3DT Holdings, LLC Is Excited To Announce Advanced Research Projects Agency For Health (ARPA-H) Funding For The Development Of The World’s First Minimally Invasive Anti-Thrombotic Lymphatic Stent Therapy Under The ARPA-H Groundbreaking Lymphatic Interventions And Drug Exploration (GLIDE) Program, Led By ARPA-H Program Manager Kimberley Steele, M.D., Ph.D.

3DT is pioneeringthe first-ever minimally invasive device-drug combination to decompress the lymphatic system including treatments of obstructions of thoracic duct (the body’s major lymphatic vessel). The team will also develop a unique device-drug combination: a novel tissue-covered segmented stent that resists clots, paired with a first-in-class oral Lymphatic Targeted Anti-Thrombotic (LTAT) agent that works specifically within the lymphatics.

The major deliverables in the five-year funding period will be:

1. Pre-clinical safety and efficacy demonstration of the covered stent and shunt designs, along with GMP manufacturing of the delivery and re-entry catheters

2. Completion of a GLP animal study and submission of an FDA Early Feasibility Study (EFS) package for the TD stent system

3. Selection of an LTAT Development Candidate and submission of a pre-IND package to the FDA

4. Conduct of a first-in-human safety trial of the combined device and LTAT therapy

Clinical relevance: 

Lymphatic obstruction can lead to life-threatening complications including heart failure, chylothorax, chylous ascites, and protein-losing enteropathy. Patients affected by central conducting lymphatic anomaly (CCLA) and thoracic duct obstruction may present with pleural effusions, ascites, anasarca, plastic bronchitis, and lymphedema — conditions that are life-altering with no existing FDA-approved treatments.

Unlike other organ systems that benefit from dedicated minimally invasive tools, the lymphatic system still lacks specialized devices and procedures. The novel AT LAST technology we are developing under the ARPA-H GLIDE program will provide the first targeted, minimally invasive option to reopen or bypass TD obstructions and decompress the lymphatic system — enabling precision-based medicine for patients with no current options. 

Full announcement can be found HERE

Active Programs

Conductance Balloon Coronary Post-Dilatation Catheter

Stent malapposition leads to less optimal outcomes (restenosis and thrombosis) in coronary stenting. 3DT is developing a novel conductance balloon (CB) coronary post-dilatation catheter system (the CB catheter) that accurately measures and displays real-time balloon size. The device provides an innovative, clinically-relevant, real-time, simple, accurate, repeatable, and objective sizing measurement during coronary post-dilatation to aid in stent deployment and proper minimum stent area (MSA) / minimum stent diameter (MSD) determination.

Stabilization Device for Trans-septal Access

Transseptal (TS) procedures for accessing the left side of the heart are an important and rapidly growing space for diagnostics and therapy delivery. Currently, TS procedures are used in the following FDA-approved procedures: atrial fibrillation (AF) ablation, correction of atrial septal defects (ASD), degenerative mitral valve repair and left atrial appendage (LAA) closure. 3DT is developing a guiding catheter for device delivery into the left atrium for accurate and safe placement of steerable guides. Various design features will significantly reduce the propensity for inaccurate punctures and perforations.

Mild Hypothermia Catheter for Reperfusion Injury

ST segment elevation myocardial infarction (STEMI) is the most severe form of acute coronary syndrome (ACS) that affects nearly 500,000 Americans each year and places a heavy clinical and financial burden on the healthcare system. STEMI treatment requires prompt reperfusion to limit myocardial injury (recommended time of less than 90 minutes from hospital arrival to therapy delivery or 90-minute door to balloon time). Mild hypothermia (MH), i.e., temperature ~34°C, provides cardio-protection and decreased infarct size following MI by reducing myocardial metabolic demand, free radical creation, and platelet aggregation. 3DT is developing a novel, catheter-based method of selective auto-retroperfusion (SARP) to deliver hypothermia to the cardiac region of interest.

Valvuloplasty

Aortic stenosis (AS) affects approximately 1.5 million Americans and places a large financial burden on the U.S. healthcare system. Percutaneous catheter delivery of a prosthetic aortic valve, called transcatheter aortic valve replacement (TAVR), has emerged as a treatment option for severe AS. Paravalvular leakage is seen in up to 67% of patients 1-3 years after TAVR implantation, which is in part due to size mismatch of the TAVR device versus the native aortic valve annulus. 3DT is developing a novel 2-in-1 sizing valvuloplasty conductance balloon (SVCB) catheter system that serves as a standard valvuloplasty balloon for aortic valve dilatation prior to implant (all TAVR procedures involve valvuloplasty) as well as a valuable tool that accurately measures and displays real-time aortic annulus size during inflation.

Patent Portfolio

3DT owns a portfolio of over 200 issued and pending patents that cover inventions in the areas of electrical conductance-enabled therapeutic devices, retroperfusion-enabling devices, devices enabling pericardial access, smart clamps, magnetic occlusion and endograft/endoprosthesis devices, A-Fib/stroke prevention, valve removal / annulus remodeling, and bariatric devices.

NIH Sponsored Research

3DT is a recipient of National Institutes of Health (NIH) research grants. 3DT has policies and procedures in place to support these grants and ensure compliance with federal regulations including Financial Conflict of Interest Policies which are available upon request.