JERUSALEM, June 18, 2013 /PRNewswire/ --
RegeneCure announced today the start of a clinical study using the company's proprietary AMCA Guided Bone Regeneration (GBR) Dental Membrane as a bone stimulating aid for patients requiring dental implants.
A common problem encountered when patients have a tooth replaced with a dental implant is the lack of sufficient bone volume to house the implant. Consequently there is often a need to support the implant with a bone substitute until the natural bone regenerates. The bone substitute material, in turn, needs to be held in place by a membrane.
RegeneCure's innovative AMCA GBR membrane has important quality and safety advantages over currently-used collagen-based membranes:
The membrane is entirely synthetic, eliminating risk of contamination by pathogens present in animal-tissue-derived membranes:
The AMCA GBR membrane is strong, degrades slowly over time, giving the natural bone more time to properly regenerate;
The membrane accelerates healing by enabling excellent cell adherence, proliferation and differentiation of stem cells into the bone tissue, while preventing connective tissue from infiltrating into the healing space.
"Pre-clinical trials have shown excellent healing, including complete restoration of the bone," said Moshe Tzabari, CEO of RegeneCure, adding "Our technology is designed to improve and accelerate healing in a large variety of medical procedures."
About The Trial
A total of 32 patients suffering from insufficient bone volume for dental implant placement will be enrolled in the prospective, randomized, controlled study. One study arm, comprising 16 patients, will use RegeneCure's membrane; the other study arm, also comprising 16 patients, will use a collagen membrane. Study participants will include non-smokers and smokers, in order to provide clinical data for potential use in both smoking and non-smoking populations.
The study will examine if RegeneCure's membrane enables a similar or better amount of lateral bone fill compared with the collagen membrane which is considered the gold standard treatment today. Each patient will be followed over a 6-month period.
The Principal Investigators are Prof. Lior Shapira, Chairman of the Department of Periodontology at the Hadassah Medical Center, Jerusalem, Israel and Prof. Eli Machtei, Director of the Dept. of Oral Medicine & Periodontology at the Rambam Medical Center in Haifa, Israel.
The AMCA membrane is thin and flexible, drill-able, and easily sutured in the treated area. It is easy to use in orthopedic surgery and requires no special surgical knowledge or special preparation prior to use.
About the Market
The global dental implants market is set to almost double in value over the next six years, owing to the aging population and the availability of advanced solutions for dental implants in conjunction with oral regenerative tissue products. Global sales of dental implant systems reached more than $3.4 billion in 2012 with Europe (49%) as largest market before the United States (31%). In 2012, the global dental membrane market was over $200 million with annual growth of 5-10% to reach $300 million by 2017.
RegeneCure Ltd. was founded in July 2010 to develop, produce and market synthetic implants for bone reconstruction and fracture fusion for the orthopedic, dental and aesthetic fields. AMCA Membrane Implant technology is protected by worldwide patents. The company submitted a 510(k) application to the FDA in April 2012 for an initial trauma indication. The privately owned company has manufacturing facility meeting the high production standards required by European and United States authorities. In 2012, the company received ISO 13485:2003 certification.
SOURCE RegeneCure Ltd.