Dermagraft

Antonio · Jul 12, 2006

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Why would the company that bought Dermagraft but Dermagraft if Apligraf is avaible? I do not understand the reason for Dermagraft?

DaVinci · Jul 12, 2006

Not quite sure what you are asking????

Admin2 · Jul 12, 2006

Related thread:
Smith & Nephew Will End Dermagraft Production

Craig Payne · Jul 12, 2006

Apligraf is

Apligraf is supplied as a living, bi-layered skin substitute.† Like human skin, Apligraf consists of living cells and structural proteins. The lower dermal layer combines bovine type 1 collagen and human fibroblasts (dermal cells), which produce additional matrix proteins. The upper epidermal layer is formed by promoting human keratinocytes (epidermal cells) first to multiply and then to differentiate to replicate the architecture of the human epidermis
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and is manufactured by Organogenesis Inc

Dermagraft is

is a cryopreserved human fibroblast-derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold. Dermagraft is manufactured from human fibroblast cells derived from newborn foreskin tissue. During the manufacturing process, the human fibroblasts are seeded onto a bioabsorbable polyglactin mesh scaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors and cytokines, to create a three-dimensional human dermal substitute containing metabolically active, living cells
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and used to be made by Smith & Nephew until they sold it to Advanced BioHealing.

Both products have similar indications, but are essentially competitors.

NewsBot · Jul 12, 2006

Autologous full-thickness skin substitute for healing chronic wounds
British Journal of Dermatology Volume 155 Page 267 - August 2006

Background Chronic wounds represent a major problem to our society. Therefore, advanced wound-healing strategies for the treatment of these wounds are expanding into the field of tissue engineering.

Objectives To develop a novel tissue-engineered, autologous, full-thickness skin substitute of entirely human origin and to determine its ability to heal chronic wounds.

Methods Skin substitutes (fully differentiated epidermis on fibroblast-populated human dermis) were constructed from 3-mm punch biopsies isolated from patients to be treated. Acellular allodermis was used as a dermal matrix. After a prior 5-day vacuum-assisted closure therapy to prepare the wound bed, skin substitutes were applied in a simple one-step surgical procedure to 19 long-standing recalcitrant leg ulcers (14 patients; ulcer duration 0·5–50 years).

Results The success rate in culturing biopsies was 97%. The skin substitute visibly resembled an autograft. Eleven of the 19 ulcers (size 1–10 cm2) healed within 8 weeks after a single application of the skin substitute. The other eight larger (60–150 cm2) and/or complicated ulcers healed completely (n = 5) or continued to decrease substantially in size (n = 3) after the 8-week follow-up period. Wound healing occurred by direct take of the skin substitute (n = 12) and/or stimulation of granulation tissue/epithelialization (n = 7). Skin substitutes were very well tolerated and pain relief was immediate after application.

Conclusions Application of this novel skin substitute provides a promising new therapy for healing chronic wounds resistant to conventional therapies.
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NewsBot · Aug 4, 2006

Update on Tissue-Engineered Biological Dressings.
Tissue Eng. 2006 Jul 1;

Tissue-engineered biological dressings offer promise in the treatment of burns, chronic ulcers, donor site and other surgical wounds, and a variety of blistering and desquamating dermatologic conditions. For example, the prevalence of diabetic foot ulcers ranges from 4.4% to 10.5% of diabetics, resulting in 82,000 lower extremity amputations annually; venous leg ulcers affect 0.18% to 1.35% of the population; and pressure ulcers are found in 5.0% to 8.8% of institutionalized patients and 14.8% of patients in acute care facilities. Despite the large number of potential beneficiaries, cellular tissue-engineered products have suffered setbacks in recent years and have garnered considerably lower market share than commercial promoters anticipated. The mechanism of action of these products is not universally agreed upon, but delivery of growth factors and extracellular matrix components to the wound is thought to be important; graft "take" is not usually considered to occur. These "engineered" products do not specifically match a treatment modality to an underlying pathology. Clinical effect is often modest, and sometimes not justi- fiable from a cost-benefit perspective. Nevertheless, clinical reports in the literature of uses of tissueengineered biological dressings continue to mount, indicating that these products are finding niche applications where clinical utility is high and the cost can be defended. Despite commercial setbacks, the first-approved products, Dermagraft((R)), Apligraf((R)), and Cultured Epidermal Autograft (Epicel((R))) are still being marketed, and new ones, such as OrCel((R)), continue to be developed. The major indications for these products are summarized and a brief review of the available clinical literature is offered.
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NewsBot · Aug 4, 2006

Experience with the use of apligraf to heal complicated surgical and nonsurgical wounds in a private practice setting.
Adv Skin Wound Care. 2006 Jul-Aug;19(6):310-23

ABSTRACT: Apligraf is supplied as a ready-to-use living fibroblast and keratinocyte bilayer in culture. This therapy has been shown to facilitate healing of venous ulcers and diabetic foot ulcers. Several case reports suggest that Apligraf may also be effective in healing acute excisional wounds and complicated surgical defects. Apligraf can, in appropriate settings, be used as an alternative to autografts, avoiding the morbidity of donor site wounds. The present case review summarizes outcomes in 16 patients with 18 complicated surgical and nonsurgical wounds treated with Apligraf, which was meshed or fenestrated as needed to obtain better wound coverage and to allow drainage. Of 16 patients, 15 (94%) experienced complete healing (16 of 18 wounds; 89%). Both surgical and nonsurgical wounds responded well, with healing times ranging from 21 to 550 days. Patients generally stated that they were satisfied with their degree of healing and with the opportunity to avoid the surgical procedures associated with autograft donor sites.
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NewsBot · Aug 31, 2006

Apligraf

Evaluation of Apligraf(R) persistence and basement membrane restoration in donor site wounds: a pilot study.
Hu S, Kirsner RS, Falanga V, Phillips T, Eaglstein WH.
Wound Repair Regen. 2006 Jul-Aug;14(4):427-33.

Apligraf((R)) is a bilayered tissue-engineered product consisting of a bovine collagen matrix with neonatal fibroblasts, overlaid by a stratified epithelium containing living keratinocytes. The United States Food and Drug Administration has approved its use for venous leg ulcers and neuropathic diabetic foot ulcers. Apligraf((R)) provides a dermal matrix and produces cytokines similar to the human skin. However, its mechanism of action and ultimate fate in host wounds are unclear. The aim of this study was to evaluate the persistence of Apligraf((R)) fibroblasts and keratinocytes in human acute partial-thickness wounds (split-thickness donor sites) treated with Apligraf((R)). In an open-label, within-patient, three-centered, controlled pilot study, 10 patients were treated with Apligraf((R)), Apligraf((R)) dermis only (without epidermis), and a polyurethane film for donor site wounds of the same size, depth, and anatomical location. Apligraf((R)) DNA persistence was the primary outcome measure. Basement membrane components, cosmetic outcome, time to wound healing, and safety parameters were secondary outcome measures. One week after the initial treatment, reverse transcription polymerase chain reaction analysis found that two Apligraf((R)) and two Apligraf((R)) dermis-only-treated sites had Apligraf((R)) DNA present. Four weeks posttreatment, only one Apligraf((R)) and one Apligraf((R)) dermis-only sites showed the presence of Apligraf((R)) DNA. There was no difference between the three treatment modalities in establishing basement membrane in donor site wounds. No differences in other secondary outcomes were found. Apligraf((R)) DNA persisted in a minority of patients at 4 weeks in acute partial-thickness wounds. Apligraf((R))'s success in speeding healing of acute wounds appears to be related to factors other than the persistence of donor DNA or effect on basement membrane restoration.
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NewsBot · Jun 10, 2009

Efficacy and Safety of Fresh Fibroblast Allografts in the Treatment of Diabetic Foot Ulcers.
Dermatol Surg. 2009 Jun 3. [Epub ahead of print]

BACKGROUND AND OBJECTIVE Various types of allogenic skin substitutes composed of cryopreserved keratinocytes, fibroblasts, or both have been used for treatments of diabetic foot ulcers, but the effects have generally not been dramatic because cryopreservation impairs cell activities. The purpose of the study was to evaluate the use of non-cryopreserved fresh human fibroblast allografts in treating diabetic foot ulcers.

MATERIALS AND METHODS Human dermal fibroblasts from healthy teenagers were cultured and applied over the foot ulcers of 37 patients with diabetes. Control treatment was performed in 18 patients. Eight weeks after treatment, the percentages of complete healing, mean healing times, and patient satisfaction were compared, with follow-up ranging from 6 to 40 months.

RESULTS Our study showed that 83.8% of the treated group and 50.0% of the control group experienced complete healing. The times required for complete healing were 30.9+/-10.1 and 47.2+/-7.8 days in the treated and control groups, respectively. Patient satisfaction with fresh fibroblast treatment was also superior to satisfaction with the conventional method (mean scores: 8.0+/-1.0 and 4.9+/-1.4, respectively). No adverse events related to the study treatment occurred.

CONCLUSION The use of fresh human fibroblast allografts was found to be a safe and effective treatment for diabetic foot ulcers. The authors have indicated no significant interest with commercial supporters.
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NewsBot · Jun 21, 2011

Human Fibroblast-Derived Dermal Substitute: Results from a Treatment Investigational Device Exemption (TIDE) Study in Diabetic Foot Ulcers.
Warriner RA 3rd, Cardinal M; on behalf of the TIDE Investigators.
Adv Skin Wound Care. 2011 Jul;24(7):306-311.

OBJECTIVE:
To gain experience in the use of Dermagraft (Advanced Biohealing Inc, La Jolla, California), a human fibroblast-derived dermal substitute (HFDS), for the treatment of nonhealing diabetic foot ulcers (DFUs).

STUDY DESIGN:
An open label, noncontrolled, multicenter clinical trial of HFDS in the treatment of DFU was conducted. Subjects with DFUs underwent sharp debridement of the study ulcer and were prescribed an off-loading device. All of the subjects enrolled received applications of HFDS, beginning at day 0 and applied weekly thereafter, along with saline gauze or polyurethane foam dressings from day 0 to week 20. A maximum of 8 HFDS applications was allowed.

MAIN OUTCOME MEASURES:
The primary and secondary end points of the study were complete wound closure by weeks 12 and 20, respectively.

MAIN RESULTS:
A total of 23 centers screened 91 subjects, and 18 centers enrolled an intent-to-treat (ITT) population of 62 subjects. For the ITT population, 27 (44%) subjects healed by week 12, and 32 (52%) healed by week 20. Fifty-one subjects (82%) completed the study to week 12, and 46 subjects (74%) completed the entire 20-week study; wound closure rates in these groups were 59% and 70%, respectively. Median time to healing was 13 weeks. The overall incidence of at least 1 adverse event (44%, 27/62) was typical for this subject population. No adverse events were attributable to HFDS.

CONCLUSION:
Data from this study support the safety and efficacy of HFDS in the treatment of nonhealing DFUs.
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NewsBot · Jun 25, 2011

Press Release:
Health Economics Model Shows That Dermagraft® Combined With Conventional Care is a Cost-Effective Treatment for Diabetic Foot Ulcers in Medicare and Commercially Insured Populations
June 24, 2011

Results to be Presented at the American Diabetes Association 71st Scientific Sessions

Advanced BioHealing, Inc. (ABH), a leader in commercializing living cell-therapies, a cornerstone technology in the field of regenerative medicine, today announced results from a health economics model developed by The Lewin Group (Falls Church, VA) that showed the addition of Dermagraft® to conventional care for the treatment of chronic diabetic foot ulcers (DFUs) resulted in a significant therapeutic and cost benefit compared to conventional care alone in both Medicare and commercially insured populations.

Results demonstrated that additional costs for Dermagraft were offset by medical savings from accelerated wound healing and reduced DFU complications and amputations. Significantly more DFUs were healed using Dermagraft plus conventional care compared to conventional care alone. The model also found that patients receiving Dermagraft were predicted to have fewer ulcer-related amputations and bone resections at 52 weeks than those receiving conventional care alone and that Dermagraft plus conventional care provided a significant reduction in the 52-week cost of care for patients with DFUs, as compared to conventional care alone.

“Diabetes and associated complications, like DFUs, place a significant economic burden on the U.S. healthcare system, with Medicare spending 32 percent of its total budget on beneficiaries with diabetes,” said Dean Tozer, Senior Vice President of ABH. “The data provides an example of how advanced therapies, like Dermagraft, can be cost-effective for the Medicare system, and has the potential to change the entire discussion around how advanced therapies can be part of the solution to reducing future costs of Medicare.”

Results from the model (abstract number: 0053-LB) will be presented at the American Diabetes Association 71st Scientific Sessions during the General Poster Session II on Sunday, June 26, 2011 from 12:00 to 2:00 p.m. PDT at the San Diego Convention Center in Hall B.
Model Results

In the model, the proportion of healed ulcers was 76% in the Dermagraft plus conventional care arm versus 50% in conventional care alone. Median time to heal was 19-20 weeks for patients receiving Dermagraft compared to 51-52 weeks for those receiving conventional care alone. Additionally, patients receiving Dermagraft had fewer infections and amputations.

The average expected cost to Medicare per treated patient over 52 weeks was $23,080 for patients receiving Dermagraft compared to $28,505 for those receiving conventional care alone. The average estimated cost per healed ulcer (i.e. costs associated with the treatment of the ulcers that completely healed) was $30,344 in the Dermagraft plus conventional care arm compared to $56,516 for conventional care alone. Cost neutrality for Dermagraft was achieved at 6 months for Medicare payers and 8 months for private insurers. When using commercial reimbursement rates, Dermagraft provided similar but smaller cost effective ratios. Cost results are given in 2009 U.S. dollars.
About the Model

A Markov model was created that incorporated both clinical data from a pivotal, randomized, controlled study and U.S. cost and resource data from Medicare and private insurers claims databases to provide a cost analysis from the payer’s perspective. Weekly health state transition probabilities were derived retrospectively from results of a 12-week, randomized control trial (n=245) that compared the efficacy of Dermagraft plus conventional care in the treatment of DFUs to conventional care alone. Health states were verified by medical review and included healed, unhealed not infected, cellulitis, osteomyelitis and amputations. During weeks 1-8, Dermagraft could be used on a weekly basis for patients in the treatment group providing the ulcers were in an unhealed but not infected state. Amputee status was based on post-trial period patient follow-up for those who had adverse events. There were 6 (4.6%) ulcer-related amputations/resections among 130 patients in the Dermagraft plus conventional care arm, compared with 13 (11.3%) among 115 patients in the conventional care arm.

Diabetes is a chronic and disabling disease and the incidence is expected to grow significantly in the coming years due to an aging population and increasing trends towards obesity, unhealthy diets and sedentary lifestyles. The disease often leads to other health complications, such as heart disease, stroke and diabetic neuropathy, which can lead to DFUs. Of the chronic medical conditions that patients with diabetes are most likely to get, 15 to 25% will develop a DFU in their lifetime. Despite receiving good wound care, 70% of DFUs fail to heal within 20 weeks. The cost to treat a new DFU in the U.S. is estimated to be $51,531 in the first two years.
About Dermagraft

Dermagraft is a cryopreserved human fibroblast-derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold. Dermagraft is manufactured from human fibroblast cells. During the manufacturing process, the human fibroblasts are seeded onto a bioabsorbable, polyglactin mesh scaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors, and cytokines to create a three-dimensional human dermal substitute containing metabolically active, living cells.

Dermagraft is indicated for use in the treatment of full-thickness DFUs greater than 6 weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients who have adequate blood supply to the involved foot. Clinical data from the pivotal study showed a 64% relative increase in wound closure for Dermagraft over active control in patients with diabetic foot ulcers of greater than 6 weeks duration and a similar incidence of reported adverse events for both treatment groups.
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NewsBot · Aug 25, 2011

Press Release:
Top-Line Results from Pivotal Trial of Dermagraft® for Venous Leg Ulcers

Westport, Conn. – August 24, 2011–Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that Advanced BioHealing (ABH), its regenerative medicine business, has concluded its phase three pivotal trial of Dermagraft® in subjects with venous leg ulcers. Following preliminary analysis of the top-line results, the decision has been made not to pursue the venous leg ulcer indication.

The international pivotal trial, which enrolled more than 500 patients in eight countries, was designed as a prospective, multicenter, randomized, controlled clinical study to assess the product’s safety and efficacy in the promotion of healing venous leg ulcers.

When combined with compression therapy Dermagraft achieved a higher closure rate of venous leg ulcers than compression therapy alone. However, the data did not meet the primary end point mutually agreed upon with the FDA and EMA. The primary end point of the trial was complete healing (100% re-epithelialization, with no presence of scab or drainage) of venous leg ulcers by 16 weeks. In addition, there was a need to show a minimum absolute level of superiority over compression therapy.

Dermagraft is a bio-engineered skin substitute, FDA approved and currently marketed for the treatment of diabetic foot ulcers (DFUs). A venous leg ulcer indication would have expanded the utility of Dermagraft in a chronic wound setting.
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NewsBot · Sep 9, 2012

Press Release:
DERMAGRAFT® Approved in Canada for Treatment of Diabetic Foot Ulcers

Shire plc today announced that its lead regenerative
medicine product, DERMAGRAFT (human fibroblast-derived dermal substitute) has received
regulatory approval from Health Canada as a class IV medical device for the treatment of
diabetic foot ulcers (DFUs), a complication of diabetes.

This approval gives Shire Regenerative Medicine the potential to extend availability
of DERMAGRAFT to people with DFUs beyond the U.S., where it is currently available, and is
an important first step for the company as it continues to develop its international
expansion strategy.

“We’re thrilled to have the opportunity to bring DERMAGRAFT to Canada, as we believe
it plays an important role in the treatment of DFUs,” said Matt Pauls, Vice President of
Global Commercial Operations for Shire Regenerative Medicine. “This approval represents an
important milestone in our strategic growth plan to build a global business that provides
regenerative medicine solutions for people around the world with life-altering
conditions.”

This announcement follows Shire’s recent commitment
[http://www.shire.com/shireplc/en/media/shirenews?id=603 ] to build a new regenerative
medicine campus in San Diego to gain increased capacity to meet future demand for
DERMAGRAFT, as well as additional space and infrastructure to develop and manufacture new
regenerative medicine products.

Shire Regenerative Medicine intends to make DERMAGRAFT available in Canada in Q1 2013,
and will leverage Shire’s current infrastructure and commercial knowledge of the Canadian
healthcare system, where the total population with diabetes was estimated to be 2.7
million people (7.6% of the total Canadian population) in 2010, and is projected to rise
to 4.2 million people (10.8% of the total Canadian population) by 2020. In 2008, the
Canadian Association of Wound Care estimated that 345,000 people with diabetes will
develop a DFU in their lifetime and that DFUs were costing Canada’s healthcare system more
than $150 million annually.[ii]

Health Canada’s approval of DERMAGRAFT on August 21, 2012 is based on a Canadian
Device License Application submitted by Shire Regenerative Medicine in 2011.
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NewsBot · Jan 20, 2014

Press Release:
Organogenesis Inc. Announces Acquisition of Dermagraft® from Shire
Product Acquisition Solidifies Organogenesis Position as Industry Leader

Organogenesis Inc., a commercial leader in the field of regenerative medicine, announced today that it has purchased the Dermagraft® assets (human fibroblast-derived dermal substitute) from Shire plc (LSE: SHP, NASDAQ: SHPG).

"Organogenesis is a pioneering company in the regenerative medicine and wound healing fields, and we are now the proud owners of two products containing living cells that are FDA-approved for wound healing. In the midst of a CMS coverage decision which limits access to FDA-proven technology, this deal was necessary to keep both assets on the market and available for patient treatment," said Geoff MacKay, president and Chief Executive Officer of Organogenesis Inc. "We look forward to providing patients and clinicians with Apligraf® and Dermagraft: two evidence-based, well-proven products designed to heal chronic wounds."

Dermagraft is approved for the treatment of nonhealing diabetic foot ulcers in the U.S. and Canada. Headquartered in Canton, Mass., Organogenesis will continue to manufacture and distribute Dermagraft from its existing facilities in La Jolla, Calif.

"In the U.S. alone, more than three million people are suffering from chronic leg and foot wounds. As a physician dedicated to healing these wounds, this is very exciting news," said Robert S. Kirsner, M.D., PhD, Professor, Vice Chairman & Endowed Stiefel Laboratories Chair, Department of Dermatology & Cutaneous Surgery, at the University of Miami Miller School of Medicine and Chief of Dermatology for the University of Miami Hospital. "For many years, Organogenesis has worked with clinicians and scientists to advance scientific discussion and understanding of the field. It's terrific to see that, despite recent changes in Medicare reimbursement that have threatened patient access to wound healing products containing living cells, Organogenesis remains committed to ensuring clinicians and their patients have evidence-based tools and information to help heal these debilitating wounds."

About Organogenesis Inc.
Having pioneered the field, Massachusetts-based Organogenesis Inc. is a world leading regenerative medicine company focused in the areas of bio-active wound healing and oral regeneration. The company's mission is to bring the medical marvel of regenerative medicine products to patients and to standardize their use in everyday medical care. For more information, visit www.organogenesis.com
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NewsBot · Feb 14, 2014

Treatment of Postoperative Lower Extremity Wounds Using Human Fibroblast-Derived Dermis: A Retrospective Analysis.
Carlson RM, Smith NC, Dux K, Stuck RM.
Foot Ankle Spec. 2014 Feb 11.

Human fibroblast-derived dermis skin substitute is a well-studied treatment for diabetic foot ulcers; however, no case series currently exist for its use in healing postoperative wounds of the lower extremity. A retrospective analysis was conducted on 32 lower extremity postoperative wounds treated weekly with human fibroblast-derived dermis skin substitute. Postoperative wounds were defined as a wound resulting from an open partial foot amputation, surgical wound dehiscence, or nonhealing surgical wound of the lower extremity. Wound surface area was calculated at 4 and 12 weeks or until wound closure if prior to 12 weeks. Postoperative wounds treated with weekly applications showed mean improvement in surface area reduction of 63.6% at 4 weeks and 96.1% at 12 weeks. More than 56% of all wounds healed prior to the 12-week endpoint. Additionally, only one adverse event was noted in this group. This retrospective review supports the use of human fibroblast-derived dermis skin substitute in the treatment of postoperative lower extremity wounds. This advanced wound care therapy aids in decreased total healing time and increased rate of healing for not only diabetic foot wounds but also postoperative wounds of the lower extremity, as demonstrated by this retrospective review
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NewsBot · Nov 20, 2014

The Incidence of Lower-Extremity Amputation and Bone Resection in Diabetic Foot Ulcer Patients Treated with a Human Fibroblast-Derived Dermal Substitute.
Frykberg RG, Marston WA, Cardinal M.
Adv Skin Wound Care. 2014 Nov 18

OBJECTIVE::
Diabetic foot ulcers (DFUs) are frequently recalcitrant and at risk for infection, which may lead to lower-extremity amputation or bone resection. Reporting the incidence of amputations/bone resections may shed light on the relationship of ulcer healing to serious complications. This study aimed to evaluate the incidence of amputations/bone resections in a randomized controlled trial comparing human fibroblast-derived dermal substitute plus conventional care with conventional care alone for the treatment of DFUs.
DESIGN::
Ulcer-related amputation/bone resection data were extracted from data on all adverse events reported for the intent-to-treat population (N = 314), and amputations were categorized by type: below the knee, Syme, Chopart, transmetatarsal, ray, toe, or partial toe. Data were analyzed retrospectively for the incidence of amputation/bone resection by treatment.
SETTING::
Randomized controlled trial.
PATIENTS::
Patients with full-thickness DFUs greater than 6 weeks' duration.
INTERVENTIONS::
Standard wound care plus human fibroblast-derived dermal substitute versus standard wound care alone.
MAIN RESULTS::
The incidence of amputation/bone resection in the study was 8.9% (28/314) overall, 5.5% (9/163) for patients receiving human fibroblast-derived dermal substitute, and 12.6% (19/151) for patients receiving conventional care (P = .031). Of the 28 cases of amputation/bone resection, 27 were preceded by ulcer-related infection.
CONCLUSION::
There were significantly fewer amputations/bone resections in patients who received human fibroblast-derived dermal substitute versus conventional care, likely related to the lower incidence of infection adverse events observed in the human fibroblast-derived dermal substitute treatment group
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NewsBot · Dec 17, 2014

The Incidence of Lower-Extremity Amputation and Bone Resection in Diabetic Foot Ulcer Patients Treated with a Human Fibroblast-Derived Dermal Substitute.
Frykberg RG, Marston WA, Cardinal M.
Adv Skin Wound Care. 2015 Jan;28(1):17-20.

OBJECTIVE::
Diabetic foot ulcers (DFUs) are frequently recalcitrant and at risk for infection, which may lead to lower-extremity amputation or bone resection. Reporting the incidence of amputations/bone resections may shed light on the relationship of ulcer healing to serious complications. This study aimed to evaluate the incidence of amputations/bone resections in a randomized controlled trial comparing human fibroblast-derived dermal substitute plus conventional care with conventional care alone for the treatment of DFUs.
DESIGN::
Ulcer-related amputation/bone resection data were extracted from data on all adverse events reported for the intent-to-treat population (N = 314), and amputations were categorized by type: below the knee, Syme, Chopart, transmetatarsal, ray, toe, or partial toe. Data were analyzed retrospectively for the incidence of amputation/bone resection by treatment.
SETTING::
Randomized controlled trial.
PATIENTS::
Patients with full-thickness DFUs greater than 6 weeks' duration.
INTERVENTIONS::
Standard wound care plus human fibroblast-derived dermal substitute versus standard wound care alone.
MAIN RESULTS::
The incidence of amputation/bone resection in the study was 8.9% (28/314) overall, 5.5% (9/163) for patients receiving human fibroblast-derived dermal substitute, and 12.6% (19/151) for patients receiving conventional care (P = .031). Of the 28 cases of amputation/bone resection, 27 were preceded by ulcer-related infection.
CONCLUSION::
There were significantly fewer amputations/bone resections in patients who received human fibroblast-derived dermal substitute versus conventional care, likely related to the lower incidence of infection adverse events observed in the human fibroblast-derived dermal substitute treatment group.
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NewsBot · Jan 5, 2015

Press release:
MiMedx Announces Receipt Of Civil Subpoena

MiMedx Group, Inc. (MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spinal, Sports Medicine, Ophthalmic and Dental sectors of healthcare, announced today that it has received a subpoena from the Office of Inspector General ("OIG") of the Department of Health and Human Services ("HHS") in connection with a civil investigation into matters primarily related to the Company's sales and marketing activities.

MiMedx intends to cooperate fully with the government in its investigation, and the Company will attempt to expedite the process. MiMedx has already begun the process of producing the responsive documents. To the Company's knowledge, no proceedings have been initiated at this time. The Company cannot predict whether any proceeding might be initiated.

Parker H. Petit, Chairman and CEO, said, "I can assure you that the corporate officers at MiMedx are not aware of anything that would stimulate this investigation. We have continually maintained and improved a robust compliance program. We have been very focused on the thoroughness of our compliance policies and our staff adhering to those policies. For instance, MiMedx employees participate in a thorough training program regarding our policies and the standards that have been established and enforced to assure their understanding and adherence to our compliance programs. Employees may convey anonymously and directly to senior management and our Board of Directors any form of concern, complaint or inquiry related to our compliance programs or other issues. With the significant growth we are experiencing, this has been and continues to be an initiative in which we devote considerable time, attention and resources."

Petit continued, "We are aware of investigations in the wound care market over the past several years, in particular, the ongoing investigation into the sales and marketing practices of Advanced BioHealing ("ABH"), the original manufacturer of Dermagraft®. We anticipated that the ABH investigation could lead to a review of other industry participants, particularly in view of the fact that several industry participants, including MiMedx and some of our competitors, have hired former ABH employees. We screen all of our applicants very carefully. With respect to former ABH applicants, we sought additional input from some former ABH corporate management who joined MiMedx and who were familiar with the suspected violations and the individuals involved. Approximately 18 months ago, we had confirmation of a violation of our compliance policies, and within 24 hours, that individual was terminated."

Petit concluded, "We expect this investigation will confirm that our policies and procedures are working as intended. If any issues are uncovered, we will certainly address them promptly and take steps to ensure future compliance."
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NewsBot · Mar 30, 2016

Pharma exec pleads guilty in VA bribery conspiracy

Federal prosecutors in Seattle say VA doctors took kickbacks to promote ‘biologic’ bandage to colleagues
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NewsBot · Apr 15, 2016

Press Release:
Organogenesis Secures $30 Million in Financing to Fund Aggressive Expansion of Commercial Operations and Product Portfolio
Apr 14, 2016, 11:50 ET from Organogenesis Inc.

CANTON, Mass. and SAN DIEGO, April 14, 2016 /PRNewswire/ -- Organogenesis Inc. – a global leader in advanced wound care innovation and technologies – has raised approximately $30 million in capital from existing investors to support a significant expansion of the company's commercial operations, sales force, PuraPly product line, and new product development in the wound care and surgical fields.

With wound care decision makers increasingly moving toward evidenced-based products and buying groups selecting companies with broader product portfolios, Organogenesis is experiencing the largest growth in the company's history, said Gary S. Gillheeney, Sr., President & CEO of Organogenesis. Part of this success is due to our expanded wound care portfolio – including the recent launch of PuraPly and PuraPly Antimicrobial (AM) - which allows us to offer products across all phases of wound healing.

The Organogenesis product portfolio expansion includes several additions to the PuraPly wound management line, the launch in the next year of an FDA-approved Class III PMA burn treatment, and new product offerings from the FortaFlex collagen matrix technology platform for soft tissue reinforcement. These portfolio additions have and will continue to increase Organogenesis product sales in the outpatient wound healing market, and position the company for new growth opportunities in the surgical and hospital inpatient markets.

We are experiencing a period of hypergrowth with the launch of PuraPly AM, the only FDA-cleared purified collagen matrix plus PHMB antimicrobial on the market today" said Gillheeney. To that end, we are excited about expanding our resources across the company to keep up with this demand and effectively manage our planned growth, including increasing our sales force to 250 representatives over the next year.

The company's market-leading, FDA-approved bioengineered living cell-based therapies, Apligraf and Dermagraft, have also experienced strong sales growth, with more than one million units of Apligraf and Dermagraft shipped for patient applications to date. Organogenesis continues to invest in new clinical data and peer-reviewed publications to demonstrate the real-world effectiveness of these pioneering products.

A major driver of Organogenesis commercial expansion has been the execution of numerous new contracts with group payer organizations (GPOs) and hospital chains, bringing the Organogenesis product portfolio to more than 1,500 additional hospitals and wound healing centers across the United States.

We are excited about these new growth opportunities and look forward to expanding Organogenesis presence in the healthcare marketplace as we work to advance our mission of bringing safe, effective, and advanced wound care products to clinicians and patients across the globe, concluded Gillheeney.

About Organogenesis Inc.

Massachusetts-based Organogenesis Inc. is a global leader in advanced wound care innovation and technologies, including bio-active wound healing and soft tissue regeneration. The company's mission is to bring safe and effective wound care products to patients and to standardize their use in everyday medical care. Among Organogenesis' portfolio of products are FDA-approved Apligraf and Dermagraft, the best-in-class products for bio-active wound healing and recently launched, FDA-cleared PuraPly Antimicrobial, which advances wound management for a wide variety of wound types.
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NewsBot · Jul 23, 2016

After rocky 2 years, Organogenesis is regenerating business

A short-lived Medicare reimbursement cut left the Canton skin-regeneration treatment business in uncertain shape two years ago. With those payments restored and new investment money in hand, the company is ready to expand its customers and product lines.
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NewsBot · Aug 4, 2016

DOJ Reach $350M Deal In Dermagraft FCA Investigation

Law360, Los Angeles (August 2, 2016, 10:05 PM ET) -- Biotech company Shire on Tuesday told investors that it reached a tentative $350 million settlement with the U.S. Department of Justice to settle False Claims Act violations and Medicaid-related claims over the sales and marketing practices relating to Dermagraft.

Massachusetts-based Shire Pharmaceuticals said in its 8-K filing that it had reached a tentative agreement with the U.S. Department of Justice in an ongoing investigation into the sales and marketing practices of the skin substitute product Dermagraft.
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Smith & Nephew Will End Dermagraft Production

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