Svelte Medical Systems Announces Final Patient Enrolled in Pivotal OPTIMIZE Study

June 5, 2019

New Providence, New Jersey — Dr. Jeremiah Depta and the research team at Rochester General Hospital in Rochester, NY, enrolled the final patient in Svelte Medical System’s OPTIMIZE clinical study on June 4, 2019.  OPTIMIZE is an IDE study designed to assess the safety and effectiveness of the Svelte Drug-Eluting Stent (DES) Integrated Delivery System (IDS) and Rapid Exchange (RX) platforms.  A total of 1,639 patients were randomized at 74 investigative sites in the US, Japan and Europe in support of US and Japan regulatory approvals.  The Svelte IDS and RX systems utilize low profile, highly conformable stents and a new class of bioresorbable drug carrier eluting sirolimus.  The fixed-wire Svelte IDS, the world’s lowest profile DES, is designed to downsize catheters to facilitate transradial intervention (TRI) and direct stenting, potentially extracting steps, time and cost from coronary stent procedures.

“We thank the OPTIMIZE study investigators for their dedication and scientific contributions to the study and look forward to presenting primary endpoint outcomes when available next year,” said Jack Darby, President and CEO of Svelte Medical Systems. “Achieving this incredible milestone would not be possible for a small, entrepreneurial company such as ours without the outstanding collaboration and support from our study steering committee, investigative teams, financiers and Svelte employees.”

The OPTIMIZE study builds on the positive outcomes previously reported in the DIRECT I and DIRECT II studies.  DIRECT I, a first-in-man study evaluating the feasibility of the Svelte IDS, completed 5-year follow-up with 0% clinically-driven major adverse cardiac events (MACE) reported.  DIRECT II, a randomized, multi-center study comparing the safety and efficacy of the Svelte IDS with the Medtronic Resolute Integrity™ DES, reports clinically-driven MACE of 9.3% and 13.7% through final 5-year follow-up in the Svelte IDS and control DES arms, respectively.  Both the IDS and RX systems hold CE Mark certification and are commercially available in Europe.

About Svelte Medical Systems

Headquartered in New Providence, New Jersey, Svelte Medical Systems (www.sveltemedical.com) is a privately-held company engaged in the development of highly deliverable balloon expandable stents.  Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits, are forward-looking statements.  A number of risks and uncertainties, such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the company’s products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings, could cause actual events to adversely differ from the expectations indicated in these forward looking statements.