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Cracking Calcium Made Easy Without Compromising on Safety

At the core of the innovative SoundBite® System is a proprietary method to generate, amplify, and deliver shock waves in a safe and controlled manner using an array of waveguide-based devices to fibro-calcific lesions across different vascular beds.

Shock waves are pressure pulses characterized by a high amplitude, rapid rise time, and short duration.

Shock waves have successfully been used in various medical therapies and have shown the ability to selectively break calcium deposits without damaging surrounding healthy elastic tissue.
Soundbite Console

The SoundBite® System consists of a re-usable SoundBite® Console and single-use SoundBite® Active Devices.

The SoundBite® Console creates shock waves which are transmitted to SoundBite® Active Device platforms. The shock wave energy and unique “jackhammer effect” at the tip of the SoundBite® Active Device helps penetrate hard fibro-calcific lesions without compromising on safety.

Leveraging Our Shock Wave Technology Platform to Transform Markets

Soundbite Medical is building a portfolio of innovative products to address clinical unmet needs across different calcified vascular beds in large, growing & underserved markets.

Our product portfolio is designed to cross, prepare, and treat arterial blockages in the legs and heart, allowing us to respond to a wide range of physician and patient needs. Our innovative products currently fall into two categories:

CTO Crossing

Chronic total occlusions (CTOs) represent the “last frontier” of percutaneous interventions.

The SoundBite® Crossing Systems represent an industry-first and only “Active” wire-based guidewire technology, designed to facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond chronic total occlusions in coronary and peripheral arteries.

The first indication we are targeting with our Crossing System is peripheral artery disease. The SoundBite® Crossing System – Peripheral is approved in major markets (FDA clearance, CE Mark, Health Canada approval) and is available in 0.018” and 0.014” platforms that are fully compatible with existing device ecosystems.

Atherectomy / Plaque Modification

The SoundBite® Active Microcatheter System which is currently in development is intended for plaque modification and atherectomy of highly calcified occlusions across different vessel beds in patients with coronary and peripheral artery disease. Plaque modification devices (including atherectomy) are designed to break or remove calcium through a variety of mechanisms to help vessel expansion and ultimately improve treatment.

Our Pipeline

Product: Crossing System

  • Description: CTO Crossing
  • Indication: Peripheral (ATK_BTK)
  • Size: 0.018″ & 0.014″ platform
  • Status: Approval
  • In partnership with ASAHI
  • Rights: SoundBite Medical

Product: Crossing System

  • Description: CTO Crossing
  • Indication: Coronary
  • Size: 0.014″ platform
  • Status: Clinical
  • Rights: SoundBite Medical

Product: Active Microcatheter

  • Description: Plaque modification / Atherectomy
  • Indication: Peripheral / Coronary
  • Status: Pre-clinical
  • Rights: SoundBite Medical

Clinical Evidence

We are committed to building our clinical evidence with our devices in support of better utilization and procedure results and outcomes for patients suffering from calcific occlusive cardiovascular disease.

92.3%

technical device success at 30-day

0%

serious adverse events

115min

(± 51) Mean procedure time

3.5min

Active Wire mean activation time

20min

mean CTO crossing time

Prospector Trial: A Prospective, Single-Arm, Multi-Centre Trial With The Soundbite® Crossing System – Peripheral, J Cardiovasc Surg 59(4):529-537, And Company Data

Peripheral Case Studies

Coronary Case Studies

Request Case Studies:

Are you interested in viewing the Peripheral or Coronary Case Studies?

Submit your email address below & a SoundBite representative will be in touch.

Request Case Studies:

Are you interested in viewing the Peripheral or Coronary Case Studies? Submit your email address below & a SoundBite representative will be in touch.




      THE SOUNDBITE VALUE PROPOSITION

      Safe, Simple, & Effective, For Fast Lesion Crossing And Preparation

      Efficacy

      • Efficient on calcium
      • Enables treatment
      • Access difficult to reach anatomy (e.g., BTK)

      Safety

      • Eliminate/reduce risk of perforation, dissection, recoil, embolization
      • Without risk to healthy elastic tissue

      Simplicity

      • Compatible with choice platform
      • Efficient integration in workflow
      • No learning curve or need for special techniques

      Publications

      • The Journal of Cardiovascular Surgery August 2018; 59(4):529-37
      • The Journal of Invasive Cardiology February 2017, Vol. 29(2)E17-20
      • The Journal of Invasive Cardiology February 2017, Vol. 29(4)E47-50

      Intellectual Property

      Soundbite Medical products and inventions are protected by patents in the United States and elsewhere. To-date, we have 4 issued patents and more than 50 International and US filings covering the core technology and 12 distinct inventions around unique methods for using this unique energy source in vascular treatments with a variety of minimally invasive and non-invasive devices for CTO crossing, vessel preparation, treatment, and drug delivery.

      SoundBite® is a registered trademark of SoundBite Medical Solutions Inc.

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