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): January 16, 2006
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 File Number) (I.R.S. Employer
incorporation or organization) 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 January 3, 2006, ThermoGenesis Corp. (the "Company") announced that the
Center for Biologics Evaluation and Research ("CBER") notified the Company that
it was reviewing the Company's pre-market application ("PMA") for its CryoSeal
FS System ("CryoSeal"). The PMA submission was based on clinical results from a
Phase III trial evaluating the safety and efficacy of CryoSeal as an adjunct to
hemostasis in liver resection surgery against the control, INSTAT(R), a collagen
absorbable hemostat. If approved, CryoSeal would be the only fibrin sealant on
the market that is produced from the patient's own blood, and an alternative to
conventional fibrin sealants that are derived from bovine tissue or pooled human
blood.
Although CBER acknowledged that it was reviewing the Company's PMA for
CryoSeal, no assurance can be given that CBER will not require further testing
and clinical data, or that CryoSeal will ultimately be approved by the FDA to be
marketed in the United States. If further testing and clinical studies are
required, there can be no assurance that the clinical studies can be
successfully completed within the Company's expected time frame and budget, or
that such studies will provide required findings for approval. If the Company is
unable to receive FDA approval for CryoSeal, the Company's business, financial
condition and results of operations could be adversely affected.
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 dated January 3, 2006 titled "Thermogenesis
Corp. Files PMA to Market CryoSeal(R) Fibrin Sealant (FS) in
Liver Resection Surgeries"
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: January 16, 2006 /s/ Matthew Plavan
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Matthew Plavan,
Chief Financial Officer
EXHIBIT INDEX
Exhibit No. Description
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99 Press Release dated January 3, 2006 titled "Thermogenesis
Corp. Files PMA to Market CryoSeal(R) Fibrin Sealant (FS) in
Liver Resection Surgeries"