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InGeneron is presently conducting U.S. Food and Drug Administration (FDA)–approved clinical studies for our therapies to address rotator cuff tendinopathy, facet joint syndrome, and wrist osteoarthritis. We are additionally researching other potential therapeutic applications, such as those to treat venous ulcers.

 

 

Regulatory Approval Process

The FDA regulatory approval process is designed to ensure that a medical device is safe and effective before it is allowed to be marketed in the U.S. In the case of our therapies, this process involves two separate phases of clinical studies.

Feasibility Studies are designed to ensure that a medical device for patient use is safe. The patient cohort is generally small, and it involves people who are receiving the specific therapy as well as those who are part of a control group. At the end of the feasibility study, an assessment is made to determine if the medical device is sufficiently safe to proceed to the pivotal study phase.

Pivotal Studies are designed to ensure that a medical device is both safe and effective—in other words, that it achieves the therapeutic results it sets out to do. Pivotal studies involve a larger group of patients and take longer to conduct and complete than feasibility studies. Pivotal studies also involve patients who receive the therapy and those who are in a control group.

Medical devices that the FDA determines to be safe and effective are approved to be marketed and used in the U.S., in accordance with the description on their FDA label.


Here is the FDA regulatory status of InGeneron’s therapies.

 

Rotator Cuff Tendinopathy

Feasibility Study Status

The feasibility study is completed. Data is being analyzed and will be released in the near future.

Pivotal Study Status

Preparations are being made for pivotal study patient recruitment. Completing a successful trial and receiving approval of an FDA premarket approval application will allow us to market our rotator cuff tendinopathy therapy in the U.S.

 

Facet Joint Syndrome

Feasibility Study Status

The FDA has approved InGeneron conducting a feasibility study. Patient recruitment has begun.

Pivotal Study Status

The pivotal study will begin pending both the conclusion of the feasibility study and regulatory approval to proceed.

 

Wrist Osteoarthritis

Feasibility Study Status

FDA has approved InGeneron conducting a feasibility study. Patient recruitment has begun.

Pivotal Study Status

The pivotal study will commence pending both the conclusion of the feasibility study and regulatory approval to proceed.

 

Venous Ulcers

Feasibility Study Status

The FDA has approved InGeneron conducting a feasibility study.