Our first product in the Java product line is an aortic valvuloplasty balloon for use as a pre-dilatation device prior to a TAVR (Transcatheter Valve Replacement) procedure or a stand-alone treatment in select patients where TAVR is not appropriate.
It is designed to be a highly deliverable, puncture resistant device that has proprietary tines which aid in stability and reduce the need for peri-procedural cardiac pacing. Minimally invasive angioplasty is the core expertise of QT Vascular today, and the Java aortic valvuloplasty balloon is a natural extension of the Group’s technology offering to a new therapeutic indication.
Dr. Eitan Konstantino, the Group’s Chief Executive Officer, commented, "The acquisition of the Java technology will open new market opportunities for us and is consistent with our corporate strategy of maintaining a strong pipeline of high value and differentiated products. With the advent of TAVR, there is now a resurgence of interest in valvuloplasty as a means of optimizing the outcomes in these very expensive procedures. We believe Java’s revolutionary design will allow it to play a unique role as the number of TAVR procedures continues to grow."
The acquisition of this novel technology platform is in line with QT Vascular’s efforts to grow its new product pipeline in recent months.
The acquisition of this technology is not expected to have a material financial impact on the Group’s earnings per share and net tangible assets per share for the current financial year ending 31 December 2014.On 15 September 2014, QT Vascular announced that it has enrolled the first European patient in the ENDURE Trial in Germany.
Patients’ enrollment in Germany and New Zealand is progressing rapidly and is consistent with the group’s expectations.
The Group previously announced on 24 July 2014, that it has applied for CE marking approval with respect to the Chocolate Touch, its advanced drug coated peripheral balloon. On 5 June 2014, QT Vascular also disclosed that its wholly owned US subsidiary, TriReme Medical LLC, received notification from the United States Food and Drug Administration (FDA) of 510(K) clearance to market the Chocolate Percutaneous Transluminal.
Coronary Angioplasty Balloon Catheter (Chocolate PTCA) in the United States, for the treatment of blocked arteries for coronary vascular diseases.