ORTHOMERICA® TO MANUFACTURE AND MARKET THE CLARREN HELMET

Orthomerica Products, Inc. is pleased to announce that it entered into an exclusive worldwide agreement to manufacture and market the Clarren Helmet in partnership with Children's Hospital and Regional Medical Center of Seattle, Washington and Dr. Sterling Clarren.

In 1979, Dr. Clarren published one of the first clinical papers documenting a cranial orthosis as a safe and effective treatment for young infants with positional plagiocephaly. Since that publication, and as a result of Dr. Clarren's original work and research at Children's Hospital, cranial remolding orthosis treatment is widely recognized and used as the solution for such head deformities.

The Clarren helmet consists of an outer shell of polypropylene plastic, thin closed-cell Aliplast foam liner, and ventilation holes. This passive design offers full containment of the cranial vault and a padded chinstrap to hold the orthosis in place.

Orthomerica is a leading manufacturer of custom cranial remolding orthoses, and has been awarded 510(k) clearance from the FDA to manufacture and market the STARband™, STARlight™ and Clarren cranial remolding orthoses for the treatment of positional plagiocephaly, scaphacephaly and brachycephaly.

All cranial remolding orthoses manufactured by Orthomerica can be fabricated in 3 to 4 days from a modified cast, unmodified cast, or scan of the infant's head using the STARscanner™ laser data acquisition system.

The STARscanner system, from Orthomerica, is the first data acquisition system to receive 510(k) clearance from the FDA, and eliminates the casting process necessary for collecting head shape data for the fabrication of a cranial remolding orthosis. The STARscanner system is notably the quickest and most precise method of collecting such data, and is currently the only technology available to accurately measure changes, over time, in both head shape and volume.

The STARscanner has been embraced by the medical profession for its ability to provide quantifiable data illustrating progress of the cranial remolding orthosis treatment process. Dr. Clarren will be utilizing the STARscanner's capabilities to conduct research for, and publish a paper on, the changes in plagiocephalic head shapes with and without intervention.

For more information, about the Clarren Helmet call Orthomerica's Custom Fabrication department at 877.737.8444 or email: custserv@orthomerica.com