Fundación Teófilo Hernando, CRO in Spain of a pivotal clinical study with the first medical device designed to restore natural breast shape and sensitivity after partial mastectomy

 The Fundación Teófilo Hernando (FTH) is participating as the CRO in Spain in a pivotal multicentre clinical study evaluating the safety and performance of the REGENERA medical device, a bio-compatible and bio-absorbable implantable structure that may have unique advantages in the treatment of postoperative breast tissue deficiencies.

REGENERA, a bioresorbable polymeric scaffold, is the first medical device designed to restore a natural breast after removal (partial mastectomy) of a malignant breast lesion, as it is designed to degrade over time within the body and be replaced by the patient's own soft tissue, restoring natural breast shape and sensation and avoiding a permanent implant. The shape and geometry of REGENERA has been established to facilitate its insertion at the implant site and to fill the volume deficit caused by the removal of the injured soft tissue after lumpectomy.

Unlike silicone implants and adipose tissue grafts, REGENERA does not require post-lumpectomy surgery, as the removed breast tissue is replaced by immediate implantation of the REGENERA medical device. This important variation reduces postoperative complications, pain and psychological impact for patients, which could lead to an improvement in their quality of life.

The international European clinical study, whose sponsor is the biomedical company TENSIVE S.r.l. (Italy), is being conducted in women aged between 40 and 70 years with a diagnosis of malignant breast lesion (with a maximum follow-up of 5 years). In Spain, the FTH is the CRO in charge of data monitoring and follow-up of the study at the participating centre, the Complexo Hospitalario Universitario A Coruña, which is already recruiting patients. The principal investigator of the study at this centre is Dr Benigno Acea Nebril.

In addition to the Spanish centre, two Italian centres are participating in the study: the Santa Chiara Hospital in Pisa, with Professor Manuela Roncella as coordinator and principal investigator of the study; and the European Institute of Oncology in Milan, with Professor Mario Rietjens and Dr. Mattia Intra as coordinators. At both centres, the study is also in the patient recruitment phase.

This is a project of great scientific and social importance, given that breast cancer is the most prevalent cancer among European women and this device can improve the quality of life of patients.

About the FTH:

The Teófilo Hernando Foundation is an entity with 28 years of experience as a CRO in the development of clinical and preclinical research studies. It is also a benchmark in Spain in drug R&D and in the training of research personnel and professionals in the pharmaceutical industry.

More information:

FTH Communication Department: Elena Arias [elena.arias@ifth.es]. 
www.fth.es