If you have questions about research at Avera, call the Avera Research Institute at 605-322-3050.
Applied research at Avera Research Institute is designed to solve practical problems and improve health and quality of life by creating or inventing marketable products. With this approach, identifying the commercialization potential is a primary goal of each research project.
Through these unique research projects, Avera has the opportunity to make a tremendous impact in medicine with broad-reaching implications.
Alucent: Innovative Treatment for Peripheral Vascular Disease
Alucent is a novel combination drug/device therapy for the treatment of peripheral vascular disease (PVD). It received approval from the Food and Drug Administration (FDA) to move forward with national Phase 1 human clinical trials in 2017. This is the first combination drug/device product developed in South Dakota to progress through the FDA approval process. It was developed by Avera scientists under the leadership of Ron Utecht, PhD, Chief Scientific Officer of Alumend.
Why Pursue a New Approach to Balloon Angioplasty?
Alucent combines balloon angioplasty with an innovative pharmaceutical process – known as Natural Vascular Scaffolding (NVS)© – that builds natural scaffolding or structure to keep the vessel open, replacing the need for a stent. NVS has the potential to be a dramatic improvement over stents, which can cause complications over time, requiring the need for retreatment. Currently, 50 percent of patients need re-intervention at two years after percutaneous transluminal angioplasty (PTA) or stent treatment.
How Does NVS Therapy Work?
A drug-delivery balloon is inserted via catheter into the diseased artery and is filled with the NVS drug. During a five-minute delivery phase, the NVS injection is delivered to the artery wall tissue through the balloon pores. A PTA is then inserted along with the NVS light fiber. The PTA balloon is inflated and the NVS light source is activated to deliver light in the treatment zone for 60 seconds. The light activates the NVS drug and produces protein cross-linking that provides the NVS effect, or scaffolding.
Testing Alucent’s Effectiveness & Safety
During the Investigational New Drug (IND) process and before progressing to human clinical trials, Alumend scientists demonstrated the safety of NVS in multiple ways, from how the body metabolizes the solution to how the delivery and light activation would impact body systems.
Going forward, this photo-activated drug therapy will be tested and eventually marketed through Alucent Medical, Inc. Alucent is owned by Alumend, LLC, Avera’s research and development company. Alucent is licensed to test and market NVS for below-the-waist treatment of PVD and has broader application for the vascular system.
Novel Photochemical Tissue Bonding Technology
Avera scientists have been instrumental in developing a photochemical tissue bonding technology for a number of clinical applications. This exciting family of naphthalimide-based photochemicals has demonstrated successful tissue bonding in numerous tissue beds.
The potential uses for these photochemical tissue-bonding compounds extend beyond the realm of vascular biology with nearly limitless tissue applications. We’re currently expanding to include research into clinical applications for dermatology, urology, ophthalmology, virology and orthopedics.