Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - REGENERA (Helping cancer survivors restoring their natural breast with resorbable implants inducing self‐tissue regeneration)

Teaser

Tensive was founded in 2012 to address the challenge of developing advanced biomaterials for regenerative medicine. We developed a bio-absorbable scaffold based on highly biocompatible polyurethane ester, which provides a biomimetic architecture that aims to promote blood...

Summary

Tensive was founded in 2012 to address the challenge of developing advanced biomaterials for regenerative medicine. We developed a bio-absorbable scaffold based on highly biocompatible polyurethane ester, which provides a biomimetic architecture that aims to promote blood vessels penetration and soft tissue recruitment. Based on these unique properties, we will bring to the market REGENERA, an innovative breast prosthesis designed to be degraded over time and replaced by the patient´s soft tissue, to restore the aspect and natural feeling of the reconstructed breast.
Currently, the two most commonly used methods for breast reconstruction are silicone implants and fat grafting. However, these methods have several limitations and associated complications, including the risk of rupture, capsular contracture, pain, and carcinogenic risks (including Anaplastic large cell lymphoma (ALCL)), among others, that lead to the need for multiple revision surgeries. REGENERA aims to solve these problems, by offering a safe, customizable, minimal invasive solution for breast reconstruction that restores the shape of a natural breast. REGENERA will not require further surgeries, thus drastically reducing the pain, medical expenses, and psychological impact for the patients.
The REGENERA phase 2 objectives are (1) to conduct the first-in-human trial (FIH) of REGENERA and (2) to comply with the regulatory requirements needed for commercialization.

Work performed

REGENERA Phase 2 project has been structured into 3 main pillars to be performed over 24 months: (1) production and industrial process setup, (2) validation and (3) cross-functional activities. During the first reporting period, we obtained the following results:
• Production and Industrial Process Setup. As a first stage, the prototype was optimized to match the specifications requested by the target clinical application. These specifications were verified through analyses performed both internally and by external certified partners. As a second stage, an upscaling study has been conducted in order to adapt the process parameters to the increased production volumes requested for the industrial production line. All these parameters have been defined, and a production line for REGENERA was developed and tested in compliance with the ISO 13485 and state-of-the-art Quality Control (QC) techniques for medical device production. The prostheses needed for the clinical trials in WP2 were then produced according to the requested standards of Quality and to Medical Device Regulations.
• Validation. In order to achieve the clinical validation of our product through a single-center First-in-Human (FIH) clinical trial (WP2), all the required documentation was prepared and submitted to the competent authorities (the Italian Ministry of Health and the Hospital Ethical Committee). We then received the approval to begin the study. Said documentation included the results of all the relevant preclinical test carried out on our product in order to validate the specifications required for Breast Reconstruction applications. In particular, the biocompatibility and efficacy of REGENERA for soft tissue regeneration were certified through in vitro and in vivo test.
• In addition, different cross-functional activities have been carried out, such as communication and dissemination to create awareness about REGENERA. The project website has been built to increase the project’s visibility and impact, and our social media presence has grown through different channels. In addition, web communications related to the project have been published on several websites. The data associated with REGENERA project resulted in 2 scientific articles and further scientific publications based on our recent preclinical studies are in preparation. Tensive took part in numerous key international events where our team promoted REGENERA and the results of the project, presenting in front of hundreds of experts in the life sciences and medical devices fields. Finally, IP management has been carried out through the filing of a patent referred to the technology platform on which REGENERA project is based, extending the protection of the existing patents, and working at the registration of REGENERA’s trademark in the countries where it will be sold.

Final results

The most common treatments for breast tissue defects present several risks and limitations:
- Gel-filled silicone implants: not lifetime devices with several complications, such as rupture (30% incidence), capsular contracture, silicone leakage, and the risk of developing Anaplastic large cell lymphoma (ALCL), interference with breast imaging that detects recurrences, back/neck pain and spinal postural alterations due to their high weight, etc.
- Saline-filled silicone implants are used as an alternative to silicone gel-filled implants to decrease leakage problems. However, they also interfere with breast imaging.
- Fat grafting. This method is still limited to small volumes and represents a source of additional pain for the patients. In general, fat grafting is a very tedious, painful, physically demanding and time-consuming surgery, also presenting potential carcinogenic risks (in fact, its safety has not yet been demonstrated).
REGENERA’s unique design aims to promote vascularization, soft tissue recruitment and volume maintaining after implantation. These features are not present in the technologies currently available on the market. REGENERA is estimated to have substantial competitive advantages over alternative solutions, such as restoring the aspect and natural feeling of the reconstructed breast, decreased number of surgical interventions needed, decreased costs, elimination of implant-associated risks, no interference with breast imaging and overall improved quality of life. Clinical validation is required to demonstrate the estimated advantages/benefits.
We expect that REGENERA will have a significant impact on various aspects: (i) Healthcare system: it will save the cost of additional surgeries (more than €200M yearly in the EU), contributing to the sustainability of the Healthcare system; (ii) Breast reconstruction patients: it will offer a solution to lumpectomy patients, for whom there are no optimal reconstructive options yet, and a better alternative for breast augmentation patients; a permanent solution by a minimal invasive procedure, that will improve patients’ quality of life; (iii) Company: it will increase Tensive’s revenues (est. cumulative profit of ~€250M with an ROI of 19.37 by 2025); (iv) Society: it will significantly benefit 735,000 women needing reconstructive surgery after breast cancer every year, together with the 1.65 million women yearly undergoing breast augmentation.

Website & more info

More info: https://www.regenerabreast.com/.