Penumbra posts mixed-bag Q4 results, grows sales 22%

Penumbra (NYSE:PEN) this week posted fourth-quarter results that beat the revenue consensus on Wall Street but missed earnings estimates.

The Alameda, California-based company reported losses of -$24.6 million, or -66¢ per share, on sales of $204 million for the three months ended Dec. 31, 2021, for a sales growth of 22.24% compared with Q4 2020.

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Data shows safety and strong performance for Penumbra’s Indigo CAT RX catheter

Penumbra (NYSE:PEN) announced today that the Cheetah clinical study for its Indigo CAT RX catheter met its primary endpoint.

Alameda, California-based Penumbra’s Indigo catheter system demonstrated high rates of blood clot removal, blood flow restoration and myocardial perfusion in conjunction with percutaneous coronary intervention (PCI) in patients with high thrombus burden.

The company presented the results of the Cheetah study at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) conference in Orlando, according to a news release.

Penumbra’s Cheetah study enrolled 400 patients with high thrombus burden who were treated with continuous mechanical aspiration thrombectomy with CAT RX prior to PCI. The trial observed 99.5% of patients experience TIMI thrombus grade 0 after CAT RX and PCI.

Additionally, 97.5% of patients had thrombolysis in myocardial infarction (TIMI) flow grade 3 after CAT RX and PCI, with TIMI increasing signif…

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Penumbra beats The Street in Q3, grows sales 25%

Penumbra (NYSE:PEN) posted third-quarter results this week that beat the overall consensus on Wall Street.

The Alameda, California-based company reported profits of $8.85 million, or 24¢ per share, on sales of $190.1 million for the three months ended Sept. 30, for a sales growth of 25.84% compared with Q3 2020.

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MedTech 100 roundup: Hot streak comes to slight halt

After several weeks of high-level performance, the medtech industry saw its first dip in a while over the last seven days.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 13) at 117.92 points, marking a -1.2% dip from the 119.41-point tally a week prior (Aug. 6).

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry remains well above the marks set around the height of the pandemic, having registered a 27.7% 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 an 89.8% ascent above that point.

The industry’s performance did not correlate with the overall markets this past week as the S&P 500 Index and Dow Jones Industrial Average fared almost identically, ticking up by 0.7% a…

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Penumbra sales grow 75% in Street-beating Q2 results

Penumbra (NYSE:PEN) posted second-quarter results this week that beat the overall consensus on Wall Street.

The Alameda, Calif.-based company reported profits of $9.2 million, or 25¢ per share, on sales of $184.3 million for the three months ended June 30, for a sales growth of 75.3% compared with Q2 2020.

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RapidAI launches workflow platform for pulmonary embolism

RapidAI announced today that it launched its mobile and web-based app to aid in the treatment of pulmonary embolism (PE).

San Mateo, Calif.-based RapidAI made available the Rapid Workflow for PE, which it designed to align hospital teams on the treatment of patients suspected of having a pulmonary embolism, according to a news release.

Rapid Workflow for PE helps hospital teams align, activate and communicate about patient status to ensure faster care, reducing the time to treatment, improving care coordination and optimizing protocols through the collection of patient status data.

“Rapid Workflow for PE is the next step in our journey to improving patient care,” RapidAI CEO Don Listwin said in the release. “When it comes to acute vascular diseases, time is of the essence. That’s why we’ve created an extensible platform that addresses the specific needs of care teams across vascular and neurovascular conditions, providing these teams with the tools they …

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FDA clears Penumbra’s Red 62 reperfusion catheter for removing brain blood clots

Penumbra (NYSE:PEN) today said its Red 62 reperfusion catheter has received FDA 510(k) clearance.

Alameda, Calif.-based Penumbra designed the catheter to navigate complex distal vessel anatomy and deliver powerful aspiration with its Penumbra Engine to remove blood clots in acute ischemic stroke patients with large vessel occlusions.

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Penumbra slides on Street-beating Q1 results

Penumbra (NYSE:PEN) yesterday posted first-quarter results that beat the earnings consensus on Wall Street and matched sales estimates.

The Alameda, Calif.-based company reported profits of $11.836 million, or 32¢ per share, on sales of $169.2 for the three months ended March 31, for a bottom-line gain of 730.6% sales growth of 23.2% compared with Q1 2020.

Earnings per share were 32¢, 23¢ ahead of The Street, where analysts were looking for sales of $169.2 million.

“Our vascular business produced outstanding growth again this quarter, with revenue expanding 50.5% year-over-year to $89.2 million, and we believe we are just getting started in vascular,” CEO Adam Elsesser said during an earnings call. “Our neuro business exceeded our expectations in the first quarter, posting total revenue of $80 million, up 2.5% year-over-year. Our neuro team’s extraordinary work following the Jet 7 Xtra Flex recall in mid-December, sets us up well …

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Penumbra beats The Street in Q4 results

Penumbra (NYSE:PEN) posted fourth-quarter results that beat the consensus forecast on Wall Street.

The Alameda, Calif.-based company reported profits of $2.6 million, or 10¢ per share, on sales of $166.9 million for the three months ended Dec. 31, 2020, for a bottom-line loss of 071.7% sales growth of 14.89% compared with Q4 2019.

Adjusted to exclude one-time items, earnings per share were 42¢, 48¢ ahead of The Street, where analysts were looking for sales of $159.7 million.

The company issued a voluntary recall of the Jet 7 Xtra Flex catheter on Dec. 15 and it was designated as Class I on Jan. 29. Penumbra also appointed a new chief financial officer and chief accounting officer during its fourth quarter. It also launched a study of its Indigo blood clot aspiration device.

Penumbra expects to log a total revenue of $675 million to $685 million in 2021 to represent growth of 20% to 22% over the 2020 full-year revenue.

Shares in PEN were up …

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FDA: Penumbra recall of some Jet 7 catheters is serious

A Penumbra recall of certain Jet 7 catheters is Class I – the most serious type of recall, the FDA recently said.

The recall, which Penumbra originally announced on Dec. 15, 2020, involved more than 30,000 distributed units of its Jet 7 Reperfusion Catheters with Xtra Flex Technology after the company received 14 reports of death related to the device. Penumbra distributed the devices between June 17, 2019 and Dec. 14, 2020.

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FDA: Penumbra recall of some Jet 7 catheters is serious

A Penumbra recall of certain Jet 7 catheters is Class I – the most serious type of recall, the FDA recently said.

The recall, which Penumbra originally announced on Dec. 15, 2020, involved more than 30,000 distributed units of its Jet 7 Reperfusion Catheters with Xtra Flex Technology after the company received 14 reports of death related to the device. Penumbra distributed the devices between June 17, 2019 and Dec. 14, 2020.

Some Jet 7 catheters pose the risk of unexpected death or serious injury while used for removing clots in stroke patients. Distal tip damage with pressurization or contrast injection could result in potential vessel damage and patient injury or death.

The FDA said in December that it received over 200 medical device reports associated with the catheter, which included deaths, serious injuries and malfunctions, according to the FDA letter warning healthcare providers. The FDA at the time said 20 of the MDRs described 14 unique patient…

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FDA: Penumbra recall of some Jet 7 catheters is serious

A Penumbra recall of certain Jet 7 catheters is Class I – the most serious type of recall, the FDA recently said.

The recall, which Penumbra originally announced on Dec. 15, 2020, involved more than 30,000 distributed units of its Jet 7 Reperfusion Catheters with Xtra Flex Technology after the company received 14 reports of death related to the device. Penumbra distributed the devices between June 17, 2019 and Dec. 14, 2020.

Get the full story on our sister site, Medical Tubing + Extrusion.

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