Drug Delivery, Regenerative Medicine, & Implant Devices
TissueGen’s patented drug delivery capabilities are ideally suited to a wide variety of implantable devices and clinical applications across a range of therapeutic indications. Our patented extrusion technology is a unique solution to devices wrestling with structural and pharmaceutical support requirements in a single form factor, such as customized drug delivery devices, regenerative medicine applications, stents, and a wide variety of other devices. A full list of therapeutic applications includes
- prostate and urinary disorder treatment;
- solid tumor remediation;
- peripheral nerve regeneration;
- spinal cord repair;
- dermal wound healing;
- treatment of retinal disease;
- and many more.
TissueGen’s extruded fibers are strong enough to pass USP standards for synthetic suture and provide an ideal platform for new “smart sutures” with the potential to dramatically improve wound healing response by using growth factors to accelerate and help direct tissue re-growth and healing.
TissueGen’s patented core technology includes fiber extrusion at room temperature, which preserves the biological activity of incorporated drugs and enables an entirely new format for drug delivery via biodegradable fibers. Controlled release and more specific drug-eluting capabilities than previously possible allow for combined structural-pharmaceutical support in a single polymer structure. The result is the delivery of more drugs than ever via implant.
TissueGen’s technology is driving a paradigm shift in tissue scaffolding, thanks to the mechanical properties of strong but supple fibers that can be woven, knitted, or braided to create biomimetic three-dimensional structures with drug delivery capabilities. TissueGen’s technology also enables fibers with controlled drug concentration gradients along the length of the fiber to encourage cell migration, and the resulting structures enable improved site-specific drug release of more biologic combinations than ever before.
Spinal Cord Injuries
TissueGen is currently developing a medical device for advancing the treatment and recovery of patients with spinal cord injuries (SCI) resulting in paralysis. Currently in animal trials, TissueGen is applying its novel fiber-based drug delivery technology, commercialized as ELUTE® Biodegradable Drug-loaded (BDL) fibers, to support the repair of previously irreversible spinal cord injuries. By providing the capability to deliver sensitive growth factors directly to the injury site, nerve regeneration can be promoted without requiring tissue to be harvested from elsewhere in the patient’s body for cell transplantation. This less invasive approach being pioneered by TissueGen could allow the patient to be treated with a single surgical procedure. TissueGen’s ELUTE BDL fibers enable the creation of three-dimensional concentration gradients of neurotrophic factors that are positionally stable over time. These gradient scaffolds may be surgically implanted into a severed spinal cord. The concentration gradients of the various neurotrophic factors may selectively entice motor and sensory axons to cross a gap in the severed spinal cord by directing and upregulating axonal growth as depicted in vitro in the figure below.
Purpose-built for devices that require both mechanical and pharmaceutical support, the TissueGen technology is already incorporated into a variety of stents, including TissueGen’s own ARCHER™ stent, a 510(k)-track biodegradable self-expanding and drug-eluting stent for the biliary, PAD, and DVT markets. Other ideal targets include devices such as meshes, slings, supports, and adhesion prevention that benefit from biodegradable implant technology.
TissueGen has partnered with some of the world’s preeminent medical device developers on specific applications for the heart, eye, peripheral artery, and nerves.
TissueGen’s experience in drug delivery to the back of the eye serves experimental treatments for diabetic retinopathy, one of the leading causes of blindness in the world. Treatment data has proven TissueGen’s ability to load and deliver a small pharmaceutical agent with clear biological impact in reducing the conversion of glucose to sorbitol, a key biochemical pathway thought to lead to blindness.
TissueGen’s biodegradable ARCHER stent has been successfully implanted in the femoral, popliteal, profunda, and iliac arteries in animals. A biodegradable peripheral stent made from fiber extruded in the form of a flat ribbon, the stent is based on a helical coil design for biomimetic performance. The histological images below demonstrate the excellent biocompatibility of the ARCHER stent.
TissueGen’s fiber-based technology is ideally suited for peripheral nerve regeneration. A roughly parallel array of fibers provides excellent scaffolding for guiding neurons, and the ability to load TissueGen fibers with biologically active NGF has been shown to attract neurons from isolated DRG cells (as shown in the associated photographs).
Caption: The first photo shows a group of DRG cells placed on top of a NGF-loaded fiber, with a thick covering of axons covering the fiber.
Caption: The second shows DRG cells in the upper right with an NGF loaded fiber (not shown) in the direction of the lower left corner. Axons leaving the DRG cells are streaming in the direction of the NGF-loaded fiber.
Caption: The micrograph shows the cross section of the rat sciatic nerve in panel A; the white dots are the cross section of fiber. Panel B is a blow-up of the rectangular section of panel A, and shows fascicular formation (marked by small arrows). Panel C is a blow-up of the square in panel B, and shows an abundance of myelinated axons (marked by arrows) and a small blood vessel. Panel C also illustrates extremely good tissue compatibility immediately next to the fiber on the far left of the image.
Please see the publications page for a number of peer-reviewed papers using TissueGen fibers in peripheral nerve work.
Solid Tumor Remediation
TissueGen has created a bi-component, gel-centered fiber loaded with an adenovirus that transduces cells to produce green fluorescent protein. In one application, a human pancreatic tumor was implanted in an immune-compromised animal, and implanted with a single strand of fiber at the center. Upon removal of the tumor, most of the cells in about a 4mm radius (scale not shown) of implantation demonstrated successful transfection by the production of green fluorescent protein.