Periodic Reporting for period 1 - TRAIFAC (Transforming Radiology with Artificial Intelligence to Fight Abdominal Cancer)
Berichtszeitraum: 2023-06-01 bis 2023-11-30
Abdominal malignant tumours represent one of the groups of oncological pathologies with the highest prevalence and mortality. Annually, new cancer cases related to organs in the abdomen (pancreas, liver, kidney, etc.) are diagnosed globally, representing more than 1.4 million annual deaths worldwide. Particularly, pancreatic cancer is the fourth cause of death by cancer in Europe, but it has the lowest 5-year survival rate among the common cancers.
Sycai Technologies S.L. (SYCAI) is a deep-tech company that has developed an Artificial Intelligence digital tool to assist radiologists to detect and classify abdominal lesions through imaging. Currently, our tool prevents the abdominal lesions from progressing to pancreatic cancer with an accuracy superior to the standard identification procedures.
The aim of the project is to face the challenge of market entrance in Europe and prepare SYCAI for sales, operations, and growth.
Sycai Technologies S.L. (SYCAI) is a deep-tech company that has developed an Artificial Intelligence digital tool to assist radiologists to detect and classify abdominal lesions through imaging. Currently, our tool prevents the abdominal lesions from progressing to pancreatic cancer with an accuracy superior to the standard identification procedures.
The aim of the project is to face the challenge of market entrance in Europe and prepare SYCAI for sales, operations, and growth.
We planned the activities in three blocks:
(1) We have updated our financial plan, validated our pricing strategy with several experts and conducted a competitors’ study.
(2) We have conducted all steps to achieve the B-Corp Certificate. As soon as we have economic results, we will be able to receive it.
(3) A FTO study has been performed, by the company TJA, which includes not only our application for pancreas, but also the applications for liver and for kidney that are about to be included in the portfolio.
(1) We have updated our financial plan, validated our pricing strategy with several experts and conducted a competitors’ study.
(2) We have conducted all steps to achieve the B-Corp Certificate. As soon as we have economic results, we will be able to receive it.
(3) A FTO study has been performed, by the company TJA, which includes not only our application for pancreas, but also the applications for liver and for kidney that are about to be included in the portfolio.
At the moment the project end the following results and key milestones have been achieved:
- Performance metrics of the software that prove the overcoming of the standard of care: sensitivity and specificity in the detection of pre-malignant lesions 93% and 82%. Accuracy in the classification of lesions (between the ones with malignant potential and the ones that will remain benign) 85%
- Clinically proven results (in a retrospective blind clinical trial):
o Increase of 10% of incidental findings of pancreatic precancerous lesions in CT scans
o Reduction of tests in at least 33% of patients due to early identification and classification of the benign lesions
o Detection of 100% of benign lesions in patients that ended up having pancreatic cancer (twice the number than radiologists detected)
- Regulatory milestones: ISO13485 obtained and CE obtention process started (technical file audited)
- First patent filed
- Commercial and pricing strategies presented and approved by our Board (first pre-sales agreed) and first 3 distribution agreement signed
- First study in the US agreed and about to start
Further actions to take in the coming months:
- Increase performance metrics of the software and create scientific evidence (including scientific publications to create awareness)
- Perform a prospective clinical trial with more patients to prove the benefits of SYCAI Medical
- Obtain CE Mark (expected Q1 2024)
- File a second patent (expected Q1 2024, patentability studies ongoing) and select countries to protect the first one (entering in national phase in February 2024)
- Increase commercial traction and sign distribution agreements in at least 3 more countries
- Complete study in the US and publish a paper with the results
- Performance metrics of the software that prove the overcoming of the standard of care: sensitivity and specificity in the detection of pre-malignant lesions 93% and 82%. Accuracy in the classification of lesions (between the ones with malignant potential and the ones that will remain benign) 85%
- Clinically proven results (in a retrospective blind clinical trial):
o Increase of 10% of incidental findings of pancreatic precancerous lesions in CT scans
o Reduction of tests in at least 33% of patients due to early identification and classification of the benign lesions
o Detection of 100% of benign lesions in patients that ended up having pancreatic cancer (twice the number than radiologists detected)
- Regulatory milestones: ISO13485 obtained and CE obtention process started (technical file audited)
- First patent filed
- Commercial and pricing strategies presented and approved by our Board (first pre-sales agreed) and first 3 distribution agreement signed
- First study in the US agreed and about to start
Further actions to take in the coming months:
- Increase performance metrics of the software and create scientific evidence (including scientific publications to create awareness)
- Perform a prospective clinical trial with more patients to prove the benefits of SYCAI Medical
- Obtain CE Mark (expected Q1 2024)
- File a second patent (expected Q1 2024, patentability studies ongoing) and select countries to protect the first one (entering in national phase in February 2024)
- Increase commercial traction and sign distribution agreements in at least 3 more countries
- Complete study in the US and publish a paper with the results