NDOM® NON-INVASIVE ENDOMETRIOSIS DETECTION

The Endometriosis Diagnostic Dilemma

A Silent Epidemic with Devastating Delays

Endometriosis affects over 200 million women worldwide (1 in 10 women of reproductive age), yet remains one of the most underdiagnosed and misunderstood conditions in gynecology.

The Traditional Diagnostic Challenge:

❌ Average diagnostic delay: 7-10 years from symptom onset to diagnosis

❌ Invasive laparoscopy remains the only definitive diagnostic method

❌ Non-specific symptoms mimic other conditions (IBS, PID, chronic pain syndromes)

❌ Imaging limitations: Ultrasound and MRI detect only moderate-severe disease; miss early-stage endometriosis

❌ CA-125 blood test: Non-specific, elevated in many conditions, poor sensitivity/specificity

Result: Women suffer years of debilitating pain, infertility, and reduced quality of life before diagnosis and appropriate treatment.

NDOM: The Revolutionary Solution

Non-Invasive Diagnostic Method for Endometriosis

NDOM is a breakthrough blood-based test that detects endometriosis through molecular profiling, offering:

✅  93.3% diagnostic accuracy for endometriosis molecular signature

✅  <5 working days from blood draw to results

✅  Non-invasive – simple blood sample, no surgery required

✅  Early detection – identifies disease before visible lesions on imaging

✅  Avoids diagnostic laparoscopy for screening and rule-out purposes

✅  University of Oviedo licensed technology – proprietary intellectual property

How NDOM Works

Molecular Signature Detection: NDOM analyzes a panel of molecular biomarkers in peripheral blood that are dysregulated in endometriosis:

Technology Platform:

• Transcriptomic and proteomic analysis of blood sample
• Proprietary algorithm developed by University of Oviedo research team
• Identifies molecular profile associated with endometriosis
• Distinguishes endometriosis patients from healthy controls with high accuracy

What NDOM Measures:

• Specific gene expression patterns altered in endometriosis
• Protein biomarkers elevated or reduced in endometriosis patients
• Inflammatory markers characteristic of endometriosis-driven inflammation
• miRNA signatures associated with endometriotic lesions
• Analysis: A proprietary algorithm integrates multiple biomarkers to generate:
• Class 0 (Non-Endometriosis Profile): Low probability of endometriosis
• Class 1 (Endometriosis Profile): High probability of endometriosis

Clinical Applications

When to Use NDOM

Primary Indications:

Suspected Endometriosis Based on Symptoms:

• Chronic pelvic pain (>6 months)
• Severe dysmenorrhea (painful periods)
• Deep dyspareunia (painful intercourse)
• Dyschezia (painful bowel movements during menstruation)
• Dysuria (painful urination)
• Chronic fatigue
• Infertility with no identified cause

Rule-Out Testing:

• Differentiate endometriosis from other causes of chronic pelvic pain (IBS, PID, adhesions)
• Avoid unnecessary laparoscopy when NDOM is negative

Early Detection/Screening:

• Women with family history of endometriosis (genetic predisposition)
• Young women with severe dysmenorrhea
• Adolescents with debilitating menstrual pain

Pre-Surgical Planning:

• Confirm endometriosis probability before laparoscopy
• Guide surgical planning and patient counseling

Infertility Workup:

• Unexplained infertility investigation
• Recurrent IVF failure (endometriosis impairs fertility even without visible lesions)
• Pre-IVF assessment

Monitoring Treatment Response:

• Post-surgical or medical treatment follow-up (research ongoing)
• Assess for disease recurrence

Sample Collection & Logistics

Blood Draw Protocol

Simple Venipuncture:

• 8-10 mL peripheral blood collected in EDTA tube (purple/lavender top)
• Standard phlebotomy procedure
• No fasting required
• No special timing relative to menstrual cycle (can be done any time)

Patient Preparation:

• No specific preparation needed
• Continue all medications (won't affect test)
• Can be performed at any phase of menstrual cycle

Advantages for Distributors

Market Opportunity

Large Underserved Market:

• 200 million women worldwide affected by endometriosis
• 7-10 year diagnostic delay = massive unmet need
• Growing awareness of endometriosis driving demand for better diagnostics

Unique Value Proposition:

• Only non-invasive blood test with high accuracy for endometriosis
• Proprietary University of Oviedo technology – exclusive licensing
• No direct competitors with comparable performance

Multiple Revenue Streams:

• Gynecology practices (high volume)
• Fertility clinics (premium pricing)
• Primary care screening programs
• Hospital systems