http://comment.colostate.edu/index.asp?page=display_article&article_id=396523010

The Limb Preservation Foundation

CBS News Program TONIGHT at 5:30 p.m.

The CBS Evening News will feature a story on today's broadcast (April 18
at 5:30 MST) about the collaborative efforts between Dr. Ross Wilkins of
the Denver Clinic for Extremities at Risk, and Dr. Stephen Withrow of
the Colorado State University Animal Cancer Center, and their efforts to
find the cause and the cure for bone cancer and other extremity diseases.

The April 18 news story will be entitled "A Tale of Two Doctors" and
will feature interviews with both doctors and information on their
research collaborations in regard to osteosarcoma. Drs. Wilkins and
Withrow have been working together for many years on collaborative
research pertaining to osteosarcoma treatments and protocols for
patients with limb cancer.

Thanks to their joint efforts, the survival rate of pediatric limb
cancer patients has increased from 60% in 1986 to 92% today. The Limb
Preservation Foundation is committed to the research being conducted by
these two doctors and is working to continue their efforts through the
development of a Limb Preservation University Chair in support of
research in Musculoskeletal Biology at the CSU Animal Cancer Center in
Fort Collins. The Foundation will be working with CSU to jointly fund
this research position with the goal of raising $3,000,000 together in
the next three years.

Dr. Ross Wilkins is Founder of The Limb Preservation Foundation and
Medical Director of the Denver Clinic for Extremities at Risk.

Dr. Stephen Withrow is the Director of the CSU Animal Cancer Center and
holds a seat on the Board of Directors of The Limb Preservation
Foundation. The Limb Preservation Foundation is a charitable
organization that was established in 1987. The mission of the Foundation
is to support the prevention and treatment of limb threatening
conditions due to trauma, tumor or infection.

The Foundation coordinates and funds patient treatment programs,
educational programs and research with the goal of addressing the needs
of individuals who are facing the potential loss of a limb.

Category: Events and Coming Attractions
Submitted: Tuesday, April 18, 2006
Subject: ACC
Contact: Lynda J Reed
E-mail: Lynda.Reed@colostate.edu
Phone: (970) 297-4175

Total tibial endoprosthesis including ankle joint and knee joint replacement in a patient with Ewing sarcoma

To read this go to: http://actaorthopscand.positionett.se/pdf/302.pdf

Georg Gosheger, Jendrik Hardes, Benedikt Leidinger, Carsten Gebert, Helmut Ahrens, Winfried Winkelmann
and Christian Goetze

Department of Orthopaedics, University of Muenster, Germany
Correspondance GG: goshegg@uni-muenster.de
Submitted 04-07-23. Accepted 05-01-09

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=16445376&dopt=Abstract

Expert Rev Anticancer Ther. 2006 Feb;6(2):239-48.  

Surgical options and outcomes in bone sarcoma.

Wafa H, Grimer RJ.

The Royal Orthopaedic Hospital NHS Trust, Bristol Road South, Northfield, Birmingham, B31 2AP, UK. hazemyw@yahoo.com

Bone sarcomas are challenging to treat. The primary goal of treatment is local control of the disease while, if possible, achieving salvage of the limb and its function. There is no ideal method of reconstruction in limb-salvage surgery but the choice of the method of reconstruction should be individualized based upon many factors including the patient's age, the extent and location of the tumor, the wishes of the patient, and the availability of surgical facilities and expertise, as well as the cost of the procedure. In this review, the authors explore the advantages and disadvantages of the different methods of limb reconstruction. The surgical management of bone sarcomas is a real challenge to the orthopedic surgeon, owing to the diversity of sites in which tumors arise, combined with the extension of the tumor into adjacent soft tissues and their proximity, in many cases, to major neurovascular structures. There have been dramatic improvements in survival for patients with osteosarcoma and Ewing's sarcoma in the past 30 years owing to increasing effectiveness of chemotherapy. This, along with developments in imaging techniques (magnetic resonance imaging in particular) has led to earlier diagnosis and more accurate preoperative staging. Whilst traditional treatment for bone tumors used to be amputation, advances in surgical techniques have made limb-salvage procedures a valid alternative method of treatment to amputation in 80-85% of patients with primary bone sarcomas.

PMID: 16445376 [PubMed - in process]

Osteotech Receives Its First Grafton(R) DBM 510(k) FDA Clearance Bone Graft Paste

EATONTOWN, N.J., Nov. 29 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: OSTE) announced today that the Food and Drug Administration ("FDA")
has cleared its 510(k) for Grafton Plus(R) DBM Paste for use as a bone graft
extender, bone graft substitute and bone void filler in orthopedic procedures.
    Sam Owusu-Akyaw, Osteotech's President and Chief Operating Officer,
stated, "The Grafton Plus(R) DBM Paste 510(k) for orthopedic use is the first
of five previously reported 510(k) applications that the Company has filed
with the FDA covering its family of Grafton(R) DBM products.  We are
particularly pleased that this 510(k) application has been cleared for all the
indications for which we applied.  To our knowledge, this is the only DBM
product on the market to receive clearance as a bone graft extender, bone
graft substitute and bone void filler."
    Mr. Owusu-Akyaw concluded, "We look forward to the FDA clearing, in the
near future, the remaining four 510(k) applications covering our Grafton(R)
DBM family of products.  We have been working diligently with the FDA
reviewers on all of our 510(k) applications and we believe that they will
receive clearance by the Agency."
    Grafton Plus(R) DBM Paste is a demineralized bone product that has been
proven to be osteoinductive in an athymic rat in vivo model as well as being
osteoconductive.  Further, results of bone formation studies in animals showed
that Grafton Plus(R) DBM Paste performed comparably to autograft.  Grafton
Plus(R) DBM is prepared utilizing a proprietary processing method that has
been validated to consistently produce DBM that is osteoinductive in an
athymic rat model and has been validated to inactivate a panel of viruses,
including: HIV-1, hepatitis B (using a duck hepatitis virus as a model),
hepatitis C (using a bovine diarrhea virus as a model), CMV and polio.  This
validated process is used to further reduce the risk of disease transmission
beyond the protection provided by donor testing and screening procedures.

    Certain statements made in this press release that are not historical
facts contain forward-looking statements (as such are defined in the Private
Securities Litigation Reform Act of 1995) regarding the Company's future
plans, objectives and expected performance.  Any such forward-looking
statements are based on assumptions that the Company believes are reasonable,
but are subject to a wide range of risks and uncertainties and, therefore,
there can be no assurance that the actual results may not differ materially
from those expressed or implied by such forward-looking statements.  Factors
that could cause actual results to differ materially include, but are not
limited to, the failure of the FDA to clear the Company's additional 510(k)
submissions for its Grafton(R) DBM and private label product lines, the
continued acceptance and growth of current products and services, differences
in anticipated and actual product and service introduction dates, the ultimate
success of those products in their marketplace, the impact of competitive
products and services, the availability of sufficient quantities of suitable
donated tissue and the success of cost control and margin improvement efforts.
Certain of these factors are detailed from time to time in the Company's
periodic reports (including the Annual report on Form 10-K for the year ended
December 31, 2004 and the Form 10-Q for each of the first three quarters of
2005) filed with the Securities and Exchange Commission.  All information in
this press release is as of November 28, 2005 and the Company undertakes no
duty to update this information.

    Osteotech, Inc., headquartered in Eatontown, New Jersey, is a leading
provider of human bone and bone connective tissue for transplantation and an
innovator in the development and marketing of biomaterial and implant products
for musculoskeletal surgery.  For further information regarding Osteotech or
this press release, please go to Osteotech's website homepage at
http://www.osteotech.com and to Osteotech's Financial Information Request Form
website page at http://www.osteotech.com/finrequest.htm.

    LAUSANNE, Switzerland, IRVINE, California, December 8
/PRNewswire-FirstCall/ -- IsoTis OrthoBiologics (SWX/Euronext: ISON) (TSX:
ISO) today announced it received 510(k) clearance from the US Food and Drug
Administration (FDA) for the use of OrthoBlast II(R) in orthopedic
applications.
    IsoTis OrthoBiologics has previously obtained 510(k) clearances for
DynaGraft II(TM), Accell Connexus (TM), OsSatura(TM), and its bone marrow
aspiration kit Aspirex. Accell(R) DBM100 and Accell TBM(TM), having no
excipient carriers, are regulated by the FDA as human tissue and not as
medical devices requiring premarket clearance.
    Pieter Wolters, President and CEO of IsoTis said: "With the 510(k)
clearance of OrthoBlast II, all IsoTis' marketed products are in compliance
with FDA regulations, and we can continue to focus on servicing the
orthopedic profession with products that are first in class in the bone
grafting market. The increased uptake of our innovative Accell product line
as a result of the high levels of BMPs it contains, and the solid market
position of first generation products like OrthoBlast II, provide us with a
healthy basis for growth in the years to come."
    OrthoBlast II is a combination of demineralized bone matrix (DBM) with
cancellous bone chips delivered in a reverse phase medium. The reverse phase
medium becomes more viscous at body temperature, but less viscous at cooler
temperatures. Therefore, it is malleable at operating room temperatures, but
thickens when placed in the operative site. This allows the DBM to be
contained at the graft site with minimal loss through irrigation and suction.
    IsoTis OrthoBiologics has a product portfolio with several innovative and
proprietary natural and synthetic bone graft substitutes on the market and
others in development, an established North American independent distribution
network, and an expanding international presence. The company's main
commercial operations are based out of Irvine, CA; its international sales
headquarters is based in Lausanne, Switzerland.
    Certain statements in this Press Release are "forward-looking statements"
within the meaning of Section 21E of the Securities Exchange Act of 1934, as
amended, including those that refer to management's plans and expectations
for future operations, prospects and financial condition. Words such as
'strategy,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'will,'
'continues,' 'estimates,' 'intends,' 'projects,' 'goals,' 'targets' and other
words of similar meaning are intended to identify such forward-looking
statements. One can also identify them by the fact that they do not relate
strictly to historical or current facts. Such statements are based on the
current expectations of the management of IsoTis S.A. only. Undue reliance
should not be placed on these statements because, by their nature, they are
subject to known and unknown risks and can be affected by factors that are
beyond the control of IsoTis. Actual results could differ materially from
current expectations due to a number of factors and uncertainties affecting
IsoTis' business, including but not limited to the timely commencement and
success of IsoTis' clinical trials and research endeavors, delays in
receiving U.S. FDA or other regulatory approvals (a.o. EMEA, CE), market
acceptance of the Company's products, development of competing therapies
and/or technologies, the terms of any future strategic alliances, the need
for additional capital, the inability to obtain, or meet conditions imposed
for the required governmental and regulatory approvals and consents. IsoTis
expressly disclaims any intent or obligation to update these forward-looking
statements except as required by law. For a more detailed description of the
risk factors and uncertainties affecting IsoTis, refer to the Company's
Annual Report on Form 20-F for the fiscal year ended December 31, 2004, filed
with the SEC and to IsoTis' reports filed from time to time with the Swiss
Stock Exchange (SWX), Euronext Amsterdam N.V., and SEDAR at http://www.sedar.com, as
well as the Toronto Stock Exchange (TSX).



SOURCE IsoTis OrthoBiologics

http://www.uthscsa.edu/hscnews/singleformat.asp?newID=1148&SearchID=

The Vertical Expandable Prosthetic Titanium rib becomes 1st new FDA-approved spine deformity treatment in 40 years

Posted: Tuesday, September 14, 2004 · Volume:XXXVII· Issue: 37

Contact: Will Sansom
Phone: (210) 567-2570
E-mail: sansom@uthscsa.edu

San Antonio (Sept. 13, 2004) – The Vertical Expandable Prosthetic Titanium Rib (VEPTR), a device that has saved the lives of 300 infants and young children who otherwise would have died from lack of breath, has been approved by the U.S. Food and Drug Administration (FDA). The inventor from The University of Texas Health Science Center at San Antonio and the Thoracic Institute at CHRISTUS Santa Rosa Children’s Hospital said it is the first new growth-sparing spine deformity treatment to gain FDA approval in more than four decades.

“We have described a new disease and have named it thoracic insufficiency syndrome,” said Robert M. Campbell Jr., M.D., professor of orthopedics at the Health Science Center, director of the Thoracic Institute at CHRISTUS Santa Rosa and inventor of the titanium rib. “It describes a group of patients who have scoliosis, may have fused ribs or a small chest, and this causes harm to respiration and lung growth. Characterizing the disease is more important than the titanium rib itself, because children with these conditions can be diagnosed more clearly using the thoracic insufficiency syndrome approach. We expect more sophisticated and better surgical solutions to be developed in the future.”

The work began in 1987 with the encouragement of Melvin D. Smith, M.D., staff physician at the Thoracic Institute and professor of pediatric general surgery at the Health Science Center. Dr. Smith went to Dr. Campbell with X-rays of infant Christopher Cardenas, who was born without a chest wall. The only option to save Christopher was to create an artificial chest wall, which the doctors were able to accomplish. Two years later, Dr. Campbell, who began college as an engineering student, developed the titanium rib and the surgeons were ready to implant it in a child – 2-year-old Christopher Cardenas. The operation was a success and Christopher, of San Antonio, now is 17.

The titanium rib is curved like a ribcage and has holes that allow the surgeons to expand the device in outpatient surgery every six months. The rib is implanted in infants as young as 6 months and in teenagers until skeletal maturity, typically age 14 in girls and age 16 in boys. “Our data suggest the earlier the better,” Dr. Campbell said. “The lung growth curve is best in the first two years of life.” The rib is made of titanium, a material that is lightweight, compatible with body tissues and does not interfere with MRI scans.

“We are starting to see several ‘Rib’ kids reach skeletal maturity,” Dr. Campbell added. “If the devices are performing their function and not causing a problem, we leave them in. It’s case by case, and there is not a global answer as to when to remove the device.”

As with any surgery, there is the potential for infection, but the surgeons have found the infection rate to be no different than for other types of surgeries. “There is a chance of devices drifting into the bone, and there can be skin problems over the rib if the kids do not have enough body weight, but we believe what it does to help the children outweighs the risks,” Dr. Campbell said.

Drs. Campbell and Smith have developed five new operations utilizing the titanium rib and have described thoracic insufficiency syndrome in four landmark papers in orthopedics journals. The surgeons have taught the titanium rib surgery techniques to other tertiary pediatric hospitals throughout the United States and all over the world. Last week, Drs. Campbell and Smith returned from a trip to a children’s hospital in Buenos Aires, Argentina. Last month, Dr. Campbell performed the surgery at Birmingham Children’s Hospital in England.

Dr. Campbell did the research in private practice for several years, but needed the support of an academic health science university for the project to proceed. He joined the Health Science Center faculty in 1992. “The Health Science Center has provided support for this research and helped make it happen,” Dr. Campbell said. “CHRISTUS Santa Rosa has been the site of all the titanium rib surgeries here in San Antonio.”
In the mid-1990s, Drs. Campbell and Smith, the Health Science Center and CHRISTUS Santa Rosa became coordinators of a multicenter FDA clinical trial to test the titanium rib. About 210 children have had the surgery at CHRISTUS Santa Rosa, and 90 at seven other children’s hospitals in Pittsburgh, Boston, Salt Lake City, Los Angeles, Seattle and Philadelphia.

“It took 13 years to gain FDA approval because it took a long time to accumulate a lot of patients with rare diseases,” Dr. Campbell said. “Also, the FDA examines very carefully any new spine treatment, especially one that is for children.”

The last major advance in spine treatment came along in 1962 – the Harrington Rod developed by Dr. Paul Harrington of Houston. The device revolutionized spine surgery, Dr. Campbell said.

For Frequently Asked Questions about the VEPTR visit: http://www.uthscsa.edu/HSCNews/archive/TitaniumRibFAQ.pdf

For the chronology of the Titanium Rib Project, visit: http://www.uthscsa.edu/HSCNews/archive/TitaniumRibChronology.pdf

For information about the Katka's twins visit: http://www.uthscsa.edu/HSCNews/archive/TitaniumRibSidebar.pdf

    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

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.