AngioDynamics slides on fiscal Q3 misses

AngioDynamicsAngioDynamics (NSDQ:ANGO) shares are down today after the medical device company missed the mark with its fiscal third-quarter sales and earnings.

Profits were nearly halved for Latham, N.Y.-based AngioDynamics during the three months ended Feb. 28, falling some -94.3% to $796,000, or 2¢ per share compared with Q3 2018. Sales grew 3.0% to $86.3 million compared with the same period last year.

Adjusted to exclude one-time items, earnings per share were 19¢, 2¢ below the consensus estimate on Wall Street, where analysts were looking for revenues of $88.3 million.

“While we had pockets of softness in our financial performance during the third quarter, our overall performance remains strong and we are confident that we will achieve our full-year guidance. We saw strong growth contributions during the quarter from AngioVac and Solero, as well as from fluid management,” president & CEO Jim Clemmer said in prepared remarks. “Additionally, I am very excited that the FDA has approved the IDE for our NanoKnife Direct clinical study, which is the next step toward this incredible technology improving the standard of care for patients afflicted with Stage III pancreatic cancer. The IDE approval also represents a milestone for AngioDynamics as we transform into an evidence-based Company focused on therapies and outcomes facilitated by our unique technologies.”

AngioDynamics stood by its prior guidance for fiscal 2019, saying it still expects to report adjusted EPS of 82¢ to 86¢ on sales of $354 million to $359 million.

ANGO shares, which closed up 9.4% at $25.01 apiece yesterday on news of the IDE approval, were off -7.2% to $23.20 each in pre-market trading. The stock was at $24.48 per share today, down -2.1%, in mid-afternoon activity.

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Smith & Nephew to acquire patient monitor dev Leaf Healthcare

Smith & Nephew, Leaf Healthcare

Smith & Nephew (NYSE:SNN) said today that it inked a deal to acquire patient monitoring system developer Leaf Healthcare for an undisclosed amount.

London-based Smith & Nephew said that the acquisition follows a successful two-year partnership deal with Pleasanton, Calif.-based Leaf Healthcare in which Smith & Nephew served as its exclusive distributor and as a strategic investor.

Leaf Healthcare’s flagship product is their Leaf patient monitoring system, which features a wearable wireless sensor designed to track patient movement and notify caregivers to prevent immobility-related health complications, such as pressure ulcers or injuries.

Smith & Nephew said that the Leaf system will join the Allevyn Life, Allevyn Gentle Border and Secura skin care products in its pressure injury prevention portfolio.

“The benefits of patient turning and improved patient mobility are well recognized, including the potential for shorter hospital stays. We are proud of the impact our technology has already made through our existing relationship with Smith & Nephew. We are excited by this new opportunity to deploy our award-winning pressure injury prevention technology through Smith & Nephew’s extensive advanced wound management portfolio,” Leaf Healthcare co-founder & CEO Dr. Barrett Larson said in a prepared statement.

Smith & Nephew said that it expects the acquisition to close during the second quarter of this year, and added that it will finance the purchase from existing cash and debt facilities.

“Consistent with our initial strategic investment, Smith & Nephew is focused on providing not just products to treat conditions, but also supporting clinicians with technologies designed for prevention as well as treatment, and helping healthcare facilities reduce the cost of care. The Leaf patient monitoring system is highly complementary to Smith & Nephew’s existing wound portfolio and we are excited by the opportunities of expanding this product within our global portfolio,” Smith & Nephew advanced wound management prez Simon Fraser said in a press release.

Last week, a group of Osiris Therapeutics (NSDQ:OSIR) shareholders announced they are suing to block its $660 million acquisition by Smith & Nephew because the purchase price is too low.

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Neovasc shares tumble on 2018 earnings release

Neovasc

Shares in Neovasc (NSDQ:NVCN) have fallen nearly 10% today after the medical device maker posted full year 2018 earnings that showed losses growing to more than triple what it reported in 2017.

The Vancouver-based company posted losses of $109.1 million, or $7.63 per share, on sales of $1.7 million, seeing losses grow 338.7% while sales shrunk 67.5% compared with the previous fiscal year.

“After achieving a steady flow of positive operational and development milestones throughout 2018, we have entered 2019 with significant momentum in the business which is driving increased awareness among cardiologists for both the Tiara and Reducer. Our sales and marketing team continues to make steady progress ramping up sales for the Reducer through our partners and distributors across the EU and Middle East and through direct sales activities in Germany. The clinical data that we have generated for the Reducer as a treatment for chronic refractory angina continues to build support among some of the leading cardiologists around the world. As a result, we have already generated a number of peer reviewed articles and presentations at medical conferences in 2019 that are putting us in front of an ever larger number of cardiologists and other treating physicians. This new data is going further in showcasing patients’ responses to the Reducer, by utilizing new technologies to measure its performance, including dipyridamole stress perfusion cardiac magnetic resonance. While still in clinical trials, the Tiara truly is a leading edge, ground-breaking device that is expected to be able to treat more patients with a larger amount of co-existing conditions. Our clinical data continues to support our efforts to further develop the Tiara as we look to bring it to market. The positive momentum we built up in 2018 for patient enrollment through the addition of several new clinical sites will support the ongoing TIARA-II study in 2019. We recently received regulatory approval in Germany and the UK to proceed with the second phase of the study,” prez &CEO Fred Colen said in a press release.

Shares in Neovasc have fallen approximately 9.3% so far today, at approximately 43¢ as of 10:44 a.m. EDT.

Yesterday, Neovasc claimed a win in its patent infringement war with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve Technologies, saying a German appeals court dismissed a case there.

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Establishment Labs shares up on mixed-bag Q4, FY2018 earnings

Establishment Labs

Shares in breast implant maker Establishment Labs rose in after-hours trading today after the company posted fourth quarter and full year 2018 earnings that beat sales expectations but missed loss-per-share consensus on Wall Street.

The New York-based company posted losses of $10.5 million, or 52¢ per share, on sales of approximately $16.4 million for the three months ended December 31, seeing sales grow 38.8% while losses grew 47.4% compared with the same period during the previous year.

Losses per share were ahead of the 36¢ loss-per-share consensus on Wall Street where analysts expected to see sales of approximately $15.7 million, which the company topped.

For the full year, Establishment Labs posted losses of approximately $21.1 million, or $1.22 per share, on sales of $61.2 million, seeing losses shrink 39.5% while sales grew 76.5% compared with the previous year.

Losses per share were again behind the $1.08 loss-per-share consensus on Wall Street, where analysts expected to see sales of approximately $60.5 million, which the company topped.

“2018 was an outstanding year for Establishment Labs as we continued to execute on our strategy of bringing our Motiva Implants to more women worldwide. Our performance is the result of our clearly differentiated, innovative product portfolio and the trust physicians and patients are placing in us and our technology. With the momentum we are carrying into 2019, we should continue to deliver top line growth,” CEO Juan Chacón-Quirós said in a press release.

Shares in Establishment Labs have risen approximately 4.9% so far in after hours trading, at $29.65 as of 4:09 p.m. EDT. 

Last October, Establishment Labs said that it inked a number of asset purchase agreements with distributors in Spain and Germany to repurchase stock they had previously held.

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Clearside Biomedical shares down on Q4 miss

Clearside Biomedical

Shares in Clearside Biomedical (NSDQ:CLSD) have fallen slightly today after the biopharmaceutical company posted fourth quarter 2018 earnings that missed expectations on Wall Street.

The Alpharetta, Ga.-based company reported research and development costs of approximately $17.5 million with a total net loss of $21.6 million, or 68¢ per share, for the three months ended December 31, seeing R&D costs grow 25.5% while losses grew 31.2% when compared with the same period during the previous year.

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

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Corindus Vascular Robotics meets The Street with Q4 earnings

Corindus Vascular RoboticsCorindus Vascular Robotics (OTC:CVRS) shares gained today after the robot-assisted surgery company reported fourth-quarter results that met the forecast on Wall Street.

Losses grew 3.1% for Waltham, Mass.-based Corindus posted to -$8.2 million, or -4¢ per share, on sales growth of 11.5% to $4.7 million for the three months ended Dec. 31, 2018, compared with the same period in 2017. Analysts were looking for LPS of -4¢.

Full-year losses were ip 25.0% to -$42.6 million, or -22¢ per share, on sales growth of 11.7% to $10.8 million compared with 2017.

“2019 is poised to be another significant year for Corindus. The successful completion of the world’s first-in-human remote robotic PCI procedure in India in December represents an exciting milestone for the future of our technology. Doctors around the world are embracing the technology and its life-saving potential for patients with limited access to care. Physicians increasingly understand that building clinical knowledge and expertise in robotics is a prerequisite to telerobotic intervention. As a result, we expect to see continued positive momentum and have seen a shortening of the sales cycle from initial discussion to installation of our robotic platform. Through the expansion of existing programs in the U.S., increased utilization and the broadening of our global footprint, we believe we are on the right path to serve patients and build shareholder value,” president & CEO Mark Toland said in prepared remarks. “Moreover, we have advanced our neurovascular work and look forward to receiving clearance from the FDA for the neurovascular indication for the CorPath GRX. We believe our technology has the potential to address the large unmet need and transform the standard of care for stroke patients, where access is limited and time to treatment is critical. We expect the private placement we recently completed, along with the potential strategic partnership we are pursuing, to provide us with the added financial flexibility to bring this indication to market.”

CVRS shares were ip 5.5% to $1.52 apiece today in mid-afternoon trading.

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Sientra plunges on Q4 earnings miss, clouded outlook

SientraA fourth-quarter earnings miss and the uncertainty around an upcoming FDA advisory panel meeting on breast implants sent Sientra (NSDQ:SIEN) shares down precipitously today.

The Santa Barbara, Calif.-based medical aesthetics company’s losses widened 38.1% to -$24.6 million, or 86¢ per share, on sales growth of 71.9% to $19.0 million for the three months ended Dec. 31, 2018, compared with Q4 2017. Analysts on Wall Street were looking for losses of -68¢.

Full-year losses were up 29.0% to -$82.6 million, or -$3.25 per share, on sales growth of 86.4% to $68.1 million compared with the prior year, Sientra said. Breast implant sales are expected to grow by at least 25% to $26 million this year, chairman & CEO Jeff Nugent said, taking into account softness during the first and second quarters around the risk that the March 25 meeting of the FDA’s General & Plastic Surgery Devices advisory panel will recommend restrictions on textured breast implants.

Although the FDA’s warning about the risk of a form of lymphoma associated with textured implants goes back at least two years, recent developments have pushed the issue into the spotlight. For years the safety watchdog’s “summary reporting” policy allowed medical device manufacturers to lump hundreds of adverse event reports into a single filing, meaning that the reported rate of bad outcomes – including deaths – was kept artificially low. From 2008 to 2015 there were only 200 reports stemming from breast implants.

But in 2017 the FDA began requiring companies to report each adverse event on its own. As a result, the agency received more than 4,000 breast implant injury reports in the second half of that year and another 8,000 during the first half of 2018.

Then, last December, Allergan yanked its textured breast implants from the European market after French regulators declined to renew its CE Mark approval until the company submitted more data on the lymphoma risk. And in February the FDA revealed 457 reports of unique cancer cases related to breast implants since 2010, including nine deaths, and announced its plans to convene the plastic surgery panel to consider breast implants.

Nugent said he expects the meeting to help settle investors’ nerves.

“Look, we’re very familiar with the history associated with breast implants. Using history as our guide, we believe that there will be a responsible action taken by the FDA that, at the end of the day, will reduce the uncertainty about the risk associated, that we believe will pick up procedures in the back half of the year,” he told analysts during a conference call yesterday. “There’s a significant amount of uncertainty associated with the risks that we are expecting to be clarified, mitigated to a significant extent in the back half.”

Still, the soft forecast and the earnings miss combined to push SIEN shares down -24.% to $8.55 apiece today in early-afternoon trading.

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Senseonics shares dip on Q4 sales miss, lowered guidance

Senseonics

Shares in Senseonics (NYSE:SENS) fell slightly today after the diabetes-focused device maker posted fourth quarter and full year 2018 earnings that beat loss-per-share consensus but missed sales expectations and lowered its guidance for the 2019 fiscal year.

The Germantown, Md.-based company posted losses of $7.3 million, or 4¢ per share, on sales of $7.2 million for the three months ended December 31, seeing losses shrink 55.2% while sales grew 148.3% compared with the same period during the previous year.

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

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Stratasys shares rise on Q4 earnings release

StratasysShares in Stratasys (NSDQ:SSYS) rose today after the 3D-printing giant met expectations on Wall Street with its fourth quarter and full year 2018 earnings release.

Minneapolis- and Rehovot, Israel-based Stratasys posted profits of $6.3 million, or 12¢ per share, on sales of $177.1 million for the three months ended December 31, seeing a swing from red ink in the bottom line while sales shrunk 1.2% compared with the same period during the previous year.

Read the whole story on our sister site, Medical Design & Outsourcing

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T2 Biosystems shares tumble on 2018 earnings release

T2 Biosystems Logo

Shares in T2 Biosystems (NSDQ:TTOO) have fallen nearly 20% today after the diagnostics maker posted its full year 2018 earnings.

For the full year, the Lexington, Mass.-based company posted losses of $51.2 million, or $1.26 per share, on sales of $10.5 million, seeing losses shrink 18.1% while sales grew 125% compared with the previous year.

For its fourth quarter, T2 Biosystems reported total sales of $1.8 million, up 6% when compared to the same period during the previous year.

“2018 was a year of major achievements for the company highlighted by the FDA clearance of the T2Bacteria panel, which has driven record levels of new interest from hospitals and allowed us to accelerate the growth of our installed base. In the fourth quarter we secured a record 14 new system contracts, contributing to 25 secured in the second half of the year, which came in at the top of our expectations. The earliest of these new T2Bacteria panel customers have now completed the installation, validation and training processes and are beginning to test patients. Concurrently, we anticipate the body of clinical evidence supporting T2Bacteria Panel will grow this year, along with the sharing of best practices and experience between hospitals. We expect this steady increase of T2Bacteria panel activity to drive greater recurring revenue through 2019, and along with growing system contracts, will contribute to achieving our revenue growth guidance for 2019 and a doubling of revenue again in 2020. In 2019 we expect to further expand our market opportunity with the T2Resistance panel, which we expect to launch as a research-use only product in the U.S. and anticipate receiving a CE mark for commercial launch in Europe by the end of 2019. On the development front, we plan to collect data for our pivotal study for the T2Lyme Panel and are encouraged by pre-clinical data that shows the potential to improve patient outcomes,” prez & CEO John McDonough said in a prepared statement.

T2 Biosystems provided guidance for 2019, saying it expects to post revenue of approximately $21 million for the full year with sales of between $1.3 million and $1.5 million for the first quarter.

Operating expenses, excluding product revenue costs, are expected to be between $10.5 million and $11.5 million for its first quarter, the company said.

Shares in T2 Biosystems have fallen approximately 18.9% so far today, at $2.54 as of 2:45 p.m. EST.

Late last month, T2 Biosystems said that it won FDA breakthrough device designation for its T2Resistance Panel diagnostic designed to detect 13 drug resistance genes from a blood sample.

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