A groundbreaking emergency treatment for stroke & vasospasm

Expanding the Golden Hour for stroke victims
Two-minute non-invasive magnetic stimulation treatment
US FDA Humanitarian Use Designation confirmed for vasospasm. Currently pursuing Humanitarian Device Exemption.

“CAUTION – Investigational device. Not yet approved by US FDA for sale. Limited by United States law to investigational use.”

A groundbreaking
emergency treatment
for stroke & vasospasm

  • Easy, non-invasive, magnetic stimulation treatment
  • Relaxes cerebral arteries, allowing superior blood perfusion
  • Just one, 2-minute stimulation
  • Goal 1: Expand the “Golden Hour” for stroke victims
  • Goal 2: Earlier treatments in ICUs, emergency departments, and ambulances

Our Leadership Team

Jeffrey Lietzke

Jeffrey Lietzke

CEO

20 years of medtech founding, commercialization, and exit experience.

Emilio Sacristan, PhD

Emilio Sacristan, PhD

PhD Chief Science Officer, Co-Founder and Director

Co-inventor of the CereFast.

Stephanie Harrington, MS

Stephanie Harrington, MS

Chief Clinical and Regulatory Officer

20 years of experience in the medical device industry.

Guy Jean L. Savoir

Guy Jean L. Savoir

Director

Businessman, entrepreneur and investor in the pharmaceutical and health-care industries.

Dr. John Andrefsky

Dr. John Andrefsky

Clinical Advisory Board

Vascular Neurologist at University Hospitals. Fellowship-trained in neurocritical care, Cleveland Clinic. 

Pre-clinical &
Clinical Testing

  • Completed healthy human subjects trial establishing safety, tolerability, and dose response
  • Vasospasm patients’ human pilot trial: all patients resolved vasospasm (fully or partially) and all survived after a single stimulation
  • NIH-sponsored early feasibility clinical trial for treatment of ischemic stroke in the emergency department – first patient enrollment expected during Q3 2024
  • Ten scientific papers published to date

Increase in brain perfusion index after one stimulation in blue; and after two stimulations 120 minutes apart in red.

Approach to Market

 

Market

Neurosurgery ICUs

Emergency Departments

Ambulances

Indication Vasospasm Ischemic Stroke Ischemic Stroke
Regulatory Humanitarian Device
Exemption
Expedited Access PMA
( Class IIa in E.U.)
Expedited Access PMA
( Class IIa in E.U.)

 

A groundbreaking emergency treatment for stroke & vasospasm

Expanding the Golden Hour for stroke victims
Two-minute non-invasive magnetic stimulation treatment
US FDA Humanitarian Use Designation confirmed for vasospasm. Currently pursuing Humanitarian Device Exemption.

“CAUTION – Investigational device. Not yet approved by US FDA for sale. Limited by United States law to investigational use.”

A groundbreaking emergency
treatment for stroke & vasospasm

  • Easy, non-invasive, magnetic stimulation treatment
  • Relaxes cerebral arteries, allowing superior blood perfusion 
  • Just one, 2-minute stimulation
  • Goal 1: Expand the “Golden Hour” for stroke victims
  • Goal 2: Earlier treatments in ICUs, emergency departments, and ambulances

Our Leadership Team

Jeffrey Lietzke

Jeffrey Lietzke

CEO

20 years of medtech founding, commercialization, and exit experience.

Emilio Sacristan, PhD

Emilio Sacristan, PhD

PhD Chief Science Officer, Co-Founder and Director

Co-inventor of the CereFast.

Stephanie Harrington, MS

Stephanie Harrington, MS

Chief Clinical and Regulatory Officer

20 years of experience in the medical device industry.

Guy Jean L. Savoir

Guy Jean L. Savoir

Director

Businessman, entrepreneur and investor in the pharmaceutical and health-care industries.

Dr. John Andrefsky

Dr. John Andrefsky

Clinical Advisory Board

Vascular Neurologist at University Hospitals. Fellowship-trained in neurocritical care, Cleveland Clinic.

Pre-clinical & Clinical Testing

  • Completed healthy human subjects trial establishing safety, tolerability, and dose response
  • Vasospasm patients’ human pilot trial: all patients resolved vasospasm (fully or partially) and all survived after a single stimulation
  • NIH-sponsored early feasibility clinical trial for treatment of ischemic stroke in the emergency department – first patient enrollment expected during Q3 2024
  • Ten scientific papers published to date

Increase in brain perfusion index after one stimulation in blue; and after two stimulations 120 minutes apart in red.

Approach to Market

 

Market

Neurosurgery ICUs

Emergency Departments

Ambulances

Indication Vasospasm Ischemic Stroke Ischemic Stroke
Regulatory Humanitarian Device
Exemption
Expedited Access PMA
( Class IIa in E.U.)
Expedited Access PMA
( Class IIa in E.U.)

 

A groundbreaking emergency treatment for stroke & vasospasm

Expanding the Golden Hour for stroke victims
Two-minute non-invasive magnetic stimulation treatment
US FDA Humanitarian Use Designation confirmed for vasospasm. Currently pursuing Humanitarian Device Exemption.

“CAUTION – Investigational device. Not yet approved by US FDA for sale. Limited by United States law to investigational use.”

A groundbreaking
emergency treatment for stroke & vasospasm

  • Easy, non-invasive, magnetic stimulation treatment
  • Relaxes cerebral arteries, allowing superior blood perfusion 
  • Just one, 2-minute stimulation
  • Goal 1: Expand the “Golden Hour” for stroke victims
  • Goal 2: Earlier treatments in ICUs, emergency departments, and ambulances

Our Leadership Team

Jeffrey Lietzke

Jeffrey Lietzke

CEO

20 years of medtech founding, commercialization, and exit experience.

Emilio Sacristan, PhD

Emilio Sacristan, PhD

PhD Chief Science Officer, Co-Founder and Director

Co-inventor of the CereFast.

Stephanie Harrington, MS

Stephanie Harrington, MS

Chief Clinical and Regulatory Officer

20 years of experience in the medical device industry.

Guy Jean L. Savoir

Guy Jean L. Savoir

Director

Businessman, entrepreneur and investor in the pharmaceutical and health-care industries.

Dr. John Andrefsky

Dr. John Andrefsky

Clinical Advisory Board

Vascular Neurologist at University Hospitals. Fellowship-trained in neurocritical care, Clevland Clinic.

Pre-clinical & Clinical Testing

  • Completed healthy human subjects trial establishing safety, tolerability, and dose response
  • Vasospasm patients’ human pilot trial: all patients resolved vasospasm (fully or partially) and all survived after a single stimulation
  • NIH-sponsored early feasibility clinical trial for treatment of ischemic stroke in the emergency department – first patient enrollment expected during Q3 2024
  • Ten scientific papers published to date

Increase in brain perfusion index after one stimulation in blue; and after two stimulations 120 minutes apart in red.

Approach to Market

 

Market

Neurosurgery ICUs

Indication Vasospasm
Regulatory Humanitarian Device Exemption

 

Market

Emergency Departments

Indication Ischemic Stroke
Regulatory Expedited Access PMA
( Class IIa in E.U.)

 

Market

Ambulances

Indication Ischemic Stroke
Regulatory Expedited Access PMA
( Class IIa in E.U.)