Paracrine Receives Full FDA Approval of Investigational Device Exemption (IDE) to Launch a U.S. Pivotal Trial in Patients With Diabetic Foot Ulcers

Pivotal trial to support marketing approval of regenerative cells processed with the Celution® System to commence in Q1 2022

SAN DIEGO--(BUSINESS WIRE)--Paracrine, Inc. announced today that the FDA has granted full approval of its Investigational Device Exemption (IDE) to conduct a new pivotal trial titled Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Diabetic Foot Ulcers (DFUs): A Prospective, Double-blind, Multi-center, Randomized, Parallel-group Study – The “ASCEND Trial.”

The ASCEND Trial is a Pivotal Trial designed to provide a robust data set on the safety and efficacy of ADRCs in the treatment of patients with DFUs. The trial will include up to 291 patients at 25 clinical sites in the U.S. Trial results will be submitted in a Premarket Approval (PMA) application to the FDA to support regulatory approval.

Dr. Robert G. Frykberg, Co-Principal Investigator for The ASCEND Trial and past Foot Care Council Chair of the American Diabetes Association, stated: “Despite recent advancements in wound care and pharmacotherapy techniques, up to one quarter of patients with diabetes will develop diabetic foot ulcers – a leading cause of disability worldwide. The goal of this pivotal study is to compare the use of ADRCs against the current standard of care and determine if ADRCs can improve clinical outcomes in this challenging patient population.”

About Paracrine

Paracrine, Inc. is a biotechnology company developing the world’s first device-based autologous multifactorial cell therapy platform to treat debilitating chronic conditions.

About Celution® System

The Celution® System is a proprietary medical device designed to process human adipose tissue to extract, isolate, and concentrate a mixture of regenerative cells for subsequent reimplantation in the same patient.

About Diabetic Foot Ulcers

Diabetes affects approximately 34.2 million people in the United States. An additional 88 million Americans (34.5% of adults) are pre-diabetic. Diabetic foot ulcers (DFUs) are responsible for more hospital admissions than any other diabetic complication. DFUs are the leading cause of non-traumatic amputations in the U.S. It has been estimated that the annual risk of developing a DFU may be as high as 4% and the lifetime risk may be as high as 34%. The economic burden of DFUs is significant, with annual direct costs reported to be $9-13 billion.

Note: The Celution® System and ADRCs are not currently approved for sale in the U.S.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding our ability to initiate and prosecute the pivotal ASCEND Trial, and our ability to support a PMA application, are forward looking statements. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical and regulatory uncertainties, the challenges inherent in convincing physicians and patients to adopt the new technology, dependence on third party performance, performance and acceptance of our products, and other risks and uncertainties. Paracrine assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.