Lyra obtained the appropriate regulatory approval for its 2nd human clinical study in three medical centers in Israel and initiated patient recruitment.
Kerem-Maharal, Israel, March 22th, 2016 – Lyra Medical, a developer of safe and easy POP trans-vaginal implant procedure, announced today the formal initiation of its 2nd clinical study enhancing the evidence-based data to support regulatory approvals and market adoption.
Based on the overwhelming success of the 1st study, Lyra’s second human multi-center trial is currently ongoing at three medical centers in Israel. The study was initiated in March 2016 and will recruit 50 women who suffer from symptomatic anterior vaginal and apical POP-Q grade ≥2 prolapse. Patients are scheduled for 1 year follow-up for regulatory approvals and will be additionally followed for another 2 years (total of 3) in a post-market settings.
Lyra Medical’s implant is a revolutionary surgical treatment for women suffering from advanced anterior vaginal wall prolapse with or without apical prolapse. The Self-Retaining Support (SRS) technology eliminates the need for complex anchoring techniques delivering a safe and long-term treatment solution.
“Lyra is committed to developing a paradigm-changing medical device to meet an acute need in the area of women’s health. We designed our previous study and continue to perform this ongoing study conservatively, with meticulous care and attention to detail. We believe that high quality and quantity of data will assure regulatory bodies as well as surgeons that the SRS can provide an extremely high success rate while not exposing patients to current known complications,” said Iram Levit, Lyra Medical’s CEO
“My previous experience with vaginal mesh made the Lyra SRS implant procedure easy to adopt. The surgery itself was short and the postoperative recovery was without any noticeable adverse events. At the follow-up visits, I was very satisfied when patients expressed their gratitude on the outcome and from the short and painless recovery period. Overall the anatomical and subjective results are excellent,” said Dr. Anna Padoa, Head of Urogynecology Unit, Assaf HaRofeh Medical Center, who has perform this study 1st procedure and participated in Lyra’s 1st study.
For more information about Lyra Medical and its technology please visit www.lyramed.com.
About Lyra Medical
Lyra Medical was established in 2011 by a team of seasoned medical device entrepreneurs to develop a new and safer organ support implant for women suffering from pelvic organ prolapse (POP).
The company’s Self-Retaining Support (SRS) technology is presently being applied in the flagship Lyra system for anterior vaginal wall, Apex and uterine prolapse. The support platform may be applicable in other pelvic organ disorder conditions, such as rectocele and urinary incontinence, as well as other clinical areas. In all these areas, there is an acute need for therapeutic solutions that deliver exceptional safety and long-term efficacy.