Aclarion President and CEO Brent Ness, has over 28 years of experience in medtech. Before Aclarion, he led Cleerly as President & CCO, driving the adoption of their AI cardiology solution through strategic partnerships. As COO of Mighty Oak Medical, he guided their FIREFLY spine navigation platform from FDA clearance to international launch. At HeartFlow, Brent spearheaded the global expansion of their image-based SaaS solution, and at Medtronic, he led the acquisition and rollout of the O-Arm technology. His career also includes leadership roles at GE Healthcare, Philips North America, and ProNerve.

Chronic low back pain affects 266 million people worldwide and is the leading cause of opioid addiction. “Aclarion is addressing the largest single expenditure in all of healthcare, the treatment and diagnosis of chronic low back pain,” says Brent Ness, CEO of Aclarion. Traditional treatments like spinal fusion surgery have a success rate of just 49–54%, leaving many patients still in pain. The root problem is that imaging tools like MRIs can’t “see” pain and use more invasive and less efficient ways to locate it. At Aclarion, Brent is spearheading the development of a tool that can.

Brent started his career selling beepers on Chicago's south side, where he learned the grind of straight-commission sales. Then he moved to Pegasus Airwave, this time selling therapy beds for burn victims. He later joined GE Healthcare under Jack Welch, worked on supply chain strategy at Global Healthcare Exchange, and gained turnaround management experience while earning his MBA. As VP at Philips North America, he oversaw a $4 billion operation, then joined Medtronic to lead global sales and marketing for its navigation division. He went on to drive M&A at ProNerve and held leadership roles at HeartFlow, Mighty Oak Medical, and Cleerly, focusing on SaaS and imaging technologies.

Today, leveraging decades of medtech and healthcare experience across Medtronic, GE Healthcare, and Philips, and a few other startups, Brent is leading Aclarion in developing Nociscan, a device he envisions becoming the standard of care in diagnosing and treating chronic low back pain.

Nociscan pairs with standard MRI machines but goes beyond traditional imaging. Instead of just showing a picture, it uses MR Spectroscopy to analyze the chemical and structural content of spinal discs. This helps doctors pinpoint which discs are truly causing the pain. The data is processed through advanced algorithms in the cloud and returned to the physician in a clear, actionable format.

Similar to platforms like HeartFlow or Cleerly, which analyze CT scans for heart conditions, Nociscan uses data-driven insights to support clinical decisions. Its accuracy could replace the invasive procedure of provocative discography, which uses needles and pressure to identify pain-causing discs. Brent highlights the potential of Nociscan: “Patient outcomes went to 97% when the levels treated correlated with Nociscan information and dropped to 54% when there was a discordance in the levels treated.”

Reimbursement is the ultimate gatekeeper in healthcare. Scaling prematurely, especially without reimbursement, can be an expensive mistake. Brent learned this first-hand: "I’ve tried to take sales forces out to market with non-reimbursed technology. And it’s difficult. It’s very difficult." Chasing adoption without reimbursement burns through resources, leaving you with little to show for it. Although Nociscan has completed more than 1,300 commercial cases to date through a cash pay model, Brent is focusing on building a reimbursement strategy instead of prematurely scaling a sales team. 

"Reimbursement requires evidence. You’ve got to create evidence to bring to the payers," Brent emphasizes. Payers won’t care about your pitch until you show them credible, compelling evidence that your technology improves outcomes and/or lowers costs. That’s why you need to invest early in clinical trials and other validation efforts. For Aclarion, this includes a national randomized control trial led by Johns Hopkins. “Those things take time, money, and investment,” Brent explains. “And we’re putting our money there instead of hiring sales reps in New Jersey, for example.” 

Brent and his team interviewed major payers in the United States to understand what Aclarion needed to secure reimbursement. They learned that until Aclarion had a few published, peer-reviewed clinical studies to support the adoption of their technology, the discussion was a non-starter.  “Your technology must at least demonstrate efficacy equivalent to the gold standard, and ideally, show improved outcomes—that’s the true benchmark. You also need a few studies, or at least one well-designed, foundational study, that clearly highlights the economic impact of adopting your technology on a broad scale, Brent emphasizes.” To support this, Aclarion commissioned a healthcare economist to run the Independent Economic Value Analysis of Low back pain (EVAL) study. The EVAL study findings project significant cost savings for the healthcare system. 

Proving the viability of your solution is a lifelong endeavor for a medtech company. “The need doesn’t end once you secure payer support,” Brent notes. Physicians across the adoption curve—especially those resistant to change—still need to be convinced. As Brent puts it, “You need to have it in your DNA."    

In Brent’s experience, the right voices matter. "The payers don’t really care when I call them," he admits, "but they do care when our list of KOLs call them." Key opinion leaders (KOLs)—respected physicians and researchers—can open doors. Experts on your side are more successful in engaging medical directors. To strengthen their approach, Aclarion has also brought on Jay Labine, MD, a former medical director of Priority Health in Michigan. Dr. Labine leverages his firsthand experience in payer decision-making to guide strategy and lead conversations with insurers. As part of Aclarion's small, focused team, he integrates feedback from the team, refines it, and uses it to effectively engage payers. While the company is still working toward reimbursement in the U.S., Brent is confident they are making meaningful progress. 

And finally, Brent advises, “Be disciplined." Ensure the market is ready for your product before hiring a salesforce or pushing for rapid adoption. It’s not glamorous, but it’s smart. want those relationships in place. You want them to see your journey and know your story,” she shares.

Reimbursement isn’t the whole puzzle. Innovation is exciting, but in medtech, it only matters if it solves a specific problem and is positioned correctly.

With Nociscan, Brent is aiming for a standard-of-care scenario. “When you come in with chronic low back pain, you’re going to get a Nociscan because that’s going to inform all sorts of treatment plans and decisions going forward.” If he can position it as a standard of care, Nociscan will be the go-to solution for patients in the massive chronic lower back pain treatment market.

So, framing your product as essential—not optional—can be a game-changer for adoption. But for that to happen, Brent emphasizes, “foundational, rock-solid science needs to be in place.”

To create a seamless solution, you need to identify a gap. But gaps in healthcare are rarely straightforward. If you’re not an expert in your niche, it’s crucial to build close relationships with those who are.

Brent’s engagement with KOLs has been invaluable in this regard. “You have to develop real, intimate relationships with your key opinion leaders. Listen intently to the problems they face. They’ll tell you if you just ask the questions and listen,” he advises. Brent adds, “Understand the nuances of how and why your customers make their decisions relative to the technology you're trying to bring forward and really hone in on that and spend time developing that value proposition message with them.” 

Involve end-users early in the development process—even co-create with them. This ensures your product aligns with practical needs, addressing real issues rather than adding unnecessary complexity. That’s how you create something indispensable, not just interesting.

Developing medtech products is resource-intensive, so a structured, stage-gated approach can help you avoid costly missteps. In Brent’s experience, disciplined processes are critical to success.

This means focusing resources on what truly matters. Each iteration must pass through checkpoints to ensure it aligns with business goals and customer needs. Brent advises, “You’ve got to tie down innovation to the business purpose and be very disciplined about it.” This approach is especially important for startups with tight budgets. Keeping operations lean and nimble helps your organization respond to internal challenges and external shifts in market conditions.

Aclarion chose to raise funds through an IPO. Unfortunately, the timing coincided with global instability caused by Russia’s invasion of Ukraine and rising inflation, which drove up costs and created economic uncertainty. Investors became risk-averse, and funding for smaller or newer companies dried up. The market for micro-cap IPOs essentially collapsed. "If I could have put the brakes on it and come back at a better time when those numbers were falling, we probably would have benefited," Brent recalls.

Faced with these challenges, Aclarion pushed ahead but raised only a quarter of the funds they had expected. This led to a pivotal “gut check” moment for the team. They reassessed priorities and became laser-focused on how they spent their limited resources.

Despite the hurdles, their foundational team remained intact and committed. Brent reflects, "Not a single person from the core team has left. Everybody’s hung in there and done an exceptional job." Looking back, he believes the constraints were a blessing in disguise: "I think I’m going to be happy we didn’t have that extra money because we’re so laser-focused out of sheer necessity to do the right things and do them quickly with urgency. There’s clarity in necessity."