SimoSpine - progress

The MdM SimOSpine project aims to enhance both the biomechanical realism and the clinical applicability of the SimOSpine technology. One important biomechanical development was the integration of muscles into thoracolumbar spine finite models, which shall be ongoing until September 2025. Active and passive muscle forces are being incorporated into the simulations, based on a previous PhD thesis executed in the BCN MedTech Biomechanics and Mechanobiology  area. Muscle attachement points from musculoskeletal model templates  are being recreated in the SimOSpine personalised Finite Element (FE) models, by using mesh morphing techniques. The goal is to replicate the follower force distribution along the spine, as muscles counterbalance the anterior distribution of the upper body weight, and give freedom to the medical doctors to simulate the possible effect of muscle weakness in specific fascicles, on the predicted postoperative outcomes.

Moreover, a new technological pipeline for real-time biomechanical predictions based on metamodeling has been developed and is functional since July 2024. This pipeline integrates data-driven surrogate models with biomechanical simulations, enabling faster and more interpretable predictions of spinal behavior under various physiological conditions. By combining high-fidelity FE analyses with machine learning techniques, the approach allows for efficient exploration of parameter spaces and supports clinical decision-making with enhanced precision. Ongoing efforts are focused on validating the metamodels against clinical data and extending the framework to accommodate patient-specific variations. In addition, several technical reports were submitted to our patent officer, in order to support the elaboration of SimOSpine's core technology in the context of Intellectual Property (IP) activities, including the preparation of patent drafts and planned submissions scheduled for Q3 2025.

Furthermore, a first user-interface platform was developed, and serves as an intuitive and interactive interface for visualizing biomechanical simulations, managing input parameters, and facilitating clinical interpretation of spine alignment and loading conditions. The platform supports integration with predictive models and simulation tools, bridging the gap between complex computational methods and end-user accessibility. From now on, it needs to keep being designed with scalability and usability in mind. 

For surgical optimization using AI techniques, the SimOSpine team focused on developing and testing AI-driven methods to support preoperative planning, particularly in optimizing spine surgery planning variables and biomechanical descriptors. This work was mainly based on training machine learning models on retrospective surgical data and integrating the outcomes into the existing SimOSpine platform to enhance its clinical decision-support capabilities. New AI-based algorithms (i.e. deep learning for medical imaging) are also being used for spine image analysis and 2D–3D reconstruction, which will improve patient-specific modeling capacity and the automation of sagittal parameter measurements.

1. TECHNOLOGY VALIDATION:

Multibody spine models are undergoing experimental validation. In March 2025, a data request was submitted for validation using 6 to 12 cadaveric specimens. This validation phase will involve comparing simulation outputs—such as range of motion (RoM), neutral zone (NZ), and intradiscal pressure (IDP)—against in vitro experimental data. These results will be essential for increasing the reliability and robustness of the models and for supporting their future acceptance in clinical and regulatory environments. The validation efforts will include both instrumented and intact (non-instrumented) spine specimens, as detailed below:

For Instrumented Specimens:

1. Article: Is pelvic fixation the only option to provide additional stability to the sacral anchorage in long lumbar instrumentation? A comparative biomechanical study of new techniques (DOI: 10.1016/j.clinbiomech.2017.02.001). What we need here: RoM and NZ for 2 specim ens with these specifications: 1- pedicle screw system L4-S1 (condition 3), 2-extension of the pedicle screw system L4-S1 to the os ilium with S2-ala-ilium screws (condition 7).

2. Article: Biomechanical in vitro comparison between anterior column realignment and pedicle subtraction osteotomy for severe sagittal imbalance correction (DOI: 10.1007/s00586-019-06087-x). What we need here: RoM and NZ for 1 specimen T12-S1 with L4 PSO and instrumented L2-S1 (PSO case).

3. Article: Thoracic spinal stability and motion behavior are affected by the length of posterior instrumentation after vertebral body replacement, but not by the surgical approach type: An in!vitro study with entire rib cage specimens (DOI: 10.3389/fbioe.2020.00572). What we need here: RoM and NZ for 2 specimens thoracic spine C7-L1 with these specifications: 1- scenario 4 with long instrumentation T4-T8, 2- scenario 5 with short instrumentation T5-T7.

For Intact (non-instrumented) Specimens:

1. Article: In vitro analysis of the segmental flexibility of the thoracic spine (DOI: 10.1371/journal.pone.0177823). What we need here: RoM and NZ for 2 specimens: 1- Case 56yrs old, male, for thoracic segments T8-T9, T2-T3, T6-T7, and T4-T5, 2- Case 71yrs old, female, for thoracic segments T5-T6, T7-T8, T9-T10, and T11-T12.

2. Article: In vitro analysis of thoracic spinal motion segment flexibility during stepwise reduction of all functional structures (DOI: 10.1007/s00586-019-06196-7). What we need here: RoM and NZ for 1 specimen (case No. 2, female, 57 yrs old, BMI 29) with three thoracic functional units (T10-T11, T6-T7, and T2-T3) including stepwise reductions (SSL, ISL, LL, FC, VA, PLL, ALL, and NUC).

3. Article: In vitro analysis of the Intradiscal pressure of the thoracic spine (DOI: 10.3389/fbioe.2020.00614). What we need here: IDPs in flexion/extension, lateral bending, and axial rotation for 2 specimens: 1- honor No. 8 (51-55 yrs old) for thoracic segments T3-T4, T8-T9, and T10-T11, 2- honor No. 18 (71-75 yrs old) for thoracic segments T5-T6, T9-T0, and T11-T12.

4. Article: Stepwise reduction of functional spinal structures increase vertebral translation and intradiscal pressure (DOI: 10.1016/j.jbiomech.2006.03.016). What we need here:  RoM, NZ, and IDPs for 2 specimens: 1- Case 52 yrs old with lumbar segment L5/L4, 2- Case 59 yrs old with lumbar segment L5/L4; including stepwise reductions (SSL, ISL, LL, FC, VA, PLL, ALL, and NUC).

For the ongoing pre-clinical validation, SimOSpine aims to establish a data transfer agreement with different hospitals in order to gain access to more clinical cases for validating its technology in the context of PJF pathology. 

Moreover, we are planning to start preparing our Quality Management System (QMS) documentation following ISO 13485 guidelines and instructions during Q3-Q4 2025. Later on, preparing the clinical trials documentation will be crucial in order to reach important milestones on our way to the class IIa Software as a Medical Device (SaMD) CE marking approval under MDR.

3. INTELLECTUAL PROPERTY (IP) PROTECTION

In 2024, SimOSpine initiated its Intellectual Property (IP) process with the UPF Innovation Unit. An internal preliminary patentability analysis confirmed its patenting potential, identifying relevant publications and patents. To ensure confidentiality, technology sharing is conducted under Non-Disclosure Agreements (NDAs).

An EU patent drafting is underway, led by our patent officer along with a Freedom to Operate (FTO) analysis. To support further protection, SimOSpine aims to secure valorization grants (AGAUR Innovadors, CaixaImpulse Health Innovation, ERC PoC) for financial backing. Furthermore protection in the US and Asia should be granted, a Patent Cooperation Treaty (PCT) application will be considered to provide room for a robust identification of international key markets, also including UK and Israel.

4. TRAINING PROGRAMS & MENTORING

Two SimOSpine members participated in the “Ciencia al Mercat” (CaM) PRIMER Program 2024, co-organized by Generalitat de Catalunya, 5 public catalan universities (i.e. Universitat Politécnica de Catalunya (UPC), Universitat de Barcelona (UB), Universitat Autónoma de Barcelona (UAB), Universitat de Girona (UdG) and Universitat Pompeu Fabra (UPF); and co-funded by the European Union. It consisted on 100 hours of theoretical and practical training for science based technology transfer, innovation and entrepreneurship and 6 hours of mentoring with experts in Innovation and Entrepreneurship at StartUB!. Then, the program ended with a demo day at the UPC Rectorate on December 2024.

Furthermore, it was decided to submit the project pitch to get a spot on the final demo day, which included all training programs from Generalitat de Catalunya, and only 20 were selected as top 20 early-stage projects in Catalunya in 2024. We were selected and had the opportunity to participate in the final event at Borsa de Barcelona on December 18th 2024.

On January 2025, a hybrid training program and mentoring was started, directly linked to AGAUR Producte 2024 grant, which is led by an innovation & scientific entrepreneurship consultancy.

5. FUNDING

On November 2024, SimOSpine was granted with the AGAUR Producte 2024 call, which ensured 150,000€ to be spent on Proof of Concept activities during 18 months, training and mentoring.

Moreover, during Q1, two technology transfer funding grants were prepared and submitted: CaixaImpulse Health Innovation Call 2025 (Phase 2: 150,000 €) and UPF Innovalora 2025 (50,000 €).

During this year, a near future public funding roadmap was planned, and includes the following grant calls: As AGAUR LLavor. Modalitat A 2023 and AGAUR Producte. Modalitat B 2024 were granted to SimOSpine, AGAUR Innovadors. Modalitat C  2025 (84,000 €) was requested, in order to follow the established AGAUR. Industria del Coneixement path. Moreover, the ERC Proof of Concept 2025 will be prepared during Q3 2025, as it will be a very competitive call, but also very important for us. If SimOSpine is granted, it would be eligible to request an EIC Transition grant (around 2,5 million €). There were two deadlines, one in March and one in September, but the first one was too tight to get there with a suitable and competitive written proposal, and universities and research centers are only eligible to participate in one of the calls per year.

6. CONGRESSES AND EVENTS

In November 2024, SimOSpine was invited and had the opportunity to participate in XPANSE 2024, an event that was held in Abu Dhabi. We had stand for 2 days in order to showcase SimOSpine value proposition and connect with industry leaders and early stage founders. Moreover, we were selected to pitch during the event, with a maximum duration of 5 minutes and competing with 60 international projects for a 20,000€ prize.

Furthermore, from December 11-13th in Brussels, SimOSpine participated in two FORGING consortium (Industry-Academia forum to uncover the potential of emerging enabling technologies) workshops, one focused on Real-Time Based Digital Twins & Simulation Technologies and the other on Human-Machine Interaction Technologies.

From March 3-6th, SimOSpine had the opportunity to participate 4YFN – MWC, where some potential relevant stakeholders for the project were met and later reached: regulatory, quality and clinical consultants, business strategy & innovation experts, validation and Good Manufacturing Practices (GMP) consultants, spine surgery clinical trials experts. SimOSpine also had the chance to participate in a Speed Dating with potential investors. As early-stage spin-off requirements and red flags were discussed, besides team, market and technology, very important feedback was gathered. In the end, potential interest was noticed, as a follow-up meeting was scheduled. Moreover, SimOSpine participated in the mentoring for startups session, where we were matched  the CEO of a software platform that handles, indexes, stores, and harmonizes imaging data, generating a standardized image quality that minimizes variability). The conversations maintained where very valuable for us, and they even offered to be in close contact in order to get feedback and advice from time to time. SimOSpine also connected with other early-stage or growth spin-offs and startups. One of them, closely related to the surgical field, showed great interest on finding potential ways of collaboration, in order to include their surgical guides into our pipeline, thus offering more value to the final users. 

Potential future congresses that would be nice to participate on as soon as the functional minimum viable product (MVP) is reached are: EuroSpine 2025 ( 22-24 October 2025; Copenhagen, Denmark), NASS 2025 (November 14-16, 2025; Denver, Colorado), and Medica 2025 (November 17-20; Dusseldorf, Germany), among others.