Smiths Group unveils Smiths Medical spinout plan, search for new CEO

Smiths Medical

Smith Medical parent company Smiths Group (LON:SMIN) today announced plans to pursue a demerger with its Smiths Medical business, which will become separately listed in the UK.

Smiths Group said it believes the demerger will strengthen both companies and allow the newly separated medical business to better capitalize on its leading positions, product launches and other value-creating opportunities. The company said it expects to complete the demerger some time during the first half of next year.

“Pursuing a demerger of Smiths Medical will lead to two stronger companies each focusing on accelerating the execution of their plans and maximising the opportunities in their respective markets. With sustained operational improvement and investment, both Smiths and Smiths Medical are well positioned to capitalise on their leadership positions and new products. Smiths will become a leading industrial technology group concentrated on the execution of its organic and inorganic growth strategy whilst maximising shareholder value,” CEO Andy Reynolds Smith said in a prepared statement.

The newly independent medical company will also need a new chief exec after its former prez & CEO Chris Holmes stepped away, effective Deceember 31, according to a Minneapolis Star Tribune report. The conglomerate said that it has already begun the search for a replacement for Holmes.

Smiths Medical will have corporate headquarters in the U.K. with operational headquarters in Plymouth, Minn., according to the report. The medical business employs approximately 7,600 employees worldwide.

Based on the work done to date, Smiths does not foresee any potential roadblocks in executing the demerger.  The strategic plan for Smiths Medical will be further developed with the leadership over the coming months,” Smiths Group said in a press release.

The demerger comes after years of seeking a buyer for Smiths Medical with no success. Last September, Smiths Medical ended possible merger plans with ICU Medical (NSDQ:ICUI) in a deal reportedly worth approximately $4 billion. The companies had been in discussions since last May.

Listed amongst other potential buyers over the past years are Baxter (NYSE:BAX), Teleflex (NYSE:TFX) and B. Braun, though no discussions were officially disclosed.

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Senseonics touts patient access program for Eversense CGM

SenseonicsSenseonics (NYSE:SENS) said today that it launched the Eversense Bridge Program, which is designed to improve patient access to Senseonics’ Eversense continuous glucose monitoring system.

The company said that the program can help users confirm their insurance benefits and obtain pre-authorization before sensor placement. The Eversense Bridge Program is also meant to help healthcare providers and patients appeal to insurers regarding denied claims.

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

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Novartis plans Alcon spinout for early April

Novartis AlconNovartis (NYSE:NVS) said today that it’s planning to list the shares of its Alcon vision care business April 9 in Switzerland and New York.

Terms for the spinout, announced last June, call for each Novartis shareholder to receive a single ALC share for every five NVS shares at the close of business April 8.

The Swiss SIX exchange and the New York Stock Exchange have each approved the listing, Novartis said.

“Alcon has secured debt financing of $3.5 billion through a group of banks. The Alcon credit rating will be investment-grade following the spin-off. Moody’s Investor Service and S&P Global Ratings have rated Alcon at Baa2 and BBB, respectively, with a stable outlook,” Novartis said.

Bank of America Merrill Lynch and UBS are advisors on the deal, the company said. Novartis bought Alcon in 2010 after a years-long courtship.

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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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Titan Medical closes $25m offering

Robotic surgical platform developer Titan Medical (NSDQ:TMDI) said today it closed a $25 million public offering.

The Toronto-based company said that it floated approximately 7.4 million units in the offering at a price of $3.40 per unit. Each unit offered was comprised of a single common share of the company and a warrant for an additional common share at a price of $4, set to expire on March 20, 2024.

The offering included a fully-exercised over-allotment option through which the company floated an additional 1.1 million units for an additional approximate $3.8 million, Titan Medical said, bringing the total raised up to approximately $28.8 million.

Shares offered in the round were listed and posted for trading on both the Toronto Stock Exchange under the symbol “TMD” and on the Nasdaq Capital Market under the symbol “TMDI,” according to a press release.

Last month, Titan Medical said that it is hoping to launch an FDA investigational device exemption trial of its Sport robotic surgery platform by the fourth quarter of this year.

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Novartis launches COPD inhalers in China

NovartisNovartis (NYSE:NVS) has launched its Ultibro Breezhaler and Seebri Breezhaler in China for the treatment of chronic obstructive pulmonary disease.

The Ultibro Breezhaler system is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide. Seebri Breezhaler is a fixed-dose formulation of glycopyrronium bromide.

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

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Novocure launches pivotal ovarian cancer trial

NovocureNovocure (NSDQ:NVCR) said today that it kicked off a Phase 3 pivotal trial testing its Tumor Treating Fields therapy combined with paclitaxel in people with recurrent, platinum-resistant ovarian cancer.

The 540-patient trial has a primary endpoint of overall survival, with secondary endpoints that include progression-free survival, objective response rate, severity and frequency of adverse events and quality of life.

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

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Appeals court declines full review of $254m Zimmer loss to Stryker

Stryker, Zimmer BiometA federal appeals court declined a full review of its earlier decision to affirm a $248 million win for Stryker (NYSE:SYK) in its surgical tool patent case against Zimmer Biomet (NYSE:ZBH).

The U.S. Court of Appeals for the Federal Circuit last December upheld treble damages in the case, based on a U.S. Supreme Court decision in Halo Electronics v. Pulse Electronics that relaxed the standard for enhanced damage awards in patent infringement cases. Zimmer Biomet appealed that per curiam decision, asking for both a three-judge panel and the full Federal Circuit bench to re-evaluate the case. The court denied both petitions March 19, setting March 26 as the date for issuing the mandate of the court.

The case dates back to December 2010, when Stryker sued Zimmer the U.S. District Court for Western Michigan, alleging infringement of three patents covering wound debridement technology by Zimmer’s Pulsavac Plus device. In February 2013 a jury awarded $70 million to Stryker; Judge Robert Jonker trebled the damages in August of that year.

The Federal Circuit in 2014 rolled back that $228 million ruling, finding that Stryker failed to prove willful infringement. Stryker appealed to the Supreme Court, which vacated the appeals court’s ruling and ordered it to reconsider the case. The Supremes found that the Federal Circuit’s test was too rigid and allowed egregious infringers to evade liability.

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Abiomed’s stake in Shockwave is worth at least $58m

Abiomed, Shockwave MedicalThe $10 million Abiomed (NSDQ:ABMD) put into Shockwave Medical (NSDQ:SWAV) has paid off so far no matter how you slice it.

Shockwave raised nearly $97 million in an initial public offering earlier this month, inking a private-placement deal with Abiomed on the side for $10.0 million worth of SWAV shares at the $17-per-share IPO price. In a regulatory filing today, Santa Clara, Calif.-based Shockwave said Abiomed owns nearly 1.7 million shares, or a 6.0% stake.

With SWAV shares trading at $34.55 apiece today in mid-morning activity (up 4.8%), Danvers, Mass.-based Abiomed’s share would be worth roughly $58.7 million if it sold right now. Measured as a slice of Shockwave’s $1.19 billion market capitalization, that 6% stake’s value jumps to $71.4 million.

Shockwave is developing a device to treat calcified coronary lesions with sonic pressure waves. The deal with Abiomed, announced last December, includes collaboration on a training and education program in the U.S. and Germany.

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Neovasc claims win in German TMVR patent case against Edwards unit CardiAQ Valve

Edwards Lifesciences, CardiAQ Valve, NeovascNeovasc (NSDQ:NVCN) today 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.

In June 2017 the District Court in Munich ruled that CardiAQ Valve contributed to the creation of Neovasc’s Tiara transcatheter mitral valve replacement, awarding”co-entitlement” rights to the patent in Europe. Both sides appealed that ruling, in the course of which CardiAQ withdrew its total ownership claim but asserted partial ownership, Vancouver-based Neovasc said today.

Munich’s Higher Regional Court dismissed the remaining claims, finding that CardiAQ “had not contributed to the invention of the Tiara” and ruling “Neovasc to be the rightful inventor and owner of all rights to the disputed Tiara European patent application,” according to Neovasc.

“We are pleased that after full consideration of the evidence, the German courts have now recognized that CardiAQ made no contribution to the invention or development of the Tiara,” CEO Fred Colen said in prepared remarks. “With this decision, which we strongly believe would be confirmed, even if appealed to and accepted as a case by the German Supreme Court, Neovasc is free to pursue its European patent application and has the sole right to commercialize the Tiara in Europe and help treat patients suffering from debilitating mitral valve disease. We will continue to vigorously defend our intellectual property against any attempts by third parties to infringe on these rights.”

The German case is only one front in the companies’ TMVR war. In the U.S., a jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing Tiara. A federal judge in Massachusetts added $21 million in enhanced damages to the decision that November; in January 2017 the Boston court added another $21 million to the judgment.

Edwards, which inherited the beef when it acquired CardiAQ Valve for $400 million in August 2014, did not immediately reply to a request for comment.

Earlier this month Neovasc inked an exchange deal for the last of the warrants it issued as part of a $65 million funding round to cover the litigation damages.

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