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World’s First FDA IDE Coronary Patient Treated With a DEB

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NYON, Switzerland, July 11, 2020 /PRNewswire/ —  MedAlliance has announced enrollment of the first patient in its study of SELUTION SLR™ 014 DEB for the treatment of In-Stent Restenosis (ISR). This is the first DEB accepted by the FDA for its ‘Breakthrough Program’. The SELUTION SLR (Sustained Limus Release) is a novel sirolimus eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).

The objectives of this prospective, randomized, single-blind multicenter study are to demonstrate the safety and efficacy of SELUTION SLR in treatment of ISR with either drug-eluting or bare metal stents (BMS). The study will support submission for FDA approval.

“This first patient was treated with the investigational device after suffering a DES ISR. We are delighted to be able to offer our patients this promising new technology,” commented Professor Pascal Vranckx, Hartcentrum Hasselt, Belgium. “We are excited to participate in a study that validates this novel technology for ISR treatment. SELUTION SLR may provide an additional treatment option for these patients. We very much look forward to the results of this study.”

Up to 418 subjects will be recruited into the study at approximately 60 sites across both the US and Europe. Subjects need to have a BMS or DES ISR involving a native coronary artery with a reference vessel diameter (RVD) of 2.00 – 4.50 mm to qualify for inclusion. Subjects will be randomized to receive either SELUTION SLR or Standard of Care (SOC) – a control group with a current DES or a non-drug eluting balloon angioplasty.

The primary endpoint for effectiveness of the study is Target Lesion Failure (TLF): defined as all cardiac death; target vessel myocardial infarction; or clinically driven Target Lesion Revascularization (TLR) at 12 months.

Subjects will be followed up at one month, six months, 12 months and then annually through five years.

“This is a particularly important study for MedAlliance,” explained Chairman and CEO Jeffrey B. Jump. “No coronary drug-eluting balloon has yet been approved in the US, where ISR currently represents 11% of all stent implantations. We are excited to introduce this breakthrough technology to help patients around the world.”

The Principal Investigator of this study is Donald Cutlip, Professor of Medicine at Harvard Medical School and Chief Medical Officer at the Baim Institute for Clinical Research. Professor Cutlip helped design the study in consultation with the Institute.

SELUTION SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and Sustained Limus Release (SLR) of the drug. Extended release of sirolimus from stents has been demonstrated highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.

SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary arterial disease in May 2020. It is now is available in Europe and all other countries where the CE Mark is recognized. The global market for DEB is estimated to be $2 Billion.

About MedAlliance

MedAlliance is a privately-owned medical technology company. It is headquartered in Switzerland, with facilities in Irvine, California; Glasgow, UK; and Singapore. MedAlliance specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. For further information visit: https://medalliance.com/

Media Contact: 
Richard Kenyon
rkenyon@medalliance.com
+44-7831-569940

Logo: https://mma.prnewswire.com/media/1196864/MedAlliance_Logo.jpg

Source: https://markets.businessinsider.com/news/stocks/world-s-first-fda-ide-coronary-patient-treated-with-a-deb-1029385081

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UK digital bank Starling’s losses doubled in 2019 — but it expects to break even this year

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Anne Boden, CEO of Starling Bank, speaking at Web Summit 2019 in Lisbon, Portugal.

Harry Murphy | Sportsfile for Web Summit via Getty Images

British digital challenger bank Starling said Thursday that its losses doubled in 2019, but that it now expects to break even by year-end amid a rebound in activity from the coronavirus crisis.

The London-based start-up posted a pre-tax loss of £53.6 million ($70.4 million) in the year ending November 30, roughly double the £26.9 million loss it reported for 2018. Revenues came in at £14.2 million, a steep rise from the £750,000 it pulled in a year earlier.

But in a separate trading update, Starling said it had seen lending activity spike in 2020 as it has taken part in the U.K. government’s emergency coronavirus financing schemes. By the end of July, the bank had £1 billion of lending on its balance sheet, the vast majority of which was government-backed lending to businesses hit by the pandemic.

That increase in lending appears to have given a significant boost to the company’s top line in recent months, with net interest income making up the bulk of the £6.7 million revenue it generated in July. Starling said it now has a run rate of £80 million, meaning it expects to make this much in annual revenue.

“We are doing really well financially and it’s a horrible thing to say but the crisis has has given us the opportunity of really spending some time to focus on getting new products out, getting new things launched and consolidating our position,” Starling’s founder and CEO Anne Boden told reporters on a call Thursday. “We are back on track to be profitable by the end of the year.”

The pandemic and resulting lockdown measures led to a 15-20% decrease in customer spending, Starling said, but this has since recovered and even surpassed pre-pandemic levels.

Founded in 2014, Starling is one of several upstarts that came about in the years following the 2008 financial crisis with the aim of challenging the big banks. Other players in the space including British peers Monzo and Revolut, and German rival N26. Starling lags behind all three on customer numbers, with 1.5 million current accounts in total.

But Boden said Starling customers have higher balances and the company isn’t as sharply impacted by a loss of international revenues, since 88% of the revenue it earns from retail customers is domestic. Going forward, the bank expects to break even by the end of 2020 and achieve monthly profitability by 2021.

“Because we have higher balances, we use those balances to lend, and we’re not half a bank, we’re a full bank,” Boden said. “We have both sides of the balance sheet, we have the best of both worlds.”

Last month, Monzo also saw its annual losses double. The fintech company even warned that disruption resulting from Covid-19 has led to “significant doubt” about its ability to continue “as a going concern.” But while Starling’s losses have mounted, the firm said it has “adequate resources to continue in operational existence for the foreseeable future.”

Starling has raised £100 million in funding since the start of the year from its two main investors, Bahamas-based trader Harald McPike and U.K. asset management firm Merian Global Investors. Unlike many of its fintech rivals, Starling hasn’t had to rely on venture capital investment. Starling said its investors had “indicated their intention and ability” to continue supporting the bank.

Source: https://www.cnbc.com/2020/08/07/starling-losses-double-in-2019-but-fintech-now-expects-to-break-even.html

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Trump issues executive orders banning U.S. transactions with WeChat and TikTok in 45 days

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A smartphone screen displays the app store view of the TikTok app in this arranged photograph in London, on Monday, Aug. 3, 2020.

Hollie Adams | Bloomberg | Getty Images

President Donald Trump on Thursday issued executive orders banning U.S. transactions with Chinese tech firms Tencent and ByteDance.

Tencent owns Chinese messaging app WeChat, and ByteDance is the Beijing-based parent company of the widely popular short video-sharing app TikTok.

The ban will take effect in 45 days and may attract retaliation from Beijing

While the scope of the ban remains unclear, the executive orders said that after 45 days, Secretary of Commerce Wilbur Ross “shall identify the transactions” that will be subjected to the prohibition. 

WeChat “automatically captures vast swaths of information from its users. This data collection threatens to allow the Chinese Communist Party access to Americans’ personal and proprietary information,” Trump said in the executive order banning the app, adding that the application also captures personal information of Chinese nationals visiting the U.S.

The US actions against TikTok and WeChat could be a turning point in Beijing’s calculus around how to respond to the US policy actions…

Eurasia Group

The order would basically ban the app in the United States as it prohibits “any transaction that is related to WeChat by any person, or with respect to any property, subject to the jurisdiction of the United States, with Tencent Holdings Ltd.” 

Tencent shares in Hong Kong tumbled almost 6.9% as of 11:38 a.m. HK/SIN on Friday. 

A similar order was issued for TikTok and its Beijing-based owner, ByteDance.

The popular app “may also be used for disinformation campaigns that benefit the Chinese Communist Party,” Trump said in the executive order banning the video-sharing app. “The United States must take aggressive action against the owners of TikTok to protect our national security.”

TikTok has consistently denied those allegations. It says that U.S. user data is stored in the country itself with a backup in Singapore, and that its data centers are located outside China, implying the information was not subjected to Chinese law.

Still, experts have pointed to existing legislation in China which could force local Chinese companies like ByteDance and others to hand over data to Beijing.

Microsoft announced Sunday that it was in talks with ByteDance to acquire TikTok’s business in the U.S., Canada, Australia and New Zealand within the next three weeks, ahead of a Sept. 15 deadline.

ByteDance and Tencent did not immediately respond to CNBC’s request for comment. 

The moves came after U.S. Secretary of State Mike Pompeo said the Trump administration wants to see “untrusted” Chinese apps like WeChat and TikTok removed from U.S. app stores. He detailed a new five-pronged “Clean Network” effort aimed at curbing potential national security risks and said because those apps have parent companies based in China, there was “significant threats to personal data of American citizens, not to mention tools for Chinese Communist Party content censorship.” 

Pompeo also said the State Department would work with other government agencies to limit the ability of Chinese cloud service providers to collect, store and process data in the U.S. 

‘Major escalation’ between U.S. and China

The latest moves represent another step in the deteriorating relations between the world’s two largest economies.

“The executive orders represent a major escalation on the US side of the confrontation with China over the use of technology and mark the first time the US government has attempted to ban a software application running on millions of mobile phones within the US,” according to analysts at political risk consultancy Eurasia Group.

While the move puts pressure on ByteDance to sell TikTok to Microsoft or other U.S. companies within the 45-day window, the implications for WeChat and Tencent could be broader depending on guidance from the Trump administration, Eurasia Group analysts said. 

“The US actions against TikTok and WeChat could be a turning point in Beijing’s calculus around how to respond to the US policy actions that have now either impacted or threatened to impact all of China’s national tech champions,” the analysts wrote. 

“The strident tone of some editorials in state backed media in recent days suggests pressure is mounting for Beijing to take steps like rolling out the much talked about but not yet implemented unreliable entities list to target the operations of US technology companies in China,” they added. 

Recently, the U.S. closed the Chinese consulate in Houston, which prompted China to do the same for the U.S. consulate in Chengdu

— CNBC’s Amanda Macias contributed to this report. 

Source: https://www.cnbc.com/2020/08/07/trump-issues-executive-orders-to-ban-us-transactions-with-wechat-tiktok.html

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Nintendo shares jump after blockbuster earnings; analysts are divided on its outlook

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Goods of Nintendo game character Isabelle, known as Shizue in Japan, from the Animal Crossing series of video games are displayed at a new Nintendo store during a press preview in Tokyo on November 19, 2019.

BEHROUZ MEHRI | AFP via Getty Images

Shares of Japanese video game maker Nintendo were higher by nearly 3% on Friday afternoon Tokyo time.

The company reported Thursday a multi-fold increase in quarterly profit on the back of strong demand for its flagship Switch console. The runaway success of its social simulation game “Animal Crossing: New Horizons” also helped boost sales.

Nintendo’s operating profit for the three months ended June 30 came in at 144.737 billion yen (approx. $1.37 billion). It was much higher than an average estimate of 71 billion yen, according to a Refinitiv SmartEstimate quoted by Reuters.

Meanwhile, “New Horizons,” the latest iteration of the Animal Crossing, has already sold 22.4 million units. It jumped to second position among the top selling Switch games, as of June 30, despite the game only launching in March this year.

Nintendo’s Switch enjoyed strong sales during the coronavirus lockdown globally. The hybrid console, launched in March 2017, allows gamers to play either on-the-go, or connected to an external screen. Sales for the device has been strong as the wider video game industry saw a spike in demand during the initial wave of lockdowns globally to curb the spread of the coronavirus pandemic.

Analysts, however, appear divided on the outlook for the firm.

Atul Goyal, a managing director at Jefferies, has a “hold” rating on Nintendo’s stock. He told CNBC’s “Street Signs” on Thursday, before Nintendo’s earnings release, that he expects sales of Switch to peak next year.

“I ran with (Nintendo) as in buy, highest conviction buy alongside Sony for the last five years,” the analyst said. That changed recently as Nintendo is “not doing enough” outside its core console gaming sector, he said.

“Console gaming is great for (Nintendo) right now, but you’re heading to a peak next year,” Goyal said.

However, Nomura analyst Junko Yamamura has a “buy” rating on Nintendo’s stock.

“We revise up out forecasts based on Apr-Jun results and current conditions. This is mainly because progress with the lengthening of the hardware and software lift cycles has exceeded our expectations,” Yamamura wrote in a note dated Friday.

Source: https://www.cnbc.com/2020/08/07/nintendo-shares-jump-after-blockbuster-earnings-analysts-are-divided-on-its-outlook.html

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