The Soundbite Solution
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.
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
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.
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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.
