Signati Medical Announces Phase 2 Study Showing a New Bipolar Radio-Frequency Sealing Tool for Trans-scrotal Vasectomy.
Initial animal study revealed effective vas deferens sealing.
May 24,2021—Signati Medical, Inc., a medical device company focused on advancing men’s health with a proprietary bipolar radio frequency sealing platform, announced today that the company initiated a second preclinical study on New Zealand rabbits. Signati has developed a unique impedance detection algorithm and was conducting this second preclinical evaluation to further correlate the radio-frequency energy delivered to the surgical site with effective vas deferens sealing. The ability of the system to monitor impedance eliminates procedure guesswork, creating effective closure of the vas deferens through scrotal skin (trans-scrotal) and improving the surgical outcome by minimizing damage to the surrounding tissue.
This additional preclinical study will seek to expand the positive findings of Signati’s initial preclinical study on New Zealand rabbits. In the initial study, validated laboratory and histological assessments were conducted in a rabbit model to demonstrate that the Signati Medical system had been designed with optimal electrosurgical radio frequency (RF) energy parameters and electrode geometry for creating an effective seal in the vas deferens. Post procedure healing was also monitored to confirm that thermal spread to 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 conducted using a no scalpel method. This was added to confirm that sealing parameters are effective should this method be preferred based on clinical preference and/or need. Post treatment histological slides have confirmed positive vas deferens sealing.
Signati’s Chief Medical Officer, Dr. Gerard Henry, was encouraged by the success of the preclinical study results stating, “We look forward to conducting further studies seeking to validate and build on the initial success of Signati’s preclinical results, which demonstrated that our custom engineered RF bipolar generator creates effective vas deferens sealing. We believe our proprietary handpiece, electrode design, and impedance detection algorithm has the potential to become a leading treatment option when performing vessel sealing, such as the vas deferens. We look forward to submitting this data in a 510k to the FDA, and the results we have seen thus far make us very confident in Signati Medical’s novel approach to trans-scrotal vessel sealing vasectomy.”
Not approved by the Food and Drug Administration (FDA).
These statements and the subject product 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 being marketed, nor is it available for sale in any country.