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.
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.
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.
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.
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.
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).
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.
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.
ZSX Medical concludes 1-year follow-up of patients from its first clinical trial with more great results. Happy birthday to clinical stage ZSX!
ZSX's first ease of use clinical trial concludes 6-month follow-up with happy patients and happy doctors.
ZSX Medical receives IDE approval from FDA and IRB approval from Thomas Jefferson University Hospital to begin its United States clinical trial. Enrollment begins!
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.
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.
ZSX is granted PCT 2844155, our 3rd European Patent, to go with our 3 US patents.
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.
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.
ZSX completes its SBIR Phase II Grant after receiving over a million dollars as part of the award. Thank you, America!
Procedures begin during ZSX's first ease of use clinical trial in Monterrey, Mexico.