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Raymedica
Regains Distribution Rights for the PDN(R) Prosthetic Disc Nucleus Device
New Distribution Network
to Be Established in Europe and India
MINNEAPOLIS, Feb. 23 -- Raymedica, Inc., an orthopedic medical technology
innovator and device manufacturer of non-fusion spinal implants for the
treatment of back pain, announced today that Medtronic, Inc. will return
the European and Indian distribution rights of the PDN -SOLO(R) Prosthetic
Disc Nucleus to Raymedica. A new distribution network will be established
to actively market the PDN-SOLO device during the second quarter of 2005.
"We are grateful for Medtronic's efforts in distributing the PDN
during this evaluation stage," said John J. Viscogliosi, Chief Executive
Officer and Chairman of the Board of Directors for Raymedica. "This
change in distribution management will, however, allow Raymedica to take
a stronger, more active and direct role in the distribution of its technology
and products and in the education and training of surgeons who will implant
the PDN device. This transition also will allow us to have greater control
over the collection of clinical data on European patients and to generate
significantly greater retrospective and prospective data.
Raymedica's goal during this transition is to work closely with Medtronic
to ensure continued support to all previously implanted patients and service
to the surgeons and hospitals involved in providing the PDN device."
The PDN device is comprised of a hydrogel material contained within a
woven polyethelene jacket. The device is designed to replace the form
and function of an otherwise failed spinal disc nucleus. To treat low-back
pain, a PDN device is implanted in the center of the spinal disc. The
device is designed to further support the annulus tissue and vertebrae
bones of a patient's spine while allowing for more flexibility and movement
than spinal fusion, the current established surgical treatment, in which
adjacent vertebrae of the spine are fused together.
The PDN-SOLO device is commercially available in Europe and other international
markets, but is not yet approved for commercial distribution in the United
States. More than 3,300 patients worldwide have received a PDN implant.
Raymedica is pursuing marketing approval from the U.S. Food and Drug Administration.
About Raymedica, Inc.
Raymedica, privately held and based in Minneapolis, developed the PDN
prosthetic disc nucleus for the surgical treatment of low-back pain that
does not respond to conservative care. Back pain is the second most common
reason patients seek medical care in the United States, with more than
1.5 million people requiring surgical treatment annually. |
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