Advanced BioHealing

Delivering the Promise of Regenerative Medicine Today

AMA and CMS Issue Final Physician Codes and Payment for DERMAGRAFT 2012

November 21, 2011

Westport, Conn. – November 21, 2011

Changes to streamline coding and reimbursement process for providers

Advanced BioHealing, Inc., Shire plc’s regenerative medicine business, today announced the American Medical Association (AMA) has assigned two new procedure codes for the application of DERMAGRAFT®, an FDA-approved living cell product for the treatment of diabetic foot ulcers.

The new Current Procedural Terminology (CPT) codes, which include CPT 15275 and 15276, are assigned a 0-day global period. These codes have no impact on DERMAGRAFT’s FDA-approved indication for treatment of diabetic foot ulcers, but will streamline the reimbursement process for providers and contractors, enabling physicians to receive appropriate compensation from Medicare and other insurers for each application of DERMAGRAFT, in accordance with its FDA-approved indication and directions for use of up to eight weekly applications over a twelve-week period.

“Diabetes is a growing epidemic and its complications, including diabetic foot ulcers, place a significant burden on patients and the U.S. healthcare system,” said Kevin Rakin, President of Regenerative Medicine for Shire. “Streamlining access to medical products like DERMAGRAFT will help improve the quality of care and reduce the costs to both the Medicare system and beneficiaries.”

The DERMAGRAFT product code (HCPCS Q4106) will remain unchanged.

The new CPT codes are:

  • 15275—Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq. cm.; first 25 sq. cm. or less wound surface area
  • 15276—Each additional 25 sq. cm. wound surface area, or part thereof (List separately in addition to code for primary procedure)

More than one million physicians and health care professionals are paid under Medicare’s fee schedule, and its rules cover more than 7,000 types of services in physician offices, hospitals and other health care settings.

Payment policies and rates adopted in the final rule will be effective for services on or after January 1, 2012.

These new codes, which will impact the application codes for all tissue cultured allogeneic skin or dermal substitute products, were established in the 2012 CPT Book from the AMA and were also included in the final Physician Fee Schedule ruling released by the Centers for Medicare and Medicaid Services (CMS) on November 1st, 2011.

For more information on the final ruling, please visit pages 511-513 and 549 at the following link: http://www.ofr.gov/OFRUpload/OFRData/2011-28597_PI.pdf.

About DERMAGRAFT®

DERMAGRAFT is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six 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 that have adequate blood supply to the involved foot.

DERMAGRAFT is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. DERMAGRAFT is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution.

About Advanced BioHealing, Inc.

Advanced BioHealing (ABH), became Shire’s regenerative medicine business following its acquisition in June 2011. ABH specializes in the development and commercialization of regenerative medicine treatments. ABH currently manufactures and markets DERMAGRAFT®, a bio-engineered skin substitute approved by the FDA for the treatment of diabetic foot ulcers. DERMAGRAFT contains fibroblasts that secrete human dermal collagen, matrix proteins and growth factors. The Company maintains its corporate office in Westport, Conn. with additional sites in San Diego, Calif. and Nashville, Tenn. To learn more about ABH, please visit www.ABH.com.

About Shire plc

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.  Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.  Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights.  Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company’s website: www.shire.com.

“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.

Advanced BioHealing Named to Prestigious Inc. 500 List of America’s Fastest Growing Private Companies

August 25, 2011

Westport, Conn. – August 25, 2011

Advanced BioHealing, Inc. (ABH), a leader in commercializing regenerative medicine therapies, today announced that it ranked in the top 200 (No. 187) on this year’s Inc. 500 list of America’s fastest-growing, privately held companies.

Inc. magazine’s annual list provides the most comprehensive look at a vital segment of the U.S. economy—America’s independent-minded entrepreneurs. ABH increased revenue from zero in 2006 to $146 million in 2010 and by year-end employed more than 300 professionals. It is this success that led to the recent acquisition of ABH by Shire plc, the global specialty biopharmaceutical company. The acquisition combines ABH’s experience and commercial capability in regenerative medicine with Shire’s expertise in developing and commercializing products targeting unmet medical needs, and in human cell biological manufacturing.

“This recognition reflects the hard work and dedication of the extraordinarily talented team here at ABH,” said Kevin Rakin, CEO. “Since 2006, we have built a fully integrated, profitable regenerative medicine company marketing, Dermagraft, an FDA-approved living cell therapy with a dedicated sales force, scalable cell-based manufacturing, and established reimbursement.”

About Advanced BioHealing, Inc.

Advanced BioHealing (ABH), a Shire company, specializes in the development and commercialization of life-altering regenerative medicine therapies. ABH currently manufactures and markets Dermagraft®, a bio-engineered skin substitute approved by the FDA for the treatment of diabetic foot ulcers, that assists in restoring damaged tissue and supports the body’s natural healing process. The Company maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about ABH, please visit the Company’s web site at www.ABH.com.

 

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

August 24, 2011

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.

About Dermagraft

Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six 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 that have adequate blood supply to the involved foot.

Dermagraft is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. Dermagraft is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine.

About Advanced BioHealing, Inc.

Advanced BioHealing (ABH), a Shire company, specializes in the development and commercialization of life-altering regenerative medicine therapies. ABH currently manufactures and markets Dermagraft®, a bio-engineered skin substitute approved by the FDA for the treatment of diabetic foot ulcers, which assists in restoring damaged tissue and supports the body’s natural healing process. The Company maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about ABH, please visit the Company’s web site at www.ABH.com.

About Shire plc

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.  Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.  Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights.  Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company’s website: www.shire.com.

 

Shire Completes Acquisition of Advanced BioHealing, Inc.

June 28, 2011

Dublin, Ireland – June 28, 2011

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that following the satisfaction of the closing conditions, including the expiry of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, the acquisition of Advanced BioHealing, Inc. (“ABH”), as first announced on May 17, 2011, has been completed.

The Advanced BioHealing business becomes part of Shire’s Specialty Pharmaceuticals business, led by Mike Cola, and will leverage biologic manufacturing expertise from Shire’s Human Genetic Therapies business. Kevin Rakin, Chief Executive Officer of Advanced BioHealing, will continue to lead this business within the Shire organization.

Notes to Editors

SHIRE PLC

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.  Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.  Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights.  Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company’s website: www.shire.com.

“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceuticals and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.

 

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

San Diego, Calif. – 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.

About Advanced BioHealing, Inc.

Advanced BioHealing (ABH) develops and commercializes living cell therapies, which promote the repair of damaged human tissue, enabling the body to heal itself. ABH, a privately-held company, participates in the rapidly growing diabetes market with its lead cell-based therapy, Dermagraft®. ABH currently manufactures and markets Dermagraft, a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. Dermagraft is FDA approved to treat DFUs and is the focus of an ongoing pivotal trial for the treatment of venous leg ulcers. The Company maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about ABH, please visit the Company’s web site at www.ABH.com.

About The Lewin Group

The Lewin Group is a premier national health care and human services consulting firm with more than 40 years’ experience finding answers and solving problems for leading organizations in the public, nonprofit, and private sectors. With its industry experience and knowledge, The Lewin Group provides its clients with high-quality products and insightful support to help them maximize the delivery of programs and services that make a difference in the lives of their constituents. For more information on The Lewin Group, visit www.lewin.com.  The Lewin Group is a division of OptumInsight (formerly Ingenix), a part of Optum. OptumInsight is a leading provider of health information, technology and consulting services. Visit www.ingenix.com for more information.  The Lewin Group operates with editorial independence and provides its clients with the very best expert and impartial health care and human services policy research and consulting services.

 

Advanced BioHealing to Present at 29th Annual J.P. Morgan Healthcare Conference

January 5, 2011

Westport, Conn. – January 5, 2011

Advanced BioHealing, Inc. (ABH), a leader in commercializing cell-based therapies and delivering on the promise of regenerative medicine, today announced that Kevin Rakin, Chairman and Chief Executive Officer of ABH will present at the 29th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2011 at 4:30 p.m. Pacific Standard Time. The conference will take place at the Westin St. Francis Hotel in San Francisco, Calif.

Also during the J.P. Morgan conference, Dean Tozer, Senior Vice President of ABH will participate in the “Regenerative Medicine State of the Industry Briefing” sponsored by the Alliance for Regenerative Medicine. The briefing will take place on Monday, January 10, 2011 at 10:00 a.m. Pacific Standard Time at the Biotech Showcase 2011 to be held at the Park 55 Hotel in San Francisco.

Kevin C. O’Boyle, Senior Vice President and Chief Financial Officer for ABH will join Mr. Rakin and Mr. Tozer in San Francisco next week.

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell-based therapies that repair damaged human tissue and enable the body to heal itself. ABH currently manufactures and markets Dermagraft®, a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. Dermagraft is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial to assess the product’s safety and efficacy in the promotion of healing venous leg ulcers. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

 

New Dermagraft Coding to Streamline Reimbursement Process for Medicare Providers

December 13, 2010

Westport, Conn. – December 13, 2010

Advanced BioHealing, Inc. (ABH), a leader in commercializing cell-based therapies and delivering on the promise of regenerative medicine, today announced the Centers for Medicare and Medicaid Services (CMS) has assigned two new procedure codes for the application of Dermagraft®, effective January 1, 2011. Dermagraft is an FDA-approved cell-based therapy for the treatment of diabetic foot ulcers and is indicated for up to eight weekly applications over a twelve-week period.

The new Healthcare Common Procedure Coding System (HCPCS) codes, which will include site preparation and debridement and 0-day global billing period, will streamline the reimbursement process for Medicare providers, enabling physicians to receive appropriate compensation for each application of Dermagraft, in accordance with its FDA-approved indication and directions for use.

The Dermagraft product code (HCPCS Q4106) will remain unchanged.

“Advanced BioHealing has been working closely with CMS officials to ensure consistent coding for Dermagraft. These efforts resulted in the creation of new codes, which will ensure that payment is made appropriately for Dermagraft each time a covered service is provided, thereby reducing administrative burden for both Medicare providers and contractors,” said Kevin Rakin, Chairman and Chief Executive Officer for ABH. “Like diabetes, diabetic foot ulcers are a growing epidemic, so streamlining access to advanced therapies like Dermagraft will help reduce the need for lower extremity amputation and additional significant costs to both the Medicare system and beneficiaries.”

More than one million physicians and health care professionals are paid under Medicare’s fee schedule, and its rules cover more than 7,000 types of services in physician offices, hospitals and other health care settings.

These new codes were established in a final ruling released by CMS on November 3, 2010. The final rule is consistent with the initial Medicare Physician Fee Schedule Proposed Rule released on June 25, 2010.

For more information, please visit the Dermagraft Reimbursement Support Center.

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

About Dermagraft®

Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 250,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.

 

Advanced BioHealing Appoints Kevin C. O’Boyle as Chief Financial Officer

December 10, 2010

Westport, Conn. – December 10, 2010

Advanced BioHealing, Inc. (ABH), a leader in commercializing cell-based therapies and delivering on the promise of regenerative medicine, today announced the appointment of Kevin C. O’Boyle, as Senior Vice President and Chief Financial Officer.

“We are pleased to welcome Kevin to our team as we continue to build a leading commercial regenerative medicine organization,” said Kevin Rakin, Chairman and Chief Executive Officer for ABH. “Kevin has an outstanding track record as CFO of companies executing high-growth strategies, focused on both organic and external opportunities, and accessing the equity markets.”

ABH has grown revenue from zero in 2006 to over $130 million in 2010 and today employs more than 350 professionals. These strong results are based on growing demand for its FDA-approved product Dermagraft® for the treatment of diabetic foot ulcers.

“I am excited about joining the exceptional team at Advanced BioHealing,” said Mr. O’Boyle. “Advanced BioHealing is a well-established leader in the field of regenerative medicine with the ability to improve patient lives with its cell-based therapy. I look forward to bringing my leadership experience to the company as it moves into its next phase of commercial growth.”

Mr. O’Boyle has 15 years experience in the healthcare industry. From January 2003 until December 2009, Mr. O’Boyle served as the Chief Financial Officer of NuVasive, Inc., a medical device company focused on spinal applications, which completed its initial public offering in May 2004. He joined NuVasive when it had less than $30 million in annual revenue and was a key member of the management team that grew the business to more than $400 million in annual revenue. Prior to that time, Mr. O’Boyle served in various positions during his six years with ChromaVision Medical Systems, Inc., a publicly-held medical device company specializing in the oncology market, including as its Chief Financial Officer and Chief Operating Officer. Mr. O’Boyle currently serves on the boards of GenMark Diagnostics, Inc., a publicly traded molecular diagnostics company, and Tornier, BV, a privately held global orthopedics company.

Mr. O’Boyle received his Bachelor of Science in Accounting from the Rochester Institute of Technology and successfully completed the Executive Management Program at the University of California Los Angeles, John E. Anderson Graduate Business School.

Advanced BioHealing to Present at Piper Jaffray Health Care Conference and Canaccord Genuity Conference

November 29, 2010

Westport, Conn. – November 29, 2010

Advanced BioHealing, Inc. (ABH), a leader in commercializing cell-based therapies and delivering on the promise of regenerative medicine, today announced that company executives will participate in two upcoming investor meetings.

Presentations are scheduled for:

  • 22nd Annual Piper Jaffray Health Care Conference—Nov. 30 – Dec. 1, 2010, in New York City—Kevin Rakin, Chairman and Chief Executive Officer will discuss Advanced BioHealing’s success in commercializing Dermagraft® and highlight future growth opportunities for the Company, on Tuesday, Nov. 30th, beginning at approximately 1:50 p.m. ET.
  • Canaccord Genuity Fifth Annual Cardiovascular, Diabetes & Obesity Conference—Dec. 7 – 8, 2010 at the Nikko Hotel in San Francisco—Dean Tozer, Senior Vice President, will provide a corporate profile on Wednesday, Dec. 8th at approximately 9:30 a.m. PT, highlighting Advanced BioHealing’s lead product, Dermagraft, an FDA-approved cell-based therapy for the treatment of diabetic foot ulcers.

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

 

 

Advanced BioHealing to Discuss Successful Commercialization of Cell-Based Therapies at Two European Regenerative Medicine Conferences

November 16, 2010

Westport, Conn. – November 16, 2010

Presentations scheduled this week for London Regenerative Medicine Network event and Commercial Translation of Regenerative Medicine

Advanced BioHealing, Inc. (ABH), a leader in commercializing cell-based therapies and delivering on the promise of regenerative medicine, announced that Senior Vice President Dean Tozer, will present case studies describing the Company’s best practices and provide an industry perspective regarding the future of regenerative medicine during the invitation-only London Regenerative Medicine Network event and Commercial Translation of Regenerative Medicine conference.

Since its launch in 2007, ABH has grown revenue from zero to a projected $130 million in 2010.  Kevin Rakin, Chairman and Chief Executive Officer for ABH, stated, “It’s critical that companies like ABH share its experience and expertise to create constituencies that will work together to drive the field of regenerative medicine forward.”

Event details include:

  • London Regenerative Medicine Network event (Nov. 17, 2010; University College London [UCL], London)—Tozer will deliver a presentation titled: Advanced BioHealing, a Commercial Perspective on the Promise of Regenerative Medicine, which will take place during an evening event on Wednesday, Nov. 17 at the UCL main campus in the Wilkins Gustave Tuck lecture theatre.
  • Commercial Translation of Regenerative Medicine (Nov. 18 – 19, 2010; Hilton London Kensington Hotel, London)—Tozer will deliver a case study and will participate in an interactive panel discussion on Friday, Nov. 19 to address worldwide views on pricing and reimbursement.

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

About Dermagraft®

Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 250,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.

 

 

Advanced BioHealing to Address Commercialization and Reimbursement of Regenerative Medicine Therapies at 2010 World Stem Cell Summit

October 1, 2010

Westport, Conn. – October 1, 2010

Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that Senior Vice President, Dean Tozer and Vice President of Government Affairs and Health Economics, Therésa Dixon will speak on behalf of the Company at the 2010 World Stem Cell Summit, sharing their more than 30 years of combined industry experience with attendees.

Tozer will present during the Industry Track panel session titled, “Commercialization of Stem Cells and International Market Trends,” on Wednesday, October 6. Dixon will participate on the Industry Track panel titled, “Reimbursement and Insurance Solutions for Cell Therapies and Related Industries” on Tuesday, October 5.

“We are very pleased that the Industry Track of the Summit Program presents the best and the brightest,” said Bernard Siegel, founder and co-chair of the World Stem Cell Summit and executive director of the Genetics Policy Institute (GPI). “Our industry panels are designed to address the needs of the life science investor community and executives from biotechnology, pharmaceutical and other regenerative medicine companies.”

“In the field of regenerative medicine, development and commercialization efforts must be innovative, successfully executed and also educate government agencies, health care providers and patients along the way,” said Tozer. “Therésa and I look forward to sharing our experiences in addressing and overcoming commercialization and reimbursement challenges for ABH’s lead product, Dermagraft®, which has contributed to the Company’s consistent, double-digit revenue growth.”

The sixth annual Summit, presented by the nonprofit GPI, will attract more than 1,000 of the most influential stem cell stakeholders from more than 30 countries representing the fields of science, business, policy, law, ethics and advocacy. Tozer and Dixon will be joined by more than 150 internationally renowned speakers—producing a unique international network designed to foster collaborations, economic development, technology transfer, commercialization, private investment and philanthropy.

The 2010 World Stem Cell Summit will take place in Detroit, Michigan on October 4-6, 2010, at the Detroit Marriott at the Renaissance Center.

For more information and to register, visit: www.worldstemcellsummit.com.

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

About Dermagraft®

Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 200,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.

 

Advanced BioHealing to Highlight Standard of Care for Treating Diabetic Foot Ulcers at Save A Leg, Save A Life National Conference

September 1, 2010

Westport, Conn. – September 1, 2010

Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that it will host two events focusing on the standard of care for treating diabetic foot ulcers (DFUs) at the second annual Save A Leg, Save A Life National Conference to be held September 2 – 4, 2010 at the Peabody Orlando hotel in Orlando, Fla.

ABH’s Heal2gether Partnership Program, a community health education program, has partnered with Save A Leg, Save A Life Foundation to develop a community outreach campaign that aims to increase awareness of DFUs and ultimately help people who are afflicted with wounds and other complications of diabetes and peripheral arterial disease.

The 2010 National Conference is focused on convening dedicated Wound Care and Vascular Specialists to start a new chapter in multidisciplinary cooperation in the missions of reducing amputations, reducing mortality, improving awareness and advancing provider education.

“There is much work that remains to be done for the treatment of DFUs, but we have already made great strides,” said Dean Tozer, Senior Vice President of ABH. “By partnering with organizations such as Save A Leg, Save A Life, we hope to continue to educate medical professionals on ways to effectively manage DFUs and increase patient adherence. Our ultimate goal is to help patients achieve a greater standard of living and a return to normalcy after their wound heals.”

As the manufacturer of Dermagraft®, a bio-engineered skin substitute approved by the U.S. Food and Drug Administration for treatment of DFUs, ABH is dedicated to raising awareness about DFUs and aims to help the hundreds of thousands of people across the nation who are at risk of developing the wounds.

ABH will support and/or host the following events at the 2010 National Conference:

  • General Session (Thursday, September 2nd from 11:20 to 11:45 a.m.)—In a session titled, “Consensus Recommendations on Advancing the Standard of Care for Treating Neuropathic Foot Ulcers in Patients with Diabetes,” Robert J. Snyder, DPM, CWS will address the evolution of DFU treatment, the subsequent formation of a new standard of care, and how doctors can implement this new standard in their practice.
  • Hands-On Workshop (Saturday, September 4th from 1:30 to 5:00 p.m.)—Attendees will have the opportunity to practice preparing and applying Dermagraft during this hands-on workshop. To date, ABH has supplied more than 200,000 pieces of Dermagraft to over 1,000 wound care centers and outpatient clinics nationwide.

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

About Dermagraft®

Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 200,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.


CMS Proposes Updated Dermagraft Coding for 2011

July 6, 2010

Westport, Conn. – July 6, 2010

Proposed coding to streamline reimbursement process for Medicare providers

Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that the Centers for Medicare and Medicaid Services (CMS) has proposed to create a new G-code for the application of Dermagraft® with a 0-day global period for calendar year 2011. This proposal was included in the Medicare Physician Fee Schedule Proposed Rule released on Friday, June 25, 2010.

Dermagraft, a bio-engineered skin substitute approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetic foot ulcers, is indicated for up to eight weekly applications over a twelve-week period.

In the proposed rule, CMS noted the importance of “ensuring that skin substitutes are properly utilized for Medicare beneficiaries who will benefit from that treatment.”

“ABH has been actively working with CMS officials to advocate for the creation of G-codes for Dermagraft to be consistent with the FDA-approved use of the product and to allow appropriate payment with the least administrative burden for Medicare providers and contractors. This proposed rule is a significant step in that direction,” said Kevin Rakin, Chairman and Chief Executive Officer for ABH. “Diabetes and diabetic foot ulcers continue to be an epidemic in the U.S. and around the world, so anything that can be done to streamline access to advanced therapies like Dermagraft will help reduce the need for lower extremity amputation and subsequent additional health care costs for both Medicare and beneficiaries.”

More than 1 million physicians and health care professionals are paid under Medicare’s fee schedule, and its rules cover more than 7,000 types of services in physician offices, hospitals and other health care settings.

CMS will accept comments on the proposed rule until August 24, 2010, and will respond to them in a final rule to be issued by November 1, 2010.  Payment policies and rates adopted in the final rule will be effective for services on or after January 1, 2011.

This proposed rule impacts only the application code for Dermagraft; the product code (HCPCS Q4106) will remain unchanged.

For more information on this proposed change, please visit page 226 at the following link: http://federalregister.gov/OFRUpload/OFRData/2010-15900_PI.pdf

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

About Dermagraft®

Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 200,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visitwww.Dermagraft.com.


Advanced BioHealing to Discuss Evolution of a Regenerative Medicine Franchise

June 23, 2010

La Jolla, Calif. – June 23, 2010

Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that Vice President and General Manager Kathy McGee will be the featured presenter at the San Diego Biotechnology Network event to be held June 23, 2010 from 5:30 to 9:00 p.m. PST at Tango Del Rey in San Diego, Calif.

Ms. McGee will share the story of ABH’s evolution into a multi-million dollar, fully integrated regenerative medicine company. She will discuss ABH’s focus on being the leader in commercializing cell-based technologies, and how that discipline has enabled the production and commercial components of ABH’s business to contribute to the Company’s successes in delivering Dermagraft® to thousands of patients across the country each year.

ABH will also have a booth at the event and representatives will be present to network with attendees throughout the evening.

The San Diego Biotechnology Network was founded in September of 2008 to address the need for more high quality, face to face networking among Biotech professionals in the greater San Diego area.

For more information on the event, please visit http://sdbn.org/2010/05/31/june-sdbn-event/.

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

About Dermagraft®

Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 200,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.


 

Advanced BioHealing Expands Operations in Middle Tennessee with New Research & Development Effort

June 22, 2010

Nashville, Tenn. – June 22, 2010

Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced a significant expansion of the Company’s operations in the Nashville area with the establishment of an expanded research and development effort.

Building on the Company’s strategic growth plan and its cell-based expertise, ABH has established a plan to expand its existing technology and competencies into new indications and therapeutic areas—an effort made possible by the Company’s double-digit revenue growth since establishing commercial operations in 2007.

To support this effort, ABH will be conducting initial research efforts at the Cumberland Emerging Technologies, Inc. (CET) Life Sciences Center in Nashville, Tenn., where the Company is currently leasing lab space. In addition, ABH has recently moved its Tennessee-based efforts into new offices in the Overlook Building in Brentwood, Tenn., where they intend to consolidate their Tennessee lab and office facilities.

The Tennessee-based research initiative is led by Charles E. Hart, Ph.D., Vice President and Chief Scientific Officer for ABH. Dr. Hart is responsible for directing the Company’s research efforts, including the identification and development of new product opportunities for the Company’s lead product, Dermagraft®. He also oversees ABH’s La Jolla, Calif.-based research team that supports the Company’s existing manufacturing activities. Prior to joining ABH, Dr. Hart served as Vice President and Chief Scientific Officer of BioMimetic Therapeutics, a biotechnology company based in Franklin, Tenn.

Dermagraft is a bio-engineered skin substitute that repairs damaged tissue and supports the body’s natural healing process. It is approved by the U.S. Food and Drug Administration for the treatment of diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers. The Company’s initial research efforts are focused on utilizing Dermagraft as an adjunct therapy to augment healing in a range of orthopedic soft tissue indications, such as rotator cuff repair.

“The Nashville area is becoming more widely recognized as a home to the healthcare industry, and we are proud to join the growing biotechnology community here,” said Dean Tozer, Senior Vice President of ABH, also based in Tennessee. “Our investments in Middle Tennessee to expand our research efforts support our strategic focus on extending the use of Dermagraft into new indications and diversifying the Company’s product portfolio. It further reflects our commitment to becoming the leading international regenerative medicine company and providing our customers with innovative living cell products that address unmet medical needs.”

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

About Dermagraft®

Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 200,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.


Advanced BioHealing to Highlight Standard of Care for Treating Diabetic Foot Ulcers at New Cardiovascular Horizons

June 2, 2010

Westport, Conn. – June 2, 2010

Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that it will host four events focusing on the standard of care for treating diabetic foot ulcers (DFUs) at this year’s New Cardiovascular Horizons (NCVH) conference in New Orleans, La.

ABH will support and/or participate in the following events at NCVH:

  • Neuropathy and Its Complications: Evaluation and Management. Sessions I and II will be held on Wednesday, June 2 from 1:30 to 6:00 p.m. and Thursday, June 3 from 1:30 to 6:30 p.m. Chaired by Allen Jacobs, DPM, Session I will feature presentations by Bradley Bakotic, DO, DPM; and Guy Pupp, DPM on the various types of neuropathy and how to effectively diagnose and manage them. Session II will also be chaired by Dr. Jacobs, and will feature discussions by Raymond Adbo, DPM; Dr. Bakotic; and Vincent Sollecito, DPM, CWS, FACFAS about clinical considerations and management of neuropathic ulceration and utilization of advanced wound healing products.
  • “Hands-On Dermagraft®” Workshop. Pieces of Dermagraft, ABH’s bio-engineered skin substitute, will be available for attendees to practice preparing and applying the product. To date, more than 200,000 pieces of Dermagraft have been supplied to over 1,000 wound care centers and outpatient clinics nationwide. The workshop will be held on Thursday, June 3 from 1:30 to 5:30 p.m.
  • Lunch Symposium: The NEW 2010 Consensus Recommendations on Advancing the Standard of Care for the Diabetic Foot Ulcer. Dr. Sollecito will address the evolution of DFU treatment, the subsequent formation of a new standard of care, why Dermagraft is central, and how doctors can implement this standard in their practice. The event will be held on Friday, June 4 from 12:00 to 1:00 p.m.
  • Presentations:
    • Treating CLI is more than Revascularization—The Role of the Podiatrist and Wound Healing Personnel. Desmond P. Bell, Jr., DPM of Wound Care on Wheels, LLC in Jacksonville, Fla. will present during the Critical Limb Ischemia Summit on Thursday, June 3 from 8:30 to 8:38 a.m.
    • Amputation Statistics and How They Impact Your Community. Dr. Bell will also present during the Hospital Administrator Forum on Thursday, June 3 from 2:40 to 2:55 p.m.
    • Surgical Strategies for Managing the Ulcerated Foot. Howard Kimmel, DPM of Louis Stokes Department of Veterans Affairs in Cleveland, Ohio will present during the VA Diabetic Foot Symposium on Friday, June 4 from 3:00 to 3:30 p.m. Dr. Kimmel will also present a poster titled, “An Evidence Based Approach to Treating DFUs in a VA Population.” The poster will be available for viewing throughout the duration of NCVH. To view the complete abstract, visit: http://www.newcvhorizons.com/site36.php.

“Although we’ve made great strides in the treatment of DFUs, there is still work to be done,” said Dean Tozer, Senior Vice President of ABH. “By highlighting the standard of care for treating DFUs at events such as NCVH, we hope to continue to educate health care providers on ways to effectively manage DFUs and improve patient outcomes. The primary goal, after all, is to help patients rapidly heal their ulcer, which should in turn provide them with a much improved quality of life. When this happens, the patient, the provider and the health care system all benefit.”

NCVH will be held June 2-5, 2010 at the Roosevelt Waldorf Astoria Hotel in New Orleans. Now in its 11th year, the fourth largest cardiovascular conference in the nation brings together the whole multidisciplinary team to concentrate on limb salvage and amputation prevention. ABH will exhibit at Booth #211 in the Exhibit Hall. For more information or to register, please visit: http://www.ncvhonline.com.

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

About Dermagraft®

Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 200,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.


Advanced BioHealing to Discuss Disruptive Innovation at BIOMEDevice Executive Forum

April 19, 2010

Westport, Conn. – April 19, 2010

Panelists to discuss how convergent medical technology is redefining the life science sector

Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that Senior Vice President Dean Tozer will participate on a panel at the BIOMEDevice Executive Forum to be held April 21 – 22, 2010, at the Boston Convention & Exhibition Center in Boston, Mass.

Mr. Tozer will take part in a keynote panel discussion titled, “Disruptive Innovation” on Wednesday, April 21, 2010, at 9:45 a.m. EST. The panel will examine how convergent medical technology is redefining the life science sector through improved medical outcomes and decreased healthcare costs.

The BIOMEDevice Executive Forum will focus on convergence and cross-sector collaborations among biotechnology, medical device, IVD, and pharmaceutical companies. The Forum’s scope will move beyond the FDA’s definition of a combination product to address the paradigm shift in the life sciences.

For more information and to register for the meeting, please visit http://www.devicelink.com/expo/bioforum10/.

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company with more than 250 employees, Advanced BioHealing maintains its corporate office in Westport, Conn., a 70,000 sq. ft. manufacturing facility in La Jolla, Calif., and research facility in Nashville, Tenn. To meet Advanced BioHealing’s executives and learn more about the Company, please visit the Company’s web site at www.ABH.com.

 

Advanced BioHealing to Participate in Panel Discussion at Inaugural Translational Regenerative Medicine Forum

March 30, 2010

Westport, Conn. – March 30, 2010

Panelists to discuss best practices in commercialization of regenerative medicine products

Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that Senior Vice President Dean Tozer will participate on a panel at the inaugural 2010 Translational Regenerative Medicine Forum to be held April 6 – 8, 2010, at the Benton Convention Center in Winston-Salem, N.C.

Mr. Tozer will take part in a panel discussion titled, “Best Practices in Commercialization” on Thursday, April 8, 2010, at 8:30 a.m. EST. Joining Tozer will be moderator R. Lee Buckler, BEd, LLB, Founder, Managing Director, and Principal Consultant of the Cell Therapy Group; Anthony Caggiano, MD, PhD, Vice President, Preclinical Development of Acorda Therapeutics; Ed Field, President and Chief Operating Officer of Aldagen; Robert Deans, PhD, Senior Vice President, Regenerative Medicine of Athersys; and Richard S. Stack, MD, FACC, President of Synecor.

The panel will explore the unique challenges of commercializing regenerative medicine products and will draw on the participants’ real-world experiences to provide best practices for how companies can successfully implement a commercialization strategy.

“Striking the right balance of resource allocation between product development and commercialization within rapidly growing companies is always a challenge,” said Tozer. “This challenge is magnified in the field of regenerative medicine because both the research and commercial efforts must be innovative, successfully executed, and also educate government agencies, health care providers and patients along the way. ABH has achieved consistent, double-digit revenue growth by addressing and overcoming commercialization challenges for our lead product, Dermagraft®, and I look forward to sharing how we faced them head on to become a leader in our field.”

ABH will also present a poster abstract titled, “Fibroblast-Based Tissue-Engineered Products for Regenerative Medicine Applications.” The abstract will summarize the composition of Dermagraft and describe how the product constituents may be involved in potential mechanisms of action that could support various clinical applications. The poster will be available for viewing at the Forum.

The Forum serves to inspire interactions between leaders in academic and clinical research, biotechnology, regulatory and healthcare policy.

For more information visit www.regenerativemedicinefoundation.org and to register for the meeting, please visit www.rmconferences.org.

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company with more than 250 employees, Advanced BioHealing maintains its corporate office in Westport, Conn., a 70,000 sq. ft. manufacturing facility in La Jolla, Calif., and a research facility in Nashville, Tenn. To meet Advanced BioHealing’s executives and learn more about the Company, please visit the Company’s web site at www.ABH.com.

About Dermagraft®

Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 200,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.

 

 

Advanced BioHealing to Showcase Dermagraft® at Diabetic Foot Global Conference

March 10, 2010

Westport, CT – March 10, 2010

Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that it will host three events featuring the Company’s lead product, Dermagraft® at this year’s Diabetic Foot Global Conference (DF Con) 2010, the largest annual interdisciplinary diabetic foot conference in North America.

Dermagraft is an FDA-approved bio-engineered skin substitute that repairs damaged tissue and supports the body’s natural healing process in patients with diabetic foot ulcers (DFUs). DFUs affect 15 to 25 percent of diabetes patients during their lifetime, putting them at risk for lower limb amputation or death if not treated properly. Dermagraft is also the focus of an ongoing pivotal trial in subjects with venous leg ulcers.

DF Con 2010 is focused on bringing together physicians and other clinicians, researchers, scientists and limb salvage experts committed to improving standards of care in the treatment of DFUs, with the goal of reducing amputations due to the disease.

“There is much work that remains to be done for the treatment of DFUs, but we have already made great strides,” said Dean Tozer, Senior Vice President of ABH. “Through events such as DF Con 2010, we hope to continue to educate medical professionals on ways to effectively manage DFUs and increase patient compliance. Ideally, this will ultimately result in a greater standard of living for these patients and a return to normalcy after their DFU heals.”

ABH will host the following events at DF Con 2010:

  • Breakfast Symposium: Optimizing the Standard of Care for Diabetic Foot Ulcers. Robert Kirsner, MD, PhD, will address the evolution of DFU treatment and the subsequent formation of a new standard of care, for which Dermagraft is central, and how doctors can implement this standard in their practice. The event will be held on Friday, March 19 from 7 a.m. to 8 a.m. in Studios D and E of the Hollywood Ballroom on the Mezzanine Level. Dr. Kirsner is a Professor and Vice Chairman in the Department of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine, and Director of the University of Miami/Cedars Wound Center.
  • Hands-On Workshop: Wound Closure. Hosted by Lee C. Rogers, DPM, and Nicholas J. Bevilacqua, DPM, Associate Medical Directors of the Amputation Prevention Center at Valley Presbyterian Hospital in Van Nuys, Calif., the workshop will be held Saturday, March 20 from 7 a.m. to 10 a.m. in the Hollywood Ballroom Studio D. At the workshop, pieces of Dermagraft will be available for attendees to practice preparing and applying to a rubber foot ulcer wound. To date, nearly 200,000 pieces of Dermagraft have been supplied to over 1,000 wound care centers and outpatient clinics nationwide.
  • Poster Presentation. Robert A. Warriner, III. M.D., FACA, FCCP, FCCWS, ABPM/UHM; Matthew Cardinal, ME; and Robert J. Snyder, DPM, CWS will present a poster abstract titled, “Delayed Progress in Wound Area Reduction After Four Weeks of Standard Care Predicts Failure to Heal Diabetic Foot Ulcers.” To better understand events that precede the failure to heal DFUs, despite early progress, investigators examined wound area measurements in 120 subjects who had achieved at least 50 percent area reduction of their DFUs following four weeks of conventional treatment. The abstract sheds light on the sub-clinical events that impact the healing of DFUs. The poster will be available for viewing throughout the duration of DF Con 2010. To view the complete abstract, visit: http://www.dfcon.com/abstracts.html.

DF Con 2010 will be held March 18-20, 2010 at the Renaissance Hollywood Hotel in Los Angeles. ABH will be exhibiting at Booth #304 in the Exhibitor Grand Ballroom.

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company with more than 250 employees, Advanced BioHealing maintains its corporate office in Westport, Conn., a 70,000 sq. ft. manufacturing facility in La Jolla, Calif., and a research facility in Nashville, Tenn. To meet Advanced BioHealing’s executives and learn more about the Company, please visit the Company’s web site at www.ABH.com.

About Dermagraft®

Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 200,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.

 

Advanced BioHealing to Present at Canaccord Adams Musculoskeletal Conference

March 6, 2010

Westport, CT – March 2, 2010

Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that Vice President and Chief Scientific Officer Charles E. Hart, Ph.D. will present at the Canaccord Adams Musculoskeletal Conference. The conference will be held March 9, 2010, at the Sheraton New Orleans Hotel in New Orleans, LA.

Dr. Hart’s presentation is scheduled for Tuesday, March 9, 2010, at 11:00 a.m. He will provide an overview of the Company including its product pipeline led by Dermagraft®, ABH’s bio-engineered skin substitute that repairs tissue damaged by disease and supports the body’s natural healing process. Dermagraft is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetic foot ulcers (DFUs) and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers. The Company has also initiated plans to extend the use of Dermagraft into orthopedic soft tissue indications.

Since launching commercial operations in 2007, ABH has experienced double-digit revenue growth achieving more than $85 million in annual revenue for 2009 and surpassing 250 employees.

“We are pleased to have been invited to present at this year’s Canaccord Adams Musculoskeletal Conference,” said Dr. Hart. “The demonstrated effectiveness of Dermagraft in the treatment of DFUs suggests that this product should have clinical utility in the treatment of a variety of orthopedic indications related to soft tissue repair, such as rotator cuff tears. Exploring these possibilities is at the core of our efforts to expand the use of Dermagraft into new therapeutic areas.”

About Advanced BioHealing, Inc.

Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company with more than 250 employees, Advanced BioHealing maintains its corporate office in Westport, CT, a 70,000 sq. ft. manufacturing facility in La Jolla, CA, and a research facility in Nashville, TN. To meet Advanced BioHealing’s executives and learn more about the Company, please visit the Company’s web site at www.ABH.com.

About Dermagraft®

Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. More than 150,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.