Lyra Medical has developed a new implant for the surgical treatment of pelvic organ prolapse (POP). The company’s self-retaining support (SRS) technology eliminates the need for complex anchoring techniques to assure a safe and efficient long-term treatment.
Backed with robust clinical evidence the SRS Implant has been proven to address the root cause of safety issues raised by all predecessors’ devices. Pre-market studies and Post-Market Surveillance (PMS) data demonstrated exceptional safety and long-term efficacy.
- Iram Levit
- [email protected]
- HaMelacha 3, Binyamina, Israel
- +97249921100
- https://lyramedical.com/
Company 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 company is certain of its ability to demonstrate a benefit/risk profile that will position it as the first-line of treatment for anterior vaginal wall and uterus prolapses.
Looking For
Lyra Medical is seeking a $16M fundraising round to reach global commercialization.
Use of proceed:
- Entry into the US market:
- FDA study
- Establishment of US operation
- EU sales growth
- Including PMCF studies
- Geographical expansion
- Establishment of new markets
We are also open to a smaller $2M round, that will allow us to continue growth in EU and other territories, as well as conduct additional, large scale international (out of the US) study, to support our growth and future bigger round fundraising effort.
Additionally, for expending our operation to geographical location outside of our current operations, we would be more than happy to meet distributors, experienced in the Urogynecology/Gynecology/Urology space with proven performance in the surgical field (high advantage to implantable solutions).