Aenitis Technologies and the Direction Générale de l'Armement (DGA) sign a partnership to develop a new AMSC-S project with a 1,2 million euros budget

An ambitious project supported by AENITIS to develop a new preparation process for healthy Mesenchymal Stromal Cells for cell therapy

Paris, October 31st 2019 - Aenitis Technologies, who's currently developing new manipulation medical devices and cell sorting based on the use of acoustic energy, announced a new partnership with the DGA in order to develop a new Acoustic Mesenchymal Stem Cell- Sorter (AMSC-S) project. Supported by the AENITIS and with the collaboration of the Centre de Transfusion Sanguine des Armées (CTSA) and l'Unité fonctionnelle de Thérapie Cellulaire de l'hôpital Saint-Louis (UTC), the objective of this project is to limit or remove negative impacts during the isolation process and prepare cells during the development of new Mesenchymal Stromal Cells (MSC) based medication.

This contract is part of the RAPID (Régime d'appui pour l'innovation duale) initiative benefiting from a 1,2 million Euros financing from the DGA and DGE for this project which is set to take about 32 months to complete.

"The partnership with Aenitis is a perfect illustration of the excellence, efficiency and openness of the Army Health Services in innovative cell therapies for the wounded," said Pr. Christophe Martinaud (MA and PhD), Blood Transfusion Center of the Armies.

« The CSsM are among the most used cells for cell therapy and constitutes a real challenge for this field. We are truly honored to work towards this major challenge of the new therapeutic axes of public health with renown partners such as the CTSA and the Unité fonctionnelle de Thérapie Cellulaire de l'hôpital Saint-Louis. The DGA and DGE's RAPID program is of vital support and very relevant for financing this type of projects that are, unfortunately, not in the line of sight of private investors. Two years ago, a study from the Boston Consulting Group pointed out that medical devices are indeed the black sheep for venture capital funds, » says Emmanuel VINCENT, Aenitis Technologies co-founder and CEO.

Among the various cell therapies, the Mesenchymal Stromal Cells (MSC), also known as Mesenchymal Stem Cells (MSC), have a potential for differentiation and particularly interesting properties. Their potential uses are vast and they are the most used cells in the field of regenerative medicine: skin grafts, hemorrhagic shock, autoimmune diseases, non-contiguous fractures, cerebrovascular accidents, infarction, etc. For all these purposes, over one hundred more begin each year; some of which are already on phase III. Across the world, more than 10 CSM-based medications are available on the market.

However, the isolation process and cell preparation, downstream processing, remains a long drawn out, complex and expensive process and it can also presents high risks of contamination. The impact of the limits of these isolation processes can be economically dangerous for those who have developed cellular therapies as highlighted by the four market withdrawals observed in Europe (Provenge, MACI, Glybera and Chondrocelect), despite proven medical benefits. Furthermore, the lack of homogeneity of the cell could explain the lack of coherence of some results obtained with the CSMs in particular.

The objective of the Acoustic Mesenchymal Stem Cell - Sorter (AMSC-S) is to develop a medical device which will allow the isolation and concentration of the CSM in order to simplify the development of new CSM based medication.

Market

Regenerative medicine groups together tissue engineering and cell therapy. It represents an 11 million Euros market worldwide and has an annual growth of approximately 26% per annum. Whereas in Europe authorizations are granted by the European Medicines Agency (EMA) and in the USA they are approved by the Food and Drug Administration (FDA), in France, 11 institutions are allowed to reproduce MTI-PP (Médicaments de Thérapie Innovante Préparés Ponctuellement) for medical purposes and 5 of them can produce specific medical prescriptions, outside of medical research, unlike the MTI.

There are multiple obstacles currently hindering the development of CSM based medicine: process cost, length, return on performance, contamination related to the open environment and clinical impacts. To do so, new sorting technologies must be developed. Based on Roots Analysis' 2019 study, more than 3000 patents have been filed in the sorting field and cell separation, which displays the importance of these issues.

This is what the Acoustic Mesenchymal Stem Cell - Sorter (AMSC-S) project wants to achieve by attaining the following five objectives:

An economical gain on the unitary isolation process: developing a continuous process, which requires less workforce, estimated at 50% of the high cost (~15 to 40k€) and limiting the usage of CSM in cell therapies;

Saving isolation and cultivation time: create an automated and continuous process which would generate a concentrated solution within a few hours;

Higher return: The ratio of viable cells / preparation time should be improved through the AMSC-S device by decreasing the time and by increasing the number of viable and functional cells obtained.

Reduced contaminations: the Aenitis process allows contact free and continuous manipulation in a sterile medical device thus limiting contact with any external environment.

Improved clinical impact by creating more homogeneous solutions and maintaining cell functionality.

Aenitis technology

Patented and used, the Aenitis technology is based on the usage of acoustic force generated between two canal walls in order to manipulate or split particles or biological objects (cells or cell clusters, bacteria, liposomes, solid particles, etc.) without contact by suspending it in a fluid at rest or dripping.

Physical principal

It consists of using ultrasound waves in order to generate acoustic radiation force between two micro-canal walls. The Acoustic Radiation Forces (ARF) pushes the particles towards the pressure node with a force that can reach a hundred times its weight. The acoustic force sustained by the suspended object is dependent on its physical properties (density) and geometric (diameter for a spherical object). Thereby, based on the amplitude of the acoustic wave, we can regroup certain species in the middle of the canal while others won't budge due to a weak acoustic radiation force. This physical phenomenon can be used in a variety of ways and knows several variants. By increasing the ultrasonic wave frequency, it is possible to create a second sound pressure node. We can then focus particles at two different heights in the micro-canal (Figure 2). Particles of different nature can be focused at two different heights in the micro-channel. Thus it's possible to separate biological species of different sizes or of different acoustic properties.

Principal actors of the AMSC-S project

The AMSC-S project will be supported by Aenitis in collaboration with the Centre de Transfusion Sanguine des Armées (CTSA), the only institution authorized to reproduce Mesenchymal Stem Cells (MSC) based preparation for treating major burn patients.

About Aenitis Technologies

Aenitis Technologies meets the challenges of developing and industrializing cell therapies by developing medical devices for cell preparation. Based on ultrasound, this innovating technology allows more efficient and continuous screening and filtering of the cells without pressure and physical contact in order to preserve them and reduce the risk of contamination. The start-up was founded in 2014 and is a spinoff of the CNRS research lab and the ESPCI Paris. It is supported by a large portfolio of intellectual property. For more information: www.aenitis.fr