Intense Therapeutic Ultrasound - Treatment for Chronic Plantar Fascia Musculoskeletal Pain Reduction

Intense therapeutic ultrasound (ITU) is an established ultrasound based therapy in which
sound waves are concentrated and focused into selected musculoskeletal tissue, to produce
selective thermal coagulative changes over a small controlled area while leaving the
surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue
response cascade and promote collagen generation in the targeted anatomy resulting in pain
reduction.

ITU has been used clinically for treating the subcutaneous musculoskeletal tissue below
facial skin for the past decade and it has received CE Mark and FDA 510(k) clearance to
market for non-surgical brow and submental tissue lifting. Over 3 Million patients worldwide
have been treated using this technology. Clinical studies have shown that 85% of patients
receiving this treatment on facial skin tissue showed an improvement in facial lifting with
no significant pain, erythema, inflammation or scarring by creating the same coagulative
changes to the connective tissue under the skin. Histologically, it has been shown that ITU
induces the production of dermal collagen with thickening of the dermis and straightening of
the elastic fibers in the reticular dermis.

On-going research in laboratory studies has shown that ITU can improve healing of damaged
Achilles tendon in a rabbit model. Preliminary results showed an increase in precursor
markers for collagen regeneration (e.g. Vascular endothelial growth factor A (VEGFa), tumor
necrosis factor alpha (TNFα), Interleukin 1 beta (IL-1β), and Transforming growth factor beta
1 (TGFβ1)) and subsequent increase in collagen formation in injured rabbit tendons treated
with ITU compared to injured, untreated rabbit tendons.

Inclusion Criteria:

- • Chronic Pain (>90 days) from previously diagnosed Plantar Fasciitis, where "Standard
of Care" regimens failed to relief pain in the affected anatomy.

- No History of surgery to the affected anatomy.

- No alternative treatment procedures within the last 90 days.

- Unilateral Pain

- Willingness to complete treatment and post treatment regimen as described.

- Patients who have provided written and verbal informed consent

Exclusion Criteria:

- • Patients currently enrolled in any other non-conservative, device, or
Investigational New Drug clinical trial, or who have participated in a clinical study
involving the Plantar Fascia, thirty days prior to study initiation;

- Patients who have participated in any other clinical study involving an
investigational product 30 days prior to enrollment that, in the opinion of the
Principal Investigator, could affect the outcome of this study;

- Patients who have received previous treatment in the symptomatic limb (not
including conservative treatment);

- At the Principal Investigator's discretion, any patient that should be excluded
based on their current condition or medical history.