7 medtech stories we missed this week: June 30, 2017

[Image from unsplash.com]

From ConforMIS touting its knee replacement study to Consulting Radiologists’s new breast cancer detection tool, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Study: Low-dose CT scanning improves Ankylosing Spondylitis assessment

A new study has shown that low-dose computed tomography (LD-CT) is more sensitive than X-rays for monitoring disease progression in people who have Ankylosing Spondylitis, according to a June 15 press release. LD-CT has previously been proven to be sensitive and reliable when assessing bone growth in different patients. The new study is designed to compare how well it can show the formation of new bony growth (syndesmophytes) and an increase in size in syndesmophytes. The study showed that LD-CT was more consistent when detecting these bone growths in AS patients than X-rays. About 30% of the patients in the study showed bony proliferation at three or more sites using LD-CT, while only 6% showed on conventional X-rays. The lead author was Dr. Anoek de Koning from the Leiden University Medical Centre in Leiden, Netherlands.

2. ConforMIS touts total knee replacement implant study

ConforMIS announced in a June 13 press release announced study results for total knee arthroplasty (TKA) patients treated with customized individually made (CIM) implants or standard off-the-shelf (OTS) implants. There were 248 participants in the study. About 3.3% had events at discharge with the CIM implants, whereas 14.1% had events with OTS implants. After 90 days, 8.1% had an event occur after discharge with the CIM implants and 18.2% with OTS implants. Additionally, 42.1% of patients were discharged in less than three days with CIM implants. OTS implants had 30.3% of patients discharged in less than three days. The hospital costs were also compared. CIM implants had an average cost of $16,192 and OTS has an average cost of $16,240. Follow-up care costs for CIM and OTS implants were $5,048 and $6,361 respectively.

3. Hemovent successfully completes first tests of extracorporeal life support device

Hemovent announced the the first series of its in vivo trails for its portable artificial lung technology platform that is used for extracorporeal CO2 removal and extracorporeal life support, according to a June 12 press release. The platform helps establish an artificial external blood circuit with a portable pump and gas exchanger system to support lung function or establish a full cardiopulmonary bypass. It is essentially an artificial lung that can give respiratory support to damaged lungs that cannot perform their natural duties. It can also be used as a temporary life support system that can take over the function of the heart during acute heart failure.

4. Image Stream Medical, Olympus launch telehealth solution

Olympus and Image Stream Medical announced in a June 12 press release that they have launched the industry’s first enterprise virtual presence solution, deemed the MedPresence. MedPresence allows surgical and interventional clinicians to virtually connect and collaborate in ways that have not been used before. The system has real-time sharing of procedural imagery, applications and in-room frame of reference for a context-rich and immersive experience. The system allows clinicians to securely connect to other clinical specialists, technicians, trainers and manufacturer representatives at any time, globally and virtually.

5. Cefaly touts migraine treatment study

New clinical trial results have shown that Cefaly has been a successful alternative to treating migraines, according to a June 12 press release. Cefaly is FDA-approved and is an external trigeminal nerve stimulation device that can prevent frequent episodic migraines. The device helps patients who are usually unaffected by oral migraine medication. The study showed the Cefaly treatment was able to reduce the headache days and acute anti-migraine medication intake. Bout 66% of the study participants reported being satisfied by the treatment. The device is available through prescriptions only and is the size of the palm of the hand. It uses a self-adhesive electrode that is placed on the forehead and a magnetic connection that sends tiny electrical impulses through the skin to the upper branches of the trigeminal nerve. The device works desensitize the trigeminovascular system.

6. Consulting Radiologists launches breast cancer detection tool

Consulting Radiologists announced in a June 9 press release that it has released a new tool to detect breast cancer, known as Abbreviated Breast Magnetic Resonance Imaging (MRI). The company says the device is not intended to replace mammograms, but it is a supplement to mammograms. It is meant to help increase cancer detection for everyone, but especially those who have dense breast tissue, younger generations and those who have an average risk of developing breast cancer. The Abbreviated Breast MRI takes about 15 minutes and is affordable, according to the company. Upon completing the exam, a Consulting Radiologists radiologist will interpret the breast imaging.

7. Ventripoint touts HealthCanada win, expanded sales team

Ventripoint is touting its recent HealthCanda win for its VMS-Plus for the measurement of volumes in the other three chambers of the heart: the right atrium, left ventricle and left atrium, according to a June 8 press release. The company has also been expanding its sales team to be able to market the VMS-Plus in different markets worldwide. Its current focus is on the Middle East and North Africa. Ventripoint recently hired a representative for the North Africa region, as well as a regulatory consultant. The company has also hired a number of marketing professionals in Canada, Asia Pacific and the U.S. and a new application specialist who will work with sales staff on sales calls while training new users.

Here’s what we missed last week.

The post 7 medtech stories we missed this week: June 30, 2017 appeared first on MassDevice.

from MassDevice http://ift.tt/2svdJ4f

Trump: Kill Obamacare now, replace later

(Reuters) – President Donald Trump urged Republican senators today to repeal Obamacare immediately if they cannot agree on a new healthcare plan to replace it, potentially sowing confusion as congressional leaders struggle for a consensus on healthcare legislation.

Senate Republican leaders had set today as the target for rewriting legislation that would repeal extensive parts of the 2010 Affordable Care Act, the law dubbed Obamacare that expanded health insurance coverage to 20 million people.

But that deadline seemed unlikely, given that by Friday most senators had already left town ahead of next week’s recess without an agreement on a clear direction for the healthcare bill.

“If Republican Senators are unable to pass what they are working on now, they should immediately REPEAL, and then REPLACE at a later date!” Trump wrote in a Twitter post.

The current legislation would repeal major elements of Obamacare, shrink the Medicaid government healthcare program for the poor, eliminate most of Obamacare’s taxes, and set up a system of government tax credits to help individuals buy private health insurance.

Conservative and moderate Republicans have spent the past few days pushing and pulling the bill in opposite directions as majority leader Sen. Mitch McConnell (R-Ky.) sought common ground. Moderates want more equity for low-income Americans, while conservatives are fighting to loosen insurance regulations.

Republican efforts were also complicated yesterday by a Congressional Budget Office report that said the existing Senate proposal would cut spending on government Medicaid for the poor by 35% by 2036.

The president’s intervention may have confused some. Shortly before his January inauguration, Trump urged lawmakers to repeal and replace Obamacare at the same time.

But some senators welcomed his involvement. Sen. Ben Sasse (R-Neb.), who had written Trump suggesting he urge Congress to first repeal Obamacare, then replace it, tweeted, “Glad you agree, Mr. Pres.”

McConnell spokesman David Popp said Republicans will continue healthcare discussions through the recess that lasts until July 10. He did not comment on Trump’s call for a full repeal of Obamacare.

Overturning Obamacare, former President Barack Obama’s signature domestic legislation, has been a goal of Republicans since the law’s passage in 2010, and has been a priority since Jan. 20, when the party assumed control of the White House as well as Congress. Trump campaigned on overturning a law that many Republicans view as a costly government intrusion.

The House of Representatives passed an Obamacare replacement in May.

The post Trump: Kill Obamacare now, replace later appeared first on MassDevice.

from MassDevice http://ift.tt/2saxHBI

MassDevice.com +5 | The top 5 medtech stories for June 30, 2017

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. LivaNova wins FDA nod for VNS therapy neurostim for young epilepsy patients

LivaNova said today it won FDA approval of its Vagus Nerve Stimulation Therapy system for patients as young as 4 years of age with partial onset seizures that are refractory to antiepileptic medications.

The London-based company touted that with the clearance, its VNS Therapy system is the only FDA-approved device for drug-resistant epilepsy in the pediatric population. Previously, the device was only approved for patients ages 12 and older. Read more

---

4. Report: Intuitive Surgical won’t sell in Pakistan until da Vinci devices back on line

Intuitive Surgical is reportedly refusing to sell any more of its da Vinci robot-assisted surgery platforms in Pakistan until the two it’s already got on the market there are brought back on line.

The Sindh Institute of Urology & Transplantation in Karachi asked to acquire a da Vinci system, according to The News of Pakistan, but Intuitive Surgical refused until a pair of disused da Vincis at other hospitals in Karachi are made operable again. Read more

---

3. LipoSeuticals closes Series A for novel drug delivery tech

LipoSeuticals said today that it closed a financing round for an undisclosed amount led by Hong Kong-based life sciences fund, Delos Capital.

The company has developed a sugar-lipid polymer-based formulation, Sulocence, which boosts drug stability and solubility. LipoSeuticals said it is applying the drug delivery technology to the reformulation of an array of marketed specialty drugs. Read more

---

2. Shareholders revive class-action kickbacks suit against Cardiovascular Systems

Shareholders revived a purported class-action kickbacks lawsuit against Cardiovascular Systems that was dismissed without prejudice earlier this year, citing in the new complaint a $25 million judgment against the company in a related case.

St. Paul, Minn.-based CSI paid $8 million to settle a federal False Claims Act suit in July 2016 that accused it of running a kickbacks program by offering free, all-expense-paid training programs “followed by explicit demands by CSI employees that attendees use CSI products on future patients,” giving away product for free, 3rd-party referral channel marketing, and “sham Speaker Bureau payments for high-prescribers and others whom CSI sought to cultivate,” according to a complaint filed by Travis Thams, who worked for CSI as a district sales manager from 2012 to 2013. The Tham lawsuit also accused the company of running an off-label promotion scheme to push sales of its unapproved 4 French catheter. Read more

---

1. Medtech M&A: The 10 biggest deals so far in 2017

The year is only half over and it’s already proving to be a busy one for mergers & acquisitions in the medical device space. In just 6 months. MassDevice.com assembled a list of the 10 of the biggest M&A deals in medtech so far – with a combined price tag of over $65 billion (and that’s not even counting the $2 billion Philips acquisition of Spectranetics). Read more

The post MassDevice.com +5 | The top 5 medtech stories for June 30, 2017 appeared first on MassDevice.

from MassDevice http://ift.tt/2sqeCjd

Improving VNS therapy: ElectroCore CEO Amato on gammaCore and its slated July launch

Neuroscience tech developer ElectroCore said recently it plans to launch its handheld gammaCore vagus nerve stimulation device in the US in mid-July, after having won clearance from the FDA in April for treating episodic cluster headaches.

Unlike other vagus nerve stimulation devices, the gammaCore is an external handheld device with no implanted component, designed to be used in a pain-free procedure, CEO Frank Amato told MassDevice.com in an interview.

“Its a first-of-its-kind type of device,” Amato said, speaking on the recently approved and soon-to-launch gammaCore. “Vagus nerve stimulators have been around for 25 years, but they require the surgical implantation of a device into the body – and one that can’t be explanted. So once you put it in, it’s in there for life.”

The gammaCore is designed to be applied to the neck where it transmits mild electrical stimulation to the vagus nerve through the skin in a non-painful manner, Amato says.

In its initial launch, which Amato said is slated for some time in mid-July, the company will focus on launching the device at specialized headache centers across the US.

“It’ll be launched proactively in roughly 50 of the 160 headache centers in the US. That’s somewhere around 25-35% of the headache centers that will be actively participating in identifying patients and offering our therapy,” Amato said.

The device will provide a significant new option for patients with episodic cluster headaches, Amato said, as there’s only 1 other product approved for treating episodic cluster headache, Amato said – injectable Sumatriptan.

“GammaCore provides another option for these patients. One that, quite frankly, they haven’t had in the past – it gives this patient population another opportunity,” Amato said.

Amato said that the gammaCore was a safe option for treating episode cluster headaches as well, with no required use of chemicals that are metabolized through the kidneys or liver, offsetting potential side effects that aren’t available with a drug or injection.

“We stimulate the nerve which runs right up into the brain stem – it’s almost the body’s super highway, if you will. And in turn, we have demonstrated pretty significant benefits for patients, clinically, and shown the device to be a safe option for patients,” Amato said.

The device will be available to any doctors who prescribe it, Amato clarified, though the company will be specifically focused on the initial slew of headache centers.

The company is also engaged in pivotal trials of the device for treating migraines – one prophylactically and one for acute use, Amato said.

“If the results are positive, then we’ll petition the FDA for an expanded label into migraine, which we would expect to get sometime in the early to middle part of 2018. At that point in time, we would plan to launch the product more broadly across the entire marketplace, servicing all 160 headache centers and neurologists who are treating headaches outside of those centers,” Amato said.

The migraine studies could also help broaden the use of the device globally, Amato added.

As for future indications, Amato said the company is exploring a wealth of options for the device, including rheumatoid arthritis, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, and neurological disorders.

In addition to those, Amato said the company also received $20 million in grants from academic centers across the US, where the device was being tested in treatment for PTSD and Gulf War Syndrome, gastroparesis and even in areas like cognitive enhancement.

“There are a number of different medical conditions and areas where vagus nerve stimulation may have a role for patients. But, prior to our opportunity to bring this technology to the market VNS therapy required surgery and an implanted device that couldn’t be removed – and that’s not a great option for many patients,” Amato said.

The post Improving VNS therapy: ElectroCore CEO Amato on gammaCore and its slated July launch appeared first on MassDevice.

from MassDevice http://ift.tt/2suV3RV

Myomo touts reduced upper extremity impairment in MyoPro trial

Myomo yesterday released results from an investigator-led study of its MyoPro myoelectric orthotic, touting reduced upper extremity impairment with the use of the device.

Cambridge, Mass.-based Myomo develops and produces myoelectric orthotics for patients with neuromuscular disorders, including its flagship MyoPro line. The orthosis devices are non-invasive, powered braces used to support weak or deformed arms and hands to allow for functional activity.

The study, conducted at the Ohio State University School of Medicine, was published in the journal the Archives of Physical Medicine and Rehabilitation.

In the study, researchers examined the use of the MyoPro on 18 chronic stroke patients with moderate post-stroke upper extremity hemiparesis. Subjects were tested to evaluate the degree of impairment without the MyoPro and compare it with impairment while wearing the device.

Results from the study indicated that the use of the MyoPro orthotic significantly reduced upper extremity impairment, with changes in functionality exceeding the clinically important difference threshold of standard impairment tests.

“The results show a clinically significant instantaneous reduction in arm and hand impairment and statistically significant improvements in a range of functional tasks and significant increases in ability for feeding and drinking. The subjects showed significant decreases in time taken to grasp a cup and increased gross manual dexterity while wearing the MyoPro. These changes exceeded the FM’s clinically important difference threshold,” study authors wrote.

The company said that the trial is the 1st of several for the device, with more underway and expected publications in the future.

“What we found was across the board with these 18 subjects, when they wore the MyoPro, their outcomes, their movements, were significantly better while they were wearing the MyoPro,” Dr. Steven Page of the Ohio State University College of Medicine Stroke Center said in a press release.

“This study is an important milestone supporting Myomo’s growing commercialization efforts. It clearly demonstrates the functional value of the MyoPro orthosis and how it meets a medical necessity. It provides useful information for clinicians who recommend and prescribe the device, as well as for payers. This is the first of several clinical studies that are underway that the company expects to see published over the coming months and years,” CEO & chair Paul Gudonis said in a prepared statement.

Earlier this month, Myomo said it launched its next-generation MyoPro 2 myoelectric arm orthosis designed to restore function to paralyzed or weakened arms.

The MyoPro 2 is designed to aid patients in performing daily living activities including eating, carrying objects and general household chores, as well as enabling certain individuals to return to work. The company said that the new version improves upon previous capabilities and adds interchangeable, extended-life rechargeable batteries designed to support continuous daily use.

The post Myomo touts reduced upper extremity impairment in MyoPro trial appeared first on MassDevice.

from MassDevice http://ift.tt/2u6Zu7D

CHF Solutions wins IDE for pediatric trial of Aquadex FlexFlow aquapheresis system

CHF Solutions (NSDQ: CHFS), formerly known as Sunshine Heart, said today that researchers at Stanford University School of Medicine’s dept. of pediatrics won FDA investigational device exemption approval to initiate a study of its Aquadex FlexFlow aquapheresis system.

The Aquadex FlexFlow is an aquapheresis system designed for diuretic-resistant fluid overload in children with decompensated heart failure, the Eden Prairie, Minn.-based company said.

In the clinical study, researchers will assess 45 children to young adults ages 6 months to 21 years with heart failure and diuretic-resistant fluid overload to evaluate the safety and effectiveness of the Aquadex FlexFlow system.

Researchers aim to determine whether aquapheresis therapy is associated with greater weight loss and a non-inferior rate of renal dysfunction compared to current optimal medical therapy. They will also evaluate impact of heart failure symptoms using a novel pediatric heart failure symptom score, adverse outcomes and need for medical management as secondary endpoints.

“We are pleased that the researchers have received FDA approval to proceed with this IDE study. Given the limitations of patient unresponsiveness to diuretic therapies over time, our solution represents a potentially transformative future standard of care. We look forward to the clinical data results and to continuing our efforts to provide patients with additional treatment options for the treatment of heart failure,” CEO & chair John Erb said in a press release.

In April, the company closed an underwritten public offering, bringing in approximately $9.2 million in gross proceeds. The round included the full exercise of the underwriter’s over-allotment option to purchase additional shares, CHF Solutions said.

The post CHF Solutions wins IDE for pediatric trial of Aquadex FlexFlow aquapheresis system appeared first on MassDevice.

from MassDevice http://ift.tt/2u6NpPP

Northwestern, University of Calgary win $3m grant for cardiac valve imaging project

Patients who are born with a bicuspid aortic valve have 2 flaps in their cardiac valve instead of 3 – and researchers from Northwestern University and the University of Calgary are planning a 5-year study to evaluate an imaging approach for preventing the complications of this genetic condition.

With a $3.3 million grant from the National Institutes of Health, the team plans to use 4D-Flow MRI to visualize 3D blood flow in real time and analyze tissue to develop a personalized treatment for patients with BAV.

“Not all BAV patients are the same, yet they are currently treated the same when it comes to timing and extent of surgery,” Paul Fedak said in prepared remarks. “Through this study we can give clinicians and surgeons the tools they need to create precise, individualized treatment plans for patients.”

“Each patient’s condition is unique. We are developing state of the art MRI techniques to help with the assessment of their condition to develop the best plan of treatment,” Alex Barker added. “The use of this novel imaging technology can provide a better understanding of the underlying cause of aortic aneurysms in addition to identifying the patients who are most at risk of complications.”

The NIH grant will enable the researchers to analyze tissue in a 450-patient group over the next 5 years, according to the team.

The post Northwestern, University of Calgary win $3m grant for cardiac valve imaging project appeared first on MassDevice.

from MassDevice http://ift.tt/2soPgCB

How to regenerate a regenerative company: Admedus CEO Paterson on the company’s turnaround efforts

For over a year, Admedus (ASX:AHZ) has been engaged in a significant restructuring effort as it looks to break trends of overspending and edge towards profitability. The company is finally seeing fruits of its labors, posting its 1st cashflow neutral quarter this year and looking to a hopeful turn to profitability in the future.

To lead the restructuring effort, the company turned to 25-year pharmaceutical vet Wayne Paterson, who told MassDevice.com in an interview that he’s been able to contribute a unique global perspective to the company, along with a wealth of experience in steering companies in the medical field in the right direction.

Before taking the reins at Admedus, Paterson had spent 25 years in global pharmaceuticals, living in 7 countries over the past 20 years – something he says helped him right the ship at Admedus. During his time at Merck, he held positions as president of Japan, president of emerging products and EU president.

Restructuring is a topic Paterson says he knows well. His restructuring at Admedus was his 4th, having turned around the European division for Merck previously.

“The last one I did was Europe for Merck, and we had about 30% out of Europe, and that was hundreds of millions of dollars and thousands of headcounts. It’s not a new process from where I sit now,” Paterson said.

So far, Paterson has helped Admedus reduce its cash burn from approximately $5 million down to $2.5 million per quarter, while reducing headcount and increasing sales and business by about 50% at the same time.

“More importantly we put in all the systems and metrics and processes you need to have to run a global organization. We restructured the US, where I sit, moved a lot of the global commercial functions to the United States, kept the back office functions in Australia, HR, finance, et cetera. We’ve started to reshape the European operations as well,” Paterson said.

Paterson said that in the restructuring, the company had “grown up” into a corporation, with the metrics and tools its needs to manage itself on a global scale. During the time, the company has launched 3 products, with an additional product, the CardioCel 3D, slated to launch some time in the 3rd quarter.

The CardioCel 3D is a 60 degree shaped collagen product designed for complex neonatal arch and pulmonary artery repair designed for use in cases in which a flat, single dimension patch material won’t work. The device won FDA clearance earlier this year.

The company now has ambitious targets as it comes out of the restricting, Paterson said, looking to bring in $21 million after 12 months. Admedus also had its 1st cashflow neutral quarter during the last quarter, Paterson said.

“That’s historical, that we had the same money in the bank in March as what we had in December, meaning that we’ve got cashflow and sales at a balancing point. Now, that won’t be the case consistently until we get right through all of this, but it shows that the right systems and processes in place give you much better control of the company. I think our commercial operations are now moving in a way that I would like,” Paterson said. “At this pace of development I am comfortable that we will get the profitability metrics,” Paterson said.

In addition to a scheduled release of the CardioCel 3D in the coming quarter, the company is also working on a transcatheter aortic valve replacement device using the company’s existing tissue technology – which Paterson said will give it an edge against the competition.

“I started to hear anecdotally that the current TAVR devices were calcifying. They’ve been around for about 5 years, so doctors are starting to see that these in situ valves are having some issues, as you would expect, as they’re made from tissues that calcify,” Paterson said. “That led me to think, ‘Well if we already have that part of the problem solved what do we do next?'”

Paterson said the company, which has facilities in Minneapolis, was able to assemble a team of specialists who had worked on previous TAVR projects. The location of the office was essential in being able to add the talent, he added.

“We were able to marshal together quite a few engineers who had worked on currently marketed TAVR’s – people who had previously been employees at some of those companies,” Paterson said. “It’s the only city where you can actually assemble 4, 5 or 6 of these guys together and say, “What can we do here?”

With the team assembled, the project has “progressed quite significantly,” Paterson said. With the tissue development already done, the group has a leg-up on the process, with a working prototype already assembled alongside a wealth of IP related to the device.

“They’ve built a better mouse trap, for want of a better term. Clearly one that won’t calcify. We’re in a bit of a perfect storm right now,” Paterson said. “When I have a decent amount of IP lodged, I will then be looking to talk to 1 or 2 of the big 4, to look to a co-development deal.”

Paterson said that while he’s happy with the company’s momentum and direction, he’s still cautious.

“We’re doing things sensibly. We’re measuring. We’re monitoring. We’re applying lessons I’ve learned at larger healthcare companies to a smaller company and making sure that we survive, firstly, from a cash point of view. Secondly, we’re making sensible decisions around our portfolio and development. With the 4 products we have in the tissue space there is probably 7 or 8 more products behind that, and really it’s just a matter of prioritizing that in a way that doesn’t break the organization if we bring these things to market,” Paterson said. “The story right now is a marathon not a sprint, and then we’re taking cautious steps to make sure the company is viable moving forwards, and we can bring these products to market.”

The post How to regenerate a regenerative company: Admedus CEO Paterson on the company’s turnaround efforts appeared first on MassDevice.

from MassDevice http://ift.tt/2sZ2nsN

Bio2 touts pivotal data on Angel catheter-filter combo

Bio2 Medical touted data yesterday from the pivotal study of its Angel catheter in 163 critically ill patients with high risk of acute pulmonary embolism and contraindications to anticoagulation.

The study met its safety endpoints and demonstrated a significant reduction in clinically significant and fatal pulmonary embolism, according to the company.

The trial evaluated patients daily for pulmonary embolism, lower extremity deep vein thrombosis, catheter-related blood stream infections and major bleeding. The primary endpoint was freedom from clinically significant PE or fatal PE at the time of discharge and 72 hours after the Angel catheter was removed.

Secondary endpoints included acute proximal DVT and averted PEs.

All of the devices were placed and removed without incident, Bio2 reported. None of the enrolled patients suffered clinically significant PE or fatal PE.

Among the 129 patients who had a pre-removal cavogram, 31 had thrombus within the filter, 11% of which were averted significant PEs.

There were no catheter-related blood stream infections in over 1,170 catheter days, according to Bio2.

“Acute PE kills more than 100,000 Americans every year, and many more around the world. This study of a combined IVC filter/central venous catheter was the culmination of a panel of dedicated investigators with careful guidance by the FDA,” primary investigator Dr. Victor Tapson said in prepared remarks. “The efficacy and safety of the device, simple bedside placement, and the need to remove it before discharge make it very appealing. Nearly the entire cohort had crucial, yet short-term filter needs so that discharge without a filter was preferred.”

The device is the 1st to be cleared by the FDA for PE prophylaxis in critically ill patients contraindicated to anticoagulation.

“The publication of the results of the Angel Catheter pivotal study represents an opportunity to create awareness and further the goal of making this unique, lifesaving product available to the American public,” CEO Christopher Banas added. “Working collaboratively with the FDA as an initial participant in the FDA’s new Early Feasibility Study Program enabled Bio2 Medical to develop a clinical protocol which contributed to the pivotal study being completed 9 months ahead of schedule due to its fast enrollment.  Congratulations to the primary investigators, whose support was a major factor in the study’s success.”

The post Bio2 touts pivotal data on Angel catheter-filter combo appeared first on MassDevice.

from MassDevice http://ift.tt/2tsKNOG

Profound Medical to pay $6m for Philips’ Sonalleve MR-HIFU biz

Profound Medical (TSX:PRN) said today that it agreed to put up about $6 million worth of its own shares to acquire the Sonalleve MR-HIFU business from Royal Philips (NYSE:PHG).

Toronto-based Profound said the deal calls for it to put up 7.4 million shares at 84.9¢ (C$1.10) apiece, representing a 22% premium over its closing price yesterday. The total deal value is $6.3 million (C$8.1 million)

The agreement also has earn-outs pegged to future revenues of 5% to 7% of Sonnalleve sales through 2020, the company said. Philips, which already sells Profound’s Tulsa-Pro prostate ablation system, also pledged to distribute the Sonalleve device which is mostly used to ablate uterine fibroids.

“This agreement with Philips is in keeping with our commitment to invest in the powerful combination of real-time MR-guidance as the imaging platform and ultrasound as the energy source for delivering non-invasive ablative technology to clinicians,” Profound CEO Dr. Arun Menawat said in prepared remarks. “From a commercial perspective, taking this technology platform approach not only benefits Profound by significantly increasing our total opportunity size, but also benefits hospital customers by providing them with the ability to better utilize their MR system assets. In addition to the immediate contribution this transaction will make to our revenue base, we believe that it will also help accelerate our growth going forward.”

“We strive to provide clinicians with a broad portfolio of targeted therapy solutions for the treatment of complex diseases such as cancer,” added Philips diagnosis & treatment chief business leader Rob Cascella. “We recognize the broader value MR-guided HIFU therapies can bring to clinicians and their patients, and we appreciate Profound’s strengths in the area of MR-guided ultrasound ablation therapy. We believe that the increased scale of the business as a result of the transfer of Philips’ MR-HIFU activities to Profound and the resulting enhanced close collaboration will accelerate the development of new clinical applications for this promising technology, while better serving the needs of our current and future MR-HIFU customers. We look forward to our continued participation in the future of MR-HIFU via both our collaboration with, and minority shareholdings in, Profound.”

($1 = C$1.29622)

The post Profound Medical to pay $6m for Philips’ Sonalleve MR-HIFU biz appeared first on MassDevice.

from MassDevice http://ift.tt/2ttHKpd

Sunovion seeks FDA nod for COPD treatment – again

Sunovion Pharmaceuticals said today that the FDA accepted the revised new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo.

The submission follows a complete response letter that the FDA issued Sunovion in May. The Marlborough, Mass.-based company didn’t provide details as to why the FDA denied its initial application.

Get the full story at our sister site, Drug Delivery Business News.

The post Sunovion seeks FDA nod for COPD treatment – again appeared first on MassDevice.

from MassDevice http://ift.tt/2t8V6oI

Report: Intuitive Surgical won’t sell in Pakistan until da Vinci devices back on line

Intuitive Surgical (NSDQ:ISRG) is reportedly refusing to sell any more of its da Vinci robot-assisted surgery platforms in Pakistan until the two it’s already got on the market there are brought back on line.

The Sindh Institute of Urology & Transplantation in Karachi asked to acquire a da Vinci system, according to The News of Pakistan, but Intuitive Surgical refused until a pair of disused da Vincis at other hospitals in Karachi are made operable again.

Intuitive said the already-installed systems at the Civil Hospital and the Government Qatar Hospital must stay on line for at least a year before it will sell any more systems in Pakistan, according to the newspaper, which cited “a senior official of the Sindh health department.”

“The reason behind the refusal was the fact that the corporation was one of international repute and the broken robotic systems at two government-run hospitals in Karachi were tarnishing its image, said the official who requested anonymity,” the paper reported.

The two existing systems, sold in 2011 at $3 million apiece, have been idle for two years after breaking down for lack of maintenance following about 100 procedures, the official said.

“The hospitals require hundreds of thousands of dollars to get the systems repaired,” he told The News, adding that the company has also rebuffed other, private Pakistani hospitals looking to buy its flagship product.

For one of the abortive deals, the local health department put up about $2.4 million (PKR250 million), the source said, “but when the manufacturing firm stated its conditions, [Sindh Institute of Urology & Transplantation] officials said they would provide half of the funds for repair of the machine at the [Civil Hospital] while the other half was to be arranged by the health department,” the official told the newspaper.

Qatar Hospital medical superintendent Dr. Khalid Masood told the paper that Intuitive asked for $381,000  to repair its da Vinci, which the hospital’s management asked the local government to provide.

A representative for Intuitive did not immediately respond to a request for comment.

($1 = PKR104.864)

The post Report: Intuitive Surgical won’t sell in Pakistan until da Vinci devices back on line appeared first on MassDevice.

from MassDevice http://ift.tt/2ttJUFa

CMS spikes Medicare Advantage data release at the last minute

Medicare Advantage, privately run health plans paid for by Medicare, have covered an increasing number of seniors and disabled people in recent years. More than 1/3 of the 58 million Medicare beneficiaries opt for these non-traditional plans.

The government has been collecting data about the care delivered to these enrollees since 2012. Last year, it began using the data to calculate payments to private insurers and officials at the Centers for Medicare and Medicaid Services were preparing to turn the data over to the public.

The Medicare Advantage data was slated to be made public at the annual meeting of AcademyHealth in New Orleans. But the session was canceled at the last minute, catching researchers and ex-Medicare officials by surprise.

CMS defended the move, saying that it would examine the 2015 numbers “to determine if it is robust enough to support research use.”

The announcement was “hugely disappointing” to former CMS chief data officer Niall Brennan, who tweeted, “Hope CMS is not backsliding on #opendata.”

Health economist Austin Frakt told ProPublica that he wanted to see the data as a researcher, but also as a taxpayer.

“We are paying an enormous amount of money to private insurance companies … but we know very little about what we’re getting for that money,” he said told the news outlet.

Data for traditional Medicare plans have been available for decades.

“The claim is that private insurers are innovating in ways that traditional program is not,” Frakt added. “We need to validate that. We need to know what they’re doing for the benefit of everyone. We can’t do that without the data.”

The private insurers in charge of Medicare Advantage plans have faced criticism lately for potentially overcharging Medicare. In 2014, the Center for Public Integrity reported that insurers collected $70 billion in inappropriate payments between 2008 and 2013.

According to statements made by a spokesperson for America’s Health Insurance Plans, the insurance industry did not request that CMS delay the release of the much-anticipated data, although it has been questioning the data’s accuracy.

“The system used to capture encounter data has numerous unresolved operational and technical issues and fails to capture a reliable, comprehensive picture of beneficiaries’ diagnoses,” the spokeswoman told ProPublica. “This could put payments at risk, which could also increase premiums and decrease benefits. We look forward to working with Administrator Verma and CMS to improve the encounter data and address these issues.”

The post CMS spikes Medicare Advantage data release at the last minute appeared first on MassDevice.

from MassDevice http://ift.tt/2ttmZd8

Augmenix debuts SpaceOar in Israel

Augmenix Inc. said this week that it launched its SpaceOar hydrogel device in Israel.

The Bedford, Mass.-based company’s absorbable prostate-rectum spacer is designed to reduce rectal injury during prostate radiotherapy.

Get the full story at our sister site, Drug Delivery Business News.

The post Augmenix debuts SpaceOar in Israel appeared first on MassDevice.

from MassDevice http://ift.tt/2u6d3UK

Shareholders revive class-action kickbacks suit against Cardiovascular Systems

Shareholders revived a purported class-action kickbacks lawsuit against Cardiovascular Systems (NSDQ:CSII) that was dismissed without prejudice earlier this year, citing in the new complaint a $25 million judgment against the company in a related case.

St. Paul, Minn.-based CSI paid $8 million to settle a federal False Claims Act suit in July 2016 that accused it of running a kickbacks program by offering free, all-expense-paid training programs “followed by explicit demands by CSI employees that attendees use CSI products on future patients,” giving away product for free, 3rd-party referral channel marketing, and “sham Speaker Bureau payments for high-prescribers and others whom CSI sought to cultivate,” according to a complaint filed by Travis Thams, who worked for CSI as a district sales manager from 2012 to 2013. The Tham lawsuit also accused the company of running an off-label promotion scheme to push sales of its unapproved 4 French catheter.

After the Tham suit was unsealed, shareholders leveled another lawsuit against CSI, alleging that the company and its management misled investors about the alleged schemes, causing a sharp drop in the company’s share price. But Judge Donovan Frank of the U.S. District Court for Minnesota dismissed that suit with leave to amend in March, ruling that the plaintiffs failed to prove their allegations in part because of their reliance on confidential witnesses in the Tham case.

A week later, CSI was found liable for approximately $25.1 million in a separate, third whistleblower and wrongful termination suit involving a former regional sales manager. That suit, filed by Steven Babyak in November 2015, alleged that the company engaged in retaliation and the eventual discharge of Babyak in response to his expressed concerns over issues relating to patient safety and violations of state and federal laws. Babyak worked for the company for 3 years before being fired in June 2015. A jury in the Superior Court of California for the County of Los Angeles found in his favor April 24, awarding Babyak $2.7 million in compensatory damages and another $22.4 million in punitive damages.

This week the shareholders amended their complaint to cite the result in the Babyak case, seeking class action status for owners of CSII stock between Sept. 12, 2011, and Jan. 21, 2016.

“Defendants’ illegal sales tactics have been confirmed through multiple sources, including: (i) evidence, including internal documentation, submitted in Babyak v. Cardiovascular Systems Inc., a California lawsuit brought by a former CSI sales representative, who won a $25 million jury verdict against CSI for terminating him in retaliation for reporting illegal marketing and sales tactics; (ii) statements by former employees, including CSI sales representatives (‘sales reps’) with direct knowledge of the practices alleged herein; and (iii) CSI’s settlement with the government to resolve claims of illegal kickbacks to physicians,” the shareholders alleged in the new complaint filed July 27.

“Documents, affidavits, and verified interrogatories filed publicly in the Babyak action show CSI executives were involved in a ‘Triangle Offense’ program, which was used to push sales reps to illegally steer referrals to doctors expressly in order to induce purchases of CSI’s PAD devices. As described by one senior CSI official to sales reps: ‘the Triangle Offense gives you control. If you own the bottom base of the triangle (referring physicians) you will control the top point of the triangle (physician end user). If the physician end user isn’t a loyalist then we can steer referrals to someone that is loyal because we control the referral spigot.’ The official told sales reps to ‘[g]et an agreement [from the customer] that you will market for them as long as he uses our device.’” according to the lawsuit [emphasis theirs].

Cardiovascular Systems said in a regulatory filing that it “believes that this lawsuit is without merit and intends to defend itself vigorously.”

The post Shareholders revive class-action kickbacks suit against Cardiovascular Systems appeared first on MassDevice.

from MassDevice http://ift.tt/2u6l5Nq

Roche buys mySugr diabetes app

Swiss drugmaker Roche (PINK:RHHBY) said today that it bought diabetes management platform mySugr for an undisclosed price. The 2 companies have worked together since 2014.

mySugr’s digital tech enables users to track things like their blood sugar, diabetes medications and physical activity.

Get the full story at our sister site, Drug Delivery Business News.

The post Roche buys mySugr diabetes app appeared first on MassDevice.

from MassDevice http://ift.tt/2t8aba7

Windtree Therapeutics touts Phase II data for inhaled surfactant

Windtree Therapeutics (NSDQ:WINT) reported data today from the 221-patient Phase IIb trial of its aerosolized KL4 surfactant for the treatment of respiratory distress syndrome in premature infants.

The Aerosurf trial evaluated aerosolized KL4 surfactant administered to premature infants 28 to 32 weeks gestational age in 2 dose groups with up to 2 repeat doses, compared to infants receiving nasal continuous positive airway pressure.

The trial evaluated incidence of nCPAP failure, time to nCPAP failure and physiological parameters indicating the effectiveness of lung function.

The inhaled therapy did not meet the primary endpoint of the study, which was reducing nCPAP failure at 72 hours.

Get the full story at our sister site, Drug Delivery Business News.

The post Windtree Therapeutics touts Phase II data for inhaled surfactant appeared first on MassDevice.

from MassDevice http://ift.tt/2t6zA3K

LipoSeuticals closes Series A for novel drug delivery tech

LipoSeuticals said today that it closed a financing round for an undisclosed amount led by Hong Kong-based life sciences fund, Delos Capital.

The company has developed a sugar-lipid polymer-based formulation, Sulocence, which boosts drug stability and solubility. LipoSeuticals said it is applying the drug delivery technology to the reformulation of an array of marketed specialty drugs.

Get the full story at our sister site, Drug Delivery Business News.

The post LipoSeuticals closes Series A for novel drug delivery tech appeared first on MassDevice.

from MassDevice http://ift.tt/2tuxGgk

Could dogs be better than medical devices at detecting cancer?

[Image from unsplash.com]

Dogs in a small Japan town are being trained to detect stomach cancer through their scent to try to combat the high rates of stomach cancer in the area, according to media reports.

The small 6,000-resident Japanese town of Kaneyama has high rates of stomach cancer and mayor Hiroshi Suzuki has taken to a sniffer dog research program to hopefully improve the accuracy of cancer screenings.

Suzuki and medical school professor Masao Miyashita conducted a research program in the town that involved dogs sniffing out cancer from test samples.

Get the full story on our sister site, Medical Design & Outsourcing.

The post Could dogs be better than medical devices at detecting cancer? appeared first on MassDevice.

from MassDevice http://ift.tt/2sWscd2

SciBase wins FDA PMA nod for Nevisense malignant melanoma detector

Medical device company SciBase said today it won FDA pre-market approval for its Nevisense device designed for the early detection of malignant melanoma.

The Stockholm-based company’s device is indicated for use on cutaneous lesions with 1 or more clinical or historical characteristics of melanoma, for obtaining additional information when considering a biopsy, the company said.

The Nevisense device is designed to detect malignant melanoma, the deadliest form of skin cancer which accounts for 75% of deaths related to skin cancer, directly on the skin, SciBase said. The company touted the device as the 1st of it’s kind on the US market.

“Most employees in the company have been working directly or indirectly on the approval for many years, and this really is a remarkable and nearly unique achievement given the size of our company. It’s no secret that the US market is the world’s largest and most profitable market for medical devices and in the long term, it represents a huge growth potential for us,” CEO Simon Grant said in a prepared statement.

SciBase said that with the approval, it will accelerate its activities and prepare for a US launch sometime after summer.

The post SciBase wins FDA PMA nod for Nevisense malignant melanoma detector appeared first on MassDevice.

from MassDevice http://ift.tt/2s6prmu

MassDevice.com +5 | The top 5 medtech stories for June 29, 2017

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. DeviceTalks: 3M’s Cindy Kent on leadership, growth and inclusion in medtech

Cindy Kent is no stranger to medtech – she’s spent 20 years in healthcare, moving up the ranks and finding her way to president & GM for 3M’s infection prevention division. She spoke with MassDevice.com Publisher Brian Johnson at the DeviceTalks event in Minnesota this week about her skills as a leader, how she ended up as an ordained minister and the importance of inclusion and mentorship in the workplace.  Read more

 

---

4. Titan Medical closes $6m offering

Titan Medical said today that it raised nearly $6 million in a public offering, with company insiders putting up another $166,000.

Toronto-based Titan, which is developing the Sport robot-assisted surgery platform, had said it might float up to 100 million shares, which would have fetched $11.5 million. In the event the company floated nearly 48.4 million shares at 11.5¢ (C15.0¢) apiece, for gross proceeds of almost $5.5 million (C$7.3 million). Each unit in the offering consisted of a stock share and a 5-year warrant priced at 15.3¢ (C20.0¢). Read more

---

3. Zimmer Biomet launches X-PSI customized total knee replacement

Zimmer Biomet said on Thursday it launched its X-PSI knee system, an X-ray-based, patient-specific surgical planning system designed for patient specific implant positioning using X-ray tech.

The X-PSI system is designed for use with all of the Warsaw, Ind.-based company’s total knee brands, and allows surgeons to use X-ray images to generate 3D anatomical models. The system is then used to view the patients’ anatomy and develop a customized 3D surgical plan, the company said. Read more

---

2. Smith & Nephew launches total knee for Navio robot-assisted surgery platform

Smith & Nephew said today that it’s adding a total knee arthroplasty application to the Navio handheld robot-assisted platform.

The European Union’s largest orthopedics player said the Navio system can be used with its Journey II, Legion Primary and Genesis II total knees. Smith & Nephew acquired Minnesota-based Blue Belt Technologies – Navio’s original maker – in January 2016 for $275 million. Read more

---

1. Bonesupport closes $57m IPO

BoneSupport said last week it closed its initial public offering, raising a total of approximately $57.1 million (SEK 500 million), not including an over-allotment option.

The Swedish company, which is developing the Cerament G injectable antibiotic-eluting bone graft substitute, said it floated approximately 17.2 million new shares at $3.40 per share (SEK 29) in the round, raising approximately $57.1 million before issue costs and $54 million (SEK 461 million) after issue costs. Read more

The post MassDevice.com +5 | The top 5 medtech stories for June 29, 2017 appeared first on MassDevice.

from MassDevice http://ift.tt/2u3piBL

Medtech M&A: The 10 biggest deals so far in 2017

Over the past several years, the healthcare industry as a whole has experienced an abundance of mergers and acquisitions – major players are buying up their peers in deals ranging from millions to billions.  The trend is continuing, and the healthcare playing field continues to be shaped by these mega-transactions.

For the medical device industry, 2017 is already proving to be a busy year full of deals that are changing the landscape.  In just 6 months, we’ve seen seen groundbreaking deals like Abbott’s $25 billion acquisition of St. Jude, Becton Dickinson’s $24 billion purchase of C.R. Bard and Medtronic’s $6.1 billion divestiture of its patient monitoring and recovery biz to Cardinal Health.

MassDevice.com has assembled a list of the 10 of the biggest M&A deals in the medical device industry so far – with a combined price tag of over $65 billion.

FIRST: Abbott closes its $25 billion St. Jude Medical buy

The post Medtech M&A: The 10 biggest deals so far in 2017 appeared first on MassDevice.

from MassDevice http://ift.tt/2u34FFw

Exactech debuts ExactechGPS TKA Plus total knee surgery planning software

Exactech (NSDQ:EXAC) said today it launched its ExactechGPS TKA Plus software application designed to provide surgeons with real-time intraoperative computer guidance during total knee arthroplasty procedures.

The ExactechGPS is designed for guided, personalized joint replacement surgery, the Gainesville, Fla.-based company said. The new TKA Plus application provides a simple tool to plan, guide and verify steps in knee replacement procedures and check the patient’s implant alignment.

“I was delighted to experience how seamlessly the system integrated into my surgical workflow. ExactechGPS TKA Plus allowed me to use simple guidance to achieve precision and accuracy in my cuts, which made the knee replacement case run smoothly. I believe this system is exactly what surgeons need to help them achieve more reproducible outcomes,” Dr. Derek Amanatullah of Stanford University Medical Center, who performed the 1st surgery using the system, said in prepared remarks.

The company said that the ExactechGPS TKA Plus is currently available in a pilot launch with full availability slated for 2018.

“The launch of TKA Plus reiterates Exactech’s commitment to delivering a fully comprehensive knee system to the marketplace. The Truliant system of new implants and instruments, combined with our ExactechGPS technology, offers orthopaedic surgeons versatility in managing total knee arthroplasty cases from primary through revision. We are encouraged by the positive responses we have received and look forward to continued momentum behind our new knee system,” knee marketing VP Joseph Pizzurro said in a prepared statement.

Last week, Exactech said it won Japanese approval for its shoulder, knee and hip replacement systems and that the devices had been recently used in their 1st procedures in the region.

The post Exactech debuts ExactechGPS TKA Plus total knee surgery planning software appeared first on MassDevice.

from MassDevice http://ift.tt/2slyzrA

LivaNova wins FDA nod for VNS therapy neurostim for young epilepsy patients

LivaNova (NSDQ:LIVN) said today it won FDA approval of its Vagus Nerve Stimulation Therapy system for patients as young as 4 years of age with partial onset seizures that are refractory to antiepileptic medications.

The London-based company touted that with the clearance, its VNS Therapy system is the only FDA-approved device for drug-resistant epilepsy in the pediatric population. Previously, the device was only approved for patients ages 12 and older.

“Epilepsy affects one in 26 Americans, and 35% of these patients fail to respond to medications. VNS Therapy offers many of these patients a chance for improved seizure control and a better quality of life. Controlling seizures in young children is life changing, allowing for improved development and educational successes that impact a child’s entire life,” Dr. Deborah Holder of the Children’s Hospital Los Angeles said in a prepared release.

LivaNova said that every day in the US, 30 children experience seizures for the 1st time and will ultimately not be able to control them with medications alone. Every year more than 10,000 children under age 18 with drug-resistant epilepsy face the consequences of seizures, the company added, which could result in potential cognitive decline and missed developmental milestones.

“Bringing VNS Therapy to children as young as age 4 in the U.S. is a huge opportunity to expand patient wellness and improve overall quality of life. We strive to provide value to patients, caregivers and healthcare professionals across the globe. Today’s announcement, along with the recent FDA approval for our expanded MRI labeling, exemplifies how we continue to deliver on that promise,” neuromodulation biz GM Jason Richey said in a prepared statement.

“Epilepsy can be a very trying and debilitating disease that can hold a child back from reaching his or her full potential. Children with frequent seizures require urgent and careful treatment to prevent further delay in their development. The data from several studies show that earlier use of VNS Therapy is proven to offer better long-term outcomes for children at a critical time in their development,” CEO Damien McDonald said in a press release.

Last week, LivaNova said it won FDA approval for expanded MRI labeling for its Vagus Nerve Stimulation Therapy device, touting it as the only epilepsy device cleared by the FDA for MRI scans.

With the approval, patients with the minimally invasive VNS system are cleared to visit any MRI center in the US, with access to more than 90% of routine scans for patients with epilepsy, the company said.

The post LivaNova wins FDA nod for VNS therapy neurostim for young epilepsy patients appeared first on MassDevice.

from MassDevice http://ift.tt/2t5kCeB

DePuy Synthes launches Viper & Expedium fenestrated screw systems

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes said today it it launched its Viper and Expedium fenestrated screw systems.

The company said the systems are designed to be used with its Confidence high viscosity spinal cement to restore the integrity of the spinal colum in patients with advanced stage spinal tumors. The screw systems are intended to provide stabilization and palliative treament for patients suffering from spinal cord compression as a results of advanced stage tumors.

The newly launched Viper and Expedium fenestrated screws are designed with a hollow shaft and fenestrations above the screw tip to enable controlled delivery of the Confidence cement into the vertebra for immediate fixation. The systems are designed for open or percutaneous spinal fusion, DePuy Synthes added.

“The ability to inject cement via fenestrated screws is a true game-changer in the field of spinal oncology. The systems are reliable and easy-to-use and can seamlessly be incorporated into open and minimally invasive approaches. The cement working characteristics, delivery system and ability to use standard hardware and tools make the systems extremely efficient,” Dr. Daniel Sciubba of Johns Hopkins Hospital said in a press release.

On Wednesday, Johnson & Johnson’s DePuy Synthes said it acquired spinal nerve localization tech dev Innovative Surgical Solutions, which operates as Sentio, for an undisclosed amount.

Wixom, Mich.-based Sentio has developed a platform designed to provide real-time feedback of nerve location using adhesive sensors applied to the skin, DePuy Synthes said. The system can be set up by OR personnel and does not require a neuromonitoring specialist.

The post DePuy Synthes launches Viper & Expedium fenestrated screw systems appeared first on MassDevice.

from MassDevice http://ift.tt/2tts7Pd

Researchers develop molecular cage for drug delivery

Researchers from Trinity College Dublin have created a molecular cage that can house different molecules for drug-delivery applications.

The cage’s hollow structure, made up of sub-cages, enables researchers to load different molecules and design them to react only when the cages are surrounded by particular environments.

Get the full story at our sister site, Drug Delivery Business News.

The post Researchers develop molecular cage for drug delivery appeared first on MassDevice.

from MassDevice http://ift.tt/2sqqJbn

Elekta taps Brainlab as select EU distro partner for stereotactic neuro devices

Elekta (STO:EKTA B) said today it tapped Brainlab to distribute its stereotactic neurological devices across select markets in the European Union.

The distribution agreement covers Elekta’s Leksell Vantage Steretactic target localization and coordinate referencing neurosurgery system, the company said, which received CE Mark approval in the EU in March. The device is currently pending 510(k) clearance in the US, Elekta added. The agreement also covers the Leksell Stereotactic system and Elekta Microdrive.

“Elekta is a leader of equipment for stereotactic neurosurgery and Brainlab has a strong presence in the neurosurgery market with its software solutions. This collaboration helps to strengthen and streamline the service and support to our customers starting in France, Belgium, Poland, Liechtenstein, Luxemburg, Portugal and Spain. With this, they will be able to access a complete solution from a single source,” Elekta western & central Europe senior VP François Pointurier said in prepared remarks.

Stockholm-based Elekta said it began collaborating with Brainlab last year to improve the interopability and safety of stereotactic surgery through the integration of Elekta’s Leksell Vantage stereotactic system into Brainlab’s Elements Stereotaxy software.

“A distribution partnership between Brainlab and Elekta will provide clinicians with improved and standardized stereotactic neurosurgery workflows,” Brainlab prez & CEO Stefan Vilsmeier said in a prepared statement.

“This latest collaboration between our companies will be mutually beneficial, strengthening our respective combined offer in neurosurgery. By joining forces in sales and support, we aim to strengthen our relationship with the neurosurgery community by offering more solutions from the Elekta portfolio,” Elekta chief strategy officer Maurits Wolleswinkel said in a press release.

The post Elekta taps Brainlab as select EU distro partner for stereotactic neuro devices appeared first on MassDevice.

from MassDevice http://ift.tt/2s5Jodc

Smith & Nephew

Smith & Nephew (NYSE:SNN) said today that it’s adding a total knee arthroplasty application to the Navio handheld robot-assisted platform.

The European Union’s largest orthopedics player said the Navio system can be used with its Journey II, Legion Primary and Genesis II total knees. Smith & Nephew acquired Minnesota-based Blue Belt Technologies – Navio’s original maker – in January 2016 for $275 million.

“The Navio partial knee replacement application has been commercially available since 2014, including UKA and PFJ options, and has developed a strong surgeon following,” U.S. commerical president Glenn Warner said in prepared remarks. “The full market release of the TKA application provides a robotics-assisted solution for one of the largest markets in orthopaedics. Smith & Nephew is committed to continued expansion and growth of the Navio robotics-assisted platform.”

“The Navio system offers game changing improvements in precision and accuracy without sacrificing efficiency. It allows surgeons the control to create a patient-specific plan in the OR and the confidence to execute with robotic precision,” added Dr. Joseph Burkhardt of Battle Creek Hospital in southwest Michigan. “For the total knee, it provides surgeons the ability to do more than they have ever been able to do with standard instruments, resulting in improved functional outcomes for the patient.”

Blue Belt won its first FDA clearance in 2012, for a partial knee replacement system then called the NavioPFS. U.S. market clearance for its Stride unicondylar knee implant followed in June 2013.

The post Smith & Nephew appeared first on MassDevice.

from MassDevice http://ift.tt/2t4KUxy

Zimmer Biomet launches X-PSI customized total knee replacement

Zimmer Biomet (NYSE:ZBH) said on Thursday it launched its X-PSI knee system, an X-ray-based, patient-specific surgical planning system designed for patient specific implant positioning using X-ray tech.

The X-PSI system is designed for use with all of the Warsaw, Ind.-based company’s total knee brands, and allows surgeons to use X-ray images to generate 3D anatomical models. The system is then used to view the patients’ anatomy and develop a customized 3D surgical plan, the company said.

“The use of innovative preoperative planning to enable patient-specific customization has the potential to become the gold standard in joint replacement care; however, its widespread clinical utility has been limited by its reliance on MRI and CT imaging, which are less accessible and not typically used for preoperative evaluation. Conversely, virtually every candidate for joint replacement surgery undergoes X-ray imaging, so we are thrilled to debut the first CE Marked, X-ray-based patient specific instrument system, and extend the benefits of customized surgical planning to joint replacement patients across the European Union. This new offering was conceptualized and developed in collaboration with Dr. Mohamed Mahfouz, Professor of Biomedical Engineering at the University of Tennessee, who pioneered the original concept,” joint reconstruction group prez Dan Williamson said in a prepared statement.

Zimmer Biomet touted the X-PSI system as the world’s 1st X-ray based patient specific system for total knee replacement surgery with CE Mark approval in the European Union. The company said it is its 4th patient specific guide in its personalized solutions franchise, and is slated to be launched in 5 countries in the EU.

“The growing use of MRI and CT-based planning software to customize implant placement has meaningfully improved patient outcomes in joint replacement surgery. Our study found that X-PSI Knee System, which uses X-ray imaging with Zimmer Biomet’s patient specific instruments planner, yields comparably high implant placement accuracy as MRI and CT-based systems, while significantly improving accessibility and clinical utility to a broader patient population,” X-PSI IDE trial lead investigator Dr. Raju Ghate of Evanston, Ill.’s NorthShore University HealthSystem said in a press release.

In May, Zimmer Biomet said it inked a deal with device incubator Bonutti Research for 2 families of patents related to knee technologies. The company licensed a patent which Bonutti says “adds to the strength” of the Persona personalized knee system and its NexGen Complete knee solution.

The post Zimmer Biomet launches X-PSI customized total knee replacement appeared first on MassDevice.

from MassDevice http://ift.tt/2tpVOzO

CardioFocus launches 3 studies of HeartLight ablation system

CardioFocus today announced the launch of 3 studies of its HeartLight endoscopic ablation system, touting that over 1,000 patients with atrial fibrillation will be enrolled across the studies.

The Marlborough, Mass.-based company’s HeartLight system is designed to allow electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural flexibility. The device includes a compliant balloon to accommodate diverse PV anatomies and has a short learning curve to allow for quick adoption of the tech, the company said.

In the 1st study, researchers will compare the acute procedure and safety outcomes along with long-term clinical 2 groups of patients being treated for paroxysmal AF, the company said. The 1st group will be treated with the HeartLight system, while the other will be treated with a commercially available contact force sensing irrigated radiofrequency ablation catheter and possible 3D electroanatomical mapping. The study is slated to enroll 350 patients at approximately 10 centers across Europe.

The 2nd study looks to enroll 400 patients, 4 separate arms. The trial aims to enroll 200 patients with paroxysmal AF and 200 with persistent AF, of which 100 of each will be treated with the HeartLight system and 100 will be treated with a cryoballoon.

In its 3rd study, the company will evaluate clinical outcomes in a cohort of patients treated during commercial use of the HeartLight system, looking to verify results from the company’s successful US clinical pivotal study. The trial aims to enroll 250 patients at 25 sites in the US.

CardioFocus said the 3 studies would help provide additional clinical evidence of the performance of its HeartLight system in patients with AF.

“The data continue to reinforce the chronic efficacy of laser balloon ablation with the HeartLight System in our most recent single center comparative analysis showing freedom from AF at one year of 93 percent,” Dr. Pieter Koopman said in a prepared statement.

“We are greatly encouraged by all the positive data collected to date on the HeartLight System and look forward to the results of these new exciting studies enrolling up to 1,000 AF patients. Our goal is to be a leader in the field of pulmonary vein isolation, which includes supporting the initiation of clinical studies that provide further evidence of the HeartLight System’s impressive safety and efficacy profile and make this technology more widely accessible to the more than 9 million1 patients, in the U.S. and Europe, who are suffering from AF,” exec chair Paul LaViolette said in a press release.

In March, CardioFocus raised $20.2 million in a round of equity and options financing, according to an SEC filing posted this week.

The post CardioFocus launches 3 studies of HeartLight ablation system appeared first on MassDevice.

from MassDevice http://ift.tt/2sV33zl

Titan Medical closes $6m offering

Titan Medical (TSX:TMD) said today that it raised nearly $6 million in a public offering, with company insiders putting up another $217,000.

Toronto-based Titan, which is developing the Sport robot-assisted surgery platform, had said it might float up to 100 million shares, which would have fetched $11.5 million. In the event the company floated nearly 48.4 million shares at 11.5¢ (C15.0¢) apiece, for gross proceeds of almost $5.5 million (C$7.3 million). Each unit in the offering consisted of a stock share and a 5-year warrant priced at 15.3¢ (C20.0¢).

Titan said another 1.4 million shares were issued to company insiders, including all directors and officers, for gross proceeds of $216,896. Bloom Burton Securities was the sole offering agent for the flotation, the company said.

Earlier this month, its shareholders approved a reverse stock split at a range of one share for 5 to 30 shares.

In April, Titan Medical said it spiked talks with Chinese distributor Longtai Medical over its Sport robot-assisted surgery platform so it can focus on winning regulatory approvals in the U.S. and Europe.

Back in October 2015, Titan inked a private placement deal with Longtai, a subsidiary of Chinese medical device distributor Ningbo Long Hengtai International Trade Co., that could have ended up being worth more than $24 million.

($1 = C$1.30927)

The post Titan Medical closes $6m offering appeared first on MassDevice.

from MassDevice http://ift.tt/2tttr4P

Spineology wins FDA nod for Rampart One lumbar interbody fusion system

Spinal tech developer Spineology said this week it won FDA clearance for its Rampart One anterior lumbar interbody fusion system.

The St. Paul, Minn.-based company said the Rampart One is designed to minimize exposure and vascular retraction requirements associated with traditional anterior spine fusion procedure, and includes both standard and oblique interbody device footprints with integrated fixation screws.

“Variable angle instrumentation and integrated guides are colinear with the access, providing the surgeon the ability to keep the incision to a minimum,” Dr. Jeremy Shore said in a prepared statement.

“For instances where there is limited to no vessel mobility, the Rampart One oblique footprint is an excellent option,” Dr. Clifford Tribus said in prepared remarks.

The Rampart One is manufactured from the company’s Invibio Peek-Optima HA enhanced material, which Spineology claims provides an improved osteoconductive surface for bone in-growth, reduced stress shielding and artifact-free imaging.

“Minimizing exposure and retraction are cornerstone elements of all Spineology anatomy conserving designs. We are very excited about this approval and look forward to entering the anterior market in the near future,” CEO John Booth said in a press release.

In March, Spineology said it won expanded FDA clearance for its Elite expandable interbody fusion system designed for spinal fusion procedures. The company said it won cleraance for a narrower 10mm version of the device, as well as an extended indication allowing the device to be used with allograft bone.

The post Spineology wins FDA nod for Rampart One lumbar interbody fusion system appeared first on MassDevice.

from MassDevice http://ift.tt/2sqGcrQ

NanoVibronix looks to raise $10m

NanoVibronix (NSDQ:NVBXU) is looking to raise approximately $9.6 million in a new offering of shares to support getting its shares listed on the Nasdaq Capital Markets, according to an SEC filing posted this week.

The offering could also be used to support a transition of the company’s headquarters to the US, according to a Globes report. The company’s CEO, CFO and marketing setup would operate out of the US, while R&D would still operate out of Israel, according to the report.

Funds will also support expanding the company’s sales leadership team and field level sales resources, research & development efforts and implementation of its surface acoustic wave platform to other applications, according to the SEC filing. Money from the offering could also be used for complimentary acquisitions, to pay holders of 2017 notes and for general working capital.

In the round, the company said it plans to offer select Series D convertible preferred stock to shareholders with more than 4.9% of its outstanding common stock, and will reduce shares of common stock sold by 1 for each preferred share sold, according to an SEC filing.

NanoVibronix is developing medical devices using its proprietary low intensity surface acoustic wave wound care and pain relief technology, which it claims can be used for a variety of medical applications. The devices are designed to be administered at home without the assistance of medical processionals, and include the CE Marked PainShield and WoundShield. The company’s PainShield also has FDA clearance, the company said.

The company has also won CE Mark approval in the European Union for its catheter based UroShield and NG-Shield devices.

Last December, NanoVibronix said it won approval from Health Canada to sell its WoundShield device in Canada.

The post NanoVibronix looks to raise $10m appeared first on MassDevice.

from MassDevice http://ift.tt/2u2svkU