Periodic Reporting for period 1 - MATTISSE (Breast self-reconstruction: The Promise of Breast Reconstruction with patients’ own tissue)
Okres sprawozdawczy: 2022-10-01 do 2023-09-30
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.
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.
Progress on production:
LATTICE MEDICAL has achieved noteworthy advancements in validating and scaling up the fabrication process. With the installation of 16 3D printers in an ISO7 clean room, the capacity to manufacture up to 1,500 implants annually is in progress. This elevated production capability ensures the creation of consistently high-quality implants, which are currently being utilized for the TIDE clinical trial. These developments mark a significant milestone in our commitment to delivering innovative medical solutions.
Progress on scientific:
Remarkable advancements have been achieved in the realm of scientific impact. Building upon promising preclinical results of the MATTISSE implant and the consistent production of implants that meet rigorous specifications, significant progress has been reached. Notably, in 2022, we secured clinical trial approval in Georgia given by the ethics committee, enable to launch the safety evaluation of the MATTISSE device. Moreover, in mid-2023, we attained the clinical trial approval by Freanch authority ANSM. These approvals represent a testament to the device's scientific merit and its potential to advance medical knowledge and patient care on a global scale. Additionally, a significant progress was achieved with the completion of the first breast reconstruction procedure in a 63 y/o patient, with 18-month hindsight after surgery. The results of this procedure are noteworthy, as they demonstrate a remarkable total breast reconstruction within six months. Equally, the absence of any adverse effects observed following the surgical procedure, highlighting the device's outstanding safety for humans. These outcomes affirm the efficacy and safety of the MATTISSE device, offering a promising new technique for breast reconstruction, that prioritize patient well-being and rapid recovery.
LATTICE MEDICAL has achieved noteworthy advancements in validating and scaling up the fabrication process. With the installation of 16 3D printers in an ISO7 clean room, the capacity to manufacture up to 1,500 implants annually is in progress. This elevated production capability ensures the creation of consistently high-quality implants, which are currently being utilized for the TIDE clinical trial. These developments mark a significant milestone in our commitment to delivering innovative medical solutions.
Progress on scientific:
Remarkable advancements have been achieved in the realm of scientific impact. Building upon promising preclinical results of the MATTISSE implant and the consistent production of implants that meet rigorous specifications, significant progress has been reached. Notably, in 2022, we secured clinical trial approval in Georgia given by the ethics committee, enable to launch the safety evaluation of the MATTISSE device. Moreover, in mid-2023, we attained the clinical trial approval by Freanch authority ANSM. These approvals represent a testament to the device's scientific merit and its potential to advance medical knowledge and patient care on a global scale. Additionally, a significant progress was achieved with the completion of the first breast reconstruction procedure in a 63 y/o patient, with 18-month hindsight after surgery. The results of this procedure are noteworthy, as they demonstrate a remarkable total breast reconstruction within six months. Equally, the absence of any adverse effects observed following the surgical procedure, highlighting the device's outstanding safety for humans. These outcomes affirm the efficacy and safety of the MATTISSE device, offering a promising new technique for breast reconstruction, that prioritize patient well-being and rapid recovery.