SaluMedica is a pioneer in the development of medical devices to replace soft tissue throughout the body. The company is dedicated to creating new applications to surpass the limits of currently available options and ultimately improve the quality of life for patients.
The invention of Salubria marks the first new biomaterial designed specifically for medical implants in years. SaluMedica's unique biomaterial, trademarked Salubria, is designed to be similar to human tissue in its mechanical and physical properties. The biostable hydrogel composition contains water in similar proportions to human tissue, making it soft and compliant. For certain applications, the material has been formulated to be exceptionally wear resistant and strong. The base organic polymer is known to be highly biocompatible and hydrophilic. These properties make it an ideal implant, suitable for development into medical products addressing various applications.
After inventing Salubria biomaterial, David N. Ku, M.D., Ph.D., President and CEO, founded SaluMedica in 1998. Dr. Ku is a Regents' Professor and Lawrence P. Huang Chair of Engineering Entrepreneurship at the Georgia Institute of Technology, and is Professor of Surgery at Emory School of Medicine. He received an M.D. from the Emory School of Medicine, a Ph.D. in Aerospace Engineering from the Georgia Institute of Technology, and a B.A. in Engineering from Harvard University.
The company has integrated a compliant Quality System according to the requirements of FDA Quality System Regulations and ISO 13485:2003.
SaluMedica's team developed its first product, the SaluBridge Nerve Cuff for peripheral nerve repair and received FDA market clearance for the US in late 2000, followed by the CE mark in 2001 for sale in Europe, and the Medical Device License for sale in Canada in early 2002. The SaluBridge nerve cuff is intended to provide a protective environment for peripheral nerve repair after injury. Nerves have been demonstrated to successfully regenerate across a gap when an entubulation technique is utilized. The SaluBridge nerve cuff eliminates the need for a nerve graft, thereby removing the risk of donor site morbidity. SaluMedica is pursuing a distribution network to make SaluBridge commerically available to the market at this time.
The Company's second product, SaluCartilage, is designed to replace cartilage surfaces worn out by arthritis and sports injury. SaluCartilage is a synthetic implant developed to replace worn-out cartilage surfaces, restoring mobility and relieving joint pain. Damaged articular cartilage may be cored out and replaced with SaluCartilage to provide a smooth, load-bearing joint surface. This procedure offers a less invasive and more cost-effective alternative to current therapies. SaluCartilage was granted the CE Mark in April 2002, allowing for sale in Europe. The FDA submission required for sale in the US is on-going.
112 Krog Street, Suite 4
Atlanta, GA 30307
Contact: Bobby Singer, Vice President, Sales