Gentle, Simple SinuSys™ Vent-Os™ Sinus Dilation System Obtains FDA Clearance

Corporation, an innovative sinus health company, today announced the
Company has received FDA clearance for its Vent-Os™
Sinus Dilation System, designed to resolve sinusitis symptoms in a
simple, two-step interventional procedure. The device enables
low-pressure, gradual dilation of the maxillary sinus ostia, which is
intended to maximize patient tolerability of the procedure in an office
setting under local anesthesia. The Company plans to commercialize the
device immediately in select markets in the U.S.

Unlike balloon dilation devices that use rapid, high-pressure inflation,
the Vent-Os Sinus Dilation System is a small, low-pressure,
self-expanding insert designed to gently and gradually open the
maxillary ostia. The Vent-Os System incorporates the Company’s
proprietary osmotic technology, which utilizes the body’s natural
mucosal fluids to expand the insert before removal. In an office
setting, patients can be comfortably relocated to the waiting room
between insertion and removal of the device.

The Vent-Os System achieved post-procedural patency in 95 percent of the
sinus ostia treated in a multi-center study and submitted as part of the
Company’s FDA application; five percent of the treated ostia could not
be visualized. In the study, the Vent-Os device was inserted into the
maxillary sinus opening at the beginning of the procedure and removed
after 60 minutes. No adverse events occurred during insertion or removal
of the device. Three-month follow-up was completed in 33 patients (55
ostia), with 93 percent of the treated ostia remaining patent and seven
percent that could not be visualized. No ostia were reported to be

Fifteen percent of patients in the study were treated in an office
setting after pre-procedural injection of anesthesia; no additional
anesthesia or medication was required for these patients for the
duration of the procedure. This is in contrast to balloon dilation
devices, which often require administration of anxiolytics, analgesics
and/or additional local injections of anesthetics during the procedure
to increase patient tolerability. The remaining patients were treated in
the operating room adjunctive to functional endoscopic sinus surgery
(FESS). More information on the study can be found at .

“In my opinion, the SinuSys team has demonstrated that gradual, low
pressure can dilate the maxillary sinus ostium," said Peter Catalano,
MD, FACS, Professor of Otolaryngology at Tufts University, Chief of
Otolaryngology at St. Elizabeth's Medical Center in Boston and an
investigator in the Vent-Os study. "The Vent-Os system is very easy to
deploy and is exceptionally well-tolerated by patients under local
anesthesia. SinuSys’ unique osmotic expansion technology appears to be
an ideal intervention for patients requiring ventilation and drainage of
the maxillary sinus, especially for procedures to be performed in an
office setting.”

SinuSys Chief Executive Officer Tom Schreck added, “With the Vent-Os
System, it was our intent to design a device that solved the current
clinical challenges with treating sinus disease in a way that was easy
for both physicians and their patients. Our maxillary sinus device is
showing initial clinical success and we look forward to developing the
same simple, gentle technology for use in other sinus anatomy.”

The FDA cleared the Vent-Os Sinus Dilation System for dilation of the
maxillary sinus ostia and associated spaces in adults for diagnostic and
therapeutic procedures. The Vent-Os System has also received the CE
Mark, Health Canada license and Australian Therapeutic Goods
Administration (TGA) Certificate, and is currently being commercialized
in those regions.

Chronic sinusitis affects more than 31 million people in the United
States. It is more prevalent than heart disease and asthma, and has a
greater impact on patients’ quality of life than chronic back pain or
congestive heart failure. The majority of patients with chronic
sinusitis are treated with oral antibiotics and/or nasal steroids, which
can increase the risk of antibiotic resistance and cause unwanted side
effects such as epistaxis (nose bleeds), nasal ulcers, and nasal and
oral infections. The most effective surgical treatment is Functional
Endoscopic Sinus Surgery (FESS), which is conducted in a surgical suite
under general anesthesia or IV sedation. The United States healthcare
system currently spends more than $8 billion annually on improving the
health of patients with sinus conditions.

SinuSys Corp. ()
develops medical device therapies to improve the health of millions of
patients suffering from sinusitis worldwide. The company’s proprietary
self-expanding, osmotic technology is designed to be atraumatic,
tissue-sparing and easy to use, potentially enabling clinicians to
intervene at earlier stages of sinus disease. The company seeks to
provide improved options for the 20 percent of sinusitis patients whose
disease is not resolved with drug therapy.

Chronic CommunicationsMichelle McAdam,

Source: SinuSys Corporation