Periodic Reporting for period 1 - MECHANOMICS-POC (A new device to analyse the regional variations of mechanical properties in cells and tissues: prototyping and assessment of commercial potential for drug discovery applications)
Período documentado: 2022-05-01 hasta 2023-10-31
From the interdisciplinary BIOLOCHANICS ERC CoG, we came up with a technological innovation which combines biaxial extension–distension testing, optical coherence tomography (OCT) and artificial intelligence (AI), enabling:
1. to stretch tissues and measure the induced mechanical strain with a 10 µm spatial resolution,
2. to map the distribution of local stiffness properties with a 10 µm spatial resolution.
Our specific objectives were to (O1) build an integrated user-friendly prototype ready for exploitation in CVD; (O2) adapt the prototype to follow standards to help the future commercialization; (O3) determine further IPR strategy; (O4) establish the commercialization roadmap including market research, industrial partnerships and lead management.
The implementation of the project involved a progressive evolution of the different proposed objectives. Progress on specific objective O4 had a significant impact on the approach to the project's overall objective. The tasks and corresponding work-packages related to the different specific objectives were restructured and redefined. The respective changes and the goals achieved are explained. However, the general scope of the project maintained its initial context.
We established very close collaborations with 3 other partners: Technische Universität Wien (TUW), Technische Universität Graz (TUG) and Company MatchID®. Consequently, 2 pilot projects (strategic use cases) were defined and are being conducted by our new spin-off company KAOMX at European research centers headed by key opinion leaders (KOLs).
1. to stretch tissues and measure the induced mechanical strain with a 10 µm spatial resolution,
2. to map the distribution of local stiffness properties with a 10 µm spatial resolution.
Our specific objectives were to (O1) build an integrated user-friendly prototype ready for exploitation in CVD; (O2) adapt the prototype to follow standards to help the future commercialization; (O3) determine further IPR strategy; (O4) establish the commercialization roadmap including market research, industrial partnerships and lead management.
The implementation of the project involved a progressive evolution of the different proposed objectives. Progress on specific objective O4 had a significant impact on the approach to the project's overall objective. The tasks and corresponding work-packages related to the different specific objectives were restructured and redefined. The respective changes and the goals achieved are explained. However, the general scope of the project maintained its initial context.
We established very close collaborations with 3 other partners: Technische Universität Wien (TUW), Technische Universität Graz (TUG) and Company MatchID®. Consequently, 2 pilot projects (strategic use cases) were defined and are being conducted by our new spin-off company KAOMX at European research centers headed by key opinion leaders (KOLs).
WP1: Hardware developments and maturation.
The study started with a screening of existing technologies that offered a possible solution to the biaxial stretching system. However, for all cases, the technical specifications do not correspond to the standards required for the conception of our device. In addition, the possible customization offered by the suppliers increased the costs considerably.
A second screening was carried out considering the mechatronic components required for the design of the uniaxial and biaxial stretching system including.
Concerning Optical Coherence Tomography (OCT) technology, we evaluated different OCT providers, image digitization strategies, immersion media and lens distances.
Methods and techniques were also defined to verify and validate the resolution and accuracy of the selected mechatronic components.
After the prototype's conceptual design was defined, we started to synchronize and automate the displacement protocols, mechanical load measurement and image acquisition considering the ISO/IEC 25010 software quality model (via standardization). The control objective is to design robust controllers to ensure both stability and good performances of the system despite disturbances and model uncertainty. Robustness and real-time implementability are the main features in the optimization procedure and are used to determine the controller parameters.
The mechatronic components synchronization engine was developed in Python (open-source for KOLs). In particular, velocity, positions, loads and elapsed time are the main data sets to be stored and saved for the corresponding data post-processing. Related to the OCT image acquisition and pre-processing, the goal is to integrate the software of the OCT technology provider with the software developed for the biaxial device control system. Based on the use-cases, evaluate the performance of optical acquisitions in terms of synchronization and relative to different stretching conditions. This requires dealing with large-size images and time-consuming calculations.
In addition, we tested additional porcine coronary arteries which allows us to give feedback on the device design and define the test protocol. Furthermore, optical acquisitions are currently used to establish protocols for different types of samples (soft tissues and 3D bioprinted tissue constructs). The goal is to correct possible distortions of OCT images related to refraction index variations, definition of the use conditions of the technique (opacity/transparency, thickness/scattering, refractive index, immersion medium), quantification of spatial resolution and uncertainties.
WP2: Market research
A first study was commissioned from a consulting firm with expertise in emerging technology assessment and global market evaluation. The Valoritech® program allowed us to articulate a strategic vision to promote and accelerate our innovation, identifying new research and development opportunities. As a result, the vision, needs and market segments were defined.
WP3: Go-to-market pathway/strategy
We have identified more than 100 university laboratories worldwide where the device technology meets a real need. The time to market of this first business application is estimated to be approximately 4 years after the end of the ERC-PoC project. The business model related to this first target market needs to be refined. Having started selling the device to universities, our mid-term goal is to enter the market of engineering companies dedicated to R&D in biotechnology in 7-8 years. We have started to qualify this market, which has yet to be quantified. In France alone, more than 2.000 companies are registered as engineering companies engaged in biotechnological R&D (NAF 7211). The time to market of this second business application will be longer (2032) and requires successful access to the first market segment to ensure enough credibility and attractiveness.
The study started with a screening of existing technologies that offered a possible solution to the biaxial stretching system. However, for all cases, the technical specifications do not correspond to the standards required for the conception of our device. In addition, the possible customization offered by the suppliers increased the costs considerably.
A second screening was carried out considering the mechatronic components required for the design of the uniaxial and biaxial stretching system including.
Concerning Optical Coherence Tomography (OCT) technology, we evaluated different OCT providers, image digitization strategies, immersion media and lens distances.
Methods and techniques were also defined to verify and validate the resolution and accuracy of the selected mechatronic components.
After the prototype's conceptual design was defined, we started to synchronize and automate the displacement protocols, mechanical load measurement and image acquisition considering the ISO/IEC 25010 software quality model (via standardization). The control objective is to design robust controllers to ensure both stability and good performances of the system despite disturbances and model uncertainty. Robustness and real-time implementability are the main features in the optimization procedure and are used to determine the controller parameters.
The mechatronic components synchronization engine was developed in Python (open-source for KOLs). In particular, velocity, positions, loads and elapsed time are the main data sets to be stored and saved for the corresponding data post-processing. Related to the OCT image acquisition and pre-processing, the goal is to integrate the software of the OCT technology provider with the software developed for the biaxial device control system. Based on the use-cases, evaluate the performance of optical acquisitions in terms of synchronization and relative to different stretching conditions. This requires dealing with large-size images and time-consuming calculations.
In addition, we tested additional porcine coronary arteries which allows us to give feedback on the device design and define the test protocol. Furthermore, optical acquisitions are currently used to establish protocols for different types of samples (soft tissues and 3D bioprinted tissue constructs). The goal is to correct possible distortions of OCT images related to refraction index variations, definition of the use conditions of the technique (opacity/transparency, thickness/scattering, refractive index, immersion medium), quantification of spatial resolution and uncertainties.
WP2: Market research
A first study was commissioned from a consulting firm with expertise in emerging technology assessment and global market evaluation. The Valoritech® program allowed us to articulate a strategic vision to promote and accelerate our innovation, identifying new research and development opportunities. As a result, the vision, needs and market segments were defined.
WP3: Go-to-market pathway/strategy
We have identified more than 100 university laboratories worldwide where the device technology meets a real need. The time to market of this first business application is estimated to be approximately 4 years after the end of the ERC-PoC project. The business model related to this first target market needs to be refined. Having started selling the device to universities, our mid-term goal is to enter the market of engineering companies dedicated to R&D in biotechnology in 7-8 years. We have started to qualify this market, which has yet to be quantified. In France alone, more than 2.000 companies are registered as engineering companies engaged in biotechnological R&D (NAF 7211). The time to market of this second business application will be longer (2032) and requires successful access to the first market segment to ensure enough credibility and attractiveness.
The plan is now to create a spin-off company, named KaomX®, to commercialize the device to the first market segment by 2027. KaomX® will be launched in December 2023. KaomX® will collaborate with MatchID® and IMT for the software development, and with TUG, TUW and IMT for the hardware part. All partners will agree on IP ownership from the beginning, with IMT keeping the exclusive right of industrial exploitation. The transfer of IP from IMT to the spin-off will take the form of exclusive licenses with an option to purchase and progressive costs to avoid overloading the company’s finance before it generates its first commercial revenues. Such an agreement has already been established between IMT and other spin-off companies in the past.