Periodic Reporting for period 1 - CKDSens (A novel healthcare tool for the active ageing with chronic kidney disease)
Période du rapport: 2019-03-01 au 2019-08-31
CreatSens Health, a technology-based company from Spain with almost 500k€ in funding already raised, is developing a new point-of-care platform for the personalized management of kidney function. This platform provides an early and daily diagnose of kidney dysfunction thanks to the real-time monitoring of key renal biomarkers (creatinine and potassium) in order to avoid arrhythmias and heart attacks derived from the non-monitoring of patients. More than 90 million people in EU and hundreds of millions around the world suffer from some degree of Chronic Kidney Disease (CKD), a condition where kidney function is impaired and that may have very serious health implications. The early detection and control of this silent condition is crucial, since every year millions of people die prematurely due to complications originated by CKD. CKD is a latent disease where symptoms do not appear until they are irreversible. This is why early-monitoring and diagnostics tools are decisive to reduce acute episodes and increase treatment efficacy. The project aims to improve current healthcare by introducing a new tool that will help professionals to measure relevant biomarkers which improve the monitoring of their patients and will help patients themselves by reducing the number of blood extractions and visits to the hospital and minimizing pain. Starting in Spain, France and the UK, the success of this technology will help to strengthen Europe’s innovation leadership position in this area. Through the combination of a robust technology with an end-user, design-thinking approach, CreatSens Health introduces a high-performance, affordable and user-friendly medical platform composed of a physical device and a software platform providing a new solution for a near-patient care scenario. We propose a paradigm-shifting, disruptive approach by decentralizing the determination of biomarkers (currently carried in the hospitals by specialists) with new diagnostic systems that aim to connect patients’ concerns and real-time data with the healthcare provider. This proposal is part of our strategic long-term plan and the overall objectives of the project are:
a) Clinical validation: technology, decentralized use, cost/benefit validation.
b) Scale-up of current prototype reaching TRL 8.
c) CE mark as an in vitro diagnostic medical device and 510(k) procedure for the FDA.
d) Fabrication agreements with medical devices’ manufacturers with ISO 13485 certification.
e) Distribution agreement with renal companies already in the market with well-established channels to connect physicians and patients offering high-tech services.
a) Clinical validation: technology, decentralized use, cost/benefit validation.
b) Scale-up of current prototype reaching TRL 8.
c) CE mark as an in vitro diagnostic medical device and 510(k) procedure for the FDA.
d) Fabrication agreements with medical devices’ manufacturers with ISO 13485 certification.
e) Distribution agreement with renal companies already in the market with well-established channels to connect physicians and patients offering high-tech services.
The work performed during the SME Phase I have three focus: The first focus was about to validate that the technology to measure potassium and creatinine is enough robust to be used with a new membrane to increase the lifetime of the product. The second objective was to validate the market potential and market segmentation, and discriminate which will be the main countries to target during the market access approach. As a third focus, we have changed and validated the commercialization strategy, where we change from a direct sells strategy to a sublicense strategy, thanks to the recommendations from our mentor. Therefore, the main results of the project are:
• Technology growth with the development and validation of a POC device for potassium determination in blood, validation of creatinine biomarkers in the hospital and optimization of the reference membrane for a more reliable and robust measurement.
• Market viability of our device with several KOL and physicians.
• Business model refining based on either payment per use or subscription.
As a summary, we can increase the lifetime of the sensors, our market is enough big and well segmented to create value in a very specific target patient and our initial commercialization strategy was financially difficult, so the best strategy is to change to a licensing model.
• Technology growth with the development and validation of a POC device for potassium determination in blood, validation of creatinine biomarkers in the hospital and optimization of the reference membrane for a more reliable and robust measurement.
• Market viability of our device with several KOL and physicians.
• Business model refining based on either payment per use or subscription.
As a summary, we can increase the lifetime of the sensors, our market is enough big and well segmented to create value in a very specific target patient and our initial commercialization strategy was financially difficult, so the best strategy is to change to a licensing model.
CreatSens Health was aimed to provide a unique paper-based potassium and creatinine potentiometric sensor solution helping the healthcare professional to better manage the information that can be generated in primary care centres, doctor’s office or patient’s home. Biochemical and physical information will be integrated in a technological platform allowing to predict, early detect and to prevent acute conditions from home.
With real-time biomarkers information, specialists would greatly reduce the progression of the disease. CreatSens Health has established agreements with several Key Opinion Leaders (KOL) in nephrology and cardiology. After a first round of intensive meetings in order to introduce the concept, approach and technology to the medical community, the team now leads a project to run a collaborative test to validate both the technology and the medical hypothesis.
CreatSens has diversified core and lateral markets. Core to the value proposition is the antihypertensive drugs market, which covers diseases such as chronic kidney diseases and cardiovascular complications. This is a high-volume market. Needs and benefits were detected in the healthcare medical devices market, especially from the nephrological point of view, where potassium and creatinine determinations create high value to support decision makers.
Regarding the lateral markets, it comprises the fields of radiotherapy and cardiology imaging, diabetic nephropathy and bipolar disorder. In radiotherapy and cardiology imaging, we detect the need of in-situ creatinine analysis before a Computed Axial Tomography scan (CAT scan).
The expected potential impact will:
• Provide a fast (results in <5 minutes), painless and easy to use monitoring system for CKD.
• Increase the quality of life (Qol) of patients by improving the monitoring quality of their CKD. We provide an effective solution available to patients where and when they need it. Reduce of acute episodes and increase of the efficacy of treatments through consistent monitoring and re-adjustment of pharmaceutical doses, diet and exercise (personalized care).
• Reduces direct healthcare costs related to CKD management by 30% by delaying the start of dialysis. We will contribute to a more efficient and sustainable healthcare system.
• Reduces waiting time in hospitals by more than 20%, which means a positive impact on the patient’s productivity and/or active life: wellbeing .
All this is possible thanks to the unique combination of real-time monitoring diagnostics tools in combination with predictive software analyses.
With real-time biomarkers information, specialists would greatly reduce the progression of the disease. CreatSens Health has established agreements with several Key Opinion Leaders (KOL) in nephrology and cardiology. After a first round of intensive meetings in order to introduce the concept, approach and technology to the medical community, the team now leads a project to run a collaborative test to validate both the technology and the medical hypothesis.
CreatSens has diversified core and lateral markets. Core to the value proposition is the antihypertensive drugs market, which covers diseases such as chronic kidney diseases and cardiovascular complications. This is a high-volume market. Needs and benefits were detected in the healthcare medical devices market, especially from the nephrological point of view, where potassium and creatinine determinations create high value to support decision makers.
Regarding the lateral markets, it comprises the fields of radiotherapy and cardiology imaging, diabetic nephropathy and bipolar disorder. In radiotherapy and cardiology imaging, we detect the need of in-situ creatinine analysis before a Computed Axial Tomography scan (CAT scan).
The expected potential impact will:
• Provide a fast (results in <5 minutes), painless and easy to use monitoring system for CKD.
• Increase the quality of life (Qol) of patients by improving the monitoring quality of their CKD. We provide an effective solution available to patients where and when they need it. Reduce of acute episodes and increase of the efficacy of treatments through consistent monitoring and re-adjustment of pharmaceutical doses, diet and exercise (personalized care).
• Reduces direct healthcare costs related to CKD management by 30% by delaying the start of dialysis. We will contribute to a more efficient and sustainable healthcare system.
• Reduces waiting time in hospitals by more than 20%, which means a positive impact on the patient’s productivity and/or active life: wellbeing .
All this is possible thanks to the unique combination of real-time monitoring diagnostics tools in combination with predictive software analyses.