Response Profiling also identifies potential drug targets, advancing the development of novel therapeutic strategies.OncoHost's profiling platform offers a new layer of information, enabling early identification of non-responsiveness to cancer treatments and the discovery of new targets to overcome treatment resistance. OncoHost's platform analyzes proteomic changes in blood samples to monitor the dynamics of biological processes induced by the patient in response to given cancer therapy. Based on robust scientific infrastructure and a strong IP position, OncoHost is launching an extensive clinical program with leading academic and clinical partners. The company utilizing proprietary proteomic analysis, we aim to understand the patient's unique response to therapy and overcome one of the major obstacles in clinical oncology today's resistance to therapy. EOFlow invests $7.OncoHost is a clinical-stage biotechnology company developing personalized strategies to increase the success of cancer therapy.Delcath Systems appoints new board chair.Henry Schein stock dips despite Street-beating Q4 revenues.GE HealthCare recalls scanner for patient crushing risk.
Mguard stent inspiremd software#
BD issues vulnerability warning for Alaris infusion monitoring software.Asensus, Karl Storz partner on surgical robot marketing, development.Shockwave Medical stock ticks up on massive Q4 earnings beat.Medtronic wins CE mark for extravascular defibrillator system.Philips recalls certain reworked Trilogy, Garbin ventilators.How Philips’ significant respiratory devices recall unfolded.Dentsply Sirona to lay off up to 10% of workforce in restructuring effort.FDA clears cranial procedure guidance system from Stryker.Layoffs in medtech: These companies recently reduced their workforce.InspireMD said it began notifying clinical and commercial partners about the problem and "intends to modify all units in the field once regulatory approval is received."įiled Under: Cardiovascular, Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance Tagged With: InspireMD "The company anticipates regulatory review to be completed by the end of the current, 2nd quarter and would then commence shipping MGuard Prime EPS back into the marketplace," according to the release. InspireMD said it "believes that it has identified the root cause of these dislodgements and, upon approval from the European regulatory agency, intends to modify all existing units of the MGuard Prime EPS in order to improve stent retention and performance." We view this action as a corporate responsibility and while it is a near-term setback, improving the quality of our product performance should result in long term clinical and commercial benefits." The costs associated with upgrading the inventory of MGuard Prime units is minimal and should have little impact on our short-term cash position. We also anticipate a delay of up to six months before resuming enrollment activities for the Master II FDA trial. "There will be a short-term impact on our revenue, as we have chosen to discontinue shipments of MGuard Prime while we work through the regulatory portion of this voluntary action. "We believed it was prudent to initiate this voluntary field action in order to proactively address the issue of stent retention and to uphold our strong commitment to quality," CEO Alan Milinazzo said in prepared remarks. "The company intends to focus on site activation during this review period in order to accelerate enrollment once the study resumes," according to the release.
Mguard stent inspiremd trial#
The FDA review is expected to delay enrollment in the Master II trial for 3-6 months, InspireMD said. InspireMD said it’s temporarily suspended enrollment in the Master II FDA trial, "pending a review by the FDA of the manufacturing improvements to the MGuard Prime EPS." The move involves only the cobalt-chrome version of the device, not the MGuard stainless steel EPS or InspireMD’s CGuard nitinol products, according to the release. To date, there have been no reports of any patients being harmed in these recent reports reviewed by the company," according to a press release. "These reports have primarily occurred during the preparation of the MGuard Prime EPS, upon removal of the protective sleeve or during withdrawal of the MGuard Prime EPS into the guide catheter. InspireMD (OTC: NSPR) said it issued a voluntary field action after receiving reports that its MGuard Prime EPS stent can dislodge during implantation procedures.
0 kommentar(er)
