Fogarty Institute graduate InterVene, a startup that has developed a minimally invasive device for the treatment of venous disease in the legs, has treated the 10th patient in their ongoing, multi-center, feasibility study in New Zealand and Australia.
Based on the encouraging initial results from this study, the company is working with the FDA to initiate a U.S. trial arm and has also submitted the results for public presentation and publication. The company is now leveraging this trial data for a Series B fundraising effort.
“The feedback we received from our physician investigators was overwhelmingly positive,” said Fletcher Wilson, founder and CEO of InterVene. “We are excited to share the initial results of this study in upcoming presentations and publications.”
A market ripe with possibilities
This is an ideal time to be in the venous interventional space, given increasing activity and strategic investments by companies such as Boston Scientific and Medtronic, and VC firms like New Enterprise Associates (NEA).
InterVene’s BlueLeaf Endovenous Valve Formation System represents the first non-implantable, catheter-based therapy to address deep vein reflux, a major underlying cause of chronic venous insufficiency (CVI)*. CVI is characterized by insufficient blood flow back to the heart and elevated venous pressures, which leads to pain, swelling, skin changes and chronic ulcers.
CVI is not uncommon — it afflicts millions of patients in the U.S. and costs the U.S. healthcare system billions of dollars annually. To date, CVI treatment for patients with deep vein reflux has been limited to compression stockings and wound care, or in some instances, invasive surgery.
Unfortunately, these methods do not address the underlying problem of deep vein valve failure, and compression therapy yields low rates of patient compliance. InterVene’s technology is intended to form new vein valves out of the layers of tissue that naturally make up a patient’s vein wall, avoiding the trauma of open surgery and allowing for multiple valves to be formed in a single procedure.
Exciting developments on the horizon for InterVene
The company has just begun raising Series B funding, with significant support from current investors.
In other developments, a physician has presented a case study from InterVene’s current clinical trial at the recent Transcatheter Cardiovascular Therapeutics (TCT) conference, the world’s largest educational meeting specializing in interventional cardiovascular medicine.
They will have a small feature presentation at VEITHsymposium in November.
They have also submitted an abstract to be presented at AVF in February 2019.
Closer to home, Fletcher will be participating in one of the Fogarty Institute’s upcoming educational seminars with fellow Fogarty Institute graduate Surbhi Sarna, CEO of nVision Medical, which was recently sold to Boston Scientific. “We continue to benefit from the Institute’s mentoring program and are excited to be part of a team giving back to early-stage entrepreneurs, so they can learn from our experiences and accelerate their time to market and patients,” said Fletcher.
* Investigational device. Limited by Federal (or United States) law to investigational use. To be used exclusively for clinical investigations.