Periodic Reporting for period 1 - CG-100 (Temporary intraluminal bypass device designed to reduce the rate of diverting stoma and its related complication by at least 70%)
Reporting period: 2022-06-01 to 2023-05-31
With ~2million annual new cases, colorectal cancer is the world’s 3rd most diagnosed & second most deadly cancer (~900,000 deaths annually, expected to rise to >1.1M by 2030). Colorectal cancer is usually treated with surgery where the diseased portions are resected & the healthy sections are reconnected through colorectal anastomosis using staplers and/or sutures.
Anastomotic leakage of colon content into the abdominal cavity is the most devastating complication associated with colorectal surgery. Leaks occur in ~22% of cases, leading to increased hospitalization time, higher re-operation rates, increased patient mortality & additional costs.
To minimize the risk of a leak, surgeons create a loop of the small bowel which is diverted outside the abdominal wall & connected to a stoma bag to collect patient’s feces for 4-6 months. Diverting stoma significantly diminishes patients’ quality of life, increases cost of care & requires an additional invasive surgery to reverse the stoma. Our novel device, CG-100, is an elastic tubular sheath that is positioned at the anastomosis site during the primary colorectal surgery & creates an internal bypass for all colon content. CG-100 is removed non-surgically 10 days after primary surgery. CG-100 addresses will improve patient quality of life, save ~1350 pa lives & reduce healthcare costs by €4B pa in EU.
The goal of this EIC project is to bring current technology to industrial readiness by combining existing findings within the technical, pre-clinical and FIH clinical areas with new elements such as manufacturing and regulatory issues to ensure clinical and commercial uptake of our innovative solution.
Anastomotic leakage of colon content into the abdominal cavity is the most devastating complication associated with colorectal surgery. Leaks occur in ~22% of cases, leading to increased hospitalization time, higher re-operation rates, increased patient mortality & additional costs.
To minimize the risk of a leak, surgeons create a loop of the small bowel which is diverted outside the abdominal wall & connected to a stoma bag to collect patient’s feces for 4-6 months. Diverting stoma significantly diminishes patients’ quality of life, increases cost of care & requires an additional invasive surgery to reverse the stoma. Our novel device, CG-100, is an elastic tubular sheath that is positioned at the anastomosis site during the primary colorectal surgery & creates an internal bypass for all colon content. CG-100 is removed non-surgically 10 days after primary surgery. CG-100 addresses will improve patient quality of life, save ~1350 pa lives & reduce healthcare costs by €4B pa in EU.
The goal of this EIC project is to bring current technology to industrial readiness by combining existing findings within the technical, pre-clinical and FIH clinical areas with new elements such as manufacturing and regulatory issues to ensure clinical and commercial uptake of our innovative solution.
The following are the up-to-date activities and achievements for the project per each work package:
WP1 - Manufacturing Scale Up & IP Management -Colospan completed the design freeze of an additional (smaller size version) device as part of product line extension. Following this process, the company started a product specification modification process for scale up manufacturing with a leading European silicone design and manufacturing partner. An IP review process was conducted during the design process to insure continuous IP protection on company products. This process will result in a 3rd family of patents which is scheduled to be executed in the next 12 months of the project.
WP2 - Pivotal Trial Preparations – Colospan clinical team drafted and finalized a full package of trial documents spanning from site evaluation process, trial protocol and training materials, full safety procedures and documents and complete monitoring plan including the formation of DSMB and CEC for the study. following this process, the company conducted evaluation of 35 different sites in US and EU based on pre-determined requirements which led to submission and initiation of 15 sites in the US and EU
WP3 - Project Management – The company is managing the project as part of its existing QMS (ISO 13485-2016 Quality Management System) which allow to manage project activities and ensure realization of goals and execution of project deliverables and milestones. The QMS includes also an ongoing risk analysis and mitigation process. An independent professional services firm was hired to perform an interim financial audit to verify full compliance with EIC financial requirements.
WP4 - Reimbursement, regulatory, health economics and commercialization plan – the company conducted a research project covering the DACH (Germany, Austria, and Switzerland) reimbursement systems and specific execution plans designed for CG-100 device. From a regulatory perspective the company submitted an update technical file designed per new MDR requirements and was able to retain MDR certificate for both device sizes.
WP1 - Manufacturing Scale Up & IP Management -Colospan completed the design freeze of an additional (smaller size version) device as part of product line extension. Following this process, the company started a product specification modification process for scale up manufacturing with a leading European silicone design and manufacturing partner. An IP review process was conducted during the design process to insure continuous IP protection on company products. This process will result in a 3rd family of patents which is scheduled to be executed in the next 12 months of the project.
WP2 - Pivotal Trial Preparations – Colospan clinical team drafted and finalized a full package of trial documents spanning from site evaluation process, trial protocol and training materials, full safety procedures and documents and complete monitoring plan including the formation of DSMB and CEC for the study. following this process, the company conducted evaluation of 35 different sites in US and EU based on pre-determined requirements which led to submission and initiation of 15 sites in the US and EU
WP3 - Project Management – The company is managing the project as part of its existing QMS (ISO 13485-2016 Quality Management System) which allow to manage project activities and ensure realization of goals and execution of project deliverables and milestones. The QMS includes also an ongoing risk analysis and mitigation process. An independent professional services firm was hired to perform an interim financial audit to verify full compliance with EIC financial requirements.
WP4 - Reimbursement, regulatory, health economics and commercialization plan – the company conducted a research project covering the DACH (Germany, Austria, and Switzerland) reimbursement systems and specific execution plans designed for CG-100 device. From a regulatory perspective the company submitted an update technical file designed per new MDR requirements and was able to retain MDR certificate for both device sizes.
CG-100 enables surgeons to achieve the holy grail of colorectal surgery by negating the need for diverting stoma & through provision of a safe & effective solution for anastomotic leakage. CG-100 allows full replacement of diverting stoma with reduction in related risk & meaningful improvement in patient quality of life. CG-100 implantation procedure does not interfere with the current common surgical techniques including open, laparoscopic, and robotic assisted surgery.
The ability to obviate the need for diverting stoma, will reshape completely the way colorectal surgery is conducted today. It will change the lives of hundreds of thousands of patients around the world and will save billions for the healthcare systems worldwide. The current economic burden of diverting stoma in EU-27 per year is > 6.5B euro (based on 270,000 eligible patients per year). the use of the CG-100 device is set to save > 19,000 euro per patient accumulating in potential savings of more than 5B euro for the entire health economic ecosystem.
The ability to obviate the need for diverting stoma, will reshape completely the way colorectal surgery is conducted today. It will change the lives of hundreds of thousands of patients around the world and will save billions for the healthcare systems worldwide. The current economic burden of diverting stoma in EU-27 per year is > 6.5B euro (based on 270,000 eligible patients per year). the use of the CG-100 device is set to save > 19,000 euro per patient accumulating in potential savings of more than 5B euro for the entire health economic ecosystem.