RECOTHROM Becomes the First and Only Topical Thrombin Indicated for Use in Children Greater Than or Equal to One Month of Age
This study was conducted in 30 pediatric patients greater than one month of age undergoing synchronous burn wound excision and skin grafting. The safety of RECOTHROM in pediatric patients greater than or equal to one month of age is supported by these data and by extrapolation of efficacy from adequate and well-controlled studies of RECOTHROM in adults. Safety and efficacy has not been established in neonates."Our purpose is to save lives, alleviate suffering and improve the economic efficiency of the approximately 2,500 leading hospitals in the world," said Brent Furse, Senior Vice President and Chief Customer Office...
Source: Medical Hemostat - May 12, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
ProFibrix Completes Patient Enrolment in Pivotal Phase III with FibrocapsTM and Reports Positive Feedback from Surgical Community
Company remains on track for 2013 filings in US and EuropeLEIDEN, The Netherlands & SEATTLE--(BUSINESS WIRE)-- ProFibrix B.V., a leader in the development of innovative bioactive products to stop bleeding (hemostasis), today announced that the company has completed enrolment of its pivotal Phase III clinical trial with Fibrocaps (FINISH-3) on schedule.FINISH-3 is a multicenter, randomized, single-blind, controlled Phase III trial of Fibrocaps in surgical patients with mild to moderate surgical bleeding. Participating surgeons enrolled a total of 718 patients in only 10 months. The main objectives of the study are to de...
Source: Medical Hemostat - April 4, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
MDCO, Bristol-Myers Squibb begin global alliance for Recothrom
The global license and two-year collaboration signed between the Medicines Company (MDCO) and Bristol-Myers Squibb (BMS) for Recothrom, a recombinant thrombin approved by the US Food and Drug Administration (FDA) for use as a topical hemostat to control non-arterial bleeding during surgical procedures has become effective.The agreement was first announced in December 2012. The companies have satisfied all required regulatory and closing conditions.Glenn Sblendorio, president and chief financial officer of The Medicines Company, said, "We look forward to the start of our global license and collaboration for Recothrom. We be...
Source: Medical Hemostat - February 13, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
ProFibrix Phase III Trial with FibrocapsTM (FINISH-3) Passes Important Safety Milestone & Almost Completes Enrolment
LEIDEN, The Netherlands & SEATTLE -- ProFibrix B.V., the leader in next generation hemostatics, today announced that the Data Monitoring Committee (DMC) of the FINISH-3 trial of Fibrocaps unanimously recommended the study to continue as designed. The DMC is an independent expert panel overseeing patient safety of this pivotal trial in spine, liver, vascular and soft tissue surgery. At its final meeting, the DMC reviewed data from the first 403 subjects enrolled in the trial, and found no safety concerns.To date, less than 9 months after the first subject was enrolled, over 85% of the 672 subjects necessary to comp...
Source: Medical Hemostat - February 13, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
