UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): November 24, 2004
THERMOGENESIS CORP.
(Exact name of registrant as specified in its charter)
Delaware 0-16375 94-3018487
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(State or other jurisdiction of (Commission (I.R.S. Employer
incorporation or organization) File Number) Identification No.)
2711 Citrus Road
Rancho Cordova, California 95742
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(Address and telephone number of principal executive offices) (Zip Code)
(916) 858-5100
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(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))
Section 8 - Other Events
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Item 8.01 Other Events.
On November 24, 2004, ThermoGenesis Corp. (the "Company") provided update
on a press release on its Thrombin Processing Device ("TPD") and DAC System for
the semi-automated separation of whole blood. The FDA determined that the TPD is
not substantially equivalent to devices marketed in interstate commerce prior to
May 28, 1976 or to any device which has been reclassified into Class I or Class
II and therefore, the TPD has been classified by statute into Class III
(Pre-Market Approval ("PMA")). The FDA has reviewed the DAC System 510(k)
submission for the semi-automated separation of whole blood and freezing of
blood components and requires additional information to complete its
determination of substantial equivalency to devices marketed in interstate
commerce. ThermoGenesis has recently provided additional information for the
FDA's review. Additional information can be found on the press release attached
as Exhibit 99.
Section 9 - Financial Statements and Exhibits
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Item 9.01 Financial Statements and Exhibits.
Exhibit No. Exhibit Description
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99 Press Release Updating Regulatory Clearance Status
for Autologous Thrombin Processing Device (TPD(TM))
and the DAC(TM) System
SIGNATURE
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 hereunto duly authorized.
THERMOGENESIS CORP.,
a Delaware Corporation
Dated: November 29, 2004 /s/ Renee M. Ruecker
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Renee Ruecker,
Chief Financial Officer
EXHIBIT INDEX
Exhibit No. Description
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99 Press Release dated November 24, 2004 titled
"Thermogenesis Updates Regulatory Clearance Status
for Autologous Thrombin Processing Device (TPD(TM))
and the DAC(TM) System "