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CurveBeam, LLC Receives FDA Approval for pedCAT

April 20, 2012 By AxoGen, Inc.

Warrington, PA – Diagnostic imaging innovator CurveBeam
announced today that it has received 510(k) approval from the U.S. Food and
Drug Administration (FDA) for pedCAT, its weight bearing, in-office 3D foot and
ankle scanner. pedCAT utilizes Cone Beam Computed Tomography (CBCT) technology
to produce undistorted and unobstructed images of the foot and ankle region
under true physiological weight bearing conditions.

“We are introducing this first of its kind modality to
podiatric surgeons and orthopedic foot & ankle specialists with tremendous
excitement and anticipation,” said Arun Singh, Chief Executive Officer of
CurveBeam. “pedCAT will give physicians immediate access to more precise and
detailed views of foot conditions, and that will optimize their treatment
planning for greater predictability of surgical outcomes,” Singh added.

Singh explained that the machines small footprint, just 4
x 5, and its speedy operation with scan times under a minute make it ideal for
in-office use. Also, immediate accessibility of advanced imaging will obviate
undesirable delays in patient care.

The patients foot and ankle are scanned in a natural weight
bearing position for a precise view of physiological weight bearing effects.
pedCAT delivers 3D volumetric data for improved diagnosis, evaluation, and
treatment planning including:

  • Preoperative planning
  • Diagnosis, confirmation or ruling out fractures
  • Evaluating subluxations & dislocations
  • Evaluating arthritic joints
  • Early detection of osteomyelitis

Click here to view the multimedia video that includes
clinical case clips or visit www.curvebeam.com/movie.

Cone Beam CT Imaging has revolutionized treatment paths in
dental and ENT practices in the past 10 years, and is now being adapted to the
foot and ankle community with the introduction of pedCAT. pedCAT is designed
and manufactured in Warrington,
PA by CurveBeam, LLC.

About CurveBeam, LLC

The team behind CurveBeam pioneered 3D Cone Beam imaging technology for dental
specialties, revolutionizing dental implants, orthodontics and oral surgery.
Today, 3D scans are virtually the standard of care prior to advanced treatment
planning or surgery, resulting in improved treatment successes.

CurveBeam is committed to bringing the power and value of
Cone Beam technology to the Foot and Ankle specialty, in conjunction with
comprehensive software tools to facilitate more accurate diagnosis and more
precise treatment plans, improving the quality of life for its patients.

For more information, visit www.CurveBeam.com
or e-mail info@curvebeam.com.

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