dilluns, 30 d’abril del 2018

Edwards Lifesciences wins CE Mark for Cardioband transcath tricuspid valve system

Edwards LifeSciences logo

Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Cardioband transcatheter tricuspid valve reconstruction system, touting it as the first commercially cleared transcath therapy for treating tricuspid heart valve disease.

The Cardioband tricuspid system is designed to be delivered through a transfemoral approach and is intended to reduce tricuspid regurgitation through annular reduction, the Irvine, Calif.-baed company said. The system features the same design and implant technique as the company’s Cardioband mitral system.

“Although open-heart surgical valve repair is practiced today, it has not been performed frequently for those suffering from tricuspid regurgitation, despite evidence of increased mortality in these patients. Now with the European approval of the Cardioband tricuspid system as the first transcatheter tricuspid therapy, patients can have access to a minimally invasive treatment designed to reduce tricuspid regurgitation and improve their symptoms and quality of life,” Dr. Georg Nickenig of Bonn, Germany’s University Hospital said in a press release.

Edwards Lifesciences touted that the transcatheter solution allows for accurate positioning that takes into account patient-specific anatomy, and allows for real-time adjustment with the ability to confirm results of the placement.

“We are very pleased to be developing the most comprehensive product portfolio to address both mitral and tricuspid valve disease and to demonstrate continued progress on this robust pipeline of innovative transcatheter therapies for patients in need. The clinical results of the Tri-Repair CE Mark study with the Cardioband tricuspid system demonstrate the promise of this treatment option for those with tricuspid regurgitation. We are committed to building a significant body of clinical evidence, including the collection of real-world data, on this important new therapy for patients who have few or no other treatment options,” transcath mitral and tricuspid therapies corporate VP Bernard Zovighian said in a prepared statement.

Edwards Lifesciences acquired the Cardioband tech when it bought Valtech Cardio in a deal worth $690 million which closed last January.

The clearance of the device was a pre-specified milestone in the deal, and as such prompted the distribution of cash and stock worth approximately $50 million to former Valtech investors, Edwards said.

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Analogic $1B go-private sale to Altaris clears first hurdle

Altaris Capital Partners, Analogic

Analogic (NSDQ:ALOG) said today it passed the first hurdle in its proposed $1 billion go-private sale to Altaris Capital Partners, announcing that it received notice from the US FTC that it was granted early termination of the waiting period under Hart-Scott-Rodino Antitrust Improvements act of 1976.

The grant was one step of many the companies will have to pass to win approval for the proposed $84 per share acquisition, which Analogic said it is hopeful will close in mid-2018.

Peabody, Mass.-based Analogic said that it still has to gain approval from its shareholders for the sale, which the company’s board of directors has unanimously recommended its shareholders vote in favor of, according to a press release.

The sale, initially announced earlier this month, follows an internal review Analogic announced last June in which the company sought to explore “strategic alternatives”, which ended with the company contacting approximately 75 potential financial and strategic buyers, domestically and internationally.

Analogic said it explored a number of other options, including a sale of the entire company and separation of its three business units, as well as continued operation on a stand-alone basis.

Analogic said that the deal represents a 25% premium over its closing share price of $67.45 as reported on June 7, 2017. The company’s shares are trading at $83.11 as of 9:35 a.m. EDT, down 13.5% so far today.

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Design for Manufacturing Breakthroughs: Producing Innovative Micro Medical Devices

This whitepaper explores how medical micro breakthrough designs are produced and how supplier and design roadblocks can be overcome without compromising the original design. By learning how to efficiently work with a molder to produce a breakthrough idea, medical OEMs can save valuable time in their supplier qualification process, decrease costs, increase speed to market, and improve functionality and quality of their micro medical device.

See MTD at Booth #1445 at MD&M East

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Cardio neuromod group Cardionomic raises $9m

Cardionomic

Cardionomic has raised $9 million in a new round of equity financing, according to an SEC filing posted this week.

The company is developing a neuromodulation therapy device to treat acute decompensated heart failure, a condition in which fluid accumulates in the lungs and other tissues in patients with heart failure.

Money in the round came from four unnamed investors, according to the filing, with the first sale dated on April 17.

The company is looking to raise an additional $608,529 in the round, bringing the total to approximately $9.6 million, according to the SEC filing.

Cardionomic has not yet stated how it plans to spend funds raised in the round.

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Body Vision Medical wins FDA nod for LungVision lung nav cath

Body Vision

Body Vision Medical said today it won FDA clearance for its LungVision lung navigation catheter.

The Israel-based company said its LungVision catheter is designed for use in conjunction with standard bronchoscopes and its LungVision system for guiding endotherapy accessories to small pulmonary modules.

“Body Vision has pioneered a new generation platform for navigation bronchoscopy that applies augmented reality approach to plan, visualize, and accurately track radiolucent bronchial nodules in real time. LungVision navigation tool has clear performance and cost benefits over current navigation tools that are bound to electro-magnetic sensing,” Dr. Krish Bhadra of CHI Memorial Hospital said in a prepared statement.

Body Vision Medical said the clearance will allow it to accelerate commercialization efforts for the LungVision platform as a whole. The LungVision imaging and navigation system was cleared last May, the company said.

“We are thrilled to introduce the LungVision tool to the medical community and patients. This FDA clearance paves the way for the LungVision platform to become the preferred choice in bronchoscopy for any lung cancer center in the U.S. We envision, this affordable LungVision platform will revolutionize the way physicians diagnose and treat peripheral lung lesions,” Body Vision CEO Dorian Averbuch said in a press release.

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Sight Sciences launches pivotal trial of TearCare dry-eye disease treatment

Sigh Sciences

Ophthalmic medical device company Sight Sciences today announced the launch of a new pivotal trial exploring the safety and effectiveness of its TearCare system in patients with dry eye disease.

The Menlo Park, Calif.-based company’s TearCare system is a wearable therapeutic eyelid technology designed to deliver energy over a specified period to liquify meibum, an oily coating on the eye’s surface which prevents tear film evaporation.

The device allows the patient to blink and for the eye to remain comfortably open during the procedure, Sight Sciences said.

“We need additional treatment options for dry eye. I like several aspects of the TearCare System’s iLid device. It is non-invasive and conforms to the patient’s lid anatomy thereby individualizing and optimizing treatment and allows the patient to blink freely throughout the procedure,” Dr. Edward Holland of the Cincinnati Eye Institute said in a prepared statement.

The randomized, controlled, 200-patient Olympia trial aims to explore the safety and effectiveness of the system in treating signs and symptoms of dry eye disease compared to a daily regimen of warm compress therapy and lid massage, the company said.

“I am excited to participate in the Olympia trial and offer a customized, non-invasive treatment option to my patients. Unlike other dry eye technologies, the TearCare System is a smart and wearable solution that automatically regulates and maintains sufficiently elevated therapeutic temperatures for a sufficient period of time to effectively melt meibum. I can further customize the procedure by using the TearCare specialized instrument to manually, fully clear the meibomian glands of melted meibum,” Dr. Paul Karpecki of Lexington, Ky.’s Kentucky Eye Institute said in prepared remarks.

The trial’s primary endpoint is tear breakup time at one month, and several other endpoints are slated to be evaluated to assess changes in dry eye signs and symptoms. Patients will be followed out to six months, after which patients will be re-treated and followed for another six months.

The study follows a pilot study which showed a significant increase in tear breakup time, reduction in corneal and conjunctival staining and improvement in patient symptoms following treatment, Sight Sciences said.

“Over the past several months, we have worked diligently to select investigational sites for successful completion of the trial. I look forward to working directly with the OLYMPIA sites and completing a trial that will provide a long-term impact in the dry eye space,” clinical and regulatory affairs VP Anne-Marie Ripley said in a prepared release.

“The initiation of this study is a significant milestone for Sight Sciences and our cutting-edge TearCare technology. I am truly proud of our team that has worked obsessively in stealth over the past five years to iterate to a final product design we think will set a new bar for dry eye therapy. Our pivotal trial brings us one step closer to our vision of delivering a first-class dry eye treatment experience for both patients and eye care professionals,” prez & CEO Paul Badawi said in a press release.

Last October, Sight Sciences said it closed a $10 million oversubscribed Series C round to support expanding manufacturing and its US commercial team and the launch of its devices into the dry eye and microinvasive surgery markets.

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Inari Medical touts FlowTriever pulmonary embolism study data

Inari Medical

Inari Medical today presented results from a study of its FlowTriever retrieval and aspiration system designed to treat pulmonary embolism, touting the safety and efficacy of the system.

Results were presented by Dr. Thomas Tu of Louisville, Ky.’s Baptist Health at the Scientific Sessions of the Society for Cardiovascular Angiography and Interventions in San Diego, Irvine, Calif.-based Inari Medical said.

“The significant improvement in right heart function shown with the FlowTriever system compares very favorably with outcomes of other techniques used to treat PE. At the same time, the impressive safety profile reflects the advantages of FlowTriever’s purely mechanical approach which avoids the use of thrombolytic drugs and resulting risk of bleeding complications,” Dr. Tu said in a prepared statement.

The study enrolled a total of 106 patients with acute pulmonary embolism at 18 US sites, with the FlowTriever system used to mechanically remove blood clots in the pulmonary arteries.

Results indicated that the mean RV/LV ratio decreased from a baseline of 1.53 to 1.15 at 48 hours post-procedure, Inari said, while also demonstrating “excellent safety” at 30 days with a 3.8% rate of major adverse events and no device related complications. Median ICU stay was a single day with an overall median hospital stay of three days.

“The FlowTriever system represents a breakthrough in treatment options for this large patient population. These results indicate that mechanical thrombectomy with the FlowTriever System will play an increasing role in the management of pulmonary embolism,” co-princpal investigator Dr. Ken Rosenfield of the Massachusetts General Hospital said in a prepared release.

“The results of the Flare study mark an exciting advancement in the treatment of acute pulmonary embolism patients. Until now, there has not been an approach to rapidly restore flow to reverse right heart strain without the use of thrombolytic drugs and their inherent risk of bleeding complications,” co-principal investigator Dr. Victor Tapson of Los Angeles’ Cedars-Sinai Medical Center said in a press release.

Last month, Inari Medical said it closed a $27 million Series C round of financing, with funds slated to support commercialization of its FlowTriever and ClotTriever catheters designed for the treatment of venous thromboembolisms.

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Zimmer Biomet to debut robotics solutions

Zimmer BiometZimmer Biomet (NYSE:ZBH) today revealed plans to unveil its robotics solutions for orthopedic surgeries this week at the annual meeting of the American Assn. of Neurological Surgeons in New Orleans.

The Warsaw, Ind.-based company said it plans to showcase two elements of its Surgery Assisting Technology suite: the WalterLorenz surgical assist arm and the Rosa Brain system it acquired in July 2016. Zimmer Biomet touts the latter as a “GPS for the brain,” helping surgeons navigate and position instruments during neurosurgeries.

“We are excited to make our Surgery Assisting Technology platform available to our customers. SAT is a focused, yet customizable, platform solution applicable to many surgical treatments within inpatient and outpatient settings. We will collaborate with our customers and provide health systems the fully integrated solutions they need to improve care for existing patients, as well as provide new treatment options within the communities we serve,” president Aure Bruneau,  said in prepared remarks. “The WalterLorenz surgical assist arm and the Rosa Brain robot are particularly exciting components of the platform – now available to surgeons. We are committed to developing tangible solutions that will provide comprehensive services from awareness and education to diagnostics, pre-operative planning, surgical procedure efficiency, post-op care and health outcome analysis.”

Zimmer Biomet said it also plans to release 10-year data at AANS on its Mobi-C cervical disc, acquired when it paid $1 billion for LDR in June 2016.

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Judge limits damages to last 4 years in DePuy patent spat

DePuy Synthes

A US District Judge last week capped damages in an orthopedic device patent infringement case against Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes, limiting damages to the last four years.

In the case, plaintiff Acantha accused DePuy of infringing on a patent with its Vector and Zero-P VA product lines.

The patent was issued originally in 2001, and reissued in 2002, according to court documents, after which Acantha began discussions with DePuy about licensing the patents. However, both companies never agreed to a licensing deal.

In 2003, Acantha inked an agreement with Stryker (NYSE:SYK)’s spine division to use the patent in its products, and later met with DePuy for possible licensing in 2006. In one of the meetings, “a DePuy executive noted that DePuy believed the Vector product manufactured by Synthes infringed Acantha’s intellectual property,” which Acantha said it was aware of, according to court documents. In 2011, J&J’s DePuy merged with Synthes.

In 2013, Acantha and Stryker amended the licensing agreement on the patent to make it non-exclusive, with Stryker agreeing to continue marking its products with the patent number. In 2014, Acantha filed against DePuy claiming infringement in the Vector and Zero-P VA products, according to court documents.

DePuy and its associated companies asserted that Acantha was limited to recovering damages from 2014, when they filed the claims, and not earlier, due to a number of reasons including that Stryker did not mark the patented products with appropriate labeling identifying the patent.

US District Judge William Griesbach agreed with the defendants, capping damages to only the last four years, according to court documents.

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Will medtech drive the next Southeastern U.S. industrial revolution?

Paul Snyder, Write2Market

South Carolina Southeastern U.S. medtech

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Once home to a thriving textile industry replete with chemical and mechanical engineers working to improve the soil and machinery converting raw cotton into commercial goods, upstate South Carolina may be on the precipice of its next industrial revolution: medtech.

Born from technology developed at the Albert Einstein College of Medicine, Greenville-based Zylö Therapeutics is utilizing the regional chemical/mechanical engineering expertise and support network to improve drug and nitric oxide delivery through a proprietary sustained delivery system called Nanopods. Formally founded in late 2017, the company secured exclusive, worldwide rights to the technology and is currently working to solve the chemical and manufacturing issues that will enable scale-up and commercialization.

Here’s how Zylö Therapeutics describes the technology: “The delivery system uses patented hydrogel-derived nanoparticles, called Nanopods, to deliver—in a sustained and controlled manner—notoriously hard-to-deliver therapeutic agents through topical administration. With our system, Zylö has harnessed the powerhouse therapeutic, nitric oxide, as well as other therapeutics that have bioavailability challenges.”

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

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Medtronic wins expanded indications for Infuse bone growth protein

Medtronic's InFuse

Medtronic (NYSE:MDT) said today it won expanded approval from the FDA for its Infuse bone growth protein implant, marking the second expansion for the implant over the past two years.

The Infuse implant contains the active ingredient rhBMP-2, a manufactured version of a bone growth protein normally present in the body. The Infuse device is designed for use with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease.

“Different spine patients can have very different surgical needs, so the more options surgeons have to combine a clinically-proven bone grafting technology like Infuse with different procedures and implants, the greater the likelihood of successful outcomes. This latest approval addresses some fairly common degenerative spine surgical correction needs,” Dr. Richard Hynes of Melbourne, Fla.’s B.A.C.K. Center said in a prepared statement.

With the new approval, the Infuse is cleared for use with additional PEEK spinal implants in oblique lateral interbody fusion and anterior lumbar interbody fusion procedures at a single level.

New indications for the Infuse bone graft include in OLIF 51 procedures with the Divergence-L interbody fusion device at a single level from L5 to S1, OLIF 25 procedures with Pivox oblique lateral spine systems at a single level from L2 to L5 and ALIF procedures with Divergence-L interbody fusion devices at a single level from L2 to S1.

“Infuse Bone Graft remains one of the most-extensively studied products in Spine that is commercially available today. The expanded approval with these PEEK devices for OLIF25, OLIF51, and ALIF procedures provide important options for surgeons and their patients,” Medtronic spine division prez Doug King said in a press release.

Earlier this month, Medtronic was dismissed as a defendant from a case claiming the use of the controversial Infuse spinal implant in an “off-label” lumbar procedure caused bone overgrowth and related pain.

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Terumo Aortic launches feasibility study of RelayBranch thoracic stent-graft

Terumo Aortic

Terumo Aortic, which formed earlier this month from a merger between Terumo Corp. (TYO:4543) subsidiary Vascutek and Bolton Medical, said today it launched an early feasibility study of its RelayBranch thoracic stent-graft system.

The Sunrise, Fla.-based company said that the first two patients in the study have been implanted with the device by Dr. Luis Sanchez and Dr. Marc Moon of St. Louis’ Washington University, with the procedures performed at Barnes Jewish Hospital.

“RelayBranch expands the range of endovascular treatment options for a high risk population. We are very pleased to be able to offer an endovascular alternative to our patients,” Dr. Sanchez said in a press release.

In the study, researchers will explore the safety and efficacy of the RelayBranch thoracic stent-graft system in treating patients with thoracic aortic pathologies which require proximal treatment to the origin of the innominate artery, Terumo Aortic said.

The RelayBranch thoracic stent-graft system is designed as an endovascular alternative for patients who require surgical interventions that are difficult to approach through a standard procedure, the company said.

The system consists of a main body graft deployed in the descending aorta and features two anterograde tunnels and a large cannulation window. Branch grafts are deployed within the tunnels for the innominate artery and left common carotid artery, the company said.

“Terumo Aortic is uniquely positioned to collaborate directly with surgeons and address unmet clinical needs. We are excited to provide patients with a less invasive treatment option through this innovative technology,” CTO John Canning said in a prepared statement.

The newly launched trial is the first US clinical trial of a double branch system designed for treating thoracic arch pathologies.

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Orbimed founder Isaly resigns on harassment accusations

OrbiMedOrbiMed founder and managing partner Sam Isaly made it official last week when he relinquished control of the private equity fund in the wake of sexual harassment allegations lodged by several former employees.

Six former employees accused Isaly, a 72-year-old investor long revered in the biotech community for his ability to pick stocks, of routinely demeaning and harassing women with hardcore pornography and sex toys, STAT reported Dec. 5. Isaly has denied the allegations. The sixth accuser contacted the outlet after that story, requesting anonymity for fear of reprisal by the hedge fund.

New York City-based OrbiMed said last December that Isaly would depart “pursuant to years-long succession planning discussions” and did not address the accusations from six women, first reported by STAT. OrbiMed said at the time that a committee of partners of Sven Borho, Carl Gordon and Jonathan Silverstein would take the reins from Isaly.

In a brief April 27 release, the fund again said that Isaly’s departure is the result of “ongoing succession planning” that gives ownership to the five remaining partners – Borho, Gordon, Silverstein, Carter Neild and Geoffrey Hsu.

“Mr. Isaly intends to continue to practice his investment skills as the Chief Investment Officer of the Isaly Family Office, and in other future activities, subject to his obligations to OrbiMed. Mr. Isaly thanks all of his colleagues and friends for their continued support and looks forward to many more years of investing excellence,” Orbimed said.

Yanping Ren, his sixth accuser, was a junior in college when she accepted a part-time internship at OrbiMed. Ren told STAT that Isaly routinely delivered vulgar and demeaning comments to women during her 18-month tenure, including remarks about their bodies. At least once a month, she said, she encountered women crying in the bathroom, “always related to something that happened in the office.”

“It was so normal in the company,” Ren told the site. “It was like a fact of life that everyone had to accept. Sam just did what he could get away with.”

Ren, now 29, told the outlet that she found Isaly’s conduct and its lack of consequences shocking. As her first experience in the world of finance, she assumed it was the norm.

“In college, you kind of hear about how crazy the workplace can be,” Ren said. “So I thought, ‘Oh this is just how it is.’”

Luckily her next job, at Vatera, was the opposite, where her boss was a woman and the culture was one of professionalism and respect, she said.

Although the fund did not respond to questions about Ren’s account, in a statement it said it “takes gender equality seriously and wishes to encourage a supportive work environment and equal opportunity for all employees.”

“When I read that statement, I found it quite funny,” Ren told STAT, “because it’s so far from the truth.”

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Tandem wins CE Mark for t:slim X2 insulin pump

Tandem DiabetesTandem Diabetes Care (NSDQ:TNDM) said today that its t:slim X2 insulin pump won CE Mark clearance in the European Union.

The San Diego, Calif.-based company plans to start selling the device in international markets in the second half of 2018. Tandem’s latest drug-pump won FDA approval in August last year.

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

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LivaNova closes $190 CRM sale to MicroPort

LivaNova, MicroPort ScientificLivaNova (NSDQ:LIVN) said today that it closed the $190 million sale of its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853).

The companies are already partners in a CRM join venture in the People’s Republic. LivaNova, formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015, said in September that it was putting the CRM business on the auction block. The business pulled in sales of $249 million last year.

After announcing its plans for the divestiture last November, LivaNova said the details of the sale were finalized last month.

“With the completion of the CRM sale to MicroPort, LivaNova’s portfolio is now concentrated on our areas of strength and leadership: cardiac surgery and neuromodulation,” CEO Damien McDonald said today in prepared remarks. “This transaction enables us to concentrate our efforts on developing market-leading businesses in these areas, and will assist us in enhancing LivaNova’s position as an innovative medical device company that improves the lives of patients around the world and creates value for our shareholders.”

LivaNova has said it expects the sale to cut  5% to 10% from its adjusted earnings per share and 20% from the top line this year, after it begins reporting the CRM numbers as a discontinued operation. MicroPort, which just last week acquired Lombard Medical Technologies (NSDQ:EVAR) out of bankruptcy, has said the LivaNova CRM acquisition isn’t expected to affect its books this year.

LivaNova has been on a mini-spree of late, acquiring ImThera for $225 million in January and just this month spending another $250 million on TandemLife.

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Aerie launches glaucoma drug in U.S.

Aerie PharmaceuticalsAerie Pharmaceuticals (NSDQ:AERI) today launched its once-daily eye-drop product, Rhopressa, which is designed to reduce intraocular pressure in patients with glaucoma or ocular hypertension.

The Durham, N.C.-based company won FDA approval for Rhopressa in December last year, two months before the agency was expected to make a decision.

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

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Boston Scientific closes $400m NxThera buy

Boston Scientific acquires NxTheraBoston Scientific (NYSE:BSX) said today that closed the $406 million acquisition of NxThera and its Rezūm benign prostatic hyperplasia device, which uses steam to ablate excess prostate tissue.

The deal called for $306 million in up-front cash from Marlborough, Mass.-based Boston Scientific, with another $100 million in potential milestones over the next four years. Boston, which in December 2015 led a $40 million funding round for NxThera, said the existing investment means it will have to put $240 million down and another $85 million on the table in milestones. NxThera is based in Maple Grove, Minn. When Boston Scientific paid $1.6 billion to Endo (NSDQ:ENDP) for the urology portfolio Endo had acquired from American Medical Systems, it also inherited an earlier investment in NxThera by AMS.

“We are confident in the potential for this system to help patients with BPH and increase the number of men choosing MITs, because it offers long-term relief from symptoms without the side effects of medications,” medsurg president Dave Pierce said in prepared remarks. “The minimally invasive therapy segment is the fastest growing category in the treatment of BPH and, as an office-based procedure, the Rezūm system is appealing to patients, clinicians and payers.”

The deal involves plans to spin-out a new company to commercialize technology for treating cancer, NxThera CEO Bob Paulson told MassDevice.com when the deal was announced in March.

“As part of this transaction, we are taking the urology cancer applications – prostate cancer, bladder cancer and kidney cancer – that can also utilize our technology. Those are being spun off into a separate, new company that will be owned by the existing investors, including Boston,” Paulson told us. “This will be funded separately and will move forward as a stand-alone entity. This is another chance for our investors down the road to demonstrate the applicability and efficacy of the technology to treat new applications and to be able to determine at that time what the right commercial strategy is and what value that may be to strategic investors.”

In January, NxThera touted three-year results from a 197-patient trial that showed clinically significant and durable improvement in symptomatic relief, with no latent adverse events, no de novo erectile disfunction and a 4.4% re-treatment rate. Rezūm won CE mark approval in the European Union in 2013 and landed 510(k) clearance from the FDA two years later.

Paulson said that the company is hopeful it will continue with further studies of its Rezum technology platform, seeking to further validate the system and explore other possible indications.

“We will continue to gather that data moving forward. There are several additional studies that were in the works, in the pipeline in terms of expanding indications and further demonstrating both the efficacy and durability of the data. The presumption is that those will move forward under Boston’s tutelage,” he told us.

Boston said it expects the buyout, forecast to close during the second quarter, to be immaterial to adjusted earnings per share until the end of 2020.

“The deal is a great combination for patients and urologists because with Boston’s resources and the fact that the global leader in urology, this gives them access to a first line treatment option for BPH which is the largest untapped market in urology and will allow them to offer their patients an entire continuum of care treatment options from a first line treatment all the way down to a surgical treatment,” Paulson told us. “So, this is a really huge win for physicians and patient choice for treating BPH.”

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United Therapeutics puts $216m on the table to buy rival SteadyMed

United TherapeuticsUnited Therapeutics (NSDQ:UTHR) today signed a deal to acquire competitor SteadyMed (NSDQ:STDY) for $4.46 per share in cash at closing and $2.63 per share in cash if the combined company can win approval for SteadyMed’s Trevyent drug-device combination therapy.

The merger, valued at $216 million, combines two companies that were in court as recently as last November, fighting over patents covering treprostinil, the active ingredient in both companies’ lead products.

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

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divendres, 27 d’abril del 2018

7 medtech stories we missed this week: April 27, 2018

missedmedtech-1103

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From DuPuy Synthes spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. DePuy Synthes launches spinal implants

DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed to be used with patients who have degenerative disc disease in their neck and back. The Proti 360º is designed to maximize the potential for bone growth while offering the benefits of PEEK and titanium. Titanium creates a bioactive surface that promotes attachment and bone-forming cell growth.

2. PavMed to commercialize EsoCheck Barrett’s Esopagus biomarker test

PavMed has signed a letter of intent with Case Western Reserve University to commercialize its EsoCheck technology, according to an April 24 press release. EsoCheck is a non-invasive, cell-sampling device that features highly accurate DNA biomarkers that detect Barrett’s Esophagus. The device is offered as an office-based test that takes five minutes to complete. A patient swallows a vitamin pill-sized capsule that has a small inflatable balloon attached to a thin catheter. The balloon swabs the target area for cells as the catheter is removed. Then the sample can be tested for DNA biomarkers.

3. Cerus wins Health Canada nod for Intercept blood system

Cerus announced in an April 25 press release that it has won Health Canada approval to commercialize its Intercept Blood System for platelets. The system is designed for ex vivo treatment and storage of platelet components. It is used to inactivate a broad range of pathogens like viruses, bacteria and protozoan parasites to reduce the risk of transfusion-transmitted infections.

4. ReShape Lifesciences enters Bahrain

ReShape Lifesciences has received registration from the National Health Regulation Authority in Bahrain to market and distribute its ReShape Balloon, according to an April 24 press release. Yousuf Mahmood Husain, one of Bahrain’s largest healthcare companies, will be the distributor of the ReShape Balloon. The device involves a non-surgical weight loss procedure that uses balloon technology that takes up room in the stomach to help obese patients lose weight.

5. Sanquin, Abbott ink multi-year blood tech deal

Sanquin and Abbott announced in an April 23 press release that they have signed a multi-year contract for the supply of primary serological equipment and consumables like Abbott’s Alinity system for blood and plasma screening. The companies already have a relationship of more than 10 years.

6. Apollo Endosurgery wins regulatory nod in Saudi Arabia

Apollo Endosurgery has gained approval from the Saudi Food and Drug Authority in Saudi Arabia for its Orbera365 managed weight loss system, according to an April 23 press release. The SFDA also issued a Medical Device Marketing Authorization for the device which allows the company to market in Saudi Arabia with its distribution partner Al-Nozha Medical. Orbera365 doubles the indwell period of the intragastric balloon from 6 months to a 12 month treatment period. The extra six months allows for more time for better patient outcomes.

7. FDA clears Lumendi’s Dilumen C2

Lumendi announced in an April 23 press release that it has received FDA 510(k) clearance for its DiLumen C2 endoscopic accessory. The device is designed to ensure complete positioning of an endoscope in the large intestine while also assisting with optical visualization, diagnosis and endoscopic treatment. It uses two balloons to create a stabilizing therapeutic zone inside the colon during endolumenal interventions and uses two 6mm diameter tool channels to make room for two independent flexible articulating hand instruments.

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Flexion touts interim data from Ph3 trial of osteoarthritis injection

Flexion TherapeuticsFlexion Therapeutics (NSDQ:FLXN) this week touted updated, interim results from an ongoing Phase IIIb study evaluating the safety and tolerability of repeat administration of its osteoarthritis injection, Zilretta.

The company’s injectable suspension is an extended-release formulation of triamcinolone acetonide designed for patients with osteoarthritis of the knee. Top-line results from Flexion’s trial showed that 95% of the study’s 205 patients experienced clinical benefit 12 weeks after their first injection of Zilretta. 179 patients received a second dose of the drug between weeks 12 and 24, the company said.

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

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The 10 hottest medtech startups of 2018

medtech startups medical device innovation

[Image from Unsplash.]

There’s a complaint sometimes that innovation is too incremental in the medical device industry. But don’t tell that to the people running the 10 companies included in Medical Design & Outsourcing and MassDevice’s list of the hottest medtech startups of 2018.

Our editors came up with a list of 20 interesting young companies. We then surveyed our readers and then whittled the list down to 10.  Along the way, we got to see that there are truly game-changing innovations out there — advances that could not only change the treatment of particular diseases but also enable healthcare systems to run more effectively and efficiently.

From neuromodulation to treat urinary and bowel dysfunction disorders and type 2 diabetes to new surgical robotics and drug delivery technology, here are 10 of the most exciting medtech startups of 2018.

Next >>

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Vyaire Medical acquires Acutronic, inks deal to acquire IMTmedical

Vyaire Medical, Acutronic, IMTmedical

Vyaire Medical said yesterday it acquired neonatal ventilation equipment developer Acutronic for an undisclosed amount, and said it inked a deal to acquire mechanical ventilation dev IMTmedical.

Both of the new acquisitions are based in Europe, with Acutronic split between Switzerland and Germany and IMTmedical based solely in Switzerland, Chicago-based Vyaire Medical said.

“The transactions we are announcing today, along with our own internal development efforts, underscore our commitment to positioning Vyaire Medical as a global respiratory care leader. Our acquisition of Acutronic and IMTmedical immediately enhance our product portfolio, expand intellectual capital and broaden our technological capabilities; all of which will accelerate Vyaire Medical’s growth. We could not be more excited about taking these amazing products, in combination with our own, to market to advance our mission of improving patient outcomes and providing increased value to our customers,” Vyaire Medical prez & CEO Dave Mowry said in a prepared statement.

Acutronic designs and manufactures neonatal ventilation equipment, Vyaire said, and is known for its ventilation products for both neonatal and pediatric intensive care units.

IMTmedical develops and manufactures ventilation equipment for acute care centers, long-term care facilities, home healthcare and emergency service and transport uses, Vyaire said.

The IMTmedical acquisition is expected to close during the second quarter, Vyaire added. Both acquisitions are expected to be complimentary to Vyaire’s existing portfolio, the company said.

“These new acquisitions are exciting steps forward for Vyaire Medical and build on the strong progress made by the company’s management over the past year and a half. We join Dave Mowry in welcoming both the Acutronic and imtmedical teams to the Vyaire family and are excited about our joint future. We look forward to our ongoing work with Vyaire Medical as it continues to grow as the leader in respiratory care,” Apax Partners partners Steven Dyson and Arthur Brothag said in a prepared statement.

Last month, Becton Dickinson (NYSE:BDX) inked a deal to divest itself of its minority stake in Vyaire, which was previously a respiratory solutions joint venture, to joint manager Apax Partners in a deal worth $435 million.

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Post-approval registry shows positive 1-year results for Abbott’s MitraClip

Abbott's MitraclipA post-approval registry study of the MitraClip mitral valve repair device from Abbott (NYSE:ABT) showed positive results at one year, according to late-breaking results presented this week at the annual meeting of the Society for Cardiovascular Angiography & Interventions in San Diego.

The real-world study, of the first 2,000 MitraClip patients treated in the Transcatheter Valve Therapy Registry, showed that 86.8% of patients had post-procedural mitral regurgitation of ≥2+ and a survival rate of 81.7% after a year. Echocardiograms showed improvement in left ventricular end-diastolic volume and left ventricular internal diameter end diastole and end systole, with 8.5ml and 0.2 cm mean reduction, respectively.

“This is a rigorous, real-world study that includes more data than we’ve seen before. For the first time, we evaluated results of an echocardiogram and walk test, and assessed the patient’s quality of life to further evaluate the effectiveness of MitraClip therapy,” lead author Dr. James Hermiller, of the Heart Center of Indiana in Indianapolis, said in prepared remarks. “The outcomes were extremely encouraging and reinforce the safety and efficacy of this treatment option in real world practice. We think it has the potential to be a new standard of care for select patients with mitral valve regurgitation.”

MitraClip won pre-market approval from the FDA in October 2013.

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Stryker Q1 beats The Street

Stryker

Shares in Stryker (NYSE:SYK) have fallen slightly today after the medical device maker posted first quarter earnings that topped Wall Street expectations but saw sales shrink slightly.

The Kalamazoo, Mich.-based company posted profits of $443 million, or $1.16 per share on sales of $3.2 billion for the three months ended March 31, seeing the bottom-line shrink 0.2% while sales grew 9.7% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share were $1.70, just ahead of the $1.60 per share consensus on Wall Street, where analysts expected too see sales of $3.2 billion, which the company met.

“We had an excellent start to 2018 with strong organic sales growth, operating margin and adjusted EPS in the first quarter. Our balanced results across businesses and regions position us well for continued positive momentum, as evidenced by our raised guidance,” chair & CEO Kevin Lobo said in a prepared statement.

Stryker released updated guidance for the rest of the year, expecting to see organic net sales growth of between 6.5% and 7% with adjusted EPS of between $7.18 and $7.25.

The company also released guidance for its upcoming second quarter, expecting to see EPS of between $1.70 and $1.75.

Shares in Stryker have fallen approximately 0.1% today, at $167.99 as of 10:57 a.m. EDT.

Last month, Stryker closed a $600 million debt offering it planned to use to buy back some of its other debt.

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Sanofi misses estimates in Q1, announces $1.5B share buyback

SanofiSanofi (NYSE:SNY) shares fell -3% today after the company posted its first-quarter results, missing estimates on Wall Street and revealing plans for a $1.5 billion share buyback program.

The Paris, France-based company saw sales decline -8.7% in the first three months of the fiscal year compared to 2017, landing at $9.55 billion for the quarter. Analysts on The Street were expecting sales of $9.67 billion.

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

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Eudamed completes actors module testing

Emergo GroupBy Ronald Boumans, Emergo Group

On April 12, 2018, 20 representatives of stakeholders from industry and European Competent Authorities (CAs) had the opportunity to test the first Eudamed module. This module will be used for entering actor data.

Get the full story here at the Emergo Group’s blog.

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, 26 d’abril del 2018

Report: J&J’s Cerenovus to discontinue Codman liver cancer pump

Johnson & Johnson

Johnson & Johnson‘s (NYSE:JNJ) Cerenovus is discontinuing production of Codman pumps designed to deliver targeted chemotherapy to the liver for patients with liver cancer, according to a New York Times report.

The devices are designed to be implanted in the abdomen to deliver chemotherapy directly to the liver to treat cancer that has spread to the area, generally from the colon or rectal tumors, according to the report.

Read the whole story on our sister site, Drug Delivery Business

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Report: Johnson & Johnson wins appeal in $151m hip verdict

Johnson & Johnson

Johnson & Johnson (NYSE:JNJ) yesterday won an appeal in a ruling that had previously awarded $151 million to five individuals who claimed they had injuries due to company’s Pinnacle metal-on-metal hip implant, according to a new Reuters report.

The ruling came down from the 5th US Circuit Court of Appeals, which said that the defective marketing claims of two plaintiffs in the case were legally insufficient and called for a new trial, according to the report.

The judgement was based on a previous judge’s evidentiary rulings and “deceptions” from the plaintiff’s lawyers, Reuters reports. US Circuit Judge Jerry Smith wrote for the three-judge appellate panel saying that US District Judge Ed Kinkeade had also erred by allowing the lawyers to present “inflammatory character evidence” about Johnson & Johnson.

The most problematic evidence identified by Smith were claims that J&J paid bribes to “henchmen” of Saddam Hussein in Iraq, which emerged from a 2011 $70 million agreement from J&J to resolve US foreign bribery probes, according to the report.

The judge went on to claim that two plaintiffs in the case had presented no evidence that their treating doctors had encountered supposedly inadequate warnings about the Pinnacle implants.

The plaintiff’s lead lawyer, Mark Lanier, rebutted the claims saying that the court “misunderstood” the issues and that they would seek a retrial as quickly as possible, according to Reuters.

J&J DePuy unit lawyer John Beisner commented that the ruling correctly identified errors in the trial that made it “impossible for defendants to get a fair trial.”

In March, An Indiana jury hit Johnson & Johnson subsidiary Ethicon with a $35 million verdict in a product liability lawsuit brought over its Prolift pelvic mesh.

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Medineering touts first uses of Robotic Endoscopy system

medineering

German robotic surgical start-up Medineering said today its Medineering Robotic Endoscopy system was used in its first clinical procedures after having won CE Mark approval in the European Union last year.

The company said that the robotic endoscopic system has been used in several clinical settings in university hospitals across Germany and Italy. The Robotic Endoscopy system is designed to support surgeons during minimally invasive ear, nose and throat surgery by moving and holding the endoscope.

“The robotic solution is a great benefit for doing complex surgery in anatomical regions, where a clear and stable image without tremor is needed. With its precise movements, the robot delivers exactly the endoscope image I need to see and I still have two hands available for instrumentation,” Dr. Francesco Doglietto of Italy’s University Hospital Brescia, who used the Medineering system during a transnasal skull base surgery, said in a prepared release.

“The Medineering solution has the potential to expand the applications of existing surgical endoscopic techniques,” Dr. Stefan Mattheis of the University Hospital Essen, who has used the endoscopic platform from Medineering, said in a prepared statement.

The Robotic Endoscope system is part of the company’s Medineering Platform for hybrid robotic surgery, and is attached to a positioning arm with a foot pedal as a control device, Medineering said.

“We deeply appreciate the passion and enthusiasm of our clinical partners and we are looking forward to pushing surgical robotics forward together,” Medineering CTO Dr. Maximilian Krinninger said in a press release.

Last October, Medineering said it won CE Mark approval in the European Union for its robotic positioning arm, which was cleared for holding and positioning passive adapters and robots in otolaryngology, neurosurgery and spinal surgery procedures.

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Restech acquires Mederi Medical

Restech, Mederi Therapeutics

Medtech developer Respiratory Technology Corp said today it acquired Mederi Therapeutics, and its Stretta catheter and Secca system, for an undisclosed amount.

Houston-based Restech said that the addition of the Stretta catheter, designed to treat gastroesophageal reflux disease, and the Secca system, designed to treat bowel incontinence, are complimentary to its existing diagnostic devices.

Mederi’s Stretta catheter system is designed to apply low-power radio frequency energy to remodel the lower esophageal sphincter to restore natural barrier function and reduce spontaneous regurgitation caused by transient relaxations of the sphincter.

The Secca device uses a low-power radiofrequency generator to remodel the muscle of the internal anal sphincter to treat bowel incontinence, the company said.

The Stretta and Secca devices will continue to be sold through Mederi RF, which will serve as a wholly-owned subsidiary of Restech. Restech has not yet announced which staff will join Restech’s management team with the acquisition.

“This acquisition provides a unique opportunity to expand our reach across the clinical spectrum. With the addition of Mederi’s technology and market penetration, and Restech’s established space in the reflux market, these complementary products will address gaps in the clinical continuum,” CEO Debra Krahel said in a prepared sattement.

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InVivo Therapeutics registers $8m offering

InVivo Therapeutics

InVivo Therapeutics (NSDQ:NVIV) today registered for an upcoming offering, looking to raise approximately $8 million, according to an SEC filing.

In the offering, the Cambridge, Mass.-based company will look to offer shares of common stock and Series A warrants.

The offering is slated to include a 45-day underwriter’s option for the purchase of additional shares, according to an SEC filing

InVivo Therapeutics has not yet stated how many shares it plans to offering the round, or at what rate it will be offering shares and warrants.

Earlier this month, InVivo pulled the trigger on a 1-for-25 reverse split of its stock, looking to put a single share in the hands of its shareholders for every 25 shares they previously owned.

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Align Tech shares rise on Street-beating Q1, iTero CFDA win, product launches

Align Technology

Shares in Align Technology (NSDQ:ALGN) rose today after the dental-focused device maker posted Street-beating Q1 earnings alongside a number of other updates, including a clearance from China’s FDA, an update on a legal spat with SmileDirectClub and multiple product launches.

The San Jose, Calif.-based company posted profits of $95.9 million, or $1.17 per share, on sales of $436.9 million for the three months ended March 31, for bottom-line growth of 38.1% while sales grew 40.8% compared with the same period last year.

Align Technology’s earnings per share were ahead of the 98¢ consensus on Wall Street, where analysts expected too see sales of $408.3 million, which the company handily topped.

“I’m pleased to report better than expected first quarter results and a strong start to the year for Align, with revenues, volumes and EPS above our guidance. Record Q1 revenues were up 41% year-over-year reflecting continued strong Invisalign volume across all geographies and customer channels, as well as iTero scanner sales which were up 84% year-over-year. Q1 Invisalign volume growth of 31% year-over-year was driven by increased utilization including strong teen case growth globally, and expansion of our customer base, which included over 4,200 new Invisalign-trained doctors worldwide,” prez & CEO Joe Hogan said in a prepared statement.

Align Tech provided updated guidance for its next quarter, expecting to see sales of between $460 million and $470 million, with EPS of between $1.02 and $1.06.

In a separate release, Align said it won Chinese FDA approval for its iTero Element intraoral scanner.

“The market opportunity in China is huge and it remains the single largest country market for Align outside of the United States. The Chinese intraoral scanner market is less than two percent penetrated today and is expected to grow 6X by 2020. Not only does the iTero Element scanner launch support the growth of our base Invisalign clear aligner business, but it also represents a major milestone for digital dentistry in China. We’re glad to take a leadership role bringing the latest and most advanced intraoral scanning technologies to the region,” Align Asia Pacific managing director Julie Tay said in a press release.

The company updated on a legal spat in which SmileDirectClub alleged that Align Tech’s opening of pilot Invisalign stores breached non-compete provisions in late February.

Align said that this month, SDC and its associated entities now seek to preliminarily and permanently enjoin activities related to the pilot store project, including requiring Align to close all existing stores and prohibit any new stores from opening.

SDC also wishes to be allowed to repurchase all of Align’s SDC Financial membership interests for a purchase price equal to Align’s current capital account balance, the company said in a press release. Align Technology said it is disputing the alligations, and will oppose and vigorously defend itself in the case.

In two other updates, the company announced the launch of a new Invisalign Go product and two new iTero scanners, the iTero Element and iTero Element 2 systems.

“Invisalign Go’s new visualization feature of multiple treatment plans is absolutely invaluable from a clinician’s point of view because it helps to explain different treatment options and choose the treatment plan that best meets the patient’s preferences. It’s a great way to communicate with a patient and it brings so much excitement. It’s one of the best new advances with the product,” Dr. Affan Saghir of Yorkshire, England, who provides Invisalign Go products said in a press release.

“We’re excited to expand the iTero portfolio with two new advanced digital scanners that expand customers’ choices and provide them with the imaging precision, intuitive chairside visualization and patient communication tools that enable efficient workflows for a full range of case assessment and restorative and orthodontic treatment. With iTero Element 2 and iTero Element Flex, we are building on a trusted platform with enhanced features and processing performance, new mobility options and greater portability designed to fit the needs of our customers’ practices and simplify their lives. Doctors can now choose the iTero Element scanner that is best for them with confidence knowing that each solution is going to deliver the precision, power, speed, and full-color imaging they’ve come to expect for their iTero-powered workflows,” Align Tech chief marketing, portfolio and biz dev officer Raphael Pascaud said in a prepared statement.

Shares in Align Technology have risen 2.7% so far today, at $252.15 as of 10:18 a.m. EDT.

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