08/10/2025
It’s important during hashtag to raise awareness of the goals we are still striving to reach. Did you know that compared with mastectomy, more than twice as many patients undergo lumpectomy every year – and three-quarters of them receive no reconstruction care at all?
It’s not because there’s no need: up to 40% of patients report asymmetry or disfigurement that requires correction after lumpectomy, while many more simply tolerate these changes, even though they can be psychologically devastating. Rather, the reason these patients are untreated is that there simply is no viable reconstruction option for them.
That’s why Tensive is developing REGENERA™ and SOFTAG™ bioresorbable implants as minimally invasive, one-step solutions that are appropriate for any lumpectomy. Our implants use a soft synthetic scaffold that resembles a very fine sponge, whose structure facilitates regrowth of blood vessels and soft tissue, and which is gradually absorbed by the body. The devices are implanted during the lumpectomy procedure.
Imaging data from a first-in-human study and interim results from our ongoing pivotal trial confirm that breast restoration with REGENERA™ is safe and results in natural tissue that preserves the original shape and feel of the breast, yet is clearly differentiated from surrounding tissues on imaging.
SOFTAG™ uses the same bioresorbable, customizable scaffold as a tumor resection marker to support precision delivery of radiotherapy to the tumor bed.
Visit our website at www.tensive.com to learn more about our work to bring REGENERA™ and SOFTAG™ to approval for women undergoing lumpectomy.