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…

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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…

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CVRx rises on Street-beating Q3

CVRx’s Barostim Neo [Image courtesy of CVRx]CVRx (NSDQ:CVRX) shares ticked up today on third-quarter results that came in ahead of the consensus forecast.

The Minneapolis-based implantable neuromodulation technology developer posted losses of $6.1 million, or 30¢ per share, on sales of $3.4 million for the three months ended Sept. 30, 2021, for a nearly doubled bottom-line slide deeper into the red despite sales growth of more than three times last year’s revenue total for the third quarter.

CVRx’s losses per share of 30¢ came in 7¢ ahead of Wall Street, where analysts were looking for sales of $3.3 million.

“We are very encouraged by our performance in the quarter. Like other procedure-based companies, we experienced COVID-19 Delta variant-related headwinds in the quarter, but were able to navigate through those challenges to deliver for our customers,” CVRx President & CEO Nadim Yared said in a news release. “We are parti…

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Medtech veteran Martha Shadan joins CVRx board of directors

CVRx today said that medtech veteran Martha Shadan has joined its board of directors.

Shadan has more than 30 years of experience in the life sciences industry and has a long track record of success in commercializing medtech innovations in startups and large companies. She is currently the CEO of Miach Orthopedics. She has also held numerous leadership roles at Smith + Nephew, Rotation Medical, Zimmer Biomet, Covidien, Bristol Myers Squibb and Merck Millipore.

In addition to serving on Minneapolis-based CVRx’s board, Shadan is also a board member at AdvaMed, where she also chairs the diversity and inclusion committee and is a founding member of the Leadership Circle for the Women’s Executive Network (WEN). She also serves as a board advisor for several other companies.

“I am honored to serve on the CVRx board,” Shadan said in a news release. “As the developer of the world’s first FDA-approved neuromodulation device to treat the symptoms of h…

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MedTech 100 roundup: Significant uptick for industry

The up-and-down nature of the medtech industry continues to carry through 2021, with a recent dip now followed by a rapid ascent.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 11) at 109.63 points, producing a 2.5% rise from the 106.96-point mark set one week prior (June 4).

It provides a welcome sight after the industry’s progress came to a halt with a -1.4% dip the week before last. The index remains in a 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 recently, 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 18.8% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 76.5% increase from the mid-pandemic low…

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CVRx is going the IPO route

CVRx plans to hold an IPO to raise up to $75 million as it seeks to further commercialize its neuromodulation device to treat the heart.

That’s according to a June 4 registration statement with the U.S. Securities and Exchange Commission that follows up on a registration confidentially filed with the SEC in April.

The plan is for Brooklyn Park, Minn.–based CVRx to trade on the Nasdaq under the symbol CVRX. Underwriters include J.P. Morgan, Piper Sandler, William Blair and Canaccord Genuity.

CVRx’s FDA-approved Barostim Neo uses patented technology to send electrical pulses to baroreceptors in the wall of the carotid artery. The treatment is meant to restore balance to the automatic nervous system and improve the symptoms of heart failure.

The company brought in about $6 million a year in 2019 and 2020, with sales only slightly down amid the COVID-19 pandemic. Company officials tout an initial $2.9 billion opportunity to treat heart fai…

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CVRx CEO Yared on selling during a pandemic and improving diversity, equality inside and outside of medtech

Nadim Yared, CEO of CVRx

In part 2 of an interview, we follow up with last week’s guest, CVRx CEO Nadim Yared, to catch up on how the medtech executive is managing during the pandemic.

Yared also shares some far-reaching views on what the medtech industry needs to work toward to improve diversity in its workforce and provide equality for society.

We also visit with Mira Sahney, CEO of Hyalex Orthopaedics, one of medtech’s most interesting startups. Hyalex was identified as a notable startup in this recent report in Medical Design and Outsourcing.

In this interview, Sahney reveals Hyalex’ origins, the state of its potential cartilage replacement product, and why start-ups have a natural advantage operating in a pandemic.

Don’t miss an episode! Subscribe to DeviceTalks Weekly on your podcast players.

DeviceTalks by MassDevice · CVRx Nadim Yared on COVID-19, diversity and …
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CVRx raises $50m to support Barostim Neo commercialization

CVRx’s Barostim Neo [Image courtesy of CVRx]

CVRx has raised $50 million in its latest round of equity financing — money the company will use to support the U.S. commercialization of its Barostim Neo heart failure treatment device.

New investors Strategic Healthcare Investment Partners and Vensana Capital led the new funding round — with participation from other new investors, Hatteras Venture Partners and Venrock Healthcare Capital Partners. Existing investors Johnson & Johnson Innovation, New Enterprise Associates, Gilde Healthcare, and Action Potential Venture Capital also participated.

The FDA-approved Barostim Neo is a neuromodulation device to treat the heart. It uses patented technology to send electrical pulses to baroreceptors in the wall of the carotid artery. The treatment is meant to restore balance to the automatic nervous system and improve the symptoms of heart failure.

…

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CVRx’s Yared speaks to the value of confidence and cooperation

Nadim Yared, CEO of CVRx

This week, CVRX reported positive six-month trial results for its Barostim Neo, an FDA-approved treatment for heart failure.

The results follow years of close work between the agency and CVRx, one of the more ambitious startups in medtech. CVRx is targeting a huge clinical need with novel neuromodulation technology.

In this week’s DeviceTalks Weekly podcast, CEO Nadim Yared walks us through the negotiations the company went through with the FDA to get to this point.

Yared, the prior chairman of the industry group AdvaMed, also shares the story of his career, which started early on when he secured a job at GE even before graduating college.

In this talk, Yared speaks to several issues including:

The power of confidence and the dangers of overconfidence when building a career. How he decided to take the job at CVRx (and why he didn’t initially want to talk abo…
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CVRx reports positive six-month trial results for Barostim Neo

CVRx announced today that it observed positive six-month results from its BeAT-HF trial for the Barostim Neo device for improving symptoms of heart failure.

Barostim Neo uses patented technology to send electrical pulses to baroreceptors in the wall of the carotid artery in an effort to restore balance to the automatic nervous system and improve the symptoms of heart failure.

The results, published in the Journal of the American College of Cardiology, were used to obtain FDA premarket approval for the Bariostim Neo.

BeAT-HF was a multi-center, prospective, controlled trial with patients randomized one-to-one to receive Barostim Neo, plus optimal medical management, or optimal medical management alone in the control. The trial included 264 patients with the following key qualifications:

NYHA Class III or Class II (with recent history of Class III) Left ventricular ejection fraction ≤ 35% On current HF guideline-directed medical therapy NT-proBNP <…
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