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:5/26/2017)... VA (PRWEB) , ... May 26, 2017 , ... ... pleased to announce a new educational seminar to focus on current legislative activity ... News(LEARN) seminar will begin at 1 p.m. Sunday, Sept. 10, and will continue ...
(Date:5/26/2017)... ... May 26, 2017 , ... via ... antimicrobial, mesh back 24/7 task chair specifically designed for clinical areas. Genie Copper ... thrilled to partner with Cupron® to provide customers with a game changing chair ...
(Date:5/26/2017)... ... 26, 2017 , ... Rob Lowe acts as host and helps educate and ... on hiking in American. Viewers can reconnect with America as it explores some of ... Many consumers have looked for an inventive new place for a family vacation, and ...
(Date:5/26/2017)... ... ... What Happened in the Garden of Eden”: retells the stories of three Bible figures in ... published author, Penelope Colt, mother, trader, horse farmer, artist and a former GM journeyman. ... At six, they moved to Dayton, Ohio, where Penny graduated high school. At ...
(Date:5/24/2017)... ... May 24, 2017 , ... Dr. Alan I. Benvenisty, MD is dual board ... He is known for his distinguished expertise and experience in the diagnosis and treatment ... training in treating renovascular disease and aortic aneurysm . He is known for ...
Breaking Medicine News(10 mins):
(Date:5/9/2017)... , May 9, 2017  Demonstrating its commitment ... of directors for the Pharmaceutical Research and Manufacturers ... membership. Biopharmaceutical companies will now have to meet ... to be eligible to join PhRMA. ... board is sending a clear message that being ...
(Date:5/8/2017)... Mich. , May 8, 2017  Diplomat Pharmacy, ... WRB Communications, Inc. ("WRB"), a health care service ... . WRB specializes in relationship management programs ... WRB will join ... Diplomat,s commercialization support services for manufacturers, biotech firms, and ...
(Date:5/4/2017)... May 4, 2017  Fortuna Fix Inc. (" Fortuna ... the first to eliminate the need for embryonic and fetal ... treat neurodegenerative diseases. Fortuna announced today ... Michael Fehlings , MD, PhD; Father Kevin FitzGerald ... MPH; and Professor James Giordano , PhD. ...
Breaking Medicine Technology: