Medical Systems, the leading developer of neurostimulation therapies
for the treatment of obstructive
sleep apnea (OSA), provided an update today on four important
Inspire has completed a Series C financing round of $14.5 million. The
funds will be used to support clinical trial patient follow-up, U.S.
regulatory submissions, and expansion of commercial activities in
Europe. Participating in this round of financing are new investors,
Medtronic and TGap Ventures, and existing investors, including Kleiner
Perkins Caufield & Byers, US Venture Partners, Synergy Life Science
Partners and GDN Holdings.
Inspire also announced the completion of patient recruitment and device
implants in the STAR
pivotal trial (Stimulation Therapy
for Apnea Reduction).
trial is a multi-center study that is evaluating the safety and
effectiveness of in patients with moderate to
severe obstructive sleep apnea (OSA).The STAR trial is being conducted
at leading medical centers across the United States and Europe. All
implanted patients are being closely followed, and the results of this
study will be the basis for a Pre-Market Approval (PMA) application to
the FDA which is targeted for early 2013.
Additionally, Laryngoscope, the journal of the American Laryngological,
Rhinological and Otological Society published in its May issue the
results of two earlier clinical trials conducted by Inspire
investigators. The publication reported that Inspire® Upper Airway
Stimulation (UAS) therapy is safe and efficacious in a select group of
patients with moderate to severe OSA who cannot or will not use CPAP as
primary treatment. The abstract of the study titled, Implanted upper
airway stimulation device for obstructive sleep apnea, is available here.
"Inspire has broadened its investor base, finished enrollment in its
STAR pivotal trial, and completed commercial implants in three European
countries," said Dr. Glen Nelson, Chairman of the Board of Inspire
Medical Systems. "Achievement of these critical milestones is a
testament to the experience and ability of Inspire's leadership team."
Inspire previously announced receipt of its CE Mark in 2010, and to date
has completed commercial implants in Germany, Italy and The Netherlands.
Inspire has a strong European team focused on the broader adoption of
Inspire therapy in Europe.
"Obstructive Sleep Apnea is a prevalent disorder affecting over 15
million people in The United States alone. A substantial number of these
patients are unable to achieve consistent benefit from conservative
therapies. The swift enrollment of our STAR pivotal trial demonstrates
the significant interest that patients have in Inspire therapy. It also
reflects the strong commitment our physician investigator group has made
to develop this promising therapy," said Tim Herbert, President and CEO
of Inspire Medical Systems. "Our focus now is to gain regulatory
approvals and to secure reimbursement mechanisms so that this patient
group will have access to our breakthrough technology."
About Obstructive Sleep Apnea (OSA)
OSA is characterized by repeated episodes of upper airway collapse
during sleep. Patients with OSA stop breathing frequently during their
sleep (apnea), often for a minute or longer. Fragmented sleep with
recurrent awakening, called arousals, leads to daytime sleepiness and
fatigue. Depending on the degree of severity, OSA can be a potentially
life-threatening condition. Recent research suggests that a person with
undiagnosed sleep apnea or a person that is noncompliant to treatment of
their sleep apnea is at increased risk for: heart attack, stroke, weight
gain, high blood pressure and heart failure.
About Inspire® Upper Airway Stimulation (UAS)
Inspire Upper Airway Stimulation (UAS) therapy is a dynamic,
implantable therapy that works with the body's natural physiology to
prevent airway obstruction during sleep. While the patient sleeps,
Inspire therapy is designed to deliver mild stimulation to the
hypoglossal nerve synchronous with each breathing cycle. The stimulation
is delivered to the muscles that control the base of tongue, preventing
the tongue from collapsing and obstructing the airway. Patients are able
to activate the Inspire therapy using a handheld programmer. In contrast
to other surgical procedures to treat sleep apnea, Inspire therapy does
not require removing or permanently altering an OSA patient's facial or
About Inspire Medical Systems
Inspire Medical Systems, based in Minneapolis, Minnesota, is the world's
leading developer of innovative, implantable neurostimulation
technologies to treat Obstructive Sleep Apnea (OSA). Utilizing
well-established technologies from the fields of cardiac pacing and
neurostimulation, Inspire has developed a proprietary Upper Airway
Stimulation (UAS) therapy for patients who suffer from OSA. Inspire was
formed in 2007 when the technology and a significant intellectual
property portfolio was spun-out of Medtronic (NYSE: MDT). Inspire
therapy is designed to significantly reduce the negative effects of
sleep apnea and restore restful sleep to patients suffering from this
challenging condition. Visit Inspire Medical Systems on the web at www.inspiresleep.com.
Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED
STATES) LAW TO INVESTIGATIONAL USE.
The Inspire system is an investigational device and is not currently for
sale in the U. S.
[ Back To NFVZone's Homepage ]