She Sense: an accurate and non-invasive test that enables simpler, earlier and more cost-effective diagnosis of patients with endometriosis

Introduction

Endometriosis is a chronic inflammatory disease defined as the presence of endometrium-like tissue outside the uterus. Establishment and growth of such endometriotic tissue is estrogen-dependent, thus it is mostly found in women of reproductive age. It is estimated that currently at least 190 million women and adolescent girls worldwide are affected by the disease during reproductive age, although some women may suffer beyond menopause.

She Sense Test

She Sense is an accurate and non-invasive test that enables simpler, earlier, and more cost-effective diagnosis of patients with endometriosis.

Project Scope

Experimental proof of principle for the novel digital biomarker has been demonstrated using early generation prototypes for research purposes in a pre-clinical model and exploratory human volunteer study. Sision Medical seeks to mature this technology and validate its use as a clinically acceptable diagnostic test.

Objectives

Therefore, the scope of this project will focus on the advancement of the She Sense test to investor readiness by:

1. Further refinement of the signal processing to optimize the digital biomarker performance.
2. Validation of the biomarker in a clinical setting.
3. Development of a sustainable business case and business model towards commercialization.

End Point

The end point of the project is the compilation and evaluation of data obtained in a prospective clinical study. EIC funding will enable Sision Medical to enhance the technology efficacy and validation in a clinical setting. This will pave the path for larger studies which will demonstrate clinically acceptable sensitivity and specificity of the She Sense diagnostic test.