dimecres, 14 de setembre del 2016

Essential Medical closes $14.9M Series B for vascular closure device

Essential MedicalEssential Medical said today that it closed a $14.9 million Series B round to support the development and commercialization of its vascular closure devices.

The round was led by Amzak Health and joined by prior backer Royal DSM venture investment arm DSM Venturing, the Malvern, Pa.-based company said.

“We are thrilled that Amzak Health has the confidence in the novel Essential Medical technology and our team to lead this round of financing along with our original investors. The Amzak group will also provide additional expertise and experience to our board of directors as our company transitions to commercialization in Europe and the initiation of the U.S. clinical trial for our Manta product,” CEO Greg Walters said in prepared remarks.

The company’s Manta vascular closure device is designed to close punctures at femoral arterial access sites after catheterization procedures, including transcatheter aortic valve replacements, endovascular treatment of abdominal aortic aneurysms, ventricular assist procedures and balloon aortic valvuloplasty procedures.

In August, Essential Medical won an investigational device exemption from the FDA to begin a trial of its X-Seal 6F vascular closure device. The 180-patient pivotal study is slated to run across 10 to 16 sites in the U.S., Canada and the European Union, the company said.

The trial will examine the safety and efficacy of the X-Seal device through the comparison of complication rates, time-to-hemostasis and time-to ambulation rates, Essential said.

Essential Medical said it’s already received CE Mark approval in the EU and completed a post-market study of the device in February. The company won CE Mark approval in the European Union for its Manta vascular closure device in July.

The post Essential Medical closes $14.9M Series B for vascular closure device appeared first on MassDevice.



from MassDevice http://ift.tt/2cJrTcx

Cap comentari:

Publica un comentari a l'entrada