UR SHAPE

UR SHAPE® is a natural breast bioprosthesis redefining reconstruction.
This bioprosthesis offers a body-friendly alternative to traditional breast reconstruction for patients who have undergone mastectomy following breast cancer.

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a natural, personalized, and resorbable bioprosthesis

  • It is a bioabsorbable hydrogel porous scaffold made from 100% natural, biologically sourced materials.
  • Its 3D-printed structure and composition create a favorable microenvironment that promotes vascularization and in situ tissue regeneration. Over time, the bioprosthesis is gradually absorbed and replaced by viable autologous tissue.
  • It is also compatible with fat grafting.
  • UR SHAPE® offers a natural alternative to conventional implants, eliminating the safety concerns associated with silicone or saline-filled devices.

 

“UR SHAPE® aims at restoring form and volume of the breast using the patient’s own tissue with minimal invasiveness in order to improve the quality of life of women undergoing breast cancer surgery.”

Dr Justin Michael Broyles, MD, Associate Plastic Surgeon – Brigham and Women’s Hospital, Assistant Professor of Surgery – Harvard Medical School

 

Proposed clinical benefits

  • Easy to implant for surgeons
  • - Easy surgery aligned with existing practices
  • - Immediate shape at implantation
  • - Less complications than traditional breast reconstruction solutions
  • Aesthetic and sustainable result for patients
  • - 100% biosourced composition inducing natural tissue regeneration, no synthetic materials
  • - Soft feeling resembling human tissue from implantation
  • - Only one surgery
  • - Adapted to all patients’ morphologies
  • - Resorbable by remodeling

Development status UR SHAPE®
Finalizing the preclinical stage development

Achievements to date include:

  • In vitro demonstration of vascularization and optimized fat survival
  • Small animal studies confirming lack of cytotoxicity
  • Large animal studies with 300cc bioprosthesis implanted for up to 8 months, showing:
    – No inflammation
    – Shape retention
    – Good tissue integration
    – Resorption via hydrolysis and phagocytosis
  • Optimized architecture and manufacturing process for scale-up
  • Developed a dry-format version of the prosthesis to enable safe storage and efficient distribution while preserving its structural and functional integrity

Regulatory & intellectual property status

UR SHAPE® is advancing through the regulatory pathway as a medical device in both Europe and the United States.

Backed by exclusive worldwide rights across four patent families, Healshape is preparing to launch early human feasibility clinical trials by the end of 2026.

 

Our strong IP portfolio and preclinical success position UR SHAPE® as a promising innovation in regenerative breast reconstruction.

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