Britecyte, Amarex, and Regenerative Orthopedics & Sports Medicine (ROSM) work together to determine the safety and efficacy of the Adipose Tissue Allograft (BRC-OA) treatment

Amarex today announced its partnership with Britecyte, the Maryland Stem Cell Research Fund (MSCRF) $1M clinical grant awardee, to support the development of Britecyte’s Adipose Tissue Allograft (BRC-OA) for the treatment of osteoarthritis (OA), a serious and debilitating disease with unmet needs. Britecyte is collaborating with Amarex and Regenerative Orthopedics & Sports Medicine (ROSM) to determine the safety and efficacy of the BRC-OA treatment, which has the potential to reverse the course of the OA disease.

MSCRF supports cutting-edge research and innovation in regenerative medicine in Maryland, helping to transition human stem cell-based technologies from the bench to the bedside. The $1M clinical grant recognizes the potential high impact of Britecyte’s adipose tissue technology for patients with OA.

“This clinical award to Britecyte represents a significant step forward in the treatment of OA by advancing our adipose therapy, marking a turning point for the health of patients impacted by this devastating condition,” said Dr. Alla Danilkovitch, Founder and Chief Scientific Officer of Britecyte, Inc. Dr. Danilkovitch is the Principal Investigator (PI) for the clinical grant. Britecyte also received a commercialization grant from the MSCRF in 2022.

Britecyte will investigate the safety and efficacy of BRC-OA in the First-in-Human (FIH) Phase 1/2a clinical study for the treatment of knee OA. The U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application, which is now in effect. The study is a multicenter, controlled, randomized, single-blind, dose-finding study performed under IND 31174 (ClinicalTrials.gov ID NCT06828666).

Britecyte, Amarex, and ROSM, three Maryland organizations, will work together on a clinical trial funded by the grant. Each company contributes unique expertise, resources, and community connections, enabling the team to leverage combined strengths to achieve the project goals. Amarex will serve as the clinical trial organization, leveraging its decades of success in moving life-saving and life-enhancing products through clinical trials to get drugs and products to market. ROSM is one of the clinical sites for the trial.

“I echo my colleague, and I am excited to serve as a co-PI for the project,” said Dr. John Ferrell, Founder, Managing Partner, and Director of Sports Medicine of ROSM. Dr. Ferrell focuses on cutting-edge regenerative medicine treatments. “This collaboration with Britecyte and our collective scientific and clinical expertise may lead to a life-changing therapy for patients,” stated Dr. Ferrell.

“We are proud to be the partner of choice for Britecyte and ROSM, supporting the clinical study funded by the MSCRF grant,” said Dr. Kush Dhody, President, Amarex Clinical Research. “Bringing innovative therapies to market is part of our DNA at Amarex,” stated Dr. Dhody.

OA is the most prevalent chronic joint disease and a leading cause of disability among adults. OA can affect any joint, but it occurs most often in the knees. Chronic pain due to cartilage damage, one of the key manifestations of OA, is the greatest burden driving patients to seek medical treatment.

Currently, there are no approved disease-modifying OA drugs targeting OA pathophysiology that can slow or reverse the progression of OA. Given the high prevalence and rapid growth of OA, the economic and health burden, and OA-associated morbidity, there is an unmet medical need for therapies that can delay, stop, or reverse the progression of OA. This clinical grant represents a promising approach to helping treat patients with OA.

About Britecyte, Inc.

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 ROSM

Regenerative Orthopedics & Sports Medicine (ROSM), a state-of-the-art Musculoskeletal & Spine Care organization, is leading the shift in orthopedics and sports medicine by providing innovative minimally invasive regenerative medicine treatments. ROSM's approach focuses on enhancing the body's natural healing capabilities to restore function and active lifestyles. For more information, visit www.rosm.org.

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.

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“We are proud to be the partner of choice for Britecyte and ROSM, supporting the clinical study funded by the MSCRF grant,” said Dr. Kush Dhody, President, Amarex Clinical Research. “Bringing innovative therapies to market is part of our DNA at Amarex."