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