Periodic Reporting for period 1 - 3L-HeCoMe (Advanced manufacturing process to obtain a partially Bio-Resorbable Adhesive/Non-Adhesive Triple Layer Mesh for intra-peritoneal Hernia Containment)
Reporting period: 2015-06-01 to 2015-11-30
A positive outcome of Phase 1 resulted in an innovation project that demonstrates high potential in terms of company competitiveness and growth, underpinned by a strategic business plan.
3L-HeCoMe is an innovative medical device for the Intraperitoneal Treatment of Abdominal Wall Hernias, which will reinforce weakened or deficient abdominal wall soft tissues. 3L-HeCoMe aims at preventing post-surgery problems and avoiding, or sensibly decreasing, the use of mechanical surgery instruments for the fixation of the mesh (grafts). 3L-HeCoMe will also reduce the surgical duration and sensibly decrease surgical costs
Task 1: Medical device for Intraperitoneal Treatment of Abdominal wall Hernias (3L-HeCoMe mesh): physical-mechanical characterization, cytotoxicity testing for lab scale validation
Task 2: 3L-HeCoMe product processing first validation, including K-Bar casting
Task 3: Selection of medical grade FDA approved dye for marking logo
Task 4: KOL extended survey targeted to surgeons and medical specialists
Task 5: 3L-HeCoMe process validation and product costing and scalability assessment
All planned activities were fully accomplished and new ones have been introduced in order to explore solutions for logo dye optimization as well as for further increasing the product flexibility.
During the feasibility study, the TRL was increased and satisfactory results were obtained at pilot scale. Nevertheless, the path towards industrialisation and commercial exploitation has not been completely accomplished and further investments by the coordinator are needed to carry out systematic functional and safety compliance tests, towards product optimisation and process industrial scale up. K-Bar coatings proved to be effective; nevertheless an improved coating process is needed in order to comply with reproducibility, with production efficiency and with the target sales volumes in the five year forecast.
3L-HeCoMe is the unique triple-layer, partially resorbable, medical device and leads to the innovative intra-peritoneal surgical treatment of abdominal wall hernia. The obtained device is unique to this kind of hernia treatment since there is no other medical device currently available on the market, intended for the same application, having an anti-adhesive layer for visceral contact and an adhesive layer for parietal contact.
3L-HeCoMe will offer:
1) avoiding hernia operation recurrence due to pain insurgence caused by mesh fixation (grafting) and adhesions
2) improving quality of life of patients by reducing hospitalization time
3) reducing global healthcare costs (e.g. grafting materials, glues, post-surgical treatment)
4) reducing social costs (faster patient recovery)