This document discusses a novel non-invasive method for detecting gut permeability and related conditions like celiac disease, obesity, and diabetes. It involves a quantitative detection kit that measures biomarkers in urine, feces, or blood to assess intestinal permeability without risks or limitations of current methods. The document outlines the market potential, comparing it to existing invasive and slower tests. It proposes a business model involving suppliers, distributors, pharmacies and test laboratories to make the kit available as a medical device or over-the-counter. Finally, it presents the team developing the method and provides their 12-month clinical development and funding plan.

2. Fatty Liver Healthy Liver Normal Celiac
Colon Cancer Diabetes Obesity NAFLD Celiac Disease
Leaky Gut Syndrome

3. Blood-flow
Blood-flow
Urine
Quantitative
detection
BladderNon-toxic
Intestinal
PermeAbility Kit
Perme bility
Blood-flow
Blood-flow
Feces
A novel method

4. Obese/Overweight in developing countries
Obese/Overweight in developed countries
1
Billion
0.9
Billion
WHO – 2014 data
Chronic
Gut-related
60M
people
↑ 57% prevalence on 2020 (WHO)
Traction Plan
1. Private hospitals and specialized clinics; Nutrition & Wellness
2. Prevention and Screening Health Centers
3. National Health System (Public Hospitals)
Market

5. Early Detection
Higher
Sensitivity Low detection limits
Accuracy
Intact reliable
probe False positives/negatives
Eligibility
No user-type
restrictions Not allowed to diabetic patients
Cost
Considerably
low Higher production costs and
expensive analysis method
Non-invasive
“Clean” and silent
Possible secondary effects
Time to result
2 hours
2-5 days

6. 100k € Regulatory
Classification
DRUG
One of the
R2WS winners
BETA Program
IP
Provisional
patent
Regulatory
Clinical
Development Plan
2016
First Year
H2020-MSCA-ITN-2017 - Marie Skłodowska-Curie Innovative Training Networks
Consortium - CLEANFISH - 765619
H2020-SMEInst-2016-2017
PermeAbility - 775582
Fund Raising

7. Suppliers
GMP/GLP
Distributors Pharmacies PATIENTS
Test
Laboratories
Kit Kit
Urine sample
Result
Medical
Device
OTC
DRUG
Business Model

8. Business Model
Proof of concept
Existing set of data
+
Existing Literature
Proved Safety
No need of pre-clinical
studies
Pre-clinical Phase I/II Phase III Phase IV

9. Short term plan
3 – 4 months
CMC Drug Substances
GMP Manufacturing
8 months
CMC Drug Product
Fixed Dose Combination (FDC)
Orodispersible Tablets (ODT)
6 months
Clinical Trial Preparation
Investigator’s Brochure
IMPD
The Next 12 months…
220k € 230k €
Clinical Trial
Phase I/II
400k €
850k
€
Series A
…

10. João Silva
• Co-founder
• Promoter
• PhD Candidate
Fátima Martins
• Co-founder
• Promoter
• PhD
John Jones
• PhD, PI, Professor
• Scientific Advisor
Paula Macedo
• PhD, PI, Professor
• Scientific Advisor
Scientific Board
Team

11. lifetag.pt
geral@lifetag.pt
Thank You