divendres, 29 de juliol del 2016

Alcon wins FDA nod for CyPass Micro-Stent

AlconNovartis (NYSE:NVS)’s Alcon unit won FDA clearance for its CyPass Micro-stent designed to reduce intraocular pressure in patients suffering from glaucoma, according to an FDA release posted today.

The device consists of the small CyPass micro-stent which is pre-loaded into the CyPass applier stent delivery tool.

The shunt is implanted to control eye pressure by creating a drainage pathway from the inside to the outermost layer of the eye, according to the FDA release.

The FDA approved the device for use in patients with primary open angle glaucoma, according to the release, to prevent damage to the optic nerve which can cause blindness.

Data from a study of 505 patients, 374 of which underwent a treatment with the CyPass stent and cataract surgery and 131 who underwent cataract surgery alone, indicated that 72.5% patients treated with the CyPass micro-stent achieved significantly lower IOP compared to those who underwent surgery alone.

Reductions in IOP lasted through the 2-year long study, according to the FDA, with complications occurring in 39.3% of CyPass patients and 35.9% of patients who underwent cataract surgery alone.

The agency said patients who have types of glaucoma other than primary open angle glaucoma, or those with eye anatomies or conditions that are unusual should not use the device.

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Technology alone may not close disparities in medical research

generic-hospital-or-1x1(Reuters) – Internet technologies may help underserved populations participate in medical research studies, but relying on those technologies to get broader participation isn’t likely to work, a new study suggests.

The study’s lead author told Reuters Health it’s important to get all groups of people represented in research, because medical recommendations are based on study results.

“Most of those are based on educated white people, and not on the full range of the American population,” said Dr. Sarah Hartz, of the Washington University School of Medicine in St. Louis, Missouri.

She pointed out that people who participate in research studies need to check in with researchers during the course of the study. Internet technologies like smart phones may make it easier for people to join those projects.

To see how well internet-based approaches would engage participants from diverse racial and socioeconomic backgrounds, researchers recruited 967 people and offered them information about their ancestry from genetic testing.

Overall, 64% of participants told researchers they would be very or extremely interested in viewing their ancestry information. But only 16% accessed the information after receiving a couple of emails, a phone call and a letter.

The numbers were even lower among African Americans and people with low income and low education levels.

Among those who were interested in the results, 19% of people with a high school diploma accessed the results, as did 4% of those without a diploma.

Twenty-two percent of people living above the federal poverty level accessed the information, compared to 10% of those living below the poverty line.

Also, 45% of educated white participants living about the poverty line accessed the results, compared to 18% of their black counterparts.

While the researchers can’t say why engagement differed between populations, Hartz said there could be underlying behavioral differences between groups.

For example, some people may not check their email as regularly as others do, she said.

“If you don’t use email regularly, it doesn’t matter if you have a smart phone,” she said.

She said the next step in the research is to identify disparities and find how to fix those gaps.

The researchers write in the journal Genetics in Medicine that their results are limited by the fact that they defined “engagement” as the participants returning to access their ancestry data.

The results might have been different if engagement had been measured differently, such as on the basis of retention or satisfaction surveys, said Lorna McNeill, who is deputy chair for health disparities research at MD Anderson Cancer Center in Houston.

Also, McNeill said, results might have been different if the information people could access was more relevant to their lives, such as how to improve their own health.

“Technology is going to help us tremendously,” said McNeill, who was not involved with the new study. “You need to combine it with other strategies of community engagement.”

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Former AcuFocus CEO Mazzo moves to head Ophthamology at Zeiss | Personnel Moves, July 28, 2016

Former AcuFocus CEO Mazzo moves to head Ophthamology at Zeiss


zeiss-mazzo

Carl Zeiss Meditec (ETR:AFX) said this week it tapped ex-AcuFocus CEO James Mazzo as the global president of its ophthalmology business as well as managing the entire company’s U.S. sales and service center.

Mazzo comes from a 3-year run as president and CEO at AcuFocus, where he led the the company to FDA approval for its Kamra inlay. AcuFocus tapped Alan Waterhouse to operate as Prez & COO and Dr. William Link as board chair as Mazzo steps away.

“I am privileged and honored to be joining Carl Zeiss Meditec. The company has been an innovative leader in the industry for over 100 years. The broad line of technology and commitment to our industry is exciting. I look forward to continuing this excellence and building Zeiss into the premier ophthalmic franchise,” James Mazzo said in prepared remarks.

In March Mazzo, the former Advanced Medical Optics CEO who was indicted 2 years ago, sought a stay pending a U.S. Supreme Court decision over issues he claims could affect the insider trading charges alleged in his case.

Mazzo was indicted in September 2014, stemming from Abbott‘s (NYSE:ABT) $2.8 billion acquisition of AMO in 2009. Prosecutors accused Mazzo of tipping close friend and neighbor Doug DeCinces about the deal. DeCinces, a former baseball player for the Baltimore Orioles, allegedly passed the information on to former teammate Eddie Murray, who agreed to settle his case for $358,000 but admitted no wrongdoing. (DeCinces agreed in 2011 to pony up $2.5 million (but admitted no guilt) to settle similar charges leveled by the SEC.)

Read more

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MassDevice.com +5 | The top 5 medtech stories for July 29, 2016

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Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. Tactile Systems reduces IPO to $46m

MassDevice.com news

Leg compression device developer Tactile Systems Technology reduced its initial public offering to $46 million.

Those estimates are down approximately 24% from the $60 million it said it hoped to bring in in June, which was 30% less than the $86 million projection the company put up when it registered the IPO in January. Read more


4. CareFusion recalls select AVEA ventilators over electrical issues

MassDevice.com news

The FDA yesterday released information on a select recall of CareFusion AVEA Ventilators due to electrical issues which could cause unexpected shutdowns.

The federal watchdog labeled the recall as a Class I, the agency’s most serious classification of recall. Class 1 designations are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. Read more


3. Align Tech releases street-beating Q2, announces deal with SmileDirectClub

MassDevice.com news

Align Technology yesterday released its 2nd quarter earnings, handily beating the street on revenue and earnings per share and announcing a new agreement with SmileDirectClub.

The reported profits of $50.1 million, or 62¢ per share, on sales of $269.4 million for the 3 months ended June 30. Read more


2. Medtronic touts 5-year Endurant stent graft data

MassDevice.com news

More than 5 years after Medtronic‘s Endurant Stent Graft System 1st gained FDA approval, the medical device giant has released data pointing to long-term durability of the treatment for abdominal aortic aneurisms.

Healio reported that Endurant showed durability and safety in patients 5 years after treatment, according to details published in the Journal of Vascular Surgery. Read more


1. BioVentus delays $150m IPO

MassDevice.com news

Orthobiologics maker Bioventus postponed its initial public offering which was slated to raise up to $150 million for the company, according to Renaissance Capital.

The company plans to float 8.8 million shares at a price range of between $16 and $18, and plans to list on the NASDAQ Global Market under the ticker “BIOV”. Read more

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Medtronic touts 5-year Endurant stent graft data

MedtronicMore than 5 years after Medtronic‘s (NYSE:MDT) Endurant Stent Graft System 1st gained FDA approval, the medical device giant has released data pointing to long-term durability of the treatment for abdominal aortic aneurisms.

Healio reported that Endurant showed durability and safety in patients 5 years after treatment, according to details published in the Journal of Vascular Surgery.

What they found: mortality rates were about 17.7%, and the rates of non-aneurysm-related mortality surpassed 99 percent, Healio noted. Only 1 patient in the assessment suffered from an aneurysm- death after declining treatment for an endoleak and then dying 4 years after the abdominal aortic aneurysm ruptured.

Follow-up addressed patients who took part in Medtronic’s Endurant U.S. investigational device exemption pivotal trial, whose results showed the device was safe and effective.

When it was conducted between June 2008 and April 2009, 150 patients with abdominal aortic aneurysms (AAA) were treated with Endurant at 26 U.S. sites. For the 5-year assessment, researchers obtained clinical follow-up on 94 percent of 101 eligible patients. They also relied on imaging follow-up for 87 percent of patients who participated.

As Healio reported, imaging from those patients was reviewed at 1,6,12,24 and 60 months, and researchers, for regulatory reasons, compared those outcomes with patients from the Medtronic Talent eLPS study.

Beyond the low rate of mortality after 5 years, they determined that 7 of 83 patients had endoleaks at that point (one was of unknown origin). This was based on an evaluation of 83 of 101 patients. Of the total number of patients they looked at, 53 had the maximum diameter of their abdominal aortic aneurysm reduced by more than 5 mm at 5 years. That measure remained stable in 25 patients, but the blockage grew larger by more than 5 mm in 5 patients.

Overall, they found survival rates were better than those produced by the Talent eLPS study.

In April, Minnesota-based Medtronic released data from yet another Endurant study. The Engage global registry study of Endurant touted lowered mortality and rupture rates compared to the earlier Evar 1 trial. Researchers presented data at the 2016 Charing Cross Symposium in London, UK.

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Micro Interventional Devices wins FDA nod for Permaseal

Micro Interventional DevicesMicro Interventional Devices said today it won FDA 510(k) clearance for its Permaseal transapical access and closure device.

The Permaseal device is designed to allow surgeons to access and close the left-ventricle without having to suture the myocardium using the companies compliant soft-tissue PolyCor anchor technology.

“The FDA market clearance of Permaseal is another tremendous achievement for MID. This exciting development comes fast on the heels of our recent European approval.  Sales in Europe are exceeding our early expectations.  With the US approval, coming earlier than expected, MID will be initiating its US commercialization ahead of schedule. As I recently commented, Permaseal is the first in a series of products designed to replace the need for suturing in structural heart procedures.  We are excited that this technology is now available to our US and European surgeons and their patients.  In the near future, PolyCor and MyoLastTM technologies will be utilized in a broad range of proprietary, catheter-based products addressing unmet needs in tricuspid repair, mitral repair and mitral valve fixation.  MID’s technology platform enables open-surgical procedures to be performed percutaneously,” CEO Michael Whitman said in a prepared statement.

MID touted data from a clinical study of the device conducted at 5 European sites which indicated a reduction in operation time, hospital stays and adverse events with use of the device, as well as lowered 12-month mortality and a 0% rate of stroke.

The company won CE Mark approval in the European Union 7 weeks prior to its FDA win.

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VytronUS raises $49m to support cardiac mapping & ablation system

VytronUSCardiac mapping & ablation system developer VytronUS said today it raised $49 million in a Series C round of equity financing.

Funds from the round will go to support technology refinements and clinical trials for the Sunnyvale, Calif.-based company’s low-intensity collimated ultrasound cardiac mapping and ablation system designed to treat atrial fibrillation and other arrhythmias.

“This financing is the culmination of the excellent progress the company has made over the last 2 years. We have developed a potentially game-changing technology platform, underscored by our successful clinical results to date. We greatly appreciate the commitment of our distinguished syndicate of investors and will use this infusion of capital to execute the multi-center EU and US clinical validation of our technology,” CEO John Pavlidis said in a press release.

The cardiac mapping and ablation system is designed to create a high resolution image of the interior of the heart to improve procedure planning and allow the physician to “draw a desired treatment pattern” on the image at the workstation, VytronUS said.

“The VytronUS system offers a potentially winning combination for AF and VT ablation: facile rendering of the 3D left atrial or ventricular anatomy, continuous transmural lesions without tissue contact, and importantly, the flexibility for operator-defined lesion paths with tissue thickness information,” Dr. Vivek Reddy of New York’s Mount Sinai Hospital said in prepared remarks.

“Despite significant limitations associated with currently available technologies, catheter ablation continues to be one of the fastest growing markets in the medical device sector. We are enthusiastic to continue our investment in VytronUS’s technology platform and outstanding team to support the company in the clinical validation phase,” VytronUS director David McIntyre said in a prepared statement.

“We have been long-term supporters of VytronUS because we believe the company’s revolutionary technology has the potential to help millions of people all over the world. With this latest investment, the company is very well positioned for success in multi-center clinical trials,” VytronUS director Dr. Justin Klein said in a prepared release.

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ResMed shares lift on solid Q4 posting

ResMedResMed (NYSE:RMD) yesterday released 4th quarter earnings that beat the Street and sent shares up, despite missing on fiscal year 2016 expectations.

For the quarter, ResMed reported profits of $83.1 million, or 59¢ per share, on sales of $518.6 for the 3 months ended June 30. That’s a 5% slide on the bottom-line even as sales grew 14.5% compared with the same quarter last year.

After adjusting to exclude 1-time items, earnings per share were 74¢, a solid 7¢ above the 67¢ that analysts on Wall Street were looking for for the quarter. Revenues topped the Street’s expectation of $475.9 million as well.

For the full year, the San Diego, Calif.-based company reported profits of $352.4 million for the 12 months ended June 30. The company’s bottom line shrunk a marginal 0.1% overall while sales for the year grew 9.5% compared to the same period last year.

Adjusted earnings per share for the year were $2.68, a good chunk below the $2.97 that analysts on Wall Street were looking for from the company. Revenue also fell short, with the Street looking for $2.1 billion for the year.

“We finished the year with double-digit constant currency revenue growth, fueled by solid performance in masks, devices, and our 1st quarter of software-as-a-service revenue from Brightree. Our board of directors has declared a 10% increase in our dividend this quarter, reflecting confidence in our long-term strategy and outlook. We are the world’s largest provider of remote connected care solutions with over 2 million patients using ResMed cloud-connected devices on bedside tables; we provide actionable information every day for patients, physicians, providers and payors. During the year, we continued to demonstrate the value of our solutions through clinical research, while transforming how healthcare is delivered through cloud-based offerings that are shaping a new frontier in connected care. Our global team ended fiscal year 2016 with $1.8 billion in revenue as we continue to drive towards our goal of changing 20 million lives by 2020. ResMed is on a trajectory to be the world’s leading tech-driven medical device company; we deliver innovative cloud-connected products and solutions that improve patient outcomes, create efficiencies for our customers, help physicians and providers better manage chronic disease, and lower overall healthcare system costs,” CEO Mick Farrell said in prepared remarks.

Shares in ResMed have ticked up 4.9% in trading today, at $68.93 as of 11:50 a.m. EDT.

In April, ResMed said it closed the $800 million acquisition of cloud-based healthcare software company Brightree.

Atlanta, Ga.-based Brightree develops cloud-based software for home or durable medical equipment for home health and hospice care. Its majority owner was private equity shop Battery, which bought its stake in 2008.

ResMed has been on an M&A tear of late, closing its acquisition of oxygen therapy company Inova Labs in February; in October 2015, the San Diego-based company closed its buyout of Curative Medical.

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BioVentus delays $150m IPO

BioventusOrthobiologics maker Bioventus postponed its initial public offering which was slated to raise up to $150 million for the company, according to Renaissance Capital.

The company plans to float 8.8 million shares at a price range of between $16 and $18, and plans to list on the NASDAQ Global Market under the ticker “BIOV”.

The initial public offering was scheduled to open today, according to Renaissance Capital, and the company has yet to announce a new date.

At the midpoint of its proposed range, the company would command a fully diluted market value of $566 million, and proceeds from the round should generate between $141 and $159 million, according to an SEC filing from the company.

The company originally announced plans for the IPO earlier this month, planning to use proceeds from the round to pay off its debt.

Durham, N.C.-based Bioventus was formed in 2012 when Smith & Nephew (NYSE:SNN) spun out its biologics and clinical therapies division in a joint venture with venture capital firm Essex Woodlands. In October 2014 Bioventus acquired the OsteoAMP product line from Advanced Biologics for an undisclosed amount; late last year the company added BioStructures, a developer of absorbable bone grafts, also for an undisclosed amount. In January Bioventus named former Medtronic (NYSE:MDT) CEO Bill Hawkins as chairman. The company tapped the CEO of Abiomed (NSDQ:ABMD), Mike Minogue, for a seat on the board last month.

The business has grown since the spinout from Smith & Nephew, which in 2010 reported $44 million in profits on $223 million in sales. Yesterday Bioventus said sales grew 4.4% to $253.7 million last year, but said losses widened by 7.4% to -$4.0 million.

Second-quarter losses also widened, rising 9.3% to -$1.0 million on sales growth of 22.6% to $65.4 million, according to the IPO registration.

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Tactile Systems reduces IPO to $46m

Tactile System TechnologiesLeg compression device developer Tactile Systems Technology reduced its initial public offering to $46 million.

Those estimates are down approximately 24% from the $60 million it said it hoped to bring in in June, which was 30% less than the $86 million projection the company put up when it registered the IPO in January.

The company said on Wednesday it plans to offer 4 million shares of common stock at a public offering price of $10 per share, with a 30-day underwriters option for an additional 600,000 shares.

Tactile Systems makes the Flexitouch fully-automated pneumatic compression device, which is designed to treat lymphedema, and the Actitouch wearable compression device designed to treat venous leg ulcers caused by chronic venous insufficiency.

The company,which reported sales of $60 million for its fiscal 2015 year, plans to trade on the NASDAQ exchange under the “TCMD” symbol. Tactile Systems said the Flexitouch delivered 92% of its revenues in 2014, while the newer ACTitouch only pulled in 5% of all sales for the company.

The company operates using a direct-to-patient and direct-to-provider model, and said its devices are approved for coverage by Medicare, certain Medicaid programs and the Veterans Administration, according to an SEC filing.

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CareFusion recalls select AVEA ventilators over electrical issues

CareFusionThe FDA yesterday released information on a select recall of CareFusion AVEA Ventilators due to electrical issues which could cause unexpected shutdowns.

The federal watchdog labeled the recall as a Class I, the agency’s most serious classification of recall. Class 1 designations are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The AVEA ventilator is designed to support continuous breathing for infants, children and adults at hospitals and professional health care facilities.

CareFusion is recalling the devices because of a faulty fuse on the ventilator’s alarm board which could cause the device to unexpectedly shut down, according to an FDA release on the recall.

If the ventilator stops operating, patients using the device may not receive necessary oxygen which could lead to serious adverse health consequences or death, the agency said.

The recall affects a total of 501 units distributed in the U.S., with multiple AVEA models and product numbers referenced by the FDA.

CareFusion instructed customers with the devices to identify and remove affected ventilators until the company can provide onsite remediation for the units.

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SPR Therapeutics wins FDA nod for peripheral nerve stim pain relief device

SPR TherapeuticsPain management company SPR Therapeutics yesterday said it won FDA 510(k) clearance for its Sprint peripheral nerve stimulation system designed to provide chronic pain relief.

The Cleveland, Ohio-based company touted the Sprint system as the 1st reversible and minimally-invasive PNS to win FDA clearance for treating chronic and acute pain, including post-operative and post-traumatic pain.

“The FDA’s clearance comes at a critical time when physicians, patients and the U.S. healthcare system are seeking therapies to manage pain while reducing opioid use. SPR has developed a drug-free treatment for relieving chronic and acute pain. With more than 100 million Americans suffering from chronic pain, and more than two million people suffering severe acute and post-operative pain every year, we believe Sprint will be a game changer in the world of pain management. Patient access to this therapy has been made possible by support and research grants from the United States Department of Defense, the National Institutes of Health and the State of Ohio. We are grateful for the enduring dedication of our team of physician investigators, clinical professionals, engineers and business colleagues,” CEO Maria Bennett said in a press release.

The Sprint system design includes a coiled wire lead and small, wearable stimulator. The lead is placed percutaneously or through the skin to connect to the wearable stimulator which delivers electrical stimulation through the lead to provide pain relief.

“Sprint brings the benefits of PNS to physicians seeking safe and effective alternatives to opioids in the treatment of chronic and acute pain. Unlike all other PNS systems, Sprint does not require permanent implantation which should reduce invasiveness, risk and cost,” Dr. Peter Staats of the American Society of Interventional Pain Physicians said in prepared remarks.

SPR Therapeutics said data from a clinical study of the device, funded by the National Institutes of Health, revealed and associative 72% reduction in average pain with use of the device.

The company plans to release the device to select health care facilities in the U.S. shortly.

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Align Tech releases street-beating Q2, announces deal with SmileDirectClub

Align TechnologyAlign Technology (NSDQ:ALGN) yesterday released its 2nd quarter earnings, handily beating the street on revenue and earnings per share and announcing a new agreement with SmileDirectClub.

The reported profits of $50.1 million, or 62¢ per share, on sales of $269.4 million for the 3 months ended June 30.

That amounts to a significant 60% bottom-line gain on sales growth of 28.6% compared with the same period in 2015.

Analysts on Wall Street were looking for revenues of $258.9 million and earnings per share of 52¢, both of which Align managed to handily top during the quarter.

Align Tech stock has ticked up approximately 2% in early-day trading, sitting at $87.15 as of 9:36 a.m. EDT.

“Q2 was driven by better than expected revenue due to continued strong year-over-year Invisalign volume across our customer base and record utilization, with international case volume up 38.3%, and North America up 15.3%. We also had continued strong demand for our iTero Element with record shipments this quarter resulting in revenue growth of almost 200% year-over-year,” CEO Joe Hogan said in prepared remarks.

The company released an up-to-date outlook for the 3rd quarter, expecting to see between $267.2 million and $273.5 million in revenue and earnings per share between 49¢ and 52¢.

The company also announced a supply agreement with SmileDirectClub to manufacture non-Invisalign clear aligners for the company’s doctor-directed at-home program for cosmetic teeth straightening.

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From discovery to delivery: Moving academic innovations to the market

generic-development-1x1“Wouldn’t it be great if we could come up with a noninvasive diagnostic assay to detect pancreatic cancer at an earlier, more treatable stage?” asked Lori Aro of Myriad Genetics. Her company has been trying to do so for years. So why hasn’t it happened?

Aro, senior director for new product planning at Myriad, outlined the business obstacles at a recent panel hosted by Boston Children’s Hospital’s Technology and Innovation Office (TIDO).

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First, who are the target patients for a pancreatic cancer test? Skinny diabetics, patients with chronic pancreatitis, patients with hereditary cancer risk — or all three? “Those three patient types all sit in different doctor’s offices,” said Aro. Simultaneously reaching endocrinologists, gastroenterologists and high-risk patients would be an insurmountable challenge, Myriad concluded.

Second, the assay would likely need to be validated in all three patient populations, with confirmatory imaging. Could the test populations be large enough to make the results statistically significant?

Third, a new test wouldn’t change care, as there is no treatment for pancreatic cancer. In fact, no current data show that earlier diagnosis improves survival. So who would pay for it?

Aro’s story exemplifies just some of the challenges in developing a new diagnostic test. Supreme Court rulings, such as Myriad vs. Association for Molecular Pathology and Mayo vs. Prometheus, have made it hard to patent diagnostic correlations. The Centers for Medicare & Medicaid Services (CMS) and, to some extent, the U.S. Food and Drug Administration (FDA) are requiring long and costly trials to demonstrate clinical utility and better patient outcomes before they will pay for a new test. And Medicare has decreased reimbursement rates for tests in general.

How do scientists interested in developing diagnostics navigate such hurdles? The panel provided six takeaways.

Read the full post on VectorGetting academic diagnostic discoveries to market: 6 tips from industry

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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dijous, 28 de juliol del 2016

Women’s health focused NVision Medical raises $12m in Series B

nVisionStealthy NVision Medical has raised $12 million in Series B financing, with funds slated to support product development, clinical studies and regulatory submissions to for its micro-catheter technology.

NVision’s microcatheter technology is designed to allow access to the fallopian tubes without the need for incisions or general anesthesia in hopes of providing “an array of clinical indications previously thought impossible,” the company said.

NVision is focused on using micro-catheter tech for cell collection from the fallopian tube and direct visualization of the fallopian tube, the company said.

“We are pleased with the high level of commitment and enthusiasm from our new and existing investors. nVision’s Series B financing validates the strength of our team’s accomplishments to date. With the Series B financing, we are poised to further develop these technologies, seek additional regulatory clearances, and demonstrate clinical utility,” CEO Surbhi Sarna said in a press release.

The round of financing was led by new investors Arboretum Ventures, and included adding Dr. Tom Shehab to the company’s board of directors.

“We believe nVision is tackling substantial unmet needs within women’s health utilizing a very novel and very promising approach. With this new funding, the company is now well positioned to reach meaningful milestones in the year ahead,” Shehab said in prepared remarks.

The round was joined by all Series A investors, including Catalyst Health Ventures, the company said.

“It’s been a pleasure to support the company from the concept phase to where it is today, having two devices cleared by the FDA and stellar clinical data. We’re very excited about the next steps for the company,” Catalyst Ventures partner Darshana Zaveri said in a prepared statement.

NVision said it won FDA 510(k) clearance for a device that collects cells from the fallopian tube and that it performed the 1st-in-human case for a device which allows for direct visualization of the fallopian tube.

Last week, NVision submitted an SEC filing for $6.5 million in funding. Money in the round came from 17 unnamed sources, and the company is still looking for another $5.5 million before closing, according to an SEC filing.

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MassDevice.com +5 | The top 5 medtech stories for July 28, 2016

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Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. Smith & Nephew touts 1st-use of Navio robotic-assisted knee system

MassDevice.com news

A New York hospital is the 1st to use Smith & Nephew new robotics-assisted total knee replacement procedure following its recent 510(k) clearance from the FDA.

The surgery took place at the John T. Mather Memorial Hospital in Port Jefferson, N.Y., involving Smith & Nephew’s handheld robotics-assisted Navio platform, and its Journey II BCS knee implant. Read more


4. Hologic posts beat-and-raise 3rd quarter earnings

MassDevice.com news

Hologic today released 3rd quarter earnings that topped analyst’s expectations, raising its outlook for the rest of the year in response.

The Marlborough, Mass.-based company reported profits of $84.8 million, or 30¢ per share, on revenue of $717.4 million for the 3 months ended June 25. That’s a huge uptick for Hologic, seeing a 188% bottom-line gain as sales grew 3.4% compared with the same quarter from 2015. Read more


3. Derma Sciences acquires BioD for $21.3m

MassDevice.com news

Derma Sciences said today it is buying regenerative medicine developer BioD for $21.3 million up front, with the possibility of an additional $56.5 million.

The deal between Princeton, N.J.-based Derma Sciences and Cordova, Tenn.-based BioD includes regulatory milestone payments up to $30 million and earn outs based on net sales growth of up to $26.5 million. Read more


2. Zimmer Biomet shares lift after reporting big gains in sales

MassDevice.com news

Zimmer Biomet shares have risen nearly 5% after releasing solid 2nd quarter earnings, beating the street on earnings per share and seeing sales swell 65.6% compared to last year.

The Warsaw, Ind.-based company reported losses of $31.3 million, or 16¢ per share, on sales of $1.9 billion for the 3 months ended June 30. Read more


1. Boston Scientific Q2 meets the street as sales grow

MassDevice.com news

Boston Scientific today reported 2nd quarter earnings that met the Street’s expectations and saw overall sales grow over 15% from last year, sending shares up lightly in pre-market trading.

The Marlborough, Mass.-based company reported losses of $207 million, or 15¢ per share, on sales of $2.1 billion for the 3 months ended June 30. Read more

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Medtronic touts 1st enrollment in Reality PAD study

MedtronicMedtronic (NYSE:MDT) said yesterday it enrolled the 1st patients in the VIVA-sponsored Reality study assessing outcomes of peripheral artery disease patients treated with directional atherectomy and drug-coated balloons.

The study is slated to enroll up to 250 subjects across 15 sites, investigating the use of Medtronic’s HawkOne, TurboHawk and In.Pact Admiral DCB for calcified and symptomatic femoropoliteal PAD patients, Fridley, Minn.-based Medtronic said.

“PAD is a complex and progressive disease. The severity of the disease can often have an impact on treatment options for patients. Long lesion length and severe calcification are obstacles that challenge both our ability to gain acute luminal gain and to maintain long-term patency. Reality is driven by the need to look at a viable treatment paradigm that combines the use of directional atherectomy and DCB therapy to address the challenges of treating complex PAD,” co-principal investigator Dr. Krishna Rocha-Singh of the Prairie Heart Institute of Illinois said in a press release.

The study plans to include angiographic and duplex ultrasound core lab adjutication, with primary patency assessed by duplex ultrasound at 12 months. Patients in the trial will be followed up to 24 months post-procedure to explore clinically driven target lesion revascularization rates.

“We know that directional atherectomy and DCB perform well as standalone treatments; and early data suggests that combined therapy may improve patient outcomes in more complex lesions. Through Reality we hope to answer this critical question with rigorous clinical data in this well designed study,” Dr. Roger Gammon of the Austin Heart Central-Heart Hospital, who treated the 1st patient enrolled in the study, said in prepared remarks.

“Medtronic is committed to improving patient lives through unique clinical partnerships, exemplified by the Reality study. This study is designed to further refine the PAD treatment algorithm by providing greater evidence for vessel preparation with directional atherectomy prior to treatment with DCB,” Medtronic peripheral biz GM Mark Pacyna said in prepared remarks.

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Heartware Q2 sees losses shrink, beats the street

HeartWareHeartWare International (NSDQ:HTWR) today released 2nd quarter earnings that beat the Street alongside shrinking losses as the company is slated to be picked up Medtronic (NYSE:MDT) in a $1.1 billion deal.

he Framingham, Mass.-based company, reported losses of $10.9 million, or 62¢ per share, on sales of $68.7 million for the 3 months ended June 30. The street was looking for $57.4 million in revenue, which HeartWare handily topped.

That amounts to a 60.3% decrease in losses as sales shrunk 6.6% compared to the same period in 2015.

Adjusted to exclude 1-time items, losses per share were 43¢. That’s slightly more than half of the 82¢ expectation set out by analysts on Wall Street.

Shares have stayed steady, down less than 1% to trade at $57.88 as of 3:37 p.m. EDT.

“Our solid second quarter performance was highlighted by a strong rebound in sales of the HVAD system in the U.S. and in most international markets. We are proud of the outstanding effort of our field team and are grateful to all of the heart failure specialists, cardiothoracic surgeons and VAD coordinators around the world who continue to demonstrate their enthusiasm and support for HeartWare and the HVAD system. During the 2nd quarter, we made significant progress on our key priorities of pursuing a DT indication for the HVAD System and advancing the MVAD System toward a return to the clinic. We also announced an agreement to be acquired by Medtronic and are looking forward to the close of the acquisition and the tremendous opportunity that we will have as part of the Medtronic organization.  The strengths and resources of the combined company will enable accelerated innovation and pipeline development, while maintaining the exceptionally high standards HeartWare has set for being responsive to our customers and their patients,” CEO Doug Godshall said in prepared remarks.

Late last month, Medtronic agreed to put up $1.1 billion for implantable cardiac pump maker HeartWare International.

The $58-per-share deal, which represents a 93.4% premium over HeartWare’s $29.98 closing price June 24, is slated to close by Oct. 28 (the end of Medtronic’s fiscal 2nd quarter). HeartWare’s 30-day closing average as of June 24 was $30.20 per share.

The deal clears the field of the 2 major cardiac assist device makers, after Medtronic’s cross-town rival, St. Jude Medical (NYSE:STJ), paid $3 billion for Thoratec in October 2015.

HeartWare’s implantable left ventricular assist devices are designed for end-stage heart failure patients, either as a destination therapy until death or as a bridge to heart transplantation.

Medtronic said that although it’s not changing its guidance as a result of the acquisition, “it is expected to provide increased confidence in the company’s ability to deliver on its FY17 revenue growth outlook.” HeartWare’s effect on earnings per share is expected to be zero to minimal for the 1st 2 years and accretive after that, the company said.

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Orthofix wins Japanese regulatory win for Phoenix spinal fixation system

OrthofixOrthofix (NSDQ:OFIX) said today it won regulatory approval from the Japanese Ministry of Health, Labor and Wellfare for its Phoenix minimally invasive spinal fixation system.

The Phoenix system allows for the percutaneous placement of pedicle screws designed to provide stabilization and correction for spinal fusion patients suffering from degenerative disc disease and other conditions, the company said.

“The Japanese approval and full market launch of the Phoenix MIS fixation system represents an important step towards broadening the availability of our spine fixation products globally by entering the 2nd largest spine market in the world. We are committed to continuing to work towards securing additional product approvals in order to provide surgeons in Japan with a full range of our spine fixation solutions,” Orthofix spine fixation prez Ray Fujikawa said in a press release.

Orthofix said the estimated spinal fusion market in Japan will be approximately $684 million by 2020, and that the initial release of Phoenix will “set the stage” for the company to bring more spinal tech to the country in the future.

Yesterday, Orthofix announced the publication of a 12-month study which examined the use of its Trinity Evolution cellular bone allograft in patients undergoing vertebral fusions, touting a greater than 90% fusion rate at 12 months

The study was published in the European Spine Journal, Lewisville, Texas-based Orthofix said.

The study evaluated the use of the Trinity Evolution, in combination with a PEEK interbody spacer and supplemental anterior fixation, for single level fusions at the vertebral locations between C3/C4 and C6/C7, the company said.

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Penumbra touts stent retriever study data

PenumbraPenumbra (NYSE:PEN) said a 198-patient trial of its next-generation stroke-treatment device along with another company product showed promise, meeting primary endpoints. Results were positive enough that a 2016 regulatory submission remains part of the plan.

“The trial results are encouraging for our Penumbra 3D Revascularization Device, and we are focused on continuing our plan to pursue regulatory submission by the end of the year,” Penumbra Chairman and CEO Adam Elsesser said in prepared remarks.

“Furthermore,” Elsesser added, “the broader implications of the data support frontline use of the Penumbra system direct aspiration devices in the vascularization of stroke patients.”

The Alameda, Calif.-based company presented details on July 27 as part of the Society of NeuroInterventional Surgery 13th Annual Meeting in Boston, Mass.

Researchers said that Penumbra’s 3D Revascularization Device, when used with the company’s Penumbra System aspiration devices, showed non-inferiority in both safety and efficacy, versus use of the Penumbra System aspiration devices on their own.

The revascularization rate in the Penumbra 3D plus aspiration device arm, hit 83.8%. For the aspiration device-only arm, the number was much lower, at 74.1%. Researchers noted that this compared favorably to the 71 percent revascularization rate published in the HERMES meta-analysis of five major randomized controlled trials in acute ischemic stroke.

Penumbra’s trial took place at 25 U.S. centers. Penumbra 3D is designed to be used with the company’s reperfusion catheters. Combined, they’re designed to remove stroke-causing vessel blockages both safely and effectively.

Also in July, Penumbra disclosed the U.S. launch of its Ace68 Reperfusion thrombectomy catheter, a device that extracts a blood clot that impedes blood flow in acute ischemic stroke patients.

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Auris Surgical Robotics closes $80m Hansen Medical buy

Auris Surgical Robotics, Hansen MedicalHansen Medical (NSDQ:HNSN) said today it completed its $80 million merger with Auris Surgical Robotics, which won approval from shareholders last week.

Through the merger agreement, Auris paid $4 per share in cash, which the company said is approximately 39.9% over the closing sale price of the common stock of Hansen Medical as reported in April.

The merger became official yesterday, making Hansen a wholly-owned subsidiary of the stealthy Auris, according to an SEC filing from Hansen Medical.

Current Auris CEO Fred Moll founded Hansen Medical in 2002 with an eye toward the intravascular space. Moll, a serial entrepreneur, also co-founded Mako Surgical, acquired in 2013 by Stryker Corp. and Restoration Robotics and its Artas hair restoration platform.

Former Hansen CEO Cary Vance and CFO Cristopher Lowe resigned as officers of the company with the merger, putting Moll back in corner office of the company he originally founded.

Mountain View, Calif.-based Hansen has a pair of platforms on the market: The Sensei system for electrophysiology procedures and the Magellan system for peripheral vascular interventions.

Redwood City, Calif.-based Auris is developing a surgical robot for ophthalmological procedures, but has not released any details surrounding the device. The acquisition will put 3 different robotic systems under Auris’ control.

As part of the deal, certain significant Hansen Medical stockholders said they will invest approximately $49 million into Auris upon the closing of the transaction.

The deal was originally announced in April.

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Merit Medical Q2 beats on EPS, misses on rev

Merit MedicalMerit Medical (NSDQ:MMSI) today released its 2nd quarter earnings, beating the Street on earnings per share but falling short on revenue.

The South Jordan, Utah-based company reported profits of $7.3 million, or 16¢ per share, on sales of $151.1 million for the 3 months ended June 30.

That amounts to a 1.5% bottom-line slide on sales growth of 9.4% compared with the same period in 2015.

After adjusting to exclude 1-time items, earnings per share were 26¢, exactly in line with what analysts on Wall Street were looking for for the quarter. Revenue fell just short of the Street’s expectations of $152.6 million.

“The 2nd quarter was packed with opportunity and activity. We hired more than 50 production and support personnel to ramp up production of various catheters and access products. This effort involved training, sourcing and manufacturing, and we estimate that approximately $3.6 million of new revenue was derived from the sale of those products. We have also acquired additional production equipment that is now coming on line for what we anticipate to be a larger than expected opportunity for the sale of such products. Our new direct operations in Canada and Australia have exceeded our initial expectations, and we believe they will continue to provide exceptional growth. We have also completed the transition of production for our HeRO product line to our South Jordan, Utah facility and have reduced our initial cost estimates. Additionally, we anticipate that we will introduce two new HeRO products during the third quarter,” CEO Fred Lampropoulos said in a press release.

Shares of Merit are up 2.5% to trade at $23.78 as of 1:33 p.m. EDT.

“Finally, substantial due diligence and planning relating to DFINE, Inc. resulted in the previously announced acquisition. During the upcoming quarters, we expect to complete the restructuring and integration of the DFINE operations, which we believe will enhance our business prospects going forward. I appreciate my staff and all those who accomplished so much in just 90 days,” Lampropoulos said in prepared remarks.

Earlier this month, Merit Medical said it paid $97.5 million in cash to acquire DFine and created a new division to incorporate DFine’s spine devices.

San Jose, Calif.-based DFine makes the StabiliT line of devices, for injecting bone cement into vertebral fractures, and the Star spine tumor ablation system. Jordan, Utah-based Merit said its new interventional oncology & spine division will unite those products with its own line of oncology devices, including embolics, microcatheters and biopsy products.

DFine put up $33.4 million in sales last year, ¾ of that coming from the U.S. Both of its devices have 510(K) clearance in the U.S. and CE Mark approval in the European Union, Merit said.

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Abiomed posts solid Q1, lifts full year outlook

AbiomedAbiomed (NSDQ:ABMD) lifted its revenue guidance for the year after posting a Street-beating 1st quarter today.

The Danvers, Mass.-based company reported profits of $12.9 million, or 29¢ per share, on sales of $103 million for the 3 months ended June 30. That amounts to a healthy 45.7% bottom-line gain as sales grew 40.3% compared with the same period last year.

Abiomed handily beat Wall Street analyst’s expectations of 23¢ in EPS and $97.2 million in revenue.

“Abiomed is creating a new era of medicine focused on the field of heart recovery and offering new treatment paradigms for high risk heart failure patients. With an estimated 6% U.S. Impella penetration rate, we are prepared for continued growth within the Protected PCI and emergent indications. Outside the U.S., we stand ready to transform the standard of care for patients in Germany, Japan and beyond,” CEO Michael Minogue said in prepared remarks.

Shares have dipped slightly, down 0.9% to trade at $114.99 as of 12:27 p.m. EDT.

The company increased the low end of its fiscal year 2017 revenue guidance $5 million, now expecting between $435 and $445 million. That would be up 32 to 35% from the prior year, the company said.

In April, Abiomed said it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery.

The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs and to allow for recovery of the native heart, according to the Danvers, Mass.-based company.

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Critics of weight-loss device urge U.S. regulator to reverse approval

aspire-bariatrics-1x1(Reuters) – Lotta Bosnyak takes extra time to chew the blueberries in her yogurt. Otherwise, she said, the device she credits with saving her life will not work.

The tube Bosnyak is referring to has been implanted into her stomach. She turns a valve and, standing over a toilet, drains out the yogurt.

The 52-year-old Delray Beach, Florida, resident was one of the 1st people to try the “AspireAssist” device four years ago in Sweden, where she is from.

“It’s one of the best ways to change your relationship to food because it does require a lot of work on the patient’s part,” said Dr. Christopher Thompson, director of therapeutic endoscopy at Brigham Woman’s Hospital in Boston.

“It’s not just a procedure that’s done and then they’re off and they don’t think about it anymore,” he added.

The device, made by Pennsylvania-based biomedical company Aspire Bariatrics, was approved for use in the United States in June.

However, critics are urging the Food and Drug Administration to reverse its decision, saying the device mimics, promotes and could lead to potentially life-threatening disorders such as bulimia and binge-eating.

“This will likely prove to be yet another in a long line list of misguided, unsuccessful and dangerous products for losing weight,” wrote Dr. Eva Trujillo, president of the Academy of Eating Disorders, in a draft of a letter to be submitted the FDA next week.

“Such a device may carry very serious physical and mental health consequences, including life-threatening situations, and should not be approved by the FDA,” said the draft, which Reuters saw.

An FDA spokeswoman said the agency approved the AspireAssist because 12-month clinical trial data provided by the manufacturer demonstrated that the device offered a reasonable assurance of safety and efficacy. She did not comment on the letter because the agency had not received it.

Advocates of the device say it is less invasive and more cost-effective than bariatric surgeries and a powerful new weapon in the global fight against obesity.

“There is absolutely no medical evidence to suggest the use of this device could lead to an eating disorder,” said Dr. Shelby Sullivan, director of bariatric endoscopy at Washington University School of Medicine in St. Louis, where the device has been tested.

“This isn’t the cold or the flu,” she added. “Obesity is a chronic disease that needs chronic treatment.”

AspireBariatrics Chief Executive Officer Kathy Crothall said the treatment, including the device placement, lifestyle counseling, monitoring, and follow-up, should cost $8,000 to $13,000 for the 1st year, depending on where the procedure takes place.

“That is three times less than the average weight-loss surgery,” Crothall said.

In the United States alone, 35% of the population is obese, a condition connected to heart disease, strokes, certain cancers and type 2 diabetes.

Bosnyak lost 150 pounds and rid herself of hypertension and type two diabetes over a year of using the device.

The Academy of Eating Disorders will keep trying to persuade the FDA to reverse its approval, saying the device sets a dangerous precedent. It said the agency had agreed to meetings with critics in the near future.

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Smith & Nephew touts 1st-use of Navio robotic-assisted knee system

Smith & NephewA New York hospital is the 1st to use Smith & Nephew (NYSE:SNN) new robotics-assisted total knee replacement procedure following its recent 510(k) clearance from the FDA.

The surgery took place at the John T. Mather Memorial Hospital in Port Jefferson, N.Y., involving Smith & Nephew’s handheld robotics-assisted Navio platform, and its Journey II BCS knee implant.

Navio provides surgeons a robotics-assisted hand piece, navigation and cut guides specific to Navio that are designed to enable better outcomes. Additionally, the system relies on software that incorporates 3D surface capture to predict elements such as joint laxity and help make precise implant positioning possible. Patients don’t need a preoperative CT scan, either, unlike other robotics-assisted platforms, Smith & Nephew said.

Mike Donoghue, senior vice president of global marketing for orthopedics at Smith & Nephew, said that the procedure and technology will help the U.S. healthcare save money longer-term. Money-saving procedures and devices have been a much bigger sell in recent years in terms of health care coverage and insurance reimbursements.

“This cost-effective procedure positions us particularly well in the U.S. market, where bundled payments and ambulatory surgery centers have shifted focus to the economic feasibility and overall value of new technology for joint replacement procedures,” Donoghue said in prepared remarks.

Smith & Nephew acquired Minnesota-based Blue Belt Technologies – Navio’s original maker – in January for $275 million. Navio is designed to work with 8 different knee systems.

At the time of its purchase, Smith & Nephew noted that Blue Belt is its “most successful” implant sales partner, and that it would continue to support implants from other manufacturers with the Blue Belt system.

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Derma Sciences acquires BioD for $21.3m

Derma Sciences, BioDDerma Sciences (NSDQ:DSCI) said today it is buying regenerative medicine developer BioD for $21.3 million up front, with the possibility of an additional $56.5 million.

The deal between Princeton, N.J.-based Derma Sciences and Cordova, Tenn.-based BioD includes regulatory milestone payments up to $30 million and earn outs based on net sales growth of up to $26.5 million.

“The acquisition of BioD is a powerful strategic business fit with Derma Sciences and furthers our commitment to being a leading provider of advanced wound care and regenerative medicine products. Combining BioD with Derma Sciences enhances our scale, and provides for a diversified and growing revenue base of complementary, high-margin advanced wound care and tissue regeneration products. We know BioD well, having licensed 2 of their products in January 2014, and we are very excited to add their full portfolio of innovative products as well as 51 talented personnel, including R&D scientists, manufacturing and processing experts, clinical support and customer service staff and direct sales representatives, as well as an expansive independent sales rep infrastructure. ” Derma Sciences interim principal exec Stephen Wills said in a press release.

Derma Sciences picked up BioD’s BioDFactor viable tissue matrix wound covering, BioDRestore elemental tissue matrix for soft tissue repair, BioDFence resorbable adhesion barrier designed to prevent scar tissue formation and the BioDOptix amniotic extracellular matrix designed as a scaffold for ocular tissue repair.

“BioD is a prime example of the kind of acquisition we look for to advance our growth strategy. In addition to bringing high-margin revenue of $22 million for the last 12 months, BioD will transform our P&L while also providing significant opportunities for cross-selling and G&A expense synergy. On a pro forma basis including the BioD business in our 2015 results and eliminating our first aid division, the sale of which we announced earlier, our 2015 gross margin increases from approximately 39% to approximately 52%, and the percentage of total revenues represented by our advanced wound care business increases from approximately 49% to approximately 70%,” Wills said.

Post-transaction, BioD will operate as a wholly owned subsidiary of Derma Sciences, with BioD CEO Russel Olsen still at the head. BioD will also gain an observer seat on Derma Sciences’ board.

“Derma Sciences is a recognized leader in advanced wound care and has been a wonderful partner over the past several years. In particular, we are very pleased with the progress they have made in conducting clinical studies to support positive coverage determinations from Medicare Administrative Contractors for Amnioexcel. We view this combination as a positive for all parties, in particular as we leverage the capabilities inherent in both companies to achieve greater growth than either of us could alone,” BioD CEO Olsen said in prepared remarks.

The deal added a significant amount to Derma Science’s 80-person sales org, with 235 independent sales reps and 7 direct sales reps coming onboard from BioD. The acquisition is expected to close within the next week, Derma Sciences said.

“The 38 Derma Sciences sales reps and 25 independent sales reps, and the 235 BioD independent sales reps and seven direct sales reps have virtually no overlap in their call-points and customer bases. As such, we look forward to sales synergies and greater efficiencies as all members of the combined organization sell a larger number of clinically differentiated, high-margin products. I know we are excited to be introducing certain Derma Sciences products to BioD’s hospital and office-based customers,” Olsen said.

Last November, Derma Sciences was evaluating all options, including a sale, after scrapping a trial of its aclerastide drug for diabetic foot ulcers.

DSCI shares plunged as much as 31%, dropping under their 6-year low today. The company makes wound care and regenerative medicine products. Aclerastide was its only drug candidate.

Derma Sciences said an independent futility analysis concluded that the trial would not meet its primary endpoint of confirmed complete wound closure of the target ulcer within 12 weeks of the start of treatment.

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Varian Medical shares rise after Street-beating Q3

Varian MedicalVarian Medical (NYSE:VAR) saw shares rise 5% after releasing 3rd quarter earnings that handily beat the Street’s expectations.

The Palo Alto, Calif.-based company reported profits of $98.9 million, or $1.04 per share, on sales of $789.4 million for the 3rd quarter.

The bottom-line shrunk 12.9% as sales grew 0.7% compared to the same quarter in 2015.

Adjusted earnings per share were $1.22, topping analysts on Wall Street’s expectations of $1.17 per share. The street was looking for sales of $779.9 million for the round, which Varian topped by more than $9 million.

Shares have risen 5% to trade at $92.94 as of 11:18 a.m. EDT.

“We generated strong gross order and revenue growth for the third quarter with substantial improvements in gross and operating margins in both our oncology and imaging components businesses. The quarter also included the booking of an order to equip a new proton therapy center in China,” CEO Dow Wilson said in a prepared statement.

CEO Wilson also released the company’s for its 4th quarter and full fiscal year 2016, expecting revenues up by 3% and non-GAAP earnings per share between $4.62 and $4.66.

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Zimmer Biomet shares lift after reporting big gains in sales

Zimmer BiometZimmer Biomet (NYSE:ZBH) shares have risen nearly 5% after releasing solid 2nd quarter earnings, beating the street on earnings per share and seeing sales swell 65.6% compared to last year.

The Warsaw, Ind.-based company reported losses of $31.3 million, or 16¢ per share, on sales of $1.9 billion for the 3 months ended June 30.

Losses shrunk 82% when compared to the same period the previous year, while sales grew a massive 65.6%, according to the company’s release.

Adjusting to exclude 1-time items puts earnings per share at $2.02, a good 5¢ above what analysts on Wall Street were looking for. Sales met Analyst expectations, which were for approximately $1.9 billion for the quarter.

Shares of Zimmer Biomet have lifted 4.7% to $128.42 as of 10:08 a.m. EDT.

“In the 2nd quarter, Zimmer Biomet accelerated revenue growth above the top end of our expectations, highlighted by the results of our S.E.T. category and our ongoing strength in the Asia Pacificregion. Our top line performance, coupled with the ongoing capture of operational synergies, supported investments into strategic growth drivers, while delivering adjusted earnings per share above our guidance range.  We will continue to execute on commercial opportunities across our broad portfolio in the second half of the year, as well as expand our clinical offerings with differentiated new technologies, services and solutions,” CEO David Dvorak said in prepared remarks

Zimmer Biomet updated its full-year 2016 guidance, expecting revenue between $7.68 and $7.71 billion and adjusted earnings per share between $7.90 and $8.00, up 5¢ on the low range from previous guidance.

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Boston Scientific Q2 meets the street as sales grow

Boston ScientificBoston Scientific (NYSE:BSX) today reported 2nd quarter earnings that met the Street’s expectations and saw overall sales grow over 15% from last year, sending shares up lightly in pre-market trading.

The Marlborough, Mass.-based company reported losses of $207 million, or 15¢ per share, on sales of $2.1 billion for the 3 months ended June 30.

That amounts to a significant turn into the red from the $102 million in profits it reported during the same period last year, even as sales grew a significant 15.4% overall.

Adjusting to exclude one time items puts the company in the black, with non-GAAP profits of $435 million, or 27¢ per share. Earnings per share were right in line with analyst expectations, while revenue topped the Street by approximately $75 million.

Shares of Boston Scientific are up 2.4% in pre-market trading at $24.24 as of 9:09 a.m. EDT.

“Our strong performance is evidence of the success of our category leadership strategy. Our deep portfolio, commitment to innovation and high-performance culture are helping us meet the needs of our customers and patients while sustaining growth and momentum,” CEO Mike Mahoney said in prepared remarks.

Boston Scientific grew its full year 2016 guidance, from between $8.1 and $8.2 billion to between $8.3 and $8.4 billion, which the company said represents growth of between 11% and 12%.

For GAAP earnings per share, the company lowered its outlook from between 59¢ to 65¢ to between 30¢ and 35¢. Non-GAAP earnings per share are up 1¢ from previous guidance at somewhere between $1.07 and $1.11.

Revenue for the 3rd quarter is expected to be in the range of $2.0 and $2.1 billion, with adjusted earnings between 25¢ and 27¢ per share.

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New crop of robots to vie for space in the operating room

generic-hospital-or-1x1(Reuters) – Even though many doctors see need for improvement, surgical robots are poised for big gains in operating rooms around the world.

Within 5 years, 1 in 3 U.S. surgeries – more than double current levels – is expected to be performed with robotic systems, with surgeons sitting at computer consoles guiding mechanical arms. Companies developing new robots also plan to expand their use in India, China and other emerging markets.

Robotic surgery has been long dominated by pioneer Intuitive Surgical (NSDQ:ISRG), which has more than 3,600 of its da Vinci machines in hospitals worldwide and said last week the number of procedures that used them jumped by 16% in the 2nd quarter compared to a year earlier.

The anticipated future growth – and perceived weaknesses of the current generation of robots – is attracting deep-pocketed rivals, including Medtronic (NYSE:MDT) and a startup backed by Johnson & Johnson (NYSE:JNJ) and Google (NSDQ:GOOG). Developers of the next wave aim to make the robots less expensive, more nimble and capable of performing more types of procedures, company executives and surgeons told Reuters.

Although surgical robots run an average of $1.5 million and entail ongoing maintenance expenses, insurers pay no more for surgeries that utilize the systems than for other types of minimally-invasive procedures, such as laparoscopy.

Still, most top U.S. hospitals for cancer treatment, urology, gynecology and gastroenterology have made the investment. The robots are featured prominently in hospital marketing campaigns aimed at attracting patients, and new doctors are routinely trained in their use.

Surgical robots are used in hernia repair, bariatric surgery, hysterectomies and the vast majority of prostate removals in the United States, according to Intuitive Surgical data.

Doctors say they reduce fatigue and give them greater precision.

But robot-assisted surgery can take more of the surgeon’s time than traditional procedures, reducing the number of operations doctors can perform. That’s turned off some like Dr. Helmuth Billy.

Billy was an early adopter of Intuitive’s da Vinci system 15 years ago. But equipping its arms with instruments slowed him down. He rarely uses it now.

“I like to do five operations a day,” Billy said. “If I have to constantly dock and undock da Vinci, it becomes cumbersome.”

SURGEONS’ WISH LIST

To gain an edge, new robots will need to outperform laparoscopic surgery, said Dr. Dmitry Oleynikov, who heads a robotics task force for the Society of American Gastrointestinal and Endoscopic Surgeons.

Surgeons told Reuters they want robots to provide a way to feel the body’s tissue remotely, called haptic sensing, and better camera image quality.

New systems also will need to be priced low enough to entice hospitals and outpatient surgical centers that have not yet invested in a da Vinci, as well as convince those with established robotic programs to consider a second vendor or switching suppliers altogether.

“That is where competitors can differentiate,” said Vik Srinivasan of the Advisory Board Co, a research and consulting firm that advises hospitals.

Developers say they are paying attention. Verb Surgical, the J&J-Google venture that is investing about $250 million in its project, said creating a faster and easier-to-use system is a priority.

Verb also envisions a system that is “always there, always on,” enabling the surgeon to use the robot for parts of a procedure as needed, said Chief Executive Scott Huennekens.

Intuitive said it too is looking to improve technology at a reasonable cost, but newcomers will face the same challenges.

“As competitors come in, they are going to have to work within that same framework,” CEO Gary Guthart said in an interview.

Device maker Medtronic has said it expects to launch its surgical robot before mid-2018 and will start in India. Others developing surgical robots include TransEnterix (NYSE:TRXC) and Canada’s Titan Medical (CVE:TMD).

An RBC Capital Markets survey found that U.S. surgeons expect about 35% of operations will involve robots in five years, up from 15% today.

J&J, which hopes to be second to market with a product from Verb, has said it sees robotics as a multibillion-dollar market opportunity. Huennekens said Verb’s surgical robot will differ from another Google robotics effort, the driverless car, in one important aspect.

“There will always be a surgeon there,” he said.

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US regulators recommend “codevelopment” approach for IVD companion Dx products

Emergo GroupBy Stewart Eisenhart, Emergo Group

The US Food and Drug Administration is recommending steps for both manufacturers and its own staff regarding contemporaneous market authorization for therapeutic products and IVD companion diagnostics.

In new draft guidance, the agency notes that “codevelopment” of therapeutic products along with IVD companion diagnostics is necessary to “facilitate innovation in precision medicine;” codevelopment as the FDA defines the term encompasses principles for product development, market authorization as well as clinical trial planning. Typically, a therapeutic product that requires an IVD device to perform safely and effectively will not receive premarket authorization if that IVD either hasn’t already obtained FDA clearance or approval, or if the IVD has not also been submitted for contemporaneous premarket review.

General recommendations for codevelopment

“Therapeutic products and IVDs typically are developed on different schedules, are subject to different regulatory requirements, and have different points of interaction with the appropriate review centers at FDA,” notes the guidance. “The merging of the two development processes to facilitate the contemporaneous marketing authorization of a therapeutic product and its corresponding IVD companion diagnostic requires that the sponsors of both products have a general understanding of both processes.”

Given the substantially different premarket review pathways for therapeutic products and IVDs, the FDA recommends that manufacturers take advantage of Pre-Submission or Pre-Sub meetings with review staff at either the Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation Research (CBER) for IVD companion diagnostics, as well as Pre-Sub meetings with Center for Drug Evaluation and Research (CDER) staff for therapeutic products.

“In either scenario, the review centers will typically consult one another to ensure coordinated review,” states the guidance.

Clinical considerations

Codevelopment of therapeutic products IVD companion diagnostics also involves additional considerations and requirements in instances where clinical trials are necessary for premarket authorization.

The guidance covers several issues manufacturers and sponsors should address when undertaking clinical investigations, including:

  • Meeting Investigational Device Exemption (IDE) and/or Investigational New Drug (IND) requirements for therapeutic products and/or IVD companion diagnostics undergoing codevelopment clinical trials
  • Conducting risk assessments of investigational IVDs for study subjects
  • Determining whether an IVD qualifies as a significant or non-significant risk investigational IVD
  • Ensuring that clinical trial designs can support safety and effectiveness claims for both therapeutic products and their IVD companion diagnostics

The FDA notes that in cases where investigational IVD companion diagnostics pose significant risks to subjects, IDE applications must be submitted and approved prior to starting clinical trials for associated therapeutic products.

“Submission of IVD data to the IND will not satisfy the IDE submission requirement,” warns the guidance.

Planning contemporaneous FDA registrations

In order to obtain US market authorization for both a therapeutic product and its IVD companion diagnostic at the same time, the FDA recommends that manufacturers bear in mind potentially significant differences in review timelines for drugs or biologics versus IVDs.

The guidance explains various methods for managing timelines, such as:

  • Modular PMA: allows registrants to submit sections of their PMA applications as they are completed rather than all at once
  • Premarket review submissions: in cases where approved IVDs are to be used for different target populations or therapeutics than those for which they are authorized, manufacturers may submit PMA supplements for devices’ new intended uses
  • Letters of authorization: therapeutic and IVD sponsors (if two separate parties) can provide letters of authorization allowing each party to refer to one another’s market applications to support clearance or approval

Manufacturers should consult the guidance directly to determine how best to utilize the FDA’s codevelopment recommendations.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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