Align Tech shares trend up despite Q4, FY2016 misses

Shares in Align Technology (NSDQ:ALGN) have risen in after hours trading today despite the dental-focused medical device company narrowly missing expectations on Wall Street with its 4th quarter and fiscal year 2016 earnings results.

The San Jose, Calif.-based company posted profits of $47.6 million, or 59¢ per share, on sales of $293.2 million for the 3 months ended Dec. 31, equating to a bottom-line that shrunk 2.6% on sales growth of 27.3% compared with the same period last year.

Earnings per share were 7¢ behind the consensus on Wall Street, where analysts were looking for sales of $292.4 for the quarter.

For the full year, Align Technology reported profits of $189.7 million, or $2.33 per share, on sales of $1.1 billion, with bottom-line growth of 31.7% with sales growth of 27.7% compared with the previous year.

Earnings per share were a few cents behind the $2.41 expectations on The Street, while revenue fell just in line with consensus for the year.

Shares in Align are up 2.1% in after hours trading, at $93.60 as of 6:41 p.m. EST.

“Q4 was another record quarter for Align, reflecting continued strong growth across all geographies and customer channels compared to the prior quarter last year. These results helped us to exceed $1 billion in annual revenue for the first time in our history. In addition, more than 700 thousand patients started orthodontic treatment with Invisalign clear aligners in 2016, helping us to surpass our 4 millionth Invisalign patient. We also saw strong adoption of our new iTero Element scanner this year, which more than tripled our scanner shipments over the prior year,” prez &CEO Joe Hogan said in a press release.

Align Technology released guidance for the upcoming 1st quarter of 2017, expecting to see net revenue between $295 and $298 million, with diluted EPS between 64¢ and 67¢.

The post Align Tech shares trend up despite Q4, FY2016 misses appeared first on MassDevice.

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

Accuray shares slide on Q2 miss

Shares in Accuray (NSDQ:ARAY) have fallen in after hours trading today after the medical device maker missed expectations on the street with its 2nd quarter earnings results.

The Sunnyvale, Calif.-based company posted losses of $9.4 million, or 11¢ per share, on sales of $87.5 million for the 3 months ended December 31. That equates to a 55.5% increase in losses while sales shrunk 19.7% compared with the same period in 2015.

Accuracy was behind the consensus on The Street, where analysts were looking for losses per share of 9¢ and sales of $90.4 million.

“Our 17% year-over-year gross order growth during the second quarter was led by increased demand for our CyberKnife system, especially from replacement orders to existing customers. In addition, gross orders were favorably impacted by solid demand for our new Radixact System, which will be fully launched by the end of the 3rd fiscal quarter. We performed above expectations in regards to gross order performance in the first half of the year and are seeing several indicators that lead us to believe our strong backlog growth will continue through the end of fiscal 2017 and into fiscal 2018,” prez & CEO Joshua Levine said in a press release.

The company reaffirmed guidance it provided in August for the coming full fiscal year, but adjusted its expectations for revenue, now expected to be between $410 and $420 million, and adjusted EBITDA, now expected to be between $32 and $38 million.

“During the 2nd half of fiscal 2017, there are two major variables that could affect our revenue including China’s timing of Class A radiotherapy licenses and the impact of a higher mix of distributor orders which could continue to result in timing uncertainty. We are proactively communicating with our independent distributor partners to understand how to provide additional support around site planning and installation activities to improve the visibility into the timing of revenue conversion,” Levine said in a prepared statement.

Shares have tumbled in after hours trading, down 9.6% to trade at $5.20 as of 5:50 p.m. EST.

The post Accuray shares slide on Q2 miss appeared first on MassDevice.

from MassDevice http://ift.tt/2ko7tLo

Medtronic looks to sell $5B medical supplies biz

Medtronic (NYSE:MDT) is working with advisors for a possible sale of its medical supplies business, according to a Bloomberg report.

The process is reportedly in an early stage, but the Fridley, Minn.-based company has been looking for prospective buyers for the division, which could be worth $5 billion.

Medtronic shares had a positive day, up 1.8% to close at $76.02.

Earlier this month, the U.S. Internal Revenue Service reportedly agreed to drastically slash the amount it claims Medtronic (NYSE:MDT) owes on loans between its subsidiaries, from a potential $1.36 billion to just $14 million.

Last summer, a federal tax judge found for the Fridley, Minn.-based company in its lawsuit against the IRS over the dispute, which involves “transfer pricing” among the company’s various units during the tax years 2005 and 2006. The tax bureau claimed Medtronic owed income tax of $548.2 million for 2005 and $810.3 million for 2006; the company disputed the bill and took the case to the U.S. Tax Court. Judge Kathleen Kerrigan found in June that Medtronic proved that the IRS was “arbitrary, capricious, or unreasonable” in its interpretation of the transfer pricing for its Puerto Rico subsidiary.

In transfer pricing, income is allocated among branches in different countries. It’s a legal tax maneuver companies can use to attribute profits from a product made and sold in the U.S. to a unit in a foreign country. If Kerrigan’s ruling had gone the other way, the IRS could have dunned Medtronic for extra taxes from 2007 on. Medtronic has said it expects to repatriate between $500 million and $4.5 billion in overseas cash once the dispute is put to bed.

This month the revenuers agreed to use a much smaller figure, $38.9 million, to calculate what Medtronic owes on transfer pricing for 2005 and 2006 combined. That means a tax tab of just $14 million, according to Law360.com.

The post Medtronic looks to sell $5B medical supplies biz appeared first on MassDevice.

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

MediWound touts Phase II study

MediWound (NSDQ:MDWD) touted data from a phase II trial of its EscharEx topical biological drug for debridement of chronic and other hard-to-heal wounds. The data includes a follow-up period of 6 months from the last treatment to 3 months from wound closure.

The randomized phase II trial enrolled 73 patients with a variety of chronic and hard-to-heal wounds including diabetic foot ulcers and venous leg ulcers. Patients received either EscharEx or a hydrogel placebo.

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

The post MediWound touts Phase II study appeared first on MassDevice.

from MassDevice http://ift.tt/2jS2G45

LivaNova touts high survival, freedom from reoperation in Perceval study

LivaNova (NSDQ:LIVN) last week released data from study of its Perceval sutureless valve, touting a high rate of freedom from reoperation and survival.

Results from the study was presented at The Society of Thoracic Surgeons 53rd annual meeting last week.

Data came from 617 patients who underwent aortic valve replacements at a single center, London-based LivaNova said, and indicated a 99% rate of freedom from reoperation and 91.3% survival rate at 16 months. The company said the study is the largest single center experience with the Perceval valve to date.

“As one of the latest solutions in valve replacement surgery, the Perceval sutureless valve optimizes the overall surgical approach for surgeons. In the presented analysis, implantation with Perceval allowed surgeons to perform minimally invasive approaches with shorter procedure times, specifically reducing the cross-clamp and cardiopulmonary bypass time, which can lead to faster recovery times for patients,” Dr. Marco Solinas of Massa, Italy’s Monasterio Tuscany Foundation said in prepared remarks.

“These positive results reinforce findings from previous studies for Perceval1, the only truly sutureless valve designed for patients requiring surgical aortic valve replacement. With the foundation of advancing technology and transforming lives, LivaNova is committed to delivering advanced solutions for cardiac surgery and we look forward to continuing the expansion of Perceval’s clinical evidence base and its growing use in the international cardiac surgery community,” cardiac surgery medical affairs VP Dr. Brian Duncan said in a press release.

Last April, LivaNova said the 1st patient in the Persist-AVR trial of its Perceval sutureless aortic valve was implanted with the device at Nancy, France’s University of Lorraine.

The company claims that the lack of suturing allows the super-elastic Perceval valve to achieve optimal effective orifice area, resulting in “excellent hemodynamics.” LivaNova said procedures utilizing the Perceval valve result in shorter intensive care unit stays, reduced ventilation time and less blood transfusions.

The Persist-AVR trial is slated to enroll over 1,200 patients with severe symptomatic aortic stenosis or steno-insufficiency in patients who are candidate for surgical replacement of their native aortic valves. In the trial, the company’s Perceval valve will be compared against standard sutured bioprosthesis in patients with aortic valve disease, the company said.

The post LivaNova touts high survival, freedom from reoperation in Perceval study appeared first on MassDevice.

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

How Acelity plans to disrupt fee-for-service to build a value-based business

Remote therapy monitoring, provided by the Ion Progress line is not in Acelity’s traditional wheelhouse. It represents a commitment from the company to treat throughout the continuum of care.

Value-based care is disrupting the old fee-for-service models in the U.S. healthcare industry, and medical device makers must adapt or perish. Here’s how wound care company Acelity is responding. 

The rise of value-based care in the U.S. is causing a major shift in the medical device industry. Health provider customers want to know how medical devices are going to improve overall efficiency and quality of care, so device makers are investing in often service-related products that are not traditionally “money makers.”

Medtech companies are also acknowledging that within an event of care, there are millions of little details that have the potential to achieve better health outcomes.

Joe Woody has been in the industry for more than 25 years, and he has seen how those details, when missed, add to the overall cost of care. Five years ago, he accepted the CEO position for what used to be KCI and has since transformed into Acelity. (Before that, he was global president of vascular therapies for Covidien, and before that, global president of the wound care business for Smith & Nephew.)

Acelity is involved in wound care and regenerative medicine, but Woody says the company is refocusing and has decided to create products that fit the “wound care continuum.” To that end, the regenerative medicine business, LifeCell, was recently sold to Allergan and 3 years ago, Acelity bought J&J’s wound care business Systagenix. “We want to cover VAC Gherapy, dressings, biologics—really anything and everything that has to do with a wound.”

Within that goal of covering the continuum of care is the larger calling to tie everything Acelity does to disrupting fee-for-service and furthering value-based care. “A few years ago, we really took a look at the way we innovate in terms of lowering the cost of care,” Woody says. That means “proving, not just saying, to customers that our products really get the best clinical outcomes.”

Read the full story on our sister site, MedicalDesignandOutsourcing.com

The post How Acelity plans to disrupt fee-for-service to build a value-based business appeared first on MassDevice.

from MassDevice http://ift.tt/2jrNhJ2

MassDevice.com +5 | The top 5 medtech stories for January 31, 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. Senate Dems force hearing delays for Price, Mnuchin at HHS, Treasury

Senate Democrats today staged an en masse boycott of a committee hearing on the Trump administration’s nominees to lead the U.S. Health & Human Services and Treasury Depts., forcing Republicans to delay the votes on Rep. Tom Price (R-Ga.) and Steve Mnuchin.

At least 1 Democrat must be present for the Senate Finance committee votes to take place; the boycott was prompted by media reports that Price and Mnuchin misled Congress during testimony before the Senate earlier this year. Read more

---

4. Zimmer Biomet’s Q4, 2016 numbers top estimates

Zimmer Biomet topped the consensus forecasts for both its 4th-quarter and full-year 2016 results, despite a nearly -50% profit slide for the quarter.

The Warsaw, Ind.-based orthopedics giant posted profits of $66.6 million, or 33¢ per share, on sales of $2.01 billion for the 3 months ended Dec. 31, for a bottom-line decline of -47.6% on sales growth of 4.1% compared with Q4 2015. Read more

---

3. PixarBio investors sue over InVivo takeover bid

PixarBio investors launched a securities class action suit against the Massachusetts-based biotech yesterday, alleging that the company lost its investors millions of dollars by issuing false statements about the prospects of a merger with InVivo Therapeutics.

The case was brought on behalf of investors who purchased or acquired PixarBio stocks between October 31, 2016 through January 20, 2017. It claims that the defendants made false, misleading statements about the company’s current shareholders, the identity and qualifications of key shareholders and employees and the company’s development efforts. Read more

---

2. Glooko, Ascensia ink diabetes data integration deal

Asensia Diabetes Care and Glooko said today they inked a global technology partnership deal through which Glooko’s Diabetes data management platform will be integrated with Ascensia’s Contour Next One and Contour Plus One blood glucose monitors.

The integration of the systems will allow direct access to blood glucose data through Glooko’s mobile application and clinic data upload products directly from the Contour Next One and Contour Plus One meters. Data will be communicated via bluetooth, with an automatic feed through the Contour Cloud, the companies said. Read more

---

1. Arguments set to begin in ex-Stryker rep’s appeal of $750k loss

A former Stryker sales rep is slated to appeal his nearly $750,000 loss in a lawsuit over his move to rival Biomet (now Zimmer Biomet), with oral arguments due to begin tomorrow.

Stryker in 2013 sued a pair of former sales agents, Christopher Ridgeway and Richard Steitzer, accusing them of scheming to poach reps and business from Stryker in Louisiana and New York. Stryker fired Ridgeway in September 2013, after discovering that he was allegedly running a pair of medical supply businesses on the side. In June of that year, Stryker alleged, Biomet began courting Ridgeway, looking to bring his entire Stryker sales teams on board. Ridgeway also allegedly induced a 3rd Stryker employee, Sheldon Green, to jump ship for Biomet and forwarded Stryker’ Louisiana customer list to Green, according to the complaint. Read more

The post MassDevice.com +5 | The top 5 medtech stories for January 31, 2017 appeared first on MassDevice.

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

Trump presses pharma execs on pricing, U.S. production

Executives from pharmaceutical companies including Johnson & Johnson (NYSE:JNJ), Amgen (NSDQ:AMGN), Merck (NYSE:MRK) and Eli Lilly (NYSE:LLY) met with President Donald Trump today to discuss issues ranging from drug pricing to regulatory approval for pharmaceuticals. The president called on the company execs to increase U.S. production and lower “astronomical” drug prices.

Although Trump doubled down on his calls for the executives to do more to lower drug prices, the meeting seemed to signal a defusing of tensions between the 2 groups. Pharmaceutical stocks tumbled last month after Trump said the companies were “getting away with murder.”

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

The post Trump presses pharma execs on pricing, U.S. production appeared first on MassDevice.

from MassDevice http://ift.tt/2jRLOu3

Pro-Dex deals Oregon Micro Systems biz to GM for $640k

Pro-Dex (NSDQ:PDEX) said yesterday it sold its Oregon Micro Systems division for $640,000 to OMS Motion, a corporation formed by the division’s long time general manager Phil Brown.

The Irvine, Calif.-based company’s OMS division designs and manufactures embedded multi-axis motion controllers to be sold to distributors or original equipment manufacturers in automation and research industries.

“The sale of our OMS division will allow us to invest in our research and development efforts of our medical device product portfolio. We are pleased that this sale was consummated so quickly, in part due to the knowledge that Phil has regarding the business and its prospects. We wish Phil and OMS Motion, Inc. continued success in the future, and thank Phil for his many years of service and leadership,” Pro-Dex prez & CEO Richard Van Kirk said in prepared remarks.

Pro-Dex said the purchase price was subject to adjustment baed on the value of OMS receivables at the closing date for the sale.

The post Pro-Dex deals Oregon Micro Systems biz to GM for $640k appeared first on MassDevice.

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

Senate Dems force hearing delays for Price, Mnuchin at HHS, Treasury

Senate Democrats today staged an en masse boycott of a committee hearing on the Trump administration’s nominees to lead the U.S. Health & Human Services and Treasury Depts., forcing Republicans to delay the votes on Rep. Tom Price (R-Ga.) and Steve Mnuchin.

At least 1 Democrat must be present for the Senate Finance committee votes to take place; the boycott was prompted by media reports that Price and Mnuchin misled Congress during testimony before the Senate earlier this year.

Sen. Orrin Hatch (R-Utah), chairman of the finance panel, called the Democratic boycott “shocking” and “offensive.”

“They’re going to vote no. They’ve made that very clear,” he said to the Republican committee members who made the hearing. “I think they ought to stop posturing and acting like idiots. What’s the matter with the other party? Are they that bitter about Donald Trump?”

Ranking member Sen. Ron Wyden (D-Ore.) said Democrats were not ready to consider either nominee.

“We’ve made clear that we need additional information to make these judgments,” he said.

Yesterday the Wall Street Journal reported that Price received a privileged offer to buy shares in Australia’s Innate Immunotherapeutics at a discount, contrary to his congressional testimony this month.

Price testified that the stock was “available to every single individual that was an investor at the time.” In fact, he was 1 of fewer than 20 U.S. investors invited last year to buy the discounted shares, the newspaper reported.

“The company is directly contradicting Congressman Price, indicating he didn’t tell the truth. And he misled the Congress and he misled the American people,” Wyden said today.

In Mnuchin’s case,Mnuchin’s former bank, showing that his former bank, OneWest, used automated “robo-signings” to approve mortgages after the former Goldman Sachs executive and OneWest chairman flatly denied those practices to senators.

Barney Keller, a spokesman for Mnuchin’s transition, dismissed the report as “bogus,” saying courts already rejected allegations that a OneWest official’s signings of documents cited in the report were “robo-signings.”

It’s unclear when the committee votes will be held. Wyden spokesman Taylor Harvey ruled out indefinite limbo for the nominees.

“Our hope is we can resolve these issues and continue the markup (voting) soon,” Harvey said.

Material from Reuters was used in this report.

The post Senate Dems force hearing delays for Price, Mnuchin at HHS, Treasury appeared first on MassDevice.

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

Ortho Kinematics raises $7.6m

Ortho Kinematics has raised $7.6 million in a new round of financing, according to an SEC filing posted this week.

The Austin, Texas-based company is offering debt, warrants and other securities to be acquired through exercising warrants or options in the round, according to the filing.

Money in the round has come from 67 unnamed investors, according to the SEC filing, and the company is seeking an additional $400,000 before it closes the round

Ortho Kinematics has not yet said how it plans to spend funds raised in the round.

Last July, Ortho Kinematics said it launched the VMA-Align diagnostic module for its Vertebral Motion Analysis system, designed to provide data to spinal surgeons for patient selection and planning for lumbar fusion surgery.

The VMA system from Ortho Kinematics uses fluoroscopy to capture images of the spine in motion, is designed to displace traditional X-ray imaging as the primary method for identifying spinal dysfunction, the company said.

VMA-Align reports will be included as part of the standard VMA diagnostic reports and require no additional workflow for existing users, Ortho Kinematics said.

The post Ortho Kinematics raises $7.6m appeared first on MassDevice.

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

Cryo tech for microscope samples wins $1.6 million in funding

Through a collaboration with ABRA Flui, the original designer of the HPM010, CryoCapsule last year launched what is says is the first high pressure freezing machine associated with an inverted microscope: the HPM Light µ. [Images courtesy of CryoCapCell]

CryoCapCell (Paris) said Tuesday that it has raised €1.5 Million ($1.6 million) from Seventure Partners’s Quadrivium 1 seed capital fund.

The money will go toward CryoCapCell’s technology to freeze living tissue samples through ultra-rapid, high-pressure vitrification (or cryogenisation), preventing the alteration of biological structures. The goal is to initially use the technology for cancer research electron-microscopy.

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

The post Cryo tech for microscope samples wins $1.6 million in funding appeared first on MassDevice.

from MassDevice http://ift.tt/2kMsFZ0

Eli Lilly posts mixed Q4 earnings

Shares in Eli Lilly (NYSE:LLY) rose today after the drug manufacturer missed earnings expectations, but beat revenue estimates on Wall Street with its 4th quarter results.

The Indianapolis-based company posted profits of $771.8 million on sales of $5.76 billion for the 3 months ended Dec. 31, for bottom-line growth of 61.3% on sales growth of 7.1% compared with the same period last year.

Adjusted to exclude 1-time items, earnings per share were 95¢, behind consensus on The Street, where analysts were looking for sales of $5.55 billion.

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

The post Eli Lilly posts mixed Q4 earnings appeared first on MassDevice.

from MassDevice http://ift.tt/2jR7Hd0

Glooko, Ascensia ink diabetes data integration deal

Asensia Diabetes Care and Glooko said today they inked a global technology partnership deal through which Glooko’s Diabetes data management platform will be integrated with Ascensia’s Contour Next One and Contour Plus One blood glucose monitors.

The integration of the systems will allow direct access to blood glucose data through Glooko’s mobile application and clinic data upload products directly from the Contour Next One and Contour Plus One meters. Data will be communicated via bluetooth, with an automatic feed through the Contour Cloud, the companies said.

“Glooko’s Diabetes data management platform has become widely used for both personal and clinical diabetes data analytics and decision support. Glooko’s broad distribution into health systems will enable us to easily and seamlessly deliver highly accurate data from our Contour Next One and Contour Plus One blood glucose monitoring systems to clinicians right in their workflow. By linking our systems to Glooko’s Diabetes data management platform, we want to enable better understanding and analysis of diabetes data, and ultimately help to improve the lives of people with diabetes,” Ascensia Diabetes CEO Michael Kloss said in prepared remarks.

Health care workers will be able to access data from either of the Ascensia systems through Glooko’s Clinic Solution, the companies said. Ascencia’s Contour Next One recently won FDA 510(k) clearance and the company expects to launch the system in the US in early 2017.

The agreement will cover all markets where Glooko and Ascnesia’s systems are marketed, and is expected to be available in late 2017.

“The usability and accuracy of the Contour Next One and Contour Plus One blood glucose monitoring systems from Ascensia Diabetes Care is impressive and we are excited to bring this rich data into the Glooko platform to help both people with diabetes and their health care professionals manage this condition,” Glooko CEO Rick Altinger said in a press release.

Last September, diabetes device developers Glooko and Diasend completed a merger, with the combined companies operating under the Glooko moniker.

The newly merged firms said their platforms operate in 4,000 diabetes clinics in 23 countries, covering more than 95% of diabetes devices used worldwide.

The companies recently raised $8 million in a new equity financing round to support accelerated integration and sales efforts. The round was led by venture capital firm Canaan Partners and joined by Social Capital, Samsung Ventures and Glooko founder Yogen Dalal.

The post Glooko, Ascensia ink diabetes data integration deal appeared first on MassDevice.

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

How UnitedHealthcare and Qualcomm are boosting wearables

UnitedHealthcare and Qualcomm are taking employee fitness to the next level—by offering $1,500 a year to employees who participate in wellness program and reach the set daily fitness goals.

Qualcomm has expanded the UnitedHealthcare Motion wellness program that gives employees activity trackers for free. It is available for self-funded employers who have 5 or more employees and companies that have full health insurance plans with 101 or more employees.

The UnitedHealthcare Motion “brings together wearable technology, telemedicine and wellness incentives to help employees take charge of their health, while also enabling employers to more effectively manage health care costs,” according to its website.

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

The post How UnitedHealthcare and Qualcomm are boosting wearables appeared first on MassDevice.

from MassDevice http://ift.tt/2jR0mdz

This 3D bioprinter can make functional human skin

A group of scientists in Spain has created a 3D bioprinter that can 3D print functional human skin, one of the first living human organs created with bioprinting.

The bioprinted skin mimics the structure of human skin. It has an external layer—the epidermis with its stratum corneum—that protects against environmental factors and a thicker, deeper layer—the dermis—that gives the bioprinted skin its elasticity and mechanical strength.

Bioprinting skin is used to make allogeneic skin on a large scale for industrial purposes and from a stock of cells. It is also used to make autologous skin for therapy from a patient’s own cells. This in-vitro engineered development allows the skin to be used as grafts for skin replacement or to establish in-vitro human skin models.

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

The post This 3D bioprinter can make functional human skin appeared first on MassDevice.

from MassDevice http://ift.tt/2jQHIT8

Sales, earnings slide for Hoya’s life care business

Sales and earnings declined during the fiscal 3rd quarter for Hoya Corp. (TYO:7741), which reported an overall profit gain for the period despite falling sales.

The Japanese conglomerate’s life care segment, which includes its eye care and endoscopy businesses, reported pre-tax profits of roughly $123.6 million (¥12.89 billion) on sales of $700.5 million (¥78.71 billion) for the 3 months ended Dec. 31. That’s a -6.4% pre-tax profit slide on a -2.0% top-line slip for the division.

Overall Hoya reported profits of $223.2 million (¥25.08 billion), or 57¢ (¥64.46) per share, on sales of $1.10 billion (¥124.10 billion), for profit growth of 4.4% on a -3.8% sales drop compared with the same period in 2015.

“During the quarter, the eyeglass lenses business grew overall due partly to stabilization of Asia operation,” CEO Hiroshi Suzuki said in prepared remarks. “For the endoscopes business, we are expecting a good outcome in the coming year with new products releases.”

Hoya said it expects to report profits of $774.3 million (¥87 billion) on sales of $4.21 billion (¥473.0 billion) for its fiscal 2017 year ending March 31.

“The eyeglass lenses business in the Japanese market has been adversely affected by shrinkage of the retail market, and Hoya’s sales have been restrained. In overseas markets, sales in all regions, including the Americas, Europe, and Asia, expanded on a local currency basis, but the impact of yen appreciation has been substantial, and overall sales in the eyeglass lenses business decreased compared with the same quarter of the previous year,” the company said. “In the contact lenses business, Hoya is continuing to open new specialized Eyecity stores and step up its promotional activities at existing stores. Sales for the third quarter expanded year on year.

“Sales of endoscopes for medical use in Europe, where the ratio of sales by region is largest, expanded on a local currency basis due to the introduction of new products and the strengthening of Hoya’s marketing capabilities. However, because of the adverse impact of the appreciation of the yen, overall sales decreased compared with the same quarter of the previous year,” Hoya said. “Sales of intraocular lenses for cataract surgery in the Japanese market, where new products were introduced last fiscal year, continued to be favorable. In addition, in overseas markets also, direct sales and sales through distributers continued to be firm, and expanded substantially over the same period of the previous year.”

The post Sales, earnings slide for Hoya’s life care business appeared first on MassDevice.

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

Pfizer misses on Q4 earnings

Shares in Pfizer (NYSE:PFE) remained steady today after the pharmaceutical company missed expectations on Wall Street with its 4th quarter results.

The U.S. pharma giant posted profits of $775 million, or 13¢ per share, for the 3 months ended December 31, 2016, compared to a bottom-line loss of $172 million in the same period last year. Pfizer also reported revenues of $13.63 billion, a -3% slide from its sales in Q4 last year.

Adjusted to exclude 1-time items, earnings per share were 47¢, behind consensus on The Street, where analysts were looking for sales of $13.55 billion.

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

The post Pfizer misses on Q4 earnings appeared first on MassDevice.

from MassDevice http://ift.tt/2jQAJK0

Building the business case for clinical research training

Most clinical research study sponsors recognize that having a properly trained research staff is key to ensuring compliance and bringing their device to market faster. The question is, how do you implement an effective training program that achieves your organization’s desired goals?

This paper addresses the three Bs – buy-in, bandwidth and budget – and concerns about whether training will produce a significant return on investment that often keep sponsors from moving forward.

There is no doubt that cost is the most significant concern for many of the companies we encounter. Companies are reluctant to invest substantial money to train staff when turnover rates in the industry tend to be high. Additionally, we find sponsors are concerned that, as the field evolves, regulations and best practices can change and training will be outdated.

A well-trained staff is critical to the success and integrity of your clinical study. That’s why IMARC Research offers comprehensive training that can be customized to meet the needs of your team and individual staff members. Our training includes cost-effective in-person training, teleconferencing, and convenient online training available through our IMARC University web-portal.

Please take time to download our “Building the Business Case for Clinical Research Training – Achieving Buy-in, Setting a Budget, and Demonstrating ROI,” to learn more about building a customized training program that meets your needs.

We also encourage you to contact us if you’d like to learn more about training options for your clinical research staff or are interested in developing a customized solution to meet your needs.

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

The post Building the business case for clinical research training appeared first on MassDevice.

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

Mylan hit with antitrust lawsuit over EpiPen device

Mylan (NSDQ:MYL) said on Monday that it is undergoing an antitrust probe by the Federal Trade Commission into the company’s commercial practices regarding its EpiPen device.

The Canonsburg, Pa.-based company reportedly responded to the allegations that it improperly fought off competition, saying “any suggestion that Mylan took any inappropriate or unlawful actions to prevent generic competition is without merit.”

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

The post Mylan hit with antitrust lawsuit over EpiPen device appeared first on MassDevice.

from MassDevice http://ift.tt/2kcRf5l

PixarBio investors sue over sham InVivo takeover bid

PixarBio (OTC:PXRB) investors launched a securities class action suit against the Massachusetts-based biotech yesterday, alleging that the company lost its investors millions of dollars by issuing false statements about the prospects of a merger with InVivo Therapeutics (NSDQ:NVIV).

The case was brought on behalf of investors who purchased or acquired PixarBio stocks between October 31, 2016 through January 20, 2017. It claims that the defendants made false, misleading statements about the company’s current shareholders, the identity and qualifications of key shareholders and employees and the company’s development efforts.

The lawsuit, filed in the U.S. District Court for Massachusetts, said that because PixarBio CEO Frank Reynolds is also the company’s chairman, chief financial officer and chief scientific officer, he had the authority to control the content and form of PixarBio’s annual reports and press releases provided to the market.

“Because of his positions within the Company and his access to material non-public information available to him but not to the public, Reynolds knew that the adverse facts specified herein had not been disclosed to and were being concealed from the public and that the positive representations being made were false and misleading,” the suit said.

Among the press releases that the lawsuit cited is a lengthy, nearly 2,700-word press release that pointed towards a -41.7% slide in the price of NVIV shares since January last year to make the case for Reynolds’ proposed merger. In the release, Reynolds asserted that he is the rightful owner of the intellectual property behind InVivo’s technology.

“We all know that NVIV current CEO Mark Perin’s [sic] took his company before NVIV as CEO into bankruptcy, and Perin [sic] has had 3 years (maybe 2 years too long) that’s enough time to succeed with a Frank Reynolds’ Neuroscaffold technology so it’s time for change. The CEO of NVIV needs to be replaced to have a shot at commercializing NVIVs true value, the NeuroScaffold for treating acute spinal cord injury invented by Frank Reynolds,” Reynolds said in prepared remarks.” PixarBio’s 2017 Deal making is NOT done. The industry needs consolidation, so let’s get busy and make US Pharma great again [sic].”

Reynolds said the $77 million offer, which he later upped to $100 million, was discounted “because NVIV has failed to develop my patents, science and know-how. NVIV appears to have lost the historically significant [spinal cord injury] primate research data, and they are now back to my 2010 IPO share price, for the second time in 3.5 years but its 2017 [sic]. It is time I take back the technology I invented to bring my neurological R&D portfolio to market by acquiring NVIV and saving the NVIV shareholder from more years of down-rounds.”

InVivo responded to the offer, saying that PixarBio’s statement “contained a number of unfounded statements that do not warrant a response.”

“InVivo Therapeutics Corporation was not privy to the announcement made today and has not had any discussions with PixarBio Corporation nor any other party regarding this matter. Given that the nature of the offer is not credible, InVivo disclaims any obligation to make any additional public statements regarding this or similar proposed transactions from PixarBio,” the company said.

On Jan. 23, PixarBio said publicly that it would end its takeover bid for InVivo and instead focus on its NeuroRelease pain platform.

The SEC later suspended trading in shares of PixarBio due to possible “manipulative or deceptive activities” and due to questions about the accuracy of claims made by the company in press releases and SEC filings.

“On January 3, 2017, the Company reported an apparently false takeover bid for InVivo. On January 20, the SEC temporarily halted trading of PixarBio shares. From January 3, 2017 through January 20, 2017, when the SEC intervened, shares in PixarBio fell from $4.59 to $2.90 per share, nearly 37%. This decline is directly attributable to the Company’s false representations about its development and business combination prospects,” the lawsuit said.

The post PixarBio investors sue over sham InVivo takeover bid appeared first on MassDevice.

from MassDevice http://ift.tt/2kQ39B9

Arguments set to begin in ex-Stryker rep’s appeal of $750k loss

A former Stryker (NYSE:SYK) sales rep is slated to appeal his nearly $750,000 loss in a lawsuit over his move to rival Biomet (now Zimmer Biomet (NYSE:ZBH)), with oral arguments due to begin tomorrow.

Stryker in 2013 sued a pair of former sales agents, Christopher Ridgeway and Richard Steitzer, accusing them of scheming to poach reps and business from Stryker in Louisiana and New York. Stryker fired Ridgeway in September 2013, after discovering that he was allegedly running a pair of medical supply businesses on the side. In June of that year, Stryker alleged, Biomet began courting Ridgeway, looking to bring his entire Stryker sales teams on board. Ridgeway also allegedly induced a 3rd Stryker employee, Sheldon Green, to jump ship for Biomet and forwarded Stryker’ Louisiana customer list to Green, according to the complaint.

Ridgeway counter-sued, alleging that Stryker defamed him by falsely telling his customers that he was bound by a non-compete, costing him millions. A federal jury in the U.S. District Court for Western Michigan in February 2016 found for Stryker, awarding $745,195 in damages on 3 counts: breach of contract, breach of fiduciary duty and a trade-secrets claim. Ridgeway appealed to the U.S. Court of Appeals for the 6th Circuit, arguing that there never was a non-compete and that Stryker fabricated the non-compete document used in his district court action.

After Stryker sought millions more in costs and attorney’s fees, Ridgeway declared bankruptcy, prompting a stay in the district court case pending the resolution of the 6th Circuit appeal.

Ridgeway also argues in his appeal that the case should have been tried under Louisiana law, where he was based, rather than under the laws of Michigan, Stryker’s home state.

“The lower court should have applied Louisiana law to the noncompete agreement. Under Michigan’s conflict-of-law rules, a choice-of-law provision will not be enforced if another state has a more significant relationship to the parties and the transaction at issue, and has a fundamental policy that would be violated by application of the law chosen by the parties. The Michigan choice-of-law clause fails because Louisiana had the closest relationship to the case and was the location of the risk the noncompete clause concerned: Ridgeway was a Louisiana citizen who sold Stryker products in Louisiana to customers located in Louisiana, and the enforcement of a noncompete clause affected his ability to make a living in Louisiana. The law of Michigan, which favors noncompete clauses, is also contrary to Louisiana’s strong public policy disfavoring them, which has been expressed by a statute making them unenforceable absent narrow, specific exceptions not satisfied here. Thus, Louisiana law should have been applied to the noncompete clause,” according to the appeal.

“The district court also erred in excluding two allegedly privileged emails showing Stryker knew Ridgeway had no noncompete agreement. First, the court applied the wrong standard in rejecting Ridgeway’s argument that the privilege was waived under the crime-fraud exception. The court required Ridgeway to produce conclusive proof of fraud rather than merely showing a reasonable basis to suspect fraud as required under Michigan law. Even Ridgeway’s substantial evidence of Stryker’s misconduct was not sufficient to satisfy this test. This alone is reversible error. The court also ignored Ridgeway’s argument that Stryker waived the privilege by voluntarily placing the validity of Ridgeway’s noncompete agreement in dispute,” Ridgeway argued, according to court documents.

The post Arguments set to begin in ex-Stryker rep’s appeal of $750k loss appeared first on MassDevice.

from MassDevice http://ift.tt/2kQ0JCX

Zimmer Biomet’s Q4, 2106 numbers top estimates

Zimmer Biomet (NYSE:ZBH) topped the consensus forecasts for both its 4th-quarter and full-year 2016 results, despite a nearly -50% profit slide for the quarter.

The Warsaw, Ind.-based orthopedics giant posted profits of $66.6 million, or 33¢ per share, on sales of $2.01 billion for the 3 months ended Dec. 31, for a bottom-line decline of -47.6% on sales growth of 4.1% compared with Q4 2015.

Adjusted to exclude 1-time items, earnings per share were 2.14, 3¢ ahead of the consensus on Wall Street, where analysts were looking for sales of $1.98 billion.

Full-year profits were a different story, rising 106.1% to $302.9 million, or $1.50 per share, on sales of $7.68 billion – a 28.1% top-line gain. Adjusted EPS for the year also beat estimates, coming in 4¢ above the consensus at $7.96 per share. Analysts were looking for sales of $7.65 billion for 2016.

“Zimmer Biomet delivered solid revenue growth in the 4th quarter. Our performance was driven, in part, by the re-acceleration of our knee and hip businesses, as well as the ongoing strength of our [sports, extremities & trauma] category and Asia-Pacific region,” president & CEO David Dvorak said in prepared remarks. “As we reflect on the completion of our 1st full year as a combined company, our achievements have further strengthened our confidence in the unique value-creation opportunity we offer in the dynamic global healthcare environment. We will continue to drive growth across our broad musculoskeletal portfolio in 2017, as we remain focused on delivering against our net synergy commitments and making ongoing progress towards optimizing and harmonizing our supply chain, and manufacturing and quality systems.”

Zimmer Biomet said it expects to report adjusted EPS of $8.50 to $8.68 on sales of $7.86 billion to $7.93 billion this year.

ZBH shares closed down -1.3% yesterday at $115.39 apiece.

The post Zimmer Biomet’s Q4, 2106 numbers top estimates appeared first on MassDevice.

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

Valeris raises $450k, looks to $3m in new equity round

Early-stage orthopedic company Valeris Medical has raised $450,000 in a new round of equity financing, aiming to raise an additional $2.6 million before closing the round, according to an SEC filing posted this week.

Money in the equity and option round came from 3 unnamed sources, with a minimum investment of $25,000 required in the round.

The company has not yet stated how it plans to spend funds raised in the round, or how long the round will stay open. The 1st sale in the round was made on Jan. 27, according to the SEC filing.

Valeris “partners with strategic surgeon experts to innovate and deliver the next level of orthopedic implants and delivery systems to better serve the medical industry and the millions of patients treated annually,” according to med device distributor Affirmative Solutions’ website.

Among the company’s products are the BoneCam Suture Anchors, which won FDA 510(k) clearance in August 2015, according to an FDA filing. The device is intended to be used for suture fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip.

The company raised $1.5 million last Sept. in a round of debt financing.

The post Valeris raises $450k, looks to $3m in new equity round appeared first on MassDevice.

from MassDevice http://ift.tt/2jMW4nz

FDA: Bard recall of Halo1 guiding sheath is Class I

The FDA today announced a Class 1 recall of C.R. Bard’s (NYSE:BCR) the Halo One thin-walled guiding sheaths over issues associated with sheath separation, kinking and tip damage during use.

The Murray Hill, N.J.-based company’s Halo One sheath is designed to introduce and guide the placement of interventional or diagnostic devices into veins and arteries through an incision on the patient’s leg.

A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.

The federal watchdog said Bard is recalling the device over issues with the sheath body which result in it separating from the sheath hub while removing the device from the patient’s leg. The company also reported that the sheath can kink, and that its tip may become damaged during the procedure, which could cause adverse health consequences.

Such malfunctions could result in prolonged procedure times or additional surgical interventions to removed detached components from the patient. The agency warned that affected products could cause other serious adverse health consequences, including internal tears and perforations of arteries and veins, excessive bleeding and death.

The recall affects Halo One thin-walled guiding sheaths with product codes HAL545, HAL590 and HAL510F, manufactured between April 12, 2016 and July 7, 2016 and distributed between June 24, 2016 and July 12, 2016. A total of 25 different lot numbers were named in the recall, with 101 devices distributed in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah and Washington.

Bard said it began notifying customers with the devices on Jan. 10, instructing them to remove affected unused products to return the items.

The post FDA: Bard recall of Halo1 guiding sheath is Class I appeared first on MassDevice.

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

Trumps new regulatory EO includes guidance docs, could create hurdles for FDA

A new executive order signed today would require all government agencies to eliminate 2 regulations for every new regulation instituted – including guidance documents.

The new order could have a significant impact on the FDA, as it applies to all agencies other than those related to the military and national security, or those specifically exempted by the Office of Management and Budget.

The EO, in its current state, also applies to FDA guidance documents, which will be a significant problem for medical device firms who use such documents to to conform to FDA standards and understand how the agency interprets the law.

How the executive order would operate has yet to be understood, especially considering that most regulations are not connected in terms of functionality or implementation. However, as it stands, the order could effectively require the FDA, and other public health agencies, to cut 2 regulations every time they place a new one, even if those regulations are entirely unrelated.

Any choices for elimination or new regulations would also have to pass scrutiny from the White House, and would be limited by the $0 budget set in the EO.

The order could have a significant impact on the recently passed 21st Century Cares Act, which includes language for developing a new breakthrough device pathway and other implementations what would be subject to the 1-in-2-gone rule. The order will also likely impact the reauthorization of the FDA’s user fee programs, which is slated for September.

On Jan 14, former President Obama signed the 21st Century Cures Act into law, the last step for the bill which had been 2 years in the making.

A week earlier, the U.S. Senate voted 94-5 to pass the 21st Century Cures Act, which sent the measure to President Barack Obama.

The U.S. House voted to pass the healthcare measure by a vote of 392-26 last week. Supporters of the bill said it will spur medical innovation by speeding up the regulatory process for device-makers and pharmaceutical companies, while expanding access to mental health treatment and battle the ongoing opioid epidemic. But critics, like Sen. Elizabeth Warren (D-Mass.) and Sen. Bernie Sanders (D-Vermont), have said the bill gives hand-outs to the pharmaceutical industries and cuts public health programs.

The $6.3 billion measure was sponsored by Rep. Fred Upton (R-Michigan) and authorizes $4.8 billion for the National Institutes of Health and $500 million to the FDA. The bill includes provisions which allow clinical trials for devices and drugs to be designed with fewer patients and simpler goals.

The post Trumps new regulatory EO includes guidance docs, could create hurdles for FDA appeared first on MassDevice.

from MassDevice http://ift.tt/2ka7Wi2

Insulin makers face class-action lawsuit over price collusion

A class-action lawsuit filed in the U.S. District Court of Massachusetts alleges that insulin makers Sanofi (NYSE:SNY), Novo Nordisk (NYSE:NVO) and Eli Lilly (NYSE:LLY) conspired to raise their list prices to get access to pharmacy benefit managers’ preferred lists, instead of competing with each other based on real market prices.

In the last 5 years, the 3 companies have raised the sticker prices on their drugs by more than 150%, according to the lawsuit. A recent study by the American Medical Association demonstrated that the price of insulin nearly tripled between 2002 and 2013.

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

 

The post Insulin makers face class-action lawsuit over price collusion appeared first on MassDevice.

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

Metallic hydrogen could be a reality: Why you should care

Transparent molecular hydrogen (left) at about 200 GPa became black molecular hydrogen (center) and finally reflective atomic metallic hydrogen at 495 GPa (right). [Image courtesy of Isaac Silvera/Harvard]

Harvard University scientists say they have created metallic hydrogen, a super material that until now has only been theoretical.

If the claims pan out, they could open up a host of possibilities, including in the medical device field. That’s because metallic hydrogen theoretically should be superconductive at room temperature. MRIs, for example, would no longer need supercooled magnets.

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

The post Metallic hydrogen could be a reality: Why you should care appeared first on MassDevice.

from MassDevice http://ift.tt/2jOmO4u

Varian Medical closes $600m Varex Imaging spinout

Varian Medical (NYSE:VAR) today announced it successfully completed the $600 million spin-out of its imaging components biz, Varex Imaging (NSDQ:VREX).

Salt Lake City, Utah-based Varex Medical said that common stock in the company will begin trading in the “regular way” today on the Nasdaq Global Select Market under the symbol “VREX.”

“We are very pleased that we were able to complete this successful separation and create two strong independent companies. Varian is now focused exclusively on expanding its position as the leader in systems and software for the treatment of cancer. As a cancer-fighting company we are increasing our efforts to make the treatment of cancer more effective, affordable and accessible for patients around the world.” Varian Medical CEO Dow Wilson said in a prepared release.

Varex makes X-ray tubes, flat-panel detectors, connectors and accessories for imaging, as well as supplying workstations and software for computer-aided diagnostics and image processing. Varex imaging will pursue its own growth strategies independent from Varian, through offering of components, software and services for expanded imaging applications and markets, according to the company.

As part of the separation, Varex made a $200 million cash payment to Palo Alto, Calif.-based Varian, funded from its $300 million revolving credit facility.

The transaction was completed through a distribution of Varex stock to Varian shareholders on January 20, with each Varian holder receiving 0.4 shares of Varex for every 1 share of Varian. No fractional Varex shares were offered in the distribution. Varex has approximately 38 million shares outstanding.

“The past few months have been very busy as we prepared for the spin-off of Varex Imaging and also announced the planned acquisition of the Medical Imaging business of PerkinElmer. Much of our time recently has been filled with meetings, calls and roadshow presentations with the investor and analyst community.  Overall, the past year has been an exciting time for us and I want to thank all the people at Varian and Varex who devoted so much time and effort to make the separation a success,” Varex Imaging prez & CEO Sunny Sanyal said in prepared remarks.

Varian 1st announced its plans to spin-off the business in May 2016, saying in June that it planned to re-named the spin-off as Varex Imaging to reflect “the 65-plus years of technology leadership and strong industry brand recognition of Varian and the excellence in X-ray imaging technology.”

Varex Imaging shares are trading at $27.14 today.

The post Varian Medical closes $600m Varex Imaging spinout appeared first on MassDevice.

from MassDevice http://ift.tt/2k9SDpi

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

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

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

 

5. Senate panel slated to vote on HHS nominee Price

A U.S. Senate panel is slated to vote tomorrow on whether to approve the Trump administration’s nominee to head the Health & Humans Services Dept., Rep. Tom Price (R-Ga.).

Price, a physician who is chairman of the House budget committee and a member of the House Ways & Means panel, has drawn scrutiny for the timing of some of his investments. He bought shares in Zimmer Biomet just days before introducing a bill to delay a program designed to change the way large joint implants are paid for; after the vote, Zimmer Biomet’s political action committee donated to Price’s re-election campaign. Read more

---

4. Zimmer Biomet logs 3rd win in NexGen Flex bellwether trials

Zimmer Biomet last week won its 3rd bellwether trial in the multi-district litigation brought over the NexGen Flex knee implant, after a federal jury in Illinois found against the plaintiff.

The FDA in 2007 cleared the NexGen Flex implant, designed to provide more flexibility than other knee replacement devices. Beverly Goldin is 1 of thousands of product liability plaintiffs in the MDL who allege that the device can’t withstand that extra flexion, despite the Warsaw, Ind.-based company’s marketing claims. The plaintiffs also allege that a design flaw makes the device more prone to premature loosening requiring revision procedures. Read more

---

3. FDA approves Gore’s Viabahn stent graft for iliac artery lesions

W.L. Gore & Assoc. said today that it won FDA approval for its Viabahn stent graft for treating iliac artery lesions, including those found at the aortic bifurcation.

Flagstaff, Ariz.-based Gore said the approval means the device is the only balloon-expandable stent graft indicated for the iliac artery. Read more

---

2. Covidien spinout Mallinckrodt closes $690m sale of nuclear imaging biz

Covidien spinout Mallinckrodt plc said today that it closed the $690 million sale of its nuclear imaging business to IBA Molecular. Mallinckrodt’s nuclear imaging business includes 2 manufacturing facilities and more than 800 employees.

The $690 million deal, which was announced in August last year, consists of Mallinckrodt’s portfolio of diagnostic imaging products, including medical isotope molybdenum-99, the parent isotope to technetium 99m which is used in nearly 80% of all nuclear medicine procedures around the world. Read more

---

1. Pacemaker data lead to arson charges for Ohio man

Pacemaker data reportedly led to arson and fraud charges for an Ohio man accused of torching his home for the insurance money.

Ross Compton of Middletown, Ohio, faces felony counts of aggravated arson and insurance fraud for the Sept. 19 fire at his home, which allegedly caused about $400,000 in damages and destroyed the 2,000-square-foot house, according to news reports. Read more

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

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

Merck becomes latest to offer insight into drug pricing practices

Last week, Merck (NYSE:MRK) released figures about its U.S. pricing practices, joining a growing list of companies that are revealing their pricing strategies amid criticism of the industry’s price hikes.

The company didn’t release price increases of specific products, citing competition concerns. Merck said it would update the list annually at the beginning of each calendar year.

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

The post Merck becomes latest to offer insight into drug pricing practices appeared first on MassDevice.

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

Researchers develop immune cells that infiltrate tumors

Researchers from the Okayama University have developed a group of immune cells that can infiltrate tumors and deliver viral vectors, destroying them from the inside out. The team’s work was published in the journal Scientific Reports.

The team developed the tumor-targeting technique using a human T-cell line known as HOZOT, which naturally targets human cancer cells. HOZOT cell lines are established by co-cultivating human umbilical cord blood cells and mouse stromal cells, according to the researchers. The HOZOT cells are toxic to tumors, but do not target healthy tissue.

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

The post Researchers develop immune cells that infiltrate tumors appeared first on MassDevice.

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

Hill-Rom shares dip on Q1 miss

Shares in Hill-Rom (NYSE:HRC) have dipped today after the company missed expectations on The Street with its 1st quarter earnings results.

The Chicago-based company posted profits of $23.5 million, or 36¢ per share, on sales of $637.4 million for the 3 months ended Dec. 31st, for massive bottom-line growth of 446% while sales shrunk 3.6% compared with the same period in the previous fiscal year.

After adjusting to exclude 1-time items, earnings per share were 75¢, behind the 83¢ consensus on The Street, where analysts were looking for sales of $649 million.

“Hill-Rom delivered solid earnings in the 1st quarter and made progress in expanding our capabilities, capitalizing on new product introductions, and partnering with customers to enhance outcomes for patients and their caregivers. Our performance and outlook reflect our commitment to drive sustainable performance through focused commercial and operational execution, and strategic investments that create long-term value for patients, customers and shareholders,” CEO & prez John Greisch said in a press release.

Hill-Rom said it expects to post adjusted earnings per share of between $3.74 and $3.82 for the full year, with between $330 and $340 million in operating cash flow. For the upcoming 2nd quarter, the company said it expects to report between 77¢ and 79¢, with core revenue increasing 4% to 5%.

“We remain focused on executing our strategic priorities, leveraging Hill-Rom’s strong global brands and geographic footprint, and launching new innovations to ensure sustained growth and profitability in the years ahead. With strong growth prospects and margin expansion opportunities, we are confident in our ability to achieve our 2017 guidance and long-term objectives,” Greisch said in a prepared statement.

Shares in Hill-Rom have dipped 2.2% to $58.33 in mid-day trading.

Earlier this month, Hill-Rom said that it agreed to put up $300 million for Mortara Instrument and its line of diagnostic cardiology and patient monitoring devices, not including a $40 million “tax benefit” the company expects to gain by structuring the buyout a certain way.

Milwaukee-based Mortara makes an eponymous line of cardiac monitoring devices, plus the Quinton and Burdick brands it acquired from Opko’s Cardiac Science in 2013. The company, which employs more 400 workers, posted sales of $115 million last year, Chicago-based Hill-Rom said.

The post Hill-Rom shares dip on Q1 miss appeared first on MassDevice.

from MassDevice http://ift.tt/2jLPH3N

BioSig seeks funding in the EU

BioSig Technologies (OTCQB: BSGM) said today it will engage in an institutional investor roadshow in the EU as it seeks funding for its proprietary Pure electrophysiology platform.

The company is developing a cardiac signal acquisition and display system which is designed to assist electrophysiologists in making clinical decisions for patients with abnormal heart rates and rhythms, including atrial fibrillation and ventricular tachycardia.

Minneapolis, Minn.-based BioSig said it will tour “major EU financial centers” between Feb. 27 and March 3, with board chair Kenneth Londoner delivering presentations and meeting 1-on-1 in London, Zurich, Geneva, Paris and Milan.

“Our company is proceeding with European regulatory clearance for the Pure EP System and we will continue to build commercial and investor relationships in the EU prior to launch,” Londoner said in a press release.

Earlier this month, BioSig issued a letter to its shareholders updating them on the company’s recent developments and revealing that it tapped Minnetronix to develop the 1st version of its Pure EP system.

The post BioSig seeks funding in the EU appeared first on MassDevice.

from MassDevice http://ift.tt/2kH4qeL

Volpara touts study showing benefits for density scanning before mammograms

Volpara Solutions today released results from a study of its Volpara Density measuring software, touting the benefits of the software for improving mammography performance measures.

The study included 111,898 mammograms from 53,239 women who were part of the Dutch Breast Screening Program, the New Zealand-based company said.

Results from the study suggest that automatically measuring breast density using the Volpara Density software produces results with higher reproducibility than through visual assessments, and could help with implementing density-based supplemental screenings.

“There have been several studies that have demonstrated the impact of breast density on the sensitivity of mammography, including a recent study published in the American Journal of Roentgenology that showed a strong linear relationship between volumetric breast density and sensitivity.  However, this is the 1st large-scale study to also demonstrate a strong relationship between volumetric density and other screening performance measures like recall rate, false positives or interval cancers. With the high reproducibility of the automatic Volpara Density software, this could help with evaluating risk and better inform clinical decisions about adjunctive screening options based on women’s specific density and other risk factors,” study researcher Dr Carla van Gils said in a prepared statement.

Data in the study indicated that increased breast density had a strong linear relationship to all screening performance measures except positive predictive values. The rate of recalls, false positives and total and interval breast cancers in higher breast density patients were greater than those with lower, Volpara said.

Study results indicated that women with extremely dense breasts were 7 times as likely to have an interval cancer and twice as likely to receive a false positive than those with very fatty breasts.

“This indicates that the detection of invasive breast cancers in screening is hampered to a larger extent than the detection of in situ breast cancers. A possible explanation for this is that the visibility of microcalcifications is not hampered as much in dense tissue as the visibility of invasive breast cancers. Studying this relationship further could be very important as we further develop our understanding of the effectiveness of screening,” Dr van Gils said in a press release.

The post Volpara touts study showing benefits for density scanning before mammograms appeared first on MassDevice.

from MassDevice http://ift.tt/2k9nVwI

Early research shows shark antibodies carrying drugs across blood-brain barrier

Photo credit: Albert Kok

Danish pharmaceutical company Lundbeck made an undisclosed milestone payment to biotech Ossianix Inc., after experiments showed that shark antibodies effectively shuttled potential drugs across the blood-brain barrier in mice.

The 2 companies established a research collaboration in 2014, focusing on technology development and the delivery of antibody-based therapies across the blood-brain barrier.

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

The post Early research shows shark antibodies carrying drugs across blood-brain barrier appeared first on MassDevice.

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

Pulmatrix seeks to raise $5m in direct offering

Pulmatrix (NSDQ:PULM) said today that it landed an agreement with several institutional investors to purchase $5.0 million of shares of common stock in a registered direct offering.

The Lexington, Mass.-based company agreed to sell 2 million shares of common stock at $2.50 apiece. The offering is expected to close on Feb. 2.

Pulmatrix said it anticipates that the offering will bring in $4.5 million in net proceeds, which it plans to use for general corporate purposes and debt payments.

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

The post Pulmatrix seeks to raise $5m in direct offering appeared first on MassDevice.

from MassDevice http://ift.tt/2jKOZ6Z

Senate panel slated to vote on HHS nominee Price

A U.S. Senate panel is slated to vote tomorrow on whether to approve the Trump administration’s nominee to head the Health & Humans Services Dept., Rep. Tom Price (R-Ga.).

Price, a physician who is chairman of the House budget committee and a member of the House Ways & Means panel, has drawn scrutiny for the timing of some of his investments. He bought shares in Zimmer Biomet (NYSE:ZBH) just days before introducing a bill to delay a program designed to change the way large joint implants are paid for; after the vote, Zimmer Biomet’s political action committee donated to Price’s re-election campaign.

The the administration maintains that the stock purchases were made by a broker without Price’s knowledge; he later pledged to divest all healthcare-related stocks, including his stake in Zimmer Biomet, if confirmed as HHS secretary.

Yesterday Sen. Orrin Hatch (R-Ore.), chairman of the Senate Finance committee, said the panel is due to vote tomorrow on Price’s nomination. At a hearing last week before the committee, the nominee minimized the impact he would have on changing the healthcare insurance system if confirmed, saying it would be his task to carry out the will of Congress. Legislators in the Republican-led Congress are preparing legislation to repeal and replace Obamacare.

Republicans generally support Price’s nomination, while Democrats are sharply critical. At last week’s hearing, ranking member Sen. Ron Wyden (D-Ore.) said that Price’s confirmation would “take America back to the dark days when healthcare was for the healthy and the wealthy.”

Material from Reuters was used in this report.

The post Senate panel slated to vote on HHS nominee Price appeared first on MassDevice.

from MassDevice http://ift.tt/2jKFB33

Teva wins FDA nod for inhaled asthma medications

Teva Pharmaceuticals (NYSE:TEVA) said today that the FDA approved 2 inhaled asthma medications to be delivered using the company’s RespiClick breath-activated, multi-dose dry powder inhaler. The products, AirDuo RespiClick and ArmonAir RespiClick, are indicated for use in asthma patients as young as 12 years old.

The Jerusalem-based company’s AirDuo RespiClick is a fixed dose combination of a corticosteroid and a long-acting beta-adrenergic agonist, while the ArmonAir RespiClick is an inhaled corticosteroid.

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

The post Teva wins FDA nod for inhaled asthma medications appeared first on MassDevice.

from MassDevice http://ift.tt/2jmuG0O

Zimmer Biomet logs 3rd win in NexGen Flex bellwether trials

Zimmer Biomet (NYSE:ZBH) last week won its 3rd bellwether trial in the multi-district litigation brought over the NexGen Flex knee implant, after a federal jury in Illinois found against the plaintiff.

The FDA in 2007 cleared the NexGen Flex implant, designed to provide more flexibility than other knee replacement devices. Beverly Goldin is 1 of thousands of product liability plaintiffs in the MDL who allege that the device can’t withstand that extra flexion, despite the Warsaw, Ind.-based company’s marketing claims. The plaintiffs also allege that a design flaw makes the device more prone to premature loosening requiring revision procedures.

Zimmer Biomet denies that the devices are defective and said they have a successful track record; Judge Rebecca Pallmeyer of the U.S. District Court for Northern Illinois, who is overseeing the MDL, and 2 juries have agreed so far.

“Judgment is entered in favor of defendant Zimmer Inc., and against plaintiff Beverly Jemma Goldin,” according to court documents filed Jan. 26 in the most recent trial. Pallmeyer, who did not release the jury verdict form, ordered both parties to submit any post-judgment filings within 30 days.

Zimmer Biomet won the 2nd bellwether last fall when Pallmeyer found that the plaintiff failed to prove that a design defect caused the implant to fail. The jury in the 1st bellwether in November 2015 likewise cleared the company, finding that the plaintiff failed to prove defective design and failure to warn claims.

At least 5,900 NexGen product liability lawsuits have been consolidated into the MDL under Pallmeyer, but the going hasn’t been smooth. It was a challenge to find suitable bellwethers; in June 2015 the judge issued a so-called “Lone Pine” order requiring plaintiffs to prove their cases. Named for a 1986 decision dismissing a mass toxic tort case against a New Jersey landfill, a Lone Pine order requires plaintiffs to show a link between their injuries and the product accused of causing them.

The post Zimmer Biomet logs 3rd win in NexGen Flex bellwether trials appeared first on MassDevice.

from MassDevice http://ift.tt/2jKo4Ih