Periodic Reporting for period 1 - AssesSkin (Development of a non-invasive medical device to measure the skin biomechanical properties: assessment of the commercial feasibility)
Periodo di rendicontazione: 2024-04-01 al 2025-09-30
Skin pathologies including wounds, scars and tumors represent important public health issues. (e.g. melanoma is the first cancer in terms of increasing frequency). Moreover, skin firmness is an essential property aimed by cosmetic products. However, skin assessment methods remain based on empirical considerations and it is still difficult to determine the skin biomechanical properties, which prevents developing a personalized medicine approach. Such medical device is needed by the physicians to adapt the therapeutic strategy and by the cosmetic manufacturers to develop and validate their product, and to propose the optimal product in a customer-specific manner.
AssesSkin is based on results obtained in the ERC CoG project BoneImplant and aims at developing and validating a medical device consisting in a decision support-system allowing to assess the skin biomechanical properties. The objectives of AssesSkin are i) to achieve a minimum viable product that will be validated in vitro and in vivo, and ii) to investigate its commercial potential and design an exploitation strategy via spin-off creation or licensing. We will explore the possibility to license the technology to ImpacTell, an already existing spin-off of the same laboratory. The originality is to use an impact-based measurement method, which allows to obtain a non-invasive, cheap and easy to use medical device.
Regulatory issues will be at the heart of the development and we will work in order to clear the regulatory pathway of the future medical device. The team is constituted by members with complementary skills (engineers, a business developer, a dermatologist and a plastic surgeon).
AssesSkin will allow the promotion of innovative solution and services in dermatology, plastic surgery and in the cosmetic industry. The long-term vision is for the technology to become a reference in these fields. Strong impacts are associated to AssesSkin, in particular for patients, physicians and cosmetic manufacturers.
AssesSkin is based on results obtained in the ERC CoG project BoneImplant and aims at developing and validating a medical device consisting in a decision support-system allowing to assess the skin biomechanical properties. The objectives of AssesSkin are i) to achieve a minimum viable product that will be validated in vitro and in vivo, and ii) to investigate its commercial potential and design an exploitation strategy via spin-off creation or licensing. We will explore the possibility to license the technology to ImpacTell, an already existing spin-off of the same laboratory. The originality is to use an impact-based measurement method, which allows to obtain a non-invasive, cheap and easy to use medical device.
Regulatory issues will be at the heart of the development and we will work in order to clear the regulatory pathway of the future medical device. The team is constituted by members with complementary skills (engineers, a business developer, a dermatologist and a plastic surgeon).
AssesSkin will allow the promotion of innovative solution and services in dermatology, plastic surgery and in the cosmetic industry. The long-term vision is for the technology to become a reference in these fields. Strong impacts are associated to AssesSkin, in particular for patients, physicians and cosmetic manufacturers.
Over the past few decades, various non-invasive approaches, such as elastographic techniques, have emerged to quantify the elastic properties of tissues. However, despite their promising performance, these imaging techniques are expensive and complex to use. This work presents a new, simple, real-time, and low-cost non-invasive approach for the biomechanical characterization of skin.
This technique is based on an impact analysis method. A force signal is recorded during the impact of an instrumented hammer on a cylindrical punch in contact with the tissue to be characterized. This signal comprises several peaks resulting from the punch's rebounds between the hammer and the soft tissue. An indicator of tissue stiffness is deduced from the time interval between these peaks. Using various soft tissue phantoms (homogeneous and bilayered), in vitro studies were designed to determine the performance of this new method (in terms of reproducibility, volume of interest, and stiffness and spatial sensitivity). A comparative study was then conducted with other devices such as Cutometer® (a reference method in the cosmetics industry), MyotonPro® (widely used in research), IndentoPro®, and Durometer.
In light of the results, a decision-support device (MVP) to assess the mechanical properties of skin has been developed. Various aspects will need to be clarified to complete the development of the future medical device. New indicators of these phenomena could be derived from the force signal. Alternatively, these mechanical properties could also be estimated using an inverse model-based inversion approach.
Following the initial measurements on biological tissues, subsequent investigations should aim to approximate future utilization conditions, specifically in vivo skin characterization. Until a suitable prototype for clinical studies is developed, research will be conducted using animal models. The protocol for monitoring wound healing mechanics and hyaluronic acid injection-induced hydration could be reproduced with a new animal model, more consistent with the human model in terms of skin structure, and by extending the period and reducing the measurement intervals of the protocol to refine the results.
A clinical study involving human subjects will be possible with the final version of the product after having cleared all regulatory requirements. We have validated the class of the set-up as the regulatory pathway in the context of a medical device, which implies setting up a Quality Management system and obtaining pre-series on which various tests will need to be carried out.
We have performed an additional market study to validate our choices. Moreover, we have established a clear marketing plan. Overall, the company will retain control over the production and know-how of Smart-Hammer through its subcontractors. We already have contacts with major companies who are interested in the future product. We now consider the creation of the company in the direction to perform the clinical transfer.
This technique is based on an impact analysis method. A force signal is recorded during the impact of an instrumented hammer on a cylindrical punch in contact with the tissue to be characterized. This signal comprises several peaks resulting from the punch's rebounds between the hammer and the soft tissue. An indicator of tissue stiffness is deduced from the time interval between these peaks. Using various soft tissue phantoms (homogeneous and bilayered), in vitro studies were designed to determine the performance of this new method (in terms of reproducibility, volume of interest, and stiffness and spatial sensitivity). A comparative study was then conducted with other devices such as Cutometer® (a reference method in the cosmetics industry), MyotonPro® (widely used in research), IndentoPro®, and Durometer.
In light of the results, a decision-support device (MVP) to assess the mechanical properties of skin has been developed. Various aspects will need to be clarified to complete the development of the future medical device. New indicators of these phenomena could be derived from the force signal. Alternatively, these mechanical properties could also be estimated using an inverse model-based inversion approach.
Following the initial measurements on biological tissues, subsequent investigations should aim to approximate future utilization conditions, specifically in vivo skin characterization. Until a suitable prototype for clinical studies is developed, research will be conducted using animal models. The protocol for monitoring wound healing mechanics and hyaluronic acid injection-induced hydration could be reproduced with a new animal model, more consistent with the human model in terms of skin structure, and by extending the period and reducing the measurement intervals of the protocol to refine the results.
A clinical study involving human subjects will be possible with the final version of the product after having cleared all regulatory requirements. We have validated the class of the set-up as the regulatory pathway in the context of a medical device, which implies setting up a Quality Management system and obtaining pre-series on which various tests will need to be carried out.
We have performed an additional market study to validate our choices. Moreover, we have established a clear marketing plan. Overall, the company will retain control over the production and know-how of Smart-Hammer through its subcontractors. We already have contacts with major companies who are interested in the future product. We now consider the creation of the company in the direction to perform the clinical transfer.
In silico models were developed to study the behavior of the impact analysis method as a function of soft tissue properties in a controlled environment. First, a numerical model using finite elements and a one-dimensional acoustic analytical model considering a linear elastic soft tissue were compared with experimental data. Then, the acoustic modeling was refined by redefining the soft tissue material to include viscosity and nonlinearity. In parallel, various artificial intelligence tools were applied to a database of soft tissue phantoms of varying stiffness. After data analysis, various Young's modulus prediction models for the phantoms were implemented using machine learning (e.g. support vector machines, k-nearest neighbors, and decision trees) and deep learning (e.g. convolutional neural networks). The first characterizations of biological tissues were obtained from murine models. On the one hand, a preliminary ex vivo study on a mouse model of neurofibromatosis type 1 quantified the performance of the impact analysis technique in discriminating skin regions affected by cutaneous neurofibromas from healthy areas. On the other hand, an in vivo study was conducted to monitor changes in the mechanical properties of skin tissues during healing after tissue loss and hydration following intradermal hyaluronic acid injection.
Eventually, we have validated the regulatory pathway and set up a viable business plan, allowing to consider the creation of the company as soon as private equity funding is available.
This work validates a new technique for the mechanical characterization of soft tissues, demonstrating improved performance compared to the literature. These results pave the way for the development of a decision-support method for quantifying the biomechanical properties of the skin. Furthermore, the accessibility and affordability of this technology make it possible to consider its integration i) in clinical practice for the diagnosis or monitoring of dermatological diseases and ii) in the cosmetic industry to justify the claims of new formulations or to personalize skin care advice.
Eventually, we have validated the regulatory pathway and set up a viable business plan, allowing to consider the creation of the company as soon as private equity funding is available.
This work validates a new technique for the mechanical characterization of soft tissues, demonstrating improved performance compared to the literature. These results pave the way for the development of a decision-support method for quantifying the biomechanical properties of the skin. Furthermore, the accessibility and affordability of this technology make it possible to consider its integration i) in clinical practice for the diagnosis or monitoring of dermatological diseases and ii) in the cosmetic industry to justify the claims of new formulations or to personalize skin care advice.