Minimally invasive, one-step solutions that meet the needs of millions of women undergoing lumpectomy worldwide
Millions of women and a smaller number of men undergo surgery after a breast cancer diagnosis every year. While reconstruction is common following a total mastectomy, more than twice as many patients undergo lumpectomy every year – and three-quarters of them receive no reconstruction care at all.
That is not because there’s no need: up to 40% of patients report asymmetry or disfigurement that requires correction after lumpectomy. Many more simply tolerate these changes, even though they can be psychologically devastating. Research shows asymmetry after breast-conserving surgery is correlated with poor psychosocial functioning, fear of recurrence, and reduced quality of life. [1]
Rather, the reason these patients are untreated is that there simply is no viable reconstruction option for them. Tensive’s REGENERA™ provides a minimally invasive, one-step solution that is appropriate for any lumpectomy.
[1] Jennifer F. Waljee et al., Effect of Esthetic Outcome After Breast-Conserving Surgery on Psychosocial Functioning and Quality of Life, Journal of Clinical Oncology, Volume 26, Number 20, July 10, 2008.
Few alternatives
Breast reconstruction options today consist of silicone or saline breast implants and surgical procedures such as oncoplastic surgery or fat-grafting. Even in the small number of cases when these can be used following lumpectomy, they entail one or more additional surgeries, with associated risks, painful recovery, high costs, and uncertain outcomes.
Breast implants – silicone or saline – are not an option for most lumpectomies because they are not customizable to the size of the defect. They come with risks of rupture, contracture, and increased rates of cancer. U.S. Food and Drug Administration. (2022 & 2023). Implants are not a permanent solution: up to 40% require reimplantation within 4 years. Each procedure exposes patients to additional surgical risks and a painful recovery. Implants also may interfere with follow-up imaging. The lifetime treatment cost is high.
Autologous solutions such as fat grafting and muscle flaps, in which surgeons use tissue from other parts of the body, are invasive, complex and require specific expertise.
Multiple lengthy surgeries are often needed for this costly and painful procedure, and the cosmetic outcomes are variable and uncertain.
REGENERA™ for reconstruction
Tensive’s REGENERA™ is designed to allow the body’s own tissue to regrow after breast cancer surgery. The procedure is minimally invasive, easy to learn for surgeons, and happens during the same surgery as the lumpectomy. The result is a breast reconstruction that looks and feels like the patient’s natural breast.
The soft synthetic scaffold resembles a very fine sponge, whose structure facilitates ingrowth of blood vessels and soft tissue, and which is gradually absorbed by the body.
Imaging data from a first-in-human study and interim results from our ongoing pivotal trial confirm volume replacement and the ingrowth of cellular, hydrated, and vascularized tissue. Clinical data show high patient and physician satisfaction.
Breast restoration with REGENERA™ results in natural tissue that preserves the original shape and feel of the breast, yet is clearly differentiated from surrounding tissues on imaging. This supports a more targeted delivery of radiotherapy and more accurate monitoring for potential recurrence.
REGENERA™/SOFTAG™ for tissue marking
The implant is clearly differentiated from surrounding tissue on diagnostic imaging, supporting more targeted radiotherapy delivery and more accurate monitoring for potential recurrence.