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Key Tech names next CEO as co-founder plans to retire

Key Tech co-founder and CEO Jenny Regan [Photo courtesy of Key Tech]

Key Tech co-founder Jenny Regan plans to retire as CEO of the product development firm at the end of August, making way for VP of Strategy Alex Flamm to take her place.

Regan has been CEO since she and her co-founders launched the Baltimore firm in 1998. The company said it now has 75 interdisciplinary medical product designers and hundreds of clients in the medical technology industry, including Becton Dickinson, GE, Thermo Fisher, HemoSonics, GenMark and Abiomed.

Regan, who led Key Tech’s transition to a fully employee-owned company in 2019, will join the Key Tech Advisory Board.

“I’m incredibly proud of what we’ve built and how much good we’ve been able to do,” Regan said in an announcement posted to the company’s website last week. “I’m confident in our new leadership and will always be inspired by the talen…

These 10 medtech companies’ stocks performed best in 2021

(From Ishant Mishra on Unsplash)

Following a year like no other in 2020, 2021 was when many looked to rebound — including the medtech industry.

A number of medtech companies followed up a challenging, pandemic-enveloped year with impressive performances. Plenty of them had already proven in 2020 that they were capable of a quick bounce-back.

Here are 10 medtech companies that saw their stocks soar even higher in 2021:

(This list includes members of the MassDevice MedTech 100 Index of the world’s largest medical device companies. Performance is measured in stock price change from Dec. 31, 2020, to Dec. 31, 2021.)

Get the full story at our sister site, MassDevice.

Abiomed reports $261M in sales in Q3 results

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

The Danvers, Massachusetts-based heart device company reported profits of $45.8 million, or $1.00 per share, on sales of $261.2 million for the three months ended Dec. 31, 2021, on sales growth of 12.74% compared with Q4 2020.

Adjusted to exclude one-time items, earnings per share were $1.13, 16¢ ahead of The Street, where analysts were looking for sales of $252.8 million.

“Despite a slower start in October due to the COVID resurgence and hospital labor shortages, our Abiomed 2.0 playbook allowed us to adapt and execute, grow sequentially, and support the most patients ever in a quarter. These record results would not have been possible without the dedication of our customers and employees supporting critically ill patients 24 x 7 on-site, online and in the cloud with Impella Connect,” CEO and president Michael Minogue said in a news release. “Our focus…

Artificial heart developer BiVacor taps former Abiomed exec as CEO

BiVacor this week announced that former Abiomed executive Thomas Vassiliades was appointed CEO, effective immediately.

Prior to joining the company, Vassiliades was most recently the general manager of the surgery and heart failure business at Abiomed.

He has also served as the chief medical officer of the coronary and structural heart business of Medtronic, and as the chief medical officer and integration lead for Medtronic’s mechanical circulatory support effort in 2016. Vassiliades was a practicing cardiac surgeon for more than 18 years before joining the medical device industry.

“BiVacor led an extensive CEO search, and Tom was a clear choice given his experience, background, leadership style and exceptional track record,” BiVacor founder Daniel Timms said. “Tom has the skillset and credibility to guide BiVacor through its next chapter of transformation and advancement as we undertake the next stage of clinical activities leading up to first in…

Abiomed beats The Street in Q2, lowers full-year outlook

Abiomed (NSDQ:ABMD) posted second-quarter results this week that beat the overall consensus on Wall Street.

The Danvers, Massachusetts-based cardiovascular device company reported profits of $56.95 million, or $1.24 per share, on sales of $248.1 million for the three months ended September 30, for a bottom-line loss of -8.5% on sales growth of 18.3% compared with Q2 2020.

Adjusted to exclude one-time items, earnings per share were $1.03, 6¢ ahead of The Street, where analysts were looking for sales of $247.7 million.

“In Q2, we made progress on product innovation and regulatory milestones while leveraging our commercial field team and Abiomed 2.0 Playbook in a challenging environment,” president and CEO Michael Minogue said in a news release. “Abiomed remains focused on disciplined execution and sustainable growth as we continue to pursue our goal of becoming the global standard of care for heart pumps that recover hearts and save lives.”

Abiomed …

FDA grants breakthrough device designation for Abiomed’s Impella ECP heart pump

Abiomed (NSDQ:ABMD) today announced that the FDA has granted breakthrough device designation for its Impella ECP expandable percutaneous heart pump.

Danvers, Mass.-based Abiomed designed the Impella ECP heart pump to be compatible with small-bore access and closure techniques. It measures 3 mm in diameter when inserted and removed from the body. It expands in the heart to support the heart’s pumping function and provides a flow greater than 3.5 L/min.

The FDA granted breakthrough device designation based on positive clinical data from the company’s first 21 Impella ECP patients who were treated as part of an FDA-regulated early feasibility study, which was approved in June 2020.

“This is yet another validation from the FDA of the clinical benefits of Impella technology and an affirmation of the innovative nature of Impella ECP which, due to its smaller vascular access size, has the potential to provide even safer procedures and be available t…

MedTech 100 roundup: Industry ticks up again

The medtech industry has been rising for weeks and the latest seven-day stretch was no exception as stocks ticked up again.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 6) at 119.41 points, marking a 0.5% rise from the previous week’s tally of 118.86 points (July 30). Not including the the week in which the index shot up to 145.88 points and quickly tumbled down, the latest marks would represent the index’s all-time best.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 29.3% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 92.2% ascent above that point.

The industry’s performance did not correlate with the overall markets this past week as t…

Abiomed beats The Street in Q1, boosts full-year revenue guidance

Abiomed (NASDAQ: ABMD) posted first-quarter results that beat the consensus forecast on Wall Street, with the company boosting its revenue growth forecast to 22–24% for the fiscal year.

The Danvers, Mass.–based maker of circulatory and oxygenation support devices reported a loss of –$26.5 million, or –59¢ per share, on sales of $252.5 million for the three months ended June 30, 2021 — versus a profit of $44.5 million, or 98¢ per share, on sales of $164.8 million during the previous Q1.

Worldwide Impella heart pump product revenue was up 55% to $241.5 million. In addition, the company in June announced FDA approval of its next-gen Impella RP with SmartAssist.

Adjusted to exclude one-time items, earnings per share were $1.10, a nickel ahead of The Street, where analysts were looking EPS of $1.05 on sales of $240.91 million.

“Q1 was a solid start with record global revenue and patient utilization in U.S., Europe and Japan, and we believe we are well…

FDA grants PMA to Abiomed’s next-generation Impella RP

[Image from Abiomed]Abiomed (NSDQ:ABMD) announced today that the FDA granted premarket approval (PMA) to its Impella RP with SmartAssist.

Danvers, Mass.-based Abiomed received PMA for the Impella RP right heart pump with SmartAssist as a safe and effective treatment for acute right heart failure for up to 14 days, according to a news release.

The company touts ImpellaRP with SmartAssist as the first single-access, temporary percutaneous ventricular support device with dual-sensor technology.

Dual-sensor technology offers real-time guidance and trends to help with pump management and weaning, the company said. Impella RP with SmartAssist also features a design for simplified setup and insertion and enhancements through Impella Connect, enabling remote monitoring from any internet-connected device through a secure, HIPAA-compliant website.

The FDA indicated for RP with SmartAssist under PMA for providing temporary right ventricular support for up to 14…

MedTech 100 roundup: Rebound hits a snag

Two weeks ago, medtech was on the rise following a rough stretch, but the past week brought the industry slightly back down to earth.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 4) at 106.96 points, producing a -1.4% dip from the 108.5-point mark set one week prior (May 28). It halts the progress made over a couple of weeks in which the industry produced an uptick, following its 1.4% rise from May 14 to May 21.

Having endured its largest slide of 2021 in recent weeks, the index is still in a better position to produce another upswing after demonstrating signs of picking up again when April brought the industry’s all-time best performance.

Even with setbacks that slowed the industry this past week, medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 15.9% rise from the pre…

Abiomed buys PreCardia and its heart failure treatment system

Abiomed (NASDAQ: ABMD) announced this week that it has acquired PreCardia and its catheter-based system to treat acute decompensated heart failure.

The financial terms of the deal were not disclosed in the June 1 announcement.

Abiomed officials say the deal complements the company’s product portfolio, expanding options for patients with acute decompensated heart failure.

The PreCardia system is meant to quickly reduce congestion in the venous system to improve overall cardiorenal function. The technology includes a balloon catheter and pump controller to address acute decompensated heart failure through the intermittent superior vena cava occlusion.

St. Paul, Minn.–based PreCardia won FDA breakthrough device designation for its system in June 2020.

“We look forward to advancing PreCardia’s technology through the regulatory process and expanding our relationship with heart failure specialists to help improve outcomes in early-stage acu…

MedTech 100 roundup: Return to normal following recent spike

After back-to-back all-time best performances, the medtech industry had a slight regression over the course of the last week.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been continuously ticking up since the beginning of April, with its mark of 112.25 on April 16 representing an all-time best, topping the previous high of 110.96 set on Feb. 15.

Just one week later, the index topped itself again, reaching 114.58 to end the week on April 23, marking an increase of 2.1% from the previous week. However, things have settled down and the industry responded in kind, dipping -1.6% to 112.7 to end last week (April 30).

In spite of the slight decrease over the past week, the industry continues to reflect a bounceback from the struggles brought on by the COVID-19 pandemic.

Overall, has produced a 22.1% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 81.4% increase from…