Providence, RI, May 24, 2021 (GLOBE NEWSWIRE) – Signati Medical, Inc., a medical device company focused on advancing men’s health with a proprietary bipolar radiofrequency sealing platform, announced today that the company will initiate a second preclinical study on New Rabbits from Zealand. Signati has developed a unique impedance detection algorithm and was conducting this second preclinical evaluation to further correlate the radiofrequency energy supplied to the surgical site with effective sealing of the vas deferens. The ability of the system to control impedance eliminates the conjectures of the procedure, creating an effective closure of the vas deferens through the scrotal (trans-scrotal) skin and improving the surgical outcome by minimizing damage to the surrounding tissue.
This additional preclinical study will attempt to extend the positive results of Signati’s initial preclinical study on New Zealand rabbits. In the initial study, validated histological and laboratory evaluations were performed on a rabbit model to demonstrate that the Signati Medical system had been designed with optimal electrosurgical radiofrequency (RF) energy parameters and electrode geometry to create an effective seal on the vas deferens. Post-procedure healing was also monitored to confirm that thermal diffusion to the surrounding tissue did not cause damage. The methods and conditions of the first study remained the same in the second study, with the addition of rabbit models performed using a scalpel-free method. This was added to confirm that the sealing parameters are effective in case this method is preferred based on preference and / or clinical need. Post-treatment histological slides have confirmed a positive sealing of the vas deferens.
Dr. Signati’s chief medical officer, Dr. Gerard Henry, was encouraged by the success of the results of the preclinical study stating: “We look forward to conducting studies that attempt to validate and leverage the initial success of Signati’s preclinical results, which demonstrated that our custom design RF bipolar generator creates effective sealing of vas deferens.We believe that our unique impedance and handpiece detection algorithm has the potential to become a leading treatment option when performing a deferential sealing. vessels, such as vas deferens. We look forward to sending this data in a 510k to the FDA, and the results we’ve seen so far give us a lot of confidence in Signati Medical’s new approach to trans-scrotal vessel sealing vasectomy. “
Not approved by the Food and Drug Administration (FDA).
These claims and the product in question have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. The device is not currently marketed or available for sale in any country.