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Diagnostic tool for Vaginitis

Periodic Reporting for period 1 - VagX (Diagnostic tool for Vaginitis)

Reporting period: 2019-05-01 to 2019-10-31

Vaginitis is one of the most common gynecology disorders, resulting in vaginal discharge, itch or pain and general discomfort to the patient.
Worldwide, hundreds of millions of women suffer from vaginitis each year, however poorly diagnosed.

By providing appropriate diagnostic tool to care givers, GynTools will save time, costs, load on health systems, health complications and suffer of patients.

The current feasibility study evaluated the GyniTM System (formerly VagX), an automated in vitro diagnostic device to aid in the diagnosis of vaginitis. The actions undertaken as part of the grant agreement were technological, commercial and feasibility assessments.

The overall objectives of the technological feasibility were to better understand technology performance through testing and verification and risk identification with mitigation plans. This assessment resulted in a detailed design and development plan. The Design History File currently includes detailed design inputs, final specifications for the Vaginal Discharge Sampler, a detailed Verification and Validation plan, and a Risk Management Summary compliant with ISO 14971. Significant progress was made to the software architecture, preliminary clinical studies have been conducted and planning for a multi-site clinical validation study is currently in progress. Biocompatibility studies are near completion and analytical studies are currently being planned.

The overall objectives of the commercial feasibility included target market assessment, internationalization strategy development, and regulatory and IPR management, resulting in a comprehensive market analysis on five EU countries with support from key stakeholders. The internationalization strategy includes initial marketing in Germany followed by sales in other EU countries. ISO 13485 audit assessments were scheduled. Following a pre-submission meeting with the US FDA, GynTools will apply for FDA clearance under 510(k) in addition to CLIA waiver. IPR management is in progress, including a trademark application in the US and application for two additional patents.

Finally, the overall objectives of the economic feasibility were to develop an appropriate business model and pricing strategy, better understand the financial strategy definition by refining operational cost estimations and revenue projections, and develop a detailed business plan and profitability roadmap. A comprehensive analysis was performed on internal resources and the capacity to develop a commercial network subsequent to market launch. A detailed financial plan was prepared for the following two and five years. Following the decision to conduct initial marketing activities in Germany, a thorough analysis was performed on local distribution partners and reimbursement regulations, and a German based consulting firm was recruited to aid in the transition.
The overall objectives of the feasibility study are three-fold:
(1) To better understand technology performance on gynecologists and patients through testing and verification to ensure an optimal end-user experience and identification of main risks and barriers with mitigation plans.
(2) To research and better understand commercial issues with key stakeholders through an assessment of target markets, internationalization strategy (i.e. marketing and distribution), and regulatory and IPR management.
(3) To develop an appropriate business model and pricing strategy for Europe and beyond, better understand the financial strategy definition by refining operational cost estimations and revenue projections and developing a detailed business plan and profitability roadmap.

GynTools progressed with:
1. Technical feasibility
2. Market feasibility, business model
3. Regulation (EU & USA)
4. Clinical study and studies preparations.

GynTools system design was followed by system integration and we are currently bench- testing it in order to proceed to a clinical trial in December 2019.
Market research pointed Germany as first target for commercial penetration. EU KOLs (leading gynecologists) were addressed for their professional opinion.
Regulatory wise- we passed phase 1 of EU NB audit for ISO13485 certification and met the FDA in pre-sub meeting.
First clinical trial shows very good results.
In the past months we progressed tremendously in all aspects; now we are progressing to a clinical trial that will validate the Gyni system and will allow us to start sales.
We focused our marketing analysis in Europe and chose Germany to begin with.
The extremely good clinical results we got so far are promising. Placing Gyni in clinics word wide will reduce significantly diagnosis errors, wrong treatment, health complications and over-load on health care providers.
Overall Gyni system graphic impression