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Der m a gr a f t R ei m b u rse m ent H o t l ine

THE medical magazine for users of dermagraft ®

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I NSI D E : The Future of Dermagraft

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2010 & Beyond

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Do the Math

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SPRING 2010

Advanced BioHealing

On the Road to Further DFU Awareness

Case Study

Presented by: Elaine Soter, MD

Identifying the Not-So-Obvious Dermagraft Patient


Der m a gr a f t C a se S t u d y

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

Date: 5/12/09

Date: 6/2/09

Date: 6/9/09

2 Weeks Post Standard Therapy

6 Weeks Post Standard Therapy

1st Dermagraft Application

Plantar

Plantar

Plantar

Heel

Heel

Heel

Date: 6/16/09

Date: 6/30/09

Date: 7/7/09

2nd Dermagraft Application

3rd Dermagraft Application

Healed

Plantar

Plantar

Plantar

Heel

Heel

Heel

Heel Ulcer Wound Area Dermagraft Initiated

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.

0.8 0.7

0.4

Wound Area in cm²

Wound Area in cm²

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One application of Dermagraft each week has proven to be most effective for wound closure. Dermagraft: Delivering living cell therapy.

Plantar Ulcer Wound Area

0.3 0.2 0.1

0.6 0.5 0.4 0.3 Dermagraft Initiated

0.2 0.1

0

5/12

5/19

5/26

6/2 6/9 Date

6/16

6/30

7/7

0.0

5/12

5/19

5/26

6/2

Date

6/9

6/16

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visit us at www. dermagraft.com O n D e r m a g r a f t ® I S P R I N G 2 0 1 0 I w w w. d e r m a gr a f t . c o m

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CO V E R

Der m a gr a f t C a se S t u d y

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

Dermagraft Case Study

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.

Presented by: Elaine Soter, MD

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.

For wound s t ha t a ppe ar t o be younge r a nd hea l t hie r,

Ela ine Soter, MD

Diagnosis

Medical Director, Midwest Wound Care & Hyperbaric Medicine

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

Regional Medical Director, Diversified Clinical Services 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.

Wound Treatment & Outcome Patient was treated for 6 weeks with standard therapy and her PMS 187 wounds failed to progress to closure. Having not met significant volume reduction clinical markers for healing (4 weeks >50% 1795 reduction) a decision was made on 6/2/09 to switch to active living 158 cell therapy. After the 1st application of Dermagraft, a dressing was 157 applied that included a non-adherent Wound Veil and foam dressing. 156 Patient was instructed to offload by best possible means for 155 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.

t he r is k of a mp uta t i on ma y not b e so a ppa re nt .

SPRING 2010

INDEX

On Dermagraft

I Do the Math 3 I The Future of Dermagraft 2010 & Beyond 1

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BioHealing I OnAdvanced the Road to Further DFU Awareness

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Study I Case 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

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O n D e r m a g r a f t ® I S P R I N G 2 0 1 0 I w w w. d e r m a gr a f t . c o m

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 7 immediateBlack 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.”

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

The Obvious Dermagraft Patient

For some wounds, Standard of Care it may be obvious High risk, limb-threatening, and that if treat ulcers Thetough NottoSo Obvious aggressive Dermagraft Patient treatment is not taken immediately to heal the wound, the patient could be at a “Failure to reduce the size of an ulcer after 4 serious risk weeks of treatment that includes appropriate debridement reduction should of amputation (see Tableand 1).pressure But for other prompt consideration of adjuvant therapy.”* wounds that appear to be younger and How do today’s measurements compare to 4 weeks ago? 1 of2 amputation 3 4 5 6 7not8 be9 healthier, the0 risk may so apparent (see Table 2).

©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

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

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

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.”

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

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

At Advanced BioHealing, we couldn’t agree more.

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

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u p c o m ing c o n f eren c es

CO V E R

Do the Math continued Living skin equivalents may be of particular benefit in healing DFU’s

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

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

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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.

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

The Future of Dermagraft: 2010 & Beyond

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.  

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

The largest randomized, controlled clinical study on a skin graft and/or bioengineered replacement, planned to date.

For more information or to track the progress of the study, please visit clinicaltrials.gov.

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 indications, 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.  

Prevention, incidence of diabetes is expected

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).

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.

Advanced BioHealing is on the Road to Further DFU Awareness

As a chronic medical condition among many

Make the transition

diabetes patients, it is estimated that 15-25%

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.”

putting them at a 14-24% risk for lower

will develop a foot ulcer in their lifetime,

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

limb amputation and a 45% chance of death

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.

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.

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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.

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