What is ECMO?

ECMO is a very complex lifesaving technology that provides circulatory and respiratory support to very sick patients experiencing some kind of circulatory or respiratory failures due to a range of clinical conditions including premature birth, congenital defects, influenza complications (increasingly), COPD, severe trauma from battlefields or serious accidents. It can also be used to keep donor’s organs perfused after death or recondition and preserve them for transplants purposes (a growing concern for transplant doctors).

 

Elsius’s Portable Cardiopulmonary Assist System

 

pCAS explanation
Portable Cardiopulmonary Assist System

Next-generation advanced compact circulatory support system providing enhanced efficiency, usability, portability, and blood compatibility
• Comprised of a disposable, integrated pump-oxygenator driven by a touch-screen based controller console
• Current system may be used as a “partial support” adult system or a “full support” pediatric system
• Leverages Ension surface technologies:
– Ension bioactive surface (EBS)
– Ension infection resistant surface (EIRS)

A principal feature of the pCAS system is the Ension Bioactive Surface (EBS)
It’s a proprietary engineered surface developed by Ension specifically for ECMO/ECLS (gas exchange) applications
It’s a covalently bonded, highly gas permeable, heparin-based bioactive surface treatment
EBS is designed to mitigate activation of cellular elements in the blood and development of thrombi

All blood contacting surfaces of the pump-oxygenator unit are treated with the EBS

pCAS system components
The System Components

– Pump-oxygenator (sealed magnetic drive)
Completely sealed system
Custom pump impeller designed for ECMO/ECLS applications
Custom designed micro-mixing high efficiency oxygenator
Integration of pump and oxygenator affords small priming volume and decreased system complexity
Accommodates a range of cannula sizes and circuit configurations

– Controller console
Touch screen-based user interface and controller hardware designed specifically for ECMO/ECLS applications
Compact size allows easy transportability
Integrated battery for portable operation
System data logging and trend review capabilities

Physical and operational characteristics
Overall size and mass sfad

• Pump-oxygenator: 6.75” in length (including inlet barbed fitting), 4.5” (maximum diameter), Approximately 1 lb.
• Controller console: Approximately 14” x 11” x 16”, Approximately 14 lbs.
• Priming volume: Less than 100 ml., Blood flow rate range, Up to 6 liters per minute (LPM)

IP (Intellectual Propety)
Intellectual Propety

U.S.&Patent 8,114,465, Process for preparing a substrate coated with a biomolecule.
U.S.&Patent 8,343,567, Process for preparing a substrate coated with a biomolecule.
U.S. Patent Application, Compact integrated blood pump oxygenator with hydrogel impeller packing material and rollover impeller outlet, Serial #13/916,739

Technical specifications
Technical specifications

Partial flow adult (full flow pediatric) pump oxygenator: Rated oxygen delivery: 100 ml/min @ 2 lpm @ 1:1 sweep gas flow @ FiO2 = 60%
Fiber bundle surface area: 0.64 m2
Pump-oxygenator total priming volume: ~50 ml
Maximum blood flow: 3 lpm @ 4900 RPM
Rated blood flow: 2 lpm @ 120 mmHg @ 3500 RPM
Rated carbon dioxide removal: 100 ml/min @ 2 lpm @ 1:1 sweep gas flow

Full flow adult pump oxygenator (under development): Rated oxygen delivery: >270 ml/min @ 5 lpm @ 1:1 sweep gas flow @ FiO2 = 60%
Fiber bundle surface area: 0.94 m2
Pump-oxygenator total priming volume: ~100 ml
Maximum blood flow: >8.2 lpm @ 4900 RPM
Rated blood flow: 6 lpm @ 120 mmHg @ 4000 RPM
Rated carbon dioxide removal: >220 ml/min @ 5 lpm @ 1:1 sweep gas flow

Tecnology validation
Tecnology validation

About $16M USD of government non dilutive funding in numerous rounds associated with progressive milestones and technological gates passing (if efficacy on a certain aspect was not achieved additional funds would be withdrawn)
EBS certification with the ISO/NAMSA 10993
Extensive pre clinical tests, from laboratory to live animal models to human blood tests