Newsletter
July 2025 Issue
Study Performance Snapshot:
Cumulative Patient Enrollment
7% (18 / 261)
Site Activity
6 randomizing
10 consenting
6 pre-screening
11 no activity
Highlights
Welcome to the first issue of the THRIVE Pivotal Study newsletter! Each issue will bring you the latest updates on study performance, important reminders and everything you need to stay informed and engaged in THRIVE.
As of this issue’s release, we’re excited to report 33 activated sites (23 in the US and 10 in Europe), and 18 patients randomized. We are also celebrating Boston Scientific's acquisition of SoniVie Ltd. (you can read the full announcement here), a significant step forward for our mission and the future of TIVUS™.
We hope you enjoy this newsletter and find it valuable. Thank you for your hard work, dedication, and the excellence you bring to this study. We’re thrilled to have you as part of the THRIVE journey!
Top 5 Sites
Consents
Randomized
NC Heart
Dr. Zidar | Raleigh | North Carolina
24
10
Arkansas Heart
Dr. Paixao | Little Rock | Arkansas
08
02
Uniklinik. Erlangen
Dr. Schmieder | Erlangen | Germany
04
02
SIU School of Medicine
Dr. Flack | Springfield | Illinois
07
01
Sana Kliniken
Dr. Weil | Lubeck | Germany
05
01
Site Spotlight
Photo: First THRIVE treatment. January 31, 2025. North Carolina Heart & Vascular
North Carolina Heart & Vascular
Leading the Way in THRIVE Enrollment
This first issue, we’re proud to shine the spotlight on North Carolina Heart & Vascular and PI, Dr. Zidar, for their outstanding performance and commitment to the THRIVE study. Since conducting their first procedure on January 31, the team at NC Heart has demonstrated exceptional efficiency and dedication.
As of this newsletter’s release, they’ve successfully consented 24 patients and randomized 10, setting a remarkable example for all participating sites. Their ability to promptly schedule patients for informed consent signing and screening has played a key role in their success.
We extend our heartfelt thanks to the entire NC Heart team for their tireless efforts and continued excellence.
Keep up the great work!
Reminders
At screening visit after consent has been obtained, patient must meet systolic and diastolic office blood pressure requirements to be eligible for the study.
Please send your Screening & Enrollment log to your site manager every week.
Please remember to enter ICF details and data into the EDC within 5 business days of visit.
Urine Samples Collection
Please make sure the urine samples collection is running smoothly at your site:
1. Collect every scheduled urine sample
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Minimum volume: 5 mL per visit.
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Complete the visit CRF fields so the central lab can match results to the correct time-point.
2. Store immediately at -80 °C
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Please double-check that the dedicated freezer is logged, locked, and alarmed; record any excursions on the temperature log.
3. Hold samples on-site until the end-of-study pick-up
4. Order (free) THRIVE urine-collection kits before you run low
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Each kit contains sterile 10-mL tubes, three bar-coded cryovials and absorbent pouches.
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To order, simply send an email to your main SoniVie / Boston Scientific contact with the number of kits you need and the delivery contact; we aim to ship within five working days.
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Keep a small buffer stock (around 3 upcoming subjects) so no visit is delayed.
If anything is unclear or you encounter freezer or supply issues, please let us know right away—we’re here to help.
Thank you for your attention to these scientifically critical matters.
Important THRIVE Contacts
Erin M. Spinner, PhD
Vice President, Global Clinical SHV, RDN and ICTx Operations,
Boston Scientific
Patient Recruitment Support
PinPoint
What is PinPoint?
PinPoint is THRIVE's own Patient Recruitment Project, aimed at helping create and maintain a healthy pipeline of candidates for our participating sites. PinPoint combines our geofencing social media campaign, our external team of screeners and Monday.com, our CRM (Customer Relationship Management) software, all working together to facilitate candidates to your site.
PinPoint Reminders for Active Sites:
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Log-in daily to Monday.com.
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Check for new candidates to contact.
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Contact new candidates within 48 hours to avoid loosing their interest.
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Attempt to contact at least 3 times before archiving candidates.
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Consider using text messages and email if candidates are not answering the phone.
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Update patient status for each attempted contact.
Do you need support with Monday.com?
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For support in Europe and Israel, please contact Omri Gill: omri@sonivie.com; +972-54-483-6492
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For support in the US, please contact Carlos Lander: carlos@sonivie.com; +1-754-317-4007
Video Content
Prof. Michael Jonas explains how TIVUS™ by SoniVie can Advance Hypertension Treatment
Educational Animated Video demonstrates how TIVUS™ by SoniVie works
Thank You
Thank you for reading the first issue of the THRIVE Pivotal Study News. We hope you found the content helpful and inspiring as we continue moving forward together in this important study. Your dedication and collaboration are what make the THRIVE study possible, and we are incredibly grateful to have you as part of this effort.
Until next time - let’s keep Thriving!
Feedback?
If you have any feedback, questions, or ideas for future editions, don’t hesitate to reach out to Carlos Lander:
carlos@sonivie.com
+1-754-317-4007