Advanced Tissue Sciences/Smith & Nephew: Companies expand 50/50 joint venture through Jan. 24 letter of intent to include worldwide commercialization of ATS' Dermagraft treatment for venous ulcers and pressure sores and marketing of Dermagraft-TC temporary skin substitute for burns internationally. The deal builds on an April 1996 contract granting Smith & Nephew rights to Dermagraft for treatment of diabetic foot ulcers. Dermagraft currently is marketed outside the U.S. and is scheduled for review by FDA's General and Plastic Surgery Devices Panel on Jan. 29. Dermagraft-TC is the first human, fibroblast-derived temporary skin substitute for treatment of partial and full-thickness burns available in the U.S. Under terms of the expanded agreement, ATS will receive "at least $35 mil." from Smith & Nephew over the next twelve months, bringing the total potential payments to ATS to $181 mil., subject to certain milestones...
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
Under the terms of the new agreement, Philips will also begin bundling essential supplies – including ECG, noninvasive blood pressure (NIBP) components, and batteries – with its Medtronic-enabled monitors.
Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
