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Dermagraft Reimbursement Hotline

1-866-866-7731 Or FAX your Insurance Verification Request to 1-866-866-7713Your Sales Rep can provide you with the form you need for faxing as well.

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1-877-DERMAGRAFT (1-877-337-6247)

d E R m a G R a f T R E I m B u R S E m E N T H o T l I N E

d E R m a G R a f T c u S T o m E R a S S I S T a N c E

INSIDE:

The Future of Dermagraft2010 & Beyond

Advanced BioHealing On the Road to Further DFU Awareness

Case Study Presented by: Elaine Soter, MD

Do the MathIdentifying the

Not-So-Obvious Dermagraft

Patient

OnDermagraft

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visit us at www. dermagraft.com

Finish with Closure.Stop your patients’ diabetic foot ulcers from stalling.

One application of Dermagraft each week has proven to be most effective for wound closure.

Dermagraft: Delivering living cell therapy.

Gentzkow GD, Iwasaki SD, Hershon KS, et al. Use of Dermagraft, a cultured human dermis, to treat diabetic foot ulcers, Diabetes Care. 1996; 19:350-354.

on dermagraf t® I SPRING 2010 I www.dermagraf t . com 5

d E R m a G R a f T c a S E S T u dY

Date: 5/12/092 Weeks Post Standard Therapy

Date: 6/2/096 Weeks Post Standard Therapy

Date: 6/9/091st dermagraft application

Date: 6/16/092nd dermagraft application

Date: 6/30/093rd dermagraft application

Date: 7/7/09Healed

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on dermagraf t® I SPRING 2010 I www.dermagraf t . com4

Dermagraft Case Study

d E R m a G R a f T c a S E S T u dY

dr. Elaine Soter is a 1978 graduate of the

university of oklahoma medical School.

Before committing to fulltime wound care,

she practiced emergency medicine for 25

years, having received Board certification in

1991. She was medical director of Edmond

medical center’s Emergency department

from 1984 until 2000. dr. Soter entered the

field of Wound care and Hyperbaric medicine

in 2001 and has been the medical director

of midwest Wound care and Hyperbaric

medicine center since June of 2003. She

was selected as Regional medical director

for diversified clinical Services in october

2003 and sits on a national panel of medical

advisors for approximately 300 centers

across the country.

PRESENTEd BY: ElaINE SoTER, md

ElaINE SoTER, md

medical director, midwest Wound care & Hyperbaric medicine

Regional medical director, diversified clinical Services

Patient History

Patient is a 51-year-old female with poorly controlled diabetes with neuropathy, morbid obesity, venous insufficiency with edema, and cellulitis of the lower legs.

Diagnosis

Patient presented on 5/12/09 with a 14-month-old diabetic ulcer of the heel and an 11-month-old diabetic plantar ulcer.

Wound Treatment & Outcome

Patient was treated for 6 weeks with standard therapy and her wounds failed to progress to closure. Having not met significant volume reduction clinical markers for healing (4 weeks >50% reduction) a decision was made on 6/2/09 to switch to active living cell therapy. after the 1st application of dermagraft, a dressing was applied that included a non-adherent Wound Veil and foam dressing. Patient was instructed to offload by best possible means for the 1st week and given a post-op surgical shoe. a dH Walker boot was ordered, but was not available at the time of 1st dermagraft application. at the 2nd dermagraft application, dH Walker offloading boot was fitted and applied. The 3rd weekly dermagraft therapy was postponed due to patient hospitalization the week of June 22nd and therefore took place on 6/30/09. Patient presented on 7/7/09 with complete epithelialization of both plantar and heel wounds. offloading was continued for 2 more weeks and patient maintained a healed state at 6 week follow up. Patient finished treatment on 8/17/09 after 5 weeks of dermagraft therapy.

on dermagraf t® I SPRING 2010 I www.dermagraf t . com 1

Do the Math: Identifying the Not-So-Obvious Dermagraft PatientDermagraft is widely recognized as today’s most progressive treatment for diabetic foot ulcers (DFUs).

With over 150,000 applications to date, the u.S. food and drug administration approved bio-engineered skin substitute has become an integral part of the standard of care for dfus and has enabled clinical professionals to make a profound difference in the lives of tens of thousands of diabetic patients.

When implanted into an adequately prepared dfu, dermagraft assists in the restoration of the dermal bed allowing the patient’s dfu to heal (re-epithelialize). In the pivotal trial, dermagraft increased the proportion of dfus that heal at 12 weeks by 64% when compared to conventional therapy.

despite the proven clinical benefits of dermagraft, many professionals are electing to use the product on only the worst of wounds—those that appear to have an immediate threat of limb amputation.

as Jason Hanft, dPm, facfaS explained, however, “wounds that aren’t truly limb threatening, but are stalled could benefit from an advanced therapy like dermagraft even more than the end stage wounds.”

at advanced BioHealing, we couldn’t agree more.

You wouldn’t judge a book by its cover, right?

The primary goal in the treatment of dfus is to obtain wound closure as quickly as possible. The faster the wound heals, the less chance there is to develop infection, which

can lead to severe, high cost procedures, including amputation.

for some wounds, it may be obvious that if aggressive treatment is not taken immediately to heal the wound, the patient could be at a serious risk of amputation (see Table 1). But for other wounds that appear to be younger and healthier, the risk of amputation may not be so apparent (see Table 2).

Regardless of the appearance of a wound, however, studies show that “failure to reduce the size of an ulcer after 4 weeks of treatment that includes appropriate debridement and pressure reduction should prompt consideration of adjuvant therapy.”

By examining absolute change in ulcer area at 4 weeks, a study conducted by Peter Sheehan, md, found that patients in whom ulcer size fails to reduce by half over the first

for wounds that appear to

be younger and healthier,

the r isk of amputat ion may

not be so apparent .

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OnDermagraft

S P R I N G 2 0 1 0 I N d E X

1 I Do the Math

3 I The Future of Dermagraft 2010 & Beyond

3 I Advanced BioHealing On the Road to Fur ther DFU Awareness

4 I Case Study Presented by: Elaine Soter, MD

DG-1077-03©2010 Advanced BioHealing, Inc. All Rights Reserved. Advanced BioHealing Inc. 10933 N. Torrey Pines Rd., Suite 200, La Jolla CA 92037 www.ABH.com

“How do today’s measurements compare to 4 weeks ago?”

Make the Shift.

The Obvious Dermagraft Patient

High risk, limb-threatening, and tough to treat ulcers

©2010 Advanced BioHealing, Inc. All Rights Reserved.

DG-1081-01. 01/10. Advanced BioHealing, Inc. 10933 N. Torrey

Pines Rd., Suite 200, La Jolla, CA 92037. www.dermagraft.com

Standard of Care

The Not So Obvious Dermagraft Patient

“Failure to reduce the size of an ulcer after 4 weeks of treatment that includes appropriate debridement and pressure reduction should prompt consideration of adjuvant therapy.”*

*Boulton et al. Clinical Practice, Neuropathic Diabetic Foot Ulcers. N Engl J Med. 2004; 351: 48-55.

0 1 2 3 4 5 6 7 8 9 10How do today’s measurements compare to 4 weeks ago?

on dermagraf t® I SPRING 2010 I www.dermagraf t . com2

4 weeks of treatment are unlikely to achieve wound healing over a reasonable period of 12 weeks.

These studies, among several others, suggest that rather than assessing how healthy the wound looks today, the question should be: “How do today’s measurements compare to 4 weeks ago?”

If you don’t know where you started…

as with any goal, if you don’t know where you started, you don’t know how far you’ve come. The same goes for a chronic wound, so the first step to solving this equation must be to measure the wound upon the patient’s first visit.

“If you don’t measure the wound at the onset of treatment, you’ll have no idea if it’s getting better, worse, or staying the same,” said dr. Hanft.

This rule applies to hard-to-heal calcaneal wounds and ulcers on feet with a previous partial amputation (Table 1) just as it does to red, beefy wounds that look healthy and like they will heal easily (Table 2).

Make the transition

It is with this in mind that dr. Hanft advocates that clinical professionals must make a “transition from passive wound observer to an active wound healer.”

In a recent literature review of the “Effects on Qol, costs and mortality and the Role of Standard Wound care and advanced-care Therapies,” dr. Hanft and Robert J. Snyder, dPm, cWS advocate “re-evaluation of the treatment regimen and considering the use of advanced-care agents (topical, device, or systemic) for wounds with a 4-week treatment

history of standard wound care resulting in <50% overall wound area reduction.”

The review further states that “of the currently available advanced-care treatments, living skin equivalents may be of particular benefit in healing dfus.”

advanced BioHealing encourages all clinical professionals to ‘do the math.’ Go back and look at the wound measurements 4 weeks ago. any wound—healthy-looking or not—that has not reduced in size by 50 percent after 4 weeks of conventional treatment is considered stalled and should be reviewed for aggressive treatment immediately.  

Do the Math continued c oV E Ru P c o m I N G

c o N f E R E N c E S

In 2007, 23.6 million people, or 7.8% of

the american population, had diabetes.

Referred to as the “epidemic of our time”

by the u.S. centers for disease control and

Prevention, incidence of diabetes is expected

to increase 165% by 2050. The World Health

organization estimates 171 million people

have diabetes globally and that number is

expected to double by 2030.

as a chronic medical condition among many

diabetes patients, it is estimated that 15-25%

will develop a foot ulcer in their lifetime,

putting them at a 14-24% risk for lower

limb amputation and a 45% chance of death

within five years if not managed properly.

also generating a significant financial impact,

every new incidence of a dfu in the u.S.

costs nearly $40,000 to treat in the first two

years. In the u.S. and Europe combined, dfu

incidence is estimated to be between 1.7

to 2.5 million annually. Risk of death from

unhealed neuropathic ulcers like dfus is

greater than both breast cancer and prostate

cancer combined.

March 11 - 14 midwest Podiatry conference

Chicago, IL

March 18 - 20 diabetic foot Global conference

(df con 2010) Los Angeles, CA

April 8 - 11 Reconstructive Surgery of

the foot & ankle Atlanta, GA

April 8 - 11 american Professional Wound

care association (aPWca) Philadelphia, PA

April 17 - 20 Symposium on advanced

Wound care (SaWc) Spring Orlando, FL

Living skin equivalents may be of particular benefit in healing DFU’s

on dermagraf t® I SPRING 2010 I www.dermagraf t . com 3

Advanced BioHealing is on the Road to Further DFU Awareness

advanced BioHealing, Inc. (aBH) is dedicated to helping medical professionals address diabetic foot ulcers (dfus) with the most appropriate treatment and advanced technology possible. as a result, the company has already been on the road for a good part of 2010 as a sponsor of several podiatric medical association meetings around the country.

at two of the events on aBH’s conference trail—the New York Podiatric clinical conference in New York, NY and the Science & management Symposium, held in orlando, fl—the company sponsored a scientific presentation by Jason Hanft, dPm, facfaS during which he addressed the severity of diabetic foot wounds, the importance of the new standard of care for enhancing rapid wound closure and the use of human-derived skin equivalents, like dermagraft, for the treatment of dfus.

In an effort to further awareness of dfus as a major disease category in need of aggressive therapy, aBH will continue to have a significant presence at many upcoming meetings in 2010, both at the national and state levels.

dermagraft assists in restoring damaged tissue and supports the body’s natural healing process. It is currently approved by the u.S. food and drug administration for the treatment of diabetic foot ulcers (dfus). In the pivotal trial, dermagraft increased the proportion of dfus that heal at 12 weeks by 64% when compared to conventional therapy.

From DFU to VLU

The success that dermagraft has experienced in treating dfus has led advanced BioHealing, Inc. (aBH) to explore additional indications. In 2009, aBH initiated a pivotal clinical trial (dEVo-Trial) evaluating dermagraft in subjects with venous leg ulcers (Vlus). The company designed the trial to assess the product’s safety and efficacy in the promotion of healing venous leg ulcers.

The international trial, which is enrolling more than 400 patients in eight countries, is the largest randomized, controlled clinical study on a skin graft and/or bioengineered replacement, planned to

date. It is a prospective, multicenter, randomized, controlled clinical study, in which subjects are assigned into one of two groups. The experimental group receives weekly applications of dermagraft and four-layer compression dressings while the active comparator group receives weekly applications of four-layer compression dressings only. The company anticipates completing enrollment in the trial in 2010.

Beyond dermal applications

Based upon the biology of dermagraft and its proven ability to stimulate tissue repair, aBH intends to explore the use of the product beyond dermal applications, focusing its use in a range of soft tissue and orthopedic indi-cations, such as rotator cuff tears.

as part of aBH’s growing research efforts, the company has established a research facility in Nashville, Tennessee, primarily focused on the identification and development of new product opportunities.  

The Future of Dermagraft:

2010 & Beyond

for more information or to track the progress of the study,

please visit clinicaltrials.gov.

The largest randomized, controlled clinical study

on a skin graft and/or bioengineered replacement,

planned to date.