Tensive is a clinical‑stage medical device company developing REGENERA™/SOFTAG™ bioresorbable polymer scaffolds that replace volume and promote new tissue growth for natural breast reconstruction and tissue marking after lumpectomy. The minimally invasive, permanent solution has demonstrated safety and strong clinical outcomes in first‑in‑human trials and is currently being evaluated in a pivotal study of 94 breast‑cancer patients.
Funding
$14.6M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Women undergoing lumpectomy often lack a permanent, natural‑feeling breast reconstruction option that can be delivered minimally invasively, leading to multiple surgeries, suboptimal aesthetic outcomes, and reduced quality of life.
Solution
Tensive has created two resorbable biopolymer scaffolds—REGENERA™ for breast reconstruction and SOFTAG™ for precise tissue marking. The scaffolds are implanted at the time of lumpectomy, where their porous, cross‑linked polyurethane matrix supports infiltration of the patient’s own cells and blood vessels, enabling the formation of vascularized, adipose‑like tissue that restores breast volume. As the polymer gradually bio‑absorbs, the scaffold disappears, leaving only regenerated tissue without the need for revision surgery. SOFTAG™ uses the same material to mark the tumor bed, improving radiotherapy targeting and post‑operative monitoring. Clinical data from first‑in‑human and ongoing pivotal trials show safety, durable volume maintenance, low capsule formation, and high surgeon and patient satisfaction. Approvals are expected in early 2027.
Target Audience
Primary customers are breast surgeons and oncologic surgical teams performing lumpectomies, as well as radiotherapy departments that require accurate tumor‑bed localization.
Features
- Fully resorbable, cell‑free polyurethane scaffold with a porous architecture designed for rapid host cell infiltration and vascularization
- Mechanical properties matched to adipose and loose connective tissue, preserving natural breast shape and feel from implantation onward
- Single‑step implantation during lumpectomy eliminates the need for additional reconstructive surgeries
- Gradual bio‑absorption over months to years, leaving only regenerated native tissue without permanent foreign material
- SOFTAG™ precision marking device that demarcates the tumor bed to aid radiotherapy planning and surveillance
- Proven safety and efficacy in first‑in‑human and pivotal trials involving breast cancer patients, with low incidence of capsular contracture
- Protected by multiple issued and pending patents covering the polymer composition, scaffold design, and marking technology