BioStem Technologies Retains Clinical Research Industry Veteran Nick McCoy to Lead DFU and VLU trials for BioREtain Allografts
POMPANO BEACH, Fla., April 30, 2024 (GLOBE NEWSWIRE) — BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived tissue allografts for advanced wound care, today announced that it has retained the services of Mr. Nick McCoy, who will lead BioStem’s Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) clinical trials process as a consultant to the Company.
BioStem’s clinical focus on completing these studies proactively addresses a continually changing reimbursement landscape where future requirements for skin substitutes by MACs (Medicare Administrative Contractors) will require clinical data to support product efficacy and will be necessary for coverage.
“We are delighted to welcome Nick to the BioStem team and eager for him to lead our Clinical Operations efforts. His leadership and deep experience will allow us to accelerate completion of current and new patient trials to show real-world benefits using BioStem’s BioREtain products,” said Jason Matuszewski, CEO of BioStem Technologies. “Conducting clinical trials targeting key patient populations with diabetic foot ulcers and venous leg ulcers is part of our short-term strategy to ensure patient access. The data retrieved from these studies will facilitate product adoption across all sites of service nationwide. Nick will be instrumental in planning and executing these clinical trials,” said Matuszewski.
Mr. McCoy is an experienced clinical research professional with a demonstrated history working in the pharmaceutical, biotechnology and medical device industries. His experience spans multiple therapeutic areas and all phases of clinical research. Prior to consulting to BioStem, Mr. McCoy served at Palisade Bio, Inc., where he established the company’s clinical operations team, managed clinical development and strategic plans, and oversaw multiple clinical trials ranging from phases I-III. Prior to his time at Palisade Bio, he spent six years at TissueTech, Inc. as the Vice President of Clinical Operations, overseeing clinical programs focused on regenerative medicine in wound management, osteoarthritis, and ocular disease.
Mr. McCoy earned his Bachelor’s degree in biology from Southern Nazarene University and his Master’s certificate in Clinical Research Administration from George Washington University. Mr. McCoy maintains certification as a clinical research professional through the Association of Clinical Research Professionals.
About BioStem Technologies, Inc. (OTC: BSEM):
BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain® processing method. BioREtain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (AATB). These systems and procedures are established per current Good Tissue Practices (cGTP) and current Good Manufacturing Processes (cGMP). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE®, VENDAJE AC® and VENDAJE OPTIC®. Each BioStem Technologies placental allograft is processed at the Company’s FDA-registered and AATB-accredited site in Pompano Beach, Florida. For more information, visit biostemtechnologies.com and follow us on Twitter and LinkedIn.
Forward-Looking Statements:
Except for statements of historical fact, this release also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified using words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate”, “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company’s products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete;(4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and (10) the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
BioStem Technologies, Inc.
Phone: 954-380-8342
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
Twitter: @BSEM_Tech
Facebook: BioStemTechnologies
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
646-863-6893
