From Medtech Engineering to Patient Impact: The SAIL Fusion Story

• Chronic sacroliac joint pain is among the most debilitating of orthopedic injuries – and one of the most underdiagnosed. David Jansen’s startup, SAIL Fusion, uses validated fusion principles in a new way, resulting in the BowTie Fusion system, a huge improvement over existing SI fusion technologies.

• In medtech, clinical promise alone doesn’t drive adoption: convincing surgeons to try a new technology can be a huge challenge for startups. SAIL Fusion focused on connecting with early adopters willing to try out their implant. Early adopters became evangelists and helped further validate efficacy.

• The Science Center's Capital Readiness Program (CRP) helps companies like SAIL Fusion move from insight to execution. CRP helped prepare David for sophisticated fundraising conversations – and connected him with investors and subject matter experts who helped sharpen and accelerate his path to commercialization.

Sometimes starting a company is like jumping off a cliff. In David Jansen’s case, this happened in a more literal sense than for most.

“Roughly 30% of people who report sciatica or lower back pain are actually experiencing issues stemming from the sacroiliac joint,” David explained to us. “And I had no idea that was the case until I jumped off a cliff skiing while I was in college and destroyed my back and my knee for the rest of my life.”

That experience – combined with a nearly lifelong interest in orthopedics – would eventually connect him to his fellow founders at SAIL Fusion.

The BowTie becomes more than a fashion statement

In the startup world, it helps to have passion for what you do – and to say that about David might be an understatement: his interest in orthopedics goes all the way back to childhood.

“You don't meet many middle schoolers whose dream job is in orthopedics,” David recalled. “I was shadowing at an ortho startup where a family member worked by 10th grade. And that made me realize I didn't want to do what my family member did – but I did want to go into product design engineering.”

While managing product development at Globus Medical – the second largest orthopedic spine company in the world – part of his job was to meet with surgeons to see what was and wasn’t working. And one consistent theme was a lack of effective treatments for sacroiliac issues.

For women at the end of pregnancy, the sacroiliac (SI) joints can loosen – and they don’t always return to normal after giving birth. Symptoms can have a profound effect on everyday life: chronic SI joint pain is among the most debilitating of orthopedic injuries and chronic injuries.

“It can get to the point where they can’t hold their kid, they can’t stand for long, they can’t push a grocery cart,” David explained.

Despite its prevalence, sacroiliac joint dysfunction is not well known by the primary care physician community, likely for a few reasons. One – as Jansen points out – is that these pelvic issues are often mistaken for lower back problems due to how the pain manifests. Another reason, he explained, is that it more commonly happens to women.

“My personal theory as to why it’s not that well publicized and understood is that 80% of the time SI pathologies affect women. It’s women in the years after childbirth and their pelvises are different – they’re a little more prone to this. And I think that’s how most women report their pain– doctors just kind of ignore it.”

The dismissal of women’s pain has been under scrutiny as of late, with studies showing that female pain is often “minimized, dismissed, or undertreated by health care providers” according to Harvard Medical School. The healthcare industry – and the venture capitalists that help propel its innovations forward – has lagged in addressing health issues that affect women.

However, the tide has been turning for the last several years, with femtech on the rise both as innovators look to solve problems, and VCs look to cash in on compelling solutions that affect millions of undertreated people.

After speaking to hundreds of doctors about pain points in their everyday practice, David came to understand that traditional SI treatment technologies were not as effective as they could be.

“The techniques to treat SI joint pain haven’t improved since the 1970’s,” David explained. “These treatments are unreliable, with published complication rates that far exceed any other surgical spine procedure.”

Independently of David, three surgeons were trying to solve the same problem with the engineering design firm, Cor Medical Ventures – just with a different solution that ultimately proved difficult to launch. During COVID, the group found each other – and by combining the surgeons’ clinical expertise, Cor’s engineering capabilities, with David’s product thesis and industry contacts, SAIL Fusion was born.

Working together led to the development of the BowTie SI Fusion System, which owes its name to the bowtie shape of the implant. This isn’t a new concept: bowtie joints have been used in woodworking for centuries to maximize rigidity. The BowTie technique relies on validated and safe surgical principles for fusing bones across synovial joints – with similar methodologies already in use elsewhere in the body.

Raising capital: conviction required

Of course, the road to successfully fused sacroiliac joints wasn’t a completely smooth one. David noted that when he came on board as CEO, he arguably had very little experience with one of the most common goals when it comes to startups: raising capital.

“At the very end of the day, the only thing that you’re measured by as a CEO is whether there’s money in the bank. And so day one of the job was: ‘Oh shoot, I’ve never fundraised before.’ I’m from the Midwest; I struggle to ask anybody for money,” he explained with a laugh. “So that was a very strange step.”

Despite his lack of fundraising experience, what propelled him forward was the conviction that BowTie was a huge improvement over existing SI fusion technologies.

“Being able to talk to investors who hear my conviction, especially if they’re medically adjacent or if they’ve invested in similar technologies, they can see that this is a clinical need that hasn’t been addressed.”

Chasing success with long plane rides

When it comes to how they got their technology in the door, David took a top-down approach – first going to the innovative experts in the field, those early adopters who can quickly understand the device’s efficacy and are willing to try new, promising technologies.

“When you think about the adoption curve, there are very few early adopters,” he explained. “And so finding them in your backyard is very rare – you have to go wherever they are. For us, it was places like Shreveport, Louisiana, Coeur d’Alene, Idaho, and other places that are long plane rides – but for an early-stage company, those long plane rides were worth it.”

After the early adopters were on board, things got easier. When surgeons wanted a little more clinical evidence before getting on board, the team could use information gathered from the early adopters and package it up into shareable white papers.

“The hard part is that those early adopters are going to be your only customers for a while until you can generate the clinical data that’s relevant for your next stage of customers,” he noted.

“And then eventually, it becomes a challenge of ‘how do you keep up with that additional demand?’ But scaling to meet demand – there are worse problems to have.”

Fusing connections at Capital Readiness Program

David noted that the journey of a startup is isolation followed by engagement.

In the beginning, startups require knocking on door after door, trying to get an audience with potential clients. Then later in the commercial process, the CEO may talk to dozens of customers each week – and they all have new and variable feedback and ideas that must be sorted through and distilled.

Taking the next step from feedback gathering to action is where many startups stall – and where the right support makes all the difference. In February 2023, David arrived at the Science Center to take part in the first Cohort of the Capital Readiness Program.

The Science Center’s Capital Readiness Program (CRP) takes 10 startups and, in one week, equips them with the expert insights and one-on-one investor and industry feedback they need to sharpen their fundraising strategy and successfully commercialize.

“The mentorship is where the Capital Readiness Program was so wonderful,” David said. Startups like SAIL Fusion receive feedback sessions and personalized guidance from investors, payors and providers, giving them clarity on the path forward.

“The most amount of value generated in a week: I think it’s hundreds of thousands of dollar’s worth of consulting that you’re getting for free,” David said of his time with CRP. “And you’re able to ask the most experienced people in the Philly area about details that you absolutely need to know to run a company.”

And the benefits of CRP continue long after the program.

“I can't even count the number of those things that I learned in the Capital Readiness program that I'm applying daily,” he said. “And especially as I talk to other early-stage founders that haven't gotten there yet – a lot of the questions they’re asking are the things that I learned in the Capital Readiness Program. So it's been great to not only see its impact for me, but to be able to return the value – passing on the startup karma to the next generation of founders.”

Philly as a hub

Another benefit of CRP: it immerses startup leaders in the medtech ecosystem of Philadelphia – a growing healthcare and medtech national hub with ample opportunities for local connections and relationships.

He noted that the Philadelphia region offers strong support to local startups. “Being in Pennsylvania, if you are starting a company, the first thing you hear is to go talk to Ben Franklin,” he said – Ben Franklin Technology Partners is one of the nation’s leading technology-based economic development programs, investing throughout the commonwealth. “Ben Franklin is one of our earliest investors, and they've offered great support. And they’re the ones who recommended CRP to us,” he added.

What’s next for SAIL Fusion?

Right now, SAIL Fusion is in its “good problems” era: raising its next round of capital in order to fully commercialize. Upon entering CRP, the startup had raised $3 million; now they’re at about $6.5 million in total funding and working on their next equity round.

The number of completed surgeries has allowed them to demonstrate clinical effectiveness. A study conducted by one of their surgeons showed significant pain and disability reduction within the first few weeks following surgery. It’s these types of results that are the payoff for David despite the ever-evolving fundraising hurdles to clear and other CEO-related challenges.

“You see a patient who has chronic pain – their pain is at an 8 or 10 out of 10 every day. I'm there for the surgery, and I see the actual implant being put in, and then I hear on the flight home or the next day, ‘Hey, the patient woke up and the pain is gone.’ And that alone is why I'm in the medical device industry. We’re helping people.”