Navigation Links
NovaLign(TM) Orthopaedics, Inc. Announces its First 510(K) Clearance From the FDA for New Intramedullary Fixation System
Date:3/25/2009

MEMPHIS, Tenn., March 25 /PRNewswire/ -- NovaLign(TM) Orthopaedics, Inc., formerly known as OsteoLign, Inc., received its first 510(k) clearance from the U.S. Food and Drug Administration to market its Intramedullary Fixation System, a new system of implants and instruments for the treatment of long bone fractures, including the humerus, tibia and femur. This regulatory clearance allows NovaLign(TM) to enter the intramedullary fracture fixation market, estimated to be $700 million in the United States for 2009. NovaLign(TM) has filed multiple U.S. and foreign patent applications related to its technology.

"Attainment of this key milestone enables the company to move forward with its plans to commercialize new products that provide innovative treatment options for long bone fracture repair," said Jeffrey G. Roberts, president and CEO of NovaLign(TM).

Extensive preclinical testing in accordance with internationally recognized testing standards and applicable FDA guidances support NovaLign's 510(k) clearance. The company plans to initiate clinical studies in Europe and the United States later this year.

Using current surgical approaches, trauma surgeons insert rigid intramedullary nails through the nearest joint. "The NovaLign(TM) extra-capsular intramedullary device allows a surgeon to repair a long bone fracture without violating the nearby joint space," said James P. Stannard, M.D., professor of surgery at the University of Alabama at Birmingham. By entering the medullary canal from outside of the joint, NovaLign's goal is to avoid damage to the surrounding tissue thereby minimizing the complications that may be experienced with traditional surgical techniques.

In July 2007, NovaLign(TM) successfully raised $10 million in its Series-B financing round from a consortium of leading venture capital companies, including Versant Ventures in Menlo Park, Calif., SV Life Sciences in Boston, Mass., and Accuitive Medical Ventures in Duluth, Ga.

About NovaLign(TM) Orthopaedics Inc.:

NovaLign(TM) (http://www.novalign.com), formerly known as OsteoLign, Inc., is an early-stage start-up company founded in 2005 within The Innovation Factory, a Duluth, Ga.-based technology incubator with a history of successfully developing medical device companies covering a broad range of medical specialties. In September 2007, the company relocated to Memphis, Tenn., and is continuing to build upon its current team of orthopaedic industry professionals.


'/>"/>
SOURCE NovaLign(TM) Orthopaedics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Statement of DePuy Orthopaedics, Inc. Regarding Agreement with U.S. Attorneys Office
2. China Medical Technologies Announces Receipt of SFDA Quality Testing Certificate for its SPR-based Analysis System
3. The Quantum Group Announces Resource Reallocation to Advance PWeR(TM) Platform
4. Go Healthy Announces Receipt of Letter of Interest to Fund Distribution, Production, Packaging, Concept Stores and Bottling Facilities
5. Cord Blood America Announces Results of Shareholder Special Meeting
6. Acupuncture & Massage College Announces Ricky William's Scholarship
7. BioHorizons Announces Its 2009 Global Symposium: Bringing Together Top Thought Leaders in the Dental Implant Industry to Provide Insight on Integrating Technology into the Continuum of Care
8. Perrigo Announces FDA Approval for Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)
9. Maryland Performance Excellence Awards Program Announces Winners of Maryland Quality Awards
10. Smith & Nephew Announces Symposium for Optimizing Outcomes in Burn Care
11. The 50 Million Pound Challenge Announces One-Millionth Member
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/28/2017)... ... March 28, 2017 , ... “A Prophets Bones”: a thrilling adventure that reveals the mystery of ... were things that his parents and teachers had asked of him that he had neglected ... going to defy the Almighty Creator. There were some who would have felt themselves to ...
(Date:3/27/2017)... ... 27, 2017 , ... New patients who have sleep apnea in ... or without a referral. Sleep apnea is often left untreated because patients are not ... and chronic snoring. , Dr. Braasch seeks to raise awareness of sleep apnea ...
(Date:3/27/2017)... ... 27, 2017 , ... Drs. Bruce Trimble and Michelle Parker ... a referral. Trimble Dental offers a variety of services to meet each patient’s ... patients have discolored, crooked or missing teeth in Eau Claire, WI, Drs. Trimble ...
(Date:3/27/2017)... White Plains, NY (PRWEB) , ... March 27, 2017 , ... ... honoring Root Canal Awareness Week by teaching their patients about the key role this ... canal therapy from an experienced endodontist. To better serve those who need a ...
(Date:3/27/2017)... ... 2017 , ... This is the second major release since ... 2014. It is the culmination of collaborative efforts by members of the OSEHRA ... Member Zato Health co-funded the ONC certification and provided key technical support throughout ...
Breaking Medicine News(10 mins):
(Date:3/27/2017)... LEXINGTON, Mass. , March 27, 2017   Pulmatrix, ... innovative inhaled therapies to address serious pulmonary diseases, today announced ... allergic fungal disease, cystic fibrosis and asthma to its ... Richard B. Moss , MD, ... former Director of the Cystic Fibrosis Center at Stanford University, ...
(Date:3/27/2017)... March 27, 2017 The global ... USD 16.0 billion by 2025, according to a new ... of chronic diseases is anticipated to be responsible for ... thereby widens the scope for growth during the forecast ... population, which is highly susceptible to chronic diseases, is ...
(Date:3/27/2017)... and BOSTON , ... a leading global pharmaceutical company and Paratek Pharmaceuticals, ... the development and commercialization of innovative therapies based ... 3 trials of sarecycline for the treatment of ... primary efficacy endpoints. Sarecycline is a once-daily, oral, ...
Breaking Medicine Technology: