The Company has conducted a series of clinical trials in a number of leading medical centers in Israel. The trials were aimed to assess the efficacy of the Foot and Ankle Brace in a number of target clinical applications and scenarios. Through these studies, the Company has gained extensive feedback that had a great impact on the design of the product.

Study 1. A clinical trial was conducted in Rambam Hospital, Haifa, to evaluate the efficacy of the Universal Foot and Ankle Brace in the treatment of hip fractures. 47 patients with hip fractures were studied. The following objectives were evaluated:

  1. Level of comfort to the patient
  2. Level of support of the inured limb
  3. Assembly and removal of the brace
  4. Storage and accessibility in the medical facility
  5. Assessment of the medical benefits of the brace
  6. Staff Satisfaction

The study concluded that the brace was effective in improving the pre-operative treatment of patients with hip fractures by reducing pain and discomfort, as expressed by the patients and staff satisfaction.

Study 2. A second study was conducted at Rambam Hospital, Haifa, to evaluate the effect of immediate reduction of the rotational deformity by the application of the brace in improving blood flow to the fractured head of the thigh bone hip after readjusting the injured hip. Thus far, 8 patients with hip fractures have participated in the study. Early results are encouraging.

Study 3. A large study was conducted in collaboration with Israel’s national, leading emergency medical services provider, Magen David Adom (“Mada”), Carmel in Haifa. The study examined 40 patients, all of whom received first-aid treatment by Mada and evacuation to emergency rooms. The study evaluated the type of injuries treatment, convenience and speed of assembly of the brace, reduction in jolts during transport and the inclination of the medical staff to reuse the brace. The experienced medical personnel expressed great satisfaction from the use of the brace.

The interim results of the studies conducted by the Company demonstrate compelling medical benefits and patient and staff satisfaction from the use of the Foot and Ankle Brace and the Long Brace.

Trail A, includes descriptive data – patients with fracture of the Neck Femur, Patient that Used Brace (leg injury), and Subjects that used Canadian/triplet splint.

Trail B, includes descriptive data of subjects used Long Brace (leg injury), and descriptive data of subjects that used Canadian/triplet stabilizer.