The FDA set dates with Cartiva and Angel Medical to review premarket approval applications for Cartiva’s Synthetic Cartilage Implant and Angel Medical’s Guardian cardiac monitor system, the companies said today.
Alpharetta, Ga.-based Cartiva is slated to meet with the federal watchdog on April 20, to review the application for its SCI, which is designed to treat osteoarthritis at the base of the great toe, according to the company.
“We are looking forward to the opportunity to present the safety and clinically relevant efficacy data from our pivotal clinical study, the largest ever conducted for this painful condition. This panel meeting is the culmination of many years of hard work by our employees and clinical researchers and marks one of the final steps on the path to commercialization of Cartiva in the United States. I am also particularly pleased with the outcome of the recent FDA inspection of our facility, which is a testament to our robust quality system,” Cartiva CEO Timothy Patrick said in prepared remarks.
Cartiva said the FDA recently inspected its home-based facility without any issues, as no observations were noted and no Form 483 was filed during the 5-day inspection.
Angel Medical plans to meet with the FDA on March 16 to discuss the PMA application for its implantable Guardian cardiac monitor designed to detect rapid changes in electrical signals caused by coronary artery occlusions and notify the patient through vibration, audible alarms and visual warnings.
“The upcoming advisory panel meeting represents important progress toward our goal of obtaining FDA approval of the Guardian System. We look forward to presenting the safety and efficacy data and the overall benefit-risk profile of the Guardian System to the advisory panel and will continue to work interactively with the FDA during the review period,” Angel Medical CEO Dr. David Fischell said in a press release.
The FDA committee will review data in the PMA from the company’s 907-patient pivotal Alerts study of the Guardian system, Shrewsbury, N.J.-based Angel Medical said.
“Reducing the time to treatment following a coronary occlusion is universally accepted by cardiologists as a means to reduce the harm associated with heart attacks. Heart attack symptoms often go unrecognized, if they occur at all, leading to dangerous delays in treatment. The Guardian System could significantly benefit high-risk patients by providing them a clear signal to seek immediate medical attention if they experience a coronary occlusion,” co-principal investigator Dr. David Holmes, Jr. of the Mayo Clinic said in a prepared statement.
The company said it received the final $10 million tranche of a milestone-based $40 million comvertible note that initially closed in 2012.