Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 343

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 343
---
ptom to the underlying RVO. Because the Phase 2 clinical study that was approved under the IDE only used anti-VEGF therapy as rescue
therapy, it would currently be medically inappropriate and pose an ethical dilemma for physicians to enroll patients into a clinical study
that does not align with existing standard of care.

Submitting a
supplement to the current IDE would be appropriate in those instances where approval for relatively minor changes or amendments to the
study protocol are being requested of the FDA. However, in instances where approval for significant changes to a study are being requested
of the FDA (such as changes to the study design, treatment arms, endpoints, etc.) it is often more appropriate to withdraw the current
IDE and submit a new application. As a result, we plan to submit a new IDE to the FDA to allow for the use of anti-VEGF injections in
an updated Phase 2 study protocol. Under this revised study paradigm, we propose to compare the combination of intravenous infusion of
microspheres, therapeutic ultrasound and anti-VEGF injections (active treatment) to anti-VEGF injections alone (control) in 50 subjects
with BRVO. The proposed primary efficacy endpoints
will be BCVA and reduction in retinal edema. The primary safety endpoint will be the occurrence of ocular adverse events between the active
and control groups. Additionally, this study will assess the durability of anti-VEGF injections between the active treatment and control
groups to determine if our Reflow RVO treatment results in a reduction in the frequency of anti-VEGF injections.

| 179 |

Before the LBI-001
program moves into the pivotal trial phase, we plan to engage the FDA in an end of Phase II meeting to obtain guidance regarding the appropriate
regulatory pathway. Our Reflow RVO treatment incorporates microspheres and ultrasound, or a drug and a device. As a result,
it is likely that the regulatory review by FDA may involve the Office of Combination Products. Since the primary mechanism of action is
generated through the acoustic energy from ultrasound, we believe that the FDA should assign the Center for Devices and Radiological Health
as the lead review division for any regulatory submissions. In the event the Reflow RVO is designated by FDA as a combination
product, we anticipate that the submissions may involve a Premarket Approval Application (“PMA”) for the medical device, and
a New Drug Application (“NDA”) for the microspheres.

Soft-Tissue Reconstruction
and Repair

L