ACTIGRAFT - Product Presentation Brief

1. Background, Problem & Needs:

ACTIGRAFT is a revolutionary medical device for chronic wounds treatment.
Chronic wounds do not heal, or heal slowly, because an underlying defect impedes local blood
flow to the wound site and hinders the body’s natural wound healing processes. These types of
wounds may never heal, or take years to heal, causing patients severe emotional and physical
stress and creating a significant financial burden on patients and the whole healthcare system
and in addition could eventually lead to wound infection, necrosis and finally – amputation of
limbs.
Patients suffering from chronic wounds, experience severe damage to their health, severe pain,
drowsiness (bad smell from the wound) and severe impairment of quality of life.
Several factors can contribute to chronic wounds, including:

  •  Diabetes mellitus
  •  Continued pressure
  •  Poor circulation
  •  Neuropathy
  •  Difficulty moving
  •  Systemic illnesses
  •  Age
  •  Repeated trauma


There are 3 main types of chronic wounds:

  • Diabetic Ulcers
  •  Venous and Arterial Ulcers
  •  Pressure Ulcers

2. The Solution: Using ActiGraft® to Treat Chronic Wounds

Actigraft is the first wound care product that enables health care providers to produce – in real
time – in vitro blood clots from a patient’s whole blood. This innovative solution brings the
patient’s blood to the site of the chronic wound to initiate and support the body’s natural
healing process.
Our general approach when treating with Actigraft, is to bypass the problem of low or nonexisting blood flow in the wound (the main cause of chronic wounds), by creating and applying
an external blood clot from the patient’s own blood, outside and over the wound.
Once applied, the blood clot tissue serves as a protective covering and supports wound healing
processes which naturally occur in the patient’s body.

The Challenge of Treating Chronic Wounds – including diabetic ulcers, venous and arterial ulcers,
and pressure ulcers, is that the wound often doesn’t heal or heal slowly because an underlying
defect is impeding blood flow to the wound site. This lack of blood prevents the body from
going through its natural wound healing processes.

ActiGraft’s technology is innovating the way we treat chronic wounds by managing each stage of
the wound healing process.

3. How ActiGraft® Works:

Human skin, when injured, is capable of repairing itself to restore tissue integrity and heal the wound. This wound healing involves 4 overlapping process, beginning immediately after injury:
Hemostasis
The body works to stop the bleeding and start the healing process by activating a coagulation cascade. A fibrin blood clot forms that plugs severed blood vessels and fills in tissue discontinuity at the wound site.
Inflammation
During this phase, white blood cells and macrophages enter the wound to destroy bacteria and remove debris. The blood clot creates a fibrin scaffold that serves as a protective, provisional extracellular matrix (ECM) containing cytokines and growth factors (interleukin, transforming growth factor-β, platelet-derived growth factor, and vascular endothelial growth factor, among others) that facilitate tissue repair.
Proliferation

The blood clot recruits endothelial cells and fibroblasts to synthesize a permanent ECM.
The focus is filling and covering the wound.

Remodeling
The blood clot dries out and becomes a protective scab. Under the scab, tissue remodeling takes place undisturbed. The fibrin is replaced by fibronectin and hyaluronan, and the scab falls off to reveal a collagenous scar.
For patients that suffers from chronic wound the describes process does not happen because of the blood flow problem. By using ACTIGRAFT and creating the external blood clot, we trick the body to think there is a new and fresh wound (Acute wound) and generate the healing process as described above. Basically, we push and promote the patient’s system to renew the healing process.

4. ACTIGRAFT Advantages:

5. ACTIGRAFT Outcome: