Dear Innitius Community,
As we closed out another transformative year, we’re excited to share some pivotal milestones that showcase how Innitius continues to grow and innovate. 2024 marked a significant shift from a single- product company to a multi- solution platform, positioning us to address broader challenges in women’s healthcare. Here are the highlights from 2024:
General Update:
This year, we transitioned from a single-product focus to a multi-solution platform, expanding our scope to include four strategic areas: TPTL (Threatened Preterm Labor), PTL (Preterm Labor Prognosis), IOL (Induction of Labor), and a Science Research Platform. This evolution reflects our commitment to addressing a broader range of challenges in women’s healthcare. Alongside this strategic shift, we finalized detailed plans and budgets for all our projects, setting a clear roadmap for success through 2028.
Product Development Department:
We achieved significant milestones in product development, the first eight CerviSense Intravaginal Probes, featuring a new design, were successfully manufactured, verified, and validated. These probes mark a critical step forward in our technology.
Additionally, we completed development of the Research App, which enables seamless, automated data transfer from the probes to a database without manual intervention. This innovation is set to power our upcoming clinical trial at King’s College, starting in early 2025, focused on the PTL prognosis indication.
Furthermore, the first version of the TPTL software app was delivered and underwent penetration testing, revealing minimal vulnerabilities that are scheduled to be addressed in 2025.
Clinical Research:
We successfully completed CT1, surpassing our targets for sensitivity (70%) and specificity (90%). These results significantly outperform traditional methods like cervical length measurement and biomarkers, validating our approach. We also finalized the first version of our algorithm, which exceeded expectations and delivered robust results.
Building on this success, we designed the CT2 clinical trial protocol for the TPTL indication, in collaboration with the FDA through multiple Q-Submissions. This trial will launch in Spain and Germany in 2025.
Clinical Trial 2 Sites:
Spain:
- H. Universitario San Cecilio
- H. Universitario de Basurto
- H. Universitario de Cruces
- H. Universitario de Torrejón
- H. Clínic de Barcelona
- H. Sant Joan de Déu
- H. Vall d’Hebron
- H. Virgen Arrixaca
- H. Universitario La Paz
- H. Universitario de Málaga
- H. Universitario de A Coruña
- H. General Universitario Gregorio Marañón
- H. Universitario de Donostia
- H. Materno Infantil de Gran Canaria
Germany:
- UKSH Lubeck
- University Hospital Johannes Gutenberg Mainz
- University Hospital Frankfurt
Quality Assurance and Regulatory Affairs
This year, we defined an accelerated market access strategy leveraging a Class I device for investigational use. This approach enables earlier market feedback and is expected to lead to commercialization by Q3 2025.
Additionally, we worked closely with TÜV SÜD to align our ISO 13485 renewal and CE marking audits, ensuring compliance with the highest standards. Significant progress was also made in advancing regulatory pathways for our TPTL, PTL Prognosis, and IOL solutions.
Research & Innovation
Our efforts were bolstered by securing the Hazitek-Raginia grant, which supports the development of an automated cervix detection system.
We also successfully completed the Hazitek SmartMed project, resulting in a prototype cloud platform that integrates diverse medical data. Moreover, we drafted our first scientific paper based on clinical trial results and algorithm performance, which is slated for publication in 2025.
Team Achievements
This year brought changes to our team, despite these changes, the team rose to the occasion and achieved all project objectives.
We also strengthened our team with several strategic hires, including:
- Rut Salaverri as Head of Finance
- Clara Molinuevo as COO
- Hanan Elnazarova in Clinical Affairs
- Jon Ordeñana as Manufacturing Technician
We are actively recruiting a Data Scientist to join us in 2025.
Looking Ahead
2024 was a year of growth, transition, and achievement. We’re immensely proud of our team and grateful for the support of our community. With exciting milestones on the horizon in 2025, we’re committed to driving meaningful advancements in women’s healthcare.
