FDA clears sacroiliac joint fusion device from Nevro

Nevro (NYSE:NVRO) announced today that the FDA cleared its sacroiliac (SI) joint fusion device without the need to include an accompanying screw.

Redwood City, California-based Nevro plans to market this device as Nevro1, without the need for the NevroFix screw. The system aims to immediately transfix the SI joint, allowing the opportunity for long-term fusion. Self-contained, deployable titanium anchors transfix the sacrum and ilium to enhance the axial and rotational stability of the joint.

Additionally, Nevro’s system features proprietary instrumentation that allows for optimal intra-articular SI joint preparation. The company says this is a critical element in achieving joint fusion. Nevro1 also features 3D-printed bone-growth-enhancing technology, which helps promote bone cell growth and fusion as a result.

This marks the first regulatory clearance since Nevro acquired Vyrsa Technologies and its SI joint pain technologies last year. The FDA te…

Read more
  • 0

How does medtech CEO compensation compare?

[Image from Unsplash]Medtech CEO compensation averaged $10.5 million during the companies’ most recent fiscal years.

That number from our recent MassDevice analysis may seem like a lot to an average person — but not as much in the world of corporate CEOs.

In fact, the average compensation of S&P 500 company CEOs was $25.2 million in 2022, according to the Economic Policy Institute (EPI), a nonprofit research institute that studies the impact of economic trends and policies on working people in the U.S.

Geoff Martha, who, as CEO of Medtronic, runs the world’s largest medical device company, saw a total compensation of $15.4 million. But look over at the pharmaceutical industry, where revenue numbers are much higher, and the head of the world’s largest pharma company — Pfizer CEO Albert Bourla — brought in $33 million.

As businesses mature into publicly traded companies and revenue grows, it makes sense for CEO compensation to become larger.

Read more
  • 0

Nevro earns coverage win for spinal cord stimulation

Nevro (NYSE:NVRO) announced that Carelon Healthcare plans to expand its spinal cord stimulation (SCS) coverage.

Carelon plans to publish a new interventional pain management policy expanding SCS coverage for painful diabetic neuropathy (PDN). The policy, set to go into effect on April 14, increases PDN patient coverage by nearly 43 million additional lives.

Payers that utilize Carelon Healthcare include Anthem Blue Cross in California; Anthem Blue Cross Blue Shield in Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, New Hampshire, Nevada, New York, Ohio, Virginia, and Wisconsin; AmeriHealth; Empire BCBS; Independence Blue Cross; and various Managed Medicaid plans.

Dr. David Caraway, Nevro chief medical officer, said in a news release that results from the SENZA-PDN trial helped lead to insurance companies validating the therapy by broadening access. Caraway said the company expects its data to serve as the foundation for additional cov…

Read more
  • 0

Nevro announces layoffs

Pain-treatment device company Nevro (NYSE:NVRO) announced that it is letting go of 63 employees, about 5% of its workforce, as part of a restructuring effort.

“This restructuring supports our strategy and allows us to focus our investments to further position Nevro for long-term growth and profitability,” Nevro CEO Kevin Thornal said in a news release posted yesterday.

He later added: “As we look ahead, we remain focused on bringing innovative products to market, working closely with physicians treating patients living with chronic pain and creating value for all our stakeholders.”

The Redwood City, California–based company said most layoffs affected internally focused employees, not customer-facing personnel. The job cuts should be complete by the end of Q1 2024.

Nevro said the restructuring will have a $14 million to $15 million positive impact on its full-year 2024 adjusted EBITDA. Company officials expect the positive i…

Read more
  • 0

Nevro acquires joint fusion device maker Vyrsa, closes credit facility and refinancing

Nevro (NYSE:NVRO) announced that it acquired Vyrsa Technologies, a company developing a minimally invasive joint pain treatment.

Vyrsa has a portfolio of sacroiliac (SI) joint pain devices for use in SI joint fusion procedures. Established in 2021, the company manufactures and supports a complete portfolio of FDA-cleared devices.

Dr. David Caraway, Nevro chief medical officer, said in a news release that the Vyrsa portfolio allows physicians to tailor to patient needs. He said the implants provide “optimal stability” and enhance the opportunity for the SI joint to fuse.

Under the terms of the transaction, Nevro paid $40 million at closing. That could rise to $75 million with $35 million in additional development and sales milestone payments down the line. Nevro expects Vyrsa to bring an accretive impact for both revenue and adjusted EBITDA in 2024.

“The acquisition of Vyrsa leverages Nevro’s ability to drive long-term share…

Read more
  • 0

2-year data shows painful diabetic neuropathy relief with Nevro spinal cord stimulation

Nevro (NYSE:NVRO) today announced 24-month data from its Senza painful diabetic neuropathy (PDN) spinal cord stimulation (SCS) trial.

Redwood City, California-based Nevro published its study results in Diabetes Research and Clinical Practice. The trial evaluated the long-term efficacy of high-frequency 10 kHz SCS to treat refractory PDN. It compared patients receiving the Senza HFX SCS treatment and conventional medical management (CMM) to CMM alone.

The SENZA-PDN trial enrolled 216 patients with refractory PDN. That made it the largest randomized controlled trial for this therapy and population, Nevro said. It included 142 patients implanted with the high-frequency (HFX) SCS system, followed for 42 months. That included 84 initial recipients and 58 crossovers from CMM alone.

Data demonstrated that patients receiving this SCS treatment experienced durable pain relief and significant improvements in health-related quality of life (HRQoL) and sleep at 24 m…

Read more
  • 0

Nevro names new chief commercial officer

Nevro this week announced it appointed Greg Siller as senior VP and chief commercial officer, effective June 19.

Siller will replace Niamh Pellegrini, who is leaving the company on June 9. He has spent the last 17 years at Stryker, where he held numerous roles of varying responsibility in sales and marketing. He most recently was VP and GM of the Stryker Interventional Spine business since January 2020.

“I am delighted to welcome Greg to the Nevro team,” CEO and President Kevin Thornal said in a news release. “For the last 17 years, Greg has led the development, implementation and execution of successful commercial strategies and programs for several Stryker businesses, including most recently Stryker’s Interventional Spine business. His proven track record of success and his passion for building high-performing commercial organizations will be instrumental as we continue to focus on accelerating revenue growth, developing underpenetrate…

Read more
  • 0

Nevro enrolls first patient in PDN Sensory study

Nevro this week announced it enrolled the first patient in its painful diabetic neuropathy (PDN) sensory study.

The prospective randomized controlled trial will assess the restoration of neurological function as a primary objective in patients with intractable PDN. It will enroll up to 236 patients at multiple sites across the U.S.

Patients in the trial will be randomized to conventional medical management or 10 kHz Therapy, along with conventional medical management with optional crossover to the other treatment arm at 6 months if the criteria are met.

The FDA previously granted breakthrough device designation for the study and the potential device indication. The FDA’s designation enables Nevro to receive a quicker review for its marketing application, which seeks to broaden its FDA labeling. This will give patients and healthcare providers faster access to vital medical devices that can provide improved treatment or diagnosis of serious, irrever…

Read more
  • 0

Nevro fully launches HFX iQ spinal cord stimulation

The HFX iQ SCS system. [Image courtesy of Nevro]Nevro (NYSE:NVRO) announced today that it initiated the full U.S. market launch for its HFX iQ spinal cord stimulation (SCS) system.

Redwood City, California-based Nevro designed HFX iQ for treating chronic pain. The company commenced its full launch after it completed a successful limited market release.

In a news release, Dr. Usman Latif called HFX iQ “the future of medicine.” Latif is an interventional pain specialist at the University of Kansas Medical Center. He added that the platform’s “expanded data holds the promise of new capabilities and improved care.”

About the Nevro HFX iQ system

HFX iQ utilizes the HFX algorithm to select programs most likely to provide pain relief for patients. Nevro built this on more than 20 million data points and 80,000 implanted patients. The system combines clinical inputs like pain relief and pain score to provide an individualized program s…

Read more
  • 0

Medtech jobs: The world’s largest medical device companies are hiring

Medical device companies are trying to fill thousand of medtech jobs. [Photo by ijeab – stock.adobe.com]

The world’s largest medical device companies are still hiring for medtech jobs despite layoffs in tech and other industries.

Medtech developers — and medtech jobs — are resilient, with the industry’s COVID-19 pandemic performance only bolstering its recession-proof reputation.

That’s not to say there haven’t been job cuts in medtech, led by thousands of layoffs at Philips as it struggles with a massive recall of deadly respiratory devices. But most medical device manufacturers are still hiring, and in some cases they can’t attract enough candidates to fill every vacancy in a tight labor market.

Stryker, for example, grew to approximately 51,000 employees as of the end of 2022, increasing its headcount by nearly 11 percent last year. Boston Scientific reported nearl…

Read more
  • 0

Nevro announces CEO succession plan, preliminary Q4 results

[Image from LinkedIn]Nevro (NYSE:NVRO) today announced that Chair, CEO and President D. Keith Grossman intends to retire this year.

Grossman informed the board that he plans to retire from his CEO and president duties in 2023. He intends to do so following the selection of his successor at the spinal cord stimulation (SCS) technology developer.

Following the CEO succession, Grossman plans to continue to serve as chair of Nevro’s board. The board commenced a targeted search process for a new CEO with assistance from a leading executive search firm.

Grossman spent nearly 40 years as an executive in the medical device industry.

“I’m extremely proud of the significant progress we have made over the past four years, and I believe now more than ever Nevro is well-positioned for future growth and poised to enter an exciting period of progress,” Grossman said. “With what we believe will be continued recovery in our markets, important new products like …

Read more
  • 0

The biggest medtech stock gainers, losers in 2022

(From Ishant Mishra on Unsplash) In another roller coaster year for medtech, these are the companies that saw their stock rise and fall the most drastically.

The MassDevice MedTech 100 Index, which includes stocks of the world’s largest medical device companies, reflects the performance of many in the medtech space.

In a tough year for a lot of businesses, the Index wasn’t immune to struggles. Overall, it dropped 27.3% from this time last year. That compares to a 19.7% drop for the S&P 500 and an 8.9% dip for the Dow Jones Industrial Average.

Some businesses, though, powered through the supply chain- and inflation-related woes to see their stock rise from this time last year. Others weren’t so lucky. Here are some of the biggest gainers and losers — selected from the MedTech 100 Index — of 2022.

Biggest gainers BD — $245.27 to $254.97 — Up 4% 

While BD (NYSE:BDX) didn’t have the most significant growth, its stock remains in a …

Read more
  • 0