Israeli medical device company Allium Medical (TASE:ALMD) reported on Monday the receipt of regulatory clearance from the China Food and Drug Administration (CFDA) to market its portfolio of urological systems in China.
In conjunction with the China Food and Drug Administration's (CFDA) marketing approval, the company has signed an exclusive strategic agreement with a leading distribution organisation in China's urology market and expects to generate significant revenue in 2018.
The company's minimally-invasive urological implants are 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.
To date, over 12,000 systems for the treatment of BPH (Benign prostatic hyperplasia), Bulbar and Ureteral strictures have been implanted in major international markets. A urethral stricture is a narrowing of the urethra caused by injury and and non-infectious forms of urethritis, concluded the company.
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