Signati Medical

Uncategorized

Signati™ Medical Files IDE Study with FDA

by

Providence, RI, Sept. 26, 2023 (GLOBE NEWSWIRE) — Signati™ Medical has officially filed their IDE study with the FDA. An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. All clinical evaluations of investigational devices must have an approved IDE before the study begins. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution.

Signati’s™ GLP data shows that their device has met safety endpoints of sealing, no thermal spread, and clinically documented wound healing. The IDE study will be the final step for Signati™ to market their Sealed Vasectomy Procedure (SVP)™ to the public once fully approved by the FDA.

About Signati™ Medical, Inc.

Signati™ Medical, Inc. is a medical device company that endeavors to take vasectomy to a new level of comfort, safety, and speed. A medical device company dedicated to advancing men’s health, Signati plans to launch the first innovation in vasectomy in more than 20 years with a procedure that would be fast for physicians and comfortable for patients. The Signati Sealed Vasectomy Procedure (SVP)™, designed to take just minutes, could be done right in the urologist’s office and would offer advantages for patients including easier recovery compared to some current vasectomy techniques. To learn more, visit www.signatimed.com.

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 (FDA). 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.

CONTACT: William Prentice President & CEO, Signati Medical Inc. 128 Dorrance Street 6th Floor Providence, RI 02903 william.prentice@signatimed.com https://signatimed.com

https://finance.yahoo.com/news/signati-medical-files-ide-study-130000432.html?soc_src=social-sh&soc_trk=ma

Signati™️ Medical, Inc. Announces Dr. LeRoy Jones Has Been Appointed to Its Board of Directors

by

Providence, RI, Aug. 03, 2023 (GLOBE NEWSWIRE) — Signati™️ Medical, Inc. announced today that Dr. LeRoy Jones has been appointed to its Board of Directors. Dr. Jones is considered an authority in the field of sexual medicine, having performed over 3000 prosthetic surgeries. He has numerous publications in the field of sexual medicine. Dr. Jones is internationally recognized and has taught surgery in over 26 countries throughout the world. He is the past president of The Society of Urologic Prosthetic Surgeons and is an active member of the Sexual Medicine Society of North America. Dr. Jones is currently in private practice with Urology San Antonio in San Antonio, Texas.

Now that Signati™️ Medical, Inc. has completed its final GLP and prepares to submit for FDA approval, Dr. LeRoy Jones and Signati’s Chief Medical Officer, Dr. Gerard Henry, will lead the path to Signati’s human study at LSU in New Orleans. This is an exciting time for Signati as it will come to market with the first approved medical device to perform a vasectomy using bi-polar energy. Signati™️ Medical, Inc. continues to lead the way in minimally invasive men’s sexual health.

About Signati™️ Medical, Inc.
Signati™️ Medical, Inc. is a medical device company that endeavors to take vasectomy to a new level of comfort, safety, and speed. A medical device company dedicated to advancing men’s health, Signati plans to launch the first innovation in vasectomy in more than 20 years with a procedure that would be fast for physicians and comfortable for patients. The Signati procedure, designed to take just minutes, could be done right in the urologist’s office and would offer advantages for patients including easier recovery compared to some current vasectomy techniques.
To learn more, visit www.signatimed.com.

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 (FDA). 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.

Signati™ Medical, Inc. Completes Acquisition of SuperiorVAS Intellectual Property and Technology

by

Signati Medical Inc.
·1 min read
Providence, RI, Dec. 09, 2022 (GLOBE NEWSWIRE) — Signati™ Medical, Inc. today announced that it has completed the acquisition of all of the intellectual property and technology of SuperiorVAS, LLC, a privately held company in Raleigh, NC. The IP covers methods to create a vasectomy through ablation of the vas deferens—an advancement in a critical technology. Terms of the agreement were not disclosed.

“The acquisition of this advanced technology complements our current pipeline to provide minimally invasive vasectomy procedures. Our focus continues to be our bipolar radio frequency sealing technology for the vasectomy market,” says Bill Prentice, CEO of Signati™ Medical, Inc.

Signati’s Chief Medical Officer, Dr. Gerard Henry, adds, “The ablation of the vas deferens could be another option for Urologists to perform a minimally invasive vasectomy with the use of the Signati unique generator. We need to shift the responsibility of sterilization from women to men by simplifying the procedure and eliminating fear thus changing the perception of vastectomy.”

About Signati™ Medical
Signati™ Medical is a medical device company that endeavors to take vasectomy to a new level of comfort, safety, and speed. A medical device company dedicated to advancing men’s health, Signati™ plans to launch the first innovation in vasectomy in more than 20 years with a procedure that would be fast for physicians and comfortable for patients. Signati’s bipolar Sealed Vasectomy Procedure™, designed to take just minutes, could be done right in the urologist’s office and would offer advantages for patients including easier recovery compared to some current vasectomy techniques.

“Leading Innovation in Men’s Health”

To learn more, visit www.signatimed.com.

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 (FDA). 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.

Signati™ Medical, Inc. Debuts Innovative Bipolar Radio Frequency Sealing Platform at American Urological Association (AUA) Annual Meeting

by

Signati™ Medical, Inc. Debuts Innovative Bipolar Radio Frequency Sealing Platform at American Urological Association (AUA) Annual Meeting

Providence, RI, May 24, 2022 — Signati™ Medical, Inc. is pleased to announce the unveiling of their innovative Sealed Vasectomy Procedure at this year’s AUA Annual Meeting in New Orleans, LA.

Notably, Signati’s™ technology was featured in a 7-minute abstract and scientific video presented by Dr. Ryan Griggs which was chosen as Best Video of AUA 2022 in the Sexual Dysfunction/Infertility/Andrology section.

The Signati™ Medical proprietary bipolar radio frequency sealing platform provides the ability to monitor impedance, eliminating procedural guesswork and creating effective trans-dermal sealing of the vas deferens. The result is an improved surgical outcome by minimizing damage to the surrounding tissue.

The response to Signati™ Medical’s platform was overwhelmingly positive. Clinicians were excited about the potential impact this product could have on the vasectomy procedure, especially given the lack of innovation in this area over the last twenty years.

About Signati™

Signati™ Medical is a medical device company that endeavors to take vasectomy to a new level of comfort, safety, and speed. A medical device company dedicated to advancing men’s health, Signati™ plans to launch the first innovation in vasectomy in more than 20 years with a procedure that would be fast for physicians and comfortable for patients. The Signati™ procedure, designed to take just minutes, could be done right in the urologist’s office and would offer advantages for patients including easier recovery compared to some current vasectomy techniques.
To learn more, visit www.signatimed.com.

This product is 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 (FDA). 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.

Douglas Stein, MD Joins Signati Medical, Inc.’s Clinical Advisory Board

by

Providence, RI, Nov. 22, 2021 (GLOBE NEWSWIRE) — Signati Medical, Inc. is pleased to announce that Douglas Stein, MD has joined their Clinical Advisory Board. Having performed over 45,000 vasectomies—the most of any urologist in the US—Dr. Stein brings his vast experience and passion for vasectomy to the Signati Medical team.

About Douglas Stein, MD

After completing residency training in 1983, Dr. Doug Stein practiced adult general urology for over 17 years in Tampa, Florida. In 2000, he stopped seeing new general urology patients to devote all his time to vasectomy and vasectomy reversal, eventually providing vasectomy services at up to 21 locations in Florida, many under the federal Title 10 program for low-income men without insurance. In 2010, he began his international vasectomy mission work and has now led 38 vasectomy missions to a variety of countries including the Philippines, Haiti, Kenya, Mexico, and Indonesia. He is the Co-Founder of World Vasectomy Day, the largest annual male-oriented family planning event in history. In addition to training doctors overseas, Dr. Stein has provided individualized training for 155 doctors from 5 continents at his main office in Tampa/Lutz, Florida. He has performed over 45,000 vasectomies and 1,900 vasectomy reversals.

To read more about the Clinical Leadership Advisors, please visit www.signatimed.com.

About Signati Medical
Signati Medical is a medical device company that endeavors to take vasectomy to a new level of comfort, safety, and speed. A medical device company dedicated to advancing men’s health, Signati plans to launch the first innovation in vasectomy in more than 20 years with a procedure that would be fast for physicians and comfortable for patients. The Signati procedure, designed to take just minutes, could be done right in the urologist’s office and would offer advantages for patients including easier recovery compared to some current vasectomy techniques.
To learn more, visit www.signatimed.com.

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 (FDA). 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.

LeRoy Jones, MD and Ryan Owen, MD Join Signati Medical, Inc.’s Clinical Advisory Board

by

Providence, RI, Oct. 01, 2021 (GLOBE NEWSWIRE) — Signati Medical, Inc. is pleased to announce that LeRoy Jones, MD and Ryan Owen, MD have joined their Clinical Advisory Board. Their combined experience and expertise in men’s health as renowned board certified urologists make them an invaluable addition to the vision of Signati Medical, Inc.

About LeRoy Jones, MD
Dr. LeRoy Jones is currently in private practice with Urology San Antonio in San Antonio Texas. He opened the Center for Male Health and Wellness, a division of Urology San Antonio. He is also a Clinical Associate Professor at the University of Texas Health Science Center in San Antonio. Previous academic appointments include The University of New Mexico Health Science Center and at the Baylor College of Medicine in Houston, Texas. Dr. Jones received his medical education at Washington University St. Louis. Surgical and Urological training was at the Johns Hopkins Hospital and the Baylor College of Medicine in Houston respectively.

Dr. Jones is considered an authority in the field of sexual medicine, having performed over 3000 prosthetic surgeries. He has numerous publications in the field of sexual medicine. Dr. Jones is internationally recognized and has taught surgery in many countries all over the world. He is the past president of The Society of Urologic Prosthetic Surgeons and is an active member of the Sexual Medicine Society of North America.

About Ryan Owen, MD
Dr. Ryan Owen is fellowship trained in male reproductive health and microsurgery. His medical journey began at Texas Tech University School of Medicine. After graduation, he began a Urology residency at The University of Tennessee and then completed an additional year of fellowship at the University of North Carolina. Currently living in Lubbock, Texas, his practice focuses on a wide range of urologic disease with a focus on male reproduction. He is an assistant professor at the Texas Tech University Urology residency program, where he has introduced residents and students to clinical and surgical aspects of male reproductive health.

Dr. Owen has contributed numerous publications toward the field of urology spanning from testosterone supplementation and erectile dysfunction to genetic testing for men seeking fertility. Given his focus toward the advancement of men’s health, Dr. Owen has joined the Signati Medical team with the ambition to help create a safe and efficient method to perform a non-invasive vasectomy procedure.

To read more about the Clinical Leadership Advisors, please visit www.signatimed.com.

About Signati Medical
Signati Medical is a medical device company that endeavors to take vasectomy to a new level of comfort, safety, and speed. A medical device company dedicated to advancing men’s health, Signati plans to launch the first innovation in vasectomy in more than 20 years with a procedure that would be fast for physicians and comfortable for patients. The Signati procedure, designed to take just minutes, could be done right in the urologist’s office and would offer advantages for patients including easier recovery compared to some current vasectomy techniques.
To learn more, visit www.signatimed.com.

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 (FDA). 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.