Xeltis wins FDA breakthrough status, enrols first patient in pivotal trial [Yahoo! Finance]
Merit Medical Systems, Inc. (MMSI)
Last merit medical systems, inc. earnings: 4/23 04:01 pm
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Source: Yahoo! Finance
The Dutch company shared that the US Food and Drug Administration (FDA) has granted breakthrough device designation to its lead product, called aXess, which will expedite the route to market. Manufacturers who gain this designation are eligible for enhanced interaction with FDA experts and prioritised review when the time comes for a regulatory submission. Whilst revealing the breakthrough win, Xeltis took the opportunity to reveal it had enrolled and treated the first patient in a pivotal trial with aXess. The trial is a prospective, single arm, multi-centre study evaluating the safety and performance of the device in adults with end stage renal disease who need dialysis. It is being conducted under an investigational device exemption granted in June this year. Patients with end stage renal disease who undergo regular dialysis need a vascular access point – arteriovenous fistulas (AVF) are the preferred choice, but grafts or catheters can be used depending on a variety of factor
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MMSI
News
- Merit Medical Systems' (NASDAQ:MMSI) five-year earnings growth trails the solid shareholder returns [Yahoo! Finance]Yahoo! Finance
- Merit Medical Systems, Inc. (NASDAQ: MMSI) had its "overweight" rating re-affirmed by analysts at Piper Sandler. They now have a $116.00 price target on the stock, up previously from $114.00.MarketBeat
- Merit Medical Systems, Inc. (NASDAQ: MMSI) had its price target raised by analysts at Needham & Company LLC from $109.00 to $122.00. They now have a "buy" rating on the stock.MarketBeat
- Merit Medical Systems, Inc. (NASDAQ: MMSI) had its price target raised by analysts at Canaccord Genuity Group Inc. from $127.00 to $128.00. They now have a "buy" rating on the stock.MarketBeat
- Merit Medical Systems, Inc. (NASDAQ: MMSI) had its price target raised by analysts at Barrington Research from $114.00 to $115.00. They now have an "outperform" rating on the stock.MarketBeat
MMSI
Earnings
- 10/30/24 - Beat
MMSI
Sec Filings
- 1/28/25 - Form 8-K
- 1/14/25 - Form 144
- 1/14/25 - Form 8-K
- MMSI's page on the SEC website