FREMONT, Calif., Feb. 26 /PRNewswire/ -- Biomerix Corporation announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market REVIVE(TM). Constructed using the Biomerix Biomaterial(TM), REVIVE acts as a tissue scaffold facilitating rapid tissue ingrowth and can be utilized in a variety of soft tissue repair procedures, including the repair of inguinal hernias.
With more than 700,000 procedures per year, inguinal hernia repair is one of the most common surgeries in the U.S.(1) Hernia repair typically involves the use of a mesh to reinforce and support the surrounding tissue. REVIVE is designed to minimize the scarring response that results from implantation of a mesh, which studies have shown can lead to persistent groin pain in 30% of patients at one year(2). Clinical feedback has confirmed REVIVE offers excellent conformability to the defect and ease of handling.(3)
“Biomerix is poised for rapid growth over the course of the next few years. The company plans to launch numerous products across a range of therapeutic areas by capitalizing on its novel Biomerix Biomaterial platform technology. REVIVE is specifically designed to support tissue remodeling by enhancing the soft tissue wound healing process and thereby improves clinical outcomes,” stated Kenneth G. Hayes, President and Chief Executive Officer of Biomerix Corporation.
The company has initiated a market launch of REVIVE in the U.S. through a small direct sales force and plans to expand the group over time as additional products are brought to market.
About Biomerix Corporation
Biomerix Corporation develops and manufactures a broad portfolio of implantable medical devices based on its proprietary Biomerix Biomaterial(TM) platform technology. Unique to the Biomerix Biomaterial, is its ability to facilitate fibrovascular tissue in-growth and improve wound healing with a minimal inflammatory response, leading to better clinical outcomes. Biomerix strives to improve patient outcomes through the development of medical devices for soft tissue repair, neurovascular embolization, spine annular repair, cardiovascular repair and women’s health indications, utilizing its novel biomaterial.
For more information please call 888.308.3620 or visit www.biomerix.com.
1. Millenium U.S. Markets for Soft Tissue Repair 2008. 2. Bay-Nielsen M et. al., “Pain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study,” Ann Surg 2001 Jan;233(1):1-7. 3. Data on file with Biomerix Corporation
