Summary
Medtronic plc (MDT) filed an 8-K on October 14, 2021, to provide an important update on its SPYRAL HTN-ON MED clinical study for its Symplicity™ Renal Denervation System. The study aims to lower blood pressure in hypertensive patients on medication. The independent data safety monitoring board (DSMB) has reviewed prespecified interim data and recommended that the trial continue enrollment as planned until the full sample size is reached. This indicates that while the interim results were not compelling enough for early trial stoppage, they were positive enough to warrant continued enrollment without modification. This update is significant as Medtronic anticipates the renal denervation market to become a multi-billion dollar opportunity, with projected global revenues of over $500 million by 2026 and $2-3 billion by 2030. Despite the ongoing nature of the ON MED study, the company reiterated that this announcement does not affect its fiscal year 2022 revenue and EPS guidance, nor its long-range financial targets for organic revenue growth of 5%+ and adjusted EPS growth of 8%+. Management expresses confidence in the renal denervation program and its overall outlook.
Key Highlights
- 1Medtronic's SPYRAL HTN-ON MED clinical study interim data analysis has been reviewed by the DSMB.
- 2The DSMB recommended that the trial continue enrollment as planned, without early stoppage.
- 3The trial is designed to enroll 260 randomized patients, with follow-up expected to complete in the second half of calendar year 2022.
- 4This update does not impact Medtronic's previously issued fiscal year 2022 revenue and EPS guidance.
- 5The company maintains its long-range financial targets of 5%+ organic revenue growth and 8%+ adjusted EPS growth.
- 6Medtronic projects the renal denervation market to reach over $500 million by 2026 and $2-3 billion by 2030.
- 7Confidence in the renal denervation program is bolstered by prior study results and real-world patient data.