PrintBio Receives FDA Clearance for 3DMatrix™, the First 3D-Printed Resorbable Surgical Mesh
- PrintBio was founded by Rapha Capital Management, LLC and its investors through its SPV, Rapha Capital Investment XIV, LLC
MIAMI, May 23, 2024 / — PrintBio, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of 3DMatrix™, the first 3D-printed resorbable surgical mesh designed for use in the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery.
PrintBio, Inc., is the only clinical- and commercial-stage regenerative medicine company solving medical challenges with custom-engineered 3D-bioprinted living implants. Leveraging their first-in-human clinical experience with 3D-bioprinted and implanted living tissues, PrintBio is developing an array of biocompatible products, beginning with 3DMatrix™, a 3D-printed monofilament bioresorbable surgical mesh, utilizing its proprietary technologies, clinically tested in patients.
“PrintBio’s first entry into the resorbable surgical mesh arena is notable due to it being FDA’s first clearance of a surgical mesh product that is 3D-printed. This integrated design and manufacturing advance brings an unprecedented level of design flexibility, enabling innovative solutions limited only by the surgeon’s imagination,” said Dr. Kevin Slawin, formerly an experienced oncologic open and robotic surgeon, and now the Chairman and CEO of PrintBio, Inc. “Being innovative and ‘first’ is not new to the PrintBio team, which was also the first and only group allowed by FDA to implant a 3D-printed living organ in a patient, an event covered at the time on the front page of the NYTimes,” Slawin added.
PrintBio is pursuing its commitment to rapid innovation, moving additional novel mesh designs that offer unique solutions to meet patients’ and surgeons’ needs through the development process, including:
- New product extensions broadening the scope of our mesh product’s size, thickness, flexibility, and shape
- New mesh designs that offer differential and directional load bearing options depending on the clinical setting
About 3DMatrix
3DMatrix Surgical Mesh (3DMatrix™) is a single-use, fully absorbable, colorless, non-woven, 3D-printed, macroporous, polymeric surgical mesh made entirely of uncolored and undyed polydioxanone (PDO) monofilament, which may reduce infection and minimize biofilm formation compared to products manufactured using a woven or braided filament. 3DMatrix™ is provided in two sizes, 6 cm x 5.5 cm and 6 cm x 14.5 cm, that can be cut to the desired shape and size for each specific application at the time of use. 3DMatrix™ is a medical device used for surgical repair or reinforcement of soft tissue. Once implanted, 3DMatrix™ acts as a mechanical support to soft tissues and provides a scaffold for tissue ingrowth. It is designed to fully degrade over six to seven months. 3DMatrix™ provides temporary mechanical support and stabilization during the healing process. 3DMatrix™ is intended to be used by prescription only in a healthcare facility or hospital.
About PrintBio, Inc.
PrintBio, Inc. (https://printbio.com), is the only clinical- and commercial-stage regenerative medicine company solving medical challenges with custom-engineered 3D-bioprinted living implants. Leveraging their first in human clinical experience with 3D-bioprinted and implanted living tissues, PrintBio is developing an array of biocompatible products, beginning with 3DMatrix™, a 3D-printed monofilament bioresorbable surgical mesh utilizing its proprietary technologies, clinically tested in patients. It also offers a non GMP research-grade collagen, ColVivo™, a collagen bio-ink and solution-form collagen that can be used for translational research purposes. PrintBio’s facility is located just on the other side of the Queens-Midtown Tunnel, in Long Island City, Queens, and houses the world’s first clinical-grade manufacturing facility for living bioprinted implants and related materials.
About Rapha Capital Management, LLC
Rapha Capital Management, LLC is an investment advisory firm focused on making strategic investments in early stage, non-public biotechnology companies, through special purpose, joint venture entities (SPVs), which it manages. Rapha Capital was founded by its President, Kevin Slawin, M.D., a successful and experienced oncologic and robotic surgeon focusing now on disruptive healthcare technologies. Previously, he was the founder of Bellicum Pharmaceuticals, Inc., the very first CAR-T cell company, which he took public in 2014 with a $55 million crossover Series C and a successful $161 million IPO in December 2014. After leaving Bellicum, he founded Rapha Capital Management, LLC (https://raphacap.com), which offers alternative asset management services to Rapha’s fifteen SPVs, Rapha Capital Investment I to XV, LLC, as well as to its private equity fund, Rapha Capital PE Life Sciences Fund VI, which is the current vehicle for all investments managed by Rapha Capital Management. Rapha Capital Investment XIV, LLC is the SPV that owns and controls PrintBio, Inc.
For more information about Rapha Capital Management, email info@raphacapital.com or visit https://raphacap.com
