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)... ... ... PurhealthRX , a leading Health and Nutrition Company, is announcing the ... spectrum CBD oil will revolutionize the rapidly growing CBD market by reducing the amount ... into liquid products, while reducing costs to end users. , The team of researchers ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Many families have ... many long-term care insurance companies have a waiver for care if the client has ... period, when the family pays for care, is often waived, so the benefits from ...
(Date:10/13/2017)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has released ... understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a picture ... Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that is ...
(Date:10/13/2017)... ... 2017 , ... “America On The Brink”: the Christian history of the United ... the creation of published author, William Nowers. Captain Nowers and his wife, Millie, ... spent thirty years in the Navy. Following his career as a naval aviator ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... products to meet the demand of today’s consumer and regulatory authorities worldwide. From ... probiotic experts and tested to meet the highest standard. , These products ...
Breaking Medicine News(10 mins):
(Date:10/5/2017)... , Oct. 5, 2017  In response ... of Oral and Maxillofacial Surgeons (AAOMS) released prescribing ... – to be used as a first-line therapy ... Recognizing the ... AAOMS White Paper "Opioid Prescribing: Acute and Postoperative ...
(Date:10/4/2017)... Oct. 4, 2017  According to the Centers for Disease Control and ... October . PhysicianOne Urgent Care is helping communities across Massachusetts ... , by offering no-cost* flu shots through the end of the ... certain health insurance regulations. ... time to get a flu shot is by the end of October, ...
(Date:10/2/2017)... , Oct. 2, 2017 Diplomat Pharmacy, Inc. ... Day Software and Consulting, LLC , and named its ... Software, based in Tennessee , will ... Day expands EnvoyHealth,s service offerings for health care partners ... "In an interoperable world, ...
Breaking Medicine Technology: