Staar Surgical shares jump on Q3 Beat

Shares in Staar Surgical (NSDQ:STAA) have risen in after-hours trading today after the medical device maker beat expectations on Wall Street with its third quarter results.

The Monrovia, Calif.-based company posted profits of approximately $1.5 million, or 3¢ per share, on sales of approximately $31.8 million for the three months ended September 28, for bottom-line growth of 24.4% on sales growth of 35.3% compared with the same period during the previous year.

Adjusted to exclude one time items, earnings per share were 7¢, well ahead of the 3¢ loss-per-share expectation on Wall Street, where analysts expected to see sales of $29 million, which it handily topped.

“STAAR’s operating momentum continued during the third quarter resulting in an increase in sales of 35% over the prior year driven by the growth of our EVO Visian ICL family of lenses. ICL unit growth highlights for the quarter included China up 100%, Japan up 95%, India up 27% and Germany up 20%. We continue to see strengthening in our key international markets as we prepare for Europe’s and Korea’s high implant season beginning this quarter and extending into Q1 2019 with strong trends continuing in our Asian markets as well. In addition, we believe our full year fiscal 2018 sales growth should exceed 30% over 2017, based on current market conditions, and we fully expect to maintain GAAP profitability for the year. We are also pleased to report that implants have begun and the staged rollout of our Toric ICL lens in the U.S. with certified surgeons is in progress and ahead of schedule. Based upon the enthusiastic reception from prominent surgeons to the Toric ICL, we anticipate that this product introduction represents a positive re-entry point for STAAR in the U.S., the world’s second largest market for refractive vision correction procedures. Finally, outside the U.S. our multi-site EVO with Aspheric Optic clinical trial for presbyopia is ongoing. Our principal investigator from the initial first-in-person clinical trial of the EVO with Aspheric Optic lens for presbyopia presented his study data during our invitation only Experts Summit for surgeons held immediately ahead of the European Society of Cataract and Refractive Surgeons meeting in Vienna last month. We are very pleased with the enthusiastic reception his presentation received,” prez & CEO Caren Mason said in a press release.

Shares in Staar Surgical closed up 4.2% today, closing at $40.11. Shares have jumped another 7.1% in after-hours trading, at $42.95 as of 4:46 p.m. EDT.

In September, Staar Surgical said that it won FDA approval for its Visian toric implantable collamer lens designed for correcting myopia with astigmatism.

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Masimo Q3 beats The Street

Masimo (NSDQ:MASI) today released third quarter earnings that topped expectations on Wall Street and lifted its guidance for the remaining year.

The Irvine, Calif.-based company posted profits of $57.1 million, or $1.02 per share, on sales of $210.6 million for the three months ended September 29, for bottom-line growth of 59.3% on sales growth of 8.9% compared with the same period last year.

Adjusted to exclude one-time items, earnings per share were 71¢, ahead of the 69¢ consensus on The Street, where analysts were looking for sales of $207.6 million, which the company also topped.

“We are happy to report results for the third quarter that exceeded expectations. Our product revenue increased 12.8% on a constant currency basis to reach $202 million for the quarter. We also shipped a record 59,100 noninvasive technology boards and monitors. Our strong growth is the result of increasing demand for our innovative technologies and systems solutions, which enable our customers to automate patient management across the continuum of care and improve patient safety. We are once again raising guidance for revenue and earnings in 2018 as we continue to grow due to our life saving and life improving technologies,” chair & CEO Joe Kiani said in a press release.

Maismo lifted its guidance for the remaining fiscal year, expecting to see total sales of $854 million, up from earlier guidance of $850 million. The company now expects to post non-GAAP EPS of $2.92, up from previous guidance of $2.90.

Shares in Masimo traded up very slightly today, closing at $115.60.

Earlier this month, Masimo said that it won FDA 510(k) clearance for its RD SET sensors with measure-through motion and low perfusion SET pulse oximetry.

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KemPharm inks Apadaz licensing deal with KVK Tech

KemPharm (NSDQ:KMPH) said yesterday it inked a collaborative licensing deal with KVK Tech to obtain U.S. commercial rights to the company’s FDA-approved Apadaz drug.

Through the agreement, KemPharm is eligible to receive approximately $3.4 million in pre-launch payments and core cost reimbursement, including a $2 million milestone payment “related to the initial formulary adoption of Apadaz. The deal also includes an aggregate of up to $53 million in milestone payments related to net sales levels.

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

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Owens & Minor shares tumble despite Q3 beat

Shares in Owens & Minor (NYSE:OMI) have fallen more than 40% so far today after the company released its third quarter earnings, despite the company beating expectations on Wall Street.

The Richmond, Va.-based company posted losses of $565,000, or 1¢ per share, on sales of approximately $2.5 billion for the three months ended September 30, seeing a 105.2% swing into the red while sales grew 5.6% compared with the previous year.

Adjusted to exclude one-time items, earnings per share were 32¢, down 20% from the same quarter last year but just in line with the 32¢ consensus on Wall Street, where analysts expected too see sales of $2.5 billion, which it also met.

“Our teams are working diligently to integrate the Halyard S&IP business and to address the continuing challenges we are facing in our domestic distribution business. The strategic moves we have made into attractive alternate sites of care with Byram, and in meaningfully building our own brand product portfolio with Halyard, have strengthened and diversified our business.  These new businesses are helping to offset the continued pressures we face in our domestic distribution business,” prez & CEO P. Phipps said in an SEC filing.

Owens & Minor shifted its earning per share expectations for the full year to between $1.20 and $1.25.

“For 2018, our revised guidance range reflects lower year-to-date results and reduced expectations for our Global Solutions SBU. In addition, we expect Global Products’ production costs to be higher in the fourth quarter than in the third quarter. In light of this revised guidance range for 2018, we are re-evaluating our prior outlook for 2019 and anticipate issuing guidance for 2019 in the first quarter of next year. We remain focused on improving our operating performance and on executing our strategy to strengthen our company for the future,” CEO Phipps said in a prepared statement.

Shares in Owens & Minor have fallen approximately 41.6% today, at $8.30 as of 2:00 p.m. EDT.

In May, Owens & Minor said that it closed the $710 million acquisition of Halyard Health‘s (NYSE:HYH) surgical and infection prevention business.

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Heraeus acquires Evergreen Medical, PhysioTest

Heraeus Medical Components said today that it acquired Evergreen Medical Technologies and its PhysioTest subsidiary for an undisclosed amount.

St. Paul, Minn.-based Evergreen is a contract design, development & manufacturing consultant that specializes in neuromodulation technologies, including implantable leads and stimulation devices.

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

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Philips-Medisize launches third-gen Connected Health Platform

Phillips-Medisize said today it completed the roll-out of its third-gen Connected Health Platform, a cloud-based data system for pharmaceutical and drug delivery device developers.

The newly launched system includes information sharing and analytics capabilities as well as cybersecurity precautions and streamlined regulatory documentation, the Hudson, Wisc.-based company said.

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

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FDA clears Zimmer Biomet’s Persona knee implant

Zimmer Biomet (NYSE:ZBH) said today that the FDA granted 510(k) clearance for its Persona revision knee implant.

Warsaw, Ind.-based Zimmer said the Persona system is designed to match each patient’s unique anatomy with customized components.

“The clearance of the Persona revision knee system gives us the ability to provide surgeons with a full service portfolio for the continuum of knee arthroplasty care, from diagnostic tools, cement spacer technologies to re-implantation solutions,” vice president Todd Davis said in prepared remarks. “The Persona revision knee system gives surgeons the flexibility to truly tailor an implant solution based on each patient’s unique anatomy for a natural fit and function.”

“Given the complexity of revision procedures and the fact that every person’s anatomy is a little different, it is critical for a knee revision system to give surgeons the ability to personalize the treatment strategy in order to achieve the best outcome for each patient,” added Dr. Giles Scuderi of New York City’s Northwell Health Physician Partners.

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Fresenius posts shrinking sales, profits in Q3

Fresenius (NYSE:FMS) shares have stayed steady today after the company released third quarter earnings that saw profits and sales shrink compared to the previous year.

The Bad Homburg, Germany-based company posted profits of $322.6 million (EU €285 million), or $1.05 per share (EU €0.93), on sales of approximately $4.6 billion (EU €4.1 billion) for the three months ended September 30, seeing profits shrink 7.8% while sales shrunk 6.4% compared with the same period during the previous year.

“Our third quarter was affected by several developments whose combined impact on our results was greater than expected. Growth did not accelerate to the extent previously projected. We anticipate the impact from the current level of growth and less acquisitions to continue in the fourth quarter. We have identified countermeasures and have begun implementation. Fresenius Medical Care’s growth will continue,” CEO Rice Powell said in a press release.

Fresenius released upcoming guidance for the remaining fiscal year, expecting to see revenue growth of between 2% and 3%, or 11% to 12% at a constant currency basis.

Shares in Fresenius have risen 0.2% so far today, at $39.22 as of 10:52 a.m. EDT.

Earlier today, NxStage Medical (NSDQ:NXTM) once more delayed its pending $2 billion merger with Fresenius as the U.S. Federal Trade Commission continues to examine the deal.

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Integra LifeSciences dives on Q3 sales miss, lowered outlook

Integra LifeSciences (NSDQ:IART) shares took a dive today after the medical device company missed expectations for its third-quarter sales and lowered its top-line outlook for the rest of the year.

Plainsboro, N.J.-based Integra posted profits of $13.3 million, or 15¢ per share, on sales of $365.9 million for the three months ended Sept. 30, amounting to bottom-line growth of 320.9% on sales growth of 31.2% compared with Q3 2017.

Adjusted to exclude one-time items, earnings per share were 59¢, dead even with the average forecast on Wall Street, where analysts were looking for sales of $370.4 million.

“Despite some revenue softness in the second half of the year, we continue to make solid progress with the Codman integration and the channel expansion efforts, particularly in regenerative technologies,” president & CEO Peter Arduini said in prepared remarks. “We remain confident that 2019 organic sales will grow within our targeted long-term range of 5% to 7% and accelerate from our full-year 2018 results.”

Integra said it still expects to report adjusted EPS of $2.36 to $2.42, but cut its revenue outlook to $1.467 billion to $1.472 billion, down from $1.475 billion to $1.490 billion previously.

IART shares were off some -13.2% at $54.08 apiece today in late-morning activity.

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LivaNova takes a hit on Q3 sales miss, despite raised outlook

LivaNova (NSDQ:LIVN) shares came under pressure today after the medical device maker put up sales and earnings numbers that fell shy of expectations as it swung to third-quarter red ink, despite its boosted top-line outlook for 2018.

LivaNova posted losses of -$7.2 million, or -15¢ per share, on sales of $272.1 million for the three months ended Sept. 30, for a top-line gain of 8.3% compared with Q3 2017, when the company put up profits of $27.8 million.

Adjusted to exclude one-time items, earnings per share were 78¢, a full 12¢ under the consensus on Wall Street, where analysts were looking for sales of $275.0 million.

“The third quarter results reflect our continued momentum in accelerating our sales growth while making significant investments to deliver on our long-term strategy. Results for third quarter 2018 were strong across all regions,” CEO Damien McDonald said in prepared remarks. “Neuromodulation had another exceptional quarter of double-digit growth in all regions. Cardiovascular also performed well, driven by our oxygenator and auto-transfusion businesses. Profitability in the quarter was impacted by higher than expected site activation for our Anthem-HFrEF heart failure pivotal trial. We remain confident in our ability to deliver on our 2018 guidance while aggressively investing in future growth to deliver quality care to more patients around the world.”

LivaNova said it still expects to post adjusted EPS of $3.50 to $3.70, but raised its constant-currency sales growth forecast to 7% to 9%, up from 6% to 8% previously.

Still, investors pushed LIVN shares down -5.2% to $113.935 apiece today on the news in late-morning trading.

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Intuitive Surgical shares rise on expanded surgical robot quota in China

Intuitive Surgical (NSDQ:ISRG) shares have risen over 5% in pre-market trading after the Chinese government released a new Large-Scale Medical Equipment Configuration Plan calling for an additional 154 surgical robot systems to be deployed in the country by the end of 2020.

The official release from the Chinese Government calls for a total of 197 endoscopic surgical instrument control systems, or surgical robots, by the end of 2020. That number includes an additional 154 new systems.

The last time the government issued a similar quota expansion was in 2013, according to a Leerink Partner letter to investors by analyst Richard Newitter.

After the last quota was issued in 2013, the majority of the systems weren’t sold until 2015, Newitter wrote, leading him to believe that a similar purchasing spread will occur with the current quota expansion. He expects that 10% of the 154 units will be acquired in 2018, 30% in 2019 and 60% in 2020.

Currently, Intuitive has more than 80 robotic platforms installed in civilian and military hospitals in the region, according to the letter. Newitter expects that the majority of the new quota, approximately 90%, will go to Intuitive.

“We expect ISRG will fulfill most, if not all, of the new quota but acknowledge that competitive offerings, over time and if available before 2020, might have a shot at winning some of the placement quota,” Newitter wrote in a letter to investors. “While we do not know the exact intentions of the Chinese government, we suspect that ISRG will place the lion’s share (~90%+) of additional systems under the new quota given Da Vinci’s capabilities vs. other systems.”

He went on to say that there is “some risk around quota fulfillment timing” depending on when other major offerings, like those from Johnson & Johnson (NYSE:JNJ), Medtronic (NYSE:MDT), TransEnterix (NYSE:TRXC) and Auris Health, hit the market.

Shares in Intuitive rose over 5% in pre-market trading, and have risen 4.5% in early morning trading, at $512.89 as of 9:36 a.m. EDT.

Earlier this month, shares of Intuitive Surgical (NSDQ:ISRG) got a pre-market bump after the robot-assisted surgery pioneer posted third-quarter results that beat the consensus forecast, despite lower profits, and upped its outlook on procedure growth for the year.

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Axonics prices upsized $120m offering

Axonics Modulation Technologies yesterday priced an upsized initial public offering that could fetch a maximum of $138 million.

Irvine, Calif.-based Axonics, which makes the r-SNM device sacral neuromodulation system for treating overactive bladder, fecal incontinence and urinary retention, last week set the range for the flotation at $93.3 million to $106.7 million, saying it would issue nearly 6.7 million shares at $14 to $16 apiece.

Yesterday the company increased the number of shares to 8 million, priced at $15 each, for gross proceeds of $120 million. If a 30-day, 1.2-million-share over-allotment is fully exercised, that number would jump to $138 million. The company plans to list on the NASDAQ exchange under the “AXNX” symbol sometime today, with the offering slated to close Nov. 2.

Axonics touts the r-SNM device as the first such rechargeable system; it’s designed to deliver mild electrical stimulation using a four-electrode lead introduced through the sacrum and a pulse generator implanted in the upped buttocks. It won CE Mark approval in the European Union in June 2016; an external trial module won an FDA nod last July. It’s also approved for market in Canada and Australia. In its initial IPO filing, Axonics said it expects to file a pre-market approval bid with the FDA during the first quarter of 2019.

BofA Merrill Lynch and Morgan Stanley are joint book-runners, with Wells Fargo Securities as lead manager and SunTrust Robinson Humphrey as co-manager.

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Ensuring compliance after a medical device trial

Sandra Maddock, President and CEO, IMARC Research

Entering the “home stretch” of a medical device trial is always an exciting time. You can see the finish line in sight. You’ve planned for success, and you’ve run the race well. But before you take your victory lap, you still have a few more hurdles to clear.

Here are the three biggest ones you’re likely to encounter as you prepare to close out your study.

Final Audits

The most pressing hurdle is the FDA’s review of your trial master file, or TMF. The trial master file tells the story of your entire medical device trial. Inspectors will review the documents in this file to determine how closely your trial followed your study plan and whether you complied with all regulations. They will look for any gaps in the data, any missing signatures and anything that could potentially compromise the integrity of your study.

Given the significance of a trial master file review, it’s becoming more common for study sponsors to request an independent auditor to review their TMF before the FDA does.

After all the time, effort and money spent on your medical device trial, a trial master file audit is certainly a worthwhile investment. However, it can be daunting when you consider the costs involved. An electronic trial master file review eliminates the costs of travel expenses and the time required for your internal team to support the audit. In fact, it can reduce the total costs by as much as half.

Data Lock And Analysis

If your medical device trial is a race, your database is the trophy case. You’ve gone to great lengths to gather this data, and you need to protect it. A database lock is a crucial step to ensuring the integrity of your findings as you prepare for study closeout. This will prevent unauthorized or unintentional changes to your data after it has been reviewed and analyzed.

Follow these steps to complete the database lock:

• Make sure you have received all data, including data from external sources
• Review data for inconsistencies (an auditor can assist with this)
• Resolve all data queries
• Conduct a final audit to make sure all data is complete and accurate
• Remove “edit” access from your database

Processing, analyzing and checking all this data can seem like a monumental task, especially if it falls on just one or two people. A contract research organization (CRO) can support your team by providing assistance with data entry and data review. Your CRO can also conduct the final database lock if needed.

Inspections

Even after you’ve finalized and submitted the data for your medical device trial, you may not be out of the woods just yet. You or one of your clinical research sites could still receive a Form 483 or an FDA warning letter.

If that happens, it’s important to respond appropriately. You will also need to identify the cause of the violations and develop corrective actions to prevent future problems. This is another area where an experienced CRO can help. Professionals with expertise in monitoring and auditing will be able to identify any underlying compliance issues and devise a plan to mitigate them going forward.

When it comes to clinical research, the final leg of the race can also be stressful. But just as an Olympic track star can pass the baton to a relay team, you can delegate some of these responsibilities to a medical device CRO at any point during the trial. A CRO team can be there to coach and encourage you before your trial begins. They can step in at any point during the race to lighten your team’s load. And they can be there for you through that last strenuous lap to make sure you clear those final hurdles.

No matter where you are in your medical device trial, IMARC Research offers exceptional support to help you reach the finish line.

To learn more about working with us, contact us today.

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

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Baxter dips on Q3 sales miss

Baxter (NYSE:BAX) shares slipped today in pre-market trading after the healthcare giant posted third-quarter sales that missed the consensus forecast on Wall Street and cut its sales outlook for the rest of the year.

Chicago-area Baxter posted profits of $544 million, or $1 even per share, on sales of $2.77 billion for the three months ended Sept. 30, for a whopping bottom-line gain of 116.7% on sales growth of 2.2% compared with Q3 2017.

Adjusted to exclude one-time items, earnings per share were 80¢, 6¢ ahead of the average on The Street, where analysts were looking for sales of $2.78 billion.

“Baxter’s third-quarter performance reflects the benefit of our ongoing efforts to enhance operational excellence and innovation at the company,” chairman & CEO Joe Almeida said in prepared remarks. “While we remain confident in Baxter’s longer-term financial outlook, we have experienced a slower-than-expected return to pre-Hurricane Maria purchasing levels across certain businesses, as well as an impact from distributor de-stocking for select products that has depressed our top-line performance in 2018.

“Our commercial teams are working diligently to address customer needs and recapture these sales, and we remain focused on relentless expense management across the company. In parallel, we continue to pursue capital deployment opportunities to fuel organic and inorganic growth that will help drive increased value for patients, healthcare providers and investors,” Almeida said.

Baxter raised the low end of its earnings outlook, saying it now expects to report adjusted  EPS of $2.98 to $3, compared with $2.94 to $3 previously, but cut its sales growth guidance to 5%, down from 6% previously.

BAX shares, which closed down -2.4% at $68.66 apiece yesterday, were trading at $64.18 today in pre-market activity, down -6.5%.

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NxStage Medical, Fresenius again delay $2B merger

NxStage Medical (NSDQ:NXTM) yesterday once more delayed its pending $2 billion merger with Fresenius (NYSE:FMS) as the U.S. Federal Trade Commission continues to examine the deal.

In July, the German renal care giant and Lawrence, Mass.-based NxStage extended the deal’s closing date by 90 days, from August 7 to Nov. 5, saying it still expected to close the deal this year.

Yesterday, in a regulatory filing with the U.S. Securities & Exchange Commission, NxStage said the companies agreed this week to push the target back another thee months, to Feb. 5, 2019. For its part, Fresenius said it still expects to close the acquisition this year.

It’s been more than 14 months since the companies announced their merger plans. The FTC said a year ago that it wanted more information on the deal’s details; Fresenius is a NxStage customer, complicating its anti-monopoly implications. Last July, NxStage agreed to deal its Medisystems bloodlines business to B. Braun in a bid to mollify the FTC’s concerns.

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Accuray posts mixed bag FY2019 Q1 earnings

Accuray (NSDQ:ARAY) today released fiscal year first quarter earnings that beat Wall Street expectations for sales, but missed on loss-per-share consensus.

The Sunnyvale, Calif.-based company posted losses of $9.2 million, or 11¢ per share, on sales of $95.8 million for the three months ended September 30, seeing losses shrink 1.9% while sales grew 5.4% when compared with the same period during the previous fiscal year.

Adjusted to exclude one-time items, losses per share were 11¢, just behind the 9¢ loss-per-share consensus on The Street, where analysts were looking for sales of $94.3 million, which it topped.

“Our fiscal year is off to a good start with double digit gross order growth and revenue generation meeting our targets. We are also encouraged by the potential benefits to Accuray from the China Ministry of Health’s announcement yesterday of Type A and B quota and licenses. In addition, we’ve implemented a cost savings initiative designed to reduce our annual operating costs by approximately $15 million and provide us with a clear path to GAAP profitability, while preserving our ability to continue our product innovation objectives and drive improved sales growth going forward. These cost savings have enabled us to raise our adjusted EBITDA outlook for the current fiscal year,” prez & CEO Joshua Levine said in a press release.

The company reaffirmed its earlier guidance provided in August, expecting to see revenue of between $415 million and $425 million, representing 3% to 5% growth year over year. Accuracy said it also expects to post adjusted EBITDA of between $23 million and $29 million.

Shares in Accuracy closed up approximately 1.8% today, at $3.44. In after hours trading, shares have risen an additional approximate 2%, at $3.51 as of 4:12 p.m. EDT.

In September, Accuray released data from two studies of its CyberKnife stereotactic body radiotherapy device exploring its use in treating patients with low and intermediate-risk prostate cancer, touting high survival rates and minimal toxicity.

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Cardiovascular Systems FY2019 Q1 beats sales, misses loss-per-share consensus on The Street

Cardiovascular Systems (NSDQ:CSII) today released fiscal year 2019 first quarter earnings that beat sales consensus on Wall Street but missed expectations for losses per share for the quarter.

The St. Paul, Minn.-based company posted losses of approximately $2.9 million, or 9¢ per share, on sales of approximately $56.3 million for the three months ended September 30, seeing losses grow 46.1% while sales grew 13.3% when compared with the same period last year.

Losses per share were 9¢, behind the 5¢ loss-per-share consensus on The Street, where analysts were looking for sales of $55.5 million, which the company topped.

“We are pleased to report double-digit revenue growth. With high single-digit growth in peripheral atherectomy, high-teen domestic coronary atherectomy growth and new revenue from international distribution agreements and distributed products, we delivered our strongest quarterly growth in the last 18 months. In the first quarter, we introduced new atherectomy products and procedure support devices, and announced the first commercial launch of our peripheral OAS outside the United States. CSI’s transformation from a single-product, single-geography company to a multiproduct, multinational company focused on the most compelling unmet medical needs in interventional cardiology is now fully underway,” prez & CEO Scott Ward said in a press release.

Cardiovascular Systems reiterated its fiscal year 2019 guidance, expecting to see sales between $240 million and $250 million, with net loss equal to approximately 1% to 2% of revenue.

Shares in Cardiovascular Systems closed up 1.5% today, at $34.92.

In September, Cardiovascular Systems touted that its peripheral orbital atherectomy system was used in its first procedure outside the US as the company is reportedly looking to grow its business beyond a single product and towards supplying a full revascularization tool kit.

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NuVasive posts mixed bag Q3

NuVasive (NSDQ:NUVA) today released third quarter earnings that beat Wall Street expectations for revenue but missed on earnings per share consensus.

The San Diego-based company posted profits of $15.9 million, or 56¢ per share, on sales of $271.3 million for the three months ended September 30, seeing profits shrink 52.5% while sales grew 9.8% compared with the same period last year.

Adjusted to exclude one-time items, earnings per share were 56¢, just behind the 62¢ consensus on The Street, where analysts were looking for sales of $265.4 million.

“Our third quarter results reflect accelerated year-over-year revenue growth of nearly 10%, supported by strong performances in both spinal hardware and surgical support business lines with overall U.S. case volumes up more than 7%. With the sense the overall U.S. spine market is trending healthier, we made strategic investments this quarter on the heels of this momentum in key R&D initiatives, additions to our commercial sales force and infrastructure upgrades to improve set fulfillment—all to support a strong start to 2019 and beyond. We made solid progress with our in-source manufacturing initiatives by bringing in additional SKUs during the third quarter with throughput ramping to higher volumes. This strategic investment is on track and will become a business advantage, both to drive a competitive cost position and to control the quality required to produce evermore complex implants,” chair & CEO Gregory Lucier said in a press release.

The company adjusted its guidance for the full fiscal year, expecting to see sales of between $1,105 million and $1,110 million, up from previous guidance of between $1,095 million and $1,105 million.

Nuvasive cut its non-GAAP EPS guidance for the year, down to between $2.15 and $2.23 from earlier guidance of between $2.37 and $2.40.

Shares in the company rose 2.4% today, closing at $62.51. Shares have dropped slightly in after hours trading, down 0.8% at $62 as of 4:47 p.m. EDT.

Earlier this month, NuVasive said that it inked a strategic partnership deal with spinal and extremity surgery tech company Biedermann Technologies.

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Aegea Medical launches post-market Adaptive Vapor Ablation study

Aegea Medical said today that it launched a new post-market study exploring the long-term effects of its Adaptive Vapor Ablation technology in endometrial ablation procedures.

The PACE II study will look to enroll up to 50 women who were previously treated in the Menlo Park, Calif.-based company’s pivotal trial of the Adaptive Vapor Ablation tech and will analyze uterine cavity access and the feasibility of diagnostic and therapeutic interventions for three to four years post-treatment.

“While endometrial ablation technologies have served physicians and their patients well for some time, the issue of post-procedure uterine cavity access has never really been addressed. We believe this is a very important success metric for the therapy, as it speaks to the possibility of future uterine-related interventions. The PACE Pilot data on 11 patients treated with Adaptive Vapor Ablation technology is very promising in how Vapor Ablation can address this unmet need, preserving physician and patient options in the future,” prez & CEO Maria Sainz said in a press release.

In the pivotal PACE study, investigators found that post-procedure access to the mid-uterine cavity or beyond was possible in 82% of the 11 patients who had participated in an earlier Phase II study.

The observational endpoint of the trial includes endometrial biopsy and IUD placement, the ability to visualize the uterine cornia and ostia and the presence and characteristics of adhesions within the uterine cavity, Aegea said. The company is hopeful it will complete the trial within six months.

“Post-procedure uterine cavity access is the next big topic in endometrial ablation. Given the early performance of Aegea’s Adaptive Vapor Ablation technology in this area, I believe it has the potential to address this issue, providing physicians and patients with a more thoughtful approach to endometrial ablation that allows for future uterine interventions as necessary. Importantly, this multi-center study has been designed with objective criteria to avoid patient selection bias. Additionally, the study includes independent expert review of the hysteroscopy imagery to further increase the data’s scientific rigor,” study national principal investigator Dr. Alan Johns of Fort Worth, Texas’s Clinical Research Baylor Research Institute said in a prepared statement.

In May, Aegea Medical said that it tapped former Cardiokinetix prez & CEO Maria Sainz as its new president and chief executive officer.

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Wound tech dev Clozex Medical raises $4m

Wound closure tech developer Clozex Medical raised approximately $3.8 million in a new round of equity financing, according to a recently posted SEC filing.

Funds in the round came from 39 unnamed sources, with the first sale dated on October 16, according to the filing.

Wellesley, Mass.-based Clovex is developing wound closure products intended to address limitations of traditional suture and stapling techniques. It’s flagship technology is Clozex Closures, which are intended for multiple uses, including plastic surgery, orthopedics, dermatology, cardiothoracic surgery, emergency medicine and urgent care, according to the company’s website.

The company is looking to raise an additional approximate $490,000 in the round, which would bring the total raised up to approximately $4.3 million, according to the SEC filing.

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

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Preparing for EU MDR Product Submissions: A Sustainable Approach

By Michelle Boucher, VP of Research for Tech-Clarity

Every medical device company wanting to do business in Europe must comply with the new EU MDR regulation. Yet this is no small feat considering the more stringent requirements. While the new regulation is largely an extension of the existing regulation, it requires far more data. As a result, companies must competently manage data throughout the product lifecycle – and update it as their product changes.

Rather than see this is a challenge, Michelle Boucher, VP of Research for Tech-Clarity, views this as an opportunity. Download the guide she authored to position your company for a long-term advantage.

The guide covers all the essential details you need to understand the data requirements of EU MDR product submissions and how to comply. You’ll find guidance on:

• Determining your strategy to collect data and prepare submissions.
• Prepping your product data for the new regulation.
• Overcoming the obstacles that make data submissions challenging.
• Taking advantage of the power of Product Lifecycle Management.
• Five steps to adopting a product-centric approach.

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Acera Surgical raises $5m

Acera Surgical has raised $5.1 million in a new round of equity financing, according to a recently posted SEC filing.

The St. Louis-based company is developing an implantable nanomedical scaffold intended for medical applications including soft tissue repair, according to a St. Louis Business Journal report. Acera also produces a protective wound cover called Restrata.

Acera licensed the surgical mesh technology behind their products from the Washington University Office of Technology Management in 2012, according to the article.

A total of two anonymous investors have joined in the round, with the first sale dated on October 5, according to the SEC filing.

The company is looking to raise an additional $5 million in the round, bringing the total raised up to $10.1 million.

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

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Here’s the view from the top at Hologic

Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson.

Since then, Hologic has grown into a $3 billion business. At DeviceTalks Boston 2018, MacMillan provided exclusive insights into the Massachusetts-based company and its evolving definition of women’s healthcare.

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Biotronik receives FDA approval for covered coronary stent

 

[Image from Biotronik]

Biotronik has received FDA approval for its PK Papyrus covered coronary stent system.

The PK Papyrus coronary stent system is a balloon-expandable covered stent that is placed in the coronary artery using a balloon catheter delivery system. The stent system is designed to treat tears in heart blood vessels, known as coronary artery perforations. It is manufactured from cobalt-chromium metal alloy and covered with a polyurethane membrane.

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

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Covalon Technologies completes AquaGuard acquisition integration

Covalon Technologies said today that it successfully completed its integration of Cenorin‘s AquaGuard division, which it acquired earlier this month.

Covalon said that it closed the $12.4 million (CAD $16.1 million) acquisition of the AquaGuard business on October 1. The acquisition includes moisture protection for wound, surgical and vascular access sites, Ontario-based Covalon said.

“The speed with which we were able to successfully integrate the AquaGuard team with Covalon has exceeded my expectations. I am extremely excited that as a unified company, Covalon, along with our new AquaGuard sales force, is now able to sell a strong portfolio of infection management products such as IV Clear, MediClear PreOp, SurgiClear, and AquaGuard into an established client base of over 1,500 hospitals and clinics in the United States. I am more optimistic than ever that the synergies resulting from this successful integration are highly beneficial and accretive to Covalon,” CEO Brian Pedlar said in a press release.

The company said that it has also received the first payment of $3.5 million under a new licensing agreement with an unnamed “global medical company” for rights to use its antimicrobial coating technology. The deal includes an additional $5 million in license fees based on milestones.

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Bionik Labs pulls trigger on 1-for-150 reverse split

Robotic rehabilitation device developer Bionik Laboratories said yesterday that it implemented a 1-for-150 reverse split of its stock.

The ratio was agreed upon by the Toronto-based company’s board of directors, and is intended to satisfy the minimum stock price requirement of the Nasdaq Capital Market.

“The completion of the reverse stock split is an integral step in the process of pursuing a successful listing on Nasdaq. We believe that listing on Nasdaq will expand awareness of the company among the investment community, and potentially provide avenues for additional sources of funding as we work to execute our growth strategy,” Bionik CEO Dr. Eric Dusseux said in a prepared statement.

Bionik Laboratories said that before the split, there were approximately 350.6 million shares issued and outstanding, and that it expects there to be approximately 2.3 million shares post-split. The company also had approximately 41 million exchangeable shares issued and outstanding, and expects there to be approximately 273,575 such shares following the split.

In August, Bionik Labs said that it integrated Amazon‘s (NSDQ:AMZN) Echo and Alexa voice technology into its Arke lower body exoskeleton.

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Prevent Biometrics acquires X2 Biosystems head impact monitoring assets

Head impact monitoring tech developer Prevent Biometrics said last week it acquired the head impact monitoring assets of Seattle-based X2 Biosystems for an undisclosed amount.

Minneapolis-based Prevent Biometrics, which spun-out of the Cleveland Clinic in 2015, said that the acquisition will bring together its own Impact Monitor Mouthguard and X2’s skin patch-based platform.

Prevent Biometrics said that it is working with the U.S. Military to further develop head impact monitoring solutions for training and combat situations

“The opportunity to add X2’s patents and engineering know how is an exceptional one for Prevent. Head impact monitoring holds transformational potential for concussion safety, and our combined intellectual property gives us a tremendous competitive advantage in this emerging category,” co-founder & CEO Steve Washburn said in a prepared statement.

“Head impact monitoring is a practical example of IoT applied to sports and healthcare. Safety in youth sports is a real concern affecting millions of kids and we are happy to see Prevent continuing to make strategic moves and lead the way in making sports safer. Low-power sensors and circuits provided by Maxim enable smaller size sensors and the proliferation of head impact monitoring technology. By combining the X2 and Prevent technologies, we are excited about the many benefits this will provide to athletes, coaches, trainers, teams, researchers and healthcare professionals. Prevent’s Impact Monitor Mouthguard has emerged as the most effective product in the space, and their team has the expertise to commercialize a range of solutions to better understand concussions and immediately improve player safety,” X2-backer Maxim Ventures head Chris Neil said in a press release.

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LifeScan releases latest version of diabetes management app

LifeScan said today that it released the latest version of its OneTouch Reveal mobile app. The digital tool is designed to help people with diabetes track their blood sugar levels using their mobile devices and share data with healthcare teams and caregivers.

The newest version of LifeScan’s app includes notifications that automatically warn users of recurring high or low patterns.

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

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Carrot raises $25m for tech-enabled smoking cessation program

Digital health company Carrot said today that it raised $25 million to commercialize its tech-enabled Pivot smoking cessation program.

The round was led by Johnson & Johnson‘s (NYSE:JNJ) strategic venture capital arm, JJDC. New York Life Ventures and existing investors Khosla Ventures, Marc Benioff, founder Dr. David Utley and R7 Partners also contributed to the financing round.

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

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GE Healthcare’s Q3 profits tick up despite flat sales

Profits for the healthcare business at GE rose despite flat sales growth for the third quarter, as the parent company posted a swing to red ink on a -$22 billion charge.

The Boston-based industrial conglomerate reported healthcare profits of $861 million on sales of $4.71 billion for the three months ended Sept. 30, for bottom-line growth of 1.7% on a -0.1% sales decline compared with Q3 2017. The red ink was due to a -$21.97 billion goodwill impairment charge.

GE reported losses of -$22.81 billion, or -$2.62 per share, on sales of $29.57 billion for the quarter, for a top-line slide of -3.6%.

Adjusted to exclude one-time items, earnings per share were 14¢, 6¢ under the consensus forecast on Wall Street, where analysts were looking for sales of $29.90 billion.

GE also said it plans to slash its quarterly dividend from 12¢ to 1¢ andplans to split its power division in two, creating a natural gas unit and a steam, grid solutions, nuclear & power conversion segment.

“After my first few weeks on the job, it’s clear to me that GE is a fundamentally strong company with a talented team and great technology. However, our results are far from our full potential. We will heighten our sense of urgency and increase accountability across the organization to deliver better results,” chairman & CEO Lawrence Culp Jr. said in prepared remarks. “We are on the right path to create a more focused portfolio and strengthen our balance sheet. My priorities in my first 100 days are positioning our businesses to win, starting with power, and accelerating deleveraging. We are moving with speed to improve our financial position, starting with the actions announced today. I look forward to updating you further on our progress in early 2019.”

GE shares, which closed down -1.9% at $11.09 apiece yesterday, were down -1.9% to $11.34 today in pre-market trading.

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Livongo launches voice-enabled cellular blood pressure monitoring system

Livongo said today that it launched its Applied Health Signals platform, which seeks to provide meaningful feedback to people living with chronic conditions using novel digital tools and artificial intelligence.

As part of its newly-launched platform, the company developed a voice-enabled, at-home cellular blood pressure monitoring system and said it would provide eligible members with co-pay waivers for medications, in an effort to encourage users to cultivate healthy behaviors.

“It’s exciting to introduce products that change the way people think about and experience chronic conditions. We did that in diabetes, with unlimited free strips, cellular-connected meters, insights and care accessible 24 hours a day anywhere, all of which made it easier for our members to stay healthy. Now we’re doing the same thing for hypertension,” chief product officer Amar Kendale said in prepared remarks. “By delivering blood pressure feedback in a new relevant way and by driving positive behavior change with medication incentives, we are reducing the confusion, complexity and cost of healthcare for our members. We are making healthcare less noisy and paving the way for meaningful and measurable change. That’s what Applied Health Signals is all about.”

Livongo’s next-generation cellular blood pressure monitoring system allows users to interact with Livongo during each use. The company’s Cuff to Cloud program enables people to upload blood pressure readings directly to the Livongo cloud.

Also today, Livongo reported that it inked a partnership with Medisafe to improve medication management for people with chronic conditions. Livongo plans to leverage its relationship with Medisafe to optimize the Applied Health Signals engine over time.

“I could not be more excited to be working with industry leaders and innovators like Medisafe,” Livongo CMO Dr. Jennifer Schneider said.”These partnerships will provide a wealth of new data into our Applied Health Signals engine, and will further our ability to apply actionable, personalized and timely health signals to our members. We are already achieving measurable clinical outcomes, and as more data comes into our engine, our fly wheel begins to spin faster, and we have the ability to affect more behavior change and improve clinical outcomes for more people with chronic conditions.”

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Abiomed joins Protembis $10m Series A

Protembis said today it closed a $10 million Series A round, joined by cardiovascular device-focused Abiomed (NSDQ:ABMD), to support its embolic cerebral protection device.

The round was joined by Abiomed, Aachen and Mönchengladbach GmbH’s Seed Fonds III and a number of family offices and angel investors, the Aachen, Germany-based company said.

“Patient safety should always be our top priority. We see great potential in Protembis’ technology to make TAVI neurologically safer and thus enable TAVI to be used in an even larger patient population,” Abiomed chief technology officer Dr. Thorsten Siess said in a prepared statement.

Protembis is developing the ProtEmbo embolic cerebral protection device designed to minimize the risk of embolic cerebral lesions during minimally invasive cardiovascular interventions. The system consists of a filter device designed to be introduced into the aortic arch to prevent embolic particles from migrating into the brain.

“Literally every TAVI intervention leads to particle migration to the brain” co-managing director & co-founder Karl von Mangoldt said in a prepared release.

“Recent clinical studies have shown that up to 9 percent of TAVI patients suffer a stroke” co-managing director & co-founder Conrad Rasmus said in a press release.

Last July, Protembis said it plans to collaborate with the German Accelerator Life Sciences program as it looks to expand into the US and accelerate the clinical development plans for its cerebral embolic protection device.

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Orthofix Q3 beats The Street

Orthofix (NSDQ:OFIX) today posted third quarter earnings that topped both sales and earnings per share expectations on Wall Street.

The Lewisville, Texas-based company posted losses of $1.2 million, or 7¢ per share, on sales of $111.7 million for the three months ended September 30, seeing a 135% swing into the red while sales grew 6.1% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share were 43¢, well ahead of the 36¢ consensus on Wall Street where analysts expected to see sales of approximately $110.7 million for the quarter.

“In addition to solid financial performance on both the top line and adjusted EBITDA in the third quarter, we made significant operational progress in the alignment of our bone growth therapy, spinal implants and biologics segments into Orthofix spine. We believe that our market-leading technologies in osteogenesis stimulation and stem cell allografts, together with the M6 cervical disc, once it is approved by the U.S. Food and Drug Administration, will uniquely position us in the spine market overall and particularly in the cervical spine segment. We also believe this combination of spine products in conjunction with our historical strength in Orthofix extremities provides the platforms for us to drive accelerating growth as we move into 2019 and for the foreseeable future,” prez & CEO Brad Mason said in a press release.

The company tightened its guidance for the full year, expecting to post sales of $451 million and $455 million, slightly from expectations of between $450 million and $456 million. For adjusted EPS, the company lifted its outlook slightly, now expecting to post between $1.70 and $1.75, up from previous guidance of between $1.66 and $1.72.

Orthofix saw shares rise approximately 0.3% today, closing at $56.63.

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Impulse Dynamics wins FDA panel date for Optimizer PMA

Impulse Dynamics has set a date with the FDA’s Circulatory System Devices Panel, part of the agency’s Medical Device Advisory Committee, discussing the premarket application for the company’s Optimizer Smart impulse generator device.

The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency using what the company calls the cardiac contractility modulation – non-excitatory electrical pulses delivered to the heart muscle. The system has had CE Mark approval in the European Union for the device since 2002.

The Stuttgart, Germany-based company will meet with the panel on December 4 and 5.

The panel will be seeking input “regarding the potential indications and labeling for devices intended to treat hypertension and optimal study designs needed to evaluate the potential benefits and risks while considering issues such as medication compliance, patient perspective, and appropriate study controls,” according to an FDA posting.

Last May, Impulse Dynamics said today that it closed a $45 million equity financing round to support its cardiac contractility modulation technology designed to treat chronic heart failure.

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