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
Burrus rob headshot 300x300

Developing Healthcare Leaders

Robert T. Burrus, Jr. - Cameron School of Business - University of North Carolina Wilmington
Davidmcgowanapi300x300

2017: Energy in the Spotlight

David McGowan, III - N.C. Petroleum Council; American Petroleum Institute-NC
1 shaun olsen 300x300

Marco Marsala: A Cautionary Tale

Shaun Olsen - CloudWyze

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

Getting Ready For The Opening Round

Regional marketing plans are coming together as local officials try to leverage May's Wells Fargo Championship as a way to attract attention and potential business to the area.

Run-Through: Theaters’ Performance Numbers

It’s been a little more than a year since the Wilson Center opened on the Cape Fear Community College campus, leaving questions about how th...

Tailwind Expands In And Out Of The Terminal

Tailwind Concessions, a Wilmington-based company that runs several of ILM's eateries, flies well beyond North Carolina’s airspace. It operat...

Ico topnews Editor's Picks

City Officials To Hear Rail Realignment Update

Cece Nunn - Feb 17, 2017 Trending News

Sound Bank Announces Merger With Raleigh-based Bank Company

Jenny Callison - Feb 17, 2017 Trending News

Officials: GE Hitachi Facing Layoffs

Vince Winkel - Feb 17, 2017

HVAC Firm To Expand In Wilmington With Blue Clay Road Facilities

Cece Nunn - Feb 17, 2017
Consulting

BOSS

BOSS is a team of business experts who tap into the abundance of resources in the Wilmington, N.C., area to help clients start and grow successful businesses.

Ico trending Trending News

Ico newsinimages News in Pictures

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

Gallery Galleries

Video Videos

Wilmington's Most Intriguing People of 2016
WilmingtonBiz Expo - Key Note Lunch with Keynote Lunch with Chip Mahan - 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