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Reporting period: 2016-08-01 to 2017-01-31

According to the International Society for Aesthetic and Plastic Surgery (ISAPS), breast augmentation surgery represents one of the leading aesthetic surgical procedures in the world, with about 1.35 million of first breast augmentation surgeries and about 280,000 breast surgery revisions performed in 2014. In the same year, we estimated that around 230.000 people underwent reconstructive surgery after mastectomy (tumor resection), in order to improve the results of the intervention. These figures do not yet consider the 5 to 10 million women worldwide who have already breast implants that will need to be substituted.
Today, the most common treatment for breast tissue defects makes use of silicone implants. This technique does not reconstruct the lost fat, but only replace it and therefore does not represent a permanent solution. In fact, they need additional surgical interventions to be replaced approximately every 10/15 years. Silicone implants technology is more than 35 years old and brings with it a number of risks, among others their rupture (approx. 30% of incidence), leakage and capsular contracture.
Several scientific studies and researches claim that innovative biomaterials, used as a graft substitute, could offer a good solution for the issues identified in reconstructive and aesthetic surgery, but today this option is limited to small defects mainly due to the insufficient vascularization of the materials used to fill tissue defects. Vascularization is the ability to promote blood vessel penetration and formation in a tissue. Without vascularization, nutrients and oxygen cannot reach the cells inside the scaffold, rapidly causing tissue necrosis and consequently volume loss.
REGENERA, developed by Tensive, is a versatile bioactive and bioabsorbable polymeric scaffold characterized by an interconnected open-pore structure and an internal 3D micro-vascular channel network. The combination of these factors enables, after implantation in-vivo, cell penetration, early vascularization and maturation of stable and viable autologous tissue inside the scaffold. This innovative prosthesis aims to restore a totally natural breast to oncological patients who experienced reconstructive surgery after lumpectomy (tumor and part of surrounding tissue resection) or mastectomy (total breast removal), solving the current problems related mostly to the use of silicone implants.
In the present feasibility study, (1) an in-vivo test of REGENERA was carried out in swine model with a follow-up of 5 months and (2) a thorough market research and a strategic analysis were performed and a business plan for the clinical validation and commercialization of the prosthesis was produced. The in-vivo test confirmed the previous data related to REGENERA showing good biocompatibility, vascularization, no foreign body reactions, and the surgical feasibility of the tested prosthesis. Indeed, after 5 months of implantation in swine, Tensive prostheses of different volumes and shapes (up to 140 cc), were completely colonized by a mesynchymal cells, and vital soft tissue. A well-defined and mature vascular tissue was evidenced in all the explanted prostheses, highlighting the scaffolds capability to promote rapid recruitment of vascular tissue, which was previously verified in murine model. The absence of adipose tissue in colonizing tissue was also observed, indicating the need of further implementation of the device performance, related mainly to morphology of the internal pores and bioactive factors to enable adipose differentiation. From the market analysis resulted that the desired features for breast augmentation and reconstruction products are mainly represented by the ability to: i) offer the same feelings of a totally natural breast, ii) improve the safety performances with respect to the traditional breast implants, iii) reduce the need for the patient of undergoing multiple surgery procedures, which is especially significant for reconstruction patients, and iv) reduce the invasive nature of the surgery (e.g. less visible incision lines). From a financial point of view, the project seems feasible considering the moderate financial need (6.3M€) compared to the large business opportunity facing the silicone prostheses market of more than 1 billion $ worldwide.
The experiments and the analyses performed in this project confirmed the promising capabilities of REGENERA as a breakthrough in breast surgery therapies and evidenced small improvement required to maximise its performances. Once optimized and ready for clinical use, it will potentially offer the following competitive advantages over existing competition: (1) Device function. Restore a natural breast; support the patient’s quality of life after mastectomy/lumpectomy; life-long solution which doesn’t require additional surgery: optimal solution for lumpectomy. (2) Pricing. Higher selling price compared to silicone/saline counterparts, but significant cost saving for the patients in the long-term since REGENERA aims to allow for one time surgery. (3) Quality of life (spillover effects on other aspects of life): lower number of surgeries; less concerns for the side effects of silicone implants (e.g. rupture, leakages, contraction rate and explantations). (4) Feelings: sensation of a totally natural breast; no feeling of a “plastic” implant in the body; increased self-esteem from augmentation mammoplasty.
As a conclusion of all the data and analysis resulted from the present feasibility study we decided to continue the development of this product. In fact, we believe that this project will be of significant strategic and financial benefit for the company and its stakeholders, and will have a significant and positive impact on patients’ quality of life and public Healthcare expenditure.