Regenerative medicine company Vascudyne moves to high-capacity GMP manufacturing facility

Relocation Supports TRUE Graft Manufacturing Through Initial Commercialization

ST. PAUL, MN –News Direct– Vascudyne, Inc.

Vascudyne, Inc.a pioneer in regenerative medicine biotechnology, today announced that it has moved into 15,000 square feet of newly renovated manufacturing, warehouse, laboratory and office space.

This new facility is necessary to meet increased research and development and manufacturing demand for Vascudyne TRUE™ fabric a unique and 100% natural technology. Nothing synthetic or artificial is ever used in the manufacturing process, unlike other regenerative medicine cardiovascular devices with scaffolds made from synthetic polymers that slowly degrade in the body and can lead to an adverse immune response .

Vascudyne announced in July the first successful human use of its TRUE™ Graft for access to hemodialysis in patients with end stage renal disease.

“The addition of a dedicated 5,000 square foot ISO 7 cleanroom manufacturing facility is critical to the successful continuation of our TRUE Graft clinical studies,” said Cory Pries, Chief Quality Officer at Vascudyne. “The scalable manufacturing capability we’ve added is designed to support our current pilot clinical studies through to initial commercialization.”

“We are dedicating 2,500 square feet of ISO 7 cleanroom space to our new product development pipeline for coronary artery bypass grafts, heart valves and surgical patches,” added Dr. Zeeshan Syedain, Chief Scientific Officer of Vascudyne. “While we initially focus on cardiovascular applications for our TRUE Tissue technology, we can easily manufacture products and delivery systems for a range of medical devices, implant sites and geometries. We are excited to develop ready-to-use, off-the-shelf and regenerative implantable biomaterials. »

Vascudyne announced in december the closing of its $10M Series A financing round which fueled its growth and enabled the company to move into the new facilities.

“The continued support of our investors and promising early results from TRUE Graft’s first-in-man pilot study have propelled our growth,” said Rick Murphy, COO of Vascudyne. “We are establishing a strong presence at the epicenter of the medical aisle, the Silicon Valley of healthcare, and create great employment opportunities for talented people in the region. The move to this new factory puts us in a good position to meet the growing global demand for our products. »

Vascudyne authorized its proprietary TRUE Tissue technology developed by world leader in tissue engineering Robert Tranquillo, PhD, Distinguished Professor at McKnight University, and colleagues at the University of Minnesota in 2017.

TRUE Graft is not available for commercial sale.

About Vascudyne

Based in the heart of Medical Alley, Minnesota, Vascudyne is on a mission to improve patient care with regenerative biomaterials inspired by nature. Vascudyne, a private company founded in 2014, uses 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% organic. There are no synthetic materials or chemical fixation used, and the implanted tissues are completely cell-derived and cell-free. the TRUE Tissue Technology can be easily 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, ready-to-use allograft.

Forward-looking statements

This announcement contains forward-looking statements. Such statements may include, but are not limited to, statements identified by words such as “plans”, “may”, “will”, “could”, “would”, “should”, “believes”, “s ‘expects’, ‘anticipates’, ‘estimates’, ‘intentions’, ‘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 could cause results, Vascudyne’s actual performance or achievements are 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.