Product Research and Development

The challenge with developing implants for children seems obvious – children grow. What works for a four-year-old may not work for a ten-year-old. The bones of children have growth plates which, when disturbed, can cease bone growth for a particular limb. Also, an eight-year-old girl is not the same as an eight-year-old boy. Management of OrthoPediatrics is focused on providing solutions for these unique challenges.

OrthoPediatrics has assembled some of the best talent from the medical device industry and a world class Surgeon Advisory Board. In addition, the company has sought out the best scientific collections and data repositories that pertain to pediatric bones and bone growth. This wealth of information will help guide the company's engineers and surgeon advisors in designing the much needed anatomically appropriate implants, instrumentation and biologics for pediatric and small stature patients.

Thanks largely in part to Rainbow Babies & Children's Hospital, the Cleveland Museum of Natural History, Case Western Reserve University and Dr. Daniel Cooperman (Cleveland), OrthoPediatrics has been able to secure exclusive rights to two of the world's largest collections of pediatric skeletal data: The Hamann-Todd Osteological Collection and the Bolton-Brush Growth Study. Each is the largest of its type in the world.

The Hamann-Todd Human Osteological Collection.¹ When the laws of the State of Ohio were changed in 1911, it became possible for professors of anatomy to retain the skeletons and other specimens from the cadavers that their medical students dissected. Upon his arrival at Western Reserve University as a professor of anatomy in 1912, T. W. Todd seized this opportunity and built up a collection that, by the time of his death in 1938, contained records of over 3,600 cadavers and over 3,000 skeletons. These materials were supported by extensive documentation, thus resulting in the largest, modern, documented human skeletal collection in the world. Carl Hamann, Dean of the Western Reserve University School of Medicine, was instrumental in assisting Todd in enlarging this collection. The skeletons in the University's collection were transferred to The Cleveland Museum of Natural History during the 1950's and 1960's. With the opening of the Physical Anthropology Lab at the Museum, this collection has become one of the most researched museum collections in the world.

The best pediatric and dwarf specimens of the Hamann-Todd collection have been scanned by OrthoPediatrics' engineers and will be utilized in three-dimensional environments where the Company can develop anatomically appropriate implants using the best available data. The possession of the historical x-ray data of over 3,000 healthy children is invaluable to OrthoPediatrics for product development, because this data visibly demonstrates how pediatric bones grow over time and further enables the Company to understand the mystery of growth plates.

The Bolton-Brush Growth Study.² The Bolton-Brush Growth Study comprises the world's most extensive source of longitudinal human growth data. The Brush Inquiry was initiated in 1926 as an effort by Prof. T. Wingate Todd and his associates to examine normal human mental and physical growth and development. The Bolton Study was initiated in 1929 by B. Holly Broadbent, Sr. It concentrated on growth and development of the face and teeth. The radiograph was the primary tool used by these researchers to study the physical changes that occurred in the bones of the body with time. Radiographic data was supplemented by notes regarding nutritional, dental and medical health status and disease history. Batteries of psychological and mental tests were also given yearly. Today, under the direction of Dr. B. Holly Broadbent, Jr., the Brush Inquiry and the Bolton Study collections combine to form the Bolton-Brush Growth Study.

More than 4,000 children from Cleveland had head-to-toe x-rays of their bodies as children and were participants in the Bolton-Brush Growth Studies on normal, healthy development. The youngest children were three months old at the beginning of the study. Older children were also enrolled. They were x-rayed every three months during the first two years of life and less frequently after that. The Bolton-Brush Growth Studies have become one of the world's longest running studies on what it means to develop normally and to be a healthy child and now adult.

OrthoPediatrics' exclusive access to these collections creates a significant barrier for our competitors as it is virtually impossible to recreate this information today, no matter how much time or money may be invested due to current legal and medical regulations. The merging of the Hamann-Todd and Bolton-Brush collections has never been attempted before, yet will soon be accomplished by a handpicked team of PhD computer scientists, medical informaticists and orthopedic surgeons. This storehouse of osteological data will in turn be made available to the individuals and institutions that helped create the repository in an effort to help further pediatric science and product development for children, small stature adults and the medical professionals who treat them.

References

¹ Information obtained from the Cleveland Museum of Natural History (www.cmnh.org)
² Information obtained from Case Western Reserve University (www.case.edu)