FDA ClearedOur FDA cleared and CE marked proprietary device represents a platform surgical technology.
A Platform Technology
In studies, at three weeks following wound closure, BioFusion™ repaired tissue has been shown to be 5 times stronger than traditional mechanical closure devices, creates a continuous seam in the tissue, and leaves no foreign bodies behind.
BioFusion™ encompasses the proprietary use of low voltages and high currents, optimized specifically for the tissue to be fused. In addition, energy output to the tissue occurs in pulses. These computer controlled energy pulses create optimal temperatures that unravel large molecules in the tissue and as these molecules cool, they become intertwined and create a fusion.
Rather than continuous energy output, which creates higher temperatures that can char and kill surrounding tissues, BioFusion™ controlled energy pulses allow the tissue to remain cool which results in minimal thermal damage to surrounding tissue.
These sophisticated techniques result in the maintenance of the vascularity in the surrounding tissue and results in a union of anatomical structures without tissue death and necrosis, allowing the tissues to return to their original healthy state.
BioFusion™ is a paradigm shifting replacement for the antiquated methods of wound closure - delivering improved patient outcomes and positive economic impacts.
We’re committed to delivering disruptive surgical devices that support the achievement of superior outcomes and reliability.
Dr. Ralph Zipper, MD, FACOG, FPMRS
“Living tissue is elastic. It grows. It fights infection. It heals. Synthetic materials foster infection, retard healing, and compromise elasticity. The only substitute for healthy living tissue is healthy living tissue.”
Dr. Neeraj Kohli, MD, MBA
Associate Professor, Department of Ob/Gyn at Harvard Medical School
“The ability to treat pelvic organ prolapse with BioFusion™ has the potential to change the lives of millions of women. This is paradigm shifting technology delivered at a time of need”.
- Shorter Procedure Times
- Reduced Failure Rates
- Decreased Recovery Times
- Estimated $1.6 B Surgical Savings from GyneFuse™
100 Rialto Place, Suite 700
Melbourne, Florida 32901
P.O. Box 33
Melbourne, Florida 32902
Monday-Friday: 9:00 – 5:00 Eastern Time