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Surgeons in Operating Room

News

2024 News Releases
April 4, 2024

First Stage of Clinical Testing Complete

ZSX completes the first stage of ZIMS, the U.S. clinical study using Zip-stitch, with the 10th Zip-stitch case successfully completing 6-week follow-up. "This is a tremendous milestone for ZSX Medical, and it represents an important step forward in women's health, creating an opportunity to reduce the number of women who have to undergo invasive large-incision hysterectomy," says President and CEO Dan Mazzucco. The company will now work to obtain further funding to complete its clinical development and bring Zip-stitch to market.

2023 News Releases
November 6, 2023

ZSX Bolsters Board of Managers

ZSX Medical is pleased to announce the addition of Audrey Greenberg and Kathleen Brunner to our board, extending the breadth and depth of our Team's relevant expertise.

2023 News Releases
October 18, 2023

Pivotal Clinical Trial for Zip-stitch Underway

ZSX Medical today announced the achievement of the first clinical uses of Zip-stitch® in its pivotal U.S. clinical trial (the "ZIMS" trial). Zip‑stitch is a novel wound closure system for use in laparoscopic hysterectomy.

2023 News Releases
March 10, 2023

FDA Gives IDE Approval for ZIMS Study 

FDA has granted approval for us to begin our pivotal clinical study to evaluate the safety and efficacy of Zip-stitch.

2021 News Releases
October 1, 2021

After an interminable wait, NIH grants ZSX a $1.68MM direct to Phase II Small Business Innovation Research grant. ZSX re-enters stealth mode as it deploys the NIH funding to redesign the Zip-stitch applicator, rebuild inventory, and, eventually, to restart its pivotal clinical study.

2020 News Releases
September 5, 2020

No longer seeking angel investment in a post-COVID world, ZSX submits its second National Institutes of Health direct-to-Phase II Small Business Innovation Research (SBIR) grant application, scoring a 20. For those unfamiliar with NIH scoring, that's like a 297 in bowling or a 5.9 in figure skating (the Soviet judge gave us a 5.5).

2020 News Releases
March 11, 2020

The World Health Organization declares COVID-19 a pandemic. The COVID public health crisis sadly but rightly redefines the priorities of investors and hospitals alike. ZSX, an investor-funded company that relies on hospitals for its clinical trial progress, begins to change gears.

2019 News Releases
March 25, 2019

ZSX Medical and Thomas Jefferson University Hospital enter into agreement to perform the first United States clinical study with Zip-stitch™. We're not ones to toot our own horn, so we'll toot Jefferson's horn instead. Jefferson is nationally-ranked in 10 different medical specialties, and has become a serious force in supporting innovation in medical care in the Philadelphia area under the headship of gynecologist Stephen Klasko, MD, named best innovator in Philadelphia in 2016. ZSX is proud to partner with Jefferson to bring Zip-stitch™ into the world.

2018 News Releases
November 21, 2018

FDA says Zip-stitch™ looks good so far, but asks for additional clinical data. So ZSX prepares for its second clinical trial, this time with a shiny new reusable applicator.

2018 News Releases
August 26, 2018

ZSX Medical is selected to present three abstracts and an oral presentation at the 49th AAGL Global Congress on Minimally-invasive Gynecology in Las Vegas, Nevada. What happens at AAGL stays at AAGL, but not really because the proceedings are published in the Journal of Minimally-Invasive Gynecology.

2018 News Releases
February 28, 2018

ZSX completes its SBIR Phase II Grant after receiving over a million dollars as part of the award. Thank you, America!

2018 News Releases
May 22, 2018

ZSX Medical concludes 1-year follow-up of patients from its first clinical trial with more great results. Happy birthday to clinical stage ZSX!

2017 News Releases
November 22, 2017

ZSX's first ease of use clinical trial concludes 6-month follow-up with happy patients and happy doctors.

2021 News Releases
September 21, 2021

ZSX Medical has been awarded a direct-to-Phase II Small Business Innovation Research (SBIR) grant for $1.68M from the National Institutes of Health to fund its pivotal US trial to evaluate the safety and effectiveness of Zip-Stitch in laparoscopic hysterectomy.

2019 News Releases
August 20, 2019

ZSX Medical receives IDE approval from FDA and IRB approval from Thomas Jefferson University Hospital to begin its United States clinical trial. Enrollment begins!

2018 News Releases
October 23, 2018

Teleflex acquires Essential Medical for an undisclosed amount (insiders say it was a zillion dollars). Why is this in ZSX Medical news? Some company that makes a surgical closure system that competes with (and is better than) sutures has a great exit... you betcha that's relevant to us. Plus, Greg Walters, Essential Medical's CEO, is one of the great guys in medtech, and we're thrilled to see him succeed.

2018 News Releases
March 12, 2018

ZSX Medical submits its first 510(k) application to the FDA, and waits with patience. This is a better announcement if you read it out loud.

2017 News Releases
November 15, 2017

ZSX is granted PCT 2844155, our 3rd European Patent, to go with our 3 US patents.

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