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Hologic Launches System to Assess Osteoporosis, Heart Disease, Obesity

Bedford, Mass.-based Hologic Inc., a medtech company focused on women’s health, has begun commercialization for Horizon, a “dual energy X-ray absorptiometry” (DXA) imaging system for the assessment of osteoporosis, cardiovascular disease and obesity. Absorptiometry is a radiological technique for measuring areal bone density. The system is being launched in the United States and select international locations.

In the United States today, more than 40 million people either already have osteoporosis or are at high risk due to low bone mass. Osteoporosis can onset at any age, although the risk for developing the disease increases with age. In the future, more people will be at risk for developing osteoporosis because people are living longer and the number of elderly people in the population is increasing. Osteoporosis affects women and men of all races and ethnic groups, but it is most common in non-Hispanic white women and Asian women, according to data from the National Institute of Health’s 2011 Handout on Health: Osteoporosis.

The Hologic Horizon DXA platform is also designed to perform a single energy femur exam that allows clinicians to visualize potential atypical femur fractures (AFF), an unusual form of femur fracture which can occur as the result of bisphosphonate use—a common treatment for osteoporosis. The U.S. Food and Drug Administration (FDA) cleared the system for this use earlier in August. Horizon DXA also produces a 10-year fracture risk report hoped to aid in the early detection of osteoporosis by taking into account risk factors in addition to bone density.

“We developed our single energy femur exam in an effort to provide clinicians with the critical information needed to effectively manage patient care and improve fracture-related outcomes,” said John Jenkins, Hologic’s vice president of marketing for specialty imaging products. “An atypical femur fracture is an extremely debilitating fracture, in many instances much worse than a normal osteoporosis-related hip fracture. While these fractures are uncommon, the morbidity associated with them is significant. Recently published studies indicate that patients who suffer an AFF face extensive in-patient hospitalization, are at high risk for complications, and often report poorer health and function after the fracture. By including a convenient way for the physician to assess possible developing AFFs, early medical intervention may avoid the significant morbidity of a complete atypical femur fracture.”

“The 2010 American Society for Bone and Mineral Research (ASBMR) Task Force on AFF emphasized that physicians should ask patients on bisphosphonates about thigh or groin pain, as this often precedes AFF,” said Kevin Wilson, Ph.D., scientific director of skeletal health at Hologic. “Further, the FDA has instructed physicians to evaluate any patients on bisphosphonates with thigh or groin pain to rule out a femoral fracture.”

Patients suffering from osteoporosis are often treated with bisphosphonates to prevent or slow the loss of bone mass. Since their approval in 1995, bisphosphonates have become one of the most popular treatment options for the prevention of common osteoporosis-related fractures, primarily in post-menopausal women. Recently, studies have linked long-term bisphosphonate therapy with increased risk of AFF.

Patients with AFF frequently report having groin or thigh pain prior to being diagnosed with the fracture. These fractures are often bilateral and appear to evolve over time with initial development of a cortical bump that likely represents early periosteal thickening of the femoral shaft, which is the result of the formation of new bone in response to injury or other stimuli. In addition, a transverse cortical lucency, or thin black line, may be present in the region of the periosteal thickening and indicates an incomplete fracture. This may or may not progress to a complete fracture. Complete fractures extend through the entire femoral shaft often with the formation of a medial spike. Incomplete fractures occur in the lateral cortex only. Complete atypical femur fractures occur without trauma or with only minimal trauma and, according to Hologic, studies have shown that healing is often delayed. Treatment options for incomplete atypical femur fractures are limited and include stopping anti-resorptive and bisphosphonate therapies, restricting activities, and, in some instances, prophylactic surgery to prevent a complete fracture.

Horizon DXA produces vertebral images in high definition via Horizon’s high definition instant vertebral assessment (IVA-HD) feature. This feature is also designed to visualize abdominal aortic calcifications, a significant predictor of cardiovascular disease.

The Horizon DXA is an updated version of its predecessor, the QDR bone densitometer. Enhancements include a high-resolution multi-element detector array with ceramic detector technology for improved bone mapping and image quality; a high-frequency pulsing power supply that reportedly offers greater system stability and future flexibility; and a filter drum to support future development initiatives.

“We expect the technical advancements built into our Horizon platform will set a new standard for image quality and operational efficiency,” said Jenkins. “Hologic pioneered the DXA market with the introduction of the first QDR bone densitometer and we have maintained our leadership position through continued investment in research and development. The Horizon platform is a great example of this investment. The new system combines a wealth of proprietary, advanced technologies that provide clinicians with the most accurate diagnostic information available.”

Zacks Equity Research analysts predict that Hologic will do well with this system, considering it addresses three major health problems that are on the rise. Data from the 1995 Handout on Health: Osteoporosis said that half of women and one fourth of men over the age of 50 are prone to osteoporosis-related fracture during their lifetime. The World Health Organization estimates that 17 million deaths occur worldwide from cardiovascular disease annually; and that approximately 2.8 million individuals annually die of obesity-related complications. According to medical journal The Lancet, there has been a global increase of 82 percent in the incidence of obesity over the last 20 years.

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