R3 Vascular Announces First Patient Enrolled in Pivotal ELITE-BTK Trial for MAGNITUDE Ultra-Thin Bioresorbable Drug-Eluting Scaffold

R3 VascularAnnounces Completion of First Clinical Enrollment in Its ELITE-BTK Pivotal Trial, This StudyR3 VascularThe Next Generation of Drug-Eluting BioabsorbableStent RetrieverMagnitudeEfficacy for Below-the-Knee (BTK) PAD.

PI Evaluation

"I am honored to have enrolled the first two patients in the R3 Vascular ELITE-BTK trial, primarily because this type of technology is something patients have been urgently needing for years. My career has been dedicated to researching innovative devices for vascular diseases (including bioresorbable scaffolds). Although there have been some advancements in the BTK PAD trial field in recent years, there remains a significant unmet need. We look forward to the results of this important trial revealing...The Unique Potential of Magnitude Brings Better Treatment Options for Vascular Disease Patients.

---Brian DeRubertis  NewYork-Presbyterian and Weill Cornell Medicine

Executive Evaluation

"The completion of the first patient treatment in the ELITE-BTK pivotal trial by renowned vascular surgeon and researcher Dr. Brian DeRubertis marks our comprehensive validation of the next-generation..."Magnitude Stent Efficacy and Safety: An Important Milestone. Moving forward, we will accelerate patient enrollment to pave the way for submitting a Pre-Market Approval (PMA) application to the FDA.

---Christopher M. Owens  President and CEO of R3 Vascular

"The initiation of the trial marks our continued efforts to provide breakthrough technology for patients who have long suffered from diseases and lack effective treatment options. As a new generation of bioresorbable scaffold, MAGNITUDE is expected to address a significant unmet need in patients with chronic limb-threatening ischemia caused by below-the-knee PAD. Our stent employs a unique ultra-high molecular weight polylactic acid polymer, combined with an innovative stent design and proprietary processing technology, offering excellent biomechanical properties—both strength and ductility. We believe these features will significantly improve patient outcomes, particularly long-term clinical results. We look forward to advancing the product to market through clinical development, ultimately achieving market leadership."

---Kamal Ramzipoor  RFounder and Chief Technology Officer of R3 Vascular

According to the American Heart Association, more than 200 million people worldwide are affected by PAD, including approximately 10 to 12 million patients over the age of 40 in the United States. The most common type of PAD affects the lower extremities, leading to reduced blood flow to the legs and feet. In the U.S. alone, there are about 150,000 lower limb amputations performed annually.

Last Year FDA Approved Abbott's Absorbable StentEsprit BTK Launches in ChinaEsprit BTK, with its significantly superior efficacy over angioplasty, has made bioresorbable scaffolds highly welcomed by clinicians, patients, and medical insurance payers for the treatment of below-the-knee peripheral artery disease.Magnitude is currently the second-generation bioresorbable scaffold being advanced by R3 Vascular, with strong potential to become the second bioresorbable scaffold to reach the market and a promising contender to be Abbott's major competitor in this field.

MagnitudeIs an ultra-thinDrug-eluting bioresorbable scaffold, itsThe strut is only 98μm.Esprit BTK is thinner.

MagnitudePrepared from a unique ultra-high molecular weight polylactic acid.Ultra-high molecular weight polylactic acid, combined with a unique stent design and pricing technology, enablesMagnitude BecomesMoreThinner, stronger, more flexible.

• Excellent stent flexibility resists fracture and significantly adapts to changes in vessel diameter.
• High Radial Strength and Circumferential Support
• Balance of Strength and Ductility
• Ultra-thin Design
• The polymer exhibits significant structural stability during the degradation process.