Press Release: Roadmap for the revitalization of catheter-based renal sympathetic denervation related to clinically meaningful, optimized device design: CBSET to present compelling preclinical evidence at EuroPCR 2015

“Renal denervation, despite recent stumbles, is experiencing a resurgence with
next-generation device design. CBSET’s incontrovertible mechanistic data provides the pathway for predicting efficacy and designing more efficacious devices and protocols,” said Peter M. Markham, President and CEO, CBSET.

LEXINGTON, Mass., May 18, 2015 — Scientists at CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, will present on RF catheter-based renal denervation this week at “EuroPCR.” These presentations will provide an overview of the procedural parameters dictating successful ablation; as well as present preclinical data on a third-generation low-profile, 9-electrode, over-the-wire, RF ‘basket’ catheter, along with simultaneous bipolar/unipolar therapy algorithm ReDy™ system (Renal Dynamics, N.J.).

“We have dramatically expanded our understanding of the mechanisms that facilitate safer and more efficacious renal denervation treatments using preclinical studies and computational modeling. The data generated complete the puzzle for device innovators, who can benefit from our validation of the relevant physiology and advance their specific approaches to treat diseases involving sympathetic denervation and modulation,” said Peter Markham, President, CEO and co-founder of CBSET.

“The renal denervation community must clearly progress despite conflicting data from recent clinical trials. Sympathetic denervation and neuromodulation techniques still provide an exciting opportunity for the treatment of diseases with increased sympathetic tone, such as hypertension and of a variety of other cardiovascular diseases. As a trailblazer for understanding the factors that govern variable efficacy with renal denervation therapies, CBSET is proud to play a leading role at EuroPCR 2015 to evolve the medical technology industry’s perspectives and further optimization of RDN and other ablative therapies,” added Elazer Edelman, M.D., Ph.D., chairman and co-founder, CBSET. Dr. Edelman will present an overview of CBSET’s paradigm in the plenary session on Uncontrolled hypertension (Thursday 21st May, 09:44-09:57, Room 242AB).

“With CBSET’s help, Renal Dynamics has been able to validate a third-generation renal denervation technology in a cost-efficient fashion that minimized animal use. We could not have come this far without the guidance and support of CBSET scientists, whose special expertise and high level of credibility in the preclinical research world in general and in the RDN field in particular were of significant help to Renal Dynamics,” said Shlomo Ben-Haim, M.D., Founder and Chairman, Renal Dynamics, developer of the ReDy™ catheter system. Rami Tzafriri, Ph.D., Principal Scientist and computational expert, CBSET, will be presenting this work in the Hypertension track of the Cardiovascular Innovation Pipeline session (Tuesday 19 May, 18:06-18:21, Room 252A) and a poster (Euro15A-POS234) entitled ‘Safety and Biomarker effects of a novel multi-electrode over-the-wire renal denervation RF catheter in a porcine model.’

“We have extended our actionable knowledge in sympathetic denervation in order to enable the targeting of other diseases in which the sympathetic nervous system plays a key role,” said Dr. Erica Smith, Scientific Director of Business Development at CBSET. “The data to be presented by CBSET scientists at EuroPCR this year will identify and validate the reasons for variability in efficacy of sympathetic denervation for treating drug-resistant hypertension, as well as serve as the cornerstone of comprehension for future applications of thermal ablation therapies.”

For a copy of the CBSET EuroPCR presentations and poster, contact: Erica Smith, Ph.D., Director, Business Development: +1-781-296-5319, esmith@cbset.com

About CBSET

CBSET — 500 Shire Way, Lexington, MA 02421 — is the preclinical research leader in critically important therapeutic fields such as interventional cardiology, renal disease and dialysis, chronic drug-resistant hypertension, women’s health, minimally invasive surgery, orthopedics, biological and synthetic tissue repair, drug delivery, bioresorbable devices, and combination medical device and drug-eluting products. CBSET occupies a 35,000-square-foot, state-of-the-art facility near Boston that includes a vivarium, catheterization/imaging labs, surgical suites, dedicated labs for SEM, histopathology/pathology, and drug metabolism and pharmacokinetics. CBSET offers the latest equipment for fluoroscopy, echocardiography (TEE/TTE), electrophysiology, IVUS, optical coherence tomography (OCT), endoscopy/laparoscopy, surgical video recording, histology, microradiography, and SEM (Scanning Electron Microscopy).