Nevro Corp.

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…

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…

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…

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…

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…

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…

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…