Periodic Reporting for period 1 - INNOVHEM (Innovative diagnostic tools to improve the medical care and the health of Sickle Cell patients : preparing for launch and market access in Europe)
Reporting period: 2022-06-01 to 2023-01-31
Sickle cell disease (SCD) is the most frequent genetic disease over the world, affecting around 5 million people. Although it has been discovered at the beginning of the 20th century, its medical care is still insufficient, thus Sickle Cell Disease is still very severe. Globaly life expectancy of the patients is reduced by about 30 years. Over and above this, SCD is a large burden for patients and for society, from both a social and an economic point of view. Severe pain and multiple organ complications that patients face result in tremendous suffering, prolonged absences from school, and difficulty maintaining full employment. Long hospital stays can occur multiple times per year, leading to a complete disruption of the person’s and family’s life. In addition, because of the complexity of the pathophysiology of SCD, the associated clinical costs of SCD have been estimated to reach € 10 million for a patient living 45 years, in Europe.
According to the expert-physicians, the medical care is insufficiant because therapeutic options are limited and there is a lack of diagnostic tools to support their treatment decision during the follow-up of patients. In recent years, pharmaceutical companies have shown increasing interest in sickle cell disease, which has led to the authorisation of new molecules (e.g. Crizanlizumab, voxelotor, L-glu) and increasing therapeutic development involving some 40 companies in approximately 700 clinical studies, including the development of gene therapy. The therapeutic arsenal available to physicians is changing profoundly, particularly with the existence of several molecules that make it possible to avoid the onset of a painful crisis. But today, there is still no diagnostic tool to help the physician to use these treatments.
INNOVHEM is a french start-up whose mission is to improve the health and the quality of life of patients. Painful crisis is the most common manifestation and first cause of death of the disease. By developing a unique medical device for its risk occurence within a year, INNOVHEM will stratify the patients and guide the physician to personalise the treatments in order to avoid them, in particular to adjust current medication dosing or to decide for the use of new high cost treatments.
According to the expert-physicians, the medical care is insufficiant because therapeutic options are limited and there is a lack of diagnostic tools to support their treatment decision during the follow-up of patients. In recent years, pharmaceutical companies have shown increasing interest in sickle cell disease, which has led to the authorisation of new molecules (e.g. Crizanlizumab, voxelotor, L-glu) and increasing therapeutic development involving some 40 companies in approximately 700 clinical studies, including the development of gene therapy. The therapeutic arsenal available to physicians is changing profoundly, particularly with the existence of several molecules that make it possible to avoid the onset of a painful crisis. But today, there is still no diagnostic tool to help the physician to use these treatments.
INNOVHEM is a french start-up whose mission is to improve the health and the quality of life of patients. Painful crisis is the most common manifestation and first cause of death of the disease. By developing a unique medical device for its risk occurence within a year, INNOVHEM will stratify the patients and guide the physician to personalise the treatments in order to avoid them, in particular to adjust current medication dosing or to decide for the use of new high cost treatments.
Until now, INNOVHEM has developed and validated new biomarkers specifically designed towards the pathophysiology of Sickle Cell disease and has conducted a retrospective study on a cohort of 120 patients that led to developed a clinical score to predict the risk occurence of painful crisis. This clinical score has been developed by combining biomarkers standard of care and biomarkers INNOVHEM proprietary and an algorithm developed with machine learning.
Beyond the strong medical need and the targeted economic opportunity, our project responds to the health issues of the future.
Thanks to the product developed by INNOVHEM, patients will be offered personalized medical care, which will lead to a reduction in painful attacks, thus improving their health, but also their quality of life, by reducing the burden of hospitalizations and sick leave. The latter have significant negative effects on integration into the professional environment, on academic success and on social integration. The use of our tool will also allow for a better understanding of one's illness. The evaluation of the benefit/risk balance will be optimized at the individual level.
Clinicians will have at their disposal a simple tool, based on objective criteria, which will allow them to better follow their patients, to stratify patients according to the risk of occurrence of a painful crisis, to propose a personalized treatment adapted to their situation. This tool will help guide and secure the clinician's therapeutic orientations.
Our product will have an impact on the efficiency of healthcare systems and structures, by contributing to the rationalization of the healthcare offer, to a better management of patient flows and to the valorization of the work of healthcare structures.
Finally, the medico-economic impact of our tool is major, as its use will make it possible to avoid 20% of emergency room visits. This alone will result in clinical cost savings estimated at 30 million euros per year in Europe.
Thanks to the product developed by INNOVHEM, patients will be offered personalized medical care, which will lead to a reduction in painful attacks, thus improving their health, but also their quality of life, by reducing the burden of hospitalizations and sick leave. The latter have significant negative effects on integration into the professional environment, on academic success and on social integration. The use of our tool will also allow for a better understanding of one's illness. The evaluation of the benefit/risk balance will be optimized at the individual level.
Clinicians will have at their disposal a simple tool, based on objective criteria, which will allow them to better follow their patients, to stratify patients according to the risk of occurrence of a painful crisis, to propose a personalized treatment adapted to their situation. This tool will help guide and secure the clinician's therapeutic orientations.
Our product will have an impact on the efficiency of healthcare systems and structures, by contributing to the rationalization of the healthcare offer, to a better management of patient flows and to the valorization of the work of healthcare structures.
Finally, the medico-economic impact of our tool is major, as its use will make it possible to avoid 20% of emergency room visits. This alone will result in clinical cost savings estimated at 30 million euros per year in Europe.