Milan, Italy – 21 October 2024 - Tensive S.r.l. is excited to announce the launch of a groundbreaking multicenter clinical trial aimed at assessing the safety and performance of REGENERA in patients undergoing reconstructive surgery after lumpectomy for malignant breast lesions. This trial represents a significant advance in the post-lumpectomy breast reconstruction field.
Led by Prof. Manuela Roncella, Santa Chiara Hospital Breast Unit Director, the following 9 centers across Italy and Spain are participating this pivotal study: Santa Chiara Hospital - Pisa, Italy (Prof. Manuela Roncella), Complexo Hospitalario Universitario A Coruña - Coruña, Spain (Prof. Benigno Acea Nebril), IEO Istituto Europeo di Oncologia - Milano, Italy (Prof. Mario Rietjens), IRCCS Humanitas Research Hospital - Milano, Italy (Prof. Corrado Tinterri), IRCCS Ospedale San Raffaele - Milano, Italy (Prof. Oreste Davide Gentilini), Policlinico Universitario Agostino Gemelli IRCCS - Roma, Italy (Prof. Gianluca Franceschini), Istituto Oncologico di Candiolo FPO-IRCCS - Torino, Italy (Prof. Antonio Toesca), ICS Maugeri IRCCS - Pavia, Italy (Prof. Fabio Corsi), IRCCS Humanitas Istituto Clinico Catanese - Catania, Italy (Prof. Francesco Caruso).
This clinical trial will investigate the safety and performance of REGENERA in 92 female adult subjects aged 40-70 years undergoing reconstructive surgery after excision of a malignant tumor by lumpectomy.
“REGENERA has already demonstrated in a First in Human Study in 15 patients with non-malignant breast lesions to be a safe, easy-to-use, effective, & practical implant to treat breast disease following lumpectomy providing a natural breast shape & feeling in a single-step, minimally invasive, easy-to-adopt, & potentially cost-saving procedure. All the participating centers are excited to participate in this Pivotal clinical trial aiming to solve an unmet need in the treatment of breast lesions with lumpectomy” said Prof Roncella, PI of the study.
In conjunction with this month’s Breast Reconstruction Awareness (BRA) campaign, IEO (The European Institute of Oncology in Milan) has announced its participation in the study: Istituto Europeo di Oncologia (ieo.it). As part of his summary on developments in the field of breast reconstruction, Prof Rietjens from IEO states (translated), “In the future, implants may even no longer exist. For some years, in fact, several companies, including in Italy, have been working on the idea of replacing silicone with entirely biodegradable structures, as if they were scaffolding, which can be reabsorbed and slowly replaced by the patient's soft tissue, giving the woman back a breast as natural as possible. These will be definitive solutions, which do not require replacement over time and, hopefully, without side effects. The first multicenter clinical trial is already underway with the aim of validating the use of the REGENERA resorbable implant and the IEO is excited to participate together with some of the best Italian breast centers. We are the first to have joined, together with the Santa Chiara Hospital in Pisa, and we have already recruited the first 20 patients.”
Tensive is an innovative biomedical company on a mission to offer breast cancer survivors the option for a natural breast reconstruction, Tensive’s first product, REGENERA, utilizes the company’s innovative polymeric scaffolds applied as a bio-absorbable breast implant. It is designed to restore the natural aspect of the breast and preserve the femininity of lumpectomy patients in one single surgery.
This study holds great promise for improving the quality of life of breast lumpectomy patients and represents a step forward towards the commercialization of Tensive’s highly innovative device, REGENERA.
REGENERA is not yet commercially available and is undergoing clinical investigation pursuant to regulations for investigational medical devices.
To learn more about the trial and eligibility criteria, visit the study page on ClinicalTrials.gov.
For more information about the trial, please contact: media@tensivemed.com
If you want to learn more about Tensive's previous First in Human study of REGENERA implant in patients diagnosed with localized non-malignant breast lesions treated by excision or lumpectomy, you can read our paper on the first interim analysis published in Breast Cancer here.
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About Tensive S.r.l.
Tensive S.r.l. was founded in 2012 with the mission to offer breast cancer survivors the option for natural breast reconstruction after lumpectomy, and breast augmentation patients a superior aesthetic outcome through an innovative bio-absorbable implant.
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For more information about Tensive, visit www.tensivemed.com