Regenerative Medicine Company Vascudyne Relocates to High Capacity GMP Manufacturing Facility Relocation supports TRUE Graft manufacturing through initial commercialization
ST. PAUL, M.N.
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February 09, 2022 09:23 AM Eastern Standard Time
Vascudyne, Inc., a biotechnology trailblazer in regenerative medicine, announced today that it has relocated to 15,000 sq. ft. of recently remodeled manufacturing, warehouse, laboratory, and office space.
This new facility is needed to meet increased demand for research and development and manufacturing of Vascudyne’s TRUE™ Tissue technology that is unique and 100% natural. Nothing synthetic or artificial is ever used in the manufacturing process, in contrast to other regenerative medicine cardiovascular devices with synthetic polymer-based scaffolds that slowly degrade in the body and may lead to adverse immune response.
Vascudyne announced in July the successful first human use of its TRUE™ Graft for hemodialysis access in end-stage renal disease patients.
“The addition of a dedicated 5,000 sq. ft. ISO 7 Cleanroom manufacturing facility is paramount for the successful continuation of our TRUE Graft clinical studies,” said Cory Pries, Director of Quality at Vascudyne. “The expandable manufacturing capacity we have added is designed to support our current pilot clinical studies all the way to initial commercialization.”
"We are dedicating 2,500 sq. ft. of the ISO 7 Cleanroom space to our new product development pipeline for coronary artery bypass graft, heart valves, and surgical patches," added Dr. Zeeshan Syedain, Vascudyne’s Chief Scientific Officer. “While we are initially focusing on cardiovascular applications for our TRUE Tissue technology, we can readily manufacture products and delivery systems for a range of medical devices, implantation sites, and geometries. We are excited to develop implantable biomaterials that are ready to use, off-the-shelf, and regenerative.”
Vascudyne announced in December the closing of its Series A financing round for $10M that has fueled its growth and enabled the company’s relocation to the new facility.
“Our investors’ continued support and promising early results from TRUE Graft’s first in man pilot study have propelled our growth,” said Rick Murphy, Vascudyne’s Chief Operating Officer. “We are establishing a strong presence in the epicenter of the Medical Alley, the Silicon Valley of Healthcare, and are creating excellent employment opportunities for talented people in the area. The move to this new facility positions us well to meet growing global demand for our products.”
Vascudyne licensed its proprietary TRUE Tissue technology developed by world renowned tissue engineering leader Robert Tranquillo, PhD, Distinguished McKnight University Professor, and his colleagues from the University of Minnesota in 2017.
TRUE Graft is not available for commercial sale.
About Vascudyne
Headquartered in the heart of Medical Alley in Minnesota, Vascudyne is on a mission to improve patient care with regenerative biomaterials that are inspired by nature. Vascudyne, a privately held company founded in 2014, uses the TRUE™ Tissue technology to develop TRUE to Nature™ biomaterials for soft tissue repair and replacement. For more information, please visit https://www.vascudyne.com/.
About TRUE Tissue Technology
TRUE™ Tissue is developed from cells isolated from donor tissue and is 100% biological. There are no synthetic materials or chemical fixation used, and implanted tissues are completely cell-derived and acellular. The TRUE Tissue technology can be readily shaped into tubes, sheets, and other geometries making it suitable for many soft tissue applications, is mechanically comparable to native tissues, and is a ready to use, off-the-shelf allograft.
Forward Looking Statements
This announcement contains forward-looking statements. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements relate to future events or Vascudyne’s clinical development programs, reflect management’s current beliefs and expectations and involve known and unknown risks, uncertainties and other factors that may cause Vascudyne’s actual results, performance or achievements to be materially different. Vascudyne undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.
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