Research News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Myocor: FDA has conditionally approved Myocor's plan for a feasibility study of its iCoapsys minimally invasive mitral valve repair system, the firm announced Dec. 4. The single-arm Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) study will evaluate the device in patients with mitral valve insufficiency caused by left ventricular dysfunction and coronary artery disease. iCoapsys is a high-strength cord, anchored by pads on the outside of the heart, which stretches across the left ventricle to pull the sides of the ventricle together and decrease the distance between the mitral valve leaflets. The device can be delivered with interventional catheters through the pericardium. It is the surgically implanted version of the Coapsys that Myocor is evaluating in the Randomized Evaluation of a Surgical Treatment for Off-pump Repair of the Mitral Valve (RESTOR-MV) trial. RESTOR-MV compares Coapsys to annuloplasty repair in patients undergoing coronary artery bypass surgery who also have functional mitral regurgitation (1"The Gray Sheet" Jan. 3, 2005, p. 17)
You may also be interested in...
Financings In Brief
Remon Medical Technologies: Waltham, Mass. concern announces close of oversubscribed $26 mil. Series C financing, which will help expand U.S. presence of its wireless, intra-body communication technology for use in therapeutic products. First-time investors in the financing round include Guidant, Triathlon Medical Ventures and Medica Venture Partners. Guidant previously incorporated Remon's interactive sensor technology into its Ancure abdominal aortic aneurysm endograft (1"The Gray Sheet" Feb. 18, 2002, In Brief). Other major Remon financiers include Polaris Venture Partners, Concord Ventures, Lilly Ventures, KBL Healthcare Ventures and Ofer Hi-Tech. The privately held firm intends to commercialize its communication technology through a mixture of internal efforts and external strategic collaborations. Remon is now conducting clinical trials of its Impressure device, which offers an on-demand, non-invasive way to monitor intra-aneurysm pressures after endograft procedures. The firm's HeartLook device for measuring pulmonary artery pressure is also under investigation...
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
P&G Restores Volume Growth In Beauty, Grooming After Pricing Run
Procter & Gamble reports strong consumer spending in the US and Europe after a 3% increase in product pricing over the past year. Dragging on fiscal third-quarter results, sales of SK-II in China fell 30% for the January-March period, while lower incidence of cough and cold impacted Health Care performance.