Free Motion for Preliminary Injunction - District Court of California - California

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1 Henry C. Su (SBN 211202; [email protected]) Katharine L. Altemus (SBN 227080; [email protected]) 2 HOWREY LLP 1950 University Avenue, 4th Floor 3 East Palo Alto, California 94303 Telephone: (650) 798-3500 4 Facsimile: (650) 798-3600 5 Robert Ruyak Matthew Wolf 6 Marc Cohn HOWREY LLP 7 1229 Pennsylvania Avenue, NW Washington, DC 20004 8 Telephone: (202) 783-0800 Facsimile: (202) 383-6610 9 Attorneys for Plaintiff 10 HOLOGIC, INC., CYTYC CORPORATION and HOLOGIC LP 11 UNITED STATES DISTRICT COURT 12 NORTHERN DISTRICT OF CALIFORNIA 13 SAN FRANCISCO DIVISION 14 15 HOLOGIC, INC., 16 CYTYC CORPORATION, and HOLOGIC LP, 17 Plaintiffs, 18 vs. 19 SENORX, INC., 20 Defendant. 21 22 23 24 I, Katharine L. Altemus, declare that I am an associate in the law firm Howrey LLP and a 25 member of the Bar of this court, and I serve as one of the outside counsel for Hologic, Inc., Cytyc 26 27 28
Declaration of Katharine L. Altemus Case No. C08 00133 MEJ

) ) ) ) ) ) ) ) ) ) ) ) ) )

Case No. C08-00133-MEJ DECLARATION OF KATHARINE L. ALTEMUS IN SUPPORT OF PLAINTIFFS' MOTION FOR PRELIMINARY INJUNCTION

Date: March 20, 2008 Time: 10:00a.m. Courtroom: B, 15th floor Judge: Hon. Maria-Elena James

DM_US:20993951_1

Case 5:08-cv-00133-RMW

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1 Corporation and Hologic LP. The following declaration is based on my personal knowledge, and if 2 called upon to testify, I could and would competently testify as to the matters set forth herein. 3 1. Attached hereto as Exhibit A is a true and correct copy of correspondence from Nancy

4 Brogdon of the Food and Drug Administration ("FDA") to SenoRx, Inc. ("SenoRx), dated May 18, 5 2007, and posted on the FDA website at http://www.fda.gov/cdrh/pdf7/K071229.pdf. 6 2. Attached hereto as Exhibit B is a true and correct copy of the Instructions for Use for

7 the SenoRx Multi-Lumen Balloon Source Applicator for Brachytherapy. 8 3. Attached hereto as Exhibit C is a true and correct copy of an illustration posted on the

9 SenoRx website at http://www.senorx.com/images/SNRX_7000_conturads_7.jpg. 10 4. A publicly available news report posted on the worldwide web (and accessible via a

11 web link posted on the SenoRx website) describes the use of SenoRx's Multi-Lumen Balloon 12 Applicator to treat a patient in Arizona diagnosed with breast cancer, and includes an animation 13 provided by SenoRx to explain how the Contura device is inserted to deliver radiation treatment. 14 Within the report, the device is described as follows: "It's a balloon-based device. The balloon is 15 implanted into the breast and it replaces the tissue that was removed by the surgeon. And the goal of 16 the treatment is to treat the rind of the tissue surrounding the balloon. This animation provided to us 17 by the makers of the device shows how it works. After the balloon is inserted into the breast, it is 18 inflated and filled with a saline solution. Then radioactive seeds are sent through five separate 19 channels inside the balloon. The dose is actually directed by where the seed sits within the balloon. 20 So, having one offset from the center of the balloon allows us to pull that dose by leaving the seed in 21 the balloon for a certain period of time ­ longer than the other side has it for an example. And that 22 means the dosage of the radiation is concentrated on the tumor and doesn't burn the patient's skin. 23 And if the skin was too close to channel 1, we might put the seed longer in channel 3 and 4 versus 24 channel 1 to cool down that side of the dose." The video news report is posted online at 25 http://www.myfoxphoenix.com/myfox/pages/Home/Detail;jsessionid=18E5571CEC66E18169DF14948 26 28ED0A5?contentId=5126377&version=1&locale=EN27 US&layoutCode=VSTY&pageId=1.1.1&sflg=1. A web link to this news report (entitled "First 28
Declaration of Katharine L. Altemus

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Case No. C08 00133 MEJ

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1 Contura MLB used in Chandler, AZ") is accessible on the SenoRx website at www.SenoRx.com. A 2 true and correct copy of the video news report will be produced on CD should the Court so request. 3 5. Attached hereto as Exhibit D is a true and correct copy of a SenoRx webpage, posted as

4 http://www.senorx.com/aboutsenrx.asp. 5 6. Attached hereto as Exhibit E is a true and correct copy of a SenoRx January 17, 2008

6 press release posted at http://www.senorx.com/siteadmin/files/SenoRxLaunchesContura.pdf. 7 7. Attached hereto as Exhibit F is a true and correct copy of a SenoRx webpage, posted at

8 http://www.senorx.com/teatment.asp. 9 8. Attached hereto as Exhibit G is a true and correct copy of a webpage posted on the

10 University of Washington Medical Center website at 11 http://www.uwmedicine.org/PatientCare/MedicalSpecialties/SpecialtyCare/UWMEDICALCENTER/C 12 ancer/SpecialtyServices/brachytherapypatientinfo.htm. 13 9. Attached hereto as Exhibit H is a true and correct copy of information posted

14 electronically at http://www.mammosite.com/breast-lumpectomy/how-it-works.cfm. 15 10. Attached hereto as Exhibit I is a true and correct copy of information posted

16 electronically at 17 http://www.senorx.com/siteadmin/files/SenoRxAnnouncesThirdQuarter2007Results.pdf. 18 11. Attached hereto as Exhibit J is a true and correct copy of a SenoRx December 20, 2007

19 press release posted on the SenoRx website at 20 http://www.senorx.com/siteadmin/files/SenoRxProvides2008RevenueEstimate.pdf. 21 12. Attached hereto as Exhibit K is a true and correct copy of "Table C-10. U.S. District

22 Courts--Median Time Intervals From Filing To Trial of Civil Cases in Which Trials Were Completed, 23 by District, During the 12-Month Period Ending September 30, 2006", published by the Office of 24 Judges Programs (Statistics Division) of the Administrative Offices of the United States Courts at 25 http://www.uscourts.gov/judbus2006/appendices/c10.pdf. 26 27 28
Declaration of Katharine L. Altemus

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Case No. C08 00133 MEJ

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1

13.

Attached hereto as Exhibit L is a true and correct copy of Judge Ronald M. Whyte's

2 April 27, 2007 Claim Construction Order in the Northern District of California action Xoft, Inc. v. 3 Cytyc Corp., case no. 5:05-cv-05312-RMW. 4 14. Attached hereto as Exhibit M is a true and correct copy of Cytyc Corp.'s Administrative

5 Motion Under Civil Local Rule 12(B) To Consider Whether Cases Should Be Related, filed January 9, 6 2008 in the Northern District of California action Xoft, Inc. v. Cytyc Corp., case no. 5:05-cv-053127 RMW. 8 15. Attached hereto as Exhibit N is a true and correct copy of a SenoRx May 23, 2007 press

9 release posted on the SenoRx website at 10 http://www.senorx.com/siteadmin/files/SenoRAnnounces510_k_ClearanceforMulti11 LumenRadiationBalloon.pdf. 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
Declaration of Katharine L. Altemus

I declare under penalty of perjury that the foregoing is true and correct.

By: /s/ Katharine L. Altemus Katharine L. Altemus

Executed on February 6, 2008 East Palo Alto, California

4

Case No. C08 00133 MEJ

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Case 5:08-cv-00133-RMW

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Su"RXRi
5. 510(K) SUMMARY
April 20, 2007 SenoRx, Inc. 11 Columbia Aliso Viejo, CA 92656 P. 949.362.4800 F. 949.362.3200 Eben Gordon SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy Multi-lumen balloon source applicator Remote controlled radionuclide source applicator 21 CFR 892.5700 90 JAQ Adjustable Multi-Catheter Source Applicator (K062241) MammoSite Radiation Therapy System (K041929) 11/9/2006 (K062241) 8/26/2004 (K041929) The SenoRad applicator consists of a multi-lumen catheter connected to an inflatable spherical balloon that can be attached to commercially available High Dose Rate remote afterloader equipment for passage of the radiation source delivery wire. Five radiation source wire lumens are provided; one central lumen located along the long axis of the applicator and four curved lumens symmetrically offset from the central lumen. The balloon is inflated to a 4 or 5 cm spherical shape by a controlled volume injection of physiological saline to approximately 32 or 55 ml, respectively. The SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

Prepared date 510(k) owner

Contact person Device name Common name Classification name CFR classification Predicate device Decision date Device description

Indications for use

Summary of substantial equivalence Extensive preclinical testing was conducted to evaluate and characterize the performance of the SenoRad Multi-Lumen Balloon Source Applicator. Preclinical studies conducted included in vitro laboratory studies to demonstrate that the SenoRad applicator performed as intended under simulated use conditions. Biocompatibility testing was performed to 12

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SEN6DRX
demonstrate that the materials meet ISO 10993-1 requirements. The dosimetry of the SenoRad applicator was characterized. Based on these findings, it was concluded that the SenoRad applicator could deliver an equivalent radiation dose as the current brachytherapy applicators. The SenoRad applicator has the following similarities to the previously cleared predicate devices: same indications for use; same intended use; same intended treatment site; same operating principle; same technological characteristics; equivalent dosimetric characteristics; and same sterilization method. The materials of construction vary in a manner that has no impact on device safety. In summary, the SenoRad Multi-Lumen Balloon Source Applicator as described in this submission is substantially equivalent to the predicate devices.

13

Case 5:08-cv-00133-RMW Document 8-3 Filed 02/06/2008 DEPARTMENT OF HEALTH & HUMAN SERVICES

Page 3 of 5

Food and Drug Administration
9200 Corporate Blvd.

Rockville MD 20850

SenoRx, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25 th Street NW BUFFALO MN 55313

MAY I 8 2007

Re: K071229 Trade/Device Name: SecoRad Multi-Lumen Ballon Source Applicator for Brachytherapy Regulation Number: 21 CFR §892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: May 2, 2007 Received: May 3, 2007

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

FZ'X
11% **

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Page 2 Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53 1-542 of the Act); 21 CFR I1000-1 050. This letter will allow you to begin marketing your device as described in your Section 5 10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 80 1), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: 21 CUR 876.xxx 21 CUR 884.xxx 2! CFR 894.xxx Other (Gastroenterology/Renal/Urology, (Obstetrics/Gynecology) (Radiology) 240-276-0115 240-276-0115 240-276-0120 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address litrp:H//ww\w.fda.eov/cdrhl/industrv/support/indexitml. Sincerely yours,

Nancy C. rgo Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure

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SenoRx Inc. SenoRad Multi-Lumen Balloon Source Applicator 510(k) Submission

4.

INDICATIONS FOR USE

510(k)Number(ifknown):

1C07jt :-

Device Name:

__

SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy

__

Indications for Use:

The SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

Prescription Use

X

AND/OR

Over the Counter Use (21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

..........................................................................

(Division Sign-Off '.' Division of Reprod uctive, Abdominal, and Radiological Devices 510(k) Number ¾b1IO.Qq
11

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Source lumen #5

Source Lumen #1

Stiffening Stylet (I)
Source Lumen #4 Source Lumen #2

Longiludinal Reference line {L}

-Applicator (A)

MULTI..LUMEN BALLOON SOVRCE ApPLICAl'OR FOR BRACHYTIIERAPY
Figure 3: SOURCE WIRE LUMEN ORIENTATION

"

Figure 1: SENOllXApPLICATOR
© 2007 by Senokx Inc. All rights reserved.

I,

This product iscoveted byone ormore ofthe following U.S. Patents: 67923,754; 6,955.641; 7,241,178. Other domestic and foreign patents pending.·' "

INSTRUC1'IONS FOR USE

" '.t

Radi~lion Sourr;e

Lumen Cap (K)

.!

(COfllmt Media Tray (0)

>~ A,~rpel(El
,

EXPLANATION OF SYMBOLS ON
~

rue PACKAGE

Catalogue Number Use by Dale
Lot Number

?" Drair'IAge
10mfSYringe

~

~
~
~

MODELS

/'../

30ff~ Syr1nge(~trr

-~~~

Jif #
.
Trocar (F)

Contentc;
Sterile (Gamma radiation) Altentiun, See Instructions for Use
Do Not Reuse

[~Lil R t

A
®

B001·45 B011-45

(/\.

r

Upper Temperature Limit
Keep away from sunlight

Figure 2: ACCESSORIES

Keep dry
lUUU93 Rev. B RCO 3776

SenolU Inc.
Aliso Viejo, California

USA
Page 5
rilgc 6
Pase 1

Case 5:08-cv-00133-RMW cavity Document 8-4 toinsure the applicator wiIJ fit Filed 02/06/2008 The breast musl be ilJ1uged before implantation
appmpriatciy Do not usc if the cavity is too small orif a skin surface toballoon surface distance of'less than 5mm will result.
MULTI-LUMEN BAL~OON SOURCE APPLICATOR FOR
· To insure appropriate treatment dose distribution, the SenoRx balloon must beimaged prior to delivering each fraction ofradiation to confirm correct position, volume, skin spacing and conformance.
· If excessive resistance is encountered wht.ll aUempting to remove the SenoRx spplicator from thepatient, surgical removal isrecommended.
· Contrast media concentrations ofless than 10% arc rccomneuded 10 prevent dose allenuation,

DIRECTIONS FOR USE
Pl.ACF.MF.NT- Refer 10Figures

Page 2 of 2

I &2

BRACHYfHERAPY
Cautioll: Federal (USA) lawrestricts this device tc sale by oronthe order ofD physician.

lJESCRlPTION The SenoRx applicator cunsisis of " multi-lumen catheter attached to an infla1J1blc spherical balloon (Figure I). Lumens arc .provided for attachment to commercially available HDR (High Dose Rate) remote afterloadcr equipment for passage of the radiation SOU1tC delivery wire. Five radiation source wire lumens are provided; one centIallumen !ocaled along the long axis of the applicator and four curved lumens symmetrically onset from the cenaal lumen. A removable stiffening stylet isposil1onoo inthe centtullumen. Two proximal POlts are also provided with Lner-type connectors for balloon inflation/deflation and for application ofintracavitary vacuum.
The SenoRx Multi-Lumen Balloon Accessories provided fur introduction and deployment include: trocar with split sheath, dmi~gc catheter, three, 30 ml and one, 10 ml inflation syIingcs, #11 scalpel, contrast media tray, Iadiation lumcn caps and l:thcls

· Non-ionic contrast media is recommended for patients who am aJIf.t'gic to iodinebased agents.
PRECAUTIONS · The ScnoRx applicator must be used only by physicians trained in catheter implantation, radiation treatment planning und delivery,
· Metal vascular and marking clips should not be used during the lumpeclomy procedure to prevent potential nbmsion orpuncture ofthe ScnoRxnt balloon. Care should also be taken to directsnture knotj and fAil~ away from the cavity and whenever possible position tissue between the potential balloon surface and the rails.
· Store fhe ~cnoRx applicator atroom temperatare (20 to25°C).

I. Usc ultrasound tuidentify thelumpectnmy cavity. 2. Open the SenoRx applicator sterile package and remove the Applicator (A) and one 30 1111 Syringe (B). Remove the Inflation Port Lucr Cap (C) nnd injecl 58 ml of .sterile saline inlo the Applicator and inspect for leaks and spherical symmetry. Discard Applicator if defective. Wilhdmw saline Innuballoon, l. Prepare a maximum 10% contrast mcdialsterile saline solution 4t the Tray (D) provided. 4. Determine the desired point on the breast surface for the insertion of the SenoRx applicator. Inject appropriate ane~thetic to the skin and pathway to the lumpectomy cavity. Make a skin incision with the scalpel at the insertion point of sufficient length lu fully iusen the Trocar (F) tip. Dilate the skin incision, if desired. Advance the Trocar with Split Sheath (G) into the cavity. Remove theTrocar, 5. Attach a 30 mI syringe to the Dminuge CU~lel~r (H) and drain any fluids within the cavity by il1serting the Drainage Catheter through the Split Sheath and 5uctioning. Remove the Drainage Catheter. 6. Insert the Applicator through the Split Sheath inlo the cavity. Remove the Sheath. 7. Remove the ~liITClJing Stylet (I) from the Central Source Lumen (1). Attach a red rndiallun suurce lumen Cap (K). 8. Using the syringes provided, inflate the Applicator balloon with the contrast media solution to the desired fill volume.

(Figura 2).
.:~. __:..~ucle1ron

Desired balloon diameter

Approximate baDoon fill volume
33ml
-.

1J1eSmoRx applicator model BOO1-45 is recommended for usc with VuriSol1rce and HDR. afterloader equipment while .model B011-45 is recommended for use with GamwaMed aftedoaders.
.1

· Care must betaken when hAndling and manipulating the Sel10Rx balloon toprevent damage and foreign material contnmination oftbe balloon surface.

4cm
Scm

5Sml

~amin~: lb~ sa~e~ an~ eflecuvcaess of ~ SenoRx Applicator asa replacement for;. !
whole breast IfTJdl3tron an the treatment ofbreast cancer has not been established.
.1

A :i(;a1~1 should beused toinci,s~ the skin prior to inserting the trocar tip.
r
~

io. ~

Do not inject fluids into the VacuuinPort.
. .I

INDICATIONS FOR USE I The SenoRx Multi-Lumen Balloon is intended to provide brachythernpy when the
cbooscs to deliver intracavilary radiation to the surgical margins following lumpcctQItly for breast cancer.
ph~ician

· Replace Luer caps WId rndiation lumen caps after use. · Only clinical pcrsonacl trained inthe operation of HDR afterloaders should deliver radiation using the SenoRx applicator.
Verify lhat the appropriate aftcrloadcr connectors nre available and function with the SenoRx applicator prior tolItatmenl

9. Replace the LucrCap on tothe Inflation Purt 10. Use ultrasound to confirm appropriate placement, volume and cavity confonnance. Fluid and air surrounding the Applicator balloon may be aspirntcd with n 30 m1 Syringe attached to the Vacuum Port (LJ. The volume of the balloon may be adjusted through the lnJIation Port (C). Replace Luer Caps when finished. IJ. Apply a surgical dres~illg to the exit site with the catheter positioned lu minimize hcnding.. 12. Record the final balloon fill volume on the Labels provided and auacb to the
patient's chart.
RADIATION DELIVERY - Refer to Figure 3

CONTRAINDICATIONS
· The applicalor isnot intended for use in cavities that arc too smull, too large and/or of shapes unable toconform toanapproximaldy spherical. 4 to5 em diameter ScnoRx

· Be sure that the SenoR! applicator i~ asslrdighl as possible and free ofsharp bends and kinks prior to connecting to the HDR aflerloader,
· Inspect package before use. Discard if seal iscompromised orpackagillg isdamaged.

1. CT imnging should he used inconjunction with commercially available trcatml,l1l planning software to detcnninc the appropriale source lutncn.~, source dwell

balloon.
· The applicator isnot intended for use inpatients with unusual anatomy including a highly curved rib structure and/or unequal amounts oftissue surrounding the cavity that may cause the SenoRx balloon tobeasymmetrical,
WARNINGS
· Use caution when positioning the trocar tip near the chest wall orskin margin to avoid

COMPLICATIONS
Complications that may beassociated with the use ofthe SenoRx applicator are the same as those associated with the use of similar devices. These may include: erythema, catheter site drainage, breast pain, ecchy 1Il0S is, breast fibrosis, telangiectasia, breast induration, breast serorna, breast edema, dry desquamation, dry skin, skin discoloration, parasthesia, axilllary pain, fatigue, pnnitis, breast retraction, nausea, skin irritation, moist desquamation, hematoma, rash, asymptomatic fat necrosis, breast infection, breast blister and lymphedema.

2.
3.

uninlended tissue damage.

· Do not fill the Applicator willi more Ulan 58 1111 offluid as overfilling may result in balloon rupture untl/or device failure.

positions and dwell times for optimized radiation dcJivci)' ofa pJOcnbed dose to the targeted treatment volume. Verify correcl balloon position, volume. skin spacing and conformance using imaging prior todelivery ofeach fraction ofradiation. The ScnoRx applicator rcd-enpped, radiation source wire lumens are numbered' 1', '2', '3\ '4' and '5' and positioned as shown in Figure 3. Lumen number I' corresponds tothe offset lumen closest and parallel tothe longiluoinal radiopaque line (M) uklllg the outside ofthe catheter. Lumen number 15' corresponds to the central lumen. Remove the red caps and use (;ulIumm.:ially available connectors to attach the source lumens 10 the aftcrloadcr. After each treatment replace the red caps.
I

, The Appliculor must be pre-tested before implanLaliUIL Do not usc the balloon if it is
not approximately spherical and/or any leakage is detected.
Page 2

How SUPPLll£D
The ScnoRx applicator and accessories are provided sterile and are intended for single patient use only. Page 3

REMOVAL

Remove the SenoRx. applicator by first attaching a syringe (0 the Inflation Port and deflating the balloon and then simuhaneously rotating and pulling (unscrewing) the catheter from the cavity.
Page 4

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::: SenoRx ::: About SenoRx

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SenoRx was founded in 1998 to design, develop, manufacture and market minimally invasive devices for the diagnosis and treatment of breast cancer. Since its founding, SenoRx has developed multiple, proprietary technology platforms and a unique product portfolio that address the entire range of diagnostic and therapeutic procedures. It is the goal of SenoRx to become the leader in the marketplace by offering products and procedures that dramatically enhance patient outcomes.

SenoRx (NASDAQ: SENO), which completed its initial public offering of common stock in March 2007, develops, manufactures and sells minimally invasive medical devices used by breast care specialists for the diagnosis of breast cancer. SenoRx's field sales organization serves over 1,000 breast diagnostic and treatment centers in the United States and Canada. With 17 products that have already received FDA 510(k) clearance across the continuum of breast care, SenoRx is developing additional minimally invasive products for diagnosis and treatment of breast cancer.

SenoRx has a strong portfolio of intellectual property. The company currently has 43 issued United States patents primarily covering devices relating to breast biopsy, including biopsy site marking devices, excision devices, and balloon products, and a total
http://www.senorx.com/aboutsenrx.asp (1 of 2) [2/6/2008 12:07:46 PM]

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of 13 granted national patents from eight different European countries. In addition, SenoRx has 66 pending United States patent applications and 19 pending European patent applications.

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Press Release

SENORX LAUNCHES CONTURATM MLB ALISO VIEJO, California, January 17, 2008 ­ SenoRx, Inc. (NASDAQ:SENO) today announced that it has launched ConturaTM, its Multi-Lumen Balloon (MLB) Catheter for delivering brachytherapy to the surgical margins following lumpectomy for breast cancer. The company had previously said that it intended to transition from user preference testing, which had expanded to 34 clinical sites by the end of 2007, to full commercial launch in January 2008. Contura is one of a new class of devices which is designed to reduce radiation treatment time to five days from six to eight weeks in patients eligible for the treatment. SenoRx believes that the Contura MLB can play an important role in the shift from traditional whole breast radiation therapy to localized partial breast radiation therapy. Some patients who are presently candidates for balloon therapy are currently excluded because of the location of the lesion and their breast size. Contura's advanced multi-lumen design may address this issue for certain patients. In addition, the Contura MLB uses vacuum suction to remove excess seroma and air to enhance conformance of often irregularly shaped lumpectomy cavity walls to the balloon surface in order to deliver precise radiation dosing through multiple radiation source lumens. SenoRx has been granted three patents related either to the design or manufacturing of Contura and has additional patents pending. "Since the 510(k) clearance from the U.S. Food and Drug Administration on May 23, 2007, the positive feedback that we have gathered for Contura during the pre-launch evaluation conducted in the second half of the year, has strengthened our belief that its innovative multi-lumen design, along with the vacuum feature and its propriety manufacturing process, can provide the clinical advantages we had hoped to achieve," said Lloyd Malchow, SenoRx President and Chief Executive Officer. "We are further pleased that several clinical sites have already submitted papers and abstracts for presentation at upcoming oncology meetings." SenoRx recently provided its initial estimate for 2008 revenues for all of its product lines, which is expected to be in a range of $46 million to $50 million.

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About SenoRx SenoRx (NASDAQ: SENO) develops, manufactures and sells minimally invasive medical devices used by breast care specialists for the diagnosis and treatment of breast cancer, including its flagship EnCor® system and ConturaTM MLB. SenoRx's field sales organization serves over 1,000 breast diagnostic and treatment centers in the United States and Canada. With 18 products having received FDA 510(k) clearance across the continuum of breast care, SenoRx is developing additional minimally invasive products for diagnosis and treatment of breast cancer. For more information, visit the company's website at www.senorx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning the expected clinical advantages of ConturaTM MLB and the company's financial guidance are forward-looking statements within the meaning of the Safe Harbor. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause SenoRx's actual results to differ materially from the statements contained herein. Information on potential risk factors that could affect SenoRx's business and its financial results are detailed in its most recent quarterly report on Form 10-Q, as filed with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, especially guidance on future financial performance, which speaks only as of the date they are made. SenoRx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.

CONTACT: SenoRx, Inc. Lila Churney, Director of Investor Relations 949-362-4800 x 132

::: SenoRx ::: Treatment

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For Patients: After lumpectomy procedure, your physician may recommend whole or partial breast radiation treatment to potentially reduce the recurrence of cancer cells in the lumpectomy site.

The current standard of care for treatment of breast cancer following lumpectomy is whole breast radiation. This requires the patient to return to the radiology suite daily for five to eight weeks.

SenoRx has developed ConturaTM, a multi-lumen radiation balloon applicator for accelerated partial breast irradiation. The radiation balloon uses vacuum to remove excess fluid and to adhere closely to often irregularly shaped lumpectomy cavities in order
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to deliver precise radiation dosing through multiple seed lumens. Treatment time is reduced to days versus weeks, and accurate, targeted radiation dosing decreases potential recurrence of cancer cells in the lumpectomy site.

With our advanced multi-lumen design, more accurate treatment is achieved. Certain patients who are presently candidates for balloon therapy are currently excluded because of the location of the lesion relative to their breast size. Our multilumen approach offers a solution to this problem.

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UW Medicine - Brachytherapy Patient Info

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Patient Care » Medical Specialties » Cancer Care » Specialty Services » Brachytherapy Patient Info

1959 NE Pacific / Seattle, WA / 206-598-3300

Interstitial Breast Brachytherapy Patient Information

Preparation for Treatment
The initial catheter placement for this treatment is performed at the Seattle Cancer Care Alliance. You will need to bring your medications with you to take as instructed by your nurse.

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sedating effects of the medications. Your nurse will have more specific information on these medications during your radiation oncology visit.

Transportation
Make sure you have arranged transportation home after your procedure. You will not be able to drive yourself because of the

Diet
You can eat a light breakfast or lunch one hour prior to arrival, but you may want to limit fluid intake until after the procedure.

What to wear
Loose fitting clothing that buttons down the front will make it easier to get dressed after your procedure.
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Aspirin or anticoagulants
Do not take aspirin or anticoagulation medications prior to your procedure. Discuss this with your doctor.

Herbal supplements
Stop herbal supplements one to two weeks prior to procedure.

Thermometer
You will need an oral thermometer to check your temperature three times a day.

Placement of the Treatment Catheters
When your procedure starts, your breast will be numb from the Emla cream. First, an ultrasound will be performed to identify the lumpectomy cavity. Fluid will be drawn from the cavity with a syringe and a contrast dye will be injected. Tell the nurse or doctor if you have had any previous reactions to contrast dye. Constrast dye helps your doctor see the area of needle placement more accurately under mammography.

Next, you will be taken to the mammography room for placement of the brachytherapy catheters. Your breast will be scrubbed with an antibacterial solution to help prevent infection. Then you will be positioned face down on the table, with your affected breast lying through a hole in the table. The medication you took should help you feel relaxed and as comfortable as possible while in this position for the procedure. A plastic template is then applied to the

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UW Medicine - Brachytherapy Patient Info

breast. The template has many little holes that help your doctor to Page 3 of 5 Case 5:08-cv-00133-RMW Document 8-9 Filed 02/06/2008 guide the needles in the correct location around the lumpectomy cavity. A mammogram is taken with the template in place to ensure that it is in the right location for placement of the catheters. Once the doctor is sure that the template is in the right location, a mixture of medications will be injected into the breast that will numb the skin and tissue before placement of the needles.

After the breast is thoroughly numb, the needles are placed. Another film is taken to be sure that the needles are all in the correct location. Then the plastic catheters are threaded through the needles and the needles are removed.

You will be assisted to a sitting position, and little plastic buttons will be applied to the ends of the catheters to secure them in place. Your nurse will apply antibiotic ointment to the skin at the catheter entrance and exit sites. This will help to prevent infection. A surgical bra and additional sterile dressings will help keep everything clean and the catheters in place.

Finally, you will be allowed to be driven home. You should take your pain medications as told. You will return the next day to the UW Medical Center Cancer Center for filming and a dressing change.

Daily Treatments
On the following Monday, your radiation treatments will begin. You will be treated twice a day, with about six hours between treatments. When you arrive, a receptionist will page your nurse who will escort you to the brachytherapy treatment room and help

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you to get comfortable on a stretcher. The nurse will remove your surgical bra and dressings and check your skin for any infection or irritation. Your doctor and a physicist will connect the numbered catheters to a flexible cable. Each cable will then be connected to the treatment machine. Your treatment will be delivered and monitored from outside the room.

During the treatment, a radioactive seed will slide inside each catheter and stay there for the proper amount of time. You will not feel the radiation treatment as it is given. You will hear a clicking sound from the treatment machine.

Your nurse will then apply new dressings and you will be allowed to leave the clinic until your next scheduled appointment. There will be no radiation left inside your body after the treatment. You should expect the entire process to take about one hour each time.

After Treatment
After your last treatment, the catheters are removed with very little discomfort. There is usually little or no bleeding. Your nurse will cleanse the breast and apply antibiotic ointment to the catheter entry and exit sites.

Your nurse will send you home with all the skin care supplies you will need to care for yourself after treatment. The nurse will review instructions for your care at home and when to call your nurse or doctor.

You will need to keep checking your temperature twice a day. Call us if your temperature exceeds 100.5 degrees F, or if you notice

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increased redness, tenderness, or cloudy drainage from any holes.

You will follow up one month after treatment. If you come from out of state, your local doctor can monitor you for the first six months. You should return to the UW Medical Center Cancer Center six months after brachytherapy for your first posttreatment mammogram and physical examination.

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MammoSite 5-Day Targeted Radiation Therapy: How It Works

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Find a Physician

Request InformationSearch

About Breast Cancer Know Your Treatment Options What is MammoSite 5-Day Targeted Radiation Therapy? Advantages of MammoSite How It Works View a Demonstration What to Expect Frequently Asked Questions Clinical Trial Data Is MammoSite Right for Me? Patient Stories Resources

Home / What is MammoSite? / How It Works

How It Works
View a demonstration of this procedure. MammoSite 5-Day Targeted Radiation Therapy simplifies breast cancer treatment... 1. Placement

After the breast cancer tumor is removed (lumpectomy), a small, soft MammoSite balloon attached to a thin tube (catheter) is placed inside the lumpectomy cavity through a small incision in the breast.


The balloon is "inflated" with saline solution so that it fits snugly into the cavity. It remains inflated during the 5-day treatment. A small portion of the catheter remains outside the breast; this is secured to a cushioned gauze pad to prevent movement of the catheter.



2. Treatment

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Treatment is planned by a radiation oncologist who will take images of the MammoSite balloon catheter in the breast and determine the amount of radiation needed. During therapy, the portion of the catheter that remains outside your breast is connected to a computer-controlled High Dose Rate (HDR) machine that inserts a radiation "seed" to deliver the therapy. Once therapy is complete, the seed is removed, the catheter is unplugged, and you will be free to return to your normal daily activities. No radiation remains inside your breast in between treatments.







3. Removal



After 5 days of treatment, your MammoSite balloon catheter will be removed, usually on the last day of treatment. The balloon is gently removed through the same incision made to place it.



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Delaine, Ft. Lauderdale, FL "It's fast. It doesn't hurt." Click here to see Delaine's Story. To hear more stories, visit www.VoicesofMammoSite.com

Maryanna, San Antonio, TX "I am soon to be a five-year survivor thanks to MammoSite!" Click here to see Maryanna's Story. To hear more stories, visit www.VoicesofMammoSite.com
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SenoRx Reports Third Quarter 2007 Results
Continued Strong Growth in Revenue and Gross Margin
ALISO VIEJO, Calif., Nov 13, 2007 (PrimeNewswire via COMTEX News Network) -- SenoRx, Inc. (Nasdaq:SENO) today reported financial results for its third quarter ended September 30, 2007. Revenue for the quarter increased 44.9 percent to $8.9 million, compared with $6.1 million in the third quarter of 2006. Gross profit increased 88.0 percent to $5.4 million, or 60.1 percent of revenue, up from $2.8 million, or 46.3 percent of revenue, in the third quarter of 2006. SenoRx reported an operating loss for the third quarter of $1.8 million, an improvement of 28.8 percent compared with $2.5 million in the same period last year. The operating loss for the quarter included additional administrative expenses of approximately $338,000 incurred during the period associated with being a public company and stock-based compensation expense of $655,000, compared with $289,000 in the third quarter of 2006. Net loss for the third quarter of 2007 declined 37.2 percent to $1.7 million or 10 cents per share, compared with $2.7 million or $1.15 per share for the third quarter of 2006. Contributing to the reduction in net loss for the third quarter was a significant swing to net interest income from net interest expense resulting from the IPO proceeds. "We are pleased to report another strong quarter for SenoRx. Revenues continued to grow strongly, led by a 44.9 percent increase in biopsy disposable revenues over the same period year ago. Also contributing to the revenue increase were new incremental commercial sales of our new Contura(tm) Multi-Lumen Balloon (MLB), as well as a significant increase in biopsy capital revenue for the third quarter," said Lloyd Malchow, SenoRx President and Chief Executive Officer. "We also continued to expand our gross margin, which showed significant improvement over the third quarter last year, and continued the positive sequential trend we have been achieving during 2007. Continued growth in the installed base of EnCor systems, favorable product sales mix, improved leverage of our manufacturing overhead across increased sales volume, and continued cost reduction as we transition certain component manufacturing to low-cost FDA-approved suppliers all contributed to the improvement in gross margin." For the first nine months of 2007, SenoRx revenues increased 35.1 percent to $24.7 million, compared with $18.3 million for the same period in 2006. Gross profit grew 59.5 percent to $14.1 million from $8.9 million in the first nine months of last year. Net loss for the first nine months of 2007 decreased to $5.9 million compared with $11.5 million for the same period a year ago. 2007 Outlook SenoRx is encouraged by the continued positive progress towards its financial performance objectives over the first nine months of 2007, and remains focused on executing its strategic plan. With the company's current product offering, including regulatory approval of the Contura MLB and most recently SenoSonix(tm), an integrated breast biopsy system with state-ofthe-art ultrasound imaging, the company believes it is well positioned to become a leader in both the diagnostic and therapeutic breast care market. Based on the current outlook, SenoRx management has narrowed its guidance for full-year 2007 revenues to $34 to $35 million. In addition, SenoRx has determined to use a portion of its IPO cash proceeds to retire the 2006 subordinated note prior to year end. The subordinated note bears an interest rate of 11.5 percent per annum and does not carry a prepayment penalty. Retirement of the subordinated note will result in an approximate use of cash in the amount of $10.4 million representing the principal balance and accrued unpaid interest. The company estimates the retirement of the subordinated note will result in a non-cash charge to non-operating expense of approximately $1.3 million in the fourth quarter of 2007, representing the unamortized debt issuance and debt discount costs which would have otherwise been charged to interest expense over the term of the subordinated note. The company intends to continue maintaining a credit facility on a going forward basis. 2008 Outlook SenoRx management is currently conducting its annual strategic plan and expects to provide revenue guidance for 2008 by calendar year end 2007, following approval by management and the Board of Directors.

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SenoRx will host a conference call at 2:00 p.m. Pacific Standard Time on Tuesday, November 13. The conference call can be accessed by calling (888)230-6285 or via the company's website www.senorx.com. About SenoRx SenoRx (Nasdaq:SENO), which completed its initial public offering of common stock in April 2007, develops, manufactures and sells minimally invasive medical devices used by breast care specialists for the diagnosis of breast cancer. SenoRx's field sales organization serves over 1,000 breast diagnostic and treatment centers in the United States and Canada. With 18 products that have already received FDA 510(k) clearance across the continuum of breast care, SenoRx is developing additional minimally invasive products for diagnosis and treatment of breast cancer. For more information, visit the company's website at www.senorx.com. The SenoRx, Inc. logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=3605 Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning SenoRx's financial guidance for fiscal year 2007 are forward-looking statements within the meaning of the Safe Harbor. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause SenoRx's actual results to differ materially from the statements contained herein. SenoRx's third quarter September 30, 2007 financial results, as discussed in this release, are preliminary and unaudited, and subject to adjustment. Further information on potential risk factors that could affect SenoRx's business and its financial results are detailed in its prospectus dated March 29, 2007 and its most recent quarterly report on Form 10-Q, in each case as filed with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, especially guidance on future financial performance, which speaks only as of the date they are made. SenoRx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.

SENORX, INC. CONDENSED BALANCE SHEETS (Unaudited)

September 30, 2007 ------------ASSETS Current Assets: Cash and cash equivalents Short-term investments Accounts receivable, net of allowance for doubtful accounts of $113,169 and $120,000, respectively Inventory Prepaid expenses and deposits Total current assets Property and equipment, net Other assets, net of accumulated depreciation of $442,956, and $539,602, respectively TOTAL

December 31, 2006 -------------

$

29,136,338 13,068,123

$

7,412,986 --

5,338,554 5,920,860 691,797 ------------54,155,672 1,066,060

4,241,307 4,988,695 220,659 ------------16,863,647 1,100,599

539,899 ------------$ 55,761,631 =============

2,017,079 ------------$ 19,981,325 =============

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

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Filed 02/06/2008
$ 4,122,477

Page 3 of 5

Current Liabilities: Accounts payable Accrued expenses, including accrued employee compensation of $786,914 and $507,829, respectively Deferred revenue--current Current portion of long-term debt Total current liabilities Long-term debt--less current portion Warrant liability Total long-term liabilities Convertible promissory notes (at fair value) Commitments and contingencies (Note 12) Stockholders' Equity (Deficit): Series A convertible preferred stock -$1.00 par value; 3,000,000 shares authorized,issued and outstanding (2006) (aggregate liquidation value of $3,000,000) Series B convertible preferred stock -$2.50 par value; 3,532,040 shares authorized; 3,523,040 issued and outstanding (2006) (aggregate liquidation value of $8,807,600) Series C convertible preferred stock -$1.96 par value; 19,500,000 shares authorized; 17,861,899 (2006) issued and outstanding (aggregate liquidation value of $35,009,323) Common stock, $0.001 par value -100,000,000 shares authorized; 17,107,635 (2007) and 2,371,002 (2006) issued and outstanding Additional paid-in capital Deferred compensation Accumulated deficit Total stockholders' equity (deficit) TOTAL

2,801,971 66,850 4,883,797 ------------9,375,020 8,837,553 -------------8,837,553 --

2,109,226 36,050 3,209,621 ------------9,477,374 10,596,147 1,529,250 ------------12,125,397 11,960,000

--

3,000,000

--

8,807,600

--

35,009,323

17,108 2,371 109,006,086 5,262,394 (2,662) (126,658) (71,471,474) (65,536,476) ------------- ------------37,549,058 (13,581,446) ------------- ------------$ 55,761,631 $ 19,981,325

SENORX, INC. CONDENSED STATEMENTS OF OPERATIONS (Unaudited)

Three Months Ended September 30, ----------------------2007 2006 ------------------Net revenues $8,906,086 $6,147,677 Cost of goods sold 3,555,638 3,301,367 ------------------Gross profit 5,350,448 2,846,310 Operating expenses:

Nine Months Ended September 30, ------------------------2007 2006 --------------------$24,727,447 $18,309,700 10,582,993 9,441,656 --------------------14,144,454 8,868,044

Case 5:08-cv-00133-RMW
Selling and marketing Research and development General and administrative Total operating expenses Loss from operations Interest expense Change in fair value of convertible promissory notes and warrant valuation Interest Income Loss before provision for income taxes Provision for income taxes Net loss Net loss per share - basic and diluted Weighted average shares outstanding basic and diluted 4,354,056 1,580,130 1,205,515 ---------7,139,701 ---------(1,789,253) 452,670

Document 8-11
13,085,547 4,694,999 3,092,703 ----------20,873,249 ----------(6,728,795) 1,379,405

Filed 02/06/2008
10,688,447 3,866,133 1,504,932 ----------16,059,512 ----------(7,191,468) 612,256

Page 4 of 5

3,588,887 1,423,762 345,777 ---------5,358,426 ---------(2,512,116) 231,017

-(551,288) ----------

-(990,875) (55,262) (1,182,327) ---------- -----------

3,820,000 (115,970) -----------

(1,690,635)

(2,687,871)

(5,934,998)

(11,507,754)

-3,000 -8,000 ------------------- --------------------$(1,690,635) $(2,690,871) $(5,934,998) $(11,515,754) ========== ========== =========== ===========

$(0.10) ==========

$(1.15) $(0.50) ========== ===========

$(4.98) ===========

17,076,002 ==========

2,331,054 ==========

11,973,240 ===========

2,313,663 ===========

REVENUE BY PRODUCT CLASS (Unaudited)

Three Months Ended September 30, ---------------------2007 2006 ---------- ---------Biopsy disposable products Biopsy capital equipment products Diagnostic adjunct products Therapeutic disposables Total $3,945,941 1,029,065 3,744,039 187,041 ---------$8,906,086 ========== $2,723,793 294,494 3,129,390 ----------$6,147,677 ==========

Nine Months Ended September 30, -----------------------2007 2006 -------------------$11,487,122 2,130,294 10,897,893 212,138 ----------$24,727,447 =========== $7,667,470 1,019,958 9,622,272 ----------$18,309,700 ==========

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This news release was distributed by PrimeNewswire, www.primenewswire.com SOURCE: SenoRx, Inc. SenoRx, Inc. Lila Churney, Director of Investor Relations 949.362.4800 ext.132 (C) Copyright 2007 PrimeNewswire, Inc. All rights reserved. News Provided by COMTEX

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Press Release

SENORX PROVIDES INITIAL ESTIMATE FOR 2008 REVENUE ALISO VIEJO, California, December 20, 2007 ­ SenoRx, Inc. (NASDAQ:SENO) today provided its initial estimate for revenues in 2008, which it expects will be in a range of $46 million to $50 million. SenoRx had previously indicated that it would be finalizing its annual strategic plan in December and would provide its estimate for 2008 revenues at that time. "We are encouraged by the continuing progress we have achieved during 2007 and feel positive about the fundamentals of our business, including the increasing pace of placements for our EnCor® breast biopsy system," said Lloyd Malchow, SenoRx President and Chief Executive Officer. "We believe that key elements of our growth will be our ConturaTM MLB radiation balloon, which we expect to transition from preference testing, currently expanded to 34 clinical sites, to full commercial launch in January 2008, as well as continued favorable reimbursement patterns. "In addition, to further assist investors in developing achievable earnings models for our financial performance in 2008, we are providing an initial estimate for deferred compensation and equity-based compensation expense, which we currently expect will range between $2.8 million and $3.2 million for the coming year," continued Malchow. "These ranges could be materially impacted based upon fluctuation in the market price of the company's common stock. We will continue to provide separate disclosure on a quarterly basis related to this item of expense. Deferred compensation and equity-based compensation charges in our recently reported third quarter were $655,000." About SenoRx SenoRx (NASDAQ: SENO) develops, manufactures and sells minimally invasive medical devices used by breast care specialists for the diagnosis and treatment of breast cancer, including its flagship EnCor® system and ConturaTM MLB. SenoRx's field sales organization serves over 1,000 breast diagnostic and treatment centers in the United States and Canada. With 18 products having received FDA 510(k) clearance across the continuum of breast care, SenoRx is developing additional minimally invasive products for diagnosis and treatment of breast cancer. For more information, visit the company's website at www.senorx.com.

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Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning the expectations of future revenue growth, the timing of our Contura commercial launch, the company's ability to maintain its product pricing, the company's financial guidance, and the factors that would impact that guidance, are forward-looking statements within the meaning of the Safe Harbor. Forwardlooking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause SenoRx's actual results to differ materially from the statements contained herein. Information on potential risk factors that could affect SenoRx's business and its financial results are detailed in its most recent quarterly report on Form 10-Q, as filed with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, especially guidance on future financial performance, which speaks only as of the date they are made. SenoRx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.

CONTACT: SenoRx, Inc. Lila Churney, Director of Investor Relations 949-362-4800 x 132

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Table C-10. U.S. District Courts--Median Time Intervals from Filing to Trial of Civil Cases in Which Trials Were Completed, by District, During the 12-Month Period Ending September 30, 2006
Total Trials Number of Trials Median Time Interval in Months* Nonjury Trials Number of Trials Median Time Interval in Months* Number of Trials Jury Trials Median Time Interval In Months*

Circuit and District

TOTAL DC 1ST ME MA NH RI PR 2ND CT NY,N NY,E NY,S NY,W VT 3RD DE NJ PA,E PA,M PA,W VI 4TH MD NC,E NC,M NC,W SC VA,E VA,W WV,N WV,S

3,201 29 154 14 80 7 19 34 320 52 33 62 143 21 9 308 26 61 117 47 52 5 238 33 28 8 5 67 48 29 5 15

23.2 37.0 26.7 17.0 28.0 19.0 33.0 29.9 29.8 42.0 29.0 25.7 41.8 24.3 26.0 33.0 18.0 20.0 33.5 19.5 25.0 22.0 21.8 9.3 18.4 20.0

1,107 9 55 6 29 8 12 108 13 6 19 67 3 104 12 29 39 12 10 2 90 9 22 5 1 18 27 5 3

21.0 26.0 28.5 28.0 25.0 26.0 30.5 23.4 22.4 24.0 30.5 19.0 9.0 19.0 17.0 18.0 27.0 8.5 -

2,094 20 99 8 51 7 11 22 212 39 27 43 76 18 9 204 14 32 78 35 42 3 148 24 6 3 4 49 21 24 5 12

24.8 34.0 26.0 27.0 15.0 34.0 31.8 29.0 42.0 29.0 26.4 41.9 26.0 26.0 34.0 18.4 20.9 34.5 20.6 21.0 20.8 10.0 16.0 19.0

Case 5:08-cv-00133-RMW

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209

Table C-10. (September 30, 2006--Continued)
Total Trials Number of Trials
471 64 6 36 37 63 59 50 106 50 256 9 16 66 11 39 26 31 28 30 217 91 23 24 10 33 11 25 244 72 27 10 12 26 31 24 26 9 7

Nonjury Trials Number of Trials
188 36 1 19 4 26 22 8 51 21 54 1 1 12 3 9 9 8 6 5 58 32 4 6 11 1 4 76 27 7 3 4 5 8 6 12 3 1

Jury Trials Number of Trials
283 28 5 17 33 37 37 42 55 29 202 8 15 54 8 30 17 23 22 25 159 59 19 18 10 22 10 21 168 45 20 7 8 21 23 18 14 6 6

Circuit and District
5TH LA,E LA,M LA,W MS,N MS,S TX,N TX,E TX,S TX,W 6TH KY,E KY,W MI,E MI,W OH,N OH,S TN,E TN,M TN,W 7TH IL,N IL,C IL,S IN,N IN,S WI,E WI,W 8TH AR,E AR,W IA,N IA,S MN MO,E MO,W NE ND SD

Median Time Interval in Months*
21.1 20.0 25.5 24.0 25.5 20.0 17.7 18.8 14.6 25.9 27.5 24.0 36.0 22.3 27.0 26.5 25.4 24.7 24.4 26.4 30.0 20.0 25.0 26.0 28.0 13.4 21.4 21.7 13.0 17.0 24.0 26.4 21.5 23.4 21.0 -

Median Time Interval in Months*
19.7 22.0 25.0 25.0 17.0 13.0 11.0 23.5 15.0 24.0 26.0 23.0 21.3 21.0 22.0 -

Median Time Interval In Months*
22.8 19.2 25.0 24.0 24.0 23.0 17.0 22.0 19.8 25.6 27.5 25.8 22.8 30.4 23.0 26.0 24.0 25.7 26.5 30.5 19.0 25.0 26.0 28.0 13.4 21.5 21.0 13.5 27.0 19.0 23.0 20.0 -

210

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Table C-10. (September 30, 2006--Continued)
Total Trials Number of Trials
462 1 57 56 41 134 31 12 10 6 32 30 15 34 1 2 175 53 22 21 13 5 29 24 8 327 39 14 7 19 74 98 49 17 10

Nonjury Trials Number of Trials
199 24 25 9 70 11 9 6 4 17 7 4 13 51 15 6 8 1 2 5 13 1 115 7 3 2 7 28 43 18 5 2

Jury Trials Number of Trials
263 1 33 31 32 64 20 3 4 2 15 23 11 21 1 2 124 38 16 13 12 3 24 11 7 212 32 11 5 12 46 55 31 12 8

Circuit and District
9TH AK AZ CA,N CA,E CA,C CA,S HI ID MT NV OR WA,E WA,W GUAM NMI 10TH CO KS NM OK,N OK,E OK,W UT WY 11TH AL,N AL,M AL,S FL,N FL,M FL,S GA,N GA,M GA,S

Median Time Interval in Months*
26.0 32.0 25.0 34.0 21.3 33.0 10.0 30.0 29.5 27.0 17.0 19.0 22.5 32.0 21.0 15.8 19.0 16.4 25.0 21.9 28.5 20.0 19.0 19.2 16.3 31.0 23.0 44.0

Median Time Interval in Months*
22.2 31.0 26.0 16.9 30.0 25.5 21.0 21.0 32.0 30.0 18.2 18.5 14.8 27.0 -

Median Time Interval In Months*
28.9 33.0 25.0 36.0 25.0 33.0 30.0 32.5 17.0 18.3 22.0 29.0 22.0 16.5 18.0 16.7 23.0 23.2 28.0 20.0 17.0 22.0 19.7 31.5 28.0 -

NOTE: INCLUDES TRIALS CONDUCTED BY DISTRICT AND APPELLATE JUDGES ONLY. ALL TRIALS CONDUCTED BY MAGISTRATE JUDGES ARE EXCLUDED. EXCLUDES THE FOLLOWING TRIALS: LAND CONDEMNATION; FORFEITURES AND PENALTY CASES; PRISONER PETITIONS (HABEAS CORPUS, MOTIONS TO VACATE SENTENCE UNDER 28 U.S.C. 2255, HEARINGS ON EVIDENTIARY MATTERS); BANKRUPTCY PETITIONS; AND THREEJUDGE COURT CASES. FOR CIVIL CASES RESULTING IN A COMPLETED TRIAL, THE MEDIAN TIME IS BASED ON THE ORIGINAL FILING DATE AND THE DATE THE TRIAL WAS COMPLETED. FOR REOPENED CIVIL CASES RESULTING IN A SECOND COMPLETED TRIAL, THE MEDIAN TIME REMAINS BASED ON THE ORIGINAL FILING DATE AND THE DATE THE TRIAL WAS COMPLETED.

* TIME INTERVALS COMPUTED ONLY FOR 10 OR MORE TRIALS.

Case 5:08-cv-00133-RMW Case 5:05-cv-05312-RMW

Document 8-14 Document 109

Filed 04/27/2007 Filed 02/06/2008

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1 2 3 4 5 6 7 8 9 10 United States District Court For the Northern District of California 11 12 13 14 15 Defendants. 16 17 18 19 20 21 22 23 24
1

E-FILED on

4/27/07

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION

XOFT, INC., Plaintiff, v. CYTYC CORPORATION; and PROXIMA THERAPEUTICS, INC.