Medtronic (MDT) Status Update summary

Market opportunity and patient population

• Urge urinary incontinence (UUI) affects over 16 million people in the U.S., with only 45% seeking treatment and a large, underserved population of 9 million untreated individuals.

• Most UUI patients do not receive advanced therapies, and 87% fail medications, highlighting significant unmet need.

• 5 million patients are eligible for advanced therapies, representing a significant growth opportunity.

• The market is less than 10% penetrated, and even 1% penetration could represent a $1 billion revenue opportunity.

Product features and differentiation

• AltaViva is a minimally invasive, implantable tibial neuromodulation device with a 15-year battery life, same-day therapy activation, and a 2 cm incision.

• The device is MRI-compatible, requires only 1–2 recharges per year, and is designed for a simple patient and physician experience.

• Compared to competitors, AltaViva offers longer device longevity, immediate activation, broader MRI compatibility, and both physician and patient customization.

Clinical data and efficacy

• The TITAN 2 pivotal study included highly refractory patients, all of whom had failed at least two medications.

• 80% of patients reported improvement at 12 months, with 61% achieving a 50% or greater reduction in UUI episodes and 70% seeing meaningful quality of life gains.

• Study design was more stringent than competitors, with no concurrent OAB medications allowed.

• Adverse events occurred in 20% of subjects, mainly implant site infections (7%) and pain (3%).