New Leaf Venture Partners Announces $3.5 Million Financing in Direct Flow Medical.

NEW YORK & MENLO PARK, Calif. -- New Leaf Venture Partners (NLV Partners) announced today that it has co-led an $8 million Series A private equity financing in Direct Flow Medical, a medical device company. NLV Partners invested $3.5 million in the financing, which was co-led by Spray Venture Partners and also included existing investor EDF Ventures.

Randy Lashinski, President and Chief Executive Officer of Direct Flow Medical, stated, "We are pleased to have expanded our base of investors and to be working with venture partners that have a depth of experience and understanding of the cardiovascular device area. Proceeds of the Series A round will be used to advance into human clinical trials our lead product, the Direct Flow percutaneous aortic tissue valve prosthesis. The company's goal is to initiate its first clinical study outside of the United States in late 2006, following the successful completion of which we would expect to begin a European trial in 2007 and file for an IDE in the U.S. that same year."

In connection with the financing, Jeani Delagardelle, a managing director at NLV Partners, has joined Direct Flow Medical's board of directors. Ms. Delagardelle commented, "Direct Flow Medical's technology allows the delivery of a replacement aortic valve via a catheter and utilizes devices and techniques familiar to the interventional cardiologist, often a rapid adopter of innovative technologies. We believe that this next-generation device may be able to address the issues around safety, deliverability and repositioning requirements, providing an opportunity that fits squarely within our early-stage medical device investment strategy."

Ms. Delagardelle continued, "In our opinion, Direct Flow Medical's less-invasive, proprietary approach could significantly expand the number of aortic valve replacement procedures performed annually, which is currently estimated at 150,000 surgeries each year in the United States. Specifically, this technology is designed to enable aortic valve replacement for non-surgical candidates who are too sick for surgery and, conversely, for patients who are not sick enough to justify the risk of open-heart surgery and who are generally managed with drug therapy. Together, these patient populations represent an additional 150,000 potential procedures."

About Direct Flow Medical

Founded in 2004 by Randy Lashinski and Gordon Bishop, Direct Flow Medical is a medical device company located in Santa Rosa, CA. Direct Flow Medical is developing a percutaneous aortic tissue valve prosthesis to provide patients requiring treatment of cardiac valve insufficiency with a safe and effective percutaneous option. Approximately 1.2 million people over the age of 65 have calcified aortic valves, yet only an estimated 150,000 are surgically treated each year.

About NLV Partners

NLV Partners is a life science-dedicated venture capital firm with offices in Menlo Park and New York. Founded by the former members of Sprout Group's Healthcare Technology venture team, NLV Partners invests primarily in companies focused on clinical-stage biopharmaceutical products, early-stage medical devices, and molecular diagnostics. In addition, the NLV Partners team will continue to manage the existing $800 million healthcare technology portfolio of Sprout Group.