Periodic Reporting for period 1 - Dyneelax (The world’s first automated laximetry device that replicates daily movements and activities through a dynamic test.)
Période du rapport: 2019-07-01 au 2019-11-30
GENOUROB go on with the Dyneelax project : put medical devices in severals countries to assess the interest for General Practitioners and customers (patients). They (GP) usually used MRI explorations for detecting ACL injury when they feel an unstable knee after clinical exam on their patients. Use Dyneelax exam is more objective, faster and less expensive than MRI in this case... Motorized laximeters (from Genourob company) are now wellknown in the world but with only orthopaedists and not with GPs. We have to evangelize this new system for all GPs.
GENOUROB validated the prototype device ( on an Eurostars program) with 4 other partners (1 Lux, 1 CZ, 2 F). Now we have to validate the EMC (electro-magnetic compatibility) and Security tests with the LCIE laboratory in Paris. We get a little delay because of the administrative procédures. But it's in process and normally it would be done at the end of november 2019. After that we could get the EC mark.
GENOUROB also did a study about the reproducibility of Dyneelax tests with 2 operators (intra and inter-operators study) with a very good conclusion : best than gold standard device like 3D motion analysis system (BBraun 3D system).
Now we are in process for elaborating a study market with a coach (Anne GUIGOU) with the agreement of EASME and Cendrine CARMAGNAC (advisor of EEN-west).
GENOUROB has the ambition for becoming the leader in the field of laximeters devices for knees exams in the world.
GENOUROB want to bring solutions for GPs to get faster and with accuracy the assessments (for diagnosis) of ACL injuries with knee instability (of patients).
GENOUROB validated the prototype device ( on an Eurostars program) with 4 other partners (1 Lux, 1 CZ, 2 F). Now we have to validate the EMC (electro-magnetic compatibility) and Security tests with the LCIE laboratory in Paris. We get a little delay because of the administrative procédures. But it's in process and normally it would be done at the end of november 2019. After that we could get the EC mark.
GENOUROB also did a study about the reproducibility of Dyneelax tests with 2 operators (intra and inter-operators study) with a very good conclusion : best than gold standard device like 3D motion analysis system (BBraun 3D system).
Now we are in process for elaborating a study market with a coach (Anne GUIGOU) with the agreement of EASME and Cendrine CARMAGNAC (advisor of EEN-west).
GENOUROB has the ambition for becoming the leader in the field of laximeters devices for knees exams in the world.
GENOUROB want to bring solutions for GPs to get faster and with accuracy the assessments (for diagnosis) of ACL injuries with knee instability (of patients).
Genourob design, manufacture and market medical devices and specifically for helping Medical Practitioners to detect ACL (Anterior Cruciate Ligament) tears (complete and mostly partial are very difficult to observe with only manual exams). ACL is very important for knee stability and when you get a torn ACL you must very often operate it with an ACL graft. The last ten years expertise have shown that ACL is not alone for the knee stability and several other peripherical ligaments as ALL (Antero Lateral Ligament) are important too and has torn with ACL injury very frequently. If you can detect ACL tears with tibial translation tests (like Lachman test in clinical exam), you must assess tibial rotation movements (specifically medial rotation) for ALL tears. The specific test for detecting rotatory instability is the jerk (pivot) test but it’s very difficult to realize when the patient is not under anesthesia. Lots of manual devices exist but just for reproducing the Lachman test only.
That’s why in the last decade Genourob has produced a new medical device (the first motorized device, the GNRB, for the Lachman test and then another, the Rotam, for tibial rotation assessments. But it was two independent motorized devices and to be more efficient we decided to design an all-in-one device the Dyneelax for both tibial translation and rotation assessments.
It was spread all over the world for surgeons first. They now have validated these motorized devices and we can offer this exam for GPs (General Practitioners) who are the first concerned medical practitioners when patient get an ACL tear. Unfortunatly GPs usually used MRI now because they think that it’s the only device to confirm an ACL rupture. So we must try to warn them (GPs) that there’s a new device to get a good complementary exam and less expensive than MRI for detecting ACL tears.
The goal for us is now to introduce in GPs practices this ADL test (Automated Dynamic Laximetry test) with motorized devices when they suspect ACL tears from a patient with a knee sprain. It is not necessarily the GPs who must carry out this ADL test but in Medical Centers with assistants or perharps in radiologists or physiotherapists offices.
Validate the Dyneelax device as the reference and easy access for General Practitioners (GPs) to detect ACL tears instead of using MRI exploration (because of delays and costs for communities).
Dyneelax is the combination of GNRB and ROTAM devices which could analyze tibial translation and rotation assessments.
The first step to design this new device was to elaborate a specific work plan with several items.
This part of specifications presents an analysis of the conceptual, functional and technical requirements of the client *, in order to produce the conceptual architecture, an analysis of the data domain (risk management, compliance with ISO standards, etc.), and the different stages of software development for the product Dyneelax.
Architecture according with the standard EN 62304
Genourob medical devices are developed according to EN 62304 standards. The development follows the V-model, definition of production and maintenance processes and activities : presented in processing layers and separate interfaces.
That’s why in the last decade Genourob has produced a new medical device (the first motorized device, the GNRB, for the Lachman test and then another, the Rotam, for tibial rotation assessments. But it was two independent motorized devices and to be more efficient we decided to design an all-in-one device the Dyneelax for both tibial translation and rotation assessments.
It was spread all over the world for surgeons first. They now have validated these motorized devices and we can offer this exam for GPs (General Practitioners) who are the first concerned medical practitioners when patient get an ACL tear. Unfortunatly GPs usually used MRI now because they think that it’s the only device to confirm an ACL rupture. So we must try to warn them (GPs) that there’s a new device to get a good complementary exam and less expensive than MRI for detecting ACL tears.
The goal for us is now to introduce in GPs practices this ADL test (Automated Dynamic Laximetry test) with motorized devices when they suspect ACL tears from a patient with a knee sprain. It is not necessarily the GPs who must carry out this ADL test but in Medical Centers with assistants or perharps in radiologists or physiotherapists offices.
Validate the Dyneelax device as the reference and easy access for General Practitioners (GPs) to detect ACL tears instead of using MRI exploration (because of delays and costs for communities).
Dyneelax is the combination of GNRB and ROTAM devices which could analyze tibial translation and rotation assessments.
The first step to design this new device was to elaborate a specific work plan with several items.
This part of specifications presents an analysis of the conceptual, functional and technical requirements of the client *, in order to produce the conceptual architecture, an analysis of the data domain (risk management, compliance with ISO standards, etc.), and the different stages of software development for the product Dyneelax.
Architecture according with the standard EN 62304
Genourob medical devices are developed according to EN 62304 standards. The development follows the V-model, definition of production and maintenance processes and activities : presented in processing layers and separate interfaces.
Several data from ACL tears and MRI practices :
The population-wide incidence estimates for soft tissue knee injuries is :
Annual incidence for males and female 766 and 676 / 100 000 persons / Year respectively (data from Skane Healthcare Register in 2014.”a range of knee injuries continue to occur across the adult lfespan… when osteoarthritis is typically diagnosed and managed … may warrant futher investigation”. Pear and al ; Arthritis Research & Therapy ; 2014 ; 16 : R162.
In France it almost 45000 ACL surgeries / year (2 M in the US) : it increases year after year because of increasing sport activities (there’s also more young and older patients with ACL surgeries to decrease arthrosis risks years after injuries and return to pivot sport with less risks too).
First of all we wanted to validate Dyneelax device with beta-testers : orthopedics surgeons like Dr ROBERT (co-inventor of GNRB Device) , INSEP department (several tests with young basket ball players (50)) with a physio J. POREL, sports medicine practitioners (as Dr FAVORY, sports medicine practitioners with for 50 % GP activity and 50 % a soccer team activity) and others professionals…
Now we are ready to distribute this device among GP centers, radiologists, physiotherapists, others practitioners or well trained customers (as users).
Since 2010 GENOUROB have sold 300 GNRB devices in the world and have got of course many places where we can do this project. For instance, in France, we can begin in Paris and in five other regions (in the West in Laval, in the North in Lille, in the East in Strasbourg, in the south east in Nice, in the south west in Bordeaux).
The population-wide incidence estimates for soft tissue knee injuries is :
Annual incidence for males and female 766 and 676 / 100 000 persons / Year respectively (data from Skane Healthcare Register in 2014.”a range of knee injuries continue to occur across the adult lfespan… when osteoarthritis is typically diagnosed and managed … may warrant futher investigation”. Pear and al ; Arthritis Research & Therapy ; 2014 ; 16 : R162.
In France it almost 45000 ACL surgeries / year (2 M in the US) : it increases year after year because of increasing sport activities (there’s also more young and older patients with ACL surgeries to decrease arthrosis risks years after injuries and return to pivot sport with less risks too).
First of all we wanted to validate Dyneelax device with beta-testers : orthopedics surgeons like Dr ROBERT (co-inventor of GNRB Device) , INSEP department (several tests with young basket ball players (50)) with a physio J. POREL, sports medicine practitioners (as Dr FAVORY, sports medicine practitioners with for 50 % GP activity and 50 % a soccer team activity) and others professionals…
Now we are ready to distribute this device among GP centers, radiologists, physiotherapists, others practitioners or well trained customers (as users).
Since 2010 GENOUROB have sold 300 GNRB devices in the world and have got of course many places where we can do this project. For instance, in France, we can begin in Paris and in five other regions (in the West in Laval, in the North in Lille, in the East in Strasbourg, in the south east in Nice, in the south west in Bordeaux).