-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, QI8TjXv94uavJTbn2Bb2BSBKggK5ZW61Gcs69tFNGA+UEj2T+tMo06qgDnnF2Z3a 0pRxgIx1oVqJD2DYRntbyA== 0001001277-06-000025.txt : 20060117 0001001277-06-000025.hdr.sgml : 20060116 20060117171744 ACCESSION NUMBER: 0001001277-06-000025 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060117 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060117 DATE AS OF CHANGE: 20060117 FILER: COMPANY DATA: COMPANY CONFORMED NAME: THERMOGENESIS CORP CENTRAL INDEX KEY: 0000811212 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY APPARATUS & FURNITURE [3821] IRS NUMBER: 943018487 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 333-82900 FILM NUMBER: 06533745 BUSINESS ADDRESS: STREET 1: 2711 CITRUS ROAD CITY: RANCHO CORDOVA STATE: CA ZIP: 95742 BUSINESS PHONE: 9168585100 MAIL ADDRESS: STREET 1: 2711 CITRUS ROAD CITY: RANCHO CORDOVA STATE: CA ZIP: 95742 FORMER COMPANY: FORMER CONFORMED NAME: INSTA COOL INC OF NORTH AMERICA DATE OF NAME CHANGE: 19920703 8-K 1 for011706.txt 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 --------- -------- ---------- (State or other jurisdiction of (Commission File Number) (I.R.S. Employer incorporation or organization) Identification No.) 2711 Citrus Road Rancho Cordova, California 95742 -------------------------------- (Address and telephone number of principal executive offices) (Zip Code) (916) 858-5100 -------------- (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 - ------------------------ 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 - --------------------------------------------- Item 9.01 Financial Statements and Exhibits. Exhibit No. Exhibit Description ----------- ------------------- 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 ------------------------------------ Matthew Plavan, Chief Financial Officer EXHIBIT INDEX Exhibit No. Description ----------- ----------- 99 Press Release dated January 3, 2006 titled "Thermogenesis Corp. Files PMA to Market CryoSeal(R) Fibrin Sealant (FS) in Liver Resection Surgeries" EX-99 2 exh99.txt EXHIBIT 99 THERMOGENESIS LOGO THERMOGENESIS CORP. FILES PMA TO MARKET CRYOSEAL(R) FIBRIN SEALANT (FS) IN LIVER RESECTION SURGERIES - CryoSeal would be the First Autologous Fibrin Sealant - - Potential FDA Approval Expected Late 2006 - RANCHO CORDOVA, California (January 3, 2006) - ThermoGenesis Corp (NASDAQ: KOOL) announced today that the Center for Biologics Evaluation and Research (CBER) notified the Company that it was reviewing the Company's pre-market application (PMA) for CryoSeal FS. The PMA submission was based on clinical results from a Phase III trial evaluating the safety and efficacy of CryoSeal FS as an adjunct to hemostasis in liver resection surgery against a control, Instat, a collagen absorbable hemostat. The multi-center randomized and blinded clinical trial of 150 cancer patients showed that CryoSeal FS demonstrated superiority to the Instat control by causing statistically significant quicker time to hemostasis (cessation of bleeding) versus the control group (p-value= <0.001). If approved, CryoSeal would be the only fibrin sealant produced from the patient's own blood (autologous) on the market and an alternative to conventional fibrin sealants derived from bovine tissue and pooled human bloods which are currently used in a wide range of surgeries. Kevin Simpson, President and COO commented, "This first PMA filing is a pivotal milestone signaling our transition from an R&D and clinical stage company to an operation with recurring disposable revenues. Following regulatory approval, the CryoSeal FS System would provide the first `all-autologous' fibrin sealant product to be marketed in the United States and Japan where our distribution partner, Asahi Kasei Medical, filed documentation earlier this year to enable marketing approval." Japan, at $145 million/year, and the United States, at $116 million/year, are the two largest fibrin sealant markets in a worldwide market estimated at over $450 million/year. Regulatory Status - ----------------- ThermoGenesis Corp. has been granted the right to affix the CE Mark to the CryoSeal FS System by our European Notified Body. The product is being tested in clinical trials in Europe. Additional field trials are underway in Canada and Brazil. In Japan, the pivotal clinical trial was completed in late 2004 and the PMA was assembled in March 2005. Sales in the United States will follow FDA approval of the CryoSeal FS PMA which is expected in late CY 2006. About ThermoGenesis Corp. - ------------------------- ThermoGenesis Corp. is a leader in enabling technologies for cell therapeutics. The Company's technology platforms lead the world in their ability to produce biological products from single units of blood. o The BioArchive(R) System, now distributed by GE Healthcare, is an automated robotic cryogenic device, is used by major cord blood stem cell banks in 26 countries as a key enabling technology for cryopreserving and archiving stem cell units for transplant. o The AutoXpress(TM) System, currently undergoing Alpha testing, is a semi-automated robotic device and companion sterile closed blood processing disposable, to harvest stem cells from cord blood. Market launch by GE Healthcare is expected in 1Q CY2006. o The CryoSeal FS System, a semi-automated device and companion sterile blood processing disposable, is used to prepare hemostatic and adhesive surgical sealants from the patient's blood in about an hour. Enrollment in a 150 patient United States and 72 patient Japan pivotal clinical trials have been completed and the PMAs are under review by the United States FDA and the Japanese MHLW. o The Thrombin Processing Device (TPD(TM)) is a sterile blood processing disposable that prepares activated thrombin from a small aliquot of patient blood, or blood plasma in 25 minutes. The TPD market launch by Medtronic and Biomet is underway in Europe. The statements contained in this release which are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, including, but not limited to, certain delays beyond the Company's control with respect to market acceptance of new technologies and products, delays in testing and evaluation of products, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. For More Information, Contact: ThermoGenesis Corp. Philip H. Coelho: (916) 858-5100 Or Fern Lazar (212) 867-1762 or visit the web site at www.thermogenesis.com -----END PRIVACY-ENHANCED MESSAGE-----