HAMBURG, Germany – Startup company Pq Bypass Inc. has completed a round of funding that can provide up to an aggregate of $60 million in equity financing to be used to advance clinical develop of its Detour system, which treats long blockages in leg arteries caused by peripheral arterial disease. The goal of the company is to eventually win U.S. FDA clearance for the system.

The financing round was led by Deerfield Management and joined by existing investors, including Seroba Life Sciences and MedTech Venture Partners. The financing agreement also allowed Pq Bypass to convert around $15 million in outstanding convertible debt and interest to equity.

"With this funding we continue our pursuit of the science that will bring us closer to commercial release of this important advancement in the care of patients with PAD," said Richard Ferrari, chairman and CEO of Pq Bypass.

Ferrari, who also is a managing director of the medical devices and biotech fund De Novo Ventures, added: "We are very fortunate to have Deerfield as an anchor investor and, together, we are working to develop a minimally invasive treatment alternative for a disease that affects millions of people worldwide."

Pain, loss of mobility, amputation

The disease Ferrari is referring to is peripheral arterial disease (PAD), which can lead to leg arteries becoming blocked by long segments of plaque that restrict blood flow to the lower leg and foot. The result can be pain, loss of mobility and – some cases – amputation. Minimally invasive approaches, including angioplasty and stenting, are effective on shorter blockages.

Extremely long blockages, though, of more than 20 centimeters are difficult to treat. The minimally invasive procedures effective on short blockages do not work well on longer blockages, often resulting in repeat procedures within a year. In long blockage cases physicians usually perform open bypass surgery, which has the benefit of durability but increases risk of complications and lengthy hospital stays.

That was the medical problem that confronted the two cardiologists who in 2009 founded Sunnyvale, Calif.-based Pq Bypass: James Joye, of El Camino Hospital, Mountain View, Calif., and Richard Heuser, of St. Luke's Hospital, Phoenix, Ariz.

The question they posed to themselves was: "When a standard endovascular revascularization approach is not possible for patients with long-segment peripheral artery blockages, can we create a safe, effective, minimally invasive solution that causes less trauma to the body than open femoral-popliteal bypass surgery?"

A minimally invasive approach

They went to work, and the result was the Pq Bypass Detour system, a fully percutaneous femoral-popliteal bypass. The Detour procedure was designed to provide the durability of open bypass with the benefits of a minimally invasive approach. In the procedure, the Pq Bypass stent graft technology is placed from the superficial femoral artery into the femoral vein, and back into the popliteal artery to create a detour around the blockage. The stent graft bypass re-directs blood, restoring blood flow to the lower leg and foot of the patient.

In March 2017, the Pq Bypass Detour system received CE mark approval in Europe.

The company's technology includes the Pq Snare, an over-the-wire, dual-nitinol-caged endovascular scaffold used to present a destination and snare for guidewires; the Pq Crossing device, a spring-loaded guidewire support and delivery system; and the Torus Stent Graft system.

A true clinical conundrum

"Pq Bypass has developed a novel technology and procedure to address a true clinical conundrum in the treatment of long lesions from PAD," said Andrew ElBardissi, principal at Deerfield Management who also happens to be a thoracic surgeon.

Pq Bypass in June 2018 presented results from the DETOUR I trial evaluating the system at the Society for Vascular Surgery annual meeting in Boston. The trial enrolled lesions longer and more complex than those typically studied in superficial femoral artery clinical trials, with an average lesion length of 37 cm.

The prospective, single-arm, multicenter, core lab-adjudicated study, enrolled and treated 77 patients and 81 lesions. Primary and primary-assisted patency at 12 months in all lesions of the DETOUR I trial was 73 percent and 80 percent respectively. Secondary patency was achieved in 94 percent of patients.

The DETOUR II trial is now underway, which the company describes as "the first and only pivotal investigational trial in the United States for percutaneous bypass." The trial, which will enroll up to 292 patients at as many as 40 sites across the U.S. and Europe, and is led by national co-principal investigators Sean Lyden, chair of the Department of Vascular Surgery at the Cleveland Clinic, and Jihad Mustapha, CEO at Advanced Cardiac and Vascular Amputation Prevention Centers, based at two locations in Michigan – Grand Rapids and Lansing.

"This technology," ElBardissi said, "has the potential to be the standard of care for the segment of PAD patients who, today, have to choose between either an open surgical treatment that lasts longer or less-invasive treatment options that potentially fail approximately 50 percent of the time. In addition to improving outcomes for patients, this has the potential to significantly reduce the cost burden of long lesion PAD."

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