FDA clears surgical guidance system from Merit Medical

Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA 510(k) clearance for the Scout MD surgical guidance system.

Scout MD broadens the South Jordan, Utah–based company’s oncology portfolio. Merit designed the system to enhance the diagnosis and treatment of breast cancer, as well as other soft tissue cancers. The system includes the Scout radar localization system with Scout mini reflector and Scout Bx delivery system. It also features the Savi brachy system.

According to a news release, Scout MD supports the implantation of up to four different reflector configurations. When implanted within abnormal breast or other soft tissue, reflectors pinpoint tumor location in multiple dimensions. This enables more precise excision.

With a targeted approach, the system can help minimize damage to surrounding healthy tissue and decrease the likelihood of re-excision. Merit says it also helps to avoid the emotional and physical trauma assoc…

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Merit Medical founder, CEO to retire in 2025

Fred Lampropoulos, Merit Medical founder, president and CEO.

Merit Medical Systems (Nasdaq:MMSI) announced that Fred Lampropoulos, its founder, CEO and president, intends to retire in two years.

The company outlined its ongoing CEO succession plan process with an amended and restated employment agreement. Lampropoulos intends to continue to serve as president and CEO through Dec. 31, 2025.

To carry out its CEO succession responsibilities, the Merit board appointed a special steering committee of independent directors. Ann Millner serves as lead independent director of the committee overseeing the plan in preparation for the CEO’s retirement.

According to a news release, Merit plans to prepare the company for a CEO transition “at the appropriate time.” It enlisted executive search firm Korn Ferry to assist the board in identifying potential internal and external candidates.

Merit said it doesn’t intend to provide further upd…

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Merit Medical closes $747.5M offering

Merit Medical Systems (Nasdaq:MMSI) confirmed in an SEC filing today that it closed an offering worth $747.5 million.

The South Jordan, Utah-based disposable medical device maker announced earlier this week that it was offering $650 million in 3% senior convertible notes. It upsized the offering from a previously set price of $550 million. Included in the $650 million offering of notes, due 2029, was an option to purchase up to nearly $100 million more.

The notes bear 3% interest per year, payable semi-annually in arrears on Feb. 1 and Aug. 1 of each year, starting in August 2024.

Merit Medical’s SEC filing confirmed that the purchasers exercised their options in full, adding $97.5 million to the total amount sold.

After deducting discounts and commissions, Merit anticipates net proceeds of approximately $725.1 million. It intends to use a chunk of the proceeds to pay the cost of entering into capped call transactions. Merit intends to use a…

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Merit Medical upsizes private offering to $650M

Merit Medical Systems (Nasdaq:MMSI) announced today that it priced an upsized private placement worth $650 million.

South Jordan, Utah-based Merit is offering 3% Convertible Senior Notes due 2029 in the offering, only to qualified institutional buyers. The company granted the initial purchasers an option to purchase up to an additional $97.5 million during a 13-day period. That period begins on and includes the date of the first issuance.

Merit upsized this offering from a previously announced placement of $550 million. It expects the sale of notes to initial purchasers to close on Dec. 8, 2023.

The notes bear 3% interest per year, payable semi-annually in arrears on Feb. 1 and Aug. 1 of each year, starting in August 2024. Holders have the right to require Merit to repurchase all or part of their notes upon the occurrence of a fundamental change in cash at a fundamental change repurchase price of 100% of their principal amount plus accrued and unpaid int…

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AngioDynamics sells off dialysis portfolio for $100M

AngioDynamics (Nasdaq:ANGO) announced that it completed the sale of its dialysis product portfolio to Merit Medical Systems.

Latham, New York-based AngioDynamics sold its dialysis portfolio and the BioSentry product for $100 million in cash. The transaction includes the DuraFlow, DuraMax, Evenmore, Schon XL, Trio-CT and Vaxel Plus hemodialysis catheter brands. It also includes the BioSentry product, a tract sealant system biopsy brand.

AngioDynamics said in a news release that the combined product portfolio generated $32 million in sales in 2023.

The company plans to use net proceeds to eliminate existing debt and support further strategic investments in growth and profitability. AngioDynamics said its divested assets are included in its medical device business and don’t have a significant amount of direct costs. As a result, the company expects a dilutive impact to adjusted earnings per share. It projects a slightly dilutive impact on corporate gr…

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Medtech jobs: The world’s largest medical device companies are hiring

Medical device companies are trying to fill thousand of medtech jobs. [Photo by ijeab – stock.adobe.com]

The world’s largest medical device companies are still hiring for medtech jobs despite layoffs in tech and other industries.

Medtech developers — and medtech jobs — are resilient, with the industry’s COVID-19 pandemic performance only bolstering its recession-proof reputation.

That’s not to say there haven’t been job cuts in medtech, led by thousands of layoffs at Philips as it struggles with a massive recall of deadly respiratory devices. But most medical device manufacturers are still hiring, and in some cases they can’t attract enough candidates to fill every vacancy in a tight labor market.

Stryker, for example, grew to approximately 51,000 employees as of the end of 2022, increasing its headcount by nearly 11 percent last year. Boston Scientific reported nearl…

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Merit Medical grows profits 62% in Q4

Merit Medical Systems (Nasdaq:MMSI) this week posted fourth-quarter results that beat the overall consensus on Wall Street.

The South Jordan, Utah-based disposable medical device maker reported profits of $33.4 million, or 58¢ per share, on sales of $293.4 million, for the three months ended Dec. 31, 2023, for a bottom-line gain of 62% on sales growth of 5.36% compared to Q4 2021.

Adjusted to exclude one-time items, earnings per share were 79¢, 12¢ ahead of The Street, where analysts were looking for sales of $290.14 million.

“We delivered 8% constant currency revenue growth in the fourth quarter of 2022, at the high end of our expectations,” CEO Fred Lampropoulos said in a news release. “We are introducing 2023 financial guidance which reflects our confidence in our team’s ability to deliver continued strong execution, despite the challenging operating environment around the world.”

For fiscal 2023, Merit Medical anticipates net sales in th…

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The biggest medtech stock gainers, losers in 2022

(From Ishant Mishra on Unsplash) In another roller coaster year for medtech, these are the companies that saw their stock rise and fall the most drastically.

The MassDevice MedTech 100 Index, which includes stocks of the world’s largest medical device companies, reflects the performance of many in the medtech space.

In a tough year for a lot of businesses, the Index wasn’t immune to struggles. Overall, it dropped 27.3% from this time last year. That compares to a 19.7% drop for the S&P 500 and an 8.9% dip for the Dow Jones Industrial Average.

Some businesses, though, powered through the supply chain- and inflation-related woes to see their stock rise from this time last year. Others weren’t so lucky. Here are some of the biggest gainers and losers — selected from the MedTech 100 Index — of 2022.

Biggest gainers BD — $245.27 to $254.97 — Up 4% 

While BD (NYSE:BDX) didn’t have the most significant growth, its stock remains in a …

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Merit Medical announces launch of ‘EZ’ radial compression device

The PreludeSync EZ radial compression device [Image courtesy of Merit Medical Systems]Merit Medical Systems (NASDAQ: MMSI) today announced the U.S. launch of its PreludeSync EZ radial compression device.

South Jordan, Utah–based Merit Medical described the PreludeSync EZ as a unique cinch-style wristband. The company designed it to provide precise two-handed placement and clear visibility of the access site.

The goal is to optimize bleeding prevention for radial artery procedures. Think catheter-based delivery systems. For example, a doctor will run a catheter through a pinhole-sized site in the wrist to conduct minimally invasive scans and procedures around the heart.

The PreludeSync EZ provides a simplified alternative to the two-strap compression band currently on the market, according to the company. In addition, the PreludeSync EZ’s design features include a large window that provides clear visibility to further assist precise placement.

“…

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Merit Medical appoints new chief commercial officer

Merit Medical Systems (Nasdaq:MMSI) announced that it promoted longtime executive Joe Wright to chief commercial officer.

Wright’s new role includes responsibility for spearheading the company’s overall commercial strategy. The 17-year Merit veteran most recently served as president of the company’s international business and led units across the Asia Pacific (APAC) region and the Americas. He also had commercial responsibility for the EMEA region over the past year.

Wright has also served as president of Merit Technology and VP of global marketing. Merit said in a news release that Wright’s appointment enables the company to “increasingly align and strengthen” ITS commercial capabilities and helps to perpetuate the company’s growth strategy.

“Today is an important day for Merit,” said Fred Lampropoulos, Merit Medical chair and CEO. “I’m delighted to promote Joe Wright, as he is an accomplished business leader wh…

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Merit Medical rises on Street-beating Q3, raised guidance

Merit Medical Systems (Nasdaq:MMSI) shares are up today — a day after it reported Q3 results that topped the consensus forecast.

The South Jordan, Utah-based disposable medical device maker announced yesterday evening that it posted profits of $15.3 million in the quarter. That amounts to 27¢ per share.

Merit registered sales of $287.2 million for the three months ended Sept. 30, 2022. Its figures include a 27.6% bottom-line improvement on sales growth of 7.5%.

Adjusted to exclude one-time items, Merit posted earnings per share of 64¢. That’s 11¢ ahead of expectations on Wall Street. Analysts projected sales of $272 million.

Mike Matson at Neeham & Co. said Merit Medical enjoyed broad-based growth that drove a solid Q3 despite inflation and currency headwinds. He reiterated his Buy rating: “We believe that MMSI continues to execute on its strategy despite macro headwinds and expect it to continue to drive strong revenue growth, mar…

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Merit Medical Systems launches soft tissue biopsy system

Merit Medical Systems (Nasdaq:MMSI) announced today that it launched the TEMNO Elite soft tissue biopsy system in the U.S.

South Jordan, Utah-based Merit designed TEMNO Elite for use in various soft tissue locations. This includes the liver, lung, lymph nodes, kidney, and other soft tissue suspect lesions.

The single-use device complements a broader portfolio, the company said. The portfolio includes the TEMNO, Achieve and Tru-Cut device families.

Merit designed TEMNO Elite to retrieve superior samples, according to a news release. The TEMNO Elite Total Core biopsy technology provides samples 72% larger than competitor side-notch, semi-automatic devices. It features Sample Assist technology to simplify tissue removal as well.

Sample Assist allows clinicians to retrieve full samples with just the slide of a button. Additionally, it includes an optional, valved coaxial introducer. This enhances patient safety by reducing the risk of air entry and fl…

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