Wilmingtonbiz logo
Print
Health Care

FDA Clearance Means New Product, Revenues For Baxano

By Jenny Callison, posted Apr 10, 2014
Baxano Surgical, a medical device company focused on minimally invasive products to treat degenerative conditions of the spine, announced Thursday that it has received U.S. Food and Drug Administration clearance for a new product related to the company’s existing spinal fusion technologies.
 
Raleigh-based Baxano, which maintains a presence in Wilmington, earned clearance for its Avance MIS Pedicle Screw System, which the company’s news release stated “may be used as an adjunct to fusion in numerous degenerative and complex spinal pathologies.”
 
Company president and CEO Ken Reali said that the company was “very excited” about gaining clearance for the system.
 
“We’ve been working on this [system] for the past 22 months, working with two Raleigh-based surgeons. It’s synergistic with our existing products,” he said.

Baxano Surgical – formerly Trans1 – currently markets the AxiaLIF family of products for single and two-level lower lumbar fusion, the VEO lateral access and interbody fusion system, the iO-Flex system, a proprietary set of flexible instruments used by surgeons during spinal decompression procedures, and the iO-Tome instrument, which removes bone in spinal fusion procedures, according to the release.
 
Pedicle screws are used sometimes in a spinal fusion to add extra support and strength to the fusion while it heals. Pedicle screws are placed above and below the vertebrae that were fused.
 
Sameer Mathur and Nael Shanti are the two surgeon designers of the Avance system. They said in the release that the Avance system is designed to minimize tissue trauma and invasiveness of fusion procedures.
 
Reali said that, until now, surgeons have used pedicle screws from other sources in tandem with Baxano’s spinal fusion devices. Now Baxano offers them the full range of products designed to be used together.
 
“There’s a significant upside for us financially,” he said, adding that Baxano will also have greater control over the quality of its techniques now that it makes its own pedicle screw system.
 
Reali said that the Avance system will launch later this quarter and will continue in limited market release through the third quarter of 2014. A full launch is planned for the fourth quarter.

Join The Discussion

Similar Stories

Ico insights

INSIGHTS

SPONSORS' CONTENT

Book On Business

Bob2017

The 2017 WilmingtonBiz: Book on Business is an annual publication showcasing the Wilmington region as a center of business.

Order Your Copy Today!
Print Only
$24.95 - Qty
Print + Excel File
$79.95 - Qty

In The Current Issue

New Owner Plans Mall Changes

Some of the same strategies Rouse Properties, the new owners of Independence Mall, has used in other centers it has bought sound similar to what it might have in store for the Wilmington property.

Mega Projects: Breaking Down The Big-Ticket Projects That Could Reshape The Region

Four major infrastructure proposals in the Wilmington area would require billions in investment into the region. But as the region continues...

Wilmington Health Adds Oncology/Hematology

Jim McGrath recently joined Wilmington Health as the head of oncology/ hematology for the practice....

Ico topnews Editor's Picks

UNCW Announces 2 New Online Business Master's Degrees

Christina Haley O'Neal - About 16 hours ago

Local Real Estate Leaders Discuss Hurdles In Current Market

Cece Nunn - Jul 21, 2017 Trending News

WHQR Announces New Station Manager

Cece Nunn - Jul 20, 2017 Trending News

Developers Share Plans For Leland's Next Major Retail Center

Cece Nunn - Jul 20, 2017 Trending News
Other

Markraft Cabinets

MarKraft Cabinets specializes in cabinet and countertop design and installation in both new residential and commercial construction, as well as custom remodeling projects.

Ico trending Trending News

Ico newsinimages News in Pictures

Have a tip, pitch or guest column?  Send us a tip.

Gallery Galleries

Video Videos

Power Breakfast: Coach C.B. McGrath - June 2017
Wilmington's Most Intriguing People of 2016

Register to Continue Seeing Wilmington's Best Business Coverage!


There are three ways to register for free.

Sign in with LinkedIn, Facebook or create an account:



Already registered? Login here.

Your free registration includes:

  • Access to 10 articles per month on WilmingtonBiz.com
  • Email updates to stay informed on local business news
  • A mobile optimized website
  • Advanced notification of Business Journal events
  • Management of your digital and print subscriptions
Laptop iphone ipad