Advanced manufacturing process to obtain a partially Bio-Resorbable Adhesive/Non-Adhesive Triple Layer Mesh for intra-peritoneal Hernia Containment

Project Information

3L-HeCoMe

Grant agreement ID: 673955

DOI

10.3030/673955

Project closed

EC signature date 28 May 2015

Start date 1 June 2015

End date 30 November 2015

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

HERNIAMESH SRL
Italy

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

Summary of the context and overall objectives of the project

“3L-HeCoMe” Phase 1 SME Instrument aimed at providing support to a new businesses line characterised by a new medical device product and allowed determining the technological, practical and economic viability together with the resources needed to implement it and the risks involved.
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

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

3L-HeCoMe Feasibility Study targeted to the assessment of a new candidate product: a partially Bio-Resorbable Adhesive/Non-Adhesive Triple Layer Mesh for intra-peritoneal Hernia Containment. The Technical activities have been developed according to five scheduled tasks allocated to the two partners Herniamesh (Coordinator) and Tissuemed (Partner):

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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

During the feasibility study, the TRL was increased and satisfactory results were obtained at pilot scale, developing prototypes with significant and fundamental characteristics for hernia laparoscopy surgery that leads to better hernia treatment. 3L-HeCoMe candidate product samples proved to have: excellent anti-adhesion properties on the visceral side, good adhesive properties for optimal fixation of prosthesis in surgery practice, good handiness during application, acceptable overall thickness, and sufficient folding-unfolding performance for laparoscopy utilization; whereas flexibility is subject to further improvement. KOLs (surgeons and physicians) feedback was also positive for the selected substrate material, coating and logo, confirming that the innovative 3L-HeCoMe product is a promising one in defining a new more efficient and effective approach to the hernia repair procedures in surgery practice.

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)

Scheme representing the triple layer medical device with anti-adhesive (visceral side) PLC coating a