reva medical inc - cdi
(RV9C:Frankfurt Stock Exchange)
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09/28/12 - €0.55
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02/1/13 - €0.31
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REVA Medical, Inc., a development stage medical device company, focuses on the development and commercialization of proprietary bioresorbable stent products. The company is developing proprietary designs and biomaterial technologies that would be used for a bioresorbable stent to treat vascular disease in humans. Its products include ReZolve scaffold, a drug-eluting fully bioresorbable polymer stent to degrade and clear from the body. The company is also developing ReZolve2 scaffold, a drug-eluting fully bioresorbable polymer stent that is implanted using a balloon catheter to provide X-ray visibility, clinically relevant sizing, and a controlled and safe resorption rate. It has a licensing agreement with Integra LifeSciences Corporation to sublicense, develop, and commercialize products in the field of blood vessels. The company was formerly known as MD3, Inc. and changed its name to REVA Medical, Inc. in March 2002. REVA Medical, Inc. was founded in 1998 and is headquartered in San Diego, California.
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reva medical inc - cdi (RV9C) Key Developments
REVA Medical, Inc. released 12-month data on a subset of patients enrolled in the RESTORE clinical trial. The RESTORE trial is evaluating the safety and performance of the first-generation ReZolve(R) sirolimus-eluting bioresorbable coronary scaffold, which was implanted in 22 patients between December 2011 and July 2012. In an analysis of patients that completed 12-month angiographic follow-up to-date (8 of 22), imaging results demonstrated a mean in-stent late lumen loss (late loss) of 0.20 mm. A finding of 0.20 mm means there was very little change in the lumen area between the time of treatment when blood flow was restored and the time of follow-up. Permanent drug-eluting stents have historically exhibited late loss values in the range of 0.20 mm to 0.40 mm, which has generally corresponded to positive long-term outcomes. Since REVA's most recent report of clinical data, which included an analysis of all patients through a six-month follow-up, two additional patients were retreated for focal in-stent restenosis, or renarrowing of the artery at the implant site, and an additional patient died from unknown causes. ReZolve2 is a lower profile and sheathless version of the first-generation ReZolve scaffold that offers significantly improved deliverability and an approximate 30% increase in scaffold strength to provide increased support to significant coronary artery lesions before being resorbed by the body. REVA began implanting ReZolve2 in patients in March 2013. The initial three clinical sites enrolled eight patients during the first month of the study; enrollment with ReZolve2 will expand to approximately 30 clinical centers, including additional sites in Australia, Germany, and New Zealand. REVA expects to enroll 125 patients with ReZolve2 by September of this year to provide the data needed to apply for European CE Marking, which will allow for commercial sales in Europe and other countries that recognize the mark.
REVA Medical, Inc. announced that Michel Vanbraba has been appointed Managing Director International for the Company. In this role, he will be responsible for commercial planning activities leading up to the launch of REVA's drug-eluting bioresorbable coronary scaffold in international markets, which is anticipated to occur toward the end of 2014. Mr. Vanbrabant most recently served as Vice President of Sales & Marketing Europe for PneumRx, Inc.
REVA Medical, Inc. reported consolidated unaudited earnings results for the first quarter ended March 31, 2013. For the quarter, the company reported loss from operations of $5,721,000 against $6,343,000 a year ago. Net loss was $5,698,000 against $6,331,000 a year ago. Net loss attributable to common stockholders was $5,698,000 or $0.17 per basic and diluted share against $6,331,000 or $0.19 per basic and diluted share a year ago. Net cash used for operating activities was $4,549,000 against $5,380,000 a year ago. Purchases of property and equipment were $1,343,000 against $198,000 a year ago.
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