PRESS RELEASE

FOR IMMEDIATE RELEASE


PMG RESEARCH OF WILMINGTON AND PMG RESEARCH OF WINSTON-SALEM: THE FIRST MEDICAL CENTERS IN NORTH CAROLINA TO IMPLANT INVESTIGATIONAL DEVICE TO TREAT OBSTRUCTIVE SLEEP APNEA

Winston-Salem, NC, Friday, February 3, 2012 – Two sites in the PMG Research network, PMG Research of Wilmington and PMG Research of Winston-Salem, implanted the Apnex® Hypoglossal Nerve Stimulation (HGNS®) System in a patient to treat obstructive sleep apnea (OSA), becoming the first medical centers in North Carolina to perform this procedure. The patients are participating in a FDA-approved clinical study. The study is sponsored by Apnex Medical, Inc.

“The Apnex HGNS System is anticipated to significantly reduce the number of times a person’s breathing is interrupted each night, in people that suffer from OSA. This new treatment offers hope to people who have not been successfully treated with continuous positive airway pressure (CPAP) devices" says Douglas Lee, MD, from Wilmington Health and lead clinical trial investigator for PMG Research of Wilmington. "We are excited to be part of this important study”, explained Jason Thomason, MD, from Salem Chest Specialists and lead clinical trial investigator at PMG Research of Winston-Salem.

ABOUT OBSTRUCTIVE SLEEP APNEA

According to the World Health Organization, approximately 100 million people worldwide have OSA. In the United States, symptomatic OSA affects 1 in 4 men and 1 in 9 women. It most often occurs when the airway muscles fail to keep the airway open during sleep. Untreated OSA increases the risk of death; as well as stroke, high blood pressure, coronary artery disease, heart failure and diabetes. It causes fragmented sleep which leads to excessive daytime sleepiness, resulting in an increased risk of accidents and lost productivity. Current OSA treatments are not always successful or well tolerated.

ABOUT THE APNEX HGNS SYSTEM

The Apnex HGNS System is an implanted medical device that activates muscles of the upper airway to ensure that the airway remains open during sleep. During sleep the system monitors the patient’s breathing and delivers mild stimulation to the hypoglossal nerve, the nerve that controls the tongue. As the nerve is stimulated, the tongue gently moves forward to keep the airway open. The stimulation is timed to a patient’s own breathing pattern. The device automatically turns on when the patient is sleeping, and turns off when the patient is awake.

ABOUT THE APNEX CLINICAL STUDY

The purpose of the Apnex Clinical Study is to determine whether the Apnex HGNS System is a safe and effective treatment for OSA in patients who have not received lasting benefit from CPAP or other OSA treatments. The study is being performed by sleep specialists at clinical study centers throughout the U.S. and Australia.

The Apnex Clinical Study is now enrolling patients. People who are interested in learning if they might qualify for the study can call 1-888-975-3370 or go to http://www.sleepapneatrial.com/.

Caution: The Apnex HGNS System is an investigational device and is limited by Federal (or United States) law to investigational use only.


ABOUT PMG RESEARCH

PMG Research, Inc. is an Integrated Site Network based in Winston-Salem, NC. The staff and physicians at PMG Research have contributed to the development of numerous medications, medical devices and vaccines. PMG’s mission is to provide unparalleled service to their clinical trial participants and pharmaceutical sponsors. Visit PMG Research at http://www.pmg-research.com/.

Diabetes Medication Widely Studied in PMG Network Receives FDA Approval!

BYDUREON (exenatide extended release for injectable suspension) just received FDA approval.  Special thanks to all of the participants in these clinical trials as well as every PMG site! 

BYDUREON is the first and only treatment for adults with Type 2 Diabetes that delivers continuous glycemic control in a single weekly dose.  Learn more about BYDUREON HERE...

Birth Control Patch Studied at PMG Ready for FDA Review

Agile Therapeutics announced that clinical trials are complete for their combination hormonal contraceptive patch and the product is ready for FDA review in 2012. We will keep you posted on the progress of approval of the patch.  Thanks to all of the participants, PMG sites, and staff that contributed to this major milestone for Agile's low-dose birth control patch.  Read more about Agile's news here.

Sarah Call Gives Back to Wake Med and the MS Society

Sarah Call, Clinical Research Coordinator at PMG Research of Raleigh, showed her holiday spirit and put her Best Foot Forward by stepping up to fill in for the flautist who called in sick at the last minute for the Wake Med Hospital Holiday Music Concert.  The group was led by Sheila DeBastiani, a friend of PMG, who is involved with Wake Med's Clinical Trials Department.  Ira David Wood, III, Executive Director of Theatre in the Park in Raleigh, spoke at the event.  Check out Sarah in the video above!

Sarah volunteered her time with the Eastern North Carolina Multiple Sclerosis National Chapter this year.  Sarah shared her story of service with me and wanted to share it with you....

"My aunt has Multiple Sclerosis and I have volunteered for the past two years with the MS Scholarship Committee for the Eastern North Carolina MS National Chapter. For my community service day in 2011, I spent the day at the Chapter helping to complete patient surveys. The Eastern NC chapter has a unique program that individuals across the Eastern Carolinas can apply for financial aid for food, rent, utilities, and necessities. My role was to call anyone who had received financial aid and poll them on customer service and how user friendly the financial aid service was, and if the financial aid was able to alleviate their temporary financial troubles. The surveys had to be completed by the end of the year, and the MS Chapter had just lost their intern, so they definately needed the extra hand! One man that I spoke with, who's in a nursing home, was able to use the service to repair his wheelchair. The MS Chapter helped one woman from losing her home and another to buy clothes for her children for school. I learned that people are so grateful for even the smallest amount.  Everyone I spoke to was so grateful. It was exciting to see another corporation using the 'Best Foot Forward' policies and then going back to ensure that their customer service was up to par. Thank you for the opportunity to spend a day at the National MS Chapter!"

Great job Sarah on contributing your time and talents, and putting your Best Foot Forward to such a great cause!

PMG of Winston-Salem's TC Deluca Gives Back

TC Deluca, a Senior Clinical Research Coordinator in Winston-Salem, used her community service day this year volunteering with the Challenger Division of Little League.  Here is TC's story of service.....

"I used my service day to go to Williamsport, PA with my husband to volunteer at the Challenger Division Championship Game in August.  The Challenger Division of Little League is designed to offer the opportunity to play Little League baseball to players who are physically and mentally disabled.  My husband and I run the Challenger Division League at SW Forsyth Little League in Clemmons, NC and have done so for the last 5 years.  We have approximately 50 kids who come to play ball ever Saturday during the Spring Season.  Our kids range in age from 3-22 and represent a variety of special needs including Autism, Down's Syndrome, and Cerebral Palsy.  We have quite a few players who are confined to wheelchairs so must use a walker to get around the bases.  The reason we went to Williamsport this year is that our team has been invited to play in the Little League World Series in Williamsport in 2012!"

Great work TC!!!  Learn more about the Challenger Division of Little League here.

Sara Rowe Gives Back to her Local Community through Habitat for Humanity

Sara Rowe, PMG's Outreach and Facilities Coordinator, gave back to her local community, High Point, NC through Habitat for Humanity.  Here is Sara's story of service.....

"I participated in a Women's Build with Habitat for Humanity.  My mom volunteers at the High Point Habitat 3 days a week and asked if I would like to participate.  Habitat is currently partnering with the City of High Point to develop new homes near Washington Terrace Park.  This exciting new development brings together the vision of the city's Core Plan with the need for affordable housing in the High Point community.  What I learned that day is that a homeowner has to have the ability to pay a 25-year interest-free mortgage, have acceptable credit history and reasonable debt load, have a steady form of income and be a US citizen or a legal immigrant.  They also have to be willing to partner with Habitat by investing 250 hours per adult in sweat equity and attending educational classes. 

The house we worked on during the Women's Build had a foundation and the frame of the house when we arrived.  They had just started on this home a few weeks before.  Some of the group worked on the roof and I got to help with installing the subfloor.... what a job!  We carried, placed and nailed wood most of the day.  We had a blast and I found out that I can't hammer that well!  Hammering is not my thing, but it was certainly a great feeling knowing I was building a home for someone who really needs it.  The new owner helped us that morning....  she was extremely humble and appreciative.  It was a wonderful experience and I plan to volunteer again soon. They need it and I truly believe in what Habitat does for the community."

Well done Sara!!!  Learn more about Habitat for Humanity in High Point, NC.

PMG's Alissa Wulf Gives Back to her Alma Mater

Alissa Wulf, one of PMG Research's Senior Clinical Research Coordinators in Charleston, SC, used her community service day this year to give back to her Alma Mater, Coastal Carolina University (CCU) and the Women's Soccer Program.  During the early spring of 2011, Alissa worked closely with two other fellow alumni, the current coaching staff at CCU, and the university's athletic department to help organize and coordinate the first ever CCU Men's and Women's Soccer Joint Alumni Weekend. 

In addition to the typical work associated with planning such a large event, Alissa's main objective was to find a way to honor and remember a close friend and former teammate, April Stirton, who was tragically killed in an accident in April 2010.  Alissa had reached out to CCU's Athletic Director, the Chanticleer Athletic Foundation, and the President of the University to see what was possible.  After numerous brainstorms, emails, phone calls and the final approval of the President of the university, they were able to retire April's #26 from the women's soccer program and establish a memorial fund in her honor, with all the proceeds going to the CCU women's soccer program in her name.  April's family was in attendance for the ceremony, and together friends, teammates and family celebrated her life.  Alissa is looking forward to working on the event again in 2012.  See the press release for the event here.

As a result of Alissa's service to her Alma Mater, she was asked to represent the women's soccer program as an Association Officer for the Coastal Carolina Letterwinners Association.  The mission of the association is to enhance the tradition and values of Coastal Carolina University by encouraging CCU Athletic Letterwinners to be lifelong members of the Coastal Carolina Athletics family.  The focus is on alumni camaraderie, athletic excellence, career development and service. 

Way to go Alissa!!!