CryoLife eyes FDA approval for dissolving hemostat
|CryoLife is aiming to get PerClot FDA approved by 2015.--Courtesy of CryoLife|
CryoLife ($CRY) won the FDA's blessing to kick off a U.S. trial of its PerClot bleeding-control device, plotting a large-scale study to snag U.S. approval.
Like other hemostats, PerClot is designed to stem bleeding during surgery, but CryoLife's technology is made up of absorbable polysaccharide granules that form a barrier to stop bleeding before harmlessly degrading after a few days.
Now, with the FDA's signoff, CryoLife plans to start enrollment for a pivotal trial in the third quarter, aiming for FDA approval in 2015. The company will study PerClot's safety and efficacy on patients undergoing surgery, looking for successful hemostasis within 5 minutes while keeping an eye on adverse events.
CryoLife estimates the U.S. hemostatic market will swell to around $1.1 billion by 2014, and, if PerClot's international performance is any indication, the company is well positioned to snag a share of that growth. The sealant won a CE mark back in 2010, and its international sales jumped 34% last quarter compared to the previous year, the company said.
The Atlanta-headquartered company has been expanding its reach across surgical devices and tissue treatments, last year paying $17 million for Hemosphere and its graft to treat end-stage renal disease. In 2011, CryoLife bought Cardiogenesis for $22 million, absorbing that company's surgical technologies for coronary artery disease.
- read CryoLife's statement