FDA Clearance of NeuroShield
FDA clearance of NeuroShield® - The Breakthrough membrane
Root (Switzerland), June 3rd, 2019
Monarch Bioimplant GmbH has received the 510(k) premarket notification from the FDA allowing NeuroShield®, Monarch’s flagship product to be commercialized in the US.
NeuroShield® is a chitosan-based porous biodegradable innovative membrane approved to protect and to support the repair of damaged peripheral nerves.
Peripheral nerves are literally everywhere in the body and play vital roles. Depending on the location and severity of an injury, peripheral nerve damage can lead to different impediments from numbness and constant pain to loss of movement and sexual impotence.
NeuroShield’s efficacy has been already proven in a clinical study conducted by the well-known urologist and surgeon Prof. Francesco Porpiglia from the University of Turin, Italy. Prof. Porpiglia implanted NeuroShield in over 260 patients who had damaged the cavernous nerves around the prostate during a radical prostatectomy.
The damage of the cavernous nerves is the number one reason for sexual impotence after prostate cancer surgery. This side effect has been the main reason for many patients to refuse surgery, risking their own lives.
Prof. Porpiglia has published the outstanding results of the use of NeuroShield® in two papers at the prestigious medical journal BJUI and has also presented the innovation in numerous international medical conferences.
Leading surgeons from US, Europe and Australia who saw the published results have already made known their interest in using NeuroShield® in their hospitals. Many of them have already recognized NeuroShield® as the next standard of care.
The FDA clearance opens the doors for commercialization in the US as well Israel, Singapore, Hong Kong among other markets.
Monarch will start direct sales in the US and is looking for distributing partners in other markets.