-----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, QaEgz3iL7xof9VsJMMuBzFb7yJ61b5v05/l3E9EalAI0ahGPnfL2VYNWfvIbEfl/ 5dD10hqb/PTjurXzEIJfwA== 0001193125-04-055520.txt : 20040401 0001193125-04-055520.hdr.sgml : 20040401 20040401141712 ACCESSION NUMBER: 0001193125-04-055520 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040401 ITEM INFORMATION: Other events FILED AS OF DATE: 20040401 FILER: COMPANY DATA: COMPANY CONFORMED NAME: RITA MEDICAL SYSTEMS INC CENTRAL INDEX KEY: 0001056421 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 943199149 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-30959 FILM NUMBER: 04709010 BUSINESS ADDRESS: STREET 1: 967 N SHORELINE BLVD CITY: MOUNTAIN VIEW STATE: CA ZIP: 94013 BUSINESS PHONE: 6503858500 MAIL ADDRESS: STREET 1: 967 NORTH SHORELINE BLVD CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 8-K 1 d8k.htm FORM 8-K Form 8-K

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

 

April 1, 2004

Date of Report

(Date of earliest event reported)

 


 

RITA Medical Systems, Inc.

(Exact name of registrant as specified in its charter)

 


 

Delaware

(State or other jurisdiction of incorporation)

 

000-30959   94-3199149
(Commission File Number)   (I.R.S. Employer Identification No.)

 

967 N. Shoreline Blvd.

Mountain View, CA 94043

(Address of principal executive offices, with zip code)

 

(650) 314-3400

(Registrant’s telephone number, including area code)

 



Item 5. Other Events and Required FD Disclosure.

 

On April 1, 2004, RITA Medical Systems, Inc., a Delaware corporation (“RITA”), announced that the results of a study into the use of radiofrequency ablation (RFA) to treat breast cancer have been published in the April issue of Radiology, the journal of the Radiology Society of North America. A copy of RITA’s press release announcing this release is attached as Exhibit 99.1 hereto and incorporated by reference herein.


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 hereunto duly authorized.

 

   

RITA Medical Systems, Inc.

Date: April 1, 2004

 

By:

 

/s/ Donald Stewart


       

Donald Stewart, Chief Financial Officer and

       

Vice President Finance and Administration


RITA MEDICAL SYSTEMS, INC.

 

INDEX TO EXHIBITS

 

Exhibit Number

 

Description


99.1   Press Release of RITA Medical Systems, Inc. dated April 1, 2004.
EX-99.1 3 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

LOGO

 

Contact:    Allen & Caron Inc.    RITA Medical Systems, Inc.
     Jill Bertotti (investors)    Don Stewart, Chief Financial Officer
     949-474-4300    Stephen Pedroff, Marketing Communications
     jill@allencaron.com    650-314-3400
     Surf Media Communications dstewart@ritamed.com
     Juliana Minsky (media)    spedroff@ritamed.com
     805-962-3700     
     jm@surfmedia.com     

 

PILOT STUDY OF RADIOFREQUENCY ABLATION OF BREAST TUMORS USING

RITA MEDICAL SYSTEMS PRODUCTS PUBLISHED IN RADIOLOGY

 

Study Concludes Ultrasound Guided Percutaneous Ablation of Small Invasive Breast

Carcinomas is Feasible and Safe

 

MOUNTAIN VIEW, CA (April 1, 2004) . . . RITA Medical Systems, Inc. (Nasdaq: RITA) today announced that the results of a study into the use of radiofrequency ablation (RFA) to treat breast cancer has been published in the April issue of Radiology, the journal of the Radiology Society of North America. The authors conclude that using real-time ultrasound guidance to ablate small invasive breast carcinomas is feasible and safe.

 

Bruno D. Fornage, MD, Professor of Radiology and Surgical Oncology at The University of Texas M. D. Anderson Cancer Center, Houston, Texas, and lead author of the article commented, “The use of RFA to treat breast cancer is a promising minimally invasive treatment in selected patients. The results of the study indicate the need for further investigation of whether or not RFA can be used satisfactorily as a replacement treatment for lumpectomy of small breast tumors.”

 

In the study 21 malignant lesions were ablated in 20 patients. In all 21 cases, the target lesion that was visualized by ultrasound was completely ablated. In one case residual microscopic disease was found to be present after the ablation. The article reports that there were no adverse patient events in the study.

 

Mr. Joseph DeVivo, President and CEO of RITA Medical Systems said, “We believe that radiofrequency ablation will continue to be applied to the treatment of cancer tumors wherever they occur in the body. We applaud Dr. Fornage and his colleagues for their efforts to identify additional treatment options for breast cancer.”


MORE-MORE-MORE

Page 2-2-2

 

An abstract of the findings of the study can be found on the company’s website, www.ritamedical.com, along with excerpts from recent press coverage of the release of the article. The article can also be found on The Radiology Society of North America website, www.rsna.org.

 

About RITA Medical Systems, Inc.

 

RITA Medical Systems develops, manufactures and markets innovative products for patients with solid cancerous or benign tumors. The proprietary RITA system uses radiofrequency energy to heat tissue to a high enough temperature to ablate it or cause cell death. While the Company’s current focus is on liver cancer and metastatic bone cancer, the Company believes that its minimally invasive technology may in the future be applied to other types of tumors, including tumors of the lung, breast, uterus, prostate and kidney. The Company has received regulatory clearance in major markets worldwide, including the United States. In March 2000, RITA became the first radiofrequency ablation company to receive specific FDA clearance for unresectable liver lesions in addition to its previous general FDA clearance for the ablation of soft tissue. In October 2002, RITA again became the first company to receive specific FDA clearance, this time, for the palliation of pain associated with metastatic lesions involving bone. The Company has sold nearly 60,000 of its disposable devices throughout the world.

 

The statements in this news release related to results of studies, the use of the Company’s technology, its expectations regarding doctors’ adoption of the technology, and its expectations regarding the extension of its technology to applications beyond liver cancer and metastatic bone cancer are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Information regarding these risks is included in the Company’s filings with the Securities and Exchange Commission.

 

# # # #

GRAPHIC 4 g54437image002.jpg GRAPHIC begin 644 g54437image002.jpg M_]C_X``02D9)1@`!`0$`8`!@``#__@`<4V]F='=AEOL.MIE"I MQU.8[-%3JRD.K/S8[:!)G1W#U2AU3G'UA:U$>W'JU[%]P5WY" MM&DI;=`[3RIU/HME*20A/>MP.0I-U59 MB,PR77%-R5;QX@`#)X<^?AJV?R#2D'L[IN5"L8WOE#/P*<:9*W;E_P!'CJEV M[=&L_2[XN^+,?CFY:@KL7%(WNV/'!QJVK"H53N*U8M8J=VUTNRMXAMB5N) M0`HCJ"2>&I^5M4>D%;[[KK4-@J6Z\K>6H)3DE1ZGAK.EN,WA>]RRE4JHS(P> M>4[(?2^M#;(42>.#[`!JWX^SF4A"1)O>XW5`><42]P$^`P<>_2A.ST!0)NZY MU#N^4.?_`$ZJ;:'5*Y:MVOTJG7)6%1VVT*!>F*4K)3D\>&I%LLBU"\X%0?JM MRUU*XSJ$(["H0W.TCR6PXVKP/\`'2K1HUDY^X%-/N)BTJF,$+.%>3!Q M7/O<*M?$5^Y*@XF-&FRU*5P2S$!1GP"4`:7+LZJ@B1<,^-24$9S/?R\1X-C* M_>!KXV;2@K2U&B3[@E$X3VG^SLD^"4Y6KWC7_]!H2U5*?"2Y7J@Q:4)T>93J M6P$S)`[L#SAGO6KV:E=O4Q%.+&Y3E4<3/Y"&E?:5*<.JG73_`"2.IQC'>.11 M[2]I8H\55MT%Q")@3N2GV3YK'>A)^MWGIZ^4'V0'.TJGDGB4N\_W:M:5T:HW M;_\`/5(^S+_%KCL"_P!Z*E]B_P`:=7QHUE[:>Q'C[1:PB,`$%T+('12D@J^) M.K,V!OR%VW4F%DEAJ4"WGH2D;P^`]^K5T:Q_5_GF=]H<_$=:1V4_1M2/V%_W MBM/%U4>1<%MS*3&EB(N4D(+I3O83D;PQXC(]NO=NV[3K8I#5,IK6XTCBI1]) MQ752CU)TZ:-9PVT?2-*_<-?A&IIL`^:*Q]H;_"=6WHU%;RL:+="HLYAT0ZK" M<2MB6$YY'.ZH=1W=WOU*NG'GJ!WS(O:MN-&)35-4J.OAV% M-:#.]X%0\Y7M)TMB6,\U'35+LJ**)$<\Y*7@5RG_`-EOG[3C3C2JP\].%&V< M4-4=YSS55!\!R4I/514?-:'J]^GF#'AVQ6$0J8!=%[25>=(62MF&KJKW943&IS)7CS MGI#APVT.JE*_[)U:5@NVK;]WQ+>HB4U6H.I6)=55Z*<))W&AW9'/XGI__]&Y M=&J-V_\`SU2/LR_Q:;]B-4I]*N.H.U"='B-KA[J5/NA`)WT\`3JZ'+SM=EO? M7<--">_RI!_CJ*W%MDH-/94Q1"NKSE<&TM((;!\3U]0S[-5;3-G]XWI57)TB M&Y'$IPN/2Y:2VG)/$@'B?4!J_;4MF':5!9I4(E81E3CJAQ=6>:C_`-\@-/.C M6/ZO\\SOM#GXCK2.RGZ-J1^PO^\5J7Z-&C6<-M'TC2OW#7X1J:;`/FBL?:&_ MPG5MZ-&D%;J\6@T:559BL,QFRL]ZCT`\2<#VZC&S6E2C`E7154_^IUU?;JS_ M`#;7Z"1X8X^K'=IROVU6[NM:13\`24?G8JS^BX.0]1X@^O68XDJ;0ZNU)9*F M)D)X*&1@I6D\B/9@C6J[9K\:YK?B5:-@)?1YZ,^@L<%)]ATZZ-9DCV#+"55* MXI;5`IREDAR4/SKHS^@T/.4?=KTN[J3;J"Q9M-[-\#"JK.2')"OV$^BW]^O- M!M*JW>MZNUJ>J)3$'>DU.8HG>[PG/I'X?=IV7<:Y:D6=LW@.1H\@[CLKE(E= MZE*_13CX=W+2NJUB!LOI3MO6^ZB37Y"<5"HCCV/ZB/$?#F>/)@MZQS,A&X;H MF&ET4'>+KG\K)/_P"_7FY+[,N!\@VY%^2:$CAV*#^OLK+4)%-E'T7XB0D9\4:DCKC(X=ZO#3RFU M;Y2D)3?^`!@`4MK`^.OOY+7U_P#(!_Y8U_GJJ=J%C52WI3=9FU!-2$]PAY]+ M`:W7,=0.'$9.?`Z7[%;N^2JXJ@RW,1:BK+))X(>Z?VAP]8&K]T:R%4ID^KU5 MQR4^_,DN.%(*U%:B<\`/\AJ9P+/I-HPFZS?*B7EC?BT9M7YUWN+GU1X?^--- M5K]P;0ZQ&IL=C=:WMR)3XPW6FAZN7`/_D]`&]NBT2P&TU"Z]RJUY8[1FE)7O(:)XA3RNOJ^_F&*2_=>TJLE M89=EK1P2VV-UF,GV\$CQ)TH^3[4M;C5)/Y05%/\`0X:RF,V>Y;O-7J3[]2+9 MW=]5KNT.F1'%MQ*>VEWLH$1'9,H\Q6/-',^)R=7SHU1NW_YZI'V9?XM<=@9' MY45(9X^1?XTZOC37<5O4^YZ.[3*DT%M.#*5#TFU=%)/0C68;EMVHV?<#E/E$ MI<:4%LO(R`XG/FK2?9["-7ILOV@HNRFB!/<`J\5'GYX=NGZX\>\>WKK_T[ET M:Q_5_GJ=]H<_$=:1V4_1M2/V%_WBM2_1HT:SAMH^D:5^X:_"-338!\T5C[0W M^$ZMO1IGNNX6+7MR75G]TEE&&D$X[1P\$I]_PSIAV6T%RFVXJKSB5U*M*\KD M.*YX5Q2/<<^M6IMHTTW10(]SV[+I$C`#Z/,61Z"QQ2KV'&LI28\JDU)V.Z%, MRHCI2K!P4+2?\QK3U@74B[K6CSE*3Y6V.RE('1P=<=Q''VZDNL_2:M;FSI3K M=!4W6KA42'*@XG+,4]0V.I\?CTU!DBKW57$IR]4*C,7@$G*E'^`'N`U;-(H+ MUJ17:#;792+B>;'RG5E\&:<@C.[O=^.G/J>@TS1J@W2'G*+L]BNUBMO`B76E M(WE9//5`A/92%?\5[O[PGCXZ13;FN M&Z$IH],B&/"Y(IM,9(1_6">*CXG7@64]"\ZX*I!HR>9:=<[5_P!C2,GWXU+= MF*[6CWY"C4MJH3)12YB9)4EI"<(.=UM.2<^*M7SI!68E2FPTM4NJBF/A8)>, M=+V4X/F[JB!W>``K`YZYT?8Q+H$], M^E7@_%D)!3OIA@Y!Y@@KP1Z]3NBTZN077%5:X$U1"DX0D0D,%![\I)SIXU&; MWL:!>]-;CR7#&DL*WF9*4;RD=XQD9![L]VH5$V$*@2FY4.[)##[1WD.-Q=U2 M3X$+U/:)1[AITA)J5T?*D<)([-4%#2B>AW@?X:X5.A73-??\EO`0H[BCN-HI MJ%*;2>0WRK)([]017^C^RM14JYG2HG))ACC_`->I-0K$N*VZ>BGTV]5)BH)* M&G::A83DY."59YG7_]2X(K;[41IN2^)#R4`..A&X%JQQ.[TSW:ZZ-,U:IM>G M/H52KA32V@C"D&"EXJ5D\&!^ MGPX:7V[LKJMJ/.N4:\G(_;8#B%0$K2O'+(*O$\=3JDQJC$B%NIU)-0?WR0\F M.&0!T&Z"??I3*;>=B.MQW_)WEH(;=W`O<5C@<'GCNU7=>V55>YRW\LWM(E): M)*$>1)2A)[]T*`SXZ;\53@`6/(DJ2O'+*2K!U/X\6H-QFFWZD'G4H`6[V` M3OJQQ.`>&3QQK)T:G2ZK6!`@,*?D/NE+;:!Q)S]WCJ_[6L:)8U!*E+4Y5Y2= MUY]AO?=QU0T.GK/K/A&Z[*AK3\CRB\IA"BI-NT51=>>5GBJ2\,\2>)`S[>>H M]5)-5,(P)D^F6A2NM.BJWWEC]=*,K4?VR!J-B=:=*/\`L=,DUAX?SL]?9-9\ M&D')'K5KTJX;JJT1\0==*#=\2OUZL4AB,\T[27>S<6O&ZLY4.&/V>ND M9V@0W;R-M0:=,FN-+#E\P+(CQ79L=Z092U)0AG&0$C M)/$^(TX5NX8U$MEZO+;6_':;2YNMXWE!1`&,\.NE%%JC=;HL.J,MK;;ELI=2 MA>,I!&<'&NE3J,>D4R349:BEB*TIUP@9.`,\!WZ8K/O9N[PZMJDSH3:4A;3D MA`"'DDD921SP1QTU2MJ].B5)^EKIDML[1HUT5IRFQ*/4&T-* M6EFNE3VB4RE7@FVY$9_MBUVA?&[N#S"O'//(?'2FS+UA7K` MDRX<9^,F.[V:DO8R>&<\#I';FT:'<];7`@TN?Y,%+0B:>F&3M0(^(U([GNJGVI0_E6>%J0HA+;38!6XLC(`]Q]VE%O5ARNT=JH M.4Z33U.$CL)*<+&#S]1TYZAMCV#`LJ*[+>4)%1>&7I`3G<'/<0.>/B=-UUUN MH3M]B-!GE@\-U,60H*'B&TI*O5O@>&H))8K2XRHR*7R3CD.6JXHML5>EW M'3Y;E.EE,:O)CA194=UI!X*Y>CYQX\M2;;)`F2:_0)#$*HR&6`X750$$N(&\ MGDH`X/=G3IM$C2JCLDC-1(;\B(^RT_*!:<<;*4N#?7Q23SY MCEI#;'RG9NT2L4V51Y M0SI\V95"1+L^+$DTR5`]$'-X8 MXI'B>6J^V0,U6/.J[:(D^+0,@Q&IP(6A>>('LSG'AUUVJ%O!W;O3ZA\GNJCF M)VSCX;/9]JE*@DD\L\$_#7K;&RF13H:$4:?*EC>5$F0DDJCN`IP%8')7^'4C MIZ:P[LT"*NA:JFJG.!U)&5E6Z<9_6QC/CIOV0Q)4&P(S$R.['=#SI+;J"A0! M5W'4.V50IE/O28F93ZPPIYQXH6I)1&W>]0(XJX<#G2+:%0ZO4;KN.H1*?+66 M/)DLK;94=_*0E6[PX\SG&I?LKI,JB5&XX+\5UAM,AOLE+00E8W2,@\CTY:__ MUNEC-5-O:8\Y2:-4:327D+-0C200TES!]#AWXQUXGIJQ8ES-S;OFV\Q$<48# M*7'Y.\-Q*E8(1CGG!^!T^:KK9U`F1;WO-Z3$?9:?F!32W&RE+@WW.*2>?,?B-6AM5H=2J=MTV738RI M3M,D(?7'2,J6G''`ZXX<.[.I!$NIV99K]PHHLQ#C3:UIA.)PZO=[N'7U:40: M](F4^-*51)S*GVDN%M21E!(!P
-----END PRIVACY-ENHANCED MESSAGE-----