Company's Solutions

A new anchorless implant for the surgical treatment of Pelvic Organ Prolapse (POP):
Existing transvaginal implants (TVM) are associated with severe safety risks to the extent that they have been banned in the USA. At Lyra Medical, we understand that these risks stem from the need to anchor these implants into the pelvic structure regardless of the specific anchoring method or the implant’s material. Lyra Medical’s Self-Retaining Support (SRS) technology addresses this safety issue by eliminating the need to anchor the transvaginal implant. Additionally, this transformative technology provides durable mechanical support that restores pelvic organs to their anatomical and functional location, thereby addressing the efficacy issues of non-implant procedures (Native Tissue Repair).

This simple, proven solution provides a safe, effective and long-term treatment that far surpasses existing treatment options.

Solution highlights:

• Safe and easy to insert via simple transvaginal approach
• Eliminates mesh complications (contraction and erosion)
• Provides long-term organ support (clinically proven over a 3-year period)
• Shortens procedure time and surgeon's learning curve

Data speaks louder than words:

Lyra Medical is the only manufacturer to provide clinical data prior to its approval for clinical use in Europe and Israel. The available data clearly shows compliance with FDA requirements, which will be demonstrated at scale in the near future.

Backed with robust clinical evidence, the SRS Implant demonstrates a benefit/risk profile that will position it as the first-line of treatment for anterior vaginal wall and uterus prolapses.

Prominent Case Study

The SRS Implant is regularly used to treat Pelvic Organ Prolapse in various countries around the world. To name a few: Israel, Germany, Austria, Switzerland, Italy, Spain, Poland, Turkey, Czech Republic, Mexico and more. Lyra Medical has additional representations in other countries and plans to begin marketing rollout in the next few months.

After securing the required funds, Lyra intends to launch its US-based operations and pursue FDA approval. The vast clinical experience (over 3,500 implantations) and post-market clinical data, clearly indicate that the SRS can meet the FDA's PMA clinical study requirements .