Challenging the Status Quo in Cervical Care: Dr. Dirk Coeman Believes It’s Time to Rethink When Treating Women

Despite being performed globally, current cervical treatment procedures can lead to significant negative outcomes. These adverse effects particularly impact obstetrical results, including increased rates of prematurity, low birth rate, a higher incidence of second-trimester miscarriages, and more cases of premature rupture of membranes (PPROM). Women with CIN lesions and/or carrying an HPV strain experience a significant psycho-emotional burden. This burden is not related to the severity of dysplasia and does not appear to decrease over time.

Dirk Coeman, MD, CEO and Founder of VALÉB Inc.’s journey into medical innovation began, not in a lab but in a quiet moment of reflection between patient consultations. A professional gynecologist trained in Belgium and Scotland, Dr. Coeman had already spent decades delivering babies, performing surgeries, and guiding hopeful parents through fertility treatment. But it was a routine cone biopsy, one of thousands he had performed, that suddenly didn’t sit right with him. “We were treating young, healthy women who wanted children,” he recalls. “And we were doing it with an old, aggressive method that hadn’t evolved in 40 years. I knew there had to be a better way.”

That moment would spark a years-long mission to reimagine cervical care, leading to the creation of VALÉB in Delaware, USA. VALÉB is a device that promises not only clinical innovation but a more respectful experience for patients. Now, as a fertility specialist at the Life Expert Center (LEC) and LIFE in Leuven and his private office in Brasschaat, Dr. Coeman is preparing to launch what he believes will become a new global standard in cervical biopsies.

VALÉB, short for Vacuum-Assisted Loop Excisional Biopsy, is more than just a technological advancement. It’s the culmination of decades of clinical experience, patient conversations, and cross-disciplinary insights. It’s also a personal mission born out of empathy for the women Dr. Coeman sees every day, especially those grappling with HPV-related dysplasia and the fear of what treatment might cost them in the long run.

In the late 1990s, Dr. Coeman established a centre of reproductive medicine and began working with couples from across Europe, offering second opinions on complex fertility cases. “One couple came in with unexplained infertility,” he says. “Everything looked normal, except the woman had cervical pre-cancer. We recommended a cone biopsy. But on the way home, I remember thinking: Why are we using such an aggressive technique on someone trying to conceive?”

The standard procedure, known as LEEP or LLETZ, was developed in 1970s. It was a major improvement at the time, replacing cold knife conization with an electrified loop. But it was not without risks, including visible smoke during procedures, accidental lacerations, excessive tissue removal, and bleeding.

Worst of all, these complications disproportionately affected younger women of reproductive age. “There’s a disconnect between gynecologists and fertility specialists,” says Dr. Coeman. “One is treating disease, the other is trying to preserve the potential for life. I was standing between those worlds, and I couldn’t ignore the gap.”

He began experimenting with prototype designs in his own workspace using raw materials. Eventually, he partnered with a Belgian R&D firm that helped develop early versions of the VALÉB device, including its vacuum-assisted cup. Later, he connected with a Kansas-based engineering team that introduced an automated, motorized excision system, which could allow the procedure to be completed in 10 seconds with the press of a single button.

This resulted in a device that aims to remove only diseased tissue, eliminate surgical smoke, and prevent vaginal lacerations. VALÉB’s minimal invasiveness also aims to translate to fewer long-term complications, such as unreliable pap smears and the risk of secondary cancers due to cervical scarring. Importantly, it might reduce preterm birth rates, a complication often linked to cone biopsies, by preserving the cervix’s structural integrity.

For Dr. Coeman, the device also may have profound global implications. Its fully automated design and simple operation could allow trained nurses or paramedical personnel in underserved regions to safely perform the procedure after adequate training. “There’s tremendous potential in places like Africa, India, and even underserved high-income countries,” he says. “You simply need someone trained to set the variables and push a button.”

Despite VALÉB’s groundbreaking promise, the path to market has required relentless persistence. Regulatory hurdles, clinical validation, and eventual FDA clearance still lie ahead. Funding is also essential, although the focus has shifted toward the final stages of development and manufacturing preparation. If the current timeline holds, the device is expected to be available for use by 2027.

Reflecting on the process, Dr. Coeman says, “It’s easy to fall into the rhythm of routine medicine and follow the guidelines. But real change requires you to stop and question what’s become ‘normal.’ That’s what VALÉB represents. The epitome of women’s health innovation.”

This article is for informational purposes only and does not substitute for professional medical advice. If you are seeking medical advice, diagnosis or treatment, please consult a medical professional or healthcare provider.