VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
week in review
4
Stryker’s MacMillan Gone?!
♦ The number one news story at
the American Academy of Orthopaedic Surgeon’s annual confab was not
a paper or product but rather a single
person—former Stryker Chairman of
the Board and CEO, Stephen MacMillan. For “family reasons” he and Stryker
agreed to part. What happened?
8
Inside the Wright DPA
Meltdown: Part II ♦ Three
wrongful termination lawsuits offer an unprecedented look inside the
company’s DPA troubles. Last week
OTW looked at allegations against the
Wright Board. This week we look at
the specific complaints about Wright’s
compliance program. Fasten your seatbelts. It ain’t pretty.
12
Three Rounds Over
Dual Poly Liner: Stulberg vs. MacDonald ♦
“Dual mobility poly is more stable
and has long-term data to back it up,”
argues Dr. David Stulberg. “This construct doesn’t make sense,” counters
Dr. Steve MacDonald. “I could find no
published wear data in the literature.”
16
On (and Off) the Record ♦ “Will orthopedic
training programs close?...
Infectious complications and timing of anti TNF Meds…what’s going
on with manual skills training for
residents?...St. Vincent Team Wins
Stinchfield Award…and more.
breaking news
19
Unique Israeli Company
CartiHeal Gets CE Mark
..........................................
FDA Clears Two New Clavicle Repair
Technologies
............................................................
Football and Alzheimer’s – A Connection?
............................................................
Award Winning Israeli Spine Company
Gets 510(k) Clearance
............................................................
TiGenix: Green Light for RA Dosing
............................................................
Smith & Nephew Settles Greek Bribery Charges
............................................................
ISTO and Zimmer Announce Phase III
Study of DeNovo ET
For all news that is ortho, read on.
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2
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
Orthopedic Power Rankings
Robin Young’s Entirely Subjective Ordering of Public Orthopedic Companies
THIS WEEK: AAOS, the annual meeting for the orthopedic community, was stronger than we expected with more
attendees and more activity in the exhibit hall. We’re talking standing room only in booths. No blockbuster innovations,
but we did see many smart, incrementally better products. Bottom line, upbeat and hopeful.
LAST
WEEK
COMPANY
30-DAY
PRICE CHANGE
COMMENT
1
1
Zimmer
27.75%
10.02%
Little noticed by investors, ZMH’s inventory declined even
as sales rose last quarter. Frees up more cash.
2
2
Orthofix
14.72
13.07
Consensus on Wall Street is that OFIX is trading about
20% below where it should be.
3
3
Stryker
25.23
0.98
MacMillan’s departure was a shock. But SYK’s strong
and high quality middle management will carry the firm
forward.
4
5
Medtronic
28.63
1.38
New uses for deep brain stimulation include Alzheimer’s
and other memory disorders. Up one spot.
5
10
Integra
LifeSciences
14.81
27.68
In two categories, PE to Growth and Future PE, IART is
lowest in ortho—2nd lowest PE and 3rd lowest PSR.
6
4
NuVasive
7.26
10.62
This week’s downgrade by Robert W. Baird probably
reflects profit taking after NUVA’s big, recent run up.
7
7
Smith &
Nephew
22.80
7.16
Excellent AAOS with several interesting new products
including PICO, Healicoil and POLARCUP.
8
6
Conmed
9.65
7.22
Introduced its new line of sports medicine products
including MTF-based materials at AAOS.
9
9
Exactech
7.69
1.77
Extremities and hips are the big growers right now at
EXAC. Spine…not good.
10
8
Johnson &
Johnson
26.33
(0.81)
While JNJ may be a reliable dividend growth stock,
investors need a new catalyst to get excited.
RANK
TTM OP
MARGIN
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3
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
Robin Young’s Orthopedic Universe
WORST PERFORMERS LAST 30 DAYS
TOP PERFORMERS LAST 30 DAYS
COMPANY
1
2
3
4
5
6
7
8
9
10
Integra LifeSciences
TranS1
Bacterin Intl Holdings
Orthofix
NuVasive
Zimmer Holdings
Kensey Nash
Conmed
Smith & Nephew
CryoLife
SYMBOL
IART
TSON
BONE
OFIX
NUVA
ZMH
KNSY
CNMD
SNN
CRY
PRICE
MKT CAP
$29.98
$2.27
$2.74
$40.97
$15.62
$60.84
$22.78
$28.80
$49.84
$5.66
$804
$62
$111
$754
$660
$10,901
$198
$804
$8,913
$159
30-DAY CHG
27.68%
19.47%
17.09%
13.07%
10.62%
10.02%
8.17%
7.22%
7.16%
6.99%
COMPANY
1
2
3
4
5
6
7
8
9
10
LOWEST PRICE / EARNINGS RATIO (TTM)
COMPANY
1
2
3
4
5
Medtronic
Integra LifeSciences
Zimmer Holdings
Johnson & Johnson
Stryker
SYMBOL
MDT
IART
ZMH
JNJ
SYK
1
2
3
4
5
Integra LifeSciences
RTI Biologics Inc
Orthofix
Stryker
Zimmer Holdings
SYMBOL
IART
RTIX
OFIX
SYK
ZMH
PRICE
MKT CAP
P/E
$39.73
$29.98
$60.84
$64.60
$53.54
$41,929
$804
$10,901
$176,413
$20,488
11.93
12.39
12.65
12.92
14.55
PRICE
MKT CAP
PEG
$29.98
$4.01
$40.97
$53.54
$60.84
$804
$221
$754
$20,488
$10,901
0.49
0.94
0.99
1.35
1.35
1
2
3
4
5
1
2
3
4
5
Symmetry Medical
Alphatec Holdings
Integra LifeSciences
Conmed
Exactech
SYMBOL
SMA
ATEC
IART
CNMD
EXAC
PRICE
$7.50
$1.98
$29.98
$28.80
$17.26
MKT CAP
$272
$177
$804
$804
$227
SMA
RTIX
MAKO
ARTC
TRNX
JNJ
WMGI
SYK
MDT
EXAC
MKT CAP
$7.50
$4.01
$32.89
$30.25
$19.61
$64.60
$16.65
$53.54
$39.73
$17.26
$272
$221
$1,370
$832
$770
$176,413
$655
$20,488
$41,929
$227
30-DAY CHG
-9.09%
-5.42%
-3.80%
-1.53%
-1.21%
-0.81%
0.60%
0.98%
1.38%
1.77%
COMPANY
SYMBOL
PRICE
MKT CAP
P/E
Wright Medical
RTI Biologics Inc
NuVasive
Exactech
Synthes
WMGI
RTIX
NUVA
EXAC
SYST.VX
$16.65
$4.01
$15.62
$17.26
$170.87
$655
$221
$660
$227
$20,295
35.43
26.73
23.31
21.85
21.63
HIGHEST P/E TO GROWTH RATIO (EARNINGS ESTIMATES)
COMPANY
1
2
3
4
5
LOWEST PRICE TO SALES RATIO (TTM)
COMPANY
Symmetry Medical
RTI Biologics Inc
MAKO Surgical
ArthroCare
Tornier N.V.
Johnson & Johnson
Wright Medical
Stryker
Medtronic
Exactech
PRICE
HIGHEST PRICE / EARNINGS RATIO (TTM)
LOWEST P/E TO GROWTH RATIO (EARNINGS ESTIMATES)
COMPANY
SYMBOL
SYMBOL
NuVasive
Wright Medical
CryoLife
Johnson & Johnson
Smith & Nephew
NUVA
WMGI
CRY
JNJ
SNN
PRICE
MKT CAP
PEG
$15.62
$16.65
$5.66
$64.60
$49.84
$660
$655
$159
$176,413
$8,913
3.32
3.16
2.38
2.19
2.14
HIGHEST PRICE TO SALES RATIO (TTM)
PSR
0.75
1.03
1.10
1.13
1.19
COMPANY
1
2
3
4
5
SYMBOL
TiGenix
MAKO Surgical
Synthes
Bacterin Intl Holdings
Tornier N.V.
TIG.BR
MAKO
SYST.VX
BONE
TRNX
PRICE
MKT CAP
PSR
$0.95
$32.89
$170.87
$2.74
$19.61
$87
$1,370
$20,295
$111
$770
139.39
30.93
5.50
4.22
3.39
PSR: Aggregate current market capitalization divided by aggregate sales and the calculation excluded the companies for which sales figures are not available.
Advertise with Orthopedics This
Week
Click Here for more details
or email [email protected]
Tom Bishow: 410.356.2455 (office)
or 410.608.1697 (cell)
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4
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
Stryker’s MacMillan Gone?!
By Robin Young
Morguefile and jppi
he number one news story at the
American Academy of Orthopaedics Surgeon’s (AAOS) annual confab
was not a paper or a product but rather
a single person—former Stryker Chairman of the Board and CEO, Stephen
MacMillan. The successor to legendary Stryker CEO John Brown, Stephen
MacMillan is no longer employed at
Stryker—eight and a half years after
his arrival as its new President and
Chief Operating Officer. Stryker’s press
release regarding MacMillan’s departure
came on the second day of the AAOS
meeting and it said, in part:
T
“The Board of Directors of Stryker Corporation (NYSE: SYK)
announced today that Stephen P.
MacMillan has resigned as Chairman, President and Chief Executive
Officer for family reasons, effective
immediately. Curt Hartman, Vice
President and Chief Financial Officer, has been named Interim Chief
Executive Officer and William U.
Parfet, Lead Independent Director, becomes Non-Executive Chairman. The Board has begun a search
for a permanent successor to Mr.
MacMillan and will consider both
internal and external candidates.”
On the floor of the convention, MacMillan’s departure was by far the #1
point of discussion. And since a large
portion of the orthopedic community
was together in one place updates and
rumors spread rapidly.
At the core of all the rumors was one
story—that MacMillan, who is married,
was embroiled in overly public marital
discord. From everything OTW has
been able to learn, that story is essentially correct.
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5
Reaction From Around the AAOS
Water Cooler
Reaction from the floor of the conference was mildly critical of Stryker’s
Board but ran the gamut from blistering
to forgiving in its assessment of MacMillan. There were no positive statements
for the entire mess. Here are some of
the more common reactions from the
AAOS convention floor:
1. “All the CEO’s do it, why make a
big deal.”
2. “Extremely distractive to Stryker
employees trying to promote new
products.”
3. “Why did the Board announce
during AAOS? They should have
waited.”
4. “MacMillan failed the CEO intelligence test.”
5. “In Europe this would have been
no big deal.”
6. “MacMillan should be judged as a
manager, not on his personal life.”
7. “The analysts knew and didn’t care
so why create the disruption.”
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
pedics. How it handled this problem
is probably an indication that Stryker
remains an Eagle Scout type company.
CEOs are as flawed as any mortal—
although they can develop high levels
of hubris. Here is how other firms handled errant senior executives.
Hewlett Packard ousted its CEO Mark
Hurd on August 6, 2010 for not only
having an affair with a former contractor, but also helping her get paid for
work she didn’t do and contributing to a
corporate atmosphere where standards
of business conduct were violated.
code decreed that Boeing employees
wouldn’t engage in any conduct or
activity that might raise questions as to
the company’s honesty, impartiality or
integrity. Ironically, it was Stonecipher
who had established the ethics code
and insisted that all Boeing employees
follow it. Stonecipher had joined Boeing to help reestablish that firm’s reputation following the 2003 ethics scandal involving Boeing and U.S. Air Force
contract for aerial refueling tankers.
And then, of course, in the political
arena from Herman Cain to Congressman Anthony Weiner to “wide-stance”
Senator Larry Craig, ethically challenged office holders/candidates are
frequently hounded into retirement.
Boeing fired its CEO Harry Stonecipher, 68, in 2005 for having an affair
with a female executive which violated
the company’s code of conduct. Boe- Stephen P. MacMillan
ing’s chairman decided that Stonecipher’s affair compromised his ability One Michigan-based news outlet
OTWPrintAd_All
Ads_5x4.25:Layout
1 s1/27/12
AM Pagelast
4 week that MacMillan and
to lead the company.
Boeing’
ethic’s11:50reported
Apparently, the news that Macmillan
was dealing with “family reasons” was
known to a growing circle of people in
and around Kalamazoo from around
Christmas time to just before the Board
announcement.
We’ve Seen This Movie Before
CEOs whose personal lives prompt
board action are not new. But a Stryker
CEO falling into such a situation is a
surprise. As one person who knows
former Stryker CEO John Brown well
put it, “I don’t think John Brown had
a prurient thought even when he was
sleeping.”
Stryker Corporation has as straight
arrow a reputation as exists in ortho-
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6
his wife Amy were in the process of a
filing or getting a divorce. MacMillan’s
wife, Amy MacMillan, is an adjunct
Assistant Professor and Instructor of
Marketing at Western Michigan University. It turns out that she does have
financial ties with Stryker and earned
$458,000 from the company in 2010 as
director of a catering company.
MacMillan earned a B.A degree in Economics from Davidson College and is a
graduate of Harvard Business School’s
Advanced Management Program.
MacMillan began his career as a brand
manager for Procter & Gamble before
moving to Johnson & Johnson where
he spent 11 years in a series of roles
both in the U.S. and in Europe. His
principal accomplishment was his
role in rejuvenating the Tylenol and
Imodium brands. When he left JNJ he
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
was serving as President of Johnson &
Johnson-Merck Consumer Pharmaceuticals a joint venture between J&J and
Merck & Co. which focuses on marketing non-prescription switches of Merck
products.
From JNJ, MacMillan moved to Pharmacia Upjohn where he served as Sector Vice President, Global Specialty
Operations for Pharmacia Corporation.
He was 36 years old at the time.
MacMillan’s appointment continues the
succession plan he initiated when Mr.
MacMillan was hired, adding: “This
transition has been very smooth. Steve
has been well accepted at Stryker and
we are confident that he is the right
leader to take the Company forward.”
As CEO of Stryker Corporation, MacMillan earned $2.84 million in 2010.
He was 48 years old when he left.
Ethics and Orthopedics
MacMillan joined Stryker in 2003 as
the company’s new President and Chief
Operating Officer and heir apparent to
retiring CEO John Brown. In January
2005, MacMillan was promoted to CEO
and in 2010 he was named Chairman
of the Board.
At the time Stryker hired MacMillan,
then CEO John Brown noted that Mr.
One of the central themes in orthopedics over the past decade has been ethics. The high point of these issues came
four and a half years ago, September
2007, when four orthopedic companies
agreed to pay $311 million to settle a
claim with the Department of Justice
(DOJ) regarding financial relationships and consulting agreements with
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7
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
surgeons which, according to the DOJ,
violated federal anti-kickback statutes.
Stryker was not one of the companies
that had to pay a fine.
In addition to the money, each company agreed to implement new corporate
compliance procedures and 18 months
of oversight by a federal monitor
appointed by the Department of Justice. The four companies were Zimmer
Holdings, Inc., DePuy Orthopaedics,
Biomet, Inc. and Smith & Nephew.
The DOJ accused the four companies
of using consulting agreements with
orthopedic surgeons to induce them to
use a particular company’s joint replacement device.
Stryker, by contrast, escaped both the
fines and the DPA. Stryker, the fifth
company involved in the investiga-
tion, voluntarily cooperated with the
Attorney’s office before any of the other
companies. Because of its cooperation,
Stryker was able to execute a NonProsecution Agreement which required
the company to implement the same
reforms imposed on the other companies including 18 months of federal
monitoring.
Complying with stricter and monitored
rules regarding consulting agreements
and such activities as buying dinners
or even coffee for surgeons has been
difficult for all levels of each organization. Every company has lost business
because of these rules.
But one company from among the largest firms in orthopedics was treated differently and more favorably by regulators—that was Stryker.
Why Did Stryker’s Board Take This
Long?
Asking the boss to leave is very hard.
Particularly when the boss, as in this
case, had led his company through particularly difficult times. Stryker’s record
under MacMillan is good. Forbes listed
Stryker as one of the 100 best firms to
work for. Both in terms of sales growth
and profits, Stryker has outperformed
its peers. In 2011, for instance, sales
grew 13.5%, profits rose nearly 12%.
Over the past 18 months Stryker has
made several key strategic acquisitions
and amassed a cash balance in excess of
$3.4 billion.
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But beyond the corporate aspects,
Board members were personally fond
of MacMillan. So much of the discussion over that past few weeks, we can
imagine, has been about dealing with
the Board’s attachment to MacMillan.
Three of Stryker’s Board members are
CEOs themselves. Then there’s the real-
ization that they may have misjudged
MacMillan.
Telling the boss that he has to go, or
allowing the boss to stand down, is a
process that involves, in the case of
companies like Stryker, lawyers and
often, outside consultants. When, as
is the case here, the events that have
created the need for separation were
unexpected and out of character, it can
literally take months of moving through
denial, guilt, and anxiety before there’s
a collective agreement that the Chairman and CEO has to go.
Once a board has decided that a CEO
must resign, then there are further
debates about what to say and what
the succession plan will be. No doubt,
Stryker’s Board engaged in many anxious discussions regarding employee,
stakeholder, and shareholder and press
concerns and likely reactions. The
entire process is an ordeal. But, as if
often the case, once the CEO was gone,
there can be a sense of liberation.
People can get back to work.
Stryker’s Message
With leadership at these levels come
extraordinarily hard and difficult
requirements.
The orthopedic industry is under such
scrutiny from payers, FDA and the
Department of Justice that organizations—top to bottom—are being asked
to conduct themselves in the highest
ethical manner. Yes, we are all human
and flawed. But leaders must set the
example.
Stryker’s Board of Directors did exactly
that.
Good job. ♦
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8
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
Inside the Wright DPA Meltdown: Part II
By Walter Eisner
he meeting was unprecedented.
T
On February 11, 2011, a senior Wright
Medical Technology, Inc. executive was
warning members of the company’s
Board of Directors’ Corporate Governance Committee that the company’s
compliance program had “serious continuing problems and deficiencies.”
Those problems eventually resulted in
a 12-month extension of the company’s
Deferred Prosecution Agreement (DPA)
with the Justice Department (DOJ).
That executive was Cary Hagan, head
of the company’s operations in Europe,
Africa and the Middle East. Hagan however, was not the only Wright executive
who had warned senior company leaders of serious problems with the DPA.
Wrongful termination lawsuits filed in
early January 2012 by Hagan and two
other former Wright executives, Frank
Bono and Alicia Napoli, allege that they
were terminated for raising those warnings.
Last week we reported on certain allegations from Hagan’s lawsuit against
the company’s Board of Directors. This
week we look at the Bono and Napoli
lawsuits and specific problems identified by Hagan, Bono and Napoli over
the performance of Lisa Michels, the
company’s chief compliance officer.
Frank Bono
Frank Bono began his career with
Wright in 2007 as the company’s senior
vice president, research and develop-
The Hagan Complaint/RRY Publications LLC
ment. According to his lawsuit, he
received “sterling” performance reviews
during his tenure.
On April 1, 2009, Bono and Wright
executed a Separation Pay Agreement
(SPA) and on January 8, 2010 the title
of senior vice president and chief technology officer was added to his name.
According to Bono’s lawsuit, Wright
gave Bono an unsigned letter of termination on April 4, 2011, purporting,
says Bono, to terminate his employment “for cause.” Pursuant to the letter,
Bono claims that the Board decided to
terminate him for three reasons:
•First, that he allegedly “engaged in
actions that were directly inconsistent with the requirements of the
Company’s compliance program;”
•Second, that Bono allegedly was
“less than candid and forthcoming
with the Board and its committee
about facts related to compliance;”
•Third, that Bono allegedly “created
a backdated memo intended to
mislead certain surgeon customers
about facts related to the company’s
compliance efforts.”
Bono disputes the allegations and
claims he did nothing to give “cause”
for his termination. In fact, he claims
he was terminated for raising warnings
about the ability of Michels to ensure
the company’s compliance with the
DPA. He said he even raised the concerns with the federal Monitor.
He claims raising those concerns were
a “substantial” factor in the decision to
terminate him.
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
Defamation
After his termination, he says the company published numerous statements
that are injurious to his reputation
and ability to secure future employment. The statements included that he
was “fired” or “terminated” because he
“failed to exhibit appropriate regard for
Wright’s ongoing compliance program.”
He says Wright knew these allegations
were false and as a result of the defamatory statements, impaired his reputation and standing in the community
and has caused him personal humiliation, mental anguish, and suffering.
Alicia Napoli
Napoli began her career at Wright in
April 2008 as vice president, clinical
and regulatory and claims in her suit
that she regularly received excellent
performance reviews. On April 1, 2010
she also executed a Separation Pay
Agreement with the company.
On March 10, 2011, Napoli said she
received a reprimand letter “purporting
to ‘document the implications related to
[an] investigation of reported compliance violations by Napoli.’”
7th Annual Stem Cell Summit
The noted violations related to the company’s compliance hotline. She says the
letter stated that it was not believed that
she committed any violations of law. She
claims the letter was rife with factual
errors and misstatements as to Wright’s
policies and devoid of anything that
Napoli did wrong. She was however,
stripped of certain job responsibilities.
Final Notice
She claims every action that she took
was sanctioned by Lisa Michels and Ray
Coles, another Wright official, or was
in strict compliance with the existing
processes, policies, practices and procedures in place at Wright at the time.
If you haven’t already saved the date of February 21, 2012,
mark your calendar now. And if you want to ensure your spot
at 2012’s Stem Cell Summit register today!
www.stemcellsummit.com
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Threats of Professional Ruin
On May 3, she claims she was given an
unsigned letter of resignation. She said
she was told her that if she didn’t sign
it she would risk termination and “pro-
fessional ruin through negative media.”
She characterized Wright’s actions as
“extortionist and outrageous conduct.”
Like Bono, Napoli claims she also raised
concerns to Wright’s Board of Directors
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
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about the quality of Wright’s compliance program and about Michels’ ability to ensure Wright’s compliance. Raising those concerns were, according to
Napoli, a “substantial” factor in Wright’s
decision to terminate her.
Complaints Against Michels
What were some of those specific concerns noted in the lawsuits?
Hagan says in his suit that he was responsible to help structure and implement
“much needed” regulatory compliance
improvements and safeguards that were
required by the DOJ. He had to work
through and with Michels.
On December 2 and 3, 2010, Hagan and
his key colleagues in Compliance trav-
elled from Amsterdam to Wright’s main
office in Tennessee for the sole reason
of meeting with Michels about “serious
compliance issues he had identified and
about which he was concerned.”
Hagan says he had previously attempted
to bring these issues to Wright through
Michels and others and on May 5, 2010
began documenting those attempts in
serial meeting minutes.
Those minutes, claims Hagan, show
who was or was not present at meetings
and meetings cancelled by Michels. He
says the meetings were scheduled by
Eric Stookey, Wright’s VP of commercial operations or Gary Henly, the CEO.
“Despite her poor record of attendance,
Ms. Michels later asked that she appear
on Wright’s corporate records as the
scheduler of these discussions because
it ‘looked better’ to the Monitor,” alleges
Hagan. He says the meetings then
stopped.
Hagan says that a specific series of
meetings between himself and Michels
which were intended to take place
over that time were “carefully, specifically and well-in-advance calendared.
Michels failed to attend all but one of
these meetings and arrived at that meeting significantly late and left early.” He
says Michels “generally ignored” existing concerns regarding compliance
issues and his requests for her assistance.
Hagan said he was concerned about
Michels’ failure to attend the meetings
and her “overall lack of response and
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11
concern” to compliance matters he
was presenting. Those matter included
clarification of general unresolved compliance issues in his territory—general
clarifications such as when would meetings resume? Which national codes
were to be followed? Questions about
“Medical Education and Training Event
Policy”
One of the education and training
event policy questions identified in
Hagan’s lawsuit involved, he claims,
one “absurd” reason given for his termination by the company. And that was
that Hagan had improperly “allowed”
European employers or distributors
to pay the travel and lodging expenses
for orthopedic surgeons to attend [an]
AAOS meeting in the U.S. But, says
Hagen, the decision to do so was made
“after full disclosure to, and with the
concurrence” of, not only Michels, but
also Stookey. This “well documented”
decision had been made in a series of
multiple conference calls claims Hagan.
Neither Michels nor Stookey were
disciplined. In fact, he says Michels
remained at the company for months
after his discharge and Stookey remains
at Wright in his senior leadership position.
One former Wright employee tells OTW
that he was present when Hagan and
his team arrived from Amsterdam and
Michels allegedly cancelled a meeting.
“Cary [Hagan] was absolutely furious, because he and a few of his VPs
had flown over just for the purposes
of meeting with her. I overheard him
venting to another one of our SVPs (Bill
Griffin) about what had happened. I
believe she had cancelled the day of the
meeting,” says the former employee. He
added that Michels “did things like that
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
quite frequently” and that it was well
known in all levels of the company.
with Wright’s Compliance Program was
being properly managed was directly
called into question.”
Hagan Takes Concerns to Board
When Michels failed to address his concerns, Hagan said he took his concerns
to the Board of Directors. He also notified, in writing, Henley and Ed Steiger,
Wright’s senior VP of human resources.
Hagan said he personally requested and
obtained a direct meeting with Board’s
Corporate Governance Committee on
February 11, 2011.
His lawsuit states that he laid out examples of Michels’ “lack of management”
of his group’s compliance program,
who reported to Michels, for the preceding year. The lawsuit lists at least
nine examples of Michels’ lack of management.
Hagan says he described other “key
incompetencies” in a document
reviewed by the Board’s Governance
Committee (which included David Stevens, John Miclot and Amy Paul) on
February 11, 2011.
Hagan says the entire European compliance process moved forward “without
a single communication” from Michels
who did not participate in “any” of the
execution of their plan. He also said
Michels failed to reply to “multiple”
requests to review, edit, and comment
on their efforts for which they had
been assisted by the law firm of Hogan
Lovells.
Hagan said he was encouraged at first
by the Governance Committee’s initial
reaction to his report as the committee “seemed to recognize the repeated
and dangerous neglect” by Michels. Yet,
Hagan says, the Board failed to notify
the Monitor of his concerns.
“Incredibly,” says Hagan, instead of
intervening positively to his “in-person” report, the Board “orchestrated a
plan and scheme to deflect attention
from itself and its compliance-related
failure.”
The Board may have been successful.
After the executives were terminated,
one analyst, BMO Capital Market’s
Joanne Wuensch, wrote that it seems
the company has taken a “zero-tolerance, take-no-hostages approach” to
whatever it is that went wrong…we
continue to recommend the stock and
rate it OUTPERFORM.”
The lawsuits of Hagan, Bono and Napoli will now work their way through
the courts to a possible jury trial. Such
a trial will likely uncover additional
details of Wright’s DPA troubles. We
know that the allegations made by the
three former executives are only one
side of the story and would expect
Wright to launch a vigorous defense. ♦
The Boards Actions
Hagan said Wright’s Board had “clear
knowledge” of his report. He says the
Board’s “belief that the DPA process
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
Three Rounds Over Dual Poly Liner: Stulberg vs. MacDonald
By Elizabeth Hofheinz, M.P.H., M.Ed.
ual mobility poly is more stable
and has long-term data to back
it up,” argues Dr. David Stulberg. “This
construct doesn’t make sense,” counters
Dr. Steve MacDonald. “I could find no
published wear data in the literature.”
“D
This week’s Orthopaedic Crossfire®
debate on total hip arthroplasty (THA)
is, “Dual Poly Liner Mobility Optimizes Wear and Stability in THA.” For
the proposition was S. David Stulberg,
M.D. from Northwestern University in
Chicago. Against the proposition was
Steven J. MacDonald, M.D., F.R.C.S.
of the University of Western Ontario;
moderating is Clive P. Duncan, M.D.,
F.R.C.S.(C) of the University of British
Columbia.
Dr. Stulberg: “It’s a pleasure to celebrate
with this audience and to remind Steve
that the center of professional hockey
now resides in Chicago, not Canada.
Dual mobility is really a tripolar cup; it
has a fixed, porous-coated metal device
which articulates with a large polyethylene ball, into which is placed a bipolar 22 or 28mm head, so that you
have motion at the two surfaces—and
two bearing surfaces.”
“The concept was introduced in France
in the 1970s. As the cup initially moves
the smaller femoral head impinges and
then the large femoral head moves. The
idea was that there were a number of
issues that could predispose to instability, both in primary and revision situations. In England, dislocations account
for 16% of revisions; in Australia it’s
15%. In Canada in 2006 they accounted
for 16%; when I tried to get more recent
data I got this error message that the site
S. David Stulberg, M.D.
Northwestern University
Chicago, Illinois
VS
Steven J. MacDonald,
M.D., F.R.C.S.
University of Western Ontario
Moderator: Clive P. Duncan, M.D., F.R.C.S.(C)
University of British Columbia
Wikimedia - KaihsuTai and Current Concepts in Joint Replacement/RRY Photo Creation
was blocked [image showing error message with Dr. MacDonald’s photo]. I’m
not saying that Steve blocked it, but he
knew the debate was coming.”
“When you look at the incidence of
revision, and the incidence of instability following revision, this incidence
increases because: the hip anatomy is
distorted, deficient soft tissues, altered
hip biomechanics. There may be a role
for large femoral heads in fixed acetabular components. There are significant
disadvantages to using large femoral
heads with a fixed acetabulum. The size
of the head is limited by the patient’s
anatomy; and if you use a thin polyethylene you may end up with a device that
is intolerant to cup malposition, and is
associated with unknown wear.”
“Dual mobility is inherently more stable…there’s a bigger jump distance…
and there’s a bigger theoretical range of
motion when you use full mobility concepts. When you couple this with highly cross-linked polyethylene (HCLP),
it’s being suggested that even if these
cups are placed in abnormal positions,
something that I think no one should
try to do or tolerate. These will tolerate
malpositions perhaps better than metalmetal. But the proof is in the results…
the French results: in primaries their
revision rate using conventional poly is
extremely low (<0.4%). In revisions it’s
also very low (2.1%); surprisingly their
survival rates are very high using conventional poly.”
“The future? We could introduce
HCLP…this seems to reduce wear.
Another concern will be the impingement potential. Hemispherical cups
may be adapted to the anatomy, and can
be made anatomic so that you retain the
hemispherical advantage while avoiding
the potential for impingement. I think
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13
the dual mobility seems to offer a safe,
effective solution to hip instability. The
long-term durability may be increased,
particularly with improvements in the
polyethylene. The indications start with
revision total hips that are being done
for recurrent instability. It may be an
attractive option for most revision total
hips where instability is a problem…
also for primary patients where you
can identify the risk factors for instability. The unresolved question is, ‘Will it
be a couple that lasts long enough that
makes it interesting for primary hips in
general?’ Also, ‘Will it perform when
malpositioned?’ Thank you.”
Dr. MacDonald: “I’ve been charged
with debating dual poly liner mobility…and thankfully I’m in strong opposition. For most of us in North America
this is a new concept. It’s a monoblock
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
shell with a large piece of poly that
articulates against that shell…the ball
fits in and that gives you your ultimate
hip construct. The first question is,
‘Does it make inherent sense?’ If you
look at a total hip model, it’s a differential hardness bearing…i.e., the harder
surface (head) articulates against a softer surface. There are lots of examples of
that: every hip we basically do globally
is that construct, whether it’s metalpoly, ceramic-poly, so it’s hard on soft;
metal-on-metal…there is some—globally and in North America—differential
hardness. Always though, the head is
harder, the liner is softer. I didn’t block
the registry data…but I could have.”
“Why is it hard on soft? Because if you
reverse the situation you get increased
wear. So we have by design a construct
with inherent increased wear. The pub-
lished basic science on this construct:
I could find no published wear data
in the literature. What I did find were
advertisements, saying there’s 94%
reduction in wear compared to metalmetal if the metal-metal is at 65 degrees
of cup inclination. But we’re not advocating that, so I challenge the thinking
that we’re there with the basic science
on this construct.”
“The poly is free to go into a more closed
position…it looks good here [showing
picture], but what if it’s more closed…
the theoretical issue of edge loading
and polyethylene failure. We have two
articulating polyethylene surfaces…
one with a huge surface area. What’s
that going to do to wear and osteolysis?
Not reduce it. The claim is for improved
range of motion (ROM) and stability,
but I challenge that because we know
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14
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
in lots of good basic science, and our
own clinical acumen tells us that once
we get to a 36, 38, or 40mm head,
there really is no improvement in ROM
beyond that.”
“There is no clinical evidence for the
claim that because it’s anatomic that
it may decrease psoas impingement. I
think that left and right sockets increase
the risk for improper implantation.
Information from the Australian registry on monoblock shells shows a higher
failure rate than modular shells—certainly in metal-metal.”
“Who is this recommended for? The
techniques manual says: OA, RA, revisions, patients with a dislocation risk…
that’s basically everyone. If we can
assume that the goal of this construct
is increased stability—and David did
publish on this recently and showed a
dislocation rate in this small series of
less than 1%. But there are lots of publications with series less than 1% when
you look at certain centers.”
“I would concede we know we have
a risk of dislocation issues in revision
arthroplasty. But an acetabular component with no screw fixation, that doesn’t
help me in a revision. I’m not going to
use a monoblock shell in a revision…
I’m more worried about getting the cup
to fix than I am with instability in this
kind of construct and design.”
“So conceptually, there are challenges
with this design. Since its introduction over 30 years ago we’ve had many
advances in our thinking in terms of
materials, designs, and techniques. And
while it’s been used for 30 years we don’t
have 20 year data…and I would say any
new implant today must show equiva-
lence in terms of wear, fixation, midterm results, complications, and cost…
and we’re not there yet with this.”
Moderator Duncan: “David, do you
want to answer any of those complaints?”
Dr. Stulberg: “We have been raised in
North America on the idea that convex
polyethylene is a bad idea. But if you
actually do it and look at the results…
this idea has been around a long time.
If this were a bad idea then we would
know it. We must expand our thinking
with regard to this concept…and it’s a
good time to do it when the alternative
bearings are taking a beating.”
Moderator Duncan: “David, I think the
criticism is valid that we have no data
on the wear characteristics between the
polyethylene and the outer monoblock
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15
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
cup. Are you aware of any that aren’t
in-house?”
this shell. There is no capacity to fix it
with peripheral or polar screws.”
Dr. Stulberg: “The available testing data
is limited and it’s by and large industrial. And I think we need more information, but it’s consistent at least with
what seemed to be very good clinical
long-term results. So I think it’s a start,
but I think this concept—and the fact
that it’s being clinically used—should
now stimulate this kind of laboratory
information.”
Dr. Stulberg: “I was trying to suggest
that there were a number of ways this
concept was going to go. I’d be willing
to bet Steve a dinner at the next CCJR
that we will see this combination with
screws in the very near future.”
Moderator Duncan: “So it’s overdue.
Steve, the jump out distance of 11mm
is attractive. Are there any circumstances under which you might turn to this?”
Dr. MacDonald: “No.”
Moderator Duncan: “David, the fact
that you can’t put any screws on this is
alarming. Could we have a new design
with a recessed screw head that might
not increase the risk of poly wear?”
Dr. Stulberg: “Clive, are you asking if
screws were introduced…”
Moderator Duncan: “In a revision setting. I think Steve made a good point
that you have to depend on interference fit and friction surface fit to use
Moderator Duncan: “So that’s the
improvement you’d see that would
make it more attractive. David, what are
the indications under which you would
use it next Monday? In your clinical setting…circumstances under which you
feel this would be a good socket.”
Dr. Stulberg: “It’s a good socket in
patients who have bony anatomy that
allows a cup without screws. So you
need good coverage at the moment in
which you can get good fit of the shell
in a patient that has the potential for
instability. So that might be a revision where you have good bone stock,
and it certainly is a primary where the
patient is at significant risk and you
have enough bone stock to place this
current concept.”
Dr. Stulberg: “I don’t think I would
use it routinely in highly active people,
but I’m not sure that age in and of itself
would be a contraindication.”
Dr. MacDonald: “Moving forward we
need good quality data…and that’s
where registries help. A series of 100 or
200 is not going to give that same viable
data that we look for in a registry. The
question is, ‘Who gets that implant put
in them? Is it that elderly patient?’ That’s
a challenge because I don’t see a role for
it to get big enough numbers to capture
a good registry…and I don’t know if
that’s going to be possible. I don’t think
a case series from developers anymore
is the way to go.”
Dr. Stulberg: “I agree, and I think that
its use is increasing enough that we’re
going to be able to see this information
within the next two or three years.”
Moderator Duncan: “Please join me in
thanking the speakers.” ♦
Please visit www.CCJR.com to register
for the 2012 CCJR Spring Meeting,
May 20-23 in Las Vegas, Nevada.
Moderator Duncan: “Because of the
lack of data on wear, would you limit it
to use in elderly patients?”
“You may now view content from the CCJR Meetings on the CCJR Mobile App. Please scan
the QR code to download the CCJR Mobile App to your Android or iOS mobile device, or visit
www.ccjrmobile.com.”
QR code generated on http://qrcode.littleidiot.be
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
On (and Off) the Record
ear OTW Reader: “Will orthopedic training programs close?...
Infectious complications and timing of
anti TNF Meds…what’s going on with
manual skills training for residents?...
St. Vincent Team Wins Stinchfield
Award…and more.
D
Training Programs to Close? An
observant consultant tells OTW, “Those
of us who have been involved in accreditation and peer review of education
are concerned about what’s going on
in Washington, DC—regardless of who
wins the next election. Graduate medical education (GME) is hanging by a
thread, and whether the inevitable cuts
are substantial or less so, the future of
By Elizabeth Hofheinz
GME is just not clear. If ‘only’ 40% of
the $14 billion that the government
puts annually toward GME is cut, that
will still leave programs scrambling for
options. There is the possibility that
residents could be charged tuition,
something that could happen in orthopedic surgery because it is a highly competitive specialty. What is more likely is
that institutions will begin getting out
of fellowship subspecialty education. So
instead of having a training program
they would replace students with junior
faculty so that they could bill for services
all the while that these people are learning from the senior faculty people. Some
private hospitals that weren’t designed
to be educational institutions may get
out of GME altogether. The institutions
that are designed to be teaching hospitals will have it hardest as they will have
to cut back, but will have more patients.
This is all completely at odds with the
fact that we are going to see more and
more orthopedists retiring and the reality that we don’t have enough people to
replace them.”
Daniel Garen New VP at Wright Daniel Garen, an attorney, has been named
Senior Vice President and Chief Compliance Officer. Garen has many years
of experience with managing corporate compliance programs for public
healthcare technology companies and
has more than ten years of corporate
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17
legal experience. Garen, who earned
his law degree—as well as a master of
laws in health law—from the Loyola
University Chicago School of Law, has
held senior compliance officer positions with Siemens Corporation and
Bayer Healthcare. He served as Chief
Compliance Officer and Senior Counsel from October 2007 to August 2010
at Siemens Healthcare Sector US, and
he most recently held the position of
Vice President, Healthcare Policy and
Clinical Affairs until January 2012 at
Siemens Healthcare Sector US.
Infectious Complication? Look at the
Timing of Anti TNF Meds Dr. Beverly
Johnson is a rheumatologist at Hospital for Special Surgery (HSS), and is
lead author of the research on “Tweaking the Timing of Stopping Anti-TNF
Medications Before Knee Replacement
Surgery.” She told OTW, “I used HSS’
substantial joint replacement registry to
examine the safety of taking anti TNF
(tumor necrosis factor) medications
around the time of surgery. Specifically,
I looked at knee replacement patients
who had rheumatoid arthritis (RA).
There is not a lot of data about this,
and thus far, every national rheumatological society has different recommendations. For example, the American
College of Rheumatology recommends
stopping anti-TNF meds for one week
before surgery, then beginning again
one week postop, while in Britain the
recommendation is to stop 3-5 half
lives preoperatively and to restart after
wound healing. I wanted to see what
we are doing here at HSS. I found that
many physicians are actually stopping
anti-TNF medications for several half
lives, which is a more conservative
approach and more similar to the British guidelines. They are holding these
medications several half lives prior in
an attempt to avoid infectious complications, but this may lead to postoperative RA flare. I found that there wasn’t
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
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a difference at six months in negative
outcomes including infections, but the
overall negative outcomes were low. I
sent a survey to patients and found that
a larger percentage of patients on preop
anti-TNF had an RA flare. Basically, we
may be holding these meds too long
prior to surgery. We must weigh the risk
of the possibility of having a negative
outcome—an infection—six months
out versus the risk of flare of RA as a
result of holding the medications. More
work is needed, however, as you would
have to have two thousand surgeries in
order to say that there is a statistically
significant difference in the infection
rate between the two groups.”
Kyle Mullens, Chris Scifert Join
Orchid Orchid Design has added Kyle
Mullens to its team as Business Development Manager, while Chris Scifert,
Ph.D., is the new Engineering Manager
of the Memphis Design Center. Mullens’ was formerly Director of Business
Development at Secant Medical, and
Product Manager at K2M, Inc. At the
latter company Mullens led product
commercialization efforts for a portfolio
of minimally invasive spinal implants
and instruments. Mullens, who holds a
B.S. in Plastics Engineering from Ferris
State University in Michigan, has also
executed Business Development and
growth strategies for A.Schulman, Inc.,
an engineered polymer resin manufacturer. As for Dr. Scifert, his background
includes serving as Senior Manager,
Product Development at Medtronic
Spinal and Biologics. He has also managed engineering projects as a Senior
Engineer and Project Manager at Smith
& Nephew focusing on early intervention knee and shoulder systems. Dr.
Scifert received his B.S. in Engineering
Sciences and Mechanics at the University of Tennessee and his Ph.D. in Biomedical Engineering at the University
of Iowa with his Doctoral Dissertation
entitled ‘A Finite Element Investigation
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
into the Biomechanics of Total Artificial
Hip Dislocation.’
Manual Skills Training for Residents!
Ann Van Heest, M.D. is a hand surgeon
at the University of Minnesota, and has
been the Residency Program Director
for 13 years. She has worked steadily to
incorporate technical skills as an area of
resident evaluation. Dr. Van Heest tells
OTW, “In November 2011 the American Academy of Orthopaedic Surgeons
sponsored a surgical simulation summit,
which included representatives from
the major societies and the American
Board of Orthopaedic Surgery (ABOS).
The Council of Orthopaedic Residency
Directors has been assessing surgical
skills in residency training programs
and at this summit we began exploring
ways to incorporate this into programs
in a standardized fashion. General surgeons are already required to undergo
manual skills training, so we are hoping
to learn from their experiences…and
see if the ABOS will be open to a similar
requirement/situation for our specialty.
Part of the challenge is that such testing would have to be verified…and if
it’s going to be done on a national level
then it must be a standardized test that
is reproducible and that measures these
skills appropriately. This is really the
long range goal. The importance of
this to patient safety cannot be overemphasized. There are certain things that
residents should really learn in a lab as
opposed to on patients—such as knee
arthroscopy. Doing so would lead to
shorter operating room times because
residents would have gained higher
level skills in the lab.”
ing it easier at every point in the process
to do surgery. I receive more support
than ever before, and the technology is
more advanced than ever…I’m doing
more work and enjoying it more than
ever. Also making things better is the
abundance of ambulatory surgery centers whose quality is improving as people learn how to run them. This makes it
easier to do many cases at a higher level
of quality. I have always loved my work
and now have more confidence in my
surgery, better results, better decision
making due to experience, and many
patients returning after many years (like
old friends). The main thing I see on the
horizon that I am concerned about is a
constant increase in regulations, some
of which seem to have no relevance to
what we do.”
The Happy Orthopedic Surgeon?
Calling himself a “voice in the wilderness,” Dr. Jesse Jupiter tells OTW, “I’m
actually happier these days as an orthopedist. I find that my institution is mak-
St. Vincent Team Wins Stinchfield
Award Riding high in Los Angeles, a
team of researchers at the Joint Replacement Institute (JRI) at St. Vincent Medical Center has won The Hip Society’s
prestigious Frank Stinchfield Award.
The scientists were acknowledged for
their work on the age-related wear of
total hip replacement implants. Thomas P. Schmalzried, M.D., Medical Director of the JRI, was the preceptor for the
study, which was led by senior medical
student Andrew Battenberg. The team
used a microprocessor to measure leg
motion in hip replacement patients.
Patients in this JRI study were monitored for a minimum of ten years. The
paper, “Decreasing Patient Activity with
Aging: Implications for Cross-Linked
Polyethylene Wear,” will be presented during the American Academy of
Orthopaedic Surgeons (AAOS) conference in San Francisco on February
11, 2012. The manuscript is set to be
published in Clinical Orthopaedic and
Related Research in approximately one
year. ♦
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19
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
company
ISTO and Zimmer
Announce Phase III
Study of DeNovo ET
F
inding a way to grow new cartilage
and bone is considered by many
in the field of orthopedics as the Holy
Grail of joint preservation.
Zimmer Holdings, Inc. and ISTO Technologies, Inc. took a step closer towards
that elusive goal by announcing on
February 7 a Phase III clinical study to
evaluate ISTO’s DeNovo ET Engineered
Tissue Graft. DeNovo is an engineered
cartilage implant intended to repair
cartilage defects in the knee. The product is being developed under a collaborative relationship between ISTO and
Zimmer.
Cheryl Blanchard, Ph.D., Zimmer’s
senior vice president and chief scientific
officer told us at Zimmer’s booth at the
annual American Academy of Orthopaedic Surgeons’ meeting in San Fran-
cisco that the graft program is a natural
extension of the company’s early intervention and joint preservation portfolio. “This Phase III study will generate
meaningful data on the potential of this
novel biological solution for treatment
of cartilage lesions earlier in the continuum of care,” said Blanchard.
The Phase III study will comprise a
randomized, controlled clinical trial
involving 225 patients at up to 25 centers in the U.S. According to the joint
company announcement, the program
is designed to demonstrate superiority over the current standard of care
(microfracture) for articular cartilage
defects.
In preclinical studies, according to the
announcement, cartilage cells derived
from juvenile tissue demonstrated a significantly greater capacity for regenerating cartilage compared to cells derived
from adult cartilage.
Recognizing and harnessing the significant regenerative capacity differences
between adult and juvenile cells is an
underlying principle of ISTO’s platform
for cartilage repair. In addition, through
a proprietary scalable manufacturing
process, ISTO has developed a platform
technology for cartilage regeneration
using juvenile cartilage cells.
“It is gratifying for our team to see our
breakthrough cartilage repair technology advancing from research into a late
stage clinical trial for what is clearly a
large unmet medical need,” said Mitchell Seyedin, Ph.D., president and CEO
of ISTO.
DeNovo ET consists of living tissue
grown in a laboratory from the donated
juvenile cartilage cells. The resulting
implant is a thin disk of cartilage tissue
about the size of a quarter. This tissue is
implanted surgically into the knee joint
and is intended to grow new cartilage
to replace damaged cartilage. The shape
and fit of the implant can be customized during the implant procedure.
Rehabilitation following implantation
begins with non-weight bearing mobility exercises with progression toward
fully bearing weight on the knee by
approximately six to eight weeks after
surgery, depending on the location of
the damaged cartilage. Subsequent
rehabilitation phases focus on regaining normal activity levels, full muscle
strength and optimization of a patient’s
own desired activity levels. Complete
rehabilitation to full activity levels can
be expected to take between (or about)
12-18 months.
According to an ISTO website statement, no tissue rejection was observed
in a previous in-human safety trial and
DeNovo ET was determined to have a
satisfactory safety profile.
—WE (February 9, 2012)
ISTO Technologies, Inc.
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Smith & Nephew
Settles Greek Bribery
Charges
S
mith & Nephew has agreed to pay
the U.S. government more than $22
million to settle charges that the company bribed Greek public doctors over
more than a decade.
The government had charged Smith
& Nephew’s U.S. subsidiary under the
Foreign Corrupt Practices Act. The government alleged that the company used
a distributor to create a “slush fund” to
forward payments to doctors working
at government hospitals in Greece in
order to win business.
This won’t come as a shock to readers
of Michael Lewis’s book, Boomerang.
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
In the book Lewis claims that Greece
has a well known culture of cheating on
taxes, bribing public officials and cooking the public books.
The company has committed to pay
$22,226,799 in fines and profit disgorgement, maintain an enhanced compliance program, and appoint an independent monitor for at least 18 months
to review and report on its compliance
program.
Smith & Nephew and other medical device companies were asked by
the Securities and Exchange Commission (SEC) and Department of Justice (DOJ) in late 2007 to look into
possible improper payments to government-employed doctors and voluntarily report any issues. Smith &
Nephew found and reported evidence
of improper payments by a distributor
in Greece that had been appointed by
Smith & Nephew subsidiaries and was
terminated in 2008. A company statement noted that the individuals implicated are no longer associated with the
company.
“We have what I believe to be a worldclass compliance program, having
enhanced it significantly since this
investigation began in 2007,” commented Olivier Bohuon, the company’s new CEO in the February 6 press
release. “These legacy issues do not
reflect Smith & Nephew today. But they
underscore that we must remain vigilant every place we do business and let
nothing compromise our commitment
to integrity.”
—WE (February 7, 2012)
: Image creation by RRY Publications, LLC. Sources: Smith & Nephew and Map of Greece
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
biologics
Unique Israeli
Company CartiHeal
Gets CE Mark
A
n Israeli company has received CE
Mark certification for the EU for a
cartilage defect repair product, based
solely on a preclinical trial. The company is CartiHeal Ltd and the product
is Agili-C. Nir Altschuler, a biomedical
engineer who founded the company in
2009, said, “It is very unusual to obtain
made of aragonite and hyaluronic acid.
Both are biocompatible and biodegradable. The product does not include living tissue, in contrast to other products
under development. “We found that
these materials attract stem cells from
the bone marrow, so that only cells in
aragonite area turn into bone, and cells
in the area of the aragonite and hyaluronic acid turn into cartilage,” says
Altschuler.
The Agili-C, an articular cartilage and
osteochondral defect repair product,
is implanted through minimally inva-
that are developing stem cell-based
products include Israel’s Carticure Ltd.,
Regentis Biomaterials Ltd., and Prochon Biotech Ltd., which merged with
a U.S. company last year and is believed
by observers to be the closest to bringing a product to market.
Companies in the cartilage reconstruction segment estimate the market at
$1.6 billion a year, although most products remain experimental. CartiHeal
has raised $5 million from Accelmed,
the fund of Moshe (Mori) Arkin and
Uri Geiger, and Access Medical Ventures, a U.S. fund run by Israelis Limor
Sandach, Dvir Keren, and Michael Tal.
CartiHeal is a graduate of Peregrine
Ventures’ Incentive Technological Incubator.
—BY (February 6, 2012)
Experience. Expertise. Excellence.
Courtesy of CartiHeal Ltd.
CE Mark without clinical trials, but
the preclinical trial results were good
enough.” He established the company
based on a concept discovered at Ben
Gurion University of the Negev. The
product is also certified in Israel.
sive surgery, similar to an injection, he
says. “The cells gradually dissolve the
implant, and within a short time, the
implant can bear the body’s weight and
regular activity can be resumed.”
Agili-C is produced in two parts. One
is made of aragonite, and the other is
While the cartilage reconstruction market is experimental, company officials
believe that it is promising. Companies
Global Service
Surgical Training Centers
Surgeon Subspecialty Training
Course Management Specialists
mLAB
Cadaveric Anatomical Specimens
Oregon - Nevada - Florida - Rhode Island
Call 503.764.9919 MedCureSTC.org
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
large joints
TiGenix: Green Light
for RA Dosing
T
iGenix NV has announced that the
independent Safety Monitoring
Board has reviewed the safety data of the
first three patients of the second cohort
of the company’s Phase IIa clinical trial
in rheumatoid arthritis (Cx611)…and
has given the green light to recruit and
dose the remaining 20 patients of this
cohort and to open the third and final
cohort. This is a multicenter (20 centers
open at present), placebo-controlled
study that will enroll approximately 53
patients, divided in 3 cohorts with different dosing regimens.
“We are very pleased with reaching
the next stage in this Phase IIa trial on
schedule,” said Eduardo Bravo, CEO of
TiGenix in the February 1, 2012 news
release. “With each positive step forward that we take, in addition to promising results recently reported by other
companies and research groups in the
stem cell field, we are moving closer
to the moment that stem cell therapies
will be a mainstay of clinical practice,
providing solutions for a wide range of
unmet medical needs.”
So what exactly are RA patients receiving when they get Cx611? A suspension
of expanded allogeneic adult stem cell
product derived from human adipose
(fat) tissue (expanded adipose-derived
stem cells or ‘eASCs’) that is delivered
intravenously. The objective of the
Phase IIa trial is to determine safety, feasibility, tolerance, and optimal dosing.
TiGenix expects the final results to be
available in the first half of 2013.
Bravo told OTW, “We are delighted
that the Safety Monitoring Board has
so rapidly reviewed the safety data of
the patients in the second cohort of our
Cx611 Phase II in RA. As a result we
can now open the third and last cohort
of the study, which is running exactly
on schedule.”
—EH (February 6, 2012)
Wikimedia Commons and ÁWá
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
Tabby Cat Gets Knee Replacement
I
t is not just humans who are getting knee replacements.
A ten-year-old tabby cat named Cyrano, in a medical first,
received a new knee last week. Veterinary doctors believe
this to be the first feline total knee replacement performed
in the U.S.
Doctors from Texas and Washington D.C. were present in the
operating theater to assist the three orthopedic surgeons from
the North Carolina State University College (NCSU) of Veterinary Medicine in the six hour surgery. The implant, designed
and fabricated by an international team of collaborators, was
made from dense plastic and a cobalt chromium alloy, using
a laser process that hardens metal powder to replicate bones.
lin-Little had performed the world’s first surgery to fuse leg
implants with a cat’s bone tissue, so Cyrano’s owner turned
to him for help.
Marcellin-Little said the 20-pound tabby’s big bones were a
plus. “He’s already able to stand,” he said. “His foot is in the
right place, and he can put his foot on the ground. So far, so
good. Now we have to be very patient with letting his tissues
reattach, and it has to heal slowly.”
—BY (February 6, 2012)
“The surgery was kind of a bit difficult, but it went very
smoothly,” said Dr. Denis Marcellin-Little of NCSU, who led
the surgical team, in the January 28 news release.
The cat had previously been treated successfully for bone
cancer. But the treatment had left the animal with a painfully
damaged knee. The cat’s owner, Sandy Lerner of Upperville,
Virginia, sought the knee replacement in an effort to avoid
having to amputate the cat’s rear left leg. In 2005, Marcel-
Wikimedia Commons and Hisashi
extremities
New Mallet Can Take a
Beating
W
eighing in at two pounds, the
orthopedic mallet by The EF
Precision Group, is built to handle
the rough and tumble world of the
ortho OR…EF Precision Group has
announced that it has received a patent from the U.S. Patent Office for the
assembly of its orthopedic mallet.
“We got a call from an internationally
renowned teaching hospital requesting our engineering opinion on what
appeared to be defective orthopae-
EF Precision Group
dic mallets that were breaking in the
operating room,” says Bud Tyler, vice
president of The EF Precision Group,
in the January 25, 2012 news release.
“With our background in aerospace and
medical device manufacturing, we were
able to quickly recognize the weakness
of the existing devices and engineer a
superior product that would maintain
its integrity under demanding conditions. They wanted a solution almost
overnight; from design to assembly, we
delivered the product in less than 60
days.”
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The EF Precision orthopedic mallet—
made with a stainless steel head and
aluminum handle—has a different way
that the head and handle are put together, and, says the company, gets rids of
any shock and vibration that could lead
to mallet head breakage.
Tyler told OTW “This was an interesting
project for us, as a manufacturer that
already provides complex components
and critical devices to the aerospace
and medical industries, the mallet is a
very simple product for us. The challenge was to make a mallet that won’t
break in the operating theater. When
we first saw the mallets that were presented to us, we looked at the metallurgy of the assembly and where the
breakage was occurring. We noted two
areas of concern, and both issues had
mechanical problems causing weakness. We changed how the part was
being processed through machining
and the assembly. We first removed a
set screw that appeared to be securing
the head to the handle and engineered a
process to press the two dissimilar metals together. The head is stainless steel
and the handle is aluminum. The second feature we removed was a shoulder
on the handle, believed to be another
source of weakness.”
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
Snowboarders & Skiers Hazards Differ
S
nowboarders and skiers race down
the same snowy slopes, but the injuries they sustain when they fall are different. A study published in the January
issue of the American Journal of Sports
Medicine and reported by Jeannine
Stein, of the Los Angeles Times, found
that the most common injury to snowboarders was to their wrists—probably
occasioned by their putting out a hand
to break a fall.
Among adult skiers the most common
injuries were to the knees—mainly
anterior cruciate ligament sprains. Children who were hurt were more apt to
experience contusions on their lower
extremities.
Researchers studied the experiences
of skiers and snowboarders who were
injured at a Vermont ski resort during
the 18 seasons between 1988 and 2006.
In that time there were 2,260 total nonserious injuries experienced among
2,088 snowboarders and 9,465 injuries
among 8,645 skiers.
The control group for the study consisted of 291 non-injured snowboarders and 2,075 non-injured skiers who
were selected at random.
Snowboarders who were young, female
and inexperienced at the sport had the
highest rates of injury. Researchers speculated from their data that being active
for long periods without resting, using
improper or faulty equipment, being
dehydrated, skiing or snowboarding
above what was comfortable for their
ability and not properly adjusting to
the altitude all contributed to skiers and
snowboarders being injured.
—BY (February 6, 2012)
He added, “We built and provided five
mallets and gave them to Jefferson Hospital Orthopaedic for confirmation of
the new engineering design. The results
were very positive, they used the mallets
for 3+ months without any incidents/
breakage. To date we have delivered
over 170 mallets to two different hospitals and a local orthopaedic surgeon,
the Mallets have been in use for almost
two years without any breaks, exceeding the doctor’s expectations.”
—EH (February 8, 2012)
Source: Wikimedia Commons and SallieMcG/Caption: Photograph of original oil painting by Thomas Hudson
Connell, owned by daughter Sarah (Sallie) Connell McGrath
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
Shockwaves Treats
Plantar Fasciitis
in patients’ feet, elbows, shoulders and
hips and can cause debilitating pain.
an shock wave therapy eliminate the pain of plantar fasciitis?
A 70-year-old woman, Jean Dickie, in
Scotland believes that it can. After suffering for three years with sometimes
excruciating pain on the underside of
her heel, she went to the Consultant
Orthopaedic Foot and Ankle Surgeon
in Glasgow where she was given a
course of extracorporeal shockwave
therapy (ESWT). She now claims to be
pain-free.
C
The cost of putting a patient through
an ESWT treatment course is considerably less than the cost of invasive surgery. Surgeons in the UK say that they
prefer not to operate on patients such
as Mrs. Dickie because the outcomes
from surgery for plantar fasciitis often
do not prove too successful. ESWT has
the potential to save healthcare providers considerably because patients like
Mrs. Dickie, if the treatment proves to
be successful, will not require any further treatment from a GP or hospital.
ESWT is a relatively new treatment that
is currently available at 100 locations
in the UK, 20% of which are National
Health Service hospitals. Proponents
say that ESWT is particularly effective
when treating a range of chronic soft
tissue injuries that are commonly found
Mr. Pal Ramesh, one of the UK’s top
orthopedic specialists, runs an ESWT
clinic. He said in the January 24 news
release: “Extracorporeal shockwave
therapy is just as effective as traditional
surgery but it has lots of other benefits.
The treatment only takes minutes to
perform, it doesn’t involve anesthetic,
and the patient isn’t put in plaster and
doesn’t face a long rehabilitation that
can mean six months off work.”
During the ESWT treatment process,
Ramesh notes that low-energy shockwaves are passed through the skin to
initiate an inflammatory response in
the injured tissue. This prompts the
body to respond naturally by increasing blood circulation, the number of
blood vessels and therefore metabolism
in the injured tissue. This accelerates
the body’s natural healing response by
increasing cell generation and dissolving calcium deposits.
“It has always been very difficult to
treat some chronic conditions because
we haven’t had a truly effective solution
apart from invasive surgery,” Ramesh
added. “But extracorporeal shockwave
therapy is successfully filling that void
and it’s great that this treatment
is becoming more available.”
Spectrum Technology UK Ltd
is the exclusive distributor for
the low-energy Swiss DolorClast Extracorporeal Shockwave
Therapy device in the UK. It is
considered to be a safe treatment
option for the treatment of plantar fasciitis, Achilles tendonopathy and tennis elbow. The device
is used by a number of football
teams in the English Premier
League and was also used by
athletes at the last three Olympic
Games. The Swiss DolorClast
is the only ESWT device that
administers low-energy impulses to be actively promoted in the
UK.
Wikimedia Commons and Nevit Dimen
—BY (February 6, 2012)
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
FDA Clears Two New
Clavicle Repair Technologies
T
he FDA has granted 510(k) clearance for two products designed to
aid in the repair of the shoulder made
by Arnold, Maryland-based Suspension Orthopaedic Solutions, Inc. One
product is the Distal Clavicle Fracture
Fixation System and the second is the
Mid-Shaft Clavicle Plate.
The two devices, made of stainless
steel, “can be used in combination for
the repair of distal-clavicle fractures,”
company CEO Robert S. Collins told
OTW. “These two new FDA clearances
will expand the availability of our confidence-inspiring solutions for orthopaedic surgeons who treat difficult shoulder injuries, and reflect Suspension’s
core mission of bringing meaningful
innovation to challenging orthopaedic
injuries.”
Wikimedia Commons and fpjacquot
System addresses a widely acknowledged challenge for surgeons, which
is to effectively secure fractures of the
distal portion of the clavicle. Existing
technologies have been associated in
the clinical literature with inadequate
fixation, suture abrasion and more
time-consuming surgery. He says that
the new Mid-Shaft Clavicle Plate creates
a complete clavicle system for surgeons
treating these injuries.
Both products build on Suspension’s separate, previously cleared
products that address two injuries
to the shoulder suspensory complex: clavicle fractures and AC
[acromioclavicular] joint separation,
he added. These injuries are often
sports-related, typically occurring
in physically active people ages 18
to 55 who participate in activities
such as bicycling, football, skiing
and snowboarding.
Suspension Orthopaedic Solutions,
Inc. is a privately held medical device
company that lists as its goal the bringing of meaningful innovations to surgeons who manage traumatic injuries of
the musculoskeletal system. The company was founded in 2008.
—BY (February 6, 2012)
The Distal Clavicle Fracture Fixation
System features Suspension’s patentpending T-Loc Technology which
enables knotless, protected and precisely controlled tension for secure fixation
of multiple soft-tissue injuries.
Collins, co-founder of the company,
says that the technology is applicable
to more than 30 indications throughout the body. This would encompass a
million procedures annually in the U.S.
alone. He also says that the FDA clearances, combined with the company’s
recently closed financing with Axiom
Equity Partners, will allow the firm to
apply this core technology to other conditions.
Company co-founder, orthopaedic surgeon Dr. Jeffrey Gelfand, explained that
the Distal Clavicle Fracture Fixation
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
trauma
Football and Alzheimer’s – A Connection?
T
his past Super Bowl weekend millions of people around the world
hunkered down amidst mounds of food
and surrounded by friends to watch this
uniquely American paean to the game
of football and the art of advertising.
Yet, in the midst of the football mania a
nagging concern is dampening the revelry for a growing number of medical
professionals.
Might head injuries associated with
football contribute to the incidence
of Alzheimer’s disease among football
players? Is there a link? Medical professionals are increasingly troubled by
autopsies of retired professional athletes who played contact sports, such
as football, and the evidence they are
seeing of brain deterioration similar to
Alzheimer’s.
According to Diane Lade in a January
28 article in the Florida Sun Sentinel,
South Florida physicians, athletic organizations and Alzheimer’s researchers are looking for ways to protect the
heads of young players.
Neurologist Dr. H. Murray Todd, medical director of the Memory Disorder
Center at North Broward Medical Center in Pompano Beach, is one of those
concerned. “They talk about a player
‘getting his bell rung,’ but that bell is
his brain,” he said.
“When you look at the pros, and look
back on their life stories, you see they
were getting dinged when they were
12, 13 years old, before they ever got to
high school,” Todd said. He believes in
taking head injuries seriously, treating
them properly and not allowing players to return to the game until they are
cleared by a neurologist.
There is another concern for players of football. If they are carriers of
the Apolipoprotein E, or ApoE, gene
that research indicates is connected
to Alzheimer’s, will they be more likely to get the disease if they have had
repeated concussions? Dr. Kester Nedd,
co-director of UHealth’s
concussion
program,
replies in the affirmative.
“I absolutely think, when
you add brain injury on
top of it, those [carriers]
are more at risk.”
In Florida more middle and high school
students—38,450
of
them—play football than
any other sport, according to the Florida High
School Athletic Association.
Source: Wikimedia Commons/Courtesy: Alzheimer’s Disease Education
and Referral Center, a service of the National Institute on Aging
—BY (February 6, 2012)
spine
Custom Spine: International Green Light
T
hey’ve got a passport and their bags
are packed…Custom Spine, Inc.
has achieved ISO-13485 and received
CE Mark for all its current products
sold in the U.S., thus opening the door
for the company to commercialize its
products into the international market.
Custom Spine
In the January 30 news release, company President Mahmoud Abdelgany
commented, “We are excited to receive
CE clearance and to take the next steps
into distributing our products in the
international arena. This is a significant
milestone for Custom Spine, and we are
looking forward to working with our
international partners in offering our
products outside of the U.S.”
The darling of Custom Spine’s product
portfolio is its pedicle screw system,
ISSYS LP. According to the company, the
advanced design of ISSYS LP allows the
surgeon to fully seat the screw against
bone providing 63% greater shear force
resistance than traditional unseated
screws, while maintaining full polyaxial
motion of the screw head. Also included in the product portfolio is Pathway
AVID, a unique articulating verte-
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28
bral interbody device. The implant is
inserted in a traditional transforaminal
approach in its straight, non-articulated
position. Once placed in the disc space,
the implant is articulated using the specially designed inserter to create a large
footprint device that follows the natural periphery of the vertebra, increasing
stability and support to reduce the risk
of subsidence.
Abdelgany told OTW, “Custom Spine’s
goal in developing ISSYS LP was to
make many incremental improvements
to the current pedicle screw designs and
instruments, while allowing the company to follow the 510K [501(k)] Clearance regulatory path. At the same time,
these improvements had to differentiate
our product from competitive systems
and provide clear added benefits for the
patient and surgeon. Prior to ISSYS LP
and continuing on until today, pedicle
screws on the market were based on
the older shared design which did not
allow polyaxial motion of the screw
head if the implant was fully seated to
resist loosening. Our goal was to create
a fixation system which could provide
the surgeon with optimal bone/bone
screw contact by allowing the screw to
be fully seated in the bone while maintaining poly-axial motion of the head of
the screw for easier rod insertion.”
The company’s low profile anterior cervical plate system—Regent ACP—is
also on the international dance card
now, and features self-locking slides
that allow a variety of constructs to be
created while providing the surgeon
with confidence that the screws are
fully locked in place. The Pathway PLIF
and TLIF, and the ISSYS LP Monoaxial
and Cross Connector systems were also
cleared.
VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
Award Winning Israeli
Spine Company Gets
510(k) Clearance
the implant can be delivered through a
small incision with minimal disruption
to muscles and surrounding tissues.
N
Company officials note that the implant
also has a large capacity for bone graft
material, greater than in more traditional TLIF devices, which allows for
greater bone graft-to-endplate contact
surface area, potentially improving
fusion rates.
LT SPINE, an Israeli developer
of minimally invasive spine surgery (MISS) products, has just received
FDA 510(k) clearance for its PROW
FUSION device. NLT SPINE is a winner
of the 2011 Spine Technologies Award,
given by Orthopedics This Week during
the North American Spine Society conference in November 2011. The judges
recognized companies that presented
the most innovative and promising
products in 2011 to treat back pain.
Invented by Dr. Tzony Siegal, the
PROW FUSION device and delivery
system are intended to be used for spinal fusion in transforaminal-lumbar
interbody fusion TLIF) procedures. The
technology allows the surgeon to insert
large implants and instruments through
a small incision.
Among the attributes of the PROW
FUSION, according to the February 1
press release, is a footprint that is larger
than existing TLIF devices, which provides greater biomechanical stability
and less subsidence postoperatively.
Due to the non-linear design, which
allows for deployment of the implant
within the intervertebral disc space,
The non-linear design fits well with NLT
SPINE’s mission to deliver complete
MISS procedures, including disc space
preparation, deployment, and supplemental fixation and implant delivery, as
required. The company expects PROW
FUSION to provide benefits to patients
as well as to surgeons and hospitals. For
surgeons and hospitals, it is expected
to offer efficient and user-friendly MISS
procedures, while for patients it is
expected to minimize recovery time.
“We conclude 2011 with significant
achievements for the company on its
path to improving the care delivered
to patients suffering from spine conditions,” said Didier Toubia, CEO. “We
view our technology platform as a
significant advancement in minimally
invasive spine procedures….”
—BY (February 6, 2012)
—EH (February 10, 2012)
Courtesy of NLT Spine
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VOLUME 8, ISSUE 6 | FEBRUARY 14, 2012
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