Chronic Venous Insufficiency (CVI)
CVI is a disease of the deep venous system that leads to painful swelling and ulceration of the lower legs. In CVI patients, the valves of the deep veins, mostly the femoral vein, do not function properly. Consequently, the faulty valves do not prevent a back-flow of the venous blood on its journey towards the heart, resulting in an increased hydrostatic pressure on the venous side in the lower leg. This gives rise to a range of symptoms including swelling, varicosities, skin changes, a throbbing sensation, pain, and ulceration on the feet, around the ankle and lower leg.
The most common causes for damage to the venous valves are deep venous thrombosis (DVT) and trauma. CVI is a life-long disease occurring in various age groups and there is currently no curative treatment. Symptomatic treatment is accomplished with compression stockings and local treatment of the ulcerations.
To cure the disease, functional valves need to be reestablished. Attempts to bring synthetic valve-bearing veins to clinical use have failed likely because of technical challenges in combination with the high risk of thrombosis associated with non-biological materials. Replacement of a vein segment with a non-functioning valve by a P-TEVTM graft with a functional valve could provide a simple surgical solution.
Peripheral artery disease (PAD)
Peripheral artery disease is a common condition caused by a build-up of fatty deposits in the arteries (atherosclerosis) resulting in reduced blood flow to the limbs. This results in ischemia and leg pain when walking. To treat the disease, blocked arteries are bypassed to reestablish blood flow. VERIGRAFT’s P-TEATM grafts can offer a fully biological solution for grafting.
Ischemic heart disease (IHD)
Ischemic heart disease (IHD), is most often caused by atherosclerosis affecting the coronary arteries. Lack of blood supply to the heart muscle causes weakness and pain (angina pectoris). A completely blocked artery causes part of the muscle to die, a condition known as a heart attack or myocardial infarction (MI). To reestablish blood flow, blocked arteries are bypassed in coronary artery bypass grafting (CABG). VERIGRAFT’s P-TEATM grafts can offer a fully biological solution for the procedure.
Patients with terminal kidney failure need dialysis while waiting for a kidney transplant. Dialysis requires vascular access, which is often accomplished by virtue of an arteriovenous fistula or graft in the forearm. Both the AV fistula and graft are associated with thrombotic complications. VERIGRAFT’s P-TEATM grafts can offer a solution less susceptible to complications.
Peripheral nerve damage
Patients with peripheral nerve injury lose sensory, autonomic, and motor functions dependent on the injured nerve, with serious consequences for the patients’ quality of life. Although peripheral neurons are capable of some regeneration functional recovery is often unsatisfactory, especially following severe injuries.
Recovery from larger distance nerve defects and proximal injuries in long limbs is difficult to achieve today. VERIGRAFT’s P-TENTM grafts can offer a solution to bridge and regenerate larger nerve defects to allow successful reinnervation.
Heart valve failure
Heart valves may degenerate with age or may be affected by certain diseases or congenital abnormalities. Many patients are therefore in need of heart valve replacement. Mechanical valves and denatured valves from animals are available today, but they cannot offer a life-long solution. VERIGRAFT plans to use its personalization technology to generate fully biological heart valves for implantation. These could provide a novel cure, especially for younger patients and children.
Clinical development of P-TEVTM grafts is ongoing in the TECVI-1 clinical trial. The TECVI-1 clinical trial is a phase I/II open label exploratory study of P-TEV in which 15 patients suffering from CVI are treated with P-TEVTM grafts to evaluate feasibility and safety. All subjects will be followed for twelve months regarding safety and efficacy. The trial is ongoing in Europe and has already reached several important safety assessment milestones.
VERIGRAFT’s revolutionary technology for personalized tissue has the potential to treat a wide range of indications. The development phase for the product candidates Personalized Tissue-Engineered Veins (P-TEVTM), Personalized Tissue-Engineered Arteries (P-TEATM), Personalized Tissue-Engineered Nerves (P-TENTM) and Personalized Tissue-Engineered Heart Valves (P-TEHVTM) currently range from pre-clinical to clinical development.
Product development for regenerative medicine