OUR TECHNOLOGY
A proprietary, resorbable biopolymer that replaces volume and facilitates new tissue growth without cells or growth factors
Tensive’s REGENERA™ implant addresses an unmet need for synthetic scaffolds that are capable of providing the biological and mechanical support needed for soft tissue replacement and regeneration.
The proprietary biomaterial is composed of a biodegradable, cell-free, cross-linked polyurethane-based porous matrix. The internal structure was designed to allow the infiltration of natural cells and blood vessels, and the formation of vital and functional newly regenerated soft tissue. The mechanical properties of the biomaterial resembles that of adipose (fatty) and loose connective tissue. These characteristics enable it to provide adequate mechanical support to new tissue as it regenerates, while also maintaining the natural shape and feel of the breast from the very first day after implantation.
Clinical data obtained to date, including from patients followed for up to five years, demonstrate the implants maintain volume replacement and facilitate the regrowth of cellular, hydrated, and vascularized tissue, with very low incidence of capsule formation (scarring), and confirmed the gradual absorption of the implant over time.
As the device is implanted during the lumpectomy (tissue removal procedure) and is absorbed over time, there is no need for additional surgery.
Tensive’s SOFTAG™ implant uses the same resorbable biopolymer for tissue marking of the tumor bed. Because the biomaterial facilitates the regrowth of vascularized loose connective tissue, but not glandular tissue, the device helps to clearly demarcate the borders of the surgical intervention, facilitating radiotherapy and post-intervention monitoring.
Advanced chemistry, exceptional performance
The exceptional performance of the implants in clinical studies results from their biomechanical properties, which are achieved through Tensive’s advanced polymer chemistry.
By fine-tuning the polymer components, Tensive has produced a biomaterial with a remarkable combination of softness and resilience that closely matches that of human adipose tissue and mimics the natural micro-environment of the breast.
The material’s resilience allows the implant to maintain volume and regain shape even after prolonged pressure, for example due to a patient’s sleeping position.
The device’s internal structure is designed to enable rapid infiltration of cells and vascular tissue to facilitate reaching the inner core of the device after implantation. This is achieved thanks to an open-pore structure which is interconnected to a 3D network of channels extending through the polymeric matrix of the device.
The device’s low density (< 30 kg/m³), the intrinsic softness of the biomaterial, and the pore size work in harmony to minimize the foreign body response and counteract the formation of fibrotic scar tissue or fibrous capsule.
The biocompatibility of REGENERA™/SOFTAG™ implants have been demonstrated in accordance with ISO 10993-1:2018 and the FDA Guidance on ISO 10993-1, as well as the CDRH Guidance for Breast Implants.