SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) January 3, 1997
Mediscience Technology Corporation
(Exact name of Registrant as specified in its Charter)
New Jersey 0-7405 22-1937826
- --------------------------------------------------------------------------------
(State or other (Commission File Number) (IRS Employer
jurisdiction of Identification
incorporation) Number)
1235 Folkestone Way, Cherry Hill, New Jersey 08034
- --------------------------------------------------------------------------------
(Address of principal executive offices) (Zip Code)
(609) 428-7952
- --------------------------------------------------------------------------------
Registrant's telephone number, including area code
N/A
- --------------------------------------------------------------------------------
(Former name or former address, if changed since last report)
<PAGE>
Item 5. Other Materially Important Events
In a letter dated January 3, 1997 from the U.S. Food and Drug
Administration (FDA), Registrant, Mediscience Technology Corp. (OTC: MDSC), was
notified that the FDA approved its Investigational Device Exemption (IDE)
application to initiate phase II clinical trials with its CD Scan medical device
for early stage detection of cancer. Attached hereto and made a part hereof as
exhibit A, is the three page letter from the FDA.
<PAGE>
[GRAPHIC-LOGO}
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
Mr. Herbert L. Hugill
President and CEO
Mediscience Technology Corp.
160 Turtle Creek Circle
Oldsmar, Florida 34677
RE: G960245
CD-Scan(TM)for early stage, minimally invasive
detection of aerodigestive cancer
Dated: December 5, 1996
Received: December 6, 1996
HCFA Reimbursement Category : B2
G960245/A001 G960245/A002-A004
Dated: December 12, 1996 Dated: December 18, 1996
Received: December 19, 1996 Received: December 19, 1996
G960245/A005 G960245/A006-A007
Dated: December 20, 1996 Dated: December 23, 1996
Received: December 27, 1996 Received: December 27, 1996
Dear Mr. Hugill:
The food and Drug Administration (FDA) has reviewed your investigational device
exemptions (IDE) application. Your application is conditionally approved, and
you may begin your investigation, using a revised informed consent document
which corrects deficiency number one, at Memorial Sloan-Kettering Cancer Center,
New York, New York, where you have obtained institutional review board (IRB)
approval and submitted certification of IRB approval to FDA. Your investigation
is limited to one institution and 47 subjects.
This approval is being granted on the condition that, within 45 days from the
date of this letter, you submit information correcting the following
deficiencies.
1. Please revise the informed consent statement to reflect the present
state of knowledge with regard to the safety of the device. There is no
conclusive scientific basis to support the connection that the UV
radiation levels used with the device are not carcinogenic for
compromised tissues. The informed consent statement should be amended
as follows:
"Although preliminary tests conducted on animal and human subjects have
not revealed any adverse effects, the safety of long term exposure to
ultraviolet light itself and ultraviolet light combined with 13-cis
retinoic acid on the lining of the mouth have not been definitively
established."
2. Your protocol indicates that some of the subjects will be replaced
if subsequent clinical and histopathological evaluation disqualify the
subjects for randomization to drug treatment. The protocol does not
appear to provide follow-up patients who are replaced.
<PAGE>
Page 2 - Mr. Herbert Hugill
Please review the protocol to provide follow-up of patients who are
disqualified for randomization. Until the safety of ultraviolet
radiation exposure is established we believe all patients subjected to
UV scans with the CD-Scan(TM) device should be followed for the same
one-year period provided for the randomized subjects.
3. We were unable to find a discussion or analysis in your submission
to document the accuracy of the data provided on the optical radiation
emissions from the device. Please provide an analysis of the sources of
measurement error along with a statement of the total uncertainty in
the data.
4. You state that the probe of the device will be disinfected by
immersion in a 2.4% glutaraldehyde solution for 30 minutes prior to
application and following each use. This process will be preceded by
removing the stainless steel encasement from the optical fiber and
physically cleaning with alcohol soaked swabs. The process will be
followed by rinsing the disinfectant from the probe in sterile water
for one minute.
Please provide a set of written instructions for the user describing
the disinfection process. The instructions should contain a detailed
description of how the device is wiped of any visible debris,
disassembled, an enzymatic detergent soak (for the appropriate length
of time), a mechanical cleaning step using an enzymatic detergent, a
risne step, the glutaraldehyde soak (for the appropriate length of
time), a final rinse step, and finally, reassembly.
5. Please change the third sentence in the "Right to Refuse or
Withdraw" section of the Consent Form to read, "If you decide not to
participate, the choice of further therapy or observation only is
available to you without prejudice." We do not believe the meaning of
the current statement will be clear to the patient.
6. Your submission does not identify the two-component heat-cured epoxy
used to seal the probe fibers inside the stainless steel ferrule.
Please provide the chemical composition of the epoxy and submit
evidence that the material, in its cured state, has been tested for
cytotoxicity, sensitization, and irritation. We require this testing to
deomonstrate the biocompatibility of materials used in mucosal
tissue-contacting devices.
This information should be identified as an IDE supplement referencing the IDE
number above, and must be submitted in triplicate to:
IDE Document Main Center (HFZ-401)
Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
If you do not provide this information within 45 days from the date of this
letter, we may take steps to propose withdrawal of apporoval of your IDE
application.
<PAGE>
Page 3 - Mr. Herbert Hugill
We would like to point out that FDA approval of your IDE application does not
imply that this investigation will develop sufficient safety and effectiveness
data to assure FDA approval of a premarket approval (PMA) application for this
device. You may obtain the guideline for the preparation of a PMA application,
entitled "Premarket Approval (PMA) Manual," from the Division of Small
Manufacturers Assistance at its toll-free number (800) 638-2041 or (301)
443-6597.
We do not believe the proposed feasibility study will provide sufficient data to
support a PMA. The data and information provided in your IDE application does
not conclusively or definitely establish safety with regard to exposure of
compromised tissue to ultraviolet (UV) radiation emissions from the device. You
have indicated an intent to follow this study with a pivotal clinical trial. For
approval of a future pivotal study, we will require the completion of an animal
study that clearly demonstrates the safety of UV exposure on compromised tissue.
We also believe a study of human subjects, with a follow-up of at least 3 years,
and a concurrent control of high risk, non-UV exposed subjects, is needed to
document the safety of the device.
We have enclosed the guidance document entitled "Sponsor's Responsibilities for
a Significant Risk Device Investigation" to help you understand the functions
and duties of a sponsor. Also enclosed is the guidance document "Investigators'
Responsibilities for a Significanat Risk Device Investigation" which you should
provide to participatiang investigators.
If you have any questions, please contact J.Edward Warren at (301) 594-2080.
Sincerely yours,
/s/Lillian Yin, Ph.D.
---------------------
Lillian Yin, Ph.D.
Director, Division of Reproductive,
Abdominal, Ear, Nose and Throat,
and Radiological Devices
Offfice of Device Evaluation
Center for Devices and Radiological Health
Enclosures
(1) Sponsors Responsibilities for a Significant Risk Device Investigation
(2) Investigator's Responsibilities for a Significant Risk Device Investigation
