🔒With new CEO, investment and larger employee count, Torrington’s PRIA Healthcare eyes next growth stage

During his tenure as chief commercial officer with global medical technology company iCAD Inc., Jeff Sirek said the New Hampshire-based company built a novel technology that made screening certain cancers easier and safer for patients.

However, he said, its adoption rate remains underutilized because, more than a decade after the device was developed, it has still not received coding necessary for healthcare providers to receive full reimbursement for it.

It’s a challenge that persists for medical device companies today, which, Sirek said, was one of his motivations for joining Torrington-based PRIA Healthcare last month as its new CEO.

“I want to bring my years of experience to help other companies navigate the process of bringing medical technology to market,” Sirek said.

PRIA Healthcare, founded in 2012, specializes in helping medical technology companies — including startups — with clinical trials, securing Food and Drug Administration approval for devices, and getting clients’ devices coded for reimbursement with public and private insurers.

The company also provides patient access services to help patients and medical providers appeal denied coverage.

PRIA is tapping into a growing market, with medical technology companies attracting billions of dollars in annual venture capital investment.

Last January, PRIA received its own capital infusion from Virginia-based equity firm Aldrich Capital Partners, which invested an undisclosed amount to expand PRIA’s services and continue the company’s growth trajectory.

Sirek said that over the past decade PRIA has, on average, achieved double-digit annual growth — increasing its employee base from six in 2015 to more than 50 last year.

But with Aldrich’s investment, the company is looking to expand its services for medical device clinical trials and deepen its patient-access offerings with a goal of growing revenue between five to seven times its current levels, Sirek said.

He declined to disclose the company’s annual revenues.

In 2020, PRIA acquired California-based Lindstrom Healthcare Advocacy to expand its patient advocacy and appeals services.

Marie Austin, director of marketing strategy for PRIA Healthcare, said the company’s 10-year average for successful patient appeals is 73%.

Last spring, PRIA also inked a deal with Texas-based Genesys Spine, a medical device manufacturer, to improve patient reimbursement for the company’s spinal joint fusion systems.

Commercial viability

Sirek said he is also bringing new talent to PRIA’s team to help clients better understand and address the number of hurdles involved in bringing a medical device to market.

Sirek said as startup CEOs are pitching to investors, it’s not just about the effectiveness of the device, but also reimbursement levels for the product that can greatly impact its commercial viability.

“We need to educate our clients on the complexity of the process,” he said.

For medical device companies, there are two main pathways to required FDA approval to bring a product to market.

The first is low- to moderate-risk devices that build upon existing approved technologies; the second is for first-of-a-kind innovations that are higher risk and require clinical trials.

The goal of the review and approval process is to examine all aspects of a medical device to ensure its safety and effectiveness. But the process can be time-consuming, expensive and challenging for startups, Sirek said.

A survey by the Advanced Medical Technology Association found that 87% of medtech executives saw government regulations as a threat and disrupter to their business.

As the volume of medtech innovation increases, regulators and insurance companies — and their review processes — are scrambling to keep pace.

Sirek credits the FDA for evolving with the times. Between 2015 and 2020, the FDA cleared 222 AI-driven medical devices for clinical use under the “software as a medical device” designation.

Sirek said AI — the use of computing power to evaluate data points and recommend or take action in real-time — will play a larger role in the future of health care and be a growing part of PRIA’s client portfolio.

Cost factor

The biggest challenge for clients, Sirek said, is securing the appropriate reimbursements. The high R&D costs associated with new technologies — including clinical trials — means they often come with a premium price tag.

That can also cut into the overall reimbursement provided for surgeries, which are often divvied up between hospitals, doctors and anesthesiologists.

A 2019 report from Vizient, a healthcare performance improvement company, found that the cost for the use of innovative cardiovascular medical devices ranged from 17% to 88% of the reimbursement amount for the procedure.

Because of higher costs — or insufficient clinical evidence — of novel devices, public and private insurers may be less willing to cover their use when less expensive alternatives exist, even if there are patient benefits to the new technology.

It’s a challenge that Sirek said he hopes PRIA Healthcare can address by helping medtech companies identify the right customers, efficiently navigate regulatory constraints and execute the right go-to-market strategy.

At the same time, he noted that short- and long-term healthcare staffing shortages combined with the increasing healthcare needs of aging Baby Boomers will increase the need for innovative medical-care technology.