KURVE THERAPEUTICS × BEACON CLINICAL REGISTRY

Kurve Compassionate Use Program

Physicians prescribing intranasal therapies through the Kurve ViaNase device can enroll as observational-study sites under Beacon's regulatory umbrella — Form 3926, IRB concurrence, patient enrollment, and outcomes tracking handled end-to-end.

What this program is

Kurve Therapeutics has opened a compassionate use (expanded access) program for its ViaNase precision olfactory delivery device paired with investigational therapies. Physicians who wish to treat individual patients under expanded-access provisions of 21 CFR 312.310 must submit an individual-patient IND request — FDA Form 3926 — and obtain IRB concurrence before administration.

Beacon Clinical Registry is the processing partner. We convert the Form 3926 into a guided, mostly-pre-filled electronic submission, provide IRB coverage through our partner institutional review board, and integrate patient enrollment into observational registries so the clinical experience is captured as structured evidence — not lost in chart notes.

Two concurrent observational studies are available for patients enrolled under this program. Physicians can participate in one or both.

Available observational studies

KRV-INS-OBS-001NCT07521371

Intranasal Insulin via ViaNase in Adults with Cognitive Impairment

Observational registry of adults with cognitive impairment receiving compassionate-use intranasal insulin delivered through the Kurve ViaNase device. Tracks functional-status, cognitive, and safety outcomes over twelve months.

Therapy:: Intranasal insulin (compounded), delivered via Kurve ViaNase Controlled Particle Dispersion® (CPD) device
Condition:: Mild cognitive impairment, early-stage Alzheimer's disease, age-related cognitive decline
Visit schedule:: Baseline, then every 3 months through 12 months
Enrollment:: Up to 50 participants per site

Primary endpoints

• ADAS-Cog-13 change from baseline at 6 and 12 months
• Functional Activities Questionnaire (FAQ) at 3-month intervals
• PROMIS Cognitive Function Short Form 8a at each visit
• Safety and tolerability (adverse event reporting)

View on ClinicalTrials.gov Submit Physician Intake

KRV-MUSE-OBS-001NCT07521384

Intranasal Muse Cell Therapy via ViaNase in Neurological Injury

Multinational observational registry of patients receiving compassionate-use intranasal Muse cell therapy through the Kurve ViaNase device. Captures neurorehabilitation-linked functional outcomes and safety signals.

Therapy:: Allogeneic Muse cells (multilineage-differentiating stress-enduring cells), delivered intranasally via Kurve ViaNase Controlled Particle Dispersion® (CPD)
Condition:: Hypoxic-ischemic encephalopathy, traumatic brain injury, stroke recovery, cerebral palsy
Visit schedule:: Baseline, 30 days, 90 days, 6 months, 12 months
Enrollment:: Up to 50 participants per site

Primary endpoints

• Modified Rankin Scale at 30, 90, 180, 365 days
• Gross Motor Function Measure (GMFM-66) for pediatric cases
• Functional Independence Measure (FIM) at each visit
• Safety and tolerability (adverse event reporting)

View on ClinicalTrials.gov Submit Physician Intake

Patient Compassionate Use Interest Intake

Patients or caregivers may submit their physician's contact information so the physician can review the opportunity to enroll through the BeaconCR physician enrollment portal.

Patient First Name*

Patient Last Name*

Physician Information

This is the physician we will email about your interest. Please ensure the email address is correct.

Physician First Name*

Physician Last Name*

Physician Specialty

Physician Website

Physician Email Address*

Physician Phone Number*

Clinic / Practice Name*

Clinic City and State

Patient Information

Patient Date of Birth*

Submitted to your physician along with this request

Patient Location*

City, state, country

Patient Email Address*

Patient Phone Number*

Patient Diagnosis / Condition*

Caregiver Name (if applicable)

Relationship to Patient (if applicable)

Clinical Study / Compassionate Use Interest*

View ClinicalTrials.gov record: https://clinicaltrials.gov/study/NCT07521384

I authorize BeaconCR / Healing Hope International to contact the physician listed above regarding my interest in a compassionate use request and related observational study enrollment information.

This intake form is for physician referral and study interest routing only. Submission does not guarantee treatment access, study enrollment, compassionate use approval, eligibility, or clinical benefit. Clinical decisions must be made by a licensed treating physician.

What Beacon handles for each enrolled site

Form 3926 done right

We pre-populate every field we can — practice info, IRB statement, protocol reference — so you only fill in what is patient-specific. Guided dropdowns replace free-text where possible.

IRB coverage

Healing Hope International's IRB umbrella covers enrolled sites. No need to find your own board; your site activation includes the IRB concurrence the form requires.

Patient self-enrollment

Enter a patient phone number and they receive a secure SMS link to complete their own consent and baseline questionnaires. Saves you the front-desk time.

Observational outcomes captured

Automated delivery of validated questionnaires on the schedule each protocol specifies. You see the results; we handle the infrastructure.

Days, not months

Most sites are activated within 5 business days. Form 3926 electronic submission, IRB amendment, and patient enrollment portal go live together.

Kurve ViaNase integrated

Our intake and treatment-log templates are designed around the Kurve ViaNase Controlled Particle Dispersion® (CPD) device and the drug product combinations it is paired with.

How the flow works

1
Physician completes the site-enrollment form on this site. FDA Form 3926 fields are structured as dropdowns wherever possible; practice info and IRB statement are pre-populated.
2
Physician electronically signs (typed name + date + timestamp + IP, ESIGN-Act compliant) and selects which study(ies) they want to join.
3
Beacon's team reviews the submission within one business day, finalizes the Form 3926, files it with FDA, and confirms IRB concurrence.
4
Once the site is active, physicians enter a patient phone number and the patient automatically receives an SMS with a secure enrollment link.
5
Patient completes informed consent and baseline questionnaires on their phone. Follow-up questionnaires are delivered on the protocol schedule.
6
Outcomes data flows to the registry. Site physicians see their own patients' data plus aggregate anonymized results across the full cohort.

Become a Kurve study site

Five-minute site enrollment. Your patients could be receiving ViaNase-delivered therapy under a registered observational study within a week.

Start site enrollment