Market Overview

Micro Medical Solutions Marks First U.S. Implants of MicroStent for Peripheral Artery Disease


A clinical trial is underway for the MicroStent microvascular device,
which is designed to open occluded arteries and prevent below-the-knee

Micro Medical Solutions (MMS), an innovator in the field of
microvascular interventions that aim to improve clinical outcomes and
quality of life, announced a major milestone today in the development of
its MicroStent technology, a vascular stent specifically designed to
reduce below-the-knee amputations caused by critical limb ischemia (CLI)
resulting from peripheral artery disease (PAD). After receiving approval
from the U.S. Food and Drug Administration late last year to begin a
clinical trial evaluating the device's safety and efficacy, physicians
have completed MicroStent's first cases in the United States.

MicroStent received CE Mark approval in Europe in 2017 and continues to
be studied internationally, as well as through this clinical trial of
MicroStent in the United States. Co-principal investigator Dr. Robert E.
Beasley performed the first procedure in the trial on April 25 at Mount
Sinai Medical Center in Miami Beach, Florida. Dr. Beasley placed two 3.0
x 40mm stents in the anterior tibial artery (located between the knee
and ankle) of a patient with CLI, fully restoring blood flow to a
previously occluded vessel.

"We found implanting the MicroStent to be a very safe, quick, easy
procedure. Using a retrograde pedal puncture, we used a small 3-French
sheath to place two of these very low-profile, easy-to-deploy stents in
the anterior tibial artery in about 30 minutes. Post-procedural
ultrasound taken immediately, at 14 days and at 1 month showed a
wide-open, unobstructed artery with excellent flow," explained Dr.
Beasley. "By returning sufficient blood flow to the lower leg, we were
able to ensure adequate oxygenation to the tissue. As a result, a wound
on the patient's toe is now healing, and he is unlikely to require
below-the-knee amputation. I'm hopeful that MicroStent will represent
another tool to treat the devastating disease of CLI."

Dr. Beasley has since performed four more MicroStent procedures. Dr.
Craig Walker, co-principal investigator in the study with several cases
completed, oversees the MicroStent research site at the Cardiovascular
Institute of the South in Houma, Louisiana.

Dr. Walker noted, "With CLI, the ability to achieve patency in a vessel
is paramount to saving both the vessel and the limb. Use of MicroStent,
a self-expanding stent with great radial force and very little chronic
outward force, has resulted in patent arteries with low probability of
long-term stenosis. In fact, we have seen zero stenosis post-procedure
on both ultrasound and angiography, and one patient remarked that
dramatic pain relief occurred immediately after the MicroStent
procedure. We anticipate that this critically important technology will
continue to produce good outcomes and clinical results."

Micro Medical Solutions CEO Gregory Sullivan added, "Everyone at MMS has
been working together toward this achievement. We are very excited not
only about this milestone, but also about the progress and momentum we
are showing toward approval of MicroStent in the U.S. Ultimately, we
hope MicroStent will fulfill its purpose to reduce preventable
amputations and preserve patients' freedom and quality of life."

About Critical Limb Ischemia

Peripheral artery disease and critical limb ischemia (CLI) affect
millions each year. It has been estimated that nearly 25% of CLI
patients will undergo major amputation,1 and amputations due
to CLI continue to escalate.2 For more information on CLI,

1. Henry AJ, Hevelone ND, Belkin M, Nguyen LL. Socioeconomic and
hospital-related predictors of amputation for critical limb ischemia. J
Vasc Surg. 2011 Feb;53(2):330-9.e1.
2. Baser O, Verpillat P,
Gabriel S, et al. Prevalence, incidence, and outcomes of critical limb
ischemia in the US Medicare population. Vasc Dis Mgmt. 2013:10;E26-36.

About Micro Medical Solutions

Micro Medical Solutions is on a mission to provide solutions to some of
the most pressing unmet needs in microvascular intervention by helping
to significantly reduce the rate of amputations, improve clinical
outcomes and patient quality of life, and minimize the financial and
human costs associated with the treatment of peripheral artery disease
and critical limb ischemia. For more about Micro Medical Solutions,

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