A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects

Inclusion Criteria:

1. Subject is male or female age 22 or older

2. Diagnosed with elevated blood pressure or hypertension and verified during Visit #1by standardized seated cuff SBP

3. Have not taken antihypertensive medication for ≥30 days prior to the SEPV

4. Subject is expected to have sufficient vision, hearing, and hand strength (handstrength is demonstrated by a maximum voluntary contraction (MVC) equaling 35 unitsof force in both hands measured by a dynamometer

5. Subject has baseline BP measurements collected and completes study device trainingduring Baseline Assessment (Visit #1);

6. Subject agrees to maintain non-use of medications and over-the-counter (OTC)supplement regimen related to hypertension throughout the treatment phase;

7. Patient can comply with and agrees to complete all required study procedures, studyclinic visits, and associated activities;

8. Patient must be able to understand and give written informed consent in the languageprovided;

9. Subject must have SBP of 130 to ≤149 mmHg, if subjects present with SBP reading of ≥140mmHg they will receive heightened monitoring throughout the first month of thestudy

Exclusion Criteria:

1. Subject is a female of childbearing potential (e.g., not postmenopausal for at leastone year or has not had a hysterectomy or tubal ligation) not using medicallyeffective birth control (e.g., hormonal methods in use at least 30 days prior toscreening or barrier methods such as condom and spermicide in use at least 14 daysprior to visit 1) or is pregnant, lactating, or plans to become pregnant during thestudy).

2. BP ≥150 mmHg (systolic) and/or >90 mmHg (diastolic)

3. A history of heart failure with current New York Heart Association (NYHA) class III-IV functional classification

4. Currently has, or has had a history, of atrial fibrillation, in accordance with 2007Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European CardiacArrhythmia Society (ECAS) guidelines

5. Patient has experienced hospitalization due to a hypertensive emergency, withimpending or progressive target organ dysfunction (i.e., renal dysfunction, leftventricular hypertrophy or CNS involvement) within the past six (6) months

6. A >10 mmHg difference in seated cuff SBP between the right and left arms collectedduring the SEPV;

7. Unstable BP, defined as >5 mmHg variance between any two (2) consecutive weeklyreadings (with a maximum of four (4) attempts) to determine a baseline BPmeasurement ;

8. Arm circumference greater than 45 cm;

9. Acute illness, infection, or inflammation

10. Presence of any unstable cardiovascular disorder, such as MI, unstable angina,significant arrhythmia, stroke, or TIA; within the last six (6) months, or otherserious comorbidity that would be likely to impact life expectancy to less than one (1) year or limit patient cooperation or study compliance;

11. A history of rest or exertional angina pectoris in the previous six (6) months;

12. History of solid organ transplant

13. Any secondary form of hypertension (HTN) etiology, including but not limited toprimary aldosteronism, chronic steroid therapy and Cushing syndrome,pheochromocytoma, aorta coarctation or untreated thyroid or parathyroid disease;

14. Concurrent participation in an investigational clinical study that has not completedthe follow-up period or planned participation in another study within the next six (6) months;

15. Patient has any other condition or personal circumstance that, in the judgment ofthe investigator, might interfere with the collection of complete, good quality dataor the completion of the research study;

16. Patients who currently own or have owned another Zona Plus device and are, or havebeen, voluntarily performing the isometric handgrip activities.

17. Subject plans for greater than 10% of body weight loss/gain (10% of body weight overa 6-month period) during the study