-----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, KKovC9ge6fsAAYr0k5zqit05zzIHbOISYARwgkdzGE71iSwMvvzqmE53G1elwSKn 3bhWMDxLxRHDpfdJ4MesKw== 0001144204-04-014380.txt : 20040914 0001144204-04-014380.hdr.sgml : 20040914 20040914121229 ACCESSION NUMBER: 0001144204-04-014380 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040914 ITEM INFORMATION: Other Events FILED AS OF DATE: 20040914 DATE AS OF CHANGE: 20040914 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: 041028982 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 v06723_8k.htm

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

September 14, 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 8.01. Other Events and Required FD Disclosure.

     On September 14, 2004, RITA Medical Systems, Inc., a Delaware corporation (“RITA”), announced that CIGNA Healthcare has established national coverage for the treatment of liver cancer with radiofrequency ablation. A copy of RITA’s press release announcing this development 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: September 14, 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 September 14, 2004 


EX-99.1 2 v06723_ex99-1.htm
Contact:         Allen & Caron Inc.           RITA Medical Systems, Inc.   
    Matt Clawson (investors)     Don Stewart, Chief Financial Officer   
    949-474-4300     Stephen Pedroff, VP Marketing Communications   
    matt@allencaron.com     650-314-3400   
    SurfMedia Communications     dstewart@ritamed.com   
    Juliana Minsky (media)     spedroff@ritamed.com   



 
    805-962-3700       
    jm@surfmedia.com       

RITA MEDICAL SYSTEMS ANNOUNCES RADIOFREQUENCY ABLATION LIVER
TREATMENT COVERAGE INITIATED BY CIGNA® HEALTHCARE

August 2004 Coverage Position Published for Unresectable Primary and Metastatic Liver Cancer

     MOUNTAIN VIEW, CA (September 14, 2004) . . . RITA Medical Systems, Inc. (Nasdaq: RITA) today announced that CIGNA HealthCare has established national coverage for the treatment of liver cancer with radiofrequency ablation (RFA). In the “CIGNA HealthCare Coverage Policy” recently published to the CIGNA Corporation website, indication for RFA includes certain patients with either primary or metastatic liver cancer for whom surgery is not a treatment option. CIGNA HealthCare is one of the largest private health insurance providers in the United States, with more than 13 million medical subscribers represented in all 50 states.

     Mr. Joseph DeVivo, President and CEO of RITA Medical Systems stated, “We are pleased that all of the nation’s largest private health insurance companies now provide coverage for radiofrequency ablation treatment for liver cancer patients for whom there are few, if any other options.” Mr. DeVivo continued, “We believe that as more payers offer coverage for RFA, our installed customer base will be able to treat more patients.”

     CIGNA joins Aetna, the largest private insurance payer in the U.S. with more than 19 million medical subscribers, United Health Care with 15 million medical subscribers, HealthNet, Kaiser, Humana, PacificCare, and 38 Blue Cross Blue Shield plans in 44 states that provide coverage of RFA for liver cancer patients. The company estimates that more than 150 million Americans are covered by private insurers for RFA for the treatment of liver cancer.

     Ms. Lynn Saccoliti, Vice President of Reimbursement Affairs for RITA Medical Systems stated, “The continued momentum of positive coverage policy adoption by the nation’s largest private insurance payers is a direct result of the publishing of long-term clinical data and the review of that data by the most respected medical technology assessment organizations.” Ms. Saccoliti continued, “Our ongoing reimbursement goal is to provide patients with access to radiofrequency ablation across the spectrum of indicated procedures.”


MORE – MORE – MORE

CIGNA HEALTHCARE PROVIDES COVERAGE FOR RFA TREATMENT OF LIVER CANCER Page 2-2-2

     CIGNA HealthCare provides coverage for RFA treatment of unresectable liver lesions and unresectable colorectal liver metastases less than 5 centimeters in size, performed either surgically, laparascopically or percutaneously.

About RITA Medical Systems, Inc.

RITA Medical Systems develops manufactures and markets innovative products for cancer patients including radiofrequency ablation (RFA) systems for treating cancerous tumors as well as percutaneous vascular and spinal access systems. The Company's oncology product lines include implantable ports, some of which feature its proprietary Vortex® technology; tunneled central venous catheters; safety infusion sets and peripherally inserted central catheters used primarily in cancer treatment protocols. The proprietary RITA system uses radiofrequency energy to heat tissue to a high enough temperature to ablate it or cause cell death. In March 2000, RITA became the first RFA 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 statements in this news release related to the extent and growth of insurance coverage for RFA treatment 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 3 v06723_8kx5x1.jpg GRAPHIC begin 644 v06723_8kx5x1.jpg M_]C_X``02D9)1@`!`0```0`!``#_VP!#`!`+#`X,"A`.#0X2$1`3&"@:&!86 M&#$C)1TH.C,]/#DS.#=`2%Q.0$17137!D>%QE9V/_ MVP!#`1$2$A@5&"\:&B]C0CA"8V-C8V-C8V-C8V-C8V-C8V-C8V-C8V-C8V-C M8V-C8V-C8V-C8V-C8V-C8V-C8V-C8V/_P``1"``[`5`#`2(``A$!`Q$!_\0` M'P```04!`0$!`0$```````````$"`P0%!@<("0H+_\0`M1```@$#`P($`P4% M!`0```%]`0(#``01!1(A,4$&$U%A!R)Q%#*!D:$((T*QP152T?`D,V)R@@D* M%A<8&1HE)B7J#A(6&AXB)BI*3E)66EYB9FJ*CI*6FIZBIJK*SM+6VM[BYNL+#Q,7& MQ\C)RM+3U-76U]C9VN'BX^3EYN?HZ>KQ\O/T]?;W^/GZ_\0`'P$``P$!`0$! M`0$!`0````````$"`P0%!@<("0H+_\0`M1$``@$"!`0#!`<%!`0``0)W``$" M`Q$$!2$Q!A)!40=A<1,B,H$(%$*1H;'!"2,S4O`58G+1"A8D-.$E\1<8&1HF M)R@I*C4V-S@Y.D-$149'2$E*4U155E=865IC9&5F9VAI:G-T=79W>'EZ@H.$ MA8:'B(F*DI.4E9:7F)F:HJ.DI::GJ*FJLK.TM;:WN+FZPL/$Q<;'R,G*TM/4 MU=;7V-G:XN/DY>;GZ.GJ\O/T]?;W^/GZ_]H`#`,!``(1`Q$`/P#E!KFKDX&J M7Q/_`%\/_C5A;WQ&Z[ENM4*_WO,DQ^>:JIJU_'Q!VT:U/2Y8$NW MNI;+$_[H%`$MO=7P`::\UID;[KRW?V93^+%L_A70:19WEU]95A!`/].C+["WS:I?+N=F["*/N?9F(_VCDGC^==`I)4$]<5X=<7 M%Q?WC33NTT\KXI]T?2@0ZBBBF`4444`%%%%`!1110`4444`% M%%%`!1110`4444`%%%%`!1110`4444`%%%%`!1110`4444`%%%%`!1110`44 M44`>*C5YHH_+M(H+0'^*)/G_`.^SEOR-26VDW5W']LO9?LUKGYKB9\?/-*25C7W]![4 MADD=W96=PJ:/:-=7!^59KE=QW?[,8X'XYK1N;9-.E%WK\IO]4-LE^W)R1R(QV^O\^M65@7PW:#4]0_?:UI/0"K]CILNJM+J^MW+PV>OO\`XUZHG*@^HKQO3M$F MNHOM5Q(ME9#_`)>)@0&]E'\1KV1/NBA`.I#2TE,1P]KXRUB_DF2QTA)_*.&V ML>.N/Y5J^&_$QUBYGL[JU-K=0C)3)Y'0]>A%M;/A%CJ_BC4=:">7$5V*I/.3C&?P7]:0R6T\7ZC>PWIMM,6:6W=0L<98 MD@D@G]*@D\::S%=):R:*$N)!E(CN#,/8?@:;\.?^0EJO_`?YM5G7/^2CZ1_U MQ7^;T"-6PUJ]?1[V^U.P-FUN"RHP(W@#/?WXJMX5\52Z[>S6\]ND+)'YB[23 MD9P?YBF?$2[\G0DMD;Y[F4+CU4YHR*X32?M'B< MWM[=:KQQK(T0!"L>#D@?UK'F\0ZD_ARRU*QT\3S7#L'B56<*`2,\?2 MN?N=-U$^#'U.74[F5IE#RPR,60H6&.O?HE`'HD#L\$;R+M=E!9?0XZ5)FN)UZ_U"YU'2-'M+J2#[3$CRR(<,<^_7H":E M@M]7T;Q1!;V\E]>:9*!O:7,@3.1UZ#!Y^AH`['-5M2N6L].N;I%#-#$T@4]# M@9KEX=-U+4]0U&?5[V]LK6)R(%CEV+MR>?3@`?G5;0M1N;SPQKL%SGM=3`NQ.V-`<; MF^O;ZUG^`?\`D5X/]]__`$(TSQUI-QJFDHUJIDDMWW^6HR7!&#CWI@9T_BK7 M[2UBO[O2(5LI,%2&.<'IW./Q%=C9W,=Y:0W,1S'*@=<^A&:XFP\6:;?V*:5K MMLT8`5'8YV$KW..1R*F\82S:)!I5QI4\D-LAV>6DAV,!AESZ]Z0';9HS7&^) M;Z\N?$.CV-A(M0M;W5;FU$3,L$,,NS)! M(Z=\8^M`'<7EP+:TGN"I811L^WIG`SBJ?A[6!K>FB\6$P@N4VEMW3WKF[>SU MN?PW?P:KX^M5O"@ET_PQ=ZNMW,1&D@6W)_=AN,''KF M@#T#-&:X""UO+OPR^LRZY=K?;&E51-M4`$\;??'ZT:QKM]/X*TZ^CGDAN'GV M2/&VW=@,.WK@&BX'?YHS7G_B.#5M$M;35?[7N)+AY`LB%ODR03@+TQP1BF^( M8M2T,:?J']K74T\S_O%9_DSP<`=,=1BBX'H6:,UQGB&\FF\66FE2WTME8O'N M9HGV%B=W?Z@"K>C6FK:;XCFMFEN;G2F3*23/NP<`_P"(H`XFQT'9`E]K,ALK M$\KD?O)O95_K3=3UM[M/L.FP"SLJ79FNI&FEW*Q_;]NZ,2G$5L/[TA]?;_P#6`92L-.B\/I'/>P_:-9F_ MX]++&[83T9L=_;_(CGB@TR=[[Q!*+[5&Y6SW;@I[%ST_X"/:K[3,D,UQI[[9 M)<^?J]Z=N[CD1#KCTP/Z5BP3VD+XTNTFU&_/)N)TW*#ZK'SGZM^5`!=1ZIK* MK>ZA*MK99Q&TOR1J/1%ZGCT!Z5&;S3--!73H/MD__/U*SZO>3J(PZP1?\\X$$:GZXZ_CFO:H_N#Z M4(!U)2TAIB//OA];PSW>J":&.0`IC>H..6]:M>'T2T^(.J6\*B.(QDA%&`.5 M/3\3756&DV.FO(UE;+"TN-Y4GG_.:/[)LO[1_M`6ZB[_`.>H)!/&/Y4@./\` MAS_R$M5_X#_Z$U6M=_Y*/I'_`%Q'\WKIK#2;'39)9+.V6%I?OE2>?\YITVF6 M<^H17TL"M+(9=:\86>F6\FQHHLEB,A#RQ/Y!:H^*=$ MU:PLX;V\U-[P1R;5)SF,GOU]A7H":591ZBVH+;J+IQAIZB62%\;E/?G-`#-,NA>Z;;70(/FQ*QQZD<_K7+7W_)3['_KA_[*]=;9VD%C M;+;VT8CB3[J@].]1/IEF^HIJ#0*;I!M63)R!R/ZFF!YO:Z?,?%L>B/Q!#>-- MM[%<`_\`H('YUOZ&,_$#6AZQL/U2NI&F68U$Z@(%^ULNTR]\8Q1!IEG;WTM[ M%;JES,,/("IK21"XMY3D22%2%QZ`C/(-22QVU]X(U" MXT_3OL<2SJV!(7WA2,GGI@']*Z_4/#.D:C<_:+FS5I3U96*[OK@C-7X+2"WM M1;101I`!M$87C'TH`XF;7;%_A\ML)T-SY*P^3GYL@CG'I@9S6;J__)/=&_Z[ M/_-Z[:+PIHL4DKI8)F0%6!8D8/7`SQ^%6)="TR:QBLI+1&MH3F.,DX4\^_N: M`.2U25=.\6:%?7!VP&V12YZ#@@_EN!K:E\3^9XFM=+L$AN8I%!DE5\[>I.,< M<#'YUL7NEV=_:"UNK=)(5`VJ?X<>AZBHM,T+3M)+-8VJQLW!8DLV/J:`.*TA MK#5=2U&X\17>3"Y\N":4JH&3G`SVP!@4GAJ>W.D>)8XBJ[XW>./H=F&[?B*[ M"?POH]Q?&\EL4:8MN;DX)]2,XJ==#TU)[B9;1%DN4*2D9&Y3U&/?%`&9X!_Y M%>#_`'W_`/0C3O&.LW^B6D%Q911NC.5D,BD@<<="/>MJQLK?3[=;>TB$42DD M*/>GW$$5S"T,\:21N,,KC(-,#CO%%_H&H>'Y)Q);/=N@,>S'F!O0]Q[YI/[/ MGNOAHL=PC&:.,S1[NH4,2/\`QW^=;47A#0X9O-6P4L#D!G9@/P)Q4GB'5)]+ MMT6VTZ6\:4,H$:DA..,X'3G]*0'*>"1+JOB#[?*"4L[5(E)[':%'YX8U9?\` ML+Q'>W\=Y`NFWENQ'G>:`7P2"<<#C'UYK7\#Z/+I6DLUTFR>X;>R$?=6:M*>K*Q7=]<$9H`YGPM=7-QH6NP27#W,,$;+"[$G(VM MTSVX''O5?1)H;CP%?V$6=C:V-L+>U@2*(?PJ.OU]:J MV&@:9IUPT]I9I%*X*D@D\'M@G%`'&:7!X97PJ+V\AAENHU8.AF969LG`P#WX M[4GB+RV\#Z<\-G]BC>XW+#O+8!#GTN^U]- M(U6R5=T>Z.[,FTC@G`_$'OUK-\.F33O&9TRPO7N[`HQ?+;E7Y<]N,@X&1ZUU MVJ:+8:LJB^MEE*_=;)##\1S3M,T:PTE"MC;)$6^\W5C^)YH`YKPGX173PFHZ MD`;@#Y]_Y5-JVI+?22);I]H$9^6-8S/SZ[%^4G_>88]*T/&$TL&BNT M,CQMZHQ!KRB6[N9SB:XED'^VY-`&]=R223F6^@^T3C@-?W*J%'M&""/IDBJU MS.[6QBEUJ$0GK;VL;!?R"JI_.L6B@99(L4/#W$H]-JQ_U:GQW-E$;[3S M,1_X[MJG10!<.H/OS#;VT([!80V/Q;)_6O;$^X/I7@XZBO>$^X/I0`ZBBBF( M****`"BBB@`HHHH`****`"BBB@`HHHH`****`"BBB@`HHHH`****`"DQ2T4` 7)2T44`%%%%`!1110`4444`%%%%`'_]D_ ` end
-----END PRIVACY-ENHANCED MESSAGE-----