PQ Bypass, one of the first Fogarty Innovation startups, was recently acquired by Endologix LLC, a leader in the treatment of vascular disease. The addition of the PQ Bypass technology portfolio, which targets the treatment of complex superficial femoral artery (SFA) disease, will allow Endologix to expand its portfolio to serve both abdominal aortic aneurysm (AAA) and now peripheral arterial disease (PAD).
Similar to coronary artery disease (CAD), PAD is caused by atherosclerosis, which narrows and blocks arteries, most commonly in the legs. If left untreated, it often leads to severe disability and amputation. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 18 million people in the U.S. suffer from PAD, which is particularly prevalent in individuals over the age of 60.
While there are several options for shorter, less severe SFA lesions, open surgery remains the gold standard for treating extremely long lesions —but it is not without risks, many of which may be eliminated by PQ Bypass’ innovative, fully percutaneous femoral-popliteal bypass device.
Seeking a better, less-invasive solution
The goal of the percutaneous fem-pop bypass is to provide a minimally invasive outpatient treatment option for patients with long, complex SFA disease. The PQ Bypass technology, known as the Detour System, is used to perform this procedure via two small punctures in the skin, instead of an open surgical procedure. Unlike open fem-pop bypass surgery, which usually requires a three- to five-day stay in the hospital, along with a recovery and rehabilitation period, percutaneous fem-pop bypass is performed on an outpatient basis. Patients usually return home the same day, and resume their day-to-day activities within a few days.
The company was founded by James Joye, DO, an interventional cardiologist previously at El Camino Health who is now in private practice. His vision was to avoid the morbidity associated with open femoral-popliteal bypass surgery, with an elegant percutaneous approach that used a catheter and a graft to bypass the blockage.
“The PQ Bypass technology and procedure really is transformative as an entirely new way to treat complex SFA disease, rather than just being an evolution of an existing product, like a slightly better stent or balloon,” said PQ Bypass President Heather Simonsen.
Given that it was truly transformative, in 2020, the Detour System was granted breakthrough device designation by the Food and Drug Administration. This designation was a significant achievement and validation of both the complexity of the disease state and the potential of the Detour System as a first-of-its-kind device to change the paradigm for complex SFA treatment in the way EVAR and TAVR changed the paradigm for aortic repair.
PQ Bypass completed a $60M capital raise led by Deerfield Capital in 2019.
Sharing expertise for fellow entrepreneurs
One of the keys to PQ Bypass’ success was its focus on building a team with the right skill set and then letting that talent do what they do best, a strategy that was particularly important as the company executed against 13 consecutive quarters of hitting every single clinical, regulatory and operational corporate milestone.
“All early-stage companies need to start by establishing what they are trying to achieve and then determining what talent is needed to fulfill the mission,” said Rich Ferrari, executive chairman of the board and CEO. He believes in investing the extra money to source the right experts, as they ultimately will save time while avoiding many of the common pitfalls faced by personnel with less experience.
The company saw this benefit firsthand when the Detour System’s initial filing for breakthrough device exemption was rejected. PQ’s vice president of Regulatory Affairs and R&D, Pharoah Garma, was not going to accept that outcome and worked with Heather and PQ’s clinical advisors to take into account the feedback from the FDA to re-submit and ultimately receive breakthrough device exemption.” It was a great effort and testimony to having experts navigating through difficult situations,” said Rich.
Rich also mentions his pride in PQ’s diverse management team, noting that three-quarters of the executive team prior to the acquisition was made up of women, which is very unique in the industry. “I give a lot of lectures in business schools and often get asked about female vs. male executives. I always tell the students: All things being equal, I will hire a female over a male executive every time as I believe they are better, more well-rounded leaders. They also are significantly better at managing multiple projects, deadlines, stakeholders, and more, which is critical for startup leadership.”
Objectivity is also key, which entails making decisions based on facts and data, rather than on emotions or false positivity. For example, PQ Bypass decided to build an internal team of clinical field experts to do their clinical work rather than outsourcing, eventually allowing them to identify a solution to simplify the procedure. Rich and Heather also laud the clinical team for figuring out how to maintain their enrollment timelines during COVID-19 when everything else was shutting down.
“We didn’t skip a beat,” said Rich, adding that within five days of the COVID-19 shutdown, the PQ clinical team pivoted into a virtual case support strategy. “While other companies were still figuring out what technologies to use, we had already provided virtual case support for 20 cases. It’s important for entrepreneurs to realize there’s always going to be adversity, but it’s critical to figure out how to get around it,” added Heather.
Heather also recommends running your company as if you’re in it for the long haul, as that will promote decision making that allows the business to increase in value and become an attractive candidate for an acquisition or the public markets. “Make decisions and do the right things as if you’re going to be in the business for a long time, which ultimately will mean that you’ll maximize the value of your company.”
Finally, make sure that your team knows that every person counts by creating an immersive company culture. For PQ Bypass, that meant coalescing around a theme of “everyday leadership,” meaning that key decisions come from every level of the company. One visual reminder of that core value of empowerment was the “PQ fingerprint of success,” a large poster where each employee put their fingerprints as a symbol that they felt invested in the business by putting their personal marks on it. “We wanted each of our team members to feel invested, so they are following the same dream, goals and direction,” Rich says.