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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Wound Management buys out remaining 50% stake in Cellerate

Wound Management Tech

Wound Management Technologies (OTC:WNDM) said yesterday that it closed a deal to acquire the remaining 50% stake in the Cellerate joint venture it launched last September with The Catalyst Group.

Prior to the acquisition, Wound Management Technologies and The Catalyst Group’s CGI Cellerate RX affiliate had owned equal shares in the spun-out company.

The Cellerate JV maintains an exclusive sublicense to distribute the CellerateRX activated collagen adjuvant into wound care markets in the U.S., Canada and Mexico.

Fort Worth, Texas.-based Wound Management Tech said that Cellerate will now act as a wholly owned subsidiary and will report its financial results on a consolidated basis beginning March 15.

The deal was funded by the issuance of approximately 1.1 million shares of Wound Management Tech’s Series F convertible preferred stock, the company said. Each share of Series F preferred stock can be converted at any time into 200 shares of common stock, according to an SEC filing.

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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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Varex Imaging to pay $85m for Direct Conversion

Varex Imaging logo

Varex Imaging (NSDQ:VREX) said yesterday it inked a deal to acquire linear array digital detector maker Direct Conversion for $84.6 million (EU €75 million).

In the deal, Salt Lake City, Utah-based Varex said that it agreed to acquire at least 90% of the outstanding shares of Stockholm-based Direct Conversion, and that the $84.6 million price tag was for 100% of the company’s outstanding shares.

Varex said that $11.3 million (EU €10 million) of the total offered in the deal will be paid in either Varex common stock or cash on the first anniversary of the closing. The company said it plans to fund the acquisition using available cash and debt under its existing credit facility.

“We are excited to be joining Varex at this point in the growth and expansion of our digital detector array products. This transaction is expected to accelerate the adoption of this technology in the marketplace utilizing Varex’s position as one of the leading providers of digital detectors and its global distribution channels,” Direct Conversion CEO Spencer Gunn said in a press release.

Last year, Direct Conversion reported sales of approximately $18.1 million (EU €16 million) and projected double-digit annual growth rates over the next five years. The company reportedly has more than $45.11 million (EU €40 million) in signed multi-year supply agreements.

Varex said that it expects the deal to close by the end of the third quarter, and to be accretive to its adjusted EPS in its fiscal year 2020 and to generate a return on invested capital greater than its capital cost within three years.

“Upon closing, this acquisition will expand our product portfolio to include new linear array digital detectors along with a revenue stream from these products for certain medical, dental and industrial applications. It is expected that the current applications will widen our addressable market for digital detector products by approximately $200 million over the coming years, with additional addressable market expansion potential of up to $500 million by replacing current CT detectors with photon counting technology in the future,” Varex CEO Sunny Sanyal said in a press release.

Last month, Varex saw shares rise after it beat expectations on Wall Street with its fiscal year 2019 first quarter earnings.

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Artificial intelligence and medicine: Is it overhyped?

Artificial intelligence raises exciting possibilities for healthcare, but are companies promising more than they can deliver?

artificial intelligence ai medicine medtech medical devices hype

[Original image from iStock]

AI could possibly fuel the future of medtech, enabling such thrilling innovations as implanted devices that instantly react to minute changes, software that can identify the best treatment options for individuals facing life-threatening conditions and fully-functioning autonomous surgical systems.

But artificial intelligence’s potential also comes with an incredible level of hype.

“AI has the most transformative potential of anything I’ve seen in my life, and I graduated medical school 40 years ago. It’s the biggest thing I’ve ever seen by far,” prominent cardiologist and author Dr. Eric Topol told our sister site Medical Design & Outsourcing. “But it’s more in promise than it is in reality.”

Get the full story on MDO. 

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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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Hemodialysis device maker Phraxis raises $6m

Phraxis

Early stage medical device company Phraxis has raised approximately $5.6 million in a new round of equity and options financing, according to a recently posted SEC filing.

Phraxis is developing a novel treatment for patients who need vascular access for hemodialysis, according to the company’s website.

The St. Paul, Minn.-based company’s first product for commercialization is the InterGraft, a percutaneously delivered arteriovenous shunt intended to provide a unique, non-surgical approach for patients who need vascular access, according to the site.

Money in the round came from seven unnamed investors, with the first sale in the offering noted as having occurred on February 8, according to the filing.

Phraxis is looking to raise an additional $1.4 million in the round, according to the SEC filing, which would bring the total raised in the round to approximately $7 million.

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Semtech, Sonova ink hearing aid development deal

Sonova

Sonova Holding AG (SIX:SOON) and semiconductor maker Semtech said today they jointly developed a new advanced radio system intended for use in Sonova’s hearing aids.

The new technology, an ultra-small integrated circuit, will serve as the main component in a new generation of hearing aids and enable support for multiple radio protocols in the 2.4GHz band, the companies said.

“This chip allows Sonova to move in a new direction with our hearing aids. The breakthrough radio technology and power management are the game changers for hearing aids. It allows them to support a number of applications that have previously not been possible in a hearing aid, all at low power consumption and low supply voltage. Possible applications span from connectivity to any Bluetooth enabled audio device (e.g. a smartphone or television) to full duplex audio streaming between hearing aids and connectivity to wireless microphones,” Sonova wireless R&D director Marc Secall said in a prepared statement.

The device is also intended to operate on low power, Semtech said.

“Semtech continues to innovate and create flexible, reliable solutions for challenging applications associated with the best radio frequency connectivity at the lowest power and 0.8V supply voltage. Sonova has long been a leader for hearing devices. By implementing Semtech’s technology and enabling access to the cloud, we believe that these devices will enrich the IoT-connected solutions which Semtech is serving with LoRa Technology,” Semtech wireless and sensing products group R&D VP Jean-Paul Bardyn said in a press release.

Last November, Sonova said that it inked a deal to license Ceva’s RivieraWaves Bluetooth intellectual property for use in its Sword 3.0 wireless hearing aid chip, Ceva said today.

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