BioRestorative Therapies Announces the Appointment of Robert Paccasassi to Vice President of Quality Assurance/Regulatory Compliance
BioRestorative Therapies (NASDAQ:BRTX) has appointed Robert Paccasassi as Vice President of Quality Assurance/Regulatory Compliance. With over 25 years of experience in biotech and quality systems, he will oversee quality initiatives as the company begins patient enrollment for a Phase 2 clinical trial targeting chronic lumbar disc disease. Paccasassi’s past roles include significant positions at Merck KGaA, Regeneron, Millennium, and Biogen Idec. This leadership appointment aims to enhance the company's compliance and quality control in its stem cell therapy programs.
- Appointment of Robert Paccasassi brings over 25 years of quality assurance experience, enhancing leadership in compliance.
- Paccasassi's expertise expected to strengthen quality systems at a critical phase of product development.
- No significant clinical trial data presented yet for the upcoming Phase 2 trial, which may raise concerns among investors.
- Management change could lead to continuity issues during a crucial growth period.
MELVILLE, N.Y., Jan. 11, 2022 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the “Company" or “BioRestorative”) (NASDAQ:BRTX), a life sciences company focused on stem cell-based therapies, today announced that Robert Paccasassi has been appointed Vice President of Quality Assurance/Regulatory Compliance. Mr. Paccasassi will lead quality initiatives through the next phase of the Company’s growth as patient enrollment is initiated for the Phase 2 clinical trial to treat chronic lumbar disc disease.
Mr. Paccasassi has over 25 years of biotech operations and combined experience in Quality Assurance, Regulatory Compliance, and Manufacturing. Prior to joining BioRestorative, Mr. Paccasassi held the role of Director, Corporate Quality Systems (GMP) at Merck KGaA (Germany). Additionally, he also held Quality and Compliance roles at Regeneron Pharmaceuticals, Millennium Pharmaceuticals and Biogen Idec.. Mr. Paccasassi received his B.S. in Medical Technology/Biology from the University of Rhode Island and an MBA from Johnson and Wales University.
Mr. Paccasassi will be responsible for BioRestorative’s cGMP Quality Control and Regulatory Compliance operations as they relate to the Company’s product pipeline.
“We are fortunate to have Bob in a leadership role overseeing our quality and compliance activities.” said Lance Alstodt, CEO of BioRestorative. “Bob brings a great deal of expertise to the organization, providing capabilities and discipline to our already strong quality systems.”
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:
• Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.
• Metabolic Program (ThermoStem®): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (“BAT”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.
CONTACT:
Email: ir@biorestorative.com
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