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Press Release Source: Cyberonics, Inc |
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Cyberonics Announces Closure of Investigational Device Exemption (IDE) for Treatment-Resistant Depression (TRD), Lifetime Reimbursement Guarantee for All TRD IDE Study Patients and $15 Million TRD Indigent Care Program
Wednesday January 18, 8:00 am ET
HOUSTON, Jan. 18 /PRNewswire-FirstCall/ -- Cyberonics, Inc.
(Nasdaq: CYBX - News) today announced that FDA recently approved
its request to officially close Investigational Device Exemption (IDE) G980099
covering all pre-market studies of VNS Therapy(TM) in chronic or recurrent
treatment-resistant depression including the D-01 pilot study, the D-02 Pivotal
Study and the D-20 Treatment IDE. No additional depression studies under an
Investigational Device Exemption are currently underway or being planned by
Cyberonics. To ensure that all TRD IDE study patients continue to have access to
VNS Therapy, Cyberonics also announced today that it is providing a lifetime
reimbursement guarantee to all study patients and VNS Therapy service providers,
whereby Cyberonics will provide reimbursement for VNS Therapy services at
standard rates in the event that third party payers deny post-approval coverage
to patients in the D-01, D-02 and D-20 studies. Lastly, Cyberonics also
announced a $15 million TRD Indigent Access Program, similar to its B.J. Wilder
Therapy Access Program in epilepsy, to provide indigent Americans with TRD
access to VNS Therapy. Cyberonics will provide up to 200 VNS Therapy Systems per
year over a five year period in this program to qualified patients through
experienced hospitals and trained psychiatrists.
"Cyberonics' mission is to improve the lives of people touched
by pharmaco-resistant epilepsy and treatment-resistant depression," commented
Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief
Executive Officer. "Official closure by FDA of all TRD studies conducted under
an Investigational Device Exemption, the lifetime reimbursement guarantee for
TRD IDE study patients and the $15 million TRD Indigent Access Program will
facilitate accomplishment of that mission by providing more Americans with TRD
access to the first and only FDA-approved treatment option for their lifelong
and life-threatening illness.
"All Americans with TRD should have access to VNS Therapy for
its FDA-approved indication," continued Mr. Cummins. "Although over 85 different
third party payers, including 19 different Blue Cross/Blue Shield plans, United
Healthcare, CIGNA, Aetna, Humana and several regional Medicare carriers have to
date granted at least one American with TRD access to VNS Therapy (http://www.vnstherapy.com/depression/hcp/ReimbursementIns/casebycase.aspx ) and several State Medicaid programs now have the same coverage policy
for both epilepsy and depression, all Americans with TRD do not yet have the
same immediate, universal access to VNS Therapy that Americans with pharmaco-
resistant epilepsy have had for at least the past five years. The combination of
FDA approval, FDA's Summary of Safety and Effectiveness, the official closure by
FDA of all VNS Therapy TRD investigational studies, the rapidly building body of
peer-reviewed evidence and post-approval appropriate use and favorable patient
outcomes should convince all third party payers that VNS Therapy, the first and
only treatment specifically developed, studied, approved and labeled for TRD,
should be a covered benefit as indicated for fully-informed use. Lack of access
to the only FDA-approved treatment option for TRD can, unfortunately, have
tragic implications for Americans and their families. Cyberonics was recently
made aware of one person with three children who had suffered from
treatment-resistant depression for over 25 years who committed suicide following
a VNS Therapy coverage denial by a major private payer. Cyberonics has taken the
unprecedented steps with its lifetime reimbursement guarantee for study patients
and its $15 million TRD Indigent Access Program, to ensure that study patients
and indigent Americans with TRD have fully informed access to VNS Therapy. We
continue to work diligently with all third party payers to provide them with all
the information they need to follow our lead and give Americans with health
insurance suffering from TRD the same universal access to VNS Therapy that
Americans with epilepsy have had for over five years and that Cyberonics is now
providing to TRD study patients and indigent Americans with no insurance.
"Official closure of the TRD IDE confirms that VNS Therapy for
its approved indication for use, is neither experimental nor investigational,"
concluded Mr. Cummins. "Studies under an Investigational Device Exemption are
done to demonstrate the safety and effectiveness of devices for a proposed
indication for use. We have no plans and there are no FDA requirements for
Cyberonics to conduct further depression studies of VNS Therapy as an
investigational device for its approved indication. Consistent with the
post-market requirements of the majority of device approvals over the past five
years, Cyberonics is required by FDA to conduct post-market studies. In our
case, we originally planned, and were subsequently required by FDA's approval
order, to conduct a dosing study and long-term patient outcome registry to
elucidate the optimal dosing, predictors of response and long-term outcomes of
patients treated with post-approval VNS Therapy. Similar to our track record in
epilepsy, Cyberonics' post-approval TRD development plan goes well beyond the
FDA approval requirements and includes mechanism of action research and several
clinical studies all within the TRD approved indication for use. The purpose of
these post-approval studies is to facilitate fully-informed use of VNS Therapy
for the approved indication consistent with our mission to improve the lives of
people touched by TRD."
ABOUT VNS THERAPY AND CYBERONICS
Cyberonics, Inc. was founded in 1987 to design, develop and
market medical devices for the long-term treatment of epilepsy, depression and
other chronic treatment-resistant disorders using a unique therapy, vagus nerve
stimulation (VNS). Stimulation is delivered by the VNS Therapy System(TM), an
implantable generator similar to a cardiac pacemaker. The VNS Therapy System
delivers preprogrammed intermittent mild electrical pulses to the vagus nerve in
the patient's neck 24 hours a day. The Company's initial market was epilepsy, a
disorder characterized by recurrent seizures. Epilepsy is the second most
prevalent neurological disorder. The Cyberonics VNS Therapy System was approved
by the FDA on July 16, 1997 for use as an adjunctive therapy in reducing the
frequency of seizures in adults and adolescents over 12 years of age with
partial onset seizures that are refractory to antiepileptic medications. The VNS
Therapy System is also approved for sale as a treatment for epilepsy in all the
European Economic Area, Canada, Australia and other markets. To date, more than
32,000 epilepsy patients in 24 countries have accumulated over 94,000 patient
years of experience using VNS Therapy.
The VNS Therapy System was approved by the FDA on July 15, 2005
"as an adjunctive long-term treatment for chronic or recurrent depression for
patients 18 years of age and older who are experiencing a major depressive
episode and have not had an adequate response to four or more adequate
antidepressant treatments." As part of FDA's approval order, Cyberonics is
required to conduct a 450- patient post-market dosing study and a 1,000-
patient, five-year patient outcome registry. For more information on VNS Therapy
for treatment-resistant depression, including the contraindications, warnings
and precautions, see the Physician's and Patient's Manuals and other information
at http://www.cyberonics.com or http://www.vnstherapy.com or call 1-877-NOW 4 VNS
FREE
The VNS Therapy System has been approved for sale in the
European Economic Area and in Canada as a treatment for depression in patients
with treatment- resistant or treatment-intolerant major depressive episodes,
including unipolar depression and bipolar disorder (manic depression) since
2001.
VNS Therapy is at various levels of investigational clinical
study as a potential treatment for anxiety disorders, Alzheimer's disease,
chronic headache/migraine and bulimia. The Company is headquartered in Houston,
Texas and has an office in Brussels, Belgium. For additional information please
visit us at http://www.cyberonics.com .
SAFE HARBOR STATEMENT
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as amended and Section
21E of the Securities Exchange Act of 1934, as amended. These statements can be
identified by the use of forward-looking terminology,
including "may," "believe," "will," "expect," "anticipate," "estimate," "plan,"
"intend," and "forecast," or other similar words. Statements contained in this
press release are based upon information presently available to us and
assumptions that we believe to be reasonable. We are not assuming any duty to
update this information should those facts change or should we no longer believe
the assumptions to be reasonable. Investors are cautioned that all such
statements involve risks and uncertainties, including without limitation,
statements concerning epilepsy patients maintaining universal access to VNS
Therapy, TRD patients gaining access to VNS Therapy through case-by-case
approvals or national coverage policies, TRD patients gaining similar insurance
coverage for VNS Therapy services as Americans with epilepsy and/or Cyberonics'
funding or completing post-approval TRD studies. Our actual results may differ
materially. For a detailed discussion of these and other cautionary statements,
please refer to Cyberonics' most recent filings with the SEC, including its Form
10-K for the fiscal year ended April 29, 2005
Source: Cyberonics, Inc.
Document published January 18,
2006
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