Lombard Medical CEO Hubbert, CFO Kullback step down | Personnel Moves, April 28, 2017

Lombard Medical Technologies (NSDQ:EVAR) said this month that its CEO Simon Hubbert and CFO William Kullback are stepping down from their positions, with Kurt Lemvigh stepping into the CEO role.

Hubbert served as CEO for 6 years after joining the company in 2010, and will be replaced by Lemvigh, who has held positions with multiple companies, including Cardiac Science and GE (NYSE:GE).

“Lombard represents a unique opportunity given the strength of the company’s portfolio in the over $1.5 billion market for endovascular repair products. The key to success will be our ability to leverage the work that has been done over the years and moreover, to achieve operational excellence. For my part, I am committed to creating value for all of the stakeholders of Lombard,” Lemvigh said in a prepared statement.

“Simon made many significant contributions during his six years as CEO of Lombard including expanding the company’s product portfolio and geographic reach. On behalf of the board and shareholders, we thank Simon for his contributions and diligent efforts during a time of significant change in the endovascular aneurysm repair market. We wish him well in his future endeavors,” board chair Raymond Cohen said in a press release.

Kullback’s resignation was part of the company’s discontinuation of commercial operations in the US, the company said, and not the result of any disagreements with the company. Kullback will be moving on to “pursue a new opportunity at a San Diego, Calif.-based company,” according to an SEC filing.

 BD taps Polen as prez

Becton Dickinson & Co. (NYSE:BDX) said this week it tapped current exec vice chair and medical segment prez Tom Polen as its new company president.

With the shift, Polen will oversee all of BD’s operating segments, including medical, life sciences and the new interventional segment formed when it agreed to pick up Bard in a $24 billion deal.

“Tom brings a deep understanding of BD, the medical technology industry and the global healthcare environment. His well-deserved promotion reflects his leadership in developing and implementing BD Medical’s strategy and vision, his proven track record of delivering strong performance, and his commitment to ensuring the ongoing success of BD and its associates.  I look forward to continuing to work closely with the Board, Tom, our entire leadership team, and our associates to successfully integrate and grow the combined company in the years ahead, as we deliver on our purpose of advancing the world of health,” CEO & chair Vince Forlenza said in a press release.

“This is an exciting time for BD.  I am honored to serve in this new role as we continue our transformation into a medical technology leader focused on delivering solutions that advance the discovery, diagnostics and delivery of health care globally and helping health care providers worldwide to improve both the process of care and the treatment of disease,” Polen said in a prepared statement.

Read more

 USGI Medical appoints ex-ConMed’s Babini as prez, CEO

USGI Medical said last week it appointed ex-ConMed (NSDQ:CNMD) exec Carlos Babini as its new president and CEO.

Prior to his position as head of USGI, Babini served as VP of AirSeal system commercialization at ConMed, chief commercialization officer at Surgiquest and various other executive positions in medtech.

“I am delighted to join USGI Medical at this critical time as the company continues to establish the Pose procedure as a credible option for clinicians who have patients seeking clinical assistance to achieve weight loss. This procedure has the potential to help millions of obese patients globally who have not been able to keep weight off through diet and exercise alone, and who may not be candidates for, nor able to undertake the possible risks associated with invasive bariatric surgery,” Babini said in a prepared statement.

“I have had the pleasure of working with Mr. Babini during this initial period and in a very short time, already experienced positive momentum and engagement with the entire USGI team,” former CEO & current exec chair Scott Moonly said in a press release.

Read more

 Fresenius looks to snag Empey as new CFO

Fresenius (NYSE:FMS) has tapped Telefonica Deutschland finance chief Rachel Empty as its new chief financial officer, according to German business monthly Manager Magazin.

Fresenius CEO Sturm, who was promoted to CFO last June, said earlier this week that the company had found someone for its CFO position, but did not clarify when their current employer would let them go.

Negotiations for the move are in their final stage, the magazine said. A spokesperson for Fresenius would not comment on the report.

Read more

 Boston Scientific GC Pratt to step down

Boston Scientific (NYSE:BSX) said last week that exec VP, chief administrative officer, general counsel and secretary Timothy Pratt will retire from the company at the end of the year.

Pratt jointed Boston Scientific in May 2008 as an exec VP, GC and secretary. Over the next several months, Pratt said he intends to lead the effort to find a successor and aid in a transition to the new GC.

Read more

• Magnolia Medical taps Gerberich as CCO
• Accuracy appoints Hadjadjeba as senior VP, CCO
• ReWalk Robotics names Gricci as CCO
• Toshiba Medical picks Skyba as ultrasound biz director
• Senseonics taps Gill as sales VP

The post Lombard Medical CEO Hubbert, CFO Kullback step down | Personnel Moves, April 28, 2017 appeared first on MassDevice.

from MassDevice http://ift.tt/2peqzW7

Mentor launches breast implant warranty program

Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide said today it launched the MentorPromise Protection Plan, a new comprehensive warranty program for all Mentor breast implants sold in the US.

The San Diego, Calif.-based company said that all Mentor breast implant recipients will be automatically enrolled in the plan, with an enhanced version of the plan available for an extra fee.

“When you have a warranty program as strong as the MentorPromise Protection Plan, it makes choosing Mentor products an easy decision. Mentor’s confidence in their products reassures me that I am working with quality products, and that is exactly what my patients want,” Dr. Aldo Guerra of the American College of Surgeons said in a prepared statement.

The warranty program will supply protection beyond the company’s current plan, and will offer financial assistance for a broad range of needs, including a lifetime guarantee for product replacement and 10-year financial assistance coverage.

“We understand the importance of developing products that not only make our patients feel confident, but also give them and their surgeons the extra peace of mind that comes with choosing Mentor products. This warranty program reinforces the confidence we have in the quality of our products and our commitment to our customers and their patients,” Mentor US sales and marketing VP Warren Foust said in a press release.

Yesterday, J&J’s Mentor said it won FDA approval for its MemoryGel Xtra silicone gel-filled breast implants.

With the approval, Mentor said it also launched an Artoura breast tissue expander designed to work with the newly cleared MemoryGel Xtra implants. The Artoura breast tissue expander features a smooth shell to provide controlled expansion for reconstructive surgeries.

The post Mentor launches breast implant warranty program appeared first on MassDevice.

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

Accuracy shares dip on Q3 miss

Shares in Accuray (NSDQ:ARAY)  dropped slightly today after the medical device maker missed expectations on Wall Street with its fiscal 3rd quarter results.

The Sunnyvale, Calif.-based company posted losses of $5 million, or 6¢ per share, on sales of $97.3 million for the 3 months ended March 31, seeing the bottom-line swing into losses from reported profits of $756,000 while sales shrunk 7.6% compared with the same period last year.

Accuray posted losses per share that just missed Wall Street consensus of 0¢.  Revenue also fell short of expectations of $110.2 million.

“Our 49% year-over-year gross order growth during the third quarter was led by increased demand for our CyberKnife System especially from existing customers. In addition, gross orders were favorably impacted by solid demand for our new Radixact System, which is now in full commercial launch. The 3rd quarter gross orders have resulted in 9-month order results that are above expectations. We are seeing several indicators that lead us to believe our strong order growth will continue through the end of fiscal 2017 and into fiscal 2018,” prez & CEO Joshua Levine said in a press release.

The company updated its guidance for the rest of its fiscal year, dropping its sales expectations to between $380 and $390 million from earlier guidance of between $410 and $420 million. Guidance for EBITDA was also lowered to between $22 and $26 million from between $32 and $38 million.

Shares in Accuray dropped 1.1% today, closing at $4.55.

The post Accuracy shares dip on Q3 miss appeared first on MassDevice.

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

Carl Zeiss joins ASML in patent countersuit against Nikon over lithography tech

European semiconductor manufacturer ASML and its strategic partner Carl Zeiss (ETR:AFX) today filed a patent infringement countersuit against Nikon (TYO:7731) in response to legal action taken by Nikon against the companies.

The suits involve semiconductor manufacturing equipment, flat panel display manufacturing equipment and digital cameras.

On Monday, Nikon filed its own patent case against ASML and Zeiss accusing them of using its lithography technology without permission. ASML denies any infringement and said there was no choice but to file countersuits.

“Now that Nikon has decided to take this dispute to court, we also have to enforce our patent portfolio, and we will do this as broadly as possible,” ASML CEO Peter Wennink said in a statement, adding that it has tried for years to come to a cross-licensing agreement with Nikon.

Nikon has not yet commented on the legal actions.

Material from Reuters was used in this report.

The post Carl Zeiss joins ASML in patent countersuit against Nikon over lithography tech appeared first on MassDevice.

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

Wireless power source could enable ingestible drug delivery devices

Image: MIT News. Battery image courtesy of Ella Maru Studio / Giovanni Traverso / Abubakar Abid

Researchers from the Massachusetts Institute of Technology, Brigham and Women’s Hospital and the Charles Stark Draper Laboratory have developed the means to wirelessly power electronic devices that stay in the digestive tract indefinitely. The team suggests that these devices could be used as sensors in the GI tract or carry drugs to be delivered over a controlled period of time.

An efficient power source is a crucial part of developing ingestible electronic devices and that has previously stumped researchers.

“If we’re proposing to have systems reside in the body for a long time, power becomes crucial,” co-senior author Giovanni Traverso said in prepared remarks. “Having the ability to transmit power wirelessly opens up new possibilities as we start to approach this problem.”

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

The post Wireless power source could enable ingestible drug delivery devices appeared first on MassDevice.

from MassDevice http://ift.tt/2pH1wfA

7 medtech stories we missed this week: April 28, 2017

[Image from unsplash.com]

From FDA and Health Canada approvals to joint ventures, here are 7 medtech stories we missed this week but thought were still worth mentioning.

1. FDA clears Joimax Endovapor 2

Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device generates electricity for monopoly and bipolar cutting and coagulation of tissue structures in surgery. It has programs designed for spinal cord surgery with an interdisciplinary application. It also has 2 monopolar and 2 bipolar sockets with an easy touchpad technology.

2. Health Canada approves Eclipse MicroPen Elite

Eclipse Aesthetics announced that it has received clearance from Health Canada for the Eclipse MicroPen Elite advanced micro-needling device, according to an April 26 press release. The MicroPen Elite is an advanced medical-grade, automated, cordless, high-speed micro-needling device that is designed to improve the appearance of wrinkles, stretch marks, acne scars, skin tone and texture. It can be used on the face, neck, décolleté, arms, hands and more. The MicroPen Elite is a safe alternative to common skin resurfacing tools like lasers and dermal rollers.

3. Theraclion inks Chinese joint venture

Theraclion announced in an April 24 press release that it has signed a joint venture agreement with Inner Mongolia Furui Medical Science Co. Theraclion will own 56% of Theraclion China Co. and 44% of Inner Mongolia Furui Medical Science Co. The joint venture company will be based in Shenzhen, China and will develop the Chinese market for Theraclion’s Echopulse.

4. Mederi Therapeutics wins SAGE CSR support for GERD treatment

The Society of American Gastrointestinal and EndoScopic Surgeons (SAGES) recently issues a Clinical Spotlight Review (CSR) Guideline statement on Stretta Therapy for GERD for Mederi Therapeutics, according to an April 24 press release. The CSR recommendation suggests that Stretta significantly improves health-related quality of life score, heartburn scores, and incidence of esophagitis and esophageal acid exposure in GERD patients.

5. Millennium Medical Technologies wins FDA nod for Lipo-Loop

Millennium Medical announced in an April 24 press release that it has become the first in the nation to receive FDA clearance for a reusable fat collection and transfer system that is used in plastic or reconstructive surgery and regenerative aesthetics. Additionally, the clearance covers the use of components used with the company’s liposuction and body shaping technology. The suction canisters in the Lipo-Loop system are molded from medical-grade materials and come in sizes of 250, 500, 1,000, 2,000 and 3,000 ml. They are also packaged non-sterile but are autoclavable. Collection jars have a stainless steel Luer fitting at its base to facilitate the transfer of untreated fat back into the patient by a cleared injection apparatus.

6. Anaconda Biomed taps Creganna Medical for device dev

Anaconda BioMed announced that it has chosen Creganna Medical to develop, test and manufacture its ANCD BRAIN device, according to an April 24 press release. The product is currently aiming to go through regulatory and clinical phases. Creganna Medical will support Anaconda Biomedical in the final stages of its product development from manufacturing to obtaining CE approval in Europe.

7. SiBone logs U.K. guidelines win

SiBone announced in an April 7 press release that the U.K.’s National Institute for Health and Care Excellence has published its Interventional Procedure Guidance document for minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain. MIS SI joint fusion should be available to patients who are diagnosed in the U.K. National Health System, according to the guidance. It also suggested that the safety and efficacy of minimally invasive sacroiliac joint fusion surgery sufficient as long as there are standard arrangements.

Here’s what we missed last week.

The post 7 medtech stories we missed this week: April 28, 2017 appeared first on MassDevice.

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

Report: NAFTA renegotiations could spell trouble for US medtech industry

The North American Free Trade Agreement may not be facing the gallows after the Trump administration this week said it does not plan to terminate it – but changes to the deal could have a huge impact on the medical device industry, according to a New York Times report.

This week, Trump spoke with Mexican Pres. Enrique Peña Nieto and Canadian Prime Minister Justin Trudeau and said he would start the process or renegotiating the deal, despite previous promises to eliminate it, according to the report.

Medical device manufacturers were identified as a particularly vulnerable sector to renegotiation in the report, as the US imports approximately 30% of its medical devices and supplies, with Mexico as the leading supplier.

Major corporations, including Medtronic (NYSE:MDT) and Integer Holdings (NYSE:GB), have set up factories in the region over the past few years. Moving those businesses back to the US is easier said than done, as the FDA requires detailed inspections and approvals for new facilities and factories, according to the report.

“Our companies make plans 5, 10 years into the future, sometimes at the very least. Uncertainty is always a challenge for our industry, and I think most others. We would certainly welcome policy clarity, sooner rather than later, and would like to work with the Trump administration,” Advanced Medical Technology Association chief strategy officer Andrew Fish said, according to the Times report.

Another Times report, released earlier this month, spelled out other issues that medtech companies could face if NAFTA is significantly altered.

The post Report: NAFTA renegotiations could spell trouble for US medtech industry appeared first on MassDevice.

from MassDevice http://ift.tt/2qo5oOS

H&T Presspart, Hovione ink commercialization deal for inhaler tech

H&T Presspart said this week that it acquired the global rights to Hovione Technology‘s capsule-based dry powder inhaler. The company launched a next-gen version of the inhaler called PowdAir Plus at this year’s Respiratory Drug Delivery Europe.

The PowdAir Plus device is made of plastic and its 4-component design lessens manufacturing, assembly and production costs, according to H&T Presspart.

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

The post H&T Presspart, Hovione ink commercialization deal for inhaler tech appeared first on MassDevice.

from MassDevice http://ift.tt/2oU6qlu

MassDevice.com +5 | The top 5 medtech stories for April 28, 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. Boston Scientific looks to lead the drug-eluting PAD market

Angioplasty is not a new procedure – doctors have been widening obstructed arteries with balloons since the 1960s. But for years the medtech industry has been plagued with what Jeff Mirviss, president of Boston Scientific’s interventional peripheral biz, calls the procedure’s Achilles heel: Restenosis.

For patients treated with bare balloons, half must have the procedure done again because their arteries have re-clogged. Stents improved that rate to 1 of every 3 or 4 patients, Mirviss told Drug Delivery Business News. But drug-coated balloons designed to control scar tissue formation can bring the rate down to 1 in 20 patients. Read more

---

4. Baxter CEO Almeida: We could do an $7.5B acquistion

Baxter chairman & CEO Joe Almeida says he’s prepared to pull the trigger on a major acquisition worth as much as $7.5 billion, but any deal has to pass the healthcare giant’s M&A criteria.

Speaking with analysts earlier this week during a conference call to discuss Deerfield Park, Ill.-based Baxter’s 1st-quarter results, Almeida said that the transformation begun after he took the reins at the beginning of last year puts the company in position to execute a deal. Read more

---

3. Titan Medical spikes talks with Chinese distributor

Titan Medical said today that it’s spiking 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, Toronto-based 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. Read more

---

2. Medtronic, Abbott could still seek exit from India’s high-end stent market

Medtronic and Abbott could take another run at taking their high-end stents off the Indian market, after the Indian National Pharmaceutical Pricing Authority this week rejected their applications to withdraw.

Earlier this month, Medtronic and Abbott said they would look to withdraw select high-value coronary stents from the Indian market in light of cost caps imposed by the NPPA. Medtronic filed to remove its Resolute Onyx stent from the market, while Abbott filed to remove both its Absorb and Alpine stents. Read more

---

1. Olympus to acquire Image Stream Medical

Olympus said today that its American subsidiary plans to acquire Image Stream Medical for an undisclosed amount.

Littleton, Mass.-based Image Stream makes software designed to connect hospital imaging equipment and systems. Center Valley, Pa.-based Olympus Corp. of the Americas said it aims to build a global systems integration platform using the Image Stream tech. Read more

The post MassDevice.com +5 | The top 5 medtech stories for April 28, 2017 appeared first on MassDevice.

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

Venus Medtech wins Chinese FDA approval for Venus A-valve TAVR

Chinese heart valve maker Venus Medtech said today it won China FDA approval for its Venus A-valve device, touting it as the 1st transcatheter aortic valve implantation device to win CFDA approval.

The Venus A-valve device offers a less invasive treatment solution for inoperable and high-risk patients, providing a solution to patients in the region that previously was unavailable, the Hangzhou-based company said.

“We have worked hard to get here, and at Venus Medtech, we believe in innovation through solid science. We will continue to help save lives and treat critical cardiovascular diseases at home and abroad. My vision for Venus Medtech goes beyond TAVR, as we aim to become a leader in the structured heart space. Our CE mark study for the Venus Pulmonary valve has already started as of September 2016. Our global trial for the third generation TAVR device, which embodies pre-packaged, retrievable and embolic protection features, will begin around the end of 2017. Its success should help Venus Medtech further strengthen our position in the market, and gain traction on a more global scale,” Venus Medtech CEO Eric Zi said in a press release.

Venus Medtech said that the Venus A-valve was 1st successfully implanted in Fuwai Hospital on Sept. 10th, 2012.

A study of 101 operative cases of the device reported a successful implantation success rate of 95% and a 30-day all-cause mortality of 5%.

“Venus-A valve’s anti-calcification technology represents a significant development in the application of biological materials in the cardiovascular space, it greatly enhances the valve’s durability, prolongs the valve’s working life, and significantly improves the patient’s experience,” Xingdong Zhang of the National engineering Research Center for Biomaterials said in a prepared release.

“We really value the experience and professionalism of the team under the leadership of Mr. Eric Zi. With the launch of Venus A, we believe Venus Medtech will become a leading cardiovascular company in China, and will also open the door to compete in international markets,” Qiming Venture Partners managing partner Ms. Nisa Leung said in prepared remarks.

In March, Venus Medtech said it inked a partnership deal with Keystone Heart covering China and other Asian markets.

Through the deal, the companies will provide Venus Medtech’s transcatheter aortic valve replacement system along with Keystone’s TriGuard cerebral embolic protection device.

The post Venus Medtech wins Chinese FDA approval for Venus A-valve TAVR appeared first on MassDevice.

from MassDevice http://ift.tt/2oQJ13z

Straumann inks distro deal, ups stake in Rodo Medical

Dental device developer Rodo Medical said today that it entered into a new distribution agreement with Straumann Holding, which has increased its stake in Rodo Medical from 12% to 30% for an undisclosed sum.

The agreement will provide Straumann with exclusive distribution rights outside of North America and South Korea with an option to increase Straumann’s participation to 51% in 2021, San Jose, Calif.-based Rodo Medical said today.

“Rodo’s ability to develop a revolutionary concept, turn it into a medical device and bring it to market is impressive. Their entrepreneurial and scientific approach to innovation makes them an attractive partner for the Straumann Group. We are excited about Smileloc, which is an ingenious solution for an important clinical need and could change current paradigms,” Straumann CEO Marco Gadola  said in a prepared statement.

Rodo medical develops and produces retention devices for dental implant restorations. The company’s products have CE Mark approval in the European Union and FDA 510(k) approval in the US, where its products are commercially available.

“We are pleased to partner with the market leader, Straumann, and the synergies between the companies present great advancements in implant dentistry, particularly with the predictability and precision of digital workflows created with Rodo’s Smileloc System and Straumann’s implants and digital products,” Rodo Medical CEO Young Seo said in a press release.

The post Straumann inks distro deal, ups stake in Rodo Medical appeared first on MassDevice.

from MassDevice http://ift.tt/2pu7Y8V

Artificial pancreas shows promise in pediatric study

A pilot study evaluating an artificial pancreas in children with Type I diabetes found that the device helped kids control their condition, according to researchers at the University of Virginia.

The artificial pancreas was developed at the UVA Center for Diabetes Technology and features a smartphone powered by algorithms that wirelessly link to a glucose monitor and insulin pump.

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

The post Artificial pancreas shows promise in pediatric study appeared first on MassDevice.

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

12 interesting wearables you should know

Wearable technology is probably one of those things you probably didn’t need but still wanted because people were always talking about the devices. Fitbit, Apple and Garmin are some of the main providers of health and wellness wearables. Each of them touts being able to track your fitness activity or measures your heart rate. However, consumer wearables are not regulated by the FDA and therefore are not intended to be used as a medical device.

Wearables, though, are now coming into their own in medtech, with a bunch of devices going through the regulatory and approval process at FDA. Academic researchers, meanwhile, continue to push the boundaries of what is possible.

There is more hope than ever when it comes to non-invasive solutions to problems that many people face – everything from seizures to difficulty breathing.

Here are 12 interesting wearables you should know.

Next >>

The post 12 interesting wearables you should know appeared first on MassDevice.

from MassDevice http://ift.tt/2qfzSn6

TransEnterix files FDA 510(k) application for Senhance, prices $24.9m round

TransEnterix (NYSE:TRXC) said today it filed an application with the FDA seeking 510(k) clearance for its Senhance robotic surgery platform, and that it priced an upcoming $24.9 million round to support the company and device through the process.

The application is a huge step forward for the company, according to CEO Todd Pope, who spoke to MassDevice.com in an interview today.

“The most important milestone that we’ve hit now is that we have filed our FDA 510(k) submission with the FDA, and we wanted to make sure we have enough cash to get all the way through submission, acceptance, and a launch here in the US,” Pope said in an interview with MassDevice.com

Pope said that he’s hopeful the company’s application will be approved within 6 months, though he offered that the timeframe relies on some back-and-forth with the FDA and could be shorter or longer.

“It’s great that we’ve filed with the FDA, and it’s great that we now have cash to fund our operations well beyond the response back from the FDA and our launch here in the US,” Pope said.

The system has also seen some significant upgrades in the past few months, Pope said, as the company added compatibility with both Stryker (NYSE:SYK) and Novadaq vision systems.

“We are now compatible with 2 of the leading vision systems on the market today – Stryker and the Novadaq systems. Both of those are now compatible with our Senhance robot, and that’s a big move forward for the industry. Instead of a closed system, it’s more open architecture to allow hospitals and surgeons to use those vision systems in conjunction with the Senhance,” Pope said.

Pope said the entry was exciting for the company – and for medtech industry in the US, which hasn’t seen another robotic system cleared for the Senhance’s applications in almost 20 years.

“There hasn’t been another robot in the US market since the late 1990s for the applications, so the market is very excited. In Medtech you won’t find another category that hasn’t had a second entrance in 18 years, so that’s exciting, we feel close now and I think that’ll be a great thing for the market,” Pope said.

In the funding round TransEnterix will offer units consisting of 1 share of common stock, 1 Series A warrant to purchase antoher share of common stock and 1 Series B warrant to purchase 0.75 shares of common stock at a price of $1 per unit.

Series A warrants in the round will be exercisable at any time after issuance and usable up to 1 year, with the caveat that the units will expire within 10 days if the company receives FDA 510(k) clearance. Series B warrants in the round will be exercisable from the date of issuance through 5-years, the company said.

“So, the Series A will allow us, within those 10 days of FDA approval, to raise upwards of another $24.9 million,” Pope added.

Pope said he would be speaking more on future developments for the system and the company’s success with it in the European Union during the company’s earnings report release, scheduled for May 10.

Stifel is acting as the sole book-running manager for the offering, which is slated to close on or about May 3, according to a press release.

The post TransEnterix files FDA 510(k) application for Senhance, prices $24.9m round appeared first on MassDevice.

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

Sanofi Q1 earnings top estimates, diabetes sales fall

Shares in Sanofi (NYSE:SNY) rose today after the company beat expectations on Wall Street with its 1st quarter results.

The French company posted profits of $5.7 billion on sales of $8.65 billion for the 3 months ended March 31, for bottom-line growth of 413.5% on sales growth of 11.2% compared with the same period last year.

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

 

The post Sanofi Q1 earnings top estimates, diabetes sales fall appeared first on MassDevice.

from MassDevice http://ift.tt/2oQj1pc

Allergan closes $2.4B Zeltiq acquisition

Allergan (NYSE:AGN) said today that it closed its $2.48 billion acquisition of Zeltiq Aesthetics Inc. (NSDQ:ZLTQ) and its portfolio of body-contouring products.

Zeltiq’s FDA-approved CoolSculpting system uses a cooling mechanism to reduce the appearance of fat which has not responded to diet or exercise, without disturbing surrounding tissue.

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

The post Allergan closes $2.4B Zeltiq acquisition appeared first on MassDevice.

from MassDevice http://ift.tt/2oT8NoR

Titan Medical spikes talks with Chinese distributor

Titan Medical (CVE:TMD) said today that it’s spiking 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, Toronto-based 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.

Longtai put up a $2 million deposit toward the distribution deal, but now that talks have ended that money must be returned, Titan said.

“We are focused on our largest target markets in the United States and Europe. It is worth noting that lengthy discussions with Longtai began in October 2015 and included a good faith $2 million deposit and 2 term extensions, but with initial priority the United States and Europe, other partnering opportunities and our commitment to focus the contemplated distribution agreement is not in the best interests of Titan. We part ways with Longtai amicably and look forward to reporting on additional milestone progress in the near-term,” CEO David McNally said in prepared remarks.

Titan put the Sport program on hold last August after its development partner Ximedica suspended development until Titan could cover its bills. Adding insult to injury, a planned $16.0 million equity investment from Shanghai JuGu Equity Investment Fund, originally slated to close June 30 and extended to August 15, failed to materialize.

The companies re-started the program last October after Titan raised nearly $7.9 million with an overnight offering, putting the Sport project back on track for human factors and usability testing with Providence, R.I.-based Ximedica.

The company, which closed a $6 million offering last month, put former Domain Surgical CEO McNally in the corner office in January. He succeeded interim chief John Barker, who was named to replace John Hargrove last October while the company searched for a full-time CEO.

The post Titan Medical spikes talks with Chinese distributor appeared first on MassDevice.

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

Hill-Rom gains on fiscal Q2 beats

Hill-Rom Holdings (NYSE:HRC) shares are up today after the medical products giant beat Wall Street’s expectations for both sales and earnings during its fiscal 2nd quarter.

The Chicago-based company posted profits of $34.4 million, or 51¢ per share, on sales of $678.9 million for the 3 months ended March 31, for a bottom-line gain of 54.3% on sales growth of 7.3% compared with fiscal Q2 2016.

Adjusted to exclude 1-time items, earnings per share were 88¢, 9¢ ahead of The Street, where analysts were looking for sales of $655.1 billion.

The news pushed HRC shares up 2.8% to $75.89 apiece today in mid-morning trading.

“We delivered strong financial results across our diversified portfolio that exceeded expectations, and we are raising our full-year guidance,” president & CEO John Greisch said in prepared remarks. “Momentum in our core business, improving international growth trends, value from new product introductions and the recent acquisition of Mortara Instrument were significant contributors to our 2nd-quarter results. We continue to successfully execute on key strategic priorities while enhancing outcomes for patients and caregivers, and generating attractive returns for our shareholders.”

Hill-Rom said it now expects to put up adjusted EPS of $3.82 to $3.88 this year on sales growth of 3.5% to 4.0%, including a roughly $70 million contribution from Mortara.

For its fiscal 3rd quarter, Hill-Rom’s forecast calls for adjusted EPS of 89¢ to 91¢ on sales growth of 5% to 6% compared with Q3 2016.

The post Hill-Rom gains on fiscal Q2 beats appeared first on MassDevice.

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

Boston Scientific looks to lead the drug-eluting PAD market

Angioplasty is not a new procedure – doctors have been widening obstructed arteries with balloons since the 1960s. But for years the medtech industry has been plagued with what Jeff Mirviss, president of Boston Scientific’s interventional peripheral biz, calls the procedure’s Achilles heel: Restenosis.

For patients treated with bare balloons, half must have the procedure done again because their arteries have re-clogged. Stents improved that rate to 1 of every 3 or 4 patients, Mirviss told Drug Delivery Business News. But drug-coated balloons designed to control scar tissue formation can bring the rate down to 1 in 20 patients.

Boston Scientific (NYSE:BSX) has a prolific portfolio of peripheral intervention devices, including their Ranger paclitaxel-coated PTA balloon catheter. In a study of 105 patients with femoropoliteal lesions, the balloon yielded 86% primary patency and 91% freedom from total lesion revascularization at 12 months, lessening the need for re-interventions. Both findings were statistically significantly higher than the control arm of patients, who were treated with a bare balloon.

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

The post Boston Scientific looks to lead the drug-eluting PAD market appeared first on MassDevice.

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

Baxter CEO Almeida: We could do an $7.5B acquistion

Baxter chairman & CEO Joe Almeida says he’s prepared to pull the trigger on a major acquisition worth as much as $7.5 billion, but any deal has to pass the healthcare giant’s M&A criteria.

Speaking with analysts earlier this week during a conference call to discuss Deerfield Park, Ill.-based Baxter’s 1st-quarter results, Almeida said that the transformation begun after he took the reins at the beginning of last year puts the company in position to execute a deal.

“We’re open to the tuck-ins, and we’re doing them, and we’re working very hard to get even more opportunities. We have a good pipeline in our pharmaceutical business between partnership and some tuck-ins and even in our advanced surgery, our biosurgery business,” he said, according to a Seeking Alpha transcript. “With the performance of the company and the work that [CFO] Jay Saccaro and [‎VP of transformational change] Cathy Skala have done in our business transformation process and how quick we are integrating and simplifying our back office, I feel more confident that Baxter could do a 20%, 25% of our market cap deal without a problem, okay? It doesn’t mean that we’re going to do it, but my confidence has increased in the management of the company in really pulling off something that would be a good deal for our shareholders in terms of bringing synergies to the bottom line and a good accretion to the top line.”

With a total market capitalization of $29.94 billion as of this morning, that works out to a deal value of roughly $6 billion to $7.5 billion.

A move of that scale would put Baxter in the same company as acquisitive peers like cross-town rival Abbott (NYSE:ABT), which paid $25 billion for St. Jude Medical and is set to buy Alere for $5.3 billion. Other recent deals of note include Cardinal Health (NYSE:CAH) buying a portion of Medtronic‘s (NYSE:MDT) patient monitoring & recovery business for $6.1 billion, Fresenius (ETR:FRE) paying $4.75 billion for generic drugmaker Akorn (NSDQ:AKRX) and the $24 billion merger of Becton Dickinson (NYSE:BDX) and C. R. Bard (NYSE:BCR).

Almeida said any potential deal would 1st have to fall within the 4 pillars of Baxter’s business: Renal, critical care, pharmaceuticals and advanced surgery.

“[Y]ou have to think about what are the major prerequisites for something to get into the funnel. And 1 of them is be within those 4 pillars I mentioned before,” he explained. “The 2nd thing is to make sure there is category of leadership in the products that people make and sell. Then once you pass through those broad lenses, it’s about what can Baxter do to be a better owner for that business.”

Any deal would also have to offer synergies in distribution and sales & marketing to take advantage of Baxter’s scale in the healthcare market  – “We are in every hospital in this country,” Almeida noted.

The post Baxter CEO Almeida: We could do an $7.5B acquistion appeared first on MassDevice.

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

Olympus to acquire Image Stream Medical

Olympus (TYO:7733) said today that its American subsidiary plans to acquire Image Stream Medical for an undisclosed amount.

Littleton, Mass.-based Image Stream makes software designed to connect hospital imaging equipment and systems. Center Valley, Pa.-based Olympus Corp. of the Americas said it aims to build a global systems integration platform using the Image Stream tech.

“We are very happy to welcome Image Stream Medical to the Olympus family,” OCA president & CEO Nacho Abia. “Image Stream Medical is a top tier integration provider that continues to experience consistent market growth on the strength of its products and operational excellence. This relationship provides us with an exciting opportunity to enhance the continuum of care throughout the healthcare enterprise. We believe the acquisition of Image Stream Medical will accelerate our progress in achieving the universal goals of healthcare reform and furthers our ability to achieve our mission of contributing to society by making people’s lives healthier, safer and more fulfilling around the world.”

“Image Steam Medical was founded with the vision of solving the key clinical and business challenges for healthcare systems by facilitating collaboration across their enterprises. By connecting clinicians with the visual insights they need, and with each other no matter where they are, we help teams work more efficiently and effectively,” added Image Stream CEO Eddie Mitchell. “I couldn’t be more excited today as we move forward to join Olympus to help better realize that vision. The combination of Olympus’ unparalleled imaging and surgical technology, together with the innovative and customer-focused solutions we have cultivated at Image Stream Medical, will allow our customers to provide improved care for their patients.”

“The synergy between Olympus and Image Stream Medical is unprecedented,” OCA medical systems president Todd Usen said. “Combining Olympus’ global reach and expertise, world class support infrastructure, and market leadership with Image Stream Medical’s innovative products, will result in superior work flow and patient care and safety enhancements for healthcare enterprises. We are thrilled to soon create better platforms to provide patients with increased access to more advanced procedures, such as minimally invasive surgeries.”

Image Stream raised $8 million in December 2014.

The post Olympus to acquire Image Stream Medical appeared first on MassDevice.

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

Johnson & Johnson lands $260m Defense Dept. contract for orthopedic devices

The U.S. Defense Dept. yesterday awarded a Johnson & Johnson (NYSE:JNJ) unit a contract for orthopedic products worth nearly $260.5 million.

The 1-year contract with Piscataway, N.J.-based Johnson & Johnson Healthcare System includes 4 1-year options; the total maximum value of the agreement covers the life of the contract including the option years, if exercised, according to the Pentagon.

The deal calls for J&J to supply orthopedic products to the Army, Navy, Air Force, Marine Corps and federal civilian agencies.

The contract is slated to expire April 27, 2022, the DoD said.

The Pentagon also said it granted a $28.3 million contract to Redmond, Wash.-based Physio-Control for “medical equipment, maintenance of medical equipment, and/or spare parts for medical equipment.” Physio-Control makes automated external defibrillators. The 5-year deal does not include any option years, according to the DoD.

The deal, slated to expire April 26, 2022, also covers the Army, Navy, Air Force, Marine Corps and federal civilian agencies.

Physio-Control beat out 126 competitors to win the contract, the Pentagon said.

The post Johnson & Johnson lands $260m Defense Dept. contract for orthopedic devices appeared first on MassDevice.

from MassDevice http://ift.tt/2qe5hWS

United Therapeutics launches $250m share repurchase program

United Therapeutics (NSDQ:UTHR) said today that its board of directors approved the repurchase of up to $250 million of the biotech’s common stock.

The share repurchase program is effective immediately and United said it will stay open until the end of 2017. The company can make purchases in the open market, accelerated share repurchases or in privately negotiated transactions.

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

The post United Therapeutics launches $250m share repurchase program appeared first on MassDevice.

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

Medtronic, Abbott could still seek exit from India’s high-end stent market

Medtronic (NYSE:MDT) and Abbott (NYSE:ABT) could take another run at taking their high-end stents off the Indian market, after the Indian National Pharmaceutical Pricing Authority this week rejected their applications to withdraw.

Earlier this month, Medtronic and Abbott said they would look to withdraw select high-value coronary stents from the Indian market in light of cost caps imposed by the NPPA. Medtronic filed to remove its Resolute Onyx stent from the market, while Abbott filed to remove both its Absorb and Alpine stents.

But the NPPA rejected the applications, requesting that the companies consider other options, including permission to raise prices for their later-generation devices, before withdrawing their stents. The rejection was based on restrictions enacted Feb. 21 requiring stent makers, distributors and suppliers to maintain 6 months worth of inventory.

“The NPPA has concluded that all generations of drug-eluting stents are the same and on that basis, we had submitted withdrawal applications for Alpine and Absorb because they are no longer commercially viable for us in India. We have committed to maintaining supplies of Alpine and Absorb until the government advises us to do so, as part of the application review process. We continue to engage with relevant stakeholders on the right time to file the requisite applications, per due process,” an Abbott spokesman told Live Mint.

“Medtronic’s application for the withdrawal of Resolute Onyx was not accepted by the NPPA on the basis of incomplete paperwork. We intend to resubmit the application, and until it is re-submitted and approved we will continue to supply the Resolute Onyx stent in India. All decisions to withdraw or introduce products to the market are made only after taking into consideration all guidelines and norms set by the government and applicable legal and regulatory requirements,” Medtronic told the site via email.

Boston Scientific (NYSE:BSX), also said to be mulling an exit from the high-end Indian stent market, has asked the NPPA to allow it to sell some stents at prices that would exceed the agency’s caps, according to Live Mint. To win that argument the company must prove that its high-end products are superior to older stents.

Last year, Indian NPPA imposed price restrictions which set limits on the costs of metal, drug-eluting and bioresorbable stents. The price of bare-metal stents at about $113 (Rs 7,260) and drug-eluting stents at roughly$460 (Rs29,600).

The move led to rumors that larger players in medtech would pull their high-cost stents from the market, with Abbott denying claims that it would withdraw from the region in February.

($1 = Rs 64.3)

The post Medtronic, Abbott could still seek exit from India’s high-end stent market appeared first on MassDevice.

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

Align Technology shares rise on Q1 Beat-and-Raise

Align Technology (NSDQ:ALGN) shares have risen significantly in after hours trading today after the orthodontic device maker posted 1st quarter earnings that beat expectations on Wall Street.

The San Jose, Calif.-based company posted profits of $69.4 million, or 85¢ per share, on sales of $310.3 million for the 3 months ended March 31, for bottom-line growth of 71.2% while sales grew 30% compared with the same period last year.

Align’s earnings per share value handily topped Wall Street expectations of 67¢. Sales also topped consensus on The Street, where analysts expected to see $297.4 million for the quarter.

“2017 is off to a great start with first quarter revenues, volumes, gross margin and EPS above our expectations. For the quarter, net revenues were up 30% year-over-year, driven by strong Invisalign case shipments of 27% year-over-year to a record 38.9 thousand doctors shipped to during the quarter. These results reflect growth from both our North America and International regions, and higher than expected teenage cases across the board, which increased 32% year-over-year. iTero scanner revenues increased 47% year-over-year, and were down sequentially as expected,” prez & CEO Joe Hogan said in a press release.

Align Technology updated its guidance for the coming quarter, expecting to post net revenues of between $340 and $345 million, with diluted EPS of between 71¢ and 74¢.

Shares in Align have risen significantly in after hours trading, up 12.4%, or $14.91, to trade at $135 as of 6:06 p.m. EDT.

The post Align Technology shares rise on Q1 Beat-and-Raise appeared first on MassDevice.

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

Merit Medical sees shares rise in after hours trading on Street-topping Q1

Shares in Merit Medical (NSDQ:MMSI) have risen in after hours trading today after the medical device maker beat expectations on The Street with its 1st quarter earnings.

The South Jordan, Utah-based company posted profits of $14.8 million, or 32¢ per share, on sales of $171.1 million for the 3 months ended March 31, for bottom-line growth of 240.2% while sales grew 23.9% compared with the same period last year.

Adjusted to exclude 1-time items, earnings per share were 28¢, well above the 23¢ consensus on The Street, where analysts were looking for sales of $163.9 million.

“Our management team is pleased with our performance during the first quarter, especially with the activities involved in the integration of the acquisitions of DFINE, the critical care division of Argon and the assets of catheter connections. We delivered strong revenue growth across all sales divisions in the first quarter. We continue to focus on our promised deliverables, revenue growth, gross margin expansion, our R&D pipeline, and discipline in controlling our SG&A expenses. We plan to deliver a 2-year extension of our 3-year plan following the second quarter of 2017,” CEO & chair Fred Lampropoulos said in a press release.

Merit Medical reiterated its previous guidance for the fiscal year 2017, expecting to report revenue between $713 and $723 million with non-GAAP earnings per share between $1.15 and $1.20.

“We reaffirm our revenue guidance of $713-$723 million and non-GAAP earnings of $1.15-$1.20 per share for the year ending December 31, 2017, without reduction due to our recent public stock offering. Our guidance on GAAP EPS for the year ending December 31, 2017 is updated from $0.54-$0.60 to $0.80-$0.86 to reflect the bargain purchase gain recognized from the Argon acquisition,” Lampropolous said.

Shares have lifted 2.6% in after hours trading today, up 80¢ at $32.00 as of 5:01 p.m. EDT.

The post Merit Medical sees shares rise in after hours trading on Street-topping Q1 appeared first on MassDevice.

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

ResMed Shares dip on Q3 release despite meeting EPS expectations

ResMed (NYSE:RMD) saw shares fall today in after hours trading after the medical device maker posted 3rd quarter earnings that met earnings per share expectations, but fell short on revenue.

The San Diego-based company posted profits of $87.8 million, or 62¢ per share, on sales of $514.2 million for the 3 months ended March 31, for negative bottom-line growth of 3.3% while sales grew 13.3% compared with the same period in the previous year.

Adjusted to exclude 1-time items, earnings per share were 71¢, just in line with expectations on The Street, where analysts were expecting to see sales of $519.9 million.

“We had solid double-digit constant currency revenue growth in Q3, led by our Brightree software solutions as well as mask and device sales. This quarter we saw strong demand for our new AirFit 20 range of masks. We also made significant progress on software innovation with the launch of enhanced integration capabilities with Brightree and our AirSolutions cloud-based software platform.  In our current quarter, we are launching our latest market-leading innovation: the ResMed AirMini – the world’s smallest CPAP. Our focus on changing 20 million lives by 2020 has driven a pipeline of new products and connected care solutions that improve patient outcomes, create efficiencies for our homecare customers, and help physicians and providers better manage chronic disease while lowering healthcare costs,” CEO Mick Farrell said in a press release.

ResMed shares have dropped 6.5% in after hours trading, down $4.75 to trade at $68.10 as of 4:4o p.m. EDT.

The post ResMed Shares dip on Q3 release despite meeting EPS expectations appeared first on MassDevice.

from MassDevice http://ift.tt/2qkrP7U

Medtronic wins Health Canada nod for OsteoCool RF ablation system

Medtronic (NYSE:MDT) said today it won Health Canada approval for its OsteoCool radiofrequency ablation system for treating cancers that metastasize to the spine, and launched the system in the region.

The Fridley, Minn.-based company touted the OsteoCool system as the only cooled RF ablation technology with simultaneous, dual-probe capabilities.

“Our pain therapies business is deeply rooted in the Medtronic mission – which calls us to alleviate pain. We put an important treatment option into the hands of physicians so they can help more patients suffering from debilitating cancer pain,” Medtronic Canada restorative therapy group senior director Sandrine Moirez said in a prepared statement.

The OsteoCool system is temperature controlled and uses internally water-cooled probes to prevent overheating and damage to surrounding tissue during the procedure, Medtronic said. The systems’ 17-gauge, bipolar probes are available in 3 lengths and are usable at a variety of cannula sizes.

“Osteocool radiofrequency ablation provides a minimally invasive option for the treatment of painful bone metastases and is particularly useful in patients that have not responded well to other treatment modalities,” Dr. Roy Park of Calgary’s EFW Radiology said in a press release.

In February, Medtronic won an expanded indication from the FDA for its OsteoCool RF ablation device for palliative treatment of metastases in all bony anatomy.

Medtronic acquired the technology when it bought Baylis Medical for an undisclosed amount back in December 2015. The original OsteoCool device 1st won 510(k) clearance in March 2012. A 2nd version landed another 510(k) in June 2015, and Montreal-based Baylis won a nod in November 2015 for the 3rd iteration.

The post Medtronic wins Health Canada nod for OsteoCool RF ablation system appeared first on MassDevice.

from MassDevice http://ift.tt/2qd9wVJ

Integer Holdings schedules Q1 earnings release for May 8

Integer Holdings (NYSE:ITGR)  said last week it will release its 1st quarter earnings on May 8th, scheduled to be released after the market closes.

The release will be followed by a conference call with the management of the company, according to a press release.

In late March, Integer, which rebranded from Greatbatch last June, said that Thomas Hook was stepping down as president & CEO of the company, with company director Joseph Dziedzic taking over on an interim basis.

Hook will stay on the Frisco, Texas-based company’s board until the company’s 2017 annual meeting of stockholders, but will not seek re-election.

Dziedzic is currently a company director, and previously served as exec VP and CFO for The Brink’s Company from 2009 to 2016, Integer Holdings said. The company said it initiated a “comprehensive search” for a new prez & CEO.

“I look forward to working with the Integer management team to continue executing our strategy of delivering innovative, cost-effective solutions to our customers while generating profitable growth for our company,” Dziedzic said in a press release.

Shares in Integer closed slightly down today at $36.80, but up from their $36.50 opening on Monday.

The post Integer Holdings schedules Q1 earnings release for May 8 appeared first on MassDevice.

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

Tandem misses on Q1 earnings, beats rev estimates

Shares in Tandem Diabetes (NSDQ:TNDM) fell today after the medical device maker missed earnings expectations on Wall Street with its 1st quarter results, but beat revenue estimates.

The San Diego-based company posted losses of -$23.8 million, or -75¢ per share, on sales of $18.9 million for the 3 months ended March 31, for bottom-line loss of -13.9% on sales loss of -6% compared with the same period last year.

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

The post Tandem misses on Q1 earnings, beats rev estimates appeared first on MassDevice.

from MassDevice http://ift.tt/2oBr26c

Galatea Surgical wins FDA 510(k) for GalaForm 3D plastic surgery scaffold

Tepha Inc subsidiary Galatea Surgical said today it won FDA 510(k) clearance for its GalaForm 3D surgical scaffold device designed for use in plastic and reconstructive surgery.

The Lexington, Mass.-based company claims that the GalaForm 3D scaffold is the only 3-dimensionally contoured surgical scaffold with a reinforcing rim designed to uplift the body’s shape for easier placement. The device is based on Tepha’s proprietary P4HB bioresorbable polymer tech, the company said.

“Scaffolds play an important role in aesthetic surgery, where we deal with rejuvenating weakened tissue. We have studied soft-tissue support products through the years, but they are much different; they don’t add long-term tissue strength and aren’t as biocompatible. Galatea scaffolds are made of an easily absorbable monofilament, rather than a multifilament, which reduces infection. GalaForm 3D is a novel scaffold with out-of-the-box shape to better fit the patient’s natural curves. I’m looking forward to using this game-changing 3D scaffold in my patients that require soft tissue support,” plastic surgeon Dr. William Adams said in a prepared statement.

The device was cleared with indications for soft tissue support and to repair, elevate or reinforce soft tissue due to weaknesses or voids, Galatea Surgical said.

“One of the cornerstones of Galatea is our commitment to surgeon and patient education. We are honored to be a Premier Partner of ASAPS, an organization that is focused on providing its members with access to state-of-the-art educational and practice development programs. Innovation is an important driver of what we do at Galatea, and we are pleased to be launching GalaForm 3D, a first of its kind resorbable scaffold, in conjunction with the 50th anniversary of ASAPS. Galatea is committed to engineering innovative new products that offer significant surgeon and patient benefits and providing access to this new technology to ASAPS and its membership,” Tepha prez & CEO Andy Joiner said in a press release.

The post Galatea Surgical wins FDA 510(k) for GalaForm 3D plastic surgery scaffold appeared first on MassDevice.

from MassDevice http://ift.tt/2oNyc28

Novartis slapped with $49m fine over kickbacks

South Korea regulators said today that it fined Swiss drugmaker Novartis (NYSE:NVS)$48.8 million for offering doctors kickbacks in exchange for recommending the company’s drugs to patients.

The Ministry of Health and Welfare also decided to suspend insurance coverage of 9 variations of 2 drugs, including the Alzheimer’s drug Exelon, for 6 months, according to Reuters.

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

The post Novartis slapped with $49m fine over kickbacks appeared first on MassDevice.

from MassDevice http://ift.tt/2pE5lSO

NovoCure shares rise on Q1 EPS beat

Shares in NovoCure (NSDQ:NVCR) rose today after the medical device maker beat losses per share expectations on Wall Street with its 1st quarter earnings results.

The St. Helier, Jersey-based company posted losses of $18 million, or 21¢ per share, on sales of $34.9 million for the 3 months ended March 31, seeing bottom-line losses shrink 49.1% while sales grew a massive 167.2% compared with the same period in 2016.

Losses per share were ahead of the 24¢ consensus on The Street, while sales fell just short of expectations of $37 million.

“Our growth continued in the 1st quarter 2017. It was the ninth consecutive quarter of active patient growth since the first presentation of our EF-14 data in newly diagnosed glioblastoma. At the end of the quarter, we had more than 1,260 active patients on therapy. Our 167% year-over-year revenue growth was driven by an expanding global base of active patients as well as coverage and contracting success in the U.S. We are pleased with the progress we made this quarter and remain committed to bringing Optune to all the patients who may benefit from it. The final analyses of our EF-14 phase 3 pivotal trial presented at AACR showed a consistent improvement in overall survival when Optune was added to standard temozolomide chemotherapy for the treatment of newly diagnosed GBM. The improvement in overall survival was maintained at two, three, four and five years. The 4 and 5 year survival rates of Optune-treated patients were more than double those of patients treated with temozolomide alone. We believe that Optune plus temozolomide is an essential combination treatment for patients with newly diagnosed GBM.” CEO Asaf Danziger said in a said in a press release.

NovoCure did not release any updated guidance for the coming year with their earnings release.

“Beyond GBM, our data continue to support that TTFields may be well suited for combination with standard of care treatments for a variety of additional solid tumor types. As committed as we are to bringing Optune to patients with GBM, we are equally focused on advancing TTFields for additional solid tumor indications,” exec chair William Doyle said in a prepared statement.

Shares have risen 5% in response, up 55¢ at $11.50 as of 3:09 p.m. EST.

The post NovoCure shares rise on Q1 EPS beat appeared first on MassDevice.

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

MassDevice.com +5 | The top 5 medtech stories for April 27, 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. Avedro raises $42m, opens new Mass-based manufacturing facility

Avedro said today it raised $42 million in equity and debt financing and opened a new manufacturing facility in Burlington, Mass.

The equity financing was led by HealthQuest Capital and joined by OrbiMed Advisors and InterWest Partners, while the debt financing was supported by an affiliate of OrbiMed, the company said. Read more

---

4. Zimmer Biomet slides on lowered outlook, despite Q1 beats

Zimmer Biomet shares are off today after the orthopedics giant beat Wall Street’s 1st-quarter forecast but lowered its outlook for the rest of the year.

Warsaw, Ind.-based Zimmer Biomet posted profits of $299.4 million, or $1.47 per share, on sales of $1.98 billion for the 3 months ended March 31, for bottom-line growth of 175.2% on sales growth of 3.8% compared with Q1 2016. Adjusted to exclude 1-time items, earnings per share were $2.13, 2¢ ahead of The Street, where analysts were looking for sales of $1.96 billion. Read more

---

3. Surgical robots: Hospital CTO talks differentiators in new crop of competitors

For the last 10 years, if anyone mentioned robotic surgery or surgical robots, 95 percent of the time they meant the da Vinci robot from Intuitive Surgical. “That product has been so dominantly successful that almost everybody who talks about it is talking with that as their reference point,” said Roger Smith, chief technology officer for Florida Hospital Nicholson Center. Smith’s primary work involves researching the effectiveness of surgical robots.

Smith said that in the last several years, a few surgical robot companies have come onto the scene and are vying for market share. In the realm of abdominal or thoracic robotics, da Vinci is starting to get some competition. Read more

---

2. Boston Scientific’s Q1 sales top Wall Street, earnings miss by a penny

Boston Scientific today posted 1st-quarter sales that topped expectations on Wall Street, but share prices slid anyway in pre-market trading as investors reacted to a 1¢ miss on earnings.

The Marlborough, Mass.-based company reported profits of $290 million, or 21¢ per share, on sales of $2.16 billion for the 3 months ended March 31, for a bottom-line gain of 43.6% on sales growth of 10.0% compared with Q1 2016. Adjusted to exclude 1-time items, earnings per share came in a penny below The Street at 29¢. Analysts were looking for sales of $2.08 billion. Read more

---

1. Senate panel approves FDA nominee Gottlieb

A U.S. Senate panel voted today to approve Dr. Scott Gottlieb to lead the FDA, sending his nomination to the full Upper Chamber for a confirmation vote.

The Senate Health, Education, Labor & Pensions Committee approved Gottlieb on a 14-9 vote. The full Senate is also expected to approve the nomination. Read more

The post MassDevice.com +5 | The top 5 medtech stories for April 27, 2017 appeared first on MassDevice.

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

Pendant Bioscience joins J&J JLABS incubator in Toronto

Advanced materials and drug delivery developer Pendant Biosciences said today it won acceptance into Johnson & Johnson (NYSE:JNJ) Innovation’s JLABS incubator in Toronto.

Pendant Biosciences is developing a surface coating and drug delivery technologies through a polymer-based platform. The Nashville, Tenn.-based company said it is initially focused on developing applications within the orthopedic market.

The company’s lead product candidate is a surface modification intended to reduce risk associated with certain orthopedic transplants, which it said has the potential to operate in multiple therapeutic areas.

“We are delighted that Pendant Biosciences, which licensed its technology from Vanderbilt University, has been given this exceptional opportunity. The company’s increased footprint in Toronto will, no doubt, be invaluable, and we will be watching their continued progress with great interest,” Vanderbilt Center for Technology Transfer & Commercialization vice chancelor Alan Bentley said in a prepared statement.

The JLABS facility in Toronto is a 40,000-square foot center where start-up companies in medtech can develop their technologies without J&J taking an equity stake in the companies, Pendant Biosciences said.

“We are excited to become part of the JLABS @ Toronto community, and are honored to be the first Tennessee-based company to join this unique and dynamic life science ecosystem. Acceptance into JLABS perfectly complements our existing research and development activities being conducted with our academic collaborator and partner, Christine Allen, Ph.D., Professor and GSK Chair in Pharmaceutics and Drug Delivery at the University of Toronto, and serves to expand our presence in this important life science hub. As an early-stage company, Pendant Biosciences and its team gain immediate access to, and the ability to collaborate with, the Johnson & Johnson Innovation network, industry experts with unparalleled translational research and commercialization experience, as well as key life science investors who can help us drive development of our product candidates,” Pendant Biosciences founder & CEO Shawn Glinter said in a press release.

The post Pendant Bioscience joins J&J JLABS incubator in Toronto appeared first on MassDevice.

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

Antidepressant could help ferry drugs across blood-brain barrier

Researchers at the National Institutes of Health have found that pairing an antidepressant with neurological drugs can enhance drug delivery to the brain. The team’s research was published online in the Journal of Cerebral Blood Flow and Metabolism.

The team cautioned that more work needs to be done to determine if the discovery will hold up in the clinic, but the team’s work could enhance treatment for brain-centered conditions. Traditionally, researchers have trouble fighting neurological diseases with drugs because of the blood-brain barrier – a protective barrier that keeps dangerous compounds out of the brain, but also prevents drugs from getting in.

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

The post Antidepressant could help ferry drugs across blood-brain barrier appeared first on MassDevice.

from MassDevice http://ift.tt/2qjLh4w