Intact Vascular is a medical-device developer that makes a system for arterial dissection repair. The company is commercializing that system and plans further product development. Runway Growth Capital provided Intact with a $30 million loan to support those efforts. The financing comes as venture debt from Runway’s business development company, which provides senior term loans of $10 million to $50 million. Proceeds will be used to fund commercialization and future development of the arterial dissection repair system. Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. Its core product, the Tack Endovascular System, is designed to improve peripheral balloon angioplasty results and repair dissections while leaving >70% less metal than stents and is CE Mark Authorized. The system is pre-loaded with six self-expanding nitinol devices for above-the-knee interventions or four for below-the-knee interventions and can treat multiple dissections with a single catheter. Following FDA approval for dissection repair after balloon angioplasty above the knee, the company is ramping commercialization and expanding sales, marketing, and clinical support staffing. Intact announced a $25 million financing led by Vensana Capital, closing an initial tranche with the remainder scheduled for draw down in 2020 to support commercialization. The company is preparing to release data from its TOBA III and TOBA II BTK clinical studies later this year and is sponsoring three clinical trials (TOBA II, TOBA II BTK and TOBA III). Intact Vascular develops minimally invasive peripheral vascular devices, primarily the Tack Endovascular System for precision dissection repair after balloon angioplasty. The Tack is a first-of-its-kind implant designed to leave minimal metal in the artery, reduce mechanical stress on the arterial wall, maintain vessel integrity, enhance blood flow, and preserve future treatment options. Intact is sponsoring three clinical trials (TOBA II, TOBA III and TOBA II BTK) to evaluate the device in above-knee and below-knee indications; TOBA II completed enrollment in March 2017, TOBA III is nearing full enrollment, and TOBA II BTK is actively enrolling. The company projected completion of primary endpoint analysis for the pivotal TOBA II trial and described 2018 as a watershed year for its clinical program. To fund regulatory and trial activities, Intact closed a $20 million Series C in a two-tranche structure intended to carry the company through PMA of the Tack Endovascular System. The company is based in Wayne, Pa., and is preparing to advance toward regulatory approval and commercial launch following pivotal trial completion. Intact Vascular develops minimally invasive peripheral vascular products, centered on the Tack Endovascular System for repairing arterial dissections following percutaneous transluminal angioplasty (PTA). The Tack system enables highly targeted arterial repair while minimizing metal left behind and arterial inflammation compared with stenting. The company is sponsoring three large international clinical trials: TOBA II, TOBA II BTK, and TOBA III, which study the Tack system in above‑the‑knee (ATK) and below‑the‑knee (BTK) peripheral artery disease and combinations with PTA and drug‑coated balloons. TOBA II BTK is the first pivotal FDA‑approved trial for a vascular implant below the knee to treat critical limb ischemia (CLI). Intact plans to use the new funds to advance its ATK and BTK clinical development program and multiple product development initiatives to expand the Tack system’s utility. The company is led by President and CEO Bruce Shook and is based in Wayne, PA. Intact Vascular develops minimally invasive peripheral vascular products centered on the Tack Endovascular System. The Tack System is designed to optimize results of percutaneous balloon angioplasty and to minimize the metal left behind and arterial inflammation associated with stenting. Over three years the company refined the implant and delivery system, conducted three international clinical trials enrolling more than 170 patients, and obtained a CE‑Mark for its above‑knee system. Intact Vascular plans multiple clinical trials above and below the knee aimed at demonstrating the Tack System’s value and advancing FDA approval. The company was founded in 2012 and is based in Wayne, Pa. The firm cites peripheral artery disease’s global prevalence (more than 200 million people) as the clinical need for its technology.

Total raised

$141M

Funding rounds

8

Latest round

Debt Financing

Latest activity

Jul 2020