BREAKTHROUGH INCONTINENCE TREATMENT REACHES GLOBAL MARKETPLACE TO OFFER NEW HOPE TO MILLIONS OF WOMEN
ATLANTA, March 6, 2000-Neotonus Inc., the world leader in applying pulsed magnetic fields in medicine, announced today that the Korean FDA has granted approval for the company to market its NeoControl® Pelvic Floor Therapy System, to treat women in Korea suffering from urinary incontinence. Based on U.S. studies citing that approximately 7 percent of the total world population suffers from loss of bladder control, 85 percent of whom are women, the approval could improve the lives of an estimated 4 million Korean women.
"NeoControl was cleared by the U.S. Food and Drug Administration in 1998, and its success in the U.S. encouraged us to increase our presence in the global marketplace," said Neotonus president and CEO Tony Morris. "We have already received approval to market this product in Canada, Argentina, Australia and Europe, and the Korean approval brings us closer to our goal of eventually being the first-line treatment for incontinence in every corner of the world."
NeoControl, the first commercial product to utilize Extracorporeal Magnetic Innervation (ExMI™) technology, employs powerful pulsed magnetic fields to stimulate nerve activity in the pelvic floor, which in turn exercises the muscles that control bladder function, improving strength, endurance and circulation. While remaining fully clothed, a patient undergoes a painless, non-invasive 20-minute treatment twice a week for eight weeks. Sitting in a comfortable chair, the patient will feel her muscles
tighten and relax as they are exercised according to a physician's prescription.
NeoControl provides an effective, painless and non-invasive alternative to other treatment options, such as surgery or drugs, which are often ineffective, expensive and involve lengthy recovery periods or unpleasant side effects.
NeoControl is currently in use in more than 200 urology and obstetrics/gynecology practices throughout the United States and 12 other countries. To date, more than 20,000 NeoControl treatments have been administered to women with impressive success rates. Data from clinical studies at the Cleveland Clinic and sites in Chicago, Philadelphia and Orlando indicate that 50 percent of women who completed six weeks of NeoControlâ therapy reported being "completely dry" and an additional 30 percent reported "significant improvement" in their conditions.
Another catalyst for Neotonus' expansion was a recent $7.3 million second round of venture capital funding. This financial gain will boost the company's international efforts and accelerate its clinical research programs, product development efforts and marketing activities in the new areas of physical medicine and neurological disorders.
Based in Marietta, Ga., Neotonus Inc. provides cost-effective, non-invasive healthcare solutions utilizing advanced pulsed magnetic neuromodulation technologies. The company holds patents for a broad range of medical applications of its ExMI technology. Currently, the company is developing a number of proprietary products to address neurological and neuromuscular disorders, including other disorders of the pelvic floor, depression and re-education of damaged muscles in extremities. For more information, call 1/800-895-4298 or visit www.neocontrol.com.
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STUDY EXPLORES PULSED MAGNETIC THERAPY FOR TREATMENT OF
POST-PROSTATECTOMY URINARY INCONTINENCE IN MEN
ATLANTA, Dec. 14, 1999
-Neotonus Inc. today announced it is launching the first study using new pulsed magnetic therapy as a non-invasive treatment for urinary incontinence among men who have undergone radical prostatectomy for prostate cancer. The study offers hope to the 330,000 men who are diagnosed with prostate cancer each year, many of whom will require prostate surgery, the leading cause of incontinence in men.
The innovative treatment, called Extracorporeal Magnetic Innervation (ExMI™), uses powerful pulsing magnetic fields to strengthen the pelvic floor muscles that affect bladder control. It is estimated that as many as 65 percent of all men who have undergone radical prostatectomy experience a lack of bladder control six months or longer following surgery.
"Incontinence is a serious problem for many radical prostatectomy patients," said Dr. Lindsey Kerr, a urologist and national spokesperson for the National Association for Continence. "An effective, non-invasive treatment for men with this life-altering condition would be a major breakthrough, as current treatment options are so limited."
ExMI was developed by Neotonus in 1997 and was cleared by the U.S. Food and Drug Administration in June 1998 for the treatment of stress, urge and mixed urinary incontinence in women. The company's first product to utilize ExMI, the NeoControl® Pelvic Floor Therapy System, is currently in use in more than 125 urology and obstetrics/gynecology practices throughout the United States and 10 other countries. More than 16,500 painless, non-invasive treatments have been delivered to women thus far with impressive success rates.
"Post-prostatectomy incontinence is awkward, uncomfortable and requires significant lifestyle adjustments," said Dr. Yvonne Greene, clinical director for Neotonus. "Based on strong preliminary data, we believe ExMI will be an effective treatment for post-prostatectomy incontinence."
The multicenter trial will be led by principal investigator Dr. Ajay Nehra of the Mayo Clinic in Rochester, Minn., and will recruit male patients who are experiencing incontinence as a result of having undergone a radical prostatectomy for prostate cancer at least three months prior to the study. Co-investigators include Dr. Rodney Appell of the Cleveland Clinic in Cleveland, Ohio; Drs. Alan Wein and Eric Rovner of the University of Pennsylvania; Drs. William Ellis and Paul Lange of the University of Washington; Dr. Kurt McCammon of Eastern Virginia Medical School; and Dr. Niall Galloway of Emory School of Medicine in Atlanta.
Based in Marietta, Ga., Neotonus Inc. provides cost-effective, non-invasive healthcare solutions utilizing advanced pulsed magnetic neuromodulation technologies. The company holds several patents for a broad range of medical applications of its ExMI technology, including the painless treatment of incontinence. Currently, the company is developing a number of proprietary products to address several neurological and neuromuscular disorders, including other disorders of the pelvic floor, depression and re-education of damaged muscles in extremities. For more information, call 1/800-895-4298 or visit www.neocontrol.com.
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NEUROMODULATION COMPANY GETS $7.3 MILLION IN SECOND ROUND
Inc., inventor of extracorporeal magnetic innervation (ExMI™) for
the treatment of neurological and neuromuscular disorders, announced
today it has raised $7.3 million in its second round of venture
capital funding. Total funding now stands at $12.2 million since
the company's founding in March 1997.
Based in Marietta,
GA, Neotonus develops, manufactures and markets magnetic neuromodulation
technology for the non-invasive treatment of transcranial and peripheral
neurologic and neuromuscular disorders.
the new support, Neotonus President and CEO Tony Morris said, "Additional
support from our original investors, plus participation by several
new investors, demonstrates continuing commitment to Neotonus' technology
and business strategy. We are extremely pleased with this round
repeat investors include Noro-Mosley Partners III, L.P., Crown Investors
and The Wakefield Group II, L.P. Investors new to this round include
Adventist Health System/Sunbelt Healthcare Corporation, Antares
Capital Fund II, CB Private Equity Partners, L.P., Mayo Foundation
for Medical Education and Research, Parson Finance Limited, and
Roundtable Associates, LLC.
focus for Neotonus was on clinical research to develop applications
for its pulsed magnetic neuromodulation technology. Neotonus earned
U.S. Food and Drug Administration approval in June 1998 for its
first two products-NeoControl®, a pelvic floor therapy system with
applications for incontinence treatment, and a yet to be marketed
device for general muscle re-education.
Tony Morris said the extracorporeal magnetic innervation technology
was originally developed by Neotonus in collaboration with physicians
at Emory University School of Medicine and engineers at Georgia
Institute of Technology.
launched commercially in September 1998, is now in use in urology
and obstetrics/gynecology offices throughout the United States and
ten other countries. More than 13,000 treatments have been delivered
via more than 100 NeoControl systems in place, according to Stan
Miller, vice president of marketing for Neotonus.
clinical results, coupled with the unique non-invasive and painless
nature of magnetic neuromodulation, have driven strong demand for
our technology," Miller added. "Neotonus addresses two strong needs
in today's healthcare market-less invasive treatments required by
patients and more cost-effective and efficient care demanded by
payors." NeoControl therapy is delivered to patients while fully
capital raised in this round will be applied to continuing clinical
research programs, expansion of distribution channels, enhanced
marketing for all products, and investment in R&D on new products.
by medical sector investors is no surprise given the exploding applications
of ExMI. Other potential applications for ExMI include such illusive
disorders as severe depression, Alzheimer's disease, obsessive compulsive
disorder, and others. "Initial studies indicate the use of our technology
for refractory depression (called transcranial magnetic stimulation
or TMS ) is well tolerated by patients and quite effective," added
Morris. "The non-invasive, non-pharmacological treatment of depression
is a major step forward for medical science."
information about Neotonus and NeoControl, please visit the website
at www.neotonus.com and www.NeoControl.com.
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