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:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 million ... by frequent cessation in breathing. Oral appliances can offer significant relief to about ...
(Date:10/12/2017)... ... ... The American College of Medical Informatics (ACMI) will present the 2017 Morris F. ... AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is taking place ... the field of medical informatics, this prestigious award is presented to an individual whose ...
(Date:10/12/2017)... PA (PRWEB) , ... October 12, 2017 , ... ... is the recipient of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B ... York City on October 11, 2017. , The annual award competition recognizes editorial and ...
(Date:10/12/2017)... ... 2017 , ... Health Literacy Innovations (HLI), creator of the ... the Cancer Patient Education Network (CPEN), an independent professional organization that shares best ... alliance. , As CPEN’s strategic partner, HLI will help support CPEN members ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... Divoti USA will engrave and process all non-coated ... latest FDA requirements, which stipulates new criteria regarding medical device manufacture ... Medical ID jewelry such as Medical ID Bracelets, can rest assured ... of the new FDA requirements . ... Divoti offers this dark mark fiber laser engraving process ...
(Date:10/11/2017)... 11, 2017  Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), ... in Las Piedras, Puerto Rico , ... Following a ... sustained minor structural damage, temporary loss of power and ... been completed, manufacturing operations have resumed, and the company ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
Breaking Medicine Technology: