An aging population along with new standards of care for treating pain could signal strong growth ahead for medical device manufacturers targeting the multibillion dollar pain management market. Adapted from Medtech Insight’s June 2011 report, US Markets for Pharmacologic and Device-Based Therapeutic Approaches to Pain Management. published June 2011.ice manufacturers targeting the multibillion dollar pain management market.
FDA released two draft guidance documents and announced a new pilot program last week in an attempt to make it easier for companies to begin clinical trials in the US. The first draft guidance, issued November 10, focuses on streamlining requirements to initiate and make changes to very-early-stage clinical studies, including first-in-human trials, which are now often conducted overseas for breakthrough technologies. As part of that effort, FDA is also launching a pilot program where selected sponsors will seek to initiate early feasibility trials, including first-in-human studies, by applying the draft guidance recommendations.
Lombard Medical’s early efforts to tap into the endovascular AAA market ran into problems as the company’s initial financing strategy left it with too few resources to overcome the challenges that most start-up device companies face. The company’s most recent financing, a VIPE led by UK-investor Abingworth, should see Lombard through FDA approval and launch of its novel EVAR device that is targeted at patients with high degrees of vascular tortuosity. Early clinical data show its device is performing well against competition.
Two-and-a-half months late and with only a draft version of the regulations released, CMS is giving device and drug companies, and GPOs, more time to prepare for impending requirements to report physician payments and investment interests to the government for public posting.
The CRM market is facing continued growth challenges as manufacturers struggle to jumpstart lagging sales and broaden adoption of implantable cardioverter defibrillators and cardiac resynchronization therapy devices while facing a brewing storm in the US over appropriate device use.
The health care industry is being swept up in a technological twister, again. Ten years ago, it was the Internet. Today, it’s mobile technology. How are medical device companies, start-ups and investors harnessing this power to create better devices, improved clinical outcomes and richer financial returns?
REVA Medical started almost 14 years ago as a bare metal stent company, only to run into the drug-eluting stent (DES) revolution. In response to the DES boom, the company reinvented itself as a bioresorbable stent company and then added a drug-eluting capability. However, until the late-stent thrombosis risk of DES emerged in 2006, bioresorbable stents were largely irrelevant. REVA has survived the ups and downs of the device financing environment by adopting creative solutions, including an evolving relationship with a strategic partner and ultimately an Australian IPO.
The firm’s PMA hopes are in question after recommendations made by company nurses to investigators in the CHAMPION trial, uncovered during FDA clinical-site inspections, dominated last week’s advisory panel meeting. The panel voted 6-4 that the benefits of the device do not outweigh its risks.
The slowdown and shake-out predicted to occur in the world of venture capital has come. But has it also already gone, too? The industry has certainly retrenched, but there are also signs of new life in the venture sector. For the past two years, we've tracked a few dozen life sciences firms, with an eye on which ones have nearly tapped out their older funds and which have fresh cash to invest in young start-ups. Here's an updated look at the venture fund landscape, showing the firms with full tanks and the ones who are running on empty, based on SEC filings, firm announcements, and our own database and reporting.
In this sidebar to Obesity 2011: Back To Basics In Bariatrics, Medtech Insight interviewes Lee Kaplan, MD, director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital and co-director of an upcoming meeting delineating best practices for clinical trials in the field of bariatrics.
