Everyone from the medical devices distributor to anyone marketing medical devices should pay attention to the venture investing reports that came out last week. Investment has slipped, U.S. dominance is eroding, and nimbleness in emerging markets poses a long-term threat to United States as the leader in developing new innovative medical devices. We need more innovation. The question is, even if can do all or most of these things well, will it be enough to compete with the speed of growth in countries like China, India, and Brazil?
WellClicks helps patients find the right doctor based on a series of criteria, including language spoken and time and type of appointments (you can even require a photo). The company is gearing up for a beta version of its new product in April.
Cautiously optimistic was the word from one trade group after the FDA released details Wednesday on current and future plans for changes to the 510(k) medical device approval process.
“They’re moving in a positive direction,” Dale Wahlstrom, CEO of LifeScience Alley, the Minneapolis-based nonprofit trade association, said in a phone interview. “I was surprised to see 25 things they’re doing right now to make it better, with really tight timelines. That to me says they want to show success quickly, and that’s good as long as they implement with an appropriate amount of detail that doesn’t catch us by surprise.”
The detail, of course, is the catch.
“The area of concern is the significant number of items that they delayed decision on as they move into dialog with IOM.”
The FDA’s announced rule changes for 510(k) medical device approval are a “good indicator that we’ll get to good decisions,” said the top regulatory official for Medtronic (MDT), the Minnesota-based medical device giant, in a phone interview on Wednesday.
“This announcement was extremely important to the industry, and it was very clear that they listened,” said Susan Alpert, senior vice president and chief regulatory officer. Alpert said she was relieved to see the FDA pass its most controversial recommendations, such as requiring companies to provide much more data for more devices, to an Institute of Medicine (IOM) committee for further review. “Originally the FDA indicated it was going to ask for a lot more information on almost everything,” Alpert said. “Now it’s clear in most cases they plan to get feedback before they go to final implementation.”
Boston Scientific (NYSE:BSX) has acquired Plymouth-based Atritech, a maker of a novel product to treat atrial fibrillation, with an up-front payment of $100 million in a deal worth up to $375 million. Details will be finalized in the first quarter.
The device giant headquartered in Natick, Mass., said in a press release that it would pay out of cash on hand, with additional payments of up to $275 million through 2015 for meeting revenue and regulatory goals.
Atritech’s device, the Watchman, closes the left atrial appendage in patients with atrial fibrillation to prevent blood clots from entering the blood stream. The product thereby reduces their risk of stroke and offers a promising alternative to anticoagulant medication, the standard treatment that increases risk for bleeding.
Spinal tools company Zyga Technology received FDA clearance for its SImmetry Sacroiliac Joint Fusion System, designed for minimally invasive surgery to eliminate lower back pain by stabilizing the sacrum — vertebrae at the base of the spine which connect the spine to the pelvis.
Despite widely reported nursing job freezes in many parts of the country, nursing is still pegged as a top career for 2011 and beyond, according to the Bureau of Labor Statistics. The 2011 report says the U.S. economy will add 582,000 new registered nursing jobs by 2018.
But don’t look to hospitals, once the largest and best-paying employers. Instead, private physician offices, home health care and nursing care facilities, and employment services will provide the biggest growth area for jobs. Health care innovation and cost pressures to decrease hospital patient stays are driving more care to private offices and outpatient settings, says the report. Likewise, an aging population will keep ratcheting up demand for nurses in long-term and home-care based settings.
It’s taken two decades, but the global market for stents used to treat abdominal aortic aneurysms is finally hitting the billion mark. Patients have demanded this technology as an option since it first started being used in 1990. Two decades since has seen vast improvements in stent technology, surgeon adoption of it, and positive patient outcomes, according to the Star Tribune. Device makers can expect more growth for thoracic stents as well, as research in their efficacy to repair tears to the heart, currently considered off-label usage, progresses.
Worldwide, the market is projected to hit $1.6 billion by 2015. Currently, the U.S. market for this surgery comprises between $700 and $800 million. The European market alone will grow to $300 million by then, predicts Toronto-based Millennium Research Group.
Two months after it announced a development agreement with an up-and-coming ultrasound technology company, St. Jude Medical (NYSE:STJ) has launched a faster, more portable intracardiac ultrasound system designed for taking images inside the heart. The ViewMate Z combines St. Jude’s intracardiac echocardiography (ICE) catheter with California-based Zonare’s top-rated z.one Convertible Ultrasound system.
Medtronic (NYSE: MDT) has completed the purchase of California-based Ardian, a developer of catheter-based therapies for hypertension treatment.
Medtronic paid $800 million in cash as announced in a previous agreement and will provide additional performance-based milestone payments through Medtronic’s fiscal year 2015. Before the acquisition, Medtronic held an 11.2 percent ownership stake.
Dr. Deborah Rhodes spoke in early December at TEDWomen, one of a series of events that highlights innovative thinkers and “ideas worth spreading.” Since the speech was posted online late last week, it has become one of TEDWomen’s “most emailed” and has caused a deluge of interview requests, said a Mayo spokesperson. In her talk, Rhodes zeroed in on the center of recent controversy and confusion over mammogram guidelines: breast density.
Madison-based Echometrix expects to offer EchoSoft, software to improve ultrasound diagnosis and management of tendon and ligament injuries, by year’s end, said CEO Sam Adams. Last week, the four-year-old startup filed Securities and Exchange Commission documents seeking to raise $1 million toward that goal.
OrthoCor Medical Inc., a Minneapolis startup that makes an FDA-approved knee brace, has raised $1.5 million from angel investors. The company was one of the first of more than 100 small businesses to register for Minnesota’s angel investment tax credit.
Eden Prairie-based Celleration has raised $8 million in Series E stock toward more sales and marketing resources for its mist therapy wound healing product.
CEO Mark Wagner, who joined the company in 2009, said by phone that Celleration attracted a new Minneapolis-based investor Sightline Partners for this latest round, despite a dismal venture capital climate. Past investors such as Affinity Capital, Venture Investors, Triathlon Medical Ventures, Baird Venture Partners and New Science Ventures also contributed, leaving $112,996 in shares for the total goal as yet unsold. “I’m pleased that our investors have expressed their confidence in our team as well as the opportunity for mist therapy,” Wagner said. “We had a very good 2010, and we’re looking to drive our revenue in 2011.”
On the heels of FDA approval of its new anti-spasticity drug Gablofen, CNS Therapeutics has raised $3 million in equity, according to documents filed with the Securities and Exchange Commission.