NanomediGene LLC

 

NanomediGene is a biotech startup company founded in December 2019 which have technologies in targeted drug delivery systems of proteins, drug molecules, genes, and cellular-based therapies. We are on the pre-clinical evaluation level and looking for seed fundings and angel investors. 

Our project;
 

Drug-Eluting Bio-degradable film engineered by Estrogen Nanoparticles for Vascular Access Dysfunctions 
 

We propose to develop a novel drug-eluting biodegradable film engineered by nanoparticles for local delivery of the estrogen (17 β-estradiol; E2) molecules to the arteriovenous fistula (AVF) injury site so that it can prevent neointimal hyperplasia (unwanted tissue in blood vessels).   
We hypothesize that the designed sustained E2 loaded nanoparticles coated onto our bio-degradable polymeric-based film prevent neointima thickening, which results in the access failure of AVF. Thus, this reduces the time between surgery and when the fistula can be cannulated successfully for dialysis and minimizes the need for additional, supplementary interventions to help maintain fistula functionality. Our further goal is to reduce the morbidity associated with hemodialysis vascular access dysfunction with this local delivery approach that could easily apply at the time of surgery. Hence it is ideally suited for use in clinical settings. 

Vascular access is the lifeline for patients on hemodialysis. Arteriovenous fistulas (AVFs) are the preferred vascular access due to the lowest complication rate and greater blood flow, but AVF maturation failure remains a significant clinical problem. It can take up to 6 months for the AVFs to mature, which refers to arteriovenous dilatation that makes it suitable to perform dialysis. Until fistula mature, patients have no choice but to undergo dialysis with a catheter which is the primary cause of infection, hospitalization, and death. A significant number of AVFs (28 to 53%) never mature to support dialysis. There are no effective therapies available to prevent or treat AVF maturation failure. Also, more than 60% of mature AVFs needed frequent repairment procedures and other supplementary interventions to help to maintain fistula functionality or fail within 6-12 months. 
 Neointimal hyperplasia is not only the vascular access dysfunction but also the primary cause of restenosis after percutaneous coronary interventions such as stenting or angioplasty. If our approach would be shown to be a safe and effective therapy to inhibit neointimal formation, thereby significantly reducing vascular access dysfunction besides restenosis, it could substantially reduce the economic cost and health morbidity currently associated with this recalcitrant clinical problem. 
 In 2018, approximately 130k new cases of ESRD were reported, and over 700k patients were receiving dialysis treatment in the US. The total cost to manage maintenance HD patients in the US was approximately $28 Billion in 2018. Vascular access and its complications are important causes of morbidity; traditionally a significant cause of hospitalization and have high costs worldwide. In 2013, Medicare paid $2.8 billion for vascular access-related services, highlighting the need for innovations in HD vascular access. AVF is the first choice of vascular access. These outcomes have significant economic consequences. When these fistulas fail to mature, patients are often referred for endovascular management to evaluate and treat the lesions that inhibit fistula maturation, such as dilatating stenosis, with angioplasty. Approximately 50% of fistulas require interventions before successful AV fistula use. In some cases, multiple endovascular procedures require to aid in the maturation of the fistulas. But as access interventions become necessary, costs to maintain the AVF climb to 3-4-fold higher than initial costs. 

There is a need to improve AVF outcomes and reduce costs after AVF creation. In an attempt to reduce the morbidity associated with HD vascular access dysfunction, our local delivery approach, which could easily apply at the time of surgery, is ideally suited for use in the clinical settings of HD vascular access dysfunctions. 

Members of our company: 

1)Dr. Yasin Oduk (Founder & CEO NanomediGene LLC) has an extensive background in nanoparticles/drug delivery combined with hands-on experience with animal surgery in biomedical research. He received his doctorate in physics at UAB. He became interested in biomedical research and trained in cell culture and animal studies in Spinal Cord Injury and Pulmonary Medicine labs. He obtained his postdoctoral training in cardiovascular diseases and Biomedical Engineering at UAB. He joined the Orthodontics division at Columbia University just before establishing his company. His expertise in various disciplines, including physics, Cardiovascular health/disease, Biomedical engineering, and Orthodontics, makes him well-equipped to navigate the processes of growing a biotech company. 

2)Fatma Oduk (Co-founder & manager of NanomediGene LLC) is in charge of the administration and business aspects of the company, scientific writing, and fund recruitment. 

3)Jeff W.M. Bulte, Ph.D. (NanomediGene Scientific Advisory Board Member), is a professor of Radiology, Oncology, Biomedical Engineering, and Chemical & Biomolecular Engineering at the Johns Hopkins University School of Medicine.