July 6, 2012 — Vascular Closure Systems Inc. announced that the 30-day follow-up results for the Phase I first-in-human (FIH) clinicals have been confirmed by Doppler and ultrasound evaluation. The evaluation confirmed normal vessel healing, with complete absorption of the FastSeal sealing element. During the follow-up, no adverse events were observed — no hematoma, pseudoaneurysm or fistulas were present in any of the patients. All patients were asymptomatic and the comfort of the device was excellent, with no groin pain during the deployment, immediately after, at seven and at 30 days after the procedure.
The initial series of human clinical cases were performed by Prof. Alessandro Bortone of the Policlinico di Bari, University of Bari School of Medicine, Italy. Phase II of the FIH clinical tests are currently underway.
The detailed Phase I and Phase II FIH clinical test results will be presented at multiple upcoming medical conferences.
A second manufacturing facility (outside of the United States) has been set up and is producing FastSeal Bioabsorbable Vascular Access Closure systems. Initially, the units being produced are for clinical testing to support regulatory submissions. Once regulatory approval has been granted, the units being produced at this site will be for commercial use.
The company is planning to begin international commercialization (pending regulatory approval) during the fourth quarter of this year.
Vascular Closure Systems is also currently exploring multiple strategic options to enhance shareholder value, including, but not limited to, private funding, a possible strategic alliance, a merger or sale of the company.
For more information: www.vclosure.com