Expanded Access Policy Statement

1. Serious or Life-Threatening Condition
   • The patient has a disease or condition that is immediately life-threatening (reasonable likelihood of death within months), OR
   • The patient has a serious disease with substantial impact on day-to-day functioning.


2. No Satisfactory Alternatives
   • All approved therapies appropriate for the patient’s condition have been exhausted, are unsuitable, or are not available.
   • The patient is ineligible for enrollment in any ongoing clinical trials,
     OR
   • No clinical trials are available for the patient’s condition or geographic location.


3. Potential Benefit Justifies Risk
   • The potential clinical benefit to the patient justifies the potential risks of treatment.
   • The patient and treating physician understand and accept these risks.

4. Adequate Safety and Efficacy Data Available
   • Generally, adequate data is available after completion of Phase 2 clinical trials or upon receipt of FDA Fast Track or Breakthrough Therapy designation.
   • An established recommended dose has been identified.
   • Preliminary evidence suggests potential benefit for the patient’s condition.


5. Active Clinical Development
   • Intuitive Fluorescence Imaging, LLC is actively pursuing marketing approval for the investigational medicine.
   • Clinical trials supporting potential approval are ongoing or planned.


6. No Interference with Clinical Development
   • Providing expanded access will not compromise the enrollment or conduct of ongoing clinical trials.
   • Adequate drug supply exists to support both clinical trials and expanded access without creating shortages for enrolled trial participants.

7. Regulatory Compliance Possible
   • The request can be fulfilled in compliance with applicable U.S. and local laws and regulations.
   • A regulatory mechanism exists to support expanded access in the patient’s country or region.
   • Institutional Review Board (IRB) or Ethics Committee approval can be obtained.


8. Licensed Physician Oversight
   • A qualified, licensed physician agrees to:
     • Oversee the patient's treatment
     • Obtain informed consent
     • Submit required documentation to the FDA and IRB/Ethics Committee
     • Monitor the patient and report outcomes to Intuitive Fluorescence Imaging, LLC and regulatory authorities
     • Serve as the IND sponsor (if applicable)

• Email: expanded.access@intusurg.com

1. Patient Information
   • Detailed medical history
   • Current diagnosis and disease stage
   • Prior treatments and responses
   • Reason for clinical trial ineligibility (if applicable)
   • Current clinical status and prognosis


2. Treatment Plan
   • Proposed dosing regimen and treatment duration
   • Monitoring and safety assessment plan
   • Plan for managing potential adverse events
   • Follow-up care arrangements


3. Regulatory Documentation
   • IRB/Ethics Committee submission plan and timeline
   • Informed consent form (draft)
   • FDA submission plan (Form FDA 3926 for individual patients or appropriate IND documentation)
   • Proof of medical licensure


4. Clinical Rationale
   • Scientific basis for potential benefit
   • Assessment of benefit-risk balance
   • Available clinical or preclinical data supporting use

• Acknowledgment of Receipt: Within 5 business days
• Initial Review: Within 10–15 business days of receiving complete documentation
• Final Decision: Timing may vary based on complexity; physician will be notified of the expected timeline

All requests will be reviewed by a multidisciplinary committee including medical, regulatory, clinical operations, manufacturing, and legal representatives.

• Clinical Merit: Strength of scientific and clinical rationale
• Benefit-Risk Assessment: Likelihood of benefit versus known and potential risks
• Manufacturing Capacity: Availability of adequate drug supply
• Clinical Trial Impact: Potential effect on ongoing or planned trials
• Regulatory Feasibility: Ability to meet regulatory requirements
• Resource Availability: Capacity to support expanded access program requirements
• Equitable Access: Fair consideration of all qualified requests

• Clear explanation that the medicine is investigational and not FDA-approved
• Known and potential risks, including the possibility of serious harm
• Uncertainty regarding effectiveness
• Alternative treatment options (if any)
• Description of monitoring and follow-up requirements
• Right to withdraw from treatment at any time
• Information about who will bear costs (if any)
• Contact information for questions and reporting adverse events

Intuitive Fluorescence Imaging, LLC provides a template informed consent form that must be adapted for each specific case and approved by the IRB/Ethics Committee.

• Provide the investigational medicine at no charge (unless otherwise approved by FDA)
• Supply necessary product information and handling instructions
• Review and respond to adverse event reports
• Submit required safety reports to FDA
• Provide regulatory support and guidance
• Maintain appropriate documentation

• Obtain all necessary regulatory approvals (FDA, IRB/Ethics Committee)
• Secure informed consent from the patient
• Monitor the patient throughout treatment
• Report all adverse events to Intuitive Fluorescence Imaging, LLC and FDA as required
• Submit required reports:
  • IND safety reports (21 CFR 312.32)
  • Annual reports on ongoing treatment (21 CFR 312.33)
  • Written summary of treatment results (21 CFR 312.310(c)(2))
• Maintain comprehensive treatment records
• Ensure proper storage and handling of investigational medicine
• Comply with all regulatory requirements

• Understand and accept the investigational nature and risks of treatment
• Comply with the treatment plan and monitoring requirements
• Attend all scheduled follow-up appointments
• Report any side effects or concerns to their physician immediately
• Understand that treatment may be discontinued if safety concerns arise

• Individual Patient Expanded Access: At conclusion of treatment, a written summary of results, including all adverse effects, must be submitted to FDA within 30 days
• IND Safety Reports: All serious and unexpected suspected adverse reactions must be reported to FDA within 15 calendar days (21 CFR 312.32)
• Annual Reports: If treatment continues for one year or longer, annual progress reports must be submitted to FDA (21 CFR 312.33)

1. Insufficient Safety/Efficacy Data: Limited Phase 1 data or concerns about benefit-risk profile
2. Supply Constraints: Insufficient drug supply to support expanded access without impacting clinical trials
3. Clinical Trial Impact: Risk of compromising ongoing or planned trial enrollment, particularly in rare diseases
4. Regulatory Barriers: Inability to meet regulatory requirements in the patient's jurisdiction
5. Development Program Changes: Decision to discontinue development of the investigational medicine
6. Resource Limitations: Insufficient internal resources to safely administer and monitor expanded access program
7. Safety Concerns: New safety information that substantially changes the benefit-risk profile
8. Non-Compliance: Physician or institution history of non-compliance with regulatory requirements

• New safety information indicating unacceptable risks
• Regulatory action (FDA clinical hold, safety concerns)
• Decision to discontinue clinical development or commercialization
• Manufacturing or supply issues
• Non-compliance with program requirements
• Denial or withdrawal of FDA approval for commercial use

In such cases, patients currently receiving treatment may be allowed to continue therapy until disease progression, completion of treatment course, or commercial availability, at Intuitive Fluorescence Imaging, LLC's discretion.

1. Request written explanation of the denial decision
2. Submit additional supporting information addressing concerns raised
3. Request reconsideration by the review committee
4. Resubmit the request if circumstances change (e.g., new clinical data, changes in development program status)

Appeals should be submitted to: expandedaccess@intusurg.com within 30 days of denial notification.

• This website
• ClinicalTrials.gov (with links to expanded access protocols)
• Reagan-Udall Foundation's Expanded Access Navigator

• Expanded Access to IS-002

• FDA Expanded Access Information
• Reagan-Udall Foundation Expanded Access Navigator
• Intuitive Fluorescence Imaging, LLC Clinical Trials Information
• For Healthcare Providers
• FDA Expanded Access Information for Physicians
• FDA Form 3926 (Individual Patient Expanded Access)
• FDA Guidance: "Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers" (October 2025)

• Email: expanded.access@intusurg.com

• ClinicalTrials.gov — Search for “Intuitive Fluorescence Imaging, LLC”