RELEASE Ph2 RT-310 BPH Study

Key Inclusion Criteria:

• Male gender
• Diagnosis of symptomatic BPH
• Age ≥ 50 years up to 80 years
• International Prostate Symptom Score (IPSS) ≥ 13
• Peak urine flow rate ≥ 5mL/sec and ≤ 12 ml/sec, voided volume ≥ 150 ml
• Prostate volume 30 to 80 cc per ultrasound
• Post void residual (PVR) urine ≤ 200 ml
• Failed, intolerant, or choose to not take current medical therapy for LUTS

Key Exclusion Criteria:

• Unable or unwilling to sign the informed consent form (ICF) and/or comply with the study follow-up requirements
• Acute urinary retention, active urinary retention, history of urinary retention within 12 months of screening or at risk of urinary retention after BPH drug washout
• Unwilling to abstain from unprotected sexual intercourse for 3 months
• Unwilling to abstain from any child conceiving activities for 6 months
• Have an obstructive or protruding median lobe of the prostate
• High bladder neck determined by Investigator
• Active urinary tract infection at time of treatment
• Previous BPH surgical procedure or implants, urethral stricture, Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
• Previous rectal surgery or known history of rectal disease
• Previous pelvic surgery or irradiation
• Current or previous urethral strictures
• History of neurogenic or atonic bladder
• Stress, mixed or urge urinary incontinence, or overactive bladder (OAB), known bladder dysfunction and/or known or suspected underactive detrusor in absence of urodynamics
• Biopsy of the prostate within the past 6 weeks
• Life expectancy estimated to be less than 2 years
• History of prostate or bladder cancer, confirmed or suspected malignancy of prostate or bladder
• History of compromised renal function or upper urinary tract disease
• Known coagulopathies or participant on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
• Use of the following medications pre-screening:

Within 6 months of baseline assessment (e.g. dutasteride, Avodart, finasteride, Proscar, Propecia) Within 4 months of baseline assessment: estrogen, any drug producing androgen suppression, or anabolic steroids Within 4 weeks of baseline assessment: alpha-blockers, gonadotropin-releasing hormonal analogs, anticholinergics or cholinergic medication or phenylephrine, pseudoephedrine, diphenhydramine or imipramine medications Within 1 week of baseline assessment, unless documented on stable dose for ≥ 6 months: beta blockers, antidepressants, anticonvulsants, and antispasmodics

• Cystolithiasis within the prior 3 months
• History of co-morbidities that would affect having an elective urological procedure including prostatitis, conditions that preclude the injection of the RT-310 System.
• Other co-morbidities that could impact the study results such as:

Severe cardiac arrhythmias uncontrolled by medications or pacemaker Congestive heart failure New York Heart Association (NYHA) III or IV History of uncontrolled diabetes mellitus Significant respiratory disease in which hospitalization may be required

• Known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
• Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.
• No two documented active urinary tract infections (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen)
• Current gross hematuria and/or visible hematuria with participant urine sample without known contributing factor
• Presence of a penile implant or stent(s) in the urethra or prostate
• PSA > 10 ng/ml or confirmed or suspected prostate cancer. If PSA is > 4 ng/ml and ≤ 10 ng/ml, unless prostate cancer is ruled out by the Investigator's satisfaction, include a standard of care biopsy if indicated.
• Active or history of epididymitis within the past 3 months
• Sensitivity to RT-310