Materna Medical Achieves Reimbursement Milestone for Labor and Delivery

The Centers for Medicare & Medicaid Services has established a new ICD-10-PCS procedure code for Materna Medical Inc.’s Ellora Obstetrical System, marking a significant step toward market access and reimbursement for labor and delivery innovation.

The new ICD-10-PCS code—XU7: Intraluminal Device, Temporary Electromedical in New Technology—takes effect April 1. Once the device receives U.S. Food and Drug Administration (FDA) marketing authorization, hospitals will use this code to bill for procedures using the Ellora Obstetrical System during childbirth.

“Obtaining an ICD-10-PCS code for the use of the Ellora Obstetrical System is fundamental to market access, helping ensure that first-time mothers have timely and appropriate access to this important obstetrical innovation,” Materna Medical CEO Tracy MacNeal said. “We are thankful to the dozens of investigators, clinicians, and industry executives who submitted letters in support of the code.”

Materna Medical’s Ellora Obstetrical System is designed to address a critical unmet need in labor and delivery—reducing pelvic floor injuries during vaginal birth. These injuries, often involving muscle and nerve damage, can lead to long-term complications such as incontinence, prolapse, and chronic pain.

The EASE Pilot Study, published in the Journal of Obstetrics and Gynecology Research, demonstrated that Ellora’s use during labor was feasible, safe, and associated with promising reductions in severe pelvic floor injuries.

Additionally, a case series was presented at the Society for OBGYN Hospitalists, highlighting the long-term persistence of pelvic floor injuries following vaginal delivery, underscoring the urgent need for preventive interventions like Ellora.

“We are thrilled that Materna has achieved a rare milestone—advancing a novel medical device with published clinical evidence and a clear reimbursement pathway already established, accelerating future access once FDA marketing authorization is obtained,” stated Dr. Daniel W. Skupski, vice chief for Clinical Research, Obstetrics and Gynecology, New York-Presbyterian/Queens, Weill Cornell Medicine.

EASE trial enrollment ended last year, and data collection is ongoing to support an FDA De Novo submission. By combining clinical evidence with a clear reimbursement pathway, Materna Medical is setting the stage for an advancement in maternal health—one that could transform outcomes for millions of births.

Materna Medical is an OBGYN platform company defining a $25B market with core technologies addressing unmet needs in women’s pelvic health. With headquarters in Mountain View, Calif., the company pulls from the top minds in medtech to transform the OBGYN care standard. With a diverse team of engineers, scientists, researchers, and commercial leaders, Materna Medical strives to empower women to protect their pelvic health.

The company’s first product, Milli, is a vaginal dilator to support patients suffering from vaginismus and related painful sex. In 2019, the Milli device launched as a wellness trainer and, in 2023, received FDA clearance to sell over the counter, enabling streamlined access to people suffering from vaginismus. Milli outcomes have been studied in a post-market prospective virtual study named POMPOM.

Materna’s second product, Ellora, is an investigational device used during labor and is intended to reduce pelvic floor muscle injury during vaginal delivery in first-time moms. This product is being studied in the EASE trial, a large, randomized controlled study in 20 top U.S. hospitals.