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.
.
