Nasseo, Inc. announced today that the FDA has approved its TiArray™ Dental Implant System for commercial sale in the U.S. It was developed to address a gap in medical care that is currently adding significant costs to the US healthcare system: the failure of dental implants.
“The FDA approval of the Nasseo TiArray™ Dental Implant is an important step toward our goal of providing dentists and millions of patients worldwide with improved treatment options.” – Dr. Garrett Cale Smith (CEO)
September 16, 2013
Nasseo, Inc. announced today that the U.S. Food and Drug Administration (“FDA”) has approved its TiArray™ Dental Implant System for commercial sale in the U.S. It is the first commercial application of Nasseo’s proprietary surface modification technology, which was initially developed over 8 years out of UC San Diego Bioengineering and Materials Science Departments, and the Bio-Implant Laboratory at Lund University in Sweden. The inflammation (“peri-implantitis”) that many patients suffer in reaction to existing dental implants is currently a significant cause of both bone loss and dental implant failure over time. Patients and doctors alike are seeking better performing implants which lower inflammation and promote faster healing.
The TiArray™ Dental Implant System was developed to address a gap in medical care that is currently adding significant costs to the US healthcare system: the failure of dental implants. The $1B+ US dental implant market is growing quickly as clinicians move away from dentures and bridges. However, existing dental implants often fail, requiring repeated clinical visits and additional implants, which is expensive for patients and an inefficient use of clinician time. Due to high dental implant failure rates and growing peri-implantitis concerns, certain high-risk patient populations (e.g. heavy smokers) are being advised against implants altogether. Nasseo aims to address these concerns and provide a longer lasting dental implant.
Dr. Garrett Cale Smith, Co-Founder and CEO, says “Achieving the significant milestone of FDA approval allows us to continue to increase the value of our technology by running clinical trials with key opinion leaders at leading centers. The FDA approval of the Nasseo TiArray™ Dental Implant System is an important step toward our goal of providing dentists and millions of patients worldwide with improved treatment options.”
While the company’s FDA approval news will accelerate its timeline for clinical trials and commercialization, Nasseo is excited to attend two prominent investor and partnership conferences later this month. Dr. Smith will present the company’s work at the Rocky Mountain Life Sciences Investor & Partnership Conference taking place September 18-19 at The Ritz-Carlton in Denver, while Kayvon Pourmirzaie, Co-Founder and COO, will represent Nasseo at the NCET2 Global 1000 Corporate Venturing Conference on September 17-18 at the Marriott San Mateo. Nasseo is seeking to close on a Series A investment/corporate partnership round by the Fall 2013.
Pourmirzaie says, “Our success so far has been based not only upon our novel technology, but also the enthusiastic support of the scientific and business communities. We will continue to evaluate new strategic partnerships that support our efforts to conduct clinically relevant studies and bring Nasseo’s highly differentiated TiArray™ Dental Implant System to market.
For more information about Nasseo’s surface modification technology, the TiArray™ Dental Implant System, investment opportunities, or to request meetings at the events listed above, please contact Kayvon Pourmirzaie at kayvon(at)nasseo(dot)com.
About the Dental Implant Market
In the United States, over 70% of adults have lost at least one permanent tooth, while 25% of American adults over 65 have lost all of their teeth. This demand amounts to a fast growing $1B+ US market. However, existing implants on the market experience high failure rates and peri-implantitis issues depending upon the tooth’s location and other factors and are not recommended for a number of large populations including diabetics, heavy smokers, and patients with gum disease. The demand for dental implants is expected to double over the next five years.
About Nasseo, Inc.
Nasseo, Inc. is a medical device company using state of the art surface modification technology to provide patients and clinicians with the next generation of dental and orthopedic implants. Nasseo is a member of the BioInspire™ medical incubator and is a CONNECT Portfolio company. The Company has won many competitions including the Arizona Innovation Challenge $250K grant, the 2013 CONNECT Life Sciences Capital Competition, and the 2012 UCSD Entrepreneur Challenge, and has been selected to the 2012 World’s Best Technology (WBT) Innovation Marketplace and the 2013 TechConnect World/National Innovation Showcase. Nasseo is based in Phoenix, AZ and San Diego, CA. Please visit http://www.nasseo.com for more information.