Research Grants

Apyx® Medical (Apyx) recognizes the importance of clinical research performed by independent clinicians in enhancing the level of patient care around the world and supports these efforts through educational grants.

Apyx funds all types of Investigator-Initiated Studies (IIS) and provides educational grants to foster increased understanding of scientific, clinical, or health care issues. An IIS is a clinical study initiated, developed, and conducted by a qualified researcher external to Apyx who assumes all legal and regulatory responsibility for the trial. Potential IIS studies are funded through a competitive review process.

Researchers interested in applying for IIS funding should familiarize themselves with investigator expectations and the grant review process.

GRANT REVIEW PROCESS

Apyx carefully reviews all submitted research proposals. Each application will be reviewed for the following criteria:

- Alignment with established funding priorities
- Scientific and clinical impact
- Defined study goals, objectives, and milestones
- Investigator experience and research site infrastructure
- Feasibility
- Patient safety

INVESTIGATOR-INITIATED STUDIES RESPONSIBILITIES

Investigators are responsible for fulfilling the obligations of both sponsor and the investigator, as described in 21 CFR 812/ISO 14155. These responsibilities include:

Sponsor-Investigator Responsibilities

- Study design and research protocol development
- Study implementation and oversight
  • Participant inclusion
  • Obtaining proper informed consent
  • Compliance with protocol
- Maintenance of study documents
- Ensure data integrity and protect the privacy, rights, safety, and welfare of study subjects
- Regulatory Submissions and Compliance
  • IRB/EC approvals
  • Regulatory Agency approval (e.g. U.S.FDA IDE) if required
  • Protocol amendment submissions
  • Continuing reviews
  • Final study reports
  • Safety reporting
- Contract with third-party vendors
- Database development and data analysis
- Provide regular (at a minimum quarterly) updates to Apyx Medical on the study progress
- Publications

Apyx Medical Responsibilities

- Evaluate the proposed study for funding based on scientific merit, business alignment, and regulatory compliance
- Provide and distribute updated, approved product information
- Provide research grant funding
- Monitor trial progress in accordance with agreed upon milestones and protocols
- Review the protocol and any protocol amendments
- Review study manuscripts prior to publication

INVESTIGATOR-INITIATED STUDY APPLICATION PROCESS

1. Submit your complete proposal

You will be asked to submit your initial concept for review (Part A: Grant Proposal). If the initial concept is approved by Apyx, a full grant application will be requested. You will be notified of your proposal status via email.

Part A: Grant Proposal

Required:

- Study overview
  - Rationale
  - Design
  - Objectives and Hypothesis
  - Study Duration
- Principal Investigator CV
- Proposed Budget

Part B: Full Application

Required:

- Complete Protocol
- Detailed and Itemized Budget with justification
- Current medical license for Principal Investigator
- Co-Investigator CVs (if applicable)
- Enrollment projections
- Site W-9

Recommended:

- Case Report Forms
- IDE/IRB/EC Approval, if approval has already been received. If approval has not been obtained, the approval may be provided after the application is submitted, once obtained

Please note, only complete applications will be considered for review.

2. Proposal Review and Determination

Initial concept proposals will be reviewed on an ongoing basis. If the proposal is approved, you will be asked to submit the full grant request application (Part B: Full Application). Following receipt of the application and all documentation, the application will be reviewed, and you will be notified of the grant funding decision via email. If you have any questions regarding the process or would like to speak to the investigator-sponsored studies program team regarding your new or existing application, please contact us at clinicalresearch@apyxmedical.com.

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