Pre-Clinical Data

Lyra is committed to developing a paradigm-changing medical device to meet an acute need in the area of women’s health. The design and experimental stages are being conducted very conservatively and with meticulous care and attention to detail. As such, SRS technology demonstrated the ability to treat prolapse and was found to be well-suited to patients’ anatomy in the animal and cadaver studies carried out throughout the world. These studies went well beyond “proof-of-concept” trials and allowed Lyra to successfully reach the final design stage, including the device’s shape and sizes, while placing patient safety as the first priority.

Columbia Presbyterian Medical Center, New-York, USA

Participants: Five prominent US surgeons
Objective: Proof-of-Concept with several mechanical concepts
Results: The participating surgeons overwhelmingly endorsed the implant and its supporting concept.



Institute of Anatomy, Faculty of Medicine, University of Ljubljana, Slovenia

Participants: Lyra personnel
Objective: Finalize design in terms of shape and size
Results: Final shape and sizes selected. The need for insertion tool indicated.



Institute of Anatomy, Faculty of Medicine, University of Ljubljana, Slovenia

Participants: Three prominent Israeli surgeons
Objective: Confirm final shape and size. Examine several concepts for insertion device.
Results: The participating surgeons overwhelmingly endorsed the implant and its supporting concept. Shape and sizes were confirmed. An initial version of an insertion device was investigated and issues were raised for additional reconsideration.



Laboratoire d'anatomie de l'Université Paris-Descartes, France

Participants: Two globally recognized key-opinion leaders
Objective: Map the exact anatomical relation between the implant and surrounding blood vessels and nervous system and examine new insertion device concept. Receive key opinion leaders’ opinions and feedback.
Results: The participating surgeons overwhelmingly endorsed the procedure, the implant and its supporting concept. The risk of blood vessels or nerve impairment due to the implant location was refuted. Insertion device design and mechanical concept was generally proven, obtained feedback for further revisions needed.

 

For more information on Lyra’s pre-clinical and clinical program, please contact us at info@lyramed.com