Allium Medical (TASE: ALMD), an Israeli medical device company that specializes in minimally invasive technologies and solutions, announced today that it received regulatory clearance from the China Food and Drug Administration (CFDA) to market its portfolio of urological systems in China. The Company has an exclusive strategic agreement with a leading distribution organization in China’s urology market and expects to generate significant revenue in 2018.
The Company’s urological implants are especially designed to treat ureteral and urethra obstructions over long indwelling period while ensuring continuous intraluminal flow with full patency. The implants are covered with a special polymeric coating that prevents stone formation, tissue ingrowth and recurrent obstructions. The procedure for insertion of the implant is minimally invasive which significantly reduces the risks and complications versus surgery. Over 12,000 systems for the treatment of BPH, and Bulbar and Ureteral strictures have been implanted to date in major international markets with no Serious Adverse Events.
“We are excited about the CFDA clearance, since the Chinese market offers us huge growth opportunities because of the size and prevailing trends in the market. In addition, our strategic partner in China is solely focused on the urology market with broad geographic reach. Most of our products require minimally-invasive procedures that can be administered in office practice settings, which is especially important for the Chinese market,” said Asaf Alperovitz, CEO of Allium group. He concluded, “Gaining CFDA clearance is an important milestone as we strive to grow our APAC business. With our unique portfolio of minimally invasive urological systems, and in view of the above factors, we believe we are strongly positioned to achieve this objective.”