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NuCryo Vascular Announces Commercialization Agreement with Lokai Medical for Innovative Treatment for Peripheral Arterial Disease


NuCryo Vascular today announced that the company has signed a
commercialization agreement with Lokai Medical, a specialty distributor
of coronary/peripheral and interventional devices, to distribute the
PolarCath™ Balloon Dilatation System in the United States.

Balloon Cryoplasty® has been shown in clinical studies and in
everyday procedures to be an important option for treating peripheral
arterial disease. The controlled cooling of the plaque and artery wall
provides three potential benefits: uniform vessel dilation with less
vessel trauma, reduced vessel wall recoil and induction of apoptosis,
which promotes the natural cell death of the smooth muscle cells that
otherwise proliferate to cause restenosis. The PolarCath Cryoplasty
system was invented by James Joye, M.D., an interventional cardiologist
in Mountain View, Calif. who is a pioneer in the development of medical
devices to treat peripheral arterial disease.

"We are very excited to partner with Lokai Medical and the company's
experienced sales team to help commercialize the PolarCath Balloon
Dilatation System," said Kevin Beedon, general manager and executive
vice president of NuCryo Vascular. "NuCryo grew sales by 36 percent in
2017 vs. 2016 with an extremely small but dedicated direct sales team.
The commercialization support and clinical expertise of Lokai Medical
will help NuCryo continue its double-digit growth in the expanded
markets we can now serve."

"I am very excited for the next-generation reusable Cryoplasty inflation
device that NuCryo has re-engineered and brought back to market," said
Jonathan Aliota, M.D., interventional cardiologist from Houston, Texas.
"As a previous Cryoplasty user with Boston Scientific, I recently
reincorporated it back into my peripheral treatment algorithm and have
been extremely happy with the results. In addition, the cost, ease of
use, and time savings as compared to other balloons on the market have
been well received at my facility."

The PolarCath Peripheral Dilatation System received U.S. Food and Drug
Administration (FDA) clearance to dilate stenosis in the peripheral
vasculature (iliac, femoral, popliteal, infrapopliteal, renal, and
subclavian arteries) and for the treatment of obstructive lesions of
polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis
fistulae. The PolarCath System is also indicated for post-deployed stent
expansion of self-expanding peripheral vascular stents.

The PolarCath system, which received its first FDA clearance in 2002,
was developed by CryoVascular, Inc., a company formed by Dr. Joye and
collaborators. In 2005, CryoVascular was acquired by Boston Scientific,
which discontinued manufacturing PolarCath at the end of 2012. NuCryo
Vascular created in 2014 for the purpose of acquiring PolarCath and
resuming manufacturing of the device. NuCryo Vascular has since
re-engineered the device and received FDA approval of the non-sterile
inflation device in 2015.

About NuCryo Vascular

NuCryo Vascular LLC is a privately held company that manufactures,
markets, and sells the PolarCath (Cryoplasty) Balloon Dilatation System.

For further information, connect to

About Lokai Medical

Lokai Medical is a specialty distributor of coronary/peripheral and
interventional devices throughout the United States. Lokai Medical is
based out of Phoenix, Arizona.

For further information, connect to Mike Perko at

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