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Kidney Injury Technology

Periodic Reporting for period 1 - KIT (Kidney Injury Technology)

Reporting period: 2014-11-01 to 2015-04-30

Acute kidney injury (AKI) is characterized by the abrupt loss of kidney function, resulting in a failure to maintain fluid, electrolyte and acid-base homoeostasis over a period of hours or days. AKI is an increasing and widespread global problem that might be partially attributable to an ageing population and the age related risk factors such as incidence of cardiovascular disease, diabetes mellitus and chronic kidney disease (CKD), and an expanding number of modifiable risk factors, such as sepsis, administration of contrast media and exposure to nephrotoxic drugs such as many antibiotics, chemotherapeutic drugs, contrast agents, etc.
Current AKI diagnostic technology is far from optimal, because the diagnosis is only possible late in the course of the condition, as it relies on the measurement of signs of renal dysfunction (mostly plasma creatinine concentration, the gold standard). This diagnosis technique is unable of informing on the cause of the AKI.
Bio-inRen has been working on the identification of a new generation of urine markers for the diagnosis of risk of drug-induced AKI and the etiological diagnosis of nephrotoxicity. Since the discovery of the innovative biomarkers Bio-inRen has been working on their validation in many preclinical experimental models of AKI, and is continuously looking for additional biomarkers for building a technological platform for integral AKI diagnosis. Thus, Bio-inRen is working on developing an AKI Diagnosis Kit based on these biomarkers to be used in human urine samples. Bio-inRen is interested in licensing both, the technological platform and the AKI diagnosis test.
The objectives of the present action were:
- To size and delimit the specific market niches to which the product will be first oriented
- To assess if the concept, technical utility and impact of the product for users, consumers and society can be recognized and confirmed by specialists in this pathology and the use of these type of diagnostic technologies.
- To precise the economic needs and the contingency plan for the clinical validation and dissemination step; to perform a thorough viability assessment; and to consolidate the business plan.
- To organize the industrial property (IP) strategy oriented at consolidating the actual IP policy and file one additional patent application.
- To look for future licensers/partners for our product
We have completed the objectives anticipated in our proposal
• A rigorous study of the market for our product. The market has been better profiled with the aid of independent experts and consultants and more detailed market size and stratification has been gained, within similar boundaries to those posed by our initial estimations
• A strategy for completing the improvement of our technology, focused on increasing the clinical studies in many AKI scenarios.
• A detailed business plan for the company that reflects in a realistic way the future of the company after licensing our test. The financial plan has been developed in detail with the aid of independent, specialized consultants, and it has been profiled specifically for the continuation of the project with financial viability.
• The present patent portfolio has been extended, and a new patent has been developed in collaboration with our Patent Agency. This patent will be filed at due time (in the coming 3 months) as advised by our Patent Agency.
• As a results of our contacts with possible licensers/partners for our product, Roche Diagnostics has shown interest in Bio-inRen’s technology and a letter of intention has been signed (and is available upon request). Moreover, conversations with other players such as Sigma Aldrich and other Small and Medium Enterprises (SMEs) such as BioKit and ImmunoStep have taken place and collaboration plans to expand our technological platform have been designed to be implemented in the future.
The expected final result of the action is the licensing our technology to an In vitro Diagnostic multinational company, that will be the responsible of put it in the diagnostic market. This diagnostic technology will allow to ameliorate the treatment of the patients with AKI, as it will able to:
• Assess the individual risk of each patient to develop an AKI after a potential nephrotoxic manoeuver
• Allow early diagnosis of the AKI, thus allowing the adequate procedures for improving the outcome
• Allow specific diagnosis of the causes of AKI, thus allowing the removal or correction of the specific cause.
All these characteristic of our technology will much facilitate the care of the patients, reducing complications and expensive treatments, and thus reducing the socio-economical costs of the disease
The concept, technical utility of the prospective products and the impact for users, consumers and society we have described, have been corroborated panel of 20 potential users from 5 countries in the European Union. These experts have confirmed not only the potential utility of our technology, but also their availability and willingness to test it with little or no differences with our initial view.
In addition, 2 independent and renowned experts in the field have issued positive reports on the preclinical technology.
This SMEI action has confirmed and focused the key support determinants the project must seek to be properly developed in the next stage:
- As a unanimous conclusion from all experts who have evaluated the technology, the project needs, as the next logical step, a thorough phase of clinical validation. The technology is mature enough and interesting enough to proceed to clinical validation. This conclusion engages perfectly with the intention of our company to proceed to apply to phase II SMEI, specifically opened for the clinical validation of biomarkers.
- The feasibility assessment study and the business plan have identified phase II SMEI as a key financial and logistical support for the continuation of the project and the success of the technology, in order to convert it into a useful clinical (diagnostic) product and into stable income for our company.
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