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Main Page  »  Orthopedic Emerging Treatments, Procedures, and Doctors
December »
Tuesday, August 31
View Article  OsteoBiologics, Inc. Receives 510(k) Clearance From FDA to Market and Distribute its PolyGraft(TM) TCP Bone Graft Substitute
by Barry Sugarman on Mon 30 Aug 2004 11:27 PM AKDT
OsteoBiologics, Inc. Receives 510(k) Clearance From FDA to Market and Distribute its PolyGraft(TM) TCP Bone Graft Substitute
            

    SAN ANTONIO, Aug. 30 /PRNewswire/ -- OsteoBiologics, Inc. ("OBI"), an
innovator in tissue repair technologies, announced that it has received 510(k)
Premarket Notification from the Food and Drug Administration to market and
distribute its newest formulation of composite bone void filler device called
PolyGraft(TM) TCP Bone Graft Substitute.  The porous PolyGraft(TM) TCP
material is composed of a patented blend of polylactide-co-glycolide,
tricalcium phosphate and polyglycolide fibers.  The PolyGraft(TM) TCP material
can be fabricated into products such as granules, blocks, wedges and other
preformed shapes and is indicated to be used to fill bony voids or gaps caused
by trauma or surgery that are not intrinsic to the stability of the bony
structure.  The PolyGraft(TM) TCP is intended to be gently packed into bony
voids or gaps of the skeletal system (i.e., the extremities, spine and
pelvis), and these defects may be surgically created osseous defects or bone
defects due to traumatic injury to the bone.  "OBI has developed another
composite bone void filler in which the ceramic portion resorbs slower to
enhance strength retention," stated Fred Dinger, President and CEO of OBI.
"The availability of this technology platform gives OBI the opportunity to
continue our rapid product line expansion and enables us to provide solutions
for the body to heal itself for a broader range of unmet clinical needs."

    About OsteoBiologics, Inc.
    OBI, located in San Antonio, Texas, is a private company that develops and
manufactures bioabsorbable polymeric scaffolds, films, and related
instrumentation for the repair and replacement of bone, soft tissue and
cartilage.  Its products are based on proprietary and patented technologies
covered by U.S. and foreign patents.  The Company is focusing on
commercializing and further developing its platform technologies in
arthroscopy and sports medicine.  Additionally, OBI is actively forming
strategic alliances with companies serving other areas of medicine such as
spine, trauma, general orthopedics, and wound care to leverage its
technologies into those markets.
    Certain statements made in this press release are forward looking
statements as such term is defined in the Private Securities litigation Reform
Act of 1995.
    For more information, please contact Daniel Lee, Director of Marketing at
(210) 690-2131.
SOURCE OsteoBiologics, Inc.
Web Site: http://www.obi.com
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Saturday, August 28
View Article  Wright Medical Group, Inc. Receives FDA Clearances for the Entire Family of ALLOMATRIX Products
by Barry Sugarman on Sat 28 Aug 2004 11:41 AM EDT 
    ARLINGTON, Tenn.--(BUSINESS WIRE)--July 15, 2004--

  Notification Completes Clearance for Products Currently In Wright's
           ALLOMATRIX(R) Line of Allograft Bone Void Fillers

Wright Medical Group, Inc. (NASDAQ:WMGI), a global orthopaedic medical device company specializing in the design, manufacture and marketing of reconstructive joint devices and biologic materials, today announced receipt of marketing clearance from the United States Food and Drug Administration (FDA) for ALLOMATRIX(R) C, ALLOMATRIX(R) Custom, and ALLOMATRIX(R) DR bone graft putties that contain demineralized bone matrix (DBM) and specific volumes and configurations of donor matched, cancellous bone chips. Following the FDA-clearance of ALLOMATRIX(R) Injectable Putty in March of this year, today's regulatory announcement completes the clearance process for Wright's entire ALLOMATRIX(R) family of products.

The Company began the 510(k) premarket notification process in March of 2002, following FDA's clarification to all allograft putty providers that such products are considered medical devices and are therefore regulated under the federal Food, Drug, and Cosmetic Act. The Company has satisfied FDA's medical device requirements for demonstrating substantial equivalence, including endpoints established for each product's clinical performance and viral inactivation potential. The ALLOMATRIX(R) family of products and OSTEOSET(R) 2 DBM are the only commercially available, FDA-cleared products which contain demineralized bone matrix (DBM).

Laurence Fairey, President and Chief Executive Officer, commented, "Wright Medical has demonstrated a successful strategy of using these specialized formulations to address individual clinical needs targeted at individual orthopaedic sub-specialties. Wright's ability to understand and address specific surgical requirements by developing these focused products reinforces the Company's growing reputation for its comprehensive understanding and responsiveness to the expanding bio-orthopaedic market."

About Wright

Wright Medical Group, Inc. is a global orthopaedic medical device company specializing in the design, manufacture and marketing of reconstructive joint devices and biologic materials. The Company has been in business for more than 50 years and markets its products in over 40 countries worldwide. For more information about Wright, visit our website at www.wmt.com.

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, beliefs, estimates, and expectations and express management's current views of future performance, results, and trends. The Company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including the factors discussed in the Company's filings with the Securities and Exchange Commission (including the Company's annual report on Form 10-K for the year ended December 31, 2003), which could cause the Company's actual results to materially differ from those described in the forward-looking statements. Although the Company believes that the forward-looking statements are accurate, there can be no assurance that any forward-looking statement will prove to be accurate. A forward-looking statement should not be regarded as a representation by the Company that the results described therein will be achieved. The Company wishes to caution readers not to place undue reliance on any forward-looking statement. The forward-looking statements are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statement after this date.

    CONTACT: Wright Medical Group Inc., Arlington

John K. Bakewell, 901-867-4527


    SOURCE: Wright Medical Group, Inc.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Wright Medical Group, Inc.'s business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.
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