06 Oct, 2015, 09:00 ET
AUSTIN, Texas, Oct. 6, 2015 /PRNewswire/ -- TVA Medical, Inc., a medical device company developing minimally invasive therapies for patients suffering from End-Stage Renal Disease (ESRD), today announced the completion of a $15 million Series C financing with new investors Baxter Ventures (lead) and Boston Scientific Corporation; existing investors Sante Ventures, S3 Ventures, TriStar Technology Ventures; and other strategic investors.
The investment round will support continuation of clinical activities and acceleration of market development for the everlinQ™ endoAVF System, a catheter-based technology designed to create hemodialysis access for chronic kidney disease patients in a minimally invasive procedure. Funds will support the ongoing Novel Endovascular Access Trial (NEAT) clinical study (12-month follow up to complete in 2016) and additional global clinical research, as well as device reimbursement and market access initiatives.
"We are committed to providing kidney failure patients and caregivers with a minimally invasive endovascular arteriovenous (AV) fistula option," said Adam L. Berman, president & chief executive officer of TVA Medical. "This financing strengthens our ability to bring the innovative everlinQ endoAVF System to the global market."
Worldwide more than 2 million patients with ESRD receive hemodialysis therapy and require vascular access to connect to a dialysis machine.1 Surgical AV fistulas are currently the standard approach to achieve vascular access but are associated with high failure rates, often as high as 60 percent.2 Surgical AV fistulas also require frequent revisions, resulting in increased morbidity and unnecessary costs.3
About the everlinQ endoAVF System
The everlinQ endoAVF System is designed to create an AV fistula for hemodialysis access using a minimally invasive approach. In the procedure, two thin, flexible magnetic catheters are inserted into an artery and vein in the arm. A small burst of radiofrequency energy is used to connect the artery and vein to create the fistula, and the catheters are removed. The system has been studied outside the United States and has received CE mark. It is not currently available in the United States and has not been approved for commercial use by the U.S. Food and Drug Administration.
About TVA Medical
TVA Medical, Inc., headquartered in Austin, Texas, is developing minimally invasive therapies for end-stage renal disease and other potential applications, including a catheter-based AV fistula system. More information is available at www.TVAMedical.com
1 US Renal Data System. USRDS 2009 Annual Report.
2 Al-jaishi, et al. Am J Kidney Dis 2014;63:464-78.
3 Lok. Clin J Am Soc Nephrol 2: 1043-1053, 2007.
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SOURCE TVA Medical, Inc.
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