Clinical Study News: Tenex Health TX1 System

Tenex Health Announces Publication of Prospective Clinical Study Results.
Full press release follows.
SOURCE: Tenex Health

LAKE FOREST, Calif.--(BUSINESS WIRE)—Jan. 15, 2013—

Tenex Health Inc. (www.tenexhealth.com), a pioneer in less-invasive treatment for musculoskeletal injuries, announced the recent publication of a prospective clinical study result in the American Journal of Sports Medicine (AJSM). The study entitled Fasciotomy and Surgical Tenotomy for Recalcitrant Lateral Elbow Tendinopathy describes the TX1 System as a safe and effective tool used in percutaneous tenotomy procedures in patients suffering from chronic tennis elbow.

The TX1 System was launched in the U.S. in February of 2012 and has been used in the treatment of about 3000 patients suffering from a wide range of tendon injuries – shoulder, elbow, knee, Achilles and plantar fascia. The TX1 System consists of a pen-like hand piece and console which allows for the physician to insert an 18g needle-like probe via a percutaneous approach that specifically cuts the damaged tendon tissue while preserving the healthy tissue. The intervention is conducted under local anesthesia and ultrasound guidance which provides for a safe and patient-friendly experience. The minimally invasive nature of the treatment and documented quick recovery times allows physicians to treat these patients earlier in their course.

“The safety, efficacy, tolerance and return to activity features of this treatment were as we had hoped, but quite frankly, exceeded our expectations. We feel the concept is truly a game changer. The features of this treatment modality to both physicians and patients are a real breakthrough,” reported Dr. Bernard Morrey, the Chief Medical Officer of Tenex Health.

The publication details the results of an independently conducted IRB-approved prospective study authored by faculty from Singapore General Hospital and the Mayo Clinic. The study revealed:

i. Single treatment of 20 patients in an out-patient setting with no patient requirements of follow-up medications or physical therapy ii. No device or patient related complications occurred over 12 month follow-up period iii. Statistically significant improvement in pain within 1 week and sustained improvement for 12 months iv. Statistically significant improvement in quality of life measurement within 1 month and sustained improvement for 12 months v. Diagnostic ultrasound evidence consistent with a repaired tendon by 6 months of treatment vi. Efficacy of therapy sustained in 95% of patients at 12 month follow-up period

Jagi Gill, Founder and CEO of Tenex Health, added, “The rigor and follow-up of this clinical study clearly demonstrates a compelling option for the millions of patients suffering from tennis elbow. Furthermore, we are especially excited as the clinical results from this prospective study match what we have seen in the community at large in over 100 centers throughout the U.S.”

About Tenex Health Inc. Tenex Health, Inc. (www.tenexhealth.com) develops and markets innovative therapies for the treatment of tendon pain due to trauma or repetitive motion injuries. These tendon injuries affect more than 10 million Americans every year. The company’s proprietary TX1 Tissue Removal System is used to safely and specifically cut and debride diseased soft tissue in an outpatient setting using local anesthetic (www.fast-technique.com). Since the surrounding healthy tendon tissue is not disturbed, patients enjoy less discomfort and faster recovery times versus traditional open surgical procedures. The entire procedure is completed under local anesthesia and usually within 20 minutes.

Contact:

Tenex Health Inc.

Julie Flanery, 949-454-7500

flanery@tenexhealth.com