WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced a $25 million financing with Vensana Capital as the lead investor. Vensana was joined by existing investors including New Enterprise Associates (“NEA”), H.I.G. BioHealth Partners, and Quaker Partners. The Company reported closure of the initial tranche of the financing, with the remainder scheduled for draw down in 2020 as the Company ramps its commercialization of the Tack Endovascular System.
Use of proceeds is mainly focused on expansion of sales, marketing and clinical support staffing and initiatives following FDA’s recent approval of the Tack Endovascular System for dissection repair after balloon angioplasty above the knee. The Company is also preparing for the release of data from its TOBA III and TOBA II BTK clinical studies later this year.
“We are excited and proud to welcome Vensana Capital to the Intact Vascular team as we make the transition to a company focused on rapid commercial growth,” said Bruce Shook, President & CEO of Intact Vascular. “The Vensana team brings a wealth of medtech experience to a strong existing investor syndicate, and that combination will be a powerful driver of our commercial success.”
Patients treated with balloon angioplasty frequently suffer from dissections. Often overlooked, undiagnosed and untreated, dissections can lead to acute thrombosis and arterial occlusions, which lower long-term patency rates and require repeat procedures. Designed to resolve these dissections while leaving minimal metal behind, the Tack® implant is uniquely designed to preserve vessel integrity, minimize vessel inflammation and enhance blood flow.
“Intact Vascular is at a true inflection point,” said Justin Klein, Managing Partner at Vensana Capital. “The Intact team has developed a unique technology and a strong clinical study portfolio that position the company for significant commercial success. Vensana Capital is thrilled to support Intact Vascular’s rapidly expanding commercialization effort.”
About Intact Vascular and the Tack Endovascular System
Intact Vascular is a privately held medical device company that develops minimally- invasive peripheral vascular products. The Tack Endovascular System is designed to improve peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) or four for below-the-knee (BTK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70% less metal than stents1. Additionally, the Tack Endovascular System is designed to minimize vessel inflammation, promote healing, improve outcomes and preserve future treatment options for PAD and critical limb ischemia (CLI) patients. Visit www.intactvascular.com for more information.
Intact Vascular Clinical Program
Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III. TOBA II is investigating the combination of the Tack implant with plain angioplasty balloons and the BARD Lutonix® drug-coated balloon (DCB) in arteries above the knee and has completed its primary endpoint analysis. TOBA II BTK is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee and has completed enrollment. TOBA III has completed enrollment in Europe and is investigating the combination of the Tack implant with the Medtronic IN.PACT™ Admiral™ (DCB), inclusive of long lesions.
About Vensana Capital
Vensana Capital is a venture capital and growth equity investment firm dedicated to partnering with entrepreneurs who seek to transform healthcare with breakthrough innovations in medical technology. Launched in 2019, Vensana is actively investing in late development and commercial stage companies across the medtech sector, including medical devices, diagnostics, drug delivery, digital health, and tech-enabled services. Vensana’s investment team has a history of successfully partnering with management teams behind industry-leading companies including Cameron Health, CardiAQ, Cartiva, CV Ingenuity, Epix Therapeutics, Lutonix, Neuwave Medical, Sequent Medical, Topera, Ulthera, and VertiFlex. Learn more at www.vensanacap.com
Forward Looking Statements
This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.
1Bosiers M, Scheinert D, Hendricks JMH et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg 2016;64:109-16.
Tack Endovascular System® and Tack® are registered trademarks of Intact Vascular, Inc.
Lutonix® is a registered trademark of BD Interventional.
IN.PACT® and Admiral® are registered trademarks of Medtronic, Inc.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Contacts
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048
