Cardiva Medical, an innovator in the field of vascular closure, has announced that the company has closed on US$11 million in additional financing – bringing total equity and debt financing in the current round to US$41 million. The additional financing exceeds previous commitments for this round and includes returning equity and debt investors – including PTV Healthcare Capital, Canepa Healthcare, and affiliates of Luther King Capital Management.
Funds will be used to continue US commercial expansion of the VASCADE vascular closure system and to fund the AMBULATE clinical trial, an investigational device exemption study of Cardiva’s investigational closure system for mid-bore veins (defined as 6-12 French inner diameter access sheaths) used in cardiac ablation and other procedures.
“This additional investment reflects enthusiasm from our investors for the continued high rate of sales growth of VASCADE, as well as for the exciting potential of our mid-bore vein closure program,” said John Russell, Cardiva’s president and CEO. “With the AMBULATE trial, we are fortunate to have a world-class group of investigators engaged in this first-of-its-kind study.”
Pioneering the Next Frontier for Vascular Closure – The AMBULATE Trial
Cardiac ablation procedures are performed by specialised electrophysiologists with the goal of relieving symptoms and reducing the risk of stroke for patients with atrial fibrillation, a rhythm abnormality affecting up to 6.1 million Americans. Upon completion of these procedures, multiple access sites remain from the catheters inserted via the femoral veins in the groin. Today these sites are closed by application of manual compression and the patient is confined to bed for up to six hours prior to ambulation to protect the vascular puncture sites.
The AMBULATE trial is a prospective, multi-centre, randomised, controlled study enrolling 204 patients at leading sites across the United States. Patients are randomised to vessel closure with the Cardiva Medical system versus standard manual compression. The goal of the AMBULATE Trial is to significantly reduce the time to ambulation for patients following these complex electrophysiology procedures.