Intuitive Surgical board approves 3-for-1 stock split

Intuitive Surgical (NSDQ:ISRG) said today that its board of directors approved a 3-for-1 split of the company’s common stock

The stock split is still subject to shareholder approval, the Sunnyvale, Calif.-based company said, with a special meeting of stockholders slated for September 22.

With the split, each Intuitive shareholder would receive 2 additional shares for every share held by Sept. 29, with trading beginning on a split-adjusted basis on October 6.

Intuitive Surgical said it will provide additional details about the meeting and the proposed split in a proxy statement scheduled to go out to shareholders on August 30.

At closing today, Intuitive shares were up 1.4% at $942.25.

Earlier this week, Intuitive Surgical said it inked a licensing deal for the miniaturized robotic sealing and stapling technology developed by JustRight Surgical that includes an unspecified equity investment and joint product development program.

See the best minds in medtech live at DeviceTalks Boston on Oct. 2.

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Dentsply Sirona shares steady despite Q2 sales miss

Shares in Dentsply Sirona (NSDQ:XRAY) have fallen slightly today after the medical device maker met earnings per share expectations but missed sales consensus on Wall Street with its 2nd quarter earnings report.

The York, Penn.-based company posted losses of $1.1 billion, or $4.58 per share on sales of $992.7 million for the 3 months ended June 30, seeing a massive 1096% swing from profits to losses while sales shrunk 2.9% compared with the same period during the previous year.

Adjusted to exclude 1-time items, earnings per share were 65¢, just in line with the 65¢ consensus on Wall Street, where analysts were expecting to see sales of $1 billion.

“Our results were impacted by a number of factors, the largest of which are headwinds associated with Patterson reducing its inventory in North America and the transition of North American distribution. Year to date, operational execution has not met our expectations. Our lower outlook reflects the underperformance in the first half of the year and some of those challenges persisting in the back half of the year. In September, we should begin to benefit from the expanded distribution of our equipment in North America which should drive growth in the back half of this year and beyond. As we work through the distribution transition and integration initiatives, we are strengthening our foundation for the future. We believe that this should translate into more consistent growth and strong double digit earnings growth in the back half of the year creating momentum exiting the year going into 2018,” CEO Jeffrey Slovin said in a press release.

The company updated its earnings per share guidance for the entire years expecting to post between $2.65 and $2.75 per diluted share.

Shares in Dentsply Sirona have dipped 0.8% so far today, at $55.03 as of 2:49 p.m. EDT.

See the best minds in medtech live at DeviceTalks Boston on Oct. 2.

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SteadyMed tops Q2 sales, EPS estimates

Shares in SteadyMed (NSDQ:STDY) fell today after the pharmaceutical company beat sales expectations on Wall Street with its second quarter results, but missed EPS estimates.

The San Ramon, Calif.-based company posted a net loss of -$8.1 million on sales of $319,000 for the 3 months ended June 30, for bottom-line loss of -14% on sales growth of 239.4% compared with the same period last year.

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

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Trump declares national emergency over opioid epidemic

President Trump said yesterday that he is preparing to declare the opioid epidemic a national emergency. This is a reversal from an announcement made earlier this week by Health and Human Services Secretary Tom Price, who said that they would not declare a state of emergency.

“The opioid crisis is an emergency, and I’m saying officially right now it is an emergency,” Trump reportedly said, according to The Hill. “It’s a national emergency. We’re going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis.”

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

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Cytori Therapeutics posts mixed Q2

Shares in Cytori Therapeutics (NSDQ:CYTX) fell today after the biotech missed sales expectations on Wall Street with its second quarter results, but topped EPS estimates.

The San Diego, Calif.-based company posted a net loss of -$6 million on sales of $1.5 million for the 3 months ended June 30, for bottom-line growth of 6% on sales loss of -47% compared with the same period last year.

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

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Viveve inks distro deal with InControl Medical, posts Q2 miss

Shares in Viveve (NSDQ:VIVE) have stayed steady today after the company announced a new exclusive distribution deal with InControl Medical and released 2nd quarter earnings that missed expectations on Wall Street.

Under the agreement, Englewood, Colo.-based Viveve said it will be granted exclusive rights to distribute all of InControl Medical’s products to healthcare providers in the US.

“We are pleased with the opportunity to partner with Viveve to enable wider distribution of our clinically proven devices to U.S. medical professionals who can help the millions of patients suffering from pelvic floor and related incontinence conditions. Our hope is that these products will allow more women to have better control and an improved quality of life. Viveve and InControl share a dedicated commitment to advancing solutions for women’s health,” InControl Medical CEO Herschel Peddicord said in prepared remarks.

Viveve said it will be making a $2.5 million equity investment in InControl as part of the distribution agreement, as well.

“Completing an agreement with InControl Medical represents a significant opportunity for Viveve in the U.S. professional healthcare market. The addition of InControl Medical’s FDA cleared medical devices for stress, urge, and mixed incontinence as well as their products to improve pelvic floor strength enhances our portfolio with a range of high quality products that are used by healthcare professionals within Viveve’s currently targeted specialties. In addition to InControl Medical’s innovative devices to treat incontinence, their products aimed at improving patients’ pelvic floor strength and health complement the effectiveness of Viveve’s Geneveve treatment, that currently has regulatory clearance or approval in over 50 countries for the treatment of vaginal laxity and/or the improvement of sexual function. In the United States, the Viveve System is cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis,” Viveve CEO Patricia Scheller said in a prepared statement.

In its earnings report, Viveve posted losses of $10.4 million, or 54¢ per share, on sales of $3.1 million for the 3 months ended June 30, seeing losses grow 96.1% while sales grew 97.7% compared to the same period during the previous year.

Losses per share came in ahead of the 43¢ consensus on Wall Street, where analysts were expecting to see sales of $3.2 million for the quarter.

“During the 2nd quarter, we continued to achieve our commercial objectives and experienced growing demand for our innovative technology in the U.S. We also reached a number of important milestones that support our global commercialization strategy,” CEO Scheller said in a press release.

Shares in Viveve Medical are down 0.9% so far today, at $6.99 as of 10:56 a.m. EDT.

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EnteroMedics prices $20m preferred stock offering

EnteroMedics (NSDQ:ETRM) today priced an upcoming underwritten public offering looking to raise $20 million to support continued commercialization and product development.

In the offering, the company will offer units at $1,000 per unit, with each consisting of 1 share of Series B convertible preferred stock, convertible into 435 shares of common stock at $2.30 per share, and a 7-year warrant to purchase 435 shares of common stock also at $2.30 per share.

Preferred stock offered in the round will include a beneficial ownership blocker but has no dividend rights, the St. Paul, Minn.-based company said.

A total of 20,000 shares of preferred stock, convertible into 8.7 million shares, and warrants for an additional 8.7 million shares will be sold in the offering, the company said in a press release. The offering is expected to close August 16.

Last month, EnteroMedics said it won approval from Spain’s Ministry of Health, Social Services and Equality to initiate a clinical trial of its Gastric Vest system in Spain.

See the best minds in medtech live at DeviceTalks Boston on Oct. 2.

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IntelGenx misses Q2 sales, earnings estimates

Drug delivery company IntelGenx (CVE:IGX) missed expectations on Wall Street yesterday with its second quarter results.

The Quebec-based company posted a net loss of -$550,000 on sales of $1.1 million for the 3 months ended June 30, paring its losses by 32% on sales growth of 64% compared with the same period last year.

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

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Conservative groups jump on medical device tax repeal bandwagon

A coalition of conservative action groups yesterday jumped on the bandwagon for repealing the medical device tax, urging Congressional leaders to scrap the 2.3% levy on U.S. medtech sales.

In a letter to House speaker Rep. Paul Ryan (R-Wis.) and Senate majority leader Sen. Mitch McConnell (R-Ky.), the group also advocated for repealing a tax on certain insurance programs. Both levies, enacted as part of Obamacare, are on hiatus until next year.

The group, which includes Grover Norquist’s Americans for Tax Reform and the political arm of the American Legislative Exchange Council, warned that both taxes will lead to “higher premiums and higher costs for middle class families, seniors, and small businesses.”

“There are more than 6,500 medical device companies in the U.S., 80% of which have fewer than 50 employees. The industry contributes $150 billion annually to the economy. The tax impairs the industry’s ability to innovate, invest, and create jobs,” according to the letter, which cites figures from the center-right American Action Forum. “If Congress allows it to go into effect in 2018, the medical device tax could lead to more than 25,000 lost jobs by 2021. Over the next decade, this excise tax is projected to increase taxes by $30 billion.”

The move to repeal the medical device tax, which enjoys bipartisan support in both chambers of Congress, is also the subject of a social media campaign by industry lobby AdvaMed aiming to goad legislators from key states.

See the best minds in medtech live at DeviceTalks Boston on Oct. 2.

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Deaths prompt renewed FDA warning on intragastric balloons

The FDA yesterday updated its warning of the risks associated with fluid-filled intragastric balloons after receiving new reports of the deaths of patients implanted with the devices.

Intragastric balloons, made by Apollo Endosurgery (NSDQ:APEN) and ReShape Medical, are used to treat obesity. Placed in the stomach orally in a minimally invasive endoscopic procedure, they’re designed to be filled with fluid and stay in the stomach for six months. Apollo’s Orbera intragastric balloon system is composed of a single balloon which is filled with saline, while ReShape’s integrated dual balloon system uses 2 balloons filled with saline and methylene blue dye.

Earlier this year the federal safety watchdog warned of the risk of two types of adverse event associated with the balloons, including over-inflation requiring premature removal and the development of acute pancreatitis, also requiring premature device removal.

Yesterday the FDA said it received five reports of “unanticipated” deaths since 2016 in patients treated with the balloons, four with Apollo’s Orbera and another with ReShape’s dual-balloon system; in a press release, Apollo said there have been five deaths of Orbera patients since the agency approved the device in August 2015.

The FDA said the reports it received since 2016 indicate that the patients died within a month of implantation, with three as soon as three days later. The root causes for the deaths are unknown, the agency said, “nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction).”

The FDA also said another two patients died from complications from balloon implantation: a gastric perforation in an Orbera patient and an esophageal perforation in a ReShape patient.

Apollo said it reported all five deaths of Orbera patients in the U.s., Mexico, Brazil and Great Britain to the FDA and has had no indication that any were related to the device or its insertion procedure. No product liability lawsuits have been filed against it, the Austin, Texas-based company said, claiming an incident rate since the beginning of 2006 of less than 0.01%.

“Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously. The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity. In our physician training, we are diligent to emphasize the factors that support the safe and effective use of Orbera and we will continue to do so,” CEO Todd Newton said in prepared remarks.

“The FDA’s letter reinforces the fact that complications and adverse events can occur within patients having obesity-related co-morbid conditions. Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment in order to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms,” added CMO Dr. Christopher Gostout.

APEN shares closed down -23.3% at $4.34 apiece yesterday.

See the best minds in medtech live at DeviceTalks Boston on Oct. 2.

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