Medical Designs, LLC Announces the National Marketing Launch of the FDA-Approved SAMBA™ Screw System, a Minimally Invasive

  Medical Designs, LLC Announces the National Marketing Launch of the
  FDA-Approved SAMBA™ Screw System, a Minimally Invasive Solution for the
  Treatment of SI-Joint Dysfunction

Business Wire

SIOUX FALLS, S.D. -- April 17, 2013

Medical Designs, LLC, a pioneer in the development of minimally invasive
spinal implants, announced today the national marketing launch of the
FDA-approved SAMBA™ Screw System, a minimally invasive solution for the
treatment of SI-Joint dysfunction. Invented by Dr. Wilson Asfora, the SAMBA™
Screw System received clearance in August 2012 from the Food and Drug
Administration (FDA) for sacroiliac joint fixation.

Dr. Wilson Asfora and his surgical team at Sanford Health. The video screen
shows bilateral SAMBA(TM ...

Dr. Wilson Asfora and his surgical team at Sanford Health. The video screen
shows bilateral SAMBA(TM) screw implants. (Photo: Business Wire)

The SAMBA™ Screw System features:

  *Technologically advanced hollow titanium bone screw with radial slots
    which promote fusion by allowing osteogenic and osteoconductive material
    to flow into the SI-Joint.
  *Custom instrument set permits guided placement of multiple SAMBA™ Screws
    across the SI-Joint in a time optimized minimally invasive procedure
    resulting in immediate SI joint stabilization with expeditious and
    comfortable post-operative course.
  *SI-Joint fusion is enhanced by a unique precision engineered applicator
    tool which enables delivery through the SAMBA™ Screw pressurized insertion
    of demineralized bone, bone substitutes, or osteogenic material into the
    SI-Joint.

The inventor of the SAMBA™ Screw System, Dr. Asfora commented, “We have
completed thirty SAMBA™ Screw procedures here in Sioux Falls and the results
have been outstanding. Our design team has optimized the surgical protocol to
have fewer steps compared to other techniques. The result is less time in the
OR and faster patient recovery.”

The cannulated design of the SAMBA™ Screw with sharp bone cutting threads, is
based on the Medical Designs Asfora Bullet Cage, a lumbar fusion device which
has been implanted in hundreds of patients. “We have achieved a remarkable 98%
fusion rate with the Bullet Cage stand alone for one or two lumbar levels,”
added Dr. Asfora. “We expect a similar rate of success with the SAMBA™ Screw.”

According to a study by the Center for Spinal Stenosis and Neurologic Care,
low back pain affects more than 90% of adults at some point and is the most
common reason besides colds for primary care visits. Research conducted by the
Department of Orthopedic Surgery at the University of Minnesota showed that up
to 30% of patients presenting with low back pain had sacroiliac joint
problems.

Medical Designs, LLC intends to distribute the SAMBA™ Screw System through a
network of independent reps and distributors.

About Medical Designs, LLC

Based in Sioux Falls, South Dakota, Medical Designs, LLC works closely with
surgeons, biomedical engineers and medical professionals to develop and market
new products for the medical marketplace. The company's primary focus is the
development of spinal implants for the treatment of cervical, lumbar and
SI-Joint disorders. For more information visit www.medicaldesigns.com.

About Dr. Wilson Asfora

Dr. Asfora is currently a Neurosurgeon at Sanford Health in Sioux Falls. He
specializes in adult and pediatric neurosurgery, spine surgery, brain tumor
surgery, cerebrovascular surgery, peripheral nerve surgery, radiosurgery and
functional neurosurgery including Deep Brain Stimulation for Movement
Disorders. Dr. Asfora is board certified in neurosurgery by the American Board
of Neurological Surgery and by the Royal College of Physicians and Surgeons of
Canada. He is licensed in the states of South Dakota, California and Florida
and holds surgical privileges at the University of Miami Hospital.

Dr. Asfora has authored numerous publications on issues related to
neurosurgery. Dr. Asfora holds twenty four patents and has developed numerous
medical devices in current use at hospitals around the world. He is best known
as the inventor of the Subdural Evacuating Port System (“SEPS”), a minimally
invasive life saving device used to treat subdural hematomas and promote brain
expansion without entering the subdural space. SEPS is currently marketed
globally by Medtronic, Inc.

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Contact:

Medical Designs, LLC
Kristi Vondra
Vice President of Operations
(605) 275-1032
kvondra@medicaldesignsllc.com
 
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