Periodic Reporting for period 1 - FineBirth (Point of care diagnostic solution for definitive differentiation of true and false threatened preterm labour cases)
Période du rapport: 2023-04-01 au 2024-03-31
Preterm Labor, occurring before 37 weeks gestation, poses significant challenges in pregnancy, leading to high hospitalization rates and substantial economic burdens. FineBirth, developed by Innitius, addresses this by offering a pioneering PoC medical device. Combining torsional wave technology and AI, FineBirth provides personalized diagnosis of true or false Threatened Preterm Labor (TPTL) events, aiming to optimize care and avoid unnecessary treatments. Its components include a patented intravaginal probe, AI algorithms, an online cloud platform, and a transversal database for comprehensive data management. To ensure success, Innitius is focused on design, production, clinical validation, regulatory compliance, market analysis, and securing CE certification for European marketing.
• T1.1 Strategic, organisational and administrative management
o Activities included defining the company's mission, vision, and values, establishing management policies, setting strategic objectives, and communicating plans. Managing shareholder relations, company funds, and monitoring objectives were also crucial.
o Delivered: Strategic plan (D1.1)
• T1.2 Technical and operational management
o Activities completed include defining clear objectives for activities, time, budget, and deliverable quality, alongside establishing a robust management framework. This involves setting measurable performance indicators, conducting regular meetings, and reporting project status for corrective actions. Effective communication plans were designed for team connectivity, along with managing risks and ensuring regulatory compliance.
o Delivered: Project objectives and execution plan & Management Plan (D1.3)
• T2.3 HTA Initial Assessment
o Activities required for the development of the evidence to prepare the right strategy to provide policymakers, funders, health professionals, and patients with the necessary information to understand the benefits and comparative value of our technology and procedures.
o Delivered: Preliminary HTA dossier (D2.4)
• T2.4 FDA pre submission
o Tasks completed for FDA Q-Sub supplement involve drafting a cover letter explaining the purpose, device description, and pre-submission meeting details. Background information was collected, specific questions formulated, and a slide presentation prepared. All documents were sent to the FDA for feedback, and received guidelines were implemented into clinical strategy protocols and trial plans.
o Delivered: Pre-sub written feedback (D2.6) and Meeting minutes (2.5)
• T3.1 Market product development
o Activities completed to obtain the first representative batch of the market product include defining high-level architecture, user and product requirements, and identifying and mitigating risks. Rapid prototyping and development of the complete device were conducted, along with supply chain management. Verification plans were executed and documented to ensure product quality.
o Delivered: Design files (D3.1) Supply chain plan (D3.2) Tests plans and reports (D3.3).
• T3.3 Second Indication Research: Induction of Labour
o Activities conducted for labor induction research involved reviewing guidelines, protocols, and scientific literature, establishing a work plan, and designing potential solutions. Expert clinician interviews were conducted to understand standard procedures, leading to the standardization of a clinical induction protocol.
o Delivered: Research report (D3.6)
• T4.1 Pivotal Clinical Trial preparation
o Activities conducted to prepare for the clinical study validating FineBirth included preliminary research and defining the CT2 strategy, considering required clinical and economic evidence outlined in WP2. Additionally, the clinical protocol and all necessary trial documentation were generated. Collaborator centers and a Contract Research Organization (CRO) were selected and contracted.
o Delivered: Clinical protocols, dossier and plans (D4.1) and Contracts of collaborator centres and CRO (D4.2)
o Activities included defining the company's mission, vision, and values, establishing management policies, setting strategic objectives, and communicating plans. Managing shareholder relations, company funds, and monitoring objectives were also crucial.
o Delivered: Strategic plan (D1.1)
• T1.2 Technical and operational management
o Activities completed include defining clear objectives for activities, time, budget, and deliverable quality, alongside establishing a robust management framework. This involves setting measurable performance indicators, conducting regular meetings, and reporting project status for corrective actions. Effective communication plans were designed for team connectivity, along with managing risks and ensuring regulatory compliance.
o Delivered: Project objectives and execution plan & Management Plan (D1.3)
• T2.3 HTA Initial Assessment
o Activities required for the development of the evidence to prepare the right strategy to provide policymakers, funders, health professionals, and patients with the necessary information to understand the benefits and comparative value of our technology and procedures.
o Delivered: Preliminary HTA dossier (D2.4)
• T2.4 FDA pre submission
o Tasks completed for FDA Q-Sub supplement involve drafting a cover letter explaining the purpose, device description, and pre-submission meeting details. Background information was collected, specific questions formulated, and a slide presentation prepared. All documents were sent to the FDA for feedback, and received guidelines were implemented into clinical strategy protocols and trial plans.
o Delivered: Pre-sub written feedback (D2.6) and Meeting minutes (2.5)
• T3.1 Market product development
o Activities completed to obtain the first representative batch of the market product include defining high-level architecture, user and product requirements, and identifying and mitigating risks. Rapid prototyping and development of the complete device were conducted, along with supply chain management. Verification plans were executed and documented to ensure product quality.
o Delivered: Design files (D3.1) Supply chain plan (D3.2) Tests plans and reports (D3.3).
• T3.3 Second Indication Research: Induction of Labour
o Activities conducted for labor induction research involved reviewing guidelines, protocols, and scientific literature, establishing a work plan, and designing potential solutions. Expert clinician interviews were conducted to understand standard procedures, leading to the standardization of a clinical induction protocol.
o Delivered: Research report (D3.6)
• T4.1 Pivotal Clinical Trial preparation
o Activities conducted to prepare for the clinical study validating FineBirth included preliminary research and defining the CT2 strategy, considering required clinical and economic evidence outlined in WP2. Additionally, the clinical protocol and all necessary trial documentation were generated. Collaborator centers and a Contract Research Organization (CRO) were selected and contracted.
o Delivered: Clinical protocols, dossier and plans (D4.1) and Contracts of collaborator centres and CRO (D4.2)
Result 1: Patent and Industrial Design
Securing Innitius' new devices’ shape and ensuring their functionality and critical elements for real-world performance.
Result 2: FDA Feedback
Valuable insights on pre-clinical requirements have been obtained.
Result 3: Preliminary HTA Dossier
Insights from the Market Access study inform decisions on target markets and pricing in Europe, identifying key markets with favorable reimbursement policies.
Result 4: Preliminary Device Prototype (Beta)
Finalized design, although additional iteration is needed for uncovered topics and new requirements.
Result 5: New Indication - Induction of Labour
FineBirth not only detects premature births but also shows potential for labor induction, presenting new business opportunities.
Result 6: Design of Pivotal Clinical Trial
The trial's design has been completed and sent for FDA review.
Securing Innitius' new devices’ shape and ensuring their functionality and critical elements for real-world performance.
Result 2: FDA Feedback
Valuable insights on pre-clinical requirements have been obtained.
Result 3: Preliminary HTA Dossier
Insights from the Market Access study inform decisions on target markets and pricing in Europe, identifying key markets with favorable reimbursement policies.
Result 4: Preliminary Device Prototype (Beta)
Finalized design, although additional iteration is needed for uncovered topics and new requirements.
Result 5: New Indication - Induction of Labour
FineBirth not only detects premature births but also shows potential for labor induction, presenting new business opportunities.
Result 6: Design of Pivotal Clinical Trial
The trial's design has been completed and sent for FDA review.