2023-12-013 - J4L - Join 4 Life

J4L

2023-12-013

J4L is the first adhesive specifically designed to prevent the Postoperative Pancreatic Fístula (POPF).

Preventing the appearance of POPF in patients undergoing pancreatic neoplasia surgery will improve the health and well-being of our patients and the population, as well as increase the survival rates and reduce healthcare expenses. All the costs associated with the treatment of POPF and its related complications translate into an expenditure of economic resources that are currently spent on treatments, hospital stays and re-interventions. The cost per patient without complications is approximately €4,790.21, compared to around €28,068.16 for a patient with a fistula, which represents a 1:7 ratio.

Treatment of POFP is carried out after diagnosis through various means including percutaneous drainage, antibiotic therapy, interventional vascular radiology, or even re-intervention. The diagnosis of POFP can result in: 1) delay in the initiation of chemotherapy treatment, 2) secondary complications arising from POPF have a significant impact on patients and lead to the need for prolonged intravenous treatments, longer hospital stays, delayed adjuvant treatment, psychological stress for patients, their families, and healthcare professionals, re-interventions, and even patient mortality and 3) increase in hospital costs. The treatments for POPF and its related complications result in increased hospitalisation costs, additional medical visits, surgical procedures, and medical treatments. Currently, there is not a preventive treatment for POPF. The objective of the JOIN4LIFE (J4L) project is to provide a preventive solution to this surgical complication through the development of a biological adhesive by protecting the pancreas-intestinal anastomosis. The competitive advantage of our solution, in comparison to previously tested approaches, lies in its specific development under similar in vivo conditions that mimic the dynamics of both pancreatic and intestinal tissues, ensuring an effective sealing effect. As a result, J4L is the first device specifically designed to prevent the POPF.

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Licensing. Exploitation by sale of the product. Reimbursement of royalties.

Limitations of convencional surgical techniques, high rates of mortality and morbidity, impact on patient quality of life, signifnificant economic burden. The cost per patient without complications is approximately €4,790.21, compared to around €28,068.16 for a patient with a fistula, which represents a 1:7 ratio. In summary, the development of a specific adhesive for pancreatic fistulas represents an urgent need in pancreatic surgery and healthcare. It can drastically alter the management of this complication. Research and development in this field are crucial for improving patient care and reducing the impact of POPF on society at large.

Doctors, patients and ultimately healthcare centers worldwide would be extremily interested in our technology. First validations have been obtained with healthcare professionals.

The methodology intended to facilitate the transfer of this product to society is the CIMTI methodology: "Health Innovation Cycle". Therefore, we will advance simultaneously in each four domains: clinical, market/business, regulatory, and technology. The total amount to advance simultaneoulsy from stage 3. Proof of concept to stage 7. Solution validation raise up to 120k€.

Patentability analysis, IP strategy and procedures to integrate the feedback received by a higher mumber of healthcare professionals, KOLs, users and customers.

Clinical: Clinical validation from users, healthcare professionals and KOLs. Business/Market: Define business strategy for product transfer to the market Regulatory: Preliminar regulatory roadmap. Technology: Protect IP and reach TRL 6: Technology validated and demonstrated in a relevant environment with the appropiate in vitro and in vivo tests.

J4L is the first device specifically designed to prevent the POPF J4L is an innovative solution formed by organic adhesives based on the catechol group and the silane bases, establishing an interaction with functional groups of the pancreatic and intestinal tissue, promoting adhesion between tissues. This reaction on a molecular skeleton of the adhesive provides it with greater stability by activating tissue adhesion through chemical bonds between the adhesive and the pancreatic/intestinal surface, generating a 3D structure that will form a molecular network preventing the leakage of pancreatic secretion. The possibility to include nanotechnology or add antibiotics to the adhesive is on the table as well in a future horizon.

Strict and expensive regulation procedures

The methodology intended to facilitate the transfer of this product to society is the CIMTI methodology: "Health Innovation Cycle". Therefore, advance simultaneously in clinical, business, regulatory and technology domains following a pre established path. For the moment, we are at stage 3. Proof of concept, the idea is find financing to reach stage 7. Solution validation. Once the business model is developed, we expected to ideate and pursue an strategy to reach market in the most suitable pathway.

Patentability study

Partnership with Leitat. IP distributed between Leitat and IDIBGI.

Innovation unit departament is under the iso 9001. ISO 9001 certification reaffirms the strategic commitment of the institution to improve the quality of the processes and services offered. IDIBGI is devoted to refine the quality management procedures, for example considering the integration of the CERCA accreditation recently released by CERCA in conjunction with the ICDQ in our daily use tasks. https://cerca.cat/qualitat/

IP is shared by IDIGBI and Leitat

The adhesive is intended to improve the health and well-being of our patients and the population, as well as to increase survival rates and reduce healthcare expenses. All the costs associated with the treatment of POPF and its related complications translate into an expenditure of economic resources that are currently spent on treatments, hospital stays and re-interventions. The cost per patient without complications is approximately €4,790.21, compared to around €28,068.16 for a patient with a fistula, which represents a 1:7 ratios.