical Contraindications (Proposed)
- Pacemaker/ICD users (PEMF interaction risk)
- High-risk pregnancy (provider approval required)
- Placental complications (provider consultation)
- Multiple gestations (requires additional research)
Regulatory Pathway
LUMEN SoulTech is evaluating regulatory classification:
Lowest regulatory burden
Moderate evidence burden
Novel technology pathway
We are consulting with FDA regulatory experts and OB/GYN clinical advisors to determine the most appropriate pathway that ensures safety while maintaining accessibility.
Partner With LUMEN: Research Opportunities
Building the evidence base through collaborative clinical research
Academic Partnerships
We Seek Collaborations With:
- • University hospitals & academic medical centers
- • Maternal-fetal medicine departments
- • Midwifery and birthing center networks
- • Nursing schools (perinatal specialization)
- • Psychology departments (prenatal stress research)
Research Questions to Explore:
- • Does trimester-specific HRV biofeedback reduce prenatal anxiety?
- • Can fetal movement feedback enhance maternal-fetal attachment?
- • Does intrapartum TENS + breathing reduce pain medication use?
- • Optimal PEMF frequency for first-trimester nausea?
- • Does prenatal training improve postpartum outcomes?
What We Provide:
- Pre-prototype devices for research use
- Technical support and training
- Data analysis collaboration
- Co-authorship on publications
- Grant application support
Clinical Partnerships
We Seek Partnerships With:
- • OB/GYN practices (private and hospital-based)
- • Midwifery practices and birthing centers
- • Maternal health clinics
- • Perinatal mental health providers
- • Lactation consultants and postpartum doulas
Clinical Validation Pathways:
- • Pilot usability studies
- • Patient satisfaction surveys
- • Comparative effectiveness trials
- • Long-term outcome tracking (maternal and infant)
Provider Benefits:
- Early access to innovative technology
- Objective prenatal stress monitoring
- Non-pharmaceutical intervention option
- Potential reduced intervention rates
- Enhanced patient engagement
Interested in Research Collaboration?
Frequently Asked Questions
Healthcare Providers & Institutional Partners
Regulatory & Safety
Clinical Application
Research & Data
Technology & Evidence
Partnership & Access
Have Additional Questions? Contact Our Clinical Team
Contact Clinical TeamProvider & Researcher Updates
Quarterly Clinical Development Newsletter
Receive updates on:
- Clinical validation study results
- Research partnership opportunities
- Regulatory pathway progress
- Conference presentations and publications
- Early access opportunities for providers
Healthcare Provider Resources
Downloadable materials for institutional review and patient education
Contact for Institutional Inquiries
We welcome partnerships with healthcare providers, researchers, and academic institutions
LUMEN SoulTech is a Texas-based medical device company (HUB Certified, SAM.gov Registered) developing generational nervous system support technology. All products are investigational and not yet available for commercial sale.
