cvrx Archives - Medical Design Sourcing

Augmedics CEO takes over corner office at CVRx

Incoming CVRx CEO Kevin Hykes. [Image courtesy of Revival Healthcare Capital]CVRx (Nasdaq:CVRX) announced today that it appointed Kevin Hykes as its new president and CEO, effective Feb. 12.

Hykes already has familiarity with the Minneapolis-based neurostimulation technology developer, having joined its board in December 2022. He will continue to serve on the board, with CEO Nadim Yared set to retire from the company and resign his board seat.

Yared agreed to consult with the company to ensure a seamless transition as Hykes takes over the corner office.

“I am excited to be stepping into the role of CEO after over a year as an independent board member. I have spent the last 32 years commercializing disruptive medical devices like Barostim with the goal of bringing them to standard of care and making a difference in patient’s lives,” said Hykes. “The team has done a tremendous job demonstrating a strong clinical benefit and driving commercial adoption of Baro…

CVRx stock dips despite Street-beating Q4

CVRx (Nasdaq:CVRX) shares took a hit today despite fourth-quarter results that beat the consensus forecast.

Shares of CVRx fell 5.2% at $27.69 apiece in mid-afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 0.2%.

The Minneapolis-based neuromodulation technology developer posted losses of $9.2 million. That equals 44¢ per share, on sales of $11.3 million for the three months ended Dec. 31, 2023. The company’s bottom line ticked up 13% while remaining in the red on sales growth of 57.5%.

CVRx’s losses per share of 44¢ beat Wall Street expectations by 10¢. Sales topped projections, too, with analysts forecasting $11.1 million.

Nadim Yared, president and CEO of CVRx, highlighted milestones including label expansion for the company’s flagship Barostim system. Additionally, Yared pointed to a new CMS payment code for Barostim that ought to …

FDA approves expanded label for CVRx neuromod tech

CVRx’s Barostim Neo [Image courtesy of CVRx]CVRx (Nasdaq:CVRX) announced today that it received FDA approval for revised instructions for use for its Barostim neuromodulation system.

The new instructions for use incorporate key long-term data from the Minneapolis-based company’s BeAT-HF randomized clinical trial.

CVRx designed Barostim to deliver electrical pulses to baroreceptors in the wall of the carotid artery. These activate the body’s baroreflex, triggering an autonomic response to the heart. CVRx designed the therapy to restore balance to the autonomic nervous system, reducing the symptoms of heart failure.

The system holds FDA breakthrough device designation and FDA approval for use in heart failure patients in the U.S. It also holds CE mark approval for heart failure and resistant hypertension in Europe.

“We are very pleased to receive this important validation from FDA of the long-term results of the post-market phase of the BeA…

The best medtech innovations of 2023

Recognize this medtech innovation? It was one of the nominees for the Galien Foundation’s 2023 Prix Galien USA Awards. [Image courtesy of Boston Scientific]

The Galien Foundation’s 2023 Prix Galien USA Awards recognized a first-of-its-kind cancer diagnostic and other medtech innovations.

Announced last week, the Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.

“The outstanding quality of the submissions is a testament to the promising future of the life sciences industries,” said former Johnson & Johnson CEO and Chair Alex Gorsky — one of the awards jurors — in a news release announcing the nominees.

Last year’s winners included Cala Health, Abbott, Edwards Lifesciences and Roche. (See all of 2022’s nominees here, including many that were nominated again in 2023.)

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Study backs CVRx Barostim neuromod for patients with heart failure

CVRx’s Barostim Neo [Image courtesy of CVRx]Data presented today supported the use of the Barostim neuromodulation device from CVRx (Nasdaq:CVRX) in patients with cardiovascular diseases.

The BeAT-HF trial evaluated the Barostim extravascular, implantable neuromodulation device. Dr. Robert Zile, professor of cardiology at the Medical University of South Carolina, presented findings at the second annual Technology and Heart Failure (HF) Therapeutics (THT) conference in Boston.

Trial details

Zile said that the trial evaluated 323 randomized patients with a median follow-up of 3.6 years. The study of the FDA breakthrough device spanned 103 U.S. centers and five UK centers.

Findings included 97% freedom from major adverse neurological or cardiovascular (MANCE) system or procedure-related events. Long-term symptom improvement compared to control included a 44-meter improvement in a six-minute hall walk at 12 months. Quality of Life improved by 10 points on…

The 24 best medical device innovations of 2022

The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards.

There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021.

The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.

Nominees need to be FDA-approved for the market within the last five years and show major potential to affect healthcare. The winners will be announced in October at the Prix Galien USA Awards in New York City.

This year, the foundation nominated 24 medical device innovations, 22 biotechnology products and 33 pharmaceutical agents. The devices range from an intraocular lens to a bariatric stapler.

“Every year, evaluating and recognizing the amazing submissions that come through for the Prix Galien Awards is one of the greatest honors,” said Dr. Sue Des…

CVRx stock ticks up on Street-beating Q2 sales, raised guidance

CVRx (Nasdaq:CVRX) shares were up this morning on second-quarter results that beat the consensus revenue forecast.

The Minneapolis-based neuromodulation technology developer posted losses of $11.1 million, or 54¢ per share, on sales of just over $5 million for the three months ended June 30, 2022, for a more than $6 million bottom-line gain despite remaining in the red on sales growth of 61.1%.

CVRx’s losses per share of 54¢ fell in line with expectations on Wall Street, while the company’s revenues came in more than 6.8% ahead of analysts’ projections.

“I am very pleased with what we were able to accomplish in the second quarter. The adoption of Barostim continues to accelerate as we execute on our strategy to expand our sales force and leverage marketing initiatives to increase awareness while at the same time working with existing customers to help more patients,” CVRx President and CEO Nadim Yared said in a news release. “We anticip…

CVRx launches new Barostim programmer in U.S.

CVRx (Nasdaq:CVRX) announced that it launched its new Barostim programmer following its approval by the FDA earlier this year.

Minneapolis-based CVRx designed its second-generation programmer to operate on an upgraded cellular network to enable remote view access. It also includes an improved user interface that simplifies implantable pulse generator (IPG) programming.

According to a news release, the new Barostim programmer has compatibility with the entire portfolio of Barostim implantable systems.

The company plans to commence a complete rollout of the Barostim programmer across the U.S. market throughout 2022.

“The new Barostim Programmer builds upon the earlier model and includes significant enhancements to both hardware and software,” President and CEO Nadim Yared said in the release. “This upgrade allows CVRx to continue to provide superior customer support and reflects our commitment to innovating across all aspects of Ba…

FDA approves magnetic resonance labeling for CVRx’s Barostim neuromodulation system

CVRx’s Barostim Neo [Image courtesy of CVRx]CVRx (Nasdaq:CVRX) announced today that the FDA approved magnetic resonance (MR) conditional labeling for its Barostim system.

The Barostim neuromodulation system for treating the symptoms of heart failure now includes instructions to allow for safe MRI scans of the head and lower extremities, offering heart failure patients implanted with Barostim more diagnostic options.

Minneapolis-based CVRx said in a news release that all Barostim patients, including those already receiving Barostim therapy, can now safely receive an MRI at 1.5T when conditions of use are met.

CVRx designed the Barostim system to stimulate baroreceptors, reducing the heart’s workload and helping it to pump more efficiently to improve the symptoms for heart failure patients. Studies have shown those implanted with Barostim were able to walk further in a six-minute hall walk test, have a higher quality of life and they appeared to h…

CVRx misses in Q4, wins FDA approval for new IPG

CVRx’s Barostim Neo [Image courtesy of CVRx]CVRx (NSDQ:CVRX) posted fourth-quarter results today that fell short of the consensus forecast on Wall Street and offered its outlook for the year ahead.

The Brooklyn Park, Minnesota-based neuromodulation implant developer reported a loss of $10.57 million, or $0.52 per diluted share, on sales of $3.7 million for the three months ended Dec. 31, 2021, for a bottom-line loss of 210% and sales growth of 75% compared with Q4 2020.

The loss was $0.08 per share deeper than expected by the Street, where analysts were looking for EPS of -$0.44 on sales of $3.86 million.

Get the full story at our sister site, Medical Design & Outsourcing.

CVRx misses in Q4, wins FDA approval for new IPG

Barostim Neo [Image from CVRx]

CVRx (NSDQ:CVRX) posted fourth-quarter results today that fell short of the consensus forecast on Wall Street and offered its outlook for the year ahead.

The Brooklyn Park, Minnesota-based neuromodulation implant developer reported a loss of $10.57 million, or $0.52 per diluted share, on sales of $3.7 million for the three months ended Dec. 31, 2021, for a bottom-line loss of 210% and sales growth of 75% compared with Q4 2020.

The loss was $0.08 per share deeper than expected by the Street, where analysts were looking for EPS of -$0.44 on sales of $3.86 million.

Full-year revenue climbed to $13 million, a 115 percent increase over the year before, but just short of the company’s projection after the third quarter.

The company lost nearly $43.1 million in 2021, compared to a $14.1 million loss in 2020. Significant costs included $27.9 million for selling,…

The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news release.

Nominees need to be FDA-approved for the market within the last five years a…