Mesynthes Obtains U.S. FDA 510(k) Clearance for Endoform Dermal Template™
Novel Biomaterial for Wound Healing and Regenerative Medicine
WELLINGTON, NZ (February 2, 2010): Mesynthes, a privately held regenerative medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Endoform Dermal TemplateTM. Endoform, a proprietary extracellular matrix biomaterial, provides a unique biologic template for tissue regeneration.
“FDA marketing clearance for Endoform Dermal TemplateTM paves the way for commercial launch into the U.S. dermal market and establishes our EndoformTM platform as a new medical biomaterial for tissue repair and reconstruction,” said Dr. Brian Ward, Chief Executive Officer.
Mesynthes’s EndoformTM technology utilizes a proprietary extracellular matrix biomaterial containing a complex mixture of important biological molecules, including structural and adhesive proteins, such as collagens, elastin, fibronectin and laminin, and glycosaminoglycans.
“In tissue regeneration, it is now well recognized that a diverse mix of extracellular matrix components is important for orchestrating a regenerative response. These components provide important structure, signals, and substrates to cells within the healing tissue,” said Dr. Ward. “Once applied to the wound bed, the Endoform Dermal TemplateTM provides a uniquely supportive environment to guide the growth of cells and new tissue. Over time, EndoformTM is completely replaced by the patient’s own tissue. Clinically, the impact of applying extracellular matrix within a chronic wound is to restart the stalled healing process and stimulate new tissue growth in the wound bed. In acute wounds, extracellular matrix replaces lost dermis, advancing the wound healing process and reducing contracture.”
Chronic wounds are difficult to heal, require ongoing care, and risk complications that can lead to amputation. In the United States, the treatment costs of chronic and complex wounds have been estimated to be $20 billion per year, which creates a significant burden on the healthcare system.
Endoform Dermal TemplateTM provides a new tool to address this important issue. About the Endoform Dermal TemplateTM
Endoform Dermal TemplateTM is presented as a sterile dry sheet in a peel pouch and is strong and easy to handle in a dry or wet state. It is applied directly to the wound bed, then rehydrated, covered with a non-adherent dressing, and secured in place. EndoformTM is quick and easy to apply, available off-the shelf, and doesn’t require special storage.
Endoform Dermal TemplateTM is intended for the management of a wide variety of wounds including:
- partial and full-thickness wounds
- pressure ulcers
- venous ulcers
- diabetic ulcers
- chronic vascular ulcers
- tunnelled/undermined wounds
- surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
- draining wounds
Endoform’s unique features include its innate biology, strength, size, usability, and versatility. Also, Mesynthes’ proprietary processing and ovine (sheep)-derived biomaterial combine to add a new level of xeno-biological safety and cultural acceptability.
Mesynthes is developing a suite of medical devices for applications in regenerative medicine including products for wound care and soft tissue reconstruction based on the EndoformTM platform.
Mesynthes Ltd. is a privately held regenerative medicine company that has developed EndoformTM, a novel extracellular matrix platform for soft tissue repair and reconstruction. For more information on Mesynthes and its technology and products, please visit our web site at http://www.mesynthes.com.
Mesynthes Chief Executive Officer
Ph: +64 21 727646
Email: [email protected]
Ph: +1 (415) 821 2413
Email: [email protected]