Britecyte’s Adipose Tissue Allograft Earns “Safe to Proceed” Status from FDA

Status Marks Significant Achievement in Field of Regenerative Medicine; Britecyte Poised to Make Meaningful Impact on Osteoarthritis Treatment

GERMANTOWN, Md.--(BUSINESS WIRE)--Amarex today announced its work on behalf of Britecyte has resulted in a “safe to proceed” status by the United States Food and Drug Administration (FDA) for its Adipose Tissue Allograft (BRC-OA).

BRC-OA is intended for the treatment of osteoarthritis (OA), a serious and debilitating disease with unmet needs. OA affects over 30 million people and is the most common cause of disability in adults.

“Regenerative medicine products may provide renewed hope for patients to walk without pain,” said Alla Danilkovitch, Founder and Chief Scientific Officer of Britecyte. “Our collaboration with Amarex has resulted in the successful initiation of the clinical phase for our development program, and we look forward to accelerating the activities that will bring this novel therapy to patients who are in urgent need.”

Obtaining "safe to proceed" status for BRC-OA marks an exciting step forward in exploring its potential as a novel OA treatment. With anti-inflammatory and antioxidant properties, BRC-OA may help reduce pain, improve function, and support overall joint health, offering a promising new approach to managing OA .

BRC-OA benefits include:

• Available on-demand without quantity limitation
• Prolonged storage
• Minimally invasive injection
• No matching or immunosuppression required
• Robust manufacturing process and testing to ensure quality

“For millions of people trapped in debilitating pain, this news is a welcome relief,” said Kush Dhody, President, Amarex. “We were proud to handle the Investigational New Drug (IND) application for Britecyte and honored to act as their clinical research partner as they bring this life-enhancing product to market.”

There is no cure for OA or any approved to prevent or slow down its progression. Current therapies provide only temporary pain relief and, while demonstrating improvements in pain and functionality, have drawbacks patients must consider.

About Britecyte

Britecyte^®, Inc. is a biotechnology company pioneering the development of regenerative medicine therapies. With a focus on the biocompatibility of tissues and cells, Britecyte is redefining the field of regenerative medicine through the development of groundbreaking tissue transplantation solutions to address unmet medical needs for many diseases and conditions. Committed to shaping the future of regenerative medicine, Britecyte continues to drive progress in the field with cutting-edge technology and a patient-centered approach. For more information, visit www.britecyte.com.

About Amarex Clinical Research, LLC, an NSF company

Amarex Clinical Research, LLC, is a global, full-service Contract Research Organization (CRO) with significant expertise conducting biomedical research. The leadership team’s combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides services in Project Management: Phase I-IV, BE/BA, PK/PD; Regulatory Affairs: FDA Applications and meetings, applications to International Health Authorities, GxP Compliance Audits; Clinical Operations; Adaptive Study Designs; Statistical Analysis; Data Management; Medical Monitoring; Safety and Pharmacovigilance; and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products assisted by quality, cost-efficient services. For more information, visit www.amarexcro.com.