Periodic Reporting for period 2 - C-LANT Drainage Port (Life Saving Technology for Thoracic Trauma Treatment and Post Operative Drainage)
Reporting period: 2024-03-01 to 2024-10-31
Trauma is the 3rd leading cause of death, with thoracic trauma being leading cause of accidental death, with 60% of mortality in polytraumatic patients. Every year, 17M patients worldwide suffer from thoracic trauma, and 62.3M undergo thoracic and abdominal drainage.
Thoracic trauma causes breathing difficulties, shifting organs in the thorax and lungs and heart collapse. Chest trauma is fatal if not immediately identified; a “Golden Hour rule” is applied: a casualty has 80% survival chance if treated within 1 hour. The most effective treatment – chest tubes - are invasive procedures that first responders cannot use in the field, losing the Golden time-critical to saving lives. Even in hospital settings, chest tube complications – high-risk insertion, malpositioning, dislodgement, obstruction, kinking, ineffective drainage, leakage or infection – occur in 20-40% of cases. Globally, >300k people suffer from post-surgery chest tube complications leading to about €2.6Bn of costs associated with tube replacement only in Europe.
C-LANT, developed in the current Project, is a revolutionary device for the immediate and efficient treatment of all type of chest trauma or post-operative thoracic and abdominal procedures.
C-LANT is a whole approach that, thanks to its self-fixating system, allows a safe, automatic and patient talored adjustment to the body in seconds. The fixation system limits the depth of device insertion into the cavity and adapts itself to the patient´s thorax/abdomen, avoiding internal organ damage and ensuring the patient´s safety.
The sealing system of C-LANT makes it highly efficient. C-LANT creates a working channel that hermetically fixates any size of catheter/tube/instrument, thereby easing the drainage operation.
C-LANT is a COST-EFFICIENT solution that can 1) save lives - enabling the instant insertion of tubes at the field and 2) decrease costs - reducing the need for re-interventions due to tube complications and no need for accessories for insertion, fixation or removal.
Thoracic trauma causes breathing difficulties, shifting organs in the thorax and lungs and heart collapse. Chest trauma is fatal if not immediately identified; a “Golden Hour rule” is applied: a casualty has 80% survival chance if treated within 1 hour. The most effective treatment – chest tubes - are invasive procedures that first responders cannot use in the field, losing the Golden time-critical to saving lives. Even in hospital settings, chest tube complications – high-risk insertion, malpositioning, dislodgement, obstruction, kinking, ineffective drainage, leakage or infection – occur in 20-40% of cases. Globally, >300k people suffer from post-surgery chest tube complications leading to about €2.6Bn of costs associated with tube replacement only in Europe.
C-LANT, developed in the current Project, is a revolutionary device for the immediate and efficient treatment of all type of chest trauma or post-operative thoracic and abdominal procedures.
C-LANT is a whole approach that, thanks to its self-fixating system, allows a safe, automatic and patient talored adjustment to the body in seconds. The fixation system limits the depth of device insertion into the cavity and adapts itself to the patient´s thorax/abdomen, avoiding internal organ damage and ensuring the patient´s safety.
The sealing system of C-LANT makes it highly efficient. C-LANT creates a working channel that hermetically fixates any size of catheter/tube/instrument, thereby easing the drainage operation.
C-LANT is a COST-EFFICIENT solution that can 1) save lives - enabling the instant insertion of tubes at the field and 2) decrease costs - reducing the need for re-interventions due to tube complications and no need for accessories for insertion, fixation or removal.
During RP2, Vigor medical completed the technology transfer of C-Lant drainage port from R&D to production. 9 moulds for manufacturing of polymer components were designed and manufactured, all the metal components of the device were manufactured, full quality system was established according to ISO 13485 and being implemented, all 21 polymer components for over 300 sets of C-Lant for the V&V testing were manufactured.
As a preparation for the conduct of clinical trial required for CE approval, all the clinical documentation was prepared including study protocol, Investigator brochure, clinical report forms and informed consent forms. Clinical research organization was engaged and 3 clinical sites identified from Czech Republic and Israel. Letters of intent for the conduct of the trial and positive feedbacks for C-Lant technology were received from these centres. Additionally, usability study was planned for testing of the device by 15 doctors and 15 paramedics was planned and letters of intent obtained from 2 facilities in Israel, in which it is planned to be conducted.
During the project the device was presented to 19 new potential users of the device as a part of market research continuation, all had positive feedback regarding the technology and its proposed added value for various medical applications. Several dissemination and commercialization activities took place including participation in conferences, courses, update of website and LinkedIn page, launch of Facebook page and others, detailed in the questionnaire.
Design patent has been prepared for C-Lant in cooperation with GL Patents and is planned to be submitted in early 2025 to expand the IP of the company.
As a preparation for the conduct of clinical trial required for CE approval, all the clinical documentation was prepared including study protocol, Investigator brochure, clinical report forms and informed consent forms. Clinical research organization was engaged and 3 clinical sites identified from Czech Republic and Israel. Letters of intent for the conduct of the trial and positive feedbacks for C-Lant technology were received from these centres. Additionally, usability study was planned for testing of the device by 15 doctors and 15 paramedics was planned and letters of intent obtained from 2 facilities in Israel, in which it is planned to be conducted.
During the project the device was presented to 19 new potential users of the device as a part of market research continuation, all had positive feedback regarding the technology and its proposed added value for various medical applications. Several dissemination and commercialization activities took place including participation in conferences, courses, update of website and LinkedIn page, launch of Facebook page and others, detailed in the questionnaire.
Design patent has been prepared for C-Lant in cooperation with GL Patents and is planned to be submitted in early 2025 to expand the IP of the company.
During the current Project, Vigor Medical will deliver C-Lant technology, which is a revolutionary device and emergency kit for the immediate and efficient treatment of all type of chest trauma or post-operative thoracic and abdominal procedures.
C-LANT is a whole approach that, thanks to its self-fixating system, allows a safe, automatic and patient talored adjustment to the body in seconds. The fixation system limits the depth of device insertion into the cavity and adapts itself to the patient´s thorax/abdomen, avoiding internal organ damage and ensuring the patient´s safety.The sealing system of C-LANT makes it highly efficient. C-LANT creates a working channel that hermetically fixates any size of catheter/tube/instrument, thereby easing the drainage operation.
C-lant is an enabling technology for the usage of less experienced medical personnel pre-hospital.
We expect C-Lant to save the lives of patients with 80% of higher probability- enabling the instant insertion of tubes at the field and to decrease costs to hospitals by reducing the need for re-interventions due to tube complications and no need for accessories for insertion, fixation or removal.
To ensure the uptake and success of the project will be conduct further market research, monitor the competing companies solutions, will continue to conduct product demonstrations to EMS specialists, implement the regulatory plan towards obtaining regulatory approvals, establish and maintain the full quality system, prepare design patent to further protect Vigor’s IP, prepare a reimbursement plan to obtain an insurance coverage for device at the commercialization phase in Europe. We have already established a subsidiary in EU to further support the commercialization preparation and gaining better access to targeted customers at selected geographies.
C-LANT is a whole approach that, thanks to its self-fixating system, allows a safe, automatic and patient talored adjustment to the body in seconds. The fixation system limits the depth of device insertion into the cavity and adapts itself to the patient´s thorax/abdomen, avoiding internal organ damage and ensuring the patient´s safety.The sealing system of C-LANT makes it highly efficient. C-LANT creates a working channel that hermetically fixates any size of catheter/tube/instrument, thereby easing the drainage operation.
C-lant is an enabling technology for the usage of less experienced medical personnel pre-hospital.
We expect C-Lant to save the lives of patients with 80% of higher probability- enabling the instant insertion of tubes at the field and to decrease costs to hospitals by reducing the need for re-interventions due to tube complications and no need for accessories for insertion, fixation or removal.
To ensure the uptake and success of the project will be conduct further market research, monitor the competing companies solutions, will continue to conduct product demonstrations to EMS specialists, implement the regulatory plan towards obtaining regulatory approvals, establish and maintain the full quality system, prepare design patent to further protect Vigor’s IP, prepare a reimbursement plan to obtain an insurance coverage for device at the commercialization phase in Europe. We have already established a subsidiary in EU to further support the commercialization preparation and gaining better access to targeted customers at selected geographies.