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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20459
FORM 10-Q
Quarterly Report Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
For The Quarterly Period Ended September 28, 1997 Commission File Number 0-18170
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CRYOMEDICAL SCIENCES, INC.
--------------------------
(Exact name of registrant as specified in its charter)
Delaware 94-3076866
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(State of Incorporation) (IRS Employer I.D. Number)
1300 Piccard Drive
Suite L105
Rockville, Maryland 20850
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(Address of principal executive offices)
Registrant's telephone number, including area code (301) 417-7070
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Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes X No
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33,395,643 shares of Cryomedical Sciences, Inc. Common Stock, par value $.001
per share, were outstanding as of October 31, 1997.
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CRYOMEDICAL SCIENCES, INC.
FORM 10-Q
QUARTER ENDED SEPTEMBER 28, 1997
INDEX
Part I. Financial Information Page No.
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Item 1. Financial Statements
Consolidated Balance Sheets at
September 28, 1997 (unaudited)
and December 29, 1996 3
Consolidated Statements of
Operations for the three months and nine
months ended September 28, 1997 and
September 30, 1996 (unaudited) 4
Consolidated Statements of
Cash Flows for the nine months
ended September 28, 1997 and
September 30, 1996 (unaudited) 5
Notes to Financial Statements 6-8
Item 2. Management's Discussion and
Analysis of Financial Condition
and Results of Operations 9-11
Part II. Other Information
Item 1. Legal Proceedings 12
Item 6. Exhibits and Reports on Form 8-K 13
Signatures 14
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CRYOMEDICAL SCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
September 28, December 29,
1997 1996
(unaudited)
ASSETS
Current assets
Cash and cash equivalents $ 241,967 $ 1,769,243
Short term investments 110,150 110,150
Receivables, net allowance for doubtful accounts 1,005,793 1,374,814
of $250,173 and $246,908
Inventories 1,768,258 1,691,301
Prepaid expenses and other current assets 204,318 66,395
-------------------- --------------------
Total current assets 3,330,486 5,011,903
Fixed assets, net accumulated depreciation and amortization 970,420 1,014,114
of $1,944,359 and $1,625,635
Other assets 18,727 18,727
-------------------- --------------------
Total assets $ 4,319,633 $ 6,044,744
==================== ====================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable $ 306,368 $ 360,659
Accrued expenses 532,296 805,074
Unearned revenues 151,581 154,210
Warranty reserves 31,800 97,600
Extended warranties - current portion 86,787 420,350
Capital leases - current portion 13,709 9,706
-------------------- --------------------
Total current liabilities 1,122,541 1,847,599
-------------------- --------------------
Extended warranties, net of current portion 83,238 97,338
Capital leases, net of current portion 46,679 -
Deferred rent 33,381 105,524
-------------------- --------------------
Total liabilities 1,285,839 2,050,461
-------------------- --------------------
Stockholders' equity
Preferred stock, $.001 par value per share,
9,378,800 authorized; no shares issued - -
Common stock, par value $.001 per share,
50,000,000 shares authorized; 33,395,643 and
27,849,745 issued and outstanding, respectively 33,396 27,850
Additional paid-in capital 30,534,210 30,483,765
Unearned compensation (39,525) (22,588)
Accumulated deficit (27,494,287) (26,494,744)
-------------------- --------------------
Total stockholders' equity 3,033,794 3,994,283
-------------------- --------------------
Total liabilities and stockholders' equity $ 4,319,633 $ 6,044,744
==================== ====================
The accompanying notes are an integral part of these financial statements.
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CRYOMEDICAL SCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
Three months ended Nine months ended
September 28, September 30, September 28, September 30,
-------------------------------------- ----------------------------------------
1997 1996 1997 1996
---- ---- ---- ----
(unaudited) (unaudited)
Revenues $ 691,948 $ 954,106 $ 2,539,258 $ 4,115,906
Cost of sales 412,958 471,787 1,418,144 2,596,233
--------------- --------------- ---------------- ----------------
Gross profit 278,990 482,319 1,121,114 1,519,673
Expenses
Research and development 187,759 258,958 782,177 1,037,095
Sales and marketing 171,102 274,642 620,209 1,447,842
General and administrative 179,013 300,699 781,596 1,793,393
--------------- --------------- ---------------- ----------------
Total expenses 537,874 834,299 2,183,982 4,278,330
--------------- --------------- ---------------- ----------------
Operating loss (258,884) (351,980) (1,062,868) (2,758,657)
Interest income, net of interest expense (12,868) 2,275 63,325 8,202
--------------- --------------- ---------------- ----------------
Net loss $ (271,752) $ (349,705) $ (999,543) $ (2,750,455)
=============== =============== ================ ================
Net loss per common share $ (0.01) $ (0.01) $ (0.03) $ (0.11)
=============== =============== ================ ================
Weighted average number
of common shares outstanding 33,395,643 26,674,501 33,090,589 25,277,944
=============== =============== ================ ================
The accompanying notes are an integral part of these financial statements.
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CRYOMEDICAL SCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
Nine months ended
September 28, September 30,
---------------- ----------------
1997 1996
---- ----
(unaudited)
Cash flows from operating activities:
Net loss $ (999,543) $ (2,750,455)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 318,724 284,209
Loss on disposal of fixed assets - 31,847
Changes in operating assets and liabilities:
Decrease in receivables 369,021 349,014
(Increase) decrease in inventories (76,957) 428,936
(Increase) decrease in prepaid and other current assets (137,923) 125,279
Decrease in accounts payable (54,291) (121,471)
Decrease in accrued expenses (272,778) (31,103)
(Decrease) increase in unearned revenue (2,629) 69,674
Decrease in warranty reserves (65,800) (88,800)
Decrease in extended warranties (347,663) (660,125)
Increase (decrease) in capital leases 50,682 (24,792)
(Decrease) increase in deferred rent (72,143) 142,929
---------------- ----------------
Net cash used in operating activities (1,291,300) (2,244,858)
---------------- ----------------
Cash flows from investing activities:
Reinvestment of short term investments (4,761)
Purchase of equipment (275,030) (127,543)
---------------- ----------------
Net cash used in investing activities (275,030) (132,304)
---------------- ----------------
Cash flows from financing activities:
Proceeds from issuance of preferred stock - 1,959,935
Issuance of shares for employee stock purchase plan 12,991 32,198
Issuance of common stock - 1,910,000
Exercise of employee stock options - 282,204
Increase in unearned compensation (16,937) -
Issuance of warrants 43,000 -
Increase in notes receivable from officers - (1,407)
---------------- ----------------
Net cash provided by financing activities 39,054 4,182,930
---------------- ----------------
Net (decrease) increase in cash and cash equivalents (1,527,276) 1,805,768
Cash and cash equivalents at beginning of period 1,769,243 728,040
---------------- ----------------
Cash and cash equivalents at end of period $ 241,967 $ 2,533,808
================ ================
The accompanying notes are an integral part of these financial statements.
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CRYOMEDICAL SCIENCES, INC. AND SUBSIDIARY
NOTES TO FINANCIAL STATEMENTS
A. GENERAL
Cryomedical Sciences, Inc. (the "Company") is engaged in the
research, development, marketing and manufacture of products
for use in the field of low-temperature medicine.
The Consolidated Balance Sheet as of September 28, 1997, the
Consolidated Statements of Operations for the three and nine month
periods ended September 28, 1997 and September 30, 1996, and the
Consolidated Statements of Cash Flows for the nine month periods ended
September 28, 1997 and September 30, 1996, have been prepared without
audit. In the opinion of management, all adjustments necessary to
present fairly the financial position, results of operations, and cash
flows at September 28, 1997, and for all periods then ended, have been
recorded. All adjustments recorded were of a normal recurring nature.
Certain information and footnote disclosures normally included in
financial statements prepared in accordance with generally accepted
accounting principles have been condensed or omitted. It is suggested
that these consolidated financial statements be read in conjunction
with the financial statements and notes thereto for the six-month
transition period ended December 29, 1996 included in the Company's
Annual Report on Form 10-KT for the six-month transition period ended
December 29, 1996.
The results of operations for the three and nine month periods ended
September 28, 1997 are not necessarily indicative of the operating
results anticipated for the full year.
B. NET LOSS PER SHARE
Net loss per share is based on the weighted average number of common
shares outstanding during the three and nine month periods ended
September 28, 1997 and September 30, 1996. No effect has been given to
unexercised stock options or warrants because the effect would be
antidilutive.
C. INVENTORIES
Inventories consist of the following:
September 28, 1997 December 29, 1996
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Raw materials and purchased parts $ 846,308 $ 1,068,645
Work in process 389,337 216,254
Finished goods 711,992 586,402
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1,947,637 1,871,301
Less reserves (179,379) (180,000)
----------- ------------
$ 1,768,258 $ 1,691,301
=========== ============
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CRYOMEDICAL SCIENCES, INC. AND SUBSIDIARY
NOTES TO FINANCIAL STATEMENTS
D. CONTINGENCIES
In November 1996, the Company filed suit against EndoCare, Inc.
("EndoCare") and ZhoaHua Chang in the Circuit Court for Montgomery
County, Maryland (Case No. 161496). The lawsuit alleges, among other
things, that EndoCare misappropriated trade secrets of the Company, and
that EndoCare tortiously interfered with the Company's contracts, its
relationships with employees, and the Company's contractual and
potential business relationships with customers. The lawsuit, which
contains six counts, also alleges that Dr. Chang and EndoCare engaged
in unfair competition against the Company and civil conspiracy, and
that Dr. Chang, who was formerly employed as a Vice President of
Cryosurgical Engineering by the Company, breached contractual and
fiduciary obligations owed to the Company by his employment by
EndoCare, his retention and misuse of the Company's confidential
information, and his improper solicitation of the Company's employees
to disclose trade secret information and/or to become employed by
EndoCare. The Company has asserted that by accepting employment with
EndoCare, Dr. Chang violated the covenant not to compete contained in
his employment agreement with the Company. In an Order dated April 3,
1997, the Circuit Court of Montgomery County, Maryland ordered a
hearing on the Company's motion seeking a preliminary injunction to
enforce the covenant not to compete contained in the employment
agreement between the Company and Dr. Chang. In the hearing which
occurred on July 2, 1997, the Court issued a preliminary injunction
against EndoCare, Inc.'s Vice President of Research and Development,
Dr. Chang, and ordered Dr. Chang to terminate his employment with
EndoCare in any capacity, or any other entity in the research,
development, production, marketing, sale or distribution of
cryosurgical equipment in the United States, Canada, Europe and Taiwan,
pending a full trial on the merits of the Company's lawsuit against
EndoCare and Dr. Chang. On September 23, 1997, upon Dr. Chang's motion
to dissolve or modify the Preliminary Injunction, the Circuit Court
issued a bench ruling modifying the Preliminary Injunction against Dr.
Chang. Although the Court has not yet issued a formal written Order,
the Court stated that it would allow Dr. Chang to provide outside
consulting services for EndoCare solely in connection with EndoCare's
stent project as long as several safeguards are in place that would
isolate Dr. Chang from EndoCare's cryosurgical activities. On October
17, 1997, EndoCare filed a Motion for Summary Judgment with the Court
seeking the dismissal of the Company's claims against EndoCare. On
November 3, 1997, the parties agreed to stay all proceedings pending
the results of mediation efforts. The Company is currently seeking
compensatory damages of $10,000,000 and punitive damages of $20,000,000
in the lawsuit.
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CRYOMEDICAL SCIENCES, INC. AND SUBSIDIARY
NOTES TO FINANCIAL STATEMENTS
On June 2, 1997, the Company received notice that Concept Group, Inc.
("Concept"), a vendor of the Company, had filed suit against the
Company in the U. S. District Court for the Eastern District of
Pennsylvania, Civil Action No. 97-W-3803. Concept alleges, among other
things, that on or about January 1995, the Company filed a patent
application constituting a breach in the Development Agreement between
Concept and the Company. The lawsuit, which contains seven counts,
seeking approximately $3,000,000, alleges the patent application filing
by the Company demonstrated a theft of proprietary information from
Concept. Lastly, Concept alleges that shortly after January 1994 the
Defendant embarked on a fraudulent scheme to place and cancel orders in
an effort to financially ruin Concept and force early termination of
the Development Agreement. The defendant has admitted no liability,
believe the suits are completely without merit and will continue to
defend the Company's position vigorously.
E. NEW ACCOUNTING PRONOUNCEMENTS
Statement of Financial Accounting Standards (SFAS) No. 128 "Earnings
Per Share," was recently issued by the Financial Accounting Standards
Board. SFAS No. 128 is effective for periods ending after December 15,
1997 and early adoption is not permitted.
SFAS No. 128 requires the company to compute and present a basic and
diluted earnings per share. Had the Company computed net loss per share
in accordance with SFAS No. 128 for the three and nine months ended
September 28, 1997, there would be no difference in the reported net
loss per share.
In June 1997, Statement of Financial Accounting Standard No. 130,
"Reporting Comprehensive Income" was issued, which is effective for
fiscal years beginning after December 15, 1997. The Company will comply
with all requirements no later than fiscal 1998.
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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
The Company's business activities focus primarily on the manufacturing
and marketing related to its cryosurgical systems. The AccuProbe(R) 450 was
cleared by the FDA in April 1991, the AccuProbe(R) 530 and 550 were cleared in
December 1995, the AccuProbe(R) 600 series was cleared in March 1997 and the
Cryo-lite(R) series was cleared in July 1997. The Company plans to continue to
market these systems in the various fields for which they received clearance
from the FDA. The Company has a pending FDA 510(k) application to expand its
indications for use (labeling) for the AccuProbe(R) system family.
The Company is presently in the process of seeking funds for the
purpose of commercializing its Hypothermosol(R) series of preservation
solutions. Although the Company has contacted a number of parties who have
expressed an interest in potentially providing such funding, there can be no
assurance that such funding will be obtained.
RESULTS OF OPERATIONS
Revenues for the three and nine months ended September 28, 1997 totaled
$691,948 and $2,539,258, respectively, compared to $954,106 and $4,115,906,
respectively, for the comparable periods of the prior year, representing
decreases of 27% and 38%, respectively. The decrease in revenues in the three
and nine months ended September 28, 1997 reflect a decline in the number of
AccuProbe Systems and accessories sold. The Company believes this decline is
due primarily to lack of formal Medicare reimbursement for urologic
cryosurgery. The Company hopes that the FDA clearance of the CMS AccuProbe 600
series and the Cryo-lite(R) series hand-held cryosurgical products will increase
system, disposable probe and other accessory revenue from current levels,
although there can be no assurance in this regard. Through September 28, 1997,
the Company has placed a total of 154 AccuProbe Systems since the product was
introduced in June 1992.
Gross profit for all products for the three months ended September 28,
1997 totaled $278,990, or 40% of sales, compared to gross profit of $482,319,
or 51% of sales, for the three months ended September 30, 1996. For the nine
months ended September 28, 1997, gross profit totaled $1,121,114, or 44% of
sales, compared to gross profits of $1,519,673, or 37% of sales, for the
comparable period of the prior year. Gross profit as a percent of sales changed
in the three and nine month periods ended September 28, 1997 compared to the
prior year due to changes in the mix of product sales.
Research and development expenses for the three months ended September
28, 1997 totaled $187,759, a decrease of 27% compared to $258,958 for the
comparable period of the prior year. Research and development expenses for the
nine months ended September 28,
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1997 totaled $782,177, a decrease of 25%, compared to $1,037,095 in the
comparable period of the prior year. Development expenses decreased due to
reduction in headcount, development of smaller, less expensive products and
reversal of reserves no longer deemed necessary.
Sales and marketing expenses for the three months ended September 28,
1997 totaled $171,102, a decrease of 38% compared to $274,642 for the
comparable period of the prior year. Sales and marketing expenses for the nine
months ended September 28, 1997 totaled $620,209, a decrease of 57%, compared
to $1,447,842 for the comparable period of the prior year. Sales and marketing
expenses decreased over the comparable period of the previous year due to
reduced headcount and the associated reduction in travel and related expenses.
General and administrative expenses for the three months ended
September 28, 1997 totaled $179,013, a decrease of 40% compared to $300,699 for
the comparable period of the prior year. General and administrative expenses
for the nine months ended September 28, 1997 totaled $781,596, a decrease of
56% compared to $1,793,393 for the comparable period of the prior year. General
and administrative expenses decreased due to reductions in headcount, insurance
premiums, the use of consultants and reversal of reserves no longer deemed
necessary.
Despite a reduction in revenues, operating expenses as a percentage of
revenues decreased 18 percentage points (from 104% to 86%) for the nine months
ended September 28, 1997 compared to the nine month period in the prior year.
The Company sustained net losses of $271,752 and $999,543, respectively, for
the three and nine months ended September 28, 1997 compared to net losses of
$349,705 and $2,750,455 in the comparable periods of the prior year.
Sales of the AccuProbe are increasingly affected by the level of
reimbursement by public and private insurers in connection with procedures in
which the AccuProbe is utilized. The availability of consistent, uniform
insurance reimbursement guidelines for hospitals and physicians is an important
factor often considered by some potential customers when making a decision
regarding the purchase of any new medical device, including the AccuProbe
System. Reimbursement of hospitals and urologists by public and private
insurers such as Medicare and Blue Cross and Blue Shield is a necessary part of
gaining general acceptance for use of the AccuProbe for urological cryosurgery.
Although no national payment guidelines for urological cryosurgery have been
established by Medicare's Health Care Financing Administration ("HCFA"), the
Company was advised in October 1996 that HCFA is planning to put into effect
its Technology Advisory Committee's recommendation that a national noncoverage
policy be adopted in regard to cryoablation of the prostate. It is the
Company's understanding that HCFA is exploring the possibility of working with
various agencies, including the American Urology Association, in establishing a
nationwide randomized prospective clinical study to collect data on a
comparative basis between cryosurgery and
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radiation therapies. The results of this study will provide the basis on which a
future determination regarding Medicare reimbursement will be made. When
insurance coverage is not available, patients may either elect to pay for
treatment themselves or undergo traditional therapies which are covered by their
insurers. Uncertainty and added efforts required for the Company's customers, or
potential customers, to secure payment has constrained sales and utilization of
AccuProbe systems to a large degree and may continue to do so until formal
national coverage guidelines are established.
LIQUIDITY AND CAPITAL RESOURCES
At September 28, 1997, the Company had cash, cash equivalents, and
short-term investments totaling $352,117 and working capital of $2,207,945, as
compared to $1,879,393 and $3,164,304, respectively, at December 29, 1996. The
Company's cash and working capital positions decreased from December 29, 1996
due primarily to purchases of equipment and the net loss of $999,543 sustained
by the Company in the nine months ended September 28, 1997.
Capital expenditures for leasehold improvements and equipment totaled
$275,030, including $135,426 in consignment and loaner AccuProbe Systems, in
the nine months ended September 28, 1997, compared to $56,252 and $0
respectively, in the comparable period of the prior year. The Company does not
expect to spend more than $600,000 in total for equipment in the year ending
December 28, 1997.
The Company expects to incur expenditures over the next 12 months
related to development, manufacturing and testing of its products and for sales
and marketing efforts and other operating expenses. The Company's management
assumes that sales for the remaining quarter in 1997 may be less than the level
experienced in comparable year ago periods and believes that its current cash
and working capital position, together with potential financing and possible
additional cost cutting, will be sufficient to fund the operations of the
Company for the next 12 months, dependent, in part, on the level of sales and
marketing activity engaged in by the Company, and the amounts of development
funded by the Company. However, the Company expects to continue to reduce
expenditures if necessary and to pursue various forms of short term financing
to supplement working capital during the next 12 months and possibly additional
equity financing. Except for the sale of its products, the Company currently
has no other major sources of liquidity and has no commitments with regard to
obtaining any additional funds.
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CRYOMEDICAL SCIENCES, INC.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
In November 1996 the Company filed suit against EndoCare, Inc.
("EndoCare") and ZhoaHua Chang in the Circuit Court for Montgomery
County, Maryland (Case No. 161496). The lawsuit alleges, among other
things, that EndoCare misappropriated trade secrets of the Company,
and that EndoCare tortiously interfered with the Company's contracts,
its relationships with employees, and the Company's contractual and
potential business relationships with customers. The lawsuit, which
contains six counts, also alleges that Dr. Chang and EndoCare engaged
in unfair competition against the Company and civil conspiracy, and
that Dr. Chang, who was formerly employed as a Vice President of
Cryosurgical Engineering by the Company, breached contractual and
fiduciary obligations owed to the Company by his employment by
EndoCare, his retention and misuse of the Company's confidential
information, and his improper solicitation of the Company's employees
to disclose trade secret information and/or to become employed by
EndoCare. The Company has asserted that by accepting employment with
EndoCare, Dr. Chang violated the covenant not to compete contained in
his employment agreement with the Company. In an Order dated April 3,
1997, the Circuit Court of Montgomery County, Maryland ordered a
hearing on the Company's motion seeking a preliminary injunction to
enforce the covenant not to compete contained in the employment
agreement between the Company and Dr. Chang. In the hearing which
occurred on July 2, 1997, the Court issued a preliminary injunction
against EndoCare, Inc.'s Vice President of Research and Development,
Dr. Chang, and ordered Dr. Chang to terminate his employment with
EndoCare in any capacity, or any other entity in the research,
development, production, marketing, sale or distribution of
cryosurgical equipment in the United States, Canada, Europe and
Taiwan, pending a full trial on the merits of the Company's lawsuit
against EndoCare and Dr. Chang. On September 23, 1997, upon Dr.
Chang's motion to dissolve or modify the Preliminary Injunction, the
Circuit Court issued a bench ruling modifying the Preliminary
Injunction against Dr. Chang. Although the Court has not yet issued a
formal written Order, the Court stated that it would allow Dr. Chang
to provide outside consulting services for EndoCare solely in
connection with EndoCare's stent project as long as several
safeguards are in place that would isolate Dr. Chang from EndoCare's
cryosurgical activities. On October 17, 1997, EndoCare filed a Motion
for Summary Judgment with the Court seeking the dismissal of the
Company's claims against EndoCare. On November 3, 1997, the parties
agreed to stay all proceedings pending the
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results of mediation efforts. The Company is currently seeking
compensatory damages of $10,000,000 and punitive damages of
$20,000,000 in the lawsuit.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
(27) Financial Data Schedule.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
Cryomedical Sciences, Inc.
-------------------------------------
(Registrant)
Date: November 13, 1997
-------------------------------------
Richard J. Reinhart, Ph.D.
President and Chief Executive Officer
(Principal Executive Officer and
Principal Financial Officer)
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