Johnson & Johnson to acquire Abiomed for $16.6B

Johnson & Johnson (NYSE:JNJ) announced today that it agreed to acquire Abiomed (Nasdaq:ABMD) for approximately $16.6 billion.

Under the agreement, Johnson & Johnson intends to acquire through tender offer all outstanding Abiomed shares. That amounts to an upfront payment of $380 per share in cash. Johnson & Johson plans to complete the transaction before the end of the first quarter of 2023.

Shares of ABMD skyrocketed up more than 50% at $378.30 apiece in morning trading today. The company also reported its third-quarter earnings this morning. Meanwhile, JNJ shares dipped slightly at $172.82 apiece. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 2%.

Abiomed shareholders will receive a non-tradeable contingent value right (CVR). This entitles the holder to receive up to $35 per share in cash upon the achievement of certain commercial and clinical milestones. B…

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FDA approves Abiomed Impella RP Flex with SmartAssist for treating right heart failure

The Impella RP Flex with SmartAssist. [Image from Abiomed]Abiomed (Nasdaq:ABMD) announced today that the FDA granted its Impella RP Flex with SmartAssist pre-market approval (PMA).

Danvers, Massachusetts-based Abiomed designed the Impella RP Flex with SmartAssist to treat right heart failure. It does so for up to 14 days. The company intends to introduce Impella RP Flex in the U.S. through a controlled launch this quarter.

The FDA indicated Impella RP Flex with SmartAssist for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2. These patients develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Patients receive the Impella RP Flex via implant into the internal jugular (IJ) vein. This enables patient mobility, according to a news release. The heart pump also features dual-sensor techno…

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5 top trends shaping the medtech industry

Ashley McEvoy (left), Michael Minogue (middle) and Barry Rosenberg (right) speak at AdvaMed’s The MedTech Conference in Boston.

Ashley McEvoy is an industry veteran and the EVP and worldwide chair of Johnson & Johnson MedTech. Michael Minogue, another veteran, serves as chair, president and CEO of heart pump maker Abiomed.

Together, the two bring a wealth of medtech industry knowledge to the table. They demonstrated that in a “CEOs Unplugged” discussion at AdvaMed’s The MedTech Conference today.

McEvoy and Minogue joined Boston Consulting Group Managing Director and Senior Partner Barry Rosenberg onstage to discuss major medtech trends. The two went in-depth on five that they see in the industry right now: AI, health equity, hospital care, talent and climate change.

Here is more about the five trends:

1. AI

McEvoy said there is discussion over the potential framework for how to embrace artificial intelligence (AI) and m…

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Abiomed reaches new regulatory milestone for its Impella pumps

This screen shot from an Abiomed video demonstrates placement of the Impella 2.5 and Impella CP. Delivered in a minimally invasive way, Impella pumps actively unload the heart, aiding native heart recovery. [Image courtesy of Abiomed]Abiomed (Nasdaq:ABMD) announced that the FDA accepted and closed its post-approval study reports for its Impella heart pumps.

Danvers, Massachusetts-based Abiomed’s study reports relate to Impella’s premarket approvals (PMA). The company said in a news release that the FDA’s action represents “another affirmation” of the safety and effectiveness of Impella heart pumps.

Impella pumps treat cardiogenic shock, high-risk PCI and post-cardiotomy cardiogenic shock. They also cover cardiogenic shock in the setting of myocarditis or cardiomyopathy and right heart failure.

Abiomed said the FDA typically requires post-approval studies for medical devices under PMA. Post-approval studies use high-quality, pro…

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FDA clears Impella low-profile sheath from Abiomed

The Impella low-profile sheath. [Image from Abiomed]Abiomed (Nasdaq:ABMD) announced today that it received FDA 510(k) clearance for its Impella low-profile sheath.

Danvers, Massachusetts-based Abiomed designed its sheath to maintain the same inner diameter as the existing 14 French (Fr) sheath used for Impella CP placement. However, the new sheath reduces the outer diameter by nearly 2 Fr.

The sheath’s smaller size, along with other technological advancements, facilitates easier Impella insertion and removal. Abiomed said in a news release that it helps to reduce procedural steps and help improve outcomes.

Get the full story at our sister site, Medical Tubing & Extrusion.

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Abiomed Impella heart pump performs well in Japan study

Abiomed (Nasdaq:ABMD) announced today that a three-year study in Japan demonstrated positive results for its Impella heart pump.

Danvers, Massachusetts-based Abiomed’s study is an update to 2020 interim analysis. Results were presented at TCT 2022 in Boston.

The investigator-led study evaluated all Impella-supported patients across 109 hospitals in Japan. Of the 1,344 AMI cardiogenic shock (AMICS) patients, 30-day survival rates totaled 81%.

The analysis examined 293 consecutive Impella-supported AMICS patients in the J-PVAD Registry. Results also showed 81% survival at 30 days. Historical cardiogenic shock survival rates without Impella are approximately 50%, Abiomed said in a news release.

“The results of this study demonstrate that when Impella is used and best practices are followed, it is possible to achieve heart recovery and greater than 80% survival rates for patients with AMI cardiogenic shock,” said lead investigator Dr. Junya Ako,…

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FDA approves new research around Abiomed Impella heart pumps

This screenshot from an Abiomed video demonstrates the placement of the Impella 2.5 and Impella CP. Delivered in a minimally invasive way, Impella pumps actively unload the heart, aiding native heart recovery. [Image courtesy of Abiomed]Abiomed (Nasdaq: ABMD) said today that FDA has approved clinical research into using Impella heart pumps in severe heart attack patients with cardiogenic shock.

The FDA has approved the on-label Recover IV randomized controlled trial involving acute myocardial infarction (AMI) cardiogenic shock patients. The two-arm trial will assess whether Impella support before percutaneous coronary intervention is superior to PCI without Impella.

Often caused by a severe heart attack, cardiogenic shock involves the heart suddenly being unable to pump enough blood to meet the body’s needs, according to a Mayo Clinic description. Presently, only about half of the people with cardiogenic shock survive post-treatment. Abiomed says that multip…

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10 big earnings stories from the last quarter: How are medtech stocks doing now?

(From Ishant Mishra on Unsplash)

Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results.

Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces a strong U.S. dollar (a hurdle for American companies selling overseas), supply chain disruption and inflation.

For all of MassDevice’s medtech earnings stories, click HERE

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has mostly been on the rise over this period, getting as high as $90.10 per share (a 6.5% increase from the price of $84.60 at the start of the period). It is now at $85.27 for the last month, representing a 0.7% r…

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Abiomed scales back revenue guidance amid strong dollar

Abiomed (Nasdaq: ABMD) today reported Q1 earnings that beat The Street, but the company is scaling back revenue projections amid tough foreign exchange rates for U.S. companies.

The Danvers, Mass.–based maker of circulatory and oxygenation support devices earned $54.6 million, or $1.19 per share, off $277.1 million in sales for the quarter ended June 30, 2022 — versus a loss of $26.5 million, or 59¢ per share, off $252.6 million in sales for the same quarter a year ago.

Adjusted to exclude one-time items, EPS were $1.25, 19¢ ahead of The Street, where analysts expected EPS of $1.06 on $277.2 million in sales.

“Abiomed has achieved record revenue in five of the last six quarters despite the ongoing headwinds. Abiomed has proven to be resilient because our technology and 24 x 7 hospital support addresses the growing epidemic of heart disease in multiple emergency patient populations,” Abiomed CEO Michael R. Minogue said in a news release. “Our continued st…

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Abiomed beats The Street in Q4 results

Abiomed (Nasdaq:ABMD) posted fourth-quarter results today that beat the overall consensus on Wall Street.

The Danvers, Massachusetts-based company reported profits of $60.3 million, or $1.31 per share, on sales of $269.9 million for the three months ended December 31, for a bottom-line gain of 6.1% on sales growth of 11.86% compared with Q4 2021.

Adjusted to exclude one-time items, earnings per share were $1.16, 7¢ ahead of The Street, where analysts were looking for sales of $267.67 million.

“This was a solid report with no major surprises, and we are pleased the revenue and operating margin outlook was in line with expectations given the Fx headwinds and macroeconomic pressures being seen across the sector,” BTIG analysts Marie Thibault and Sam Eiber said.

Abiomed expects 2023 global revenue to be in the range of $1.14 billion to $1.18 billion to represent 13% to 17% growth in constant currency.

“In fiscal year 2022, we delive…

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First patient in the world implanted with Abiomed Impella BTR heart pump

Abiomed (Nasdaq:ABMD) today announced the first patient in the world was successfully treated with its Impella Bridge-to-Recovery (BTR) as part of an early feasibility study.

The first implant was performed by Dr. Duc Thinh Pham and Dr. Jane Wilcox at Northwestern Medicine Bluhm Cardiovascular Institute in Chicago.

Impella BTR is a forward flow heart pump that is implanted through the axillary artery and is placed in the left ventricle. Danvers, Massachusetts-based Abiomed designed the implant to pump more than six liters of blood per minute. According to the company, Impella BTR is less invasive than some left ventricle assist devices (LVADs) and can allow patients with chronic heart failure to have a longer-term minimally invasive heart pump option.

“Bluhm Cardiovascular Institute at Northwestern Medicine is pleased to be the first in the world to implant Impella BTR as part of this important study,” said Dr. Wilcox, chief of heart failure treatment an…

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First patient in Japan treated with Abiomed’s Impella 5.5 with SmartAssist

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]Abiomed (Nasdaq:ABMD) announced today that the first patient in Japan was successfully treated with its Impella 5.5 with SmartAssist.

The first Impella 5.5 with SmartAssist procedure in Japan took place at Osaka Police Hospital. The treated patient was an 82-year-old man treated for cardiogenic shock.

“Our facility is proud to be the first in Japan to treat patients using Impella 5.5 with SmartAssist,” Osaka Police Hospital Director Dr. Yoshiki Sawa said in a news release. “We are excited to utilize this innovative technology and look forward to providing a minimally invasive surgical option for our acute heart failure patients.”

Additionally, the total number of patients around the globe that have been treated with Danvers, Massachusetts-based Abiomed’s Impella 5.5 with SmartAssist has now surpassed 5,000.

Dr. Tamer Attia of Emory Universit…

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