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…

Read more
  • 0

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 …

Read more
  • 0

CVRx is one of the best performing stocks out of Minnesota

CVRx’s Barostim Neo [Image courtesy of CVRx]CVRx (Nasdaq:CVRX) reached near the top of a list of Minnesota S&P 500 companies with best-performing stocks.

With a 71% return in 2023, CVRx was No. 4 among the Minnesota “Fantastic Four” stocks, according to an analysis in the Star Tribune of Minneapolis. For comparison, the S&P 500 was up 24%.

The maker of the Barostim neuromodulation system saw its stock rally strongly near the end of December after the FDA approved an expanded label for the implantable system, which delivers electrical pulses to baroreceptors in the carotid artery wall to reduce heart failure systems.

CVRx said at the time of the approval that new long-term safety and efficacy data, commercial experience, and a new reimbursement assignment for Barostim would boost its market opportunity to $2.2 billion and 76,000 new patients, up from the previous estimate of $1.4 billion and 55,000 new patients.

CVRx’s …

Read more
  • 0

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…

Read more
  • 0

CVRx scores Medicare win on outpatient Barostim payments

Barostim Neo [Image courtesy of CVRx]CVRx (Nasdaq:CVRX) announced today that the Centers for Medicare and Medicaid Services (CMS) reassigned its Barostim implant procedure.

The CMS change assigns the CVRx neuromodulation implant for procedures performed in the outpatient setting. It comes as part of the 2024 Medicare Hospital Outpatient Prospective Payment System (OPPS) final rule.

Barostim’s reassignment brings it to New Technology APC 1580, which carries an average payment amount of $45,000. The new payment takes effect on Jan. 1, 2024, the Minneapolis-based company said in a news release. This change comes after Barostim was assigned to APC5465 last year — carrying an average payment of $29,000. The change comes with a transitional pass-through payment set to expire on Dec. 31, 2023.

“We sincerely appreciate the consideration taken by CMS of the resource requirements associated with the Barostim implant procedure. We believe that reassignment to AP…

Read more
  • 0

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…

Read more
  • 0

CVRx nearly doubles its revenue in Q4

CVRx (NASDAQ: CVRX) reported Street-beating Q4 results amid increased adoption of its implantable neuromodulation system for treating heart failure symptoms.

Minneapolis-based CVRx announced yesterday evening that it lost $10.5 million, or 51¢ per share, off of $7.2 million in revenue for the quarter that ended Dec. 31.  2022. Sales were up 96% compared with the same quarter one year ago.

The results beat the projections of Wall Street analysts, who predicted a loss of 56¢ off of 6.98 million in revenue.

“The growth of our commercial organization combined with the success of our marketing efforts have continued to deliver increased adoption of Barostim, resulting in the more than doubling of our U.S. heart failure business as compared to 2021. Importantly, patients continued to report a positive and meaningful impact from the therapy,” CVRx CEO Nadim Yared said in a news release.

“This has been a fantastic final quarter to a strong year, and we ar…

Read more
  • 0

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…

Read more
  • 0

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…

Read more
  • 0

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…

Read more
  • 0

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…

Read more
  • 0

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…

Read more
  • 0