INVISIBLE SCALPEL GETS CE APPROVAL

• Actisound technology uses Intense Therapeutic Ultrasound to treat musculoskeletal injuries
• CE Approval comes as Guided Therapy Systems launches across Europe

London, UK, 24 July 2018 – Guided Therapy Systems, a world leader in ultrasonic therapy and imaging technologies, today received CE Mark approval via its development partner and manufacturer, Ardent Sound Inc. for its Intense Therapeutic Ultrasound (ITU) Actisound device to be used by medical professionals across the UK and Europe.

Actisound Intense Therapeutic Ultrasound (ITU) acts like an invisible scalpel—working beneath the surface of the skin—precisely delivering small thermal ablations to tendons, ligaments, and other soft tissue to stimulate collagen growth and the regeneration of connective tissue. Unlike other energy sources such as laser, microwave and radio frequency, ultrasound is the only energy source that can penetrate safely through intervening tissue and be focused to a specific point and shape within the body. This allows physicians the unique ability to deliver treatments directly at the point of injury—up to depths of 15 mm—without ever opening the patient.

Currently, Actisound is the only non-invasive, ablative treatment for pain relief associated with the repair of musculoskeletal injuries available to medical professionals.

“CE mark is the result of many years of rigorous research, development and clinical testing. Starting today, Clinicians can offer a better, safer, and more efficient healing process,” said Michael Slayton, Ph.D, founder and CEO of Guided Therapy Systems. “Actisound’s Intense Therapeutic Ultrasound represents a completely new treatment option that wasn’t before available to chronic patients, and it’s the only option (outside of conservative therapies) that doesn’t include painful or costly procedures.”

Common therapies such as NSAIDS & Steroid Injections only temporarily reduce pain without addressing the underlying injury. Often procedures like shockwave and minimally invasive procedures including tenotomy, PRP and Stem Cell injections can be very costly and painful. Traditional surgeries are even more expensive – requiring longer recovery and “down time” and exposing patients to a number of complications associated with these invasive procedures.

Commenting on the launch, Dr Hilary Jones said, “Both acute and chronic pain injuries are now very common and effect a large proportion of the UK population. Current treatment options are limited, expensive, and not always successful. There is clearly a need from both patients and medical professionals for an alternative treatment that addresses this issue.’

Dr Jones continued, “The launch of Actisound in the UK is timely and offers a promising alternative treatment for people suffering from chronic pain and the medical research backing the device is a testament to that.”

With Actisound, no cutting or painful injections are required, and the treatment can be delivered right in the physician’s office. Actisound is affordable and fast, requiring only one or two, 10-minute treatments typically resulting in reduced pain and inflammation within 48-72 hours and soft tissue repair within 4-12 weeks.

Three multi-centre clinical studies1 have shown that more than 80% of chronic patients (with length of persisting pain averaging 15.7 months) enjoyed a significant reduction in pain combined with increased function and mobility, compared to traditional methods.

Actisound is now available for clinical and professional use by, but not limited to: Orthopedic Surgeons, Podiatrists, Sports Medicine Physicians, Physical Medicine and Rehabilitation Physicians, Rheumatologists, and Primary Care Physicians across the UK and Europe.

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Notes to editors

About Guided Therapy Systems
Guided Therapy Systems (GTS) is a leader in ultrasonic therapy and imaging. GTS is the first company to develop and commercialize products that combine ultrasound imaging with intense therapeutic ultrasound, offering physicians the ability to image and treat with the same equipment, thus targeting and evaluating tissue prior, during and after a procedure. In 2004, Guided Therapy Systems separated into two companies – Ardent Sound, Inc. became the commercial manufacturer of diagnostic ultrasound imaging devices, while GTS incubates new commercial opportunities for its intense therapeutic ultrasound platforms. GTS brought intense therapeutic ultrasound to the forefront of the aesthetic device landscape through the creation of Ulthera – the only energy-based technology with an FDA indication for non-invasive tissue lift. GTS expanded into skin care devices for the consumer market with the founding of Xthetix, Inc., which was acquired by a Fortune 100 consumer products company in 2011. Today GTS has over 270 patents issued, published, and pending in support of their imaging and Intense Therapeutic Ultrasound (ITU) technologies as they continue to create new ultrasound technologies that diagnose, treat and heal injury.

Media contact
Tobias Tripp
Kwittken on behalf of Guided Therapy Systems
E: ttripp@kwittken.com
P: +44 207 632 7675
*Interviews and images available on request

~Actisound has been used in three multi-centre clinical studies for the treatment of chronic plantar fasciitis and epicondylitis. 103 chronic patients (with length of persisting pain averaging 15.7 months) were treated. In all three studies, more than 80% of subjects enjoyed a significant reduction in pain combined with increased function and mobility.