Xeridiem® to Provide Design and Development Services to LoneStar Heart Inc.
TUCSON, Ariz., Aug. 14, 2012 /PRNewswire/ -- Xeridiem, a vertically integrated OEM that designs, develops and manufactures complex single use medical devices, will provide LoneStar Heart Inc. with design and development services for the minimally invasive delivery system for Algisyl-LVR®, an implantable biopolymer for the treatment of dilated cardiomyopathy. LoneStar Heart Inc. is developing a trio of technologies with the potential to restore the heart wall structure and prevent or reverse the progression of advanced heart failure. "This development collaboration will allow LoneStar Heart to focus on their core expertise which is further developing their Algisyl-LVR technology while relying on Xeridiem for the engineering and design control infrastructure. Essentially Xeridiem will be acting as LoneStar Heart's development team," stated Joseph Lee, Xeridiem's President.
Xeridiem designs, develops, and manufactures single use medical devices focused in gastroenterology, cardiology, and urology for established healthcare companies and venture-backed entrepreneurs. Since 1986, Xeridiem as a silent partner has enabled major medical device companies and venture-backed entrepreneurs to deliver over 22 million medical devices used worldwide and intended to reduce cost of patient care.
In recognition of design and development capabilities, Xeridiem was awarded the MDEA and R&D 100 awards in 2011. ISO 13485:2003 certified, FDA registered, and compliant to CFR 21 Part 820.
About LoneStar Heart Inc.
LoneStar Heart Inc. is developing cardiac restorative therapies for patients with heart failure that harness the heart's ability to repair itself. Based on its integrated cardiomechanical and biomolecular technologies, the privately held company is advancing a broad portfolio of products to restore the failing heart's structure and function in collaboration with the Texas Heart Institute, the University of Texas Southwestern Medical Center, and a global network of leading clinicians. These products include Algisyl-LVR™, cardiac stem-cell modulators, and cellular and genetic therapies delivered as stand-alone treatments, or in combination with the company's proprietary biopolymer matrix system. LoneStar Heart's lead product, Algisyl-LVR, is a single-use, self-gelling biopolymer implanted into the heart's left ventricle during surgery. Providing internal tissue support, Algisyl-LVR is aimed at preventing the progression of heart failure and restoring the heart's normal structure and function with a significant improvement in the patient's quality of life. Classified as a medical device, the product is undergoing a randomized controlled clinical study (AUGMENT-HF) in Europe to evaluate its safety and efficacy in patients with advanced heart failure.
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