The first cancer in women worldwide, breast cancer, accounts for 16% of all female cancers. Globally, 1.7 million patients suffer from breast cancer per year and 1 in 8 women will be affected by this cancer during their lifetime. During early detection of breast cancer, the most widely used curative method is complete or partial mastectomy (40% of women), often accompanied by several treatments (radiotherapy, chemotherapy, hormonotherapy) allowing a high remission rate. However, faced with an increasing remission rate, an average of 20% of patients benefit from reconstruction, linked to the fear of complications, being disappointed, medical or financial reasons.
Current techniques don’t meet patients’ expectations, who need simplified procedures (decrease of the number of surgeries and their related risks, costs), no long-term and safer implants that allow natural reconstruction. There is a real unmet need for the development of implantable devices for breast reconstruction surgeries.
LATTICE MEDICAL propose MATTISSE is a breakthrough breast implant which simplifies surgery and patient follow-up. It consists of two 3D-printed parts of resorbable biomaterials, the first is a support for adipose tissue (scaffold) and the second is a dome (shell) guiding the reconstruction volume, both made of the same medical grade biopolymer. During the surgical procedure, the shell and the scaffold are assembled and sutured, creating the implantable MATTISSE bioprosthesis. In the implant is embedded a small autologous flap (<< 80cc) harvested locally which regenerates during 3-6 months inside the chamber. MATTISSE bioprosthesis makes it possible to reconstruct the breast in a single and simple surgery, mastectomy and reconstruction can be done at the same time. This implant allows natural breast reconstruction with the patient’s own tissue while avoiding sequelae at the donor’s site. This prosthesis is fully degradable after 18 months, minimizing post-surgery risks. This leads to an overall cost per patient 30-60% lower than current autologous techniques.
The primary objective of this project is to complete the necessary steps (TR7 to TRL9) for introducing the MATTISSE device to the European market. This encompasses critical aspects such as conducting clinical validation to demonstrate the device's safety and efficacy, obtaining the CE mark to comply with EU regulations, and formulating effective marketing and commercialization strategies. These combined efforts will ensure that the device is not only compliant with regulations but also well-positioned and marketed to meet the needs of healthcare professionals and patients in the European market.
