I.M.P.A.C.T. System®

The I.M.P.A.C.T. System® Device

Currently Not Available in the U.S.

The I.M.P.A.C.T. System® device is an extracorporeal device that effectively extracts potentially deadly toxins from a patient's blood. This device gives doctors the ability to reduce a cytokine cascade storm, thus reducing further organ compromise and failure. Calming this cytokine storm gives the doctor's prescribed treatment and the patient's own immune system an opportunity to re-enter the fight against the initial disease or infection.

THE I.M.P.A.C.T SYSTEM® DEVICE 4-PART DIFFERENCE

1.


ENDOTOXINS REMOVED FROM BLOOD –

which reduces the trigger that perpetuates a cascading cytokine storm.

2.


CYTOKINES REMOVED FROM BLOOD –

which improves blood flow and provides an immediate relief of the physiological burden on the patient's vital organs.

3.


BILIRUBIN AND OTHER TOXINS (AND SOME DRUG OVERDOSES) REMOVED FROM PLASMA –

out of the blood to improve the patient's cognitive ability and other key vital signs, significantly reducing the load on the liver and other vital organs.

4.


Preserves Vital Blood Components –

  • Ensures low shear force / low hemolysis of blood components
  • Prevents large-scale activation of platelet activity
  • Albumin levels are unaffected
  • No adverse impact on immune gamma globulin (IGG) levels
  • Electrolyte levels unaffected
  • No adverse effects to blood volume or blood pressure

The I.M.P.A.C.T SYSTEM® Detoxification Circuit and how it works.

The I.M.P.A.C.T. System® device passes a portion of the plasma through the adsorption column. On average during a 4 hour treatment, all of the patient's plasma will have passed twice through the exclusive HLM-100 Adsorption column for detoxification.

During the treatment, the change in the patient's blood volume is miniscule.

IMPACT circuit diagram

HOW IT WORKS: The I.M.P.A.C.T. System® device is designed for use on specific hemodialysis machines currently available on the market. A patient's venous blood first passes through the cellular exclusion column (HLM-200) where plasma and any associated toxins are directed to our proprietary adsorption column (HLM-100). The remaining blood components are returned to the patient. Minimal contact with the remaining blood components results in very low hemolysis. Our exclusive HLM-100 column detoxifies the plasma before it too is returned to the patient.


What Our Competitors Say

Comparing the Design Claims of Similar Devices with the I.M.P.A.C.T. System® Device

There are a select group of devices in development and also available in various markets worldwide designed to treat blood components in parallel with other treatment protocols to provide better patient outcomes. These various devices are designed to support therapies for treating a variety of diseases, with some overlap and some that are unique to specific devices.

Because much of this information is not publicly available, this chart only depicts what each manufacturer publicly states as a design characteristic of their product. It does not validate or quantify these claims. The lack of an indicated design element does not infer that this product does not have this capability, but only that the manufacturer does not publicly make this claim.

I.M.P.A.C.T. competitive landscape

Product Details

HLM-100 product shot

HLM-100

The heart of the I.M.P.A.C.T SYSTEM® Kit is the HLM-100 Plasma Adsorption Column. This device with a surface area of approximately 200,000 sq. m. contains a proprietary blend of non-ionic adsorbent materials specifically formulated to bind toxins and cytokines associated with sepsis, liver failure and other diseases.

Key benefits:

  • Large adsorbent surface area for the high binding capacity
  • Non-ionic materials avoid alteration to serum electrolytes
  • Low pressure drop
  • Low priming volume
  • Proven biocompatibility
HLM-200 product shot

HLM-200

The HLM-200 is a polysulfone hollow fiber Plasma Separator. This device separates plasma from blood to allow the direct contact of the toxins and cytokines found in plasma with the adsorbents in the HLM-100 Adsorption Column.

Key benefits:

  • Hight molecular weight cuff allows key plasma elements to be separated and treated in the HLM-100 Adsorption Column
  • Large surface area and molecular weight cut-off provide low filter pressure drop and trans-membrane pressure to minimize formed element trauma
  • Low priming
  • Proven biocompatibility
HLM-300 product shot

HLM-300

The HLM-300 is a 0.45 micron polysulfone Hollow Fiber Capsule Filter placed downstream of the HLM-100 Adsorption Column. It's purpose is to provide an additional layer of safety.

Key benefits:

  • Low pressure
  • Proven biocompatibility
  • Easy to set up and prime

Potential Impact on Hepatic Encephalopathy

The Loma Linda UMC/ Cal-Pac MC H.E. Feasibility Clinical Trial

The data graphs have been gathered from 7 patients treated at Loma Linda Univ. Med. Cntr & Cal. Pacific (San Francisco) Med. Cntr. All of the patients started treatment with the I.M.P.A.C.T. SYSTEM® device after a 48 to 72 hours period where standard care resulted in no improvements. All seven patients began treatment with an HE Grade of 3 or 4 and improved to a Grade of 0 or 1 during the first treatment. All patients came out of their coma, or near coma state. Patient #5 (reference graph to the right) was not as dramatic due to other complications.

Due to the smaller size of the patient group in this clinical trial, this information should only be viewed as anecdotal. However, considering this reflects the entirety of our Feasibility Clinical Trial, the association between IMPACT System® treatment & the reduction in H.E. Grade and APACHE II Score is noteworthy.

impact on hepatic encephalopathy

Potential Impact on Bridge to (Liver) Transplant

The Gleneagles Hospital-Singapore Product Evaluation on I.M.P.A.C.T. System® Device

This data graph has been gathered from 4 patients treated at Gleneagles Hospital in Singapore to evaluate the effectiveness of the I.M.P.A.C.T. System® device for bridging patients with liver failure to their transplant procedure. NOTE: The case data presented to the right highlights two (2) male patients in their 20's who were admitted with Hepatitis B Flair in Acute Hepatic Failure. Both were immediately listed for liver transplant. One patient received three (3) IMPACT System treatments. The other received two (2) treatments. (Each IMPACT System treatment takes roughly 4 hours to accomplish). Both patients recovered sufficiently to be discharged without transplantation. Due to the smaller size of the patient group in this clinical trial, this information should only be viewed as anecdotal. However, considering this reflects the entirety of this Product Evaluation Trial, the rate of success and even resolution of liver crisis, as well as the biocompatibility demonstrated (up to 18 treatments by one patient being supported until transplant) is noteworthy.

impact on bridge to (liver) transplant

Though Hepatic Encephalopathy is our Main Focus —

We are encouraged by patient response in our Sepsis Clinical Study

Cytokine reduction is just one of the many benefits observed following treatment using the I.M.P.A.C.T. System® device. The data below offers a closer look at the improved APACHE II scores recorded after these sepsis patients were treated with the I.M.P.A.C.T. System® device. After each treatment every patient's condition improved and all patients treated met the desired successful outcomes. Additional clinical and technical details are available upon request from Hemolife Medical, Inc.

impact on hepatic encephalopathy

Potential Impact on Sepsis & Cytokine Reduction

The Singapore General Hospital — Sepsis Clinical Study

The data graphs have been gathered from patients treated in Singapore. The goal is to provide a look at the overall association between APACHE II Scores and cytokine reduction. Percent reduction is in parentheses. Actual patients' results may vary, which applies to all data below.

Cytokine Reduction chart - IL 6 Cytokine Reduction chart - IL 10 Cytokine Reduction chart - TNF a Cytokine Reduction chart - IL 1b Cytokine Reduction chart - IL 2 Cytokine Reduction chart - IFNg Cytokine Reduction chart - Endotoxin Removal Cytokine Reduction chart - APACHE II Cytokine Reduction chart - CRP

Potential Impact for Treating Pneumonia

Acute Respiratory Distress (ARDS) Patient Chest X-Ray

  • The pictures below are close-ups of an actual I.M.P.A.C.T. System® HML-100 adsorption column before and after a single 4 hour treatment from a patient.
  • Note the color change in the device which is indicative of bilirubin and other toxin removal of the patient's plasma which occurred during the period of treatment.
treatment results - before and after