Financings In Brief
This article was originally published in The Gray Sheet
Executive Summary
Aradigm/Novo Nordisk: Restructured licensing agreement with Novo Nordisk concerning Aradigm's AERx pulmonary drug delivery system for diabetes management results in a $55 mil. payment to Aradigm, minus previous advances. Under the Jan. 26 deal, Novo Nordisk gains assets, building leases and employees associated with AERx, which is in clinical trials (1"The Gray Sheet" Jan. 3, 2005, p. 17). Aradigm retains AERx' intellectual property and will receive royalties on sales. The move dovetails with President & CEO Bryan Lawlis' plan to focus on advancing Aradigm's needle-free Intraject system for treating migraine headaches...
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OrCel approval delayed
Ortec International plans to meet with FDA to discuss the agency's request for a confirmatory trial demonstrating OrCel bi-layered cellular matrix' safety and effectiveness for treatment of venous ulcers. The meeting will determine whether the company initiates a resolution process with FDA or opts for an estimated 40-patient prospective clinical trial to gather more data to support the firm's PMA (1"The Gray Sheet" Feb. 7, 2005, p. 25). The trial, which likely would commence in July, would delay approval by roughly an additional nine months, Ortec estimates...
OrCel approval delayed
Ortec International plans to meet with FDA to discuss the agency's request for a confirmatory trial demonstrating OrCel bi-layered cellular matrix' safety and effectiveness for treatment of venous ulcers. The meeting will determine whether the company initiates a resolution process with FDA or opts for an estimated 40-patient prospective clinical trial to gather more data to support the firm's PMA (1"The Gray Sheet" Feb. 7, 2005, p. 25). The trial, which likely would commence in July, would delay approval by roughly an additional nine months, Ortec estimates...
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...