Harnessing the power of the body’s own cells to give people hope. When vascular-related conditions don’t respond to treatment, or conventional therapies aren’t an option, they can be devastating. They compromise people’s quality of life, drain them of hope for the future and may cause death while costing the healthcare system billions of dollars. At VESSL, we’re on a mission to change all that…and change lives, too. We’re using cell- and gene-based proprietary technologies along with the body’s own healing mechanisms to develop solutions for vascular-related conditions that are effective and faster to recover from. Our breakthrough solutions are aimed for people suffering from advanced peripheral arterial disease, problems with their dialysis access sites and many other conditions. We’re not just giving them new options. We’re giving them new hope. And as fascinating as our work is, that’s what we look forward to every day. Technology has changed a lot in fifteen years. What motivates us has not. VESSL’s core technology is enabling us to develop entirely new, life-changing treatments for a wide range of blood-vessel-related disorders. We combine a patient’s own endothelial cells with specific genes and other synergistic cell types to create groundbreaking therapies for patients with peripheral arterial disease, coronary artery disease, end-stage renal disease, liver cirrhosis and diabetic retinopathy – patients for whom conventional treatments have failed or are unsuitable. Our therapies are derived from the patient’s own cells isolated from a short vein segment taken from their arm under local anesthesia. These cells are activated by the insertion of specific genes and are then re-introduced to the patient. Our pioneering approach enables the secretion of multiple factors by the activated autologous cells, closely mimicking the natural process of blood vessel formation and growth. VESSL’s leading solutions are expected to improve blood flow through the proliferation of collateral blood vessels or by a modified synthetic graft with greater biocompatibility. We’ve been immersed in developing these treatments for fifteen years. It’s amazing how technology has changed in that time. And it’s equally amazing what it enables us to do today. New therapies that are giving patients a whole new outlook on life. Peripheral artery disease (PAD) is a systemic atherosclerotic disease. It afflicts 8 million Americans and an estimated total of 25 million patients in the developed world. It is associated with diabetes, obesity, hypertension, smoking and high cholesterol levels. PAD is characterized by the narrowing or occlusion of arteries in the leg, resulting in inadequate blood flow to the leg muscles. This may cause pain when a patient engages in physical activity, but that pain will usually respond to rest. The situation could deteriorate, however, and progress to critical limb ischemia (CLI) with its attendant rest pain, ulcers that won’t heal or gangrene that may lead to limb amputation. CLI, the most severe form of PAD, develops in about 4% of PAD patients. Currently, there are about 1 million patients in the developed world, with 200,000-300,000 of them either being unsuitable for or unresponsive to conventional therapies such as bypass surgery or balloons and stents. Their quality of life has been described as similar to that of a patient with terminal-stage cancer, and many will eventually have to undergo amputation or will die. One of our primary solutions, MultiGeneAngio (MGA), is designed to offer hope to people with no other options. Using blood vessel cells isolated from a patient’s own body and into which we insert specific genes, MGA harnesses the body’s own mechanisms to grow natural bypasses. By enhancing the formation of collateral arteries, MGA significantly increases blood flow to the oxygen-starved muscles. MGA is expected to dramatically improve a patient’s quality of life, improve healing of ulcers, reduce amputations, minimize hospital stays and procedures and decrease the enormous costs associated with CLI. To date, we have completed pre-clinical experiments and two phase I/IIa human trials of MGA in PAD patients at the University of Michigan, the University of Pennsylvania and 7 medical centers in Israel. Thirty-five patients have been treated, with no safety issues and promising early indications of efficacy. About 50% of all end-stage renal disease (ESRD) patients are maintained by hemodialysis, undergoing mechanical blood cleaning several times a week for the rest of their life (or until a kidney transplant becomes available). More than 400,000 patients rely on this therapy in the US and a total of 1.25 million patients rely on it in the developed world. The economic burden of managing vascular access dysfunction is enormous and includes recurring surgical procedures required for keeping the access site open. The number of ESRD patients is projected to keep growing due to the availability of fewer donor kidneys and the increasing prevalence of diabetes and hypertension. Creating and maintaining a suitable arterio-venous access site is one of the most challenging and expensive aspects of hemodialysis treatment and frequently leads to hospitalization. Approximately 25% of all hospital stays for ESRD patients are related to problems with vascular access. The preferred form of access is called an arterio-venous fistula. To create one, a surgeon connects a vein to an artery (typically in the arm), resulting in a high-flow circuit suitable for dialysis. In 20% of these cases, poor vasculature requires the use of a synthetic graft in order to create an access site. The problem with synthetic grafts is that they have a lifespan of only two years before a replacement or correction is needed, and about half of them fail within 6 months. VESSL’s MultiGeneGraft (MGG) is a biosynthetic vascular graft lined with a patient’s own endothelial cells which are modified by specific genes. Lining the graft with these cells provides a clot-resistant vessel that’s expected to outlast and outperform synthetic products currently in use. By improving compatibility and reducing complications, MGG will reduce interventions, hospitalization time and the number of required surgeries. Pre-clinical trials demonstrated successful adhesion of the endothelial cells to the graft material and a reduction in short- and long-term failure rates. The FDA has granted IND for MGG, and a phase-I study in 10 hemodialysis patients is planned. We have a bright future ahead of us. More importantly, so do patients. Additional solutions using our technological platform are currently in different pre-clinical stages. These include: MultiGeneAngio (MGA) for treatment of coronary artery diseases (CAD) MultiGeneLiver (MGL) for liver regeneration in patients with liver cirrhosis MultiGeneEye (MGE) for treatment of diabetic retinopathy