copyright © 2010 xoft, inc. mc107 r9 03/2010. copyright © 2010 xoft, inc. - 2 - confidential mc107...

Copyright © 2010 Xoft, Inc. - 2 -

CONFIDENTIAL MC107 R9 03/2010

The global leader in Electronic Brachytherapy (eBx™)

Products based on proprietary miniaturized X-ray source technology

Key company milestones:

– FDA Clearance, Axxent System, Breast Only: Dec 2005

– Ramping up Production/Manufacturing: 2006

– Breast APBI Clinical Trial: 2007

– Soft Launch: Dec 2007

– FDA Clearance, Rest of Body (Controller/Source) : Feb 2008

– FDA Clearance Endometrial cancer: May 2008

– Breast IORT, first treatment: September 2008

– Skin cancer: July 2009

-- Pergentium Ltd distribution Nov 2009

Xoft’s Mission – Expanding access to highly conformal radiation therapy through our system of care to improve the treatment of a broad array of cancers

Xoft, Inc. – Basic Facts



The Xoft System Evolution

BREAST

REST OF BODY



The Axxent System is being used at many marquee medical centers including 5 hospitals ranked in the top 20 hospitals in the U.S.

5 of the Top 20 US Hospitals have eBx™

* Indicates ranking US News and World Report top 20 hospitals. ** indicates ranking top cancer hospitals. (1) Rankings per US News and World Report.

Academic Sites Treating Lead Physician Ranking (1) Special Interest

UCLA Medical Center Michael Steinberg M.D. 3* Multi-platform / IORT

Memorial Sloan Kettering Josh Yamada M.D. 2* IORT-Spine

New York-Presbyterian-Cornell Dattatereyudu Nori M.D. 6** IORT – Abdominal

Barnes – Jewish Hospital Robert Myerson M.D. 9* IORT – Rectal

Moffitt Cancer Center/USF Charlie Cox M.D. 16** IORT - Breast



Install Base

There are currently 53 Axxent systems installed in the U.S. (1)

Represents site with an Axxent system installed

W Y

ND

SD

NE MDINIL

IA

MN

W I

MI

NHVT

RI

CA

ID

MT

NV

UT

AZNM

COKS

OK

TX LA

AR

AL GA

FL

SC

NCTN

KYVA

DEW V

PA

OH

MO

NY

AK

HI

CT

MS

ME

NJ

OR

WA

MA

(1) One system has been installed internationally in Seoul, South Korea.



Traditional RT Treatment Options & Limitations

Xoft’s eBx system addresses many of the shortcomings of traditional RT systems



Xoft eBx™ Technology Multi-application platform

– Clinical

■ The Axxent eBx eliminates the need for radioactive isotopes

■ Offers physicians a safer and more easily managed radiotherapy platform

■ Delivers radiation directly to the tumor site sparing healthy tissue and organs

■ Offers an easy entry into IORT

– Operational

■ No radioisotope, No NRC licensing, No handling, No safety issues; allows the facility to operate in an isotope-free environment outside of the traditional bunker

– Financial

■ ~£1.0 million bunker expense eliminated as well as a barrier to offer radiation therapy



Radium Capsules

Isotope Needle and Seed Implants

Isotope Based HDR Afterloader

Cesium-137Cobalt-60

Digital Linear Accelerator

Inte

rnal

RT

Ext

ern

al R

T

Combines the Benefits of Brachytherapy with

Modern Electronic Therapy Technologies

Orthovoltage X-rays

eBx has the potential to do to isotope therapy what linear accelerators did to cobalt therapies—a generation ago

Electronic Brachytherapy (eBx)A Next Step in the Evolution of Radiation Therapy

Axxent



Why eBx™?

No shielded vault required

Platform technology – large existing market opportunity

Non-radioisotope source

Enables IORT

Minimizes dose to healthy tissue

Medical staff can remain in the room with the patient, as determined by the facility Radiation Safety Officer

Portability increases market opportunity

Xoft’s miniaturized eBx technology offers significant advantages over traditional brachytherapy



Equivalent Treatment at a Fraction of the Cost

LINAC System Bunker Cost

HDR Reloader Bunker

Axxent

+

+

=

=

=

£3.5mm

£1.8mm

£0.3mm

Xoft delivers equivalent treatment at 1/6th – 1/10th the cost of alternative systems



Non-Radioisotope Source

– Increasing regulatory control over use of radioactive isotopes in medicine

– Medical Isotopes under Nuclear Regulatory Commission (NRC) control which is now governed by the Department of Homeland Security

– Issuing directives backed by The National Academy of Sciences (NAS) to explore economic and clinically viable alternatives to isotopes which pose potential security threat

– Environmental and patient concern over use of isotopes

– Nuclear Regulatory Commission (“NRC”) requires physicians to “stand by equipment” during treatment in case of radioactive accident during brachytherapy

Among numerous other advantages, public safety and environmental concerns will also drive eBx adoption

eBx Source

Traditional Source



eBx Enabling Technology for IORT

Low energy – High dose non-isotopic disposable source is unique to Xoft and allows for safe placement of source into surgical site without the need of a shielded bunker

A single dose of intraoperative radiation may have as much effect on the tumor as 8-10 daily radiation treatments

KOL’s and soon to be released clinical data will accelerate IORT adoption



eBx’s Superior Dose Profile Spares Healthy Tissue

Unlike radioactive isotopes, eBx delivers less radiation to surrounding healthy organs and tissue (1)

Dose profile significantly reduces treatment course

– For example, in breast cancer patients, treatment is typically reduced from 6-7 weeks for external beam to 5 days

Decrease normal tissue toxicity

Significant patient comfort and compliance benefits

Dose Distribution eBx vs. Mammosite

eBx vs. HDR for Endometrial Cancer

(1) Dickler, et al. "A Dosimetric comparison of MammoSite high dose rate brachytherapy and Xoft Axxent electronic brachytherapy," Brachytherapy (6) 2007, 164-168. "A Dosimetric comparison of Xoft Axxent Electronic Brachytherapy and Ir-192 HDR brachytherapy in the treatment of endometrial cancer," Brachytherapy (7) 2008, 154.



eBx Safer for Medical Personnel and Improving Patient Care

Low energy source spares medical personnel coincidental exposure to high-energy ionizing radiation

– Source non-radioactive when switched “off”


The ability to comfort patients during treatment is viewed as a significant quality of care improvement that only eBx offers



Radiation follow ing BCS

82%86%

78%

69%

57%

42%

0%

25%

50%

75%

100%

< 10 10 – 25 25 – 50 50 – 75 75 – 100 > 100

Miles from Radiation Therapy Facility

Portability Increases Potential

Strong correlation exists between distance to treatment center and percentage of patients receiving radiation therapy

Axxent’s portability significantly increases Xoft’s addressable market opportunity

(1) Journal of National Cancer Institute, February 2, 2000 New Mexico Statistics following Breast Conserving Surgery.(2) Impact of Patient Distance to Radiation Therapy on Mastectomy Use in Early Stage Breast Cancer Patients, A. Schroen et al., Journal of Clinical Oncology, October 1, 2005

Radiation Following BCS vs. Distance from RT Facility (1)

% of Patients Opting for Mastectomy

43%47%

53%

58%

0%

25%

50%

75%

100%

≤10 10 to 25 25 to 50 >50

Miles from Radiation Therapy Facility

Choice of Mastectomy (2)

Copyright © 2010 Xoft, Inc.

Xoft System Overview



The Xoft System Evolution

BREAST

REST OF BODY



Xoft System Overview

Axxent Controller

Axxent X-ray Source

Axxent Balloon Applicator

Axxent Vaginal Applicator

Axxent Surface Applicator

FDA Cleared: – 2/29/2008 – General

radiation therapy indication

FDA Cleared: – 2/29/2008 – General

radiation therapy indication

FDA Cleared : – 12/22/2005

(breast) – 7/16/2009

(everywhere) – Intracavitary or

intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment

FDA Cleared: – 5/9/2008 – Intracavitary

brachytherapy in the vagina and rectum

FDA Cleared: – 2/11/2009 – Skin

brachytherapy, including IORT



Controller

Xoft Controller

The Axxent controller:

– Controls dose delivery

– User friendly interface

FDA clearance breast:

– December 2005

Cleared for general radiation therapy:

– February 2008

Weight 200lbsUser Interface



Miniaturized X-ray Source

Xoft: Miniaturized X-ray Source Overview

High vacuum X-ray tube technology

– 40 - 50 kV operating potential

– Output: ~1 Gy/min. 1cm into tissue

Treatment times are comparable to "Fresh" Ir-192 sources

Fully disposable device

FDA clearance breast:

– December 2005

Cleared for general radiation therapy:

– February 2008

Xoft’s miniaturized eBx technology



Axxent Source and Dose Rate Comparison Dose Rate vs. Energy Profile

The unique, proprietary non-radioisotope high dose – low energy source

Miniature X-ray Source Dose – Energy Characteristics

High dose rate – low energy source

Dose deposited locally, but sufficient to penetrate target tissue

Advantages Outpatient treatment times same as fresh (7 Ci)

Ir192 source

Source doesn’t decay over time therefore maintains constant dose profile

Minimal stray radiation to normal tissue, organs, and medical personnel

Minimal shielding required – i.e. no bunker Portable


Enables IORT

En

erg

y

Dose Rate

Low High

Low

High

Radioactive Seeds Xoft

Radioactive Sources or

External Beams



Xoft s miniaturized X-ray source delivers equivalent dose as Ir at the prescription point butlower dose to critical structures

Source Depth-Dose Characteristics (Balloon Applicator)

Same dose as Iridium-192 at the prescription point

Higher dose inside applicator (absorbed by saline)

Lower dose far away (less shielding needed)

Lower dose to critical structures (heart, lung, contralateral breast)



Use Stepping to Reduce Effect of Source Anisotropy

Single source position•2.5 cm from distal tip (position 22.5)

Stepped source•9 positions, 5 mm spacing, active range 24.5 – 20.5 cm

Note reduced anisotropy



Xoft Controller Components

Applicator hubattachment

Source connectedto source nest

Source high voltagecable attachment



Xoft Controller Well Chamber and Electrometer Components

Source in well chamberfor calibration

Well chamber connectedinternally to electrometer



Transportable



Endometrial Applicator

Skin Applicator

Balloon Applicator

Axxent: Applicators

Future development will expand eBx indications

Sterile Sheath - DaVinci

HAM App. Beth Israel

Spine App. Sloan Kettering


Current Indications Treated



Breast Cancer Overview

Incidence:

– There were approximately 254,650 cases in 2009

Breast cancer is the most common cancer among women, except for skin cancers; the chance of developing invasive breast cancer at some time in a woman's life is approximately 1 in 8 (12%)

Current treatment options included:

– External beam RT therapy - a 30 day treatment plan

– Mastectomy - a conservative, but disfiguring option

– Traditional brachytherapy - which delivers more radiation to heart and lung than eBx

Source: American Cancer Society; Cancer Facts and Figures 2008-9, SEER Incidence Data, 1999-2003. National Comprehensive Cancer Network (NCCN).

Xoft’s portability offers a unique advantage and opportunity to expand the current useage for APBI



Treating Breast Cancer with eBx

Patient Driven:

– 5 days versus 6 to 7 weeks of therapy

– Increased convenience for the frail / elderly patient

– Working woman or rural patient

– Increased access for patients

– Medical personnel can stay in the treatment room as determined by the facility Radiation Safety Officer

Physician Driven:

– Increased utilization of BCT

– Decrease normal tissue toxicity

– EconomicsSource: American Cancer Society; Cancer Facts and Figures 2008-9, SEER Incidence Data, 1999-2003. National Comprehensive Cancer Network (NCCN).

U.S. breast market: 254,650 Cases in 2009U.S. lumpectomy market: 162,575 Eligible patientseBx market: 70,000 Eligible patients

eBx’s high-dose, low-energy source delivers less radiation to critical structures such as the heart and lung



Endometrial Cancer Market Overview

Incidence:– 40,895 endometrial cases in 2009

Endometrial cancer is the fourth most common cancer in women and the most common female reproductive cancer, according to the American Cancer Society (ACS)

With eBx the patient receives less dose to rectum and bladder potentially reducing long term effects of radiation

Brachytherapy is a preferred treatment for Endometrial Cancer according to the PORTEC study (1)

– Patients who received external beam therapy reported significantly higher levels of bowel symptoms and a decrease in social functioning; Brachytherapy should be the preferred treatment

Source: American Cancer Society; Cancer Facts and Figures 2008-9, SEER Incidence Data, 1999-2003. National Comprehensive Cancer Network (NCCN).(1) J Clin Oncol 27:3547-3556. © 2009 by American Society of Clinical Oncology.



Treating Endometrial Cancer with eBx

Patient Driven:

– Increased access for the patient


Physician Driven:

– Improved Dosimetry, Axxent source does not show anisotropy like Iridium

– Doses outside PTV lower for Axxent HDR Source due to steeper dose fall-off; spares healthy tissue of the rectum and bladder

– Applicator insertion and treatment set-up similar

– No isotope handling

– Minimal shielding required

Endomentrial market : 40,895 Cases in 2009 eBx market: 27,619 Eligible

patients


Axxent has significant competitive advantages due to its more optimal dose targeting that dramatically reduces dose to the bladder and rectum



Skin Cancer Market Overview

Incidence:

– 1 million non-melanoma skin cancer

■ 750,000 basal and 250,000 squamous

Radiation therapy cases:

– 26,000

Current standard of care:

– Surgery, Mohs surgery & traditional RT

– Surgery can be disfiguring especially for areas around the face and where there is cartilage

Referring Physician:

– Dermatologist


Xoft’s customers now say patients request a non surgical approach to treatment.



Treating Skin Cancer with eBx

Patient Driven

– More convenient dose schedule compared to external beam

– An option for those who can not undergo surgery


Physician Driven

– Xoft Electronic Brachytherapy using surface applicator offers comparable technique to Ir-192 HDR brachytherapy with several advantages

■ Isotope free

■ Dosimetric advantages compared to electron beam

■ Superior dosimetry that allows for reduced margin

►1 million cases (1)

(1) American Cancer Society; Cancer Facts and Figures 2007-8.(2) SEER Incidence Data, 1999-2003 National Comprehensive Cancer Network (NCCN).

Basal and Squamous Cell Cancer Patients

Basal and Squamous Cell Cancer Patients Receiving Radiation Therapy

► 26,000 cases per year (2)

Xoft's unique dosimetric capabilities provided significant competitive advantages in treating skin cancer

Image courtesy of James S. Welsh MS, MD, FACRO



Case Study - Ajay Bhatnagar MD, MBA

74 yr old gentleman with 2.5 cm squamous cell carcinoma lesion

Self referral with chief complaint: “Tired of being cut by my dermatologist”

Xoft Electronic Brachytherapy treatment course:– Received 40.0 Gy in 8 Fractions using 35 mm surface applicator, prescribed to 0.5

cm depth– Delivered twice weekly

Pre-treatment Post-treatment*

Squamous cell carcinoma lesion

Axxent enables significant improvement in cosmesis

* 30 days post treatmentImages courtesy of Ajay Bhatnagar,MD



Ajay Bhatnagar, M.D.Cancer Treatment Services Arizona

“The Axxent eBx System allows surface brachytherapy in a minimally shielded environment without the use of radioactive isotopes or a megavoltage linear accelerator. Access as well as the radiation process is simplified.”

“Patients are quite excited about this new technology for several reasons, including the reduced shielding compared to external radiation therapy. They also prefer this treatment over surgery for their skin cancer. They often tell me that they wish they had this treatment rather than surgery for their previous skin cancers and will not do surgery again for any future skin cancers.”

"Given the small penumbra of the Axxent eBx System, smaller field sizes can be used than with electron beam therapy, therefore providing a better cosmetic outcome. eBx can effectively treat amorphous areas such as the nose, which can be difficult to treat given the dosimetric properties of electron beam therapy. The lightweight contact applicator is easy to use, especially to treat surface lesions on the nose. In addition, treatment set-up and planning is much simpler compared to electron beam therapy."

Dr. Bhatnagar - Radiation Oncologist



September 3rd, 2008 AM

7:45---Patient enters hospital

8:45--- Patient set up in OR

9:00---Sentinal node biopsy removed and sent to pathology

9:20---Lumpectomy performed

9:50---Balloon placed and radiation commences

10:15 Radiation complete and oncoplastic work commences

10:45 Surgery completed

11:45 Patients leaves hospital

Therapy complete---only follow up monitoring

September 7th—Cancer Free Patient at wedding

IORT - A New Frontier in Radiation TherapyDelivering RT and lumpectomy (with reconstruction) all in a 1 day therapy regimen



Patient DischargedThe patient was in at 7:45 AM and out at 11:45 AM



Potential Areas for Research Include

IORT – When Combined with IMRT is Gaining Support

Delivers targeted dose at time of surgery

1 procedure as opposed to a series of treatments

The dosimetric advantage provided by IORT to surgically available tumor beds will allow additional dose to secondary sites that would otherwise exceed typical tolerance limits

The biologic effectiveness of a single large radiation dose is higher than for the same dose given in a fractionated regimen

The dose of radiation is precisely delivered to the area at greatest risk of tumor recurrence (or persistence)

Customized internal shielding allows the physician to protect dose-limiting normal tissues

Can be used as a monotherapy or boost

Lung

Brain

Spine

Head

Neck

Colon

Liver



“I believe that giving a single fraction of radiation at the time of surgery will be advantageous because it will allow all the radiation to be delivered before any remaining tumor cells have a chance to grow. In addition, due to the dose distribution of the electronic brachytherapy source, it will intensify the dose to the part of the breast at highest risk for recurrence... The mobile nature of the Xoft Axxent controller, the low energy/shielding requirements associated with the Xoft source, and the rapid fall of kV radiation all make it ideal for IORT.”

Adam Dickler, M.D. - Radiation Oncologist

“A number of potential problems associated with the delivery of postoperative APBI can be negated with IORT, and specific surgical techniques can be employed at the operating table. I think this is very advantageous for IORT and because of this I think IORT could increase the number of APBI cases.”

Olga Ivanov, M.D. - Surgeon

“The fact that my treatment was done before I even woke up is beyond words...I came in with cancer, went to sleep, and when I woke up, I was completely done with my breast cancer.”

Marianne H. - Patient

IORT – Physician and Patient Perspectives



IORT – Growing Clinical and KOL Support

Continue to focus on new markets with academia

– Veronesi’s European data to be published in the U.S.

■ 1,246 patients with 7-year correlation to 1,213 patients treated with electrons

– Zeiss TARGIT Trial data to be completed and published in Q1 (2,200 cases)

■ This will give us more data on IORT than we have for APBI

– Dickler multi-center protocol: 15 cases

■ USF – Dr. Charles Cox

■ Dallas Methodist – Dr. Arve Gillette

■ Univ. of Mississippi – Dr. Michael Baird

■ Reed City

– Hoag’s: Mel Silverstein protocol

■ Dr. West @ RadNet

■ Dr. Giuliani @ St. John’s

IORT will become a significant growth driver and an important focus of sales and marketing efforts



Xoft eBx Competitive MatrixXoft enjoys numerous advantages over competitive Brachytherapy systems


Customer Service & Support



Service Support and Customer Service

Instrument installations

Customer training / orientation

Instrument telephone support assistance 24/7

48 hr On-site response

Scheduled maintenance

Instrument updates / upgrades

Service support programs and pricing

Factory / depot instrument & parts repair

Service support metrics

What Service Support Provides



Customer Survey Results - "Would You Recommend Xoft?"

“Most importantly, the approach taken with the treatment planning system by having a trained individual to help with the first few plans is critical.”

“Most importantly, the approach taken with the treatment planning system by having a trained individual to help with the first few plans is critical.”

“Easy to use, no shielding required (unlike HDR unit), physicist does not have to be present at time of tx, not a radioactive source (more strict guidelines w/ HDR)”

“Easy to use, no shielding required (unlike HDR unit), physicist does not have to be present at time of tx, not a radioactive source (more strict guidelines w/ HDR)”

“I believe in the technology. Your company is presenting this technology in the right direction.”

“I believe in the technology. Your company is presenting this technology in the right direction.”

“Excellent product with very good sales and training support”

“Excellent product with very good sales and training support”

“Quite impressed by the sales and training group. Always available to help with the smallest issues.”

“Quite impressed by the sales and training group. Always available to help with the smallest issues.”

100% of 2009 survey respondents will recommend Xoft to their colleagues

Note: Statements are actual responses from Xoft customers.


Clinical Publications



Publication Summary Reference

Breast Cancer

Dosimetric Comparison Xoft versus Ir-192

Dickler A, Kirk MC, Seif M et al. A Dosimetric Comparison of Xoft Electronic Brachytherapy and Iridium-192 High Dose Rate Brachytherapy, Brachytherapy 2007;6;164-168.

ASCO Breast Cancer Symposium- Preliminary Report of 44 Patient Study Results, 2008

Mehta V, Dooley W, Greim K et al. Early Experience With An Electronic Brachytherapy Technique For Intracavitary Partial Breast Irradiation. ASCO Breast Cancer Symposium 2008; poster presentation Dec 2008.

Dose Volume Characterisitcs of the 50 kV Source

Smitt MC, Kirby R. Dose Volume Characteristics of a 50kV Electronic Brachytherapy Source For Intra-Cavitary Accelerated Partial Breast Irradiation; Brachytherapy 2007, 6, 207-211.

RSNA Preliminary Report of 44 Patient Study Results

Mehta, VK. Early Experience with An Electronic Brachytherapy Technique For Intracavitary Partial Breast Irradiation. RSNA 2009; Abstract.

Detailed description of how to treat patients using the Xoft system intra-operatively at time of lumpectotmy for the treatment of early stage breast cancer.

Dickler A, Ivanov O, Francescatti D, Intra-operative Radiation Therapy In the Treatment of Early Stage Breast Cancer Utilizing Xoft Axxent Electronic Brachytherapy; World Journal of Surgical Oncology 2009; 7:24.

APBI Initial Experience with Xoft for the Treatment Breast Cancer & 1 Year follow-up

Mehta VK, Algan O, Greim K et al. Early Experience With An Electronic Brachytherapy Technique For Intracavitary Partial Breast Irradiation. Provisionally accepted, In Press American Journal of Clinical Oncology 2010.

Endometrial Cancer

50 kV electronic brachytherapy source can provide equivalent target volume coverage to Ir-192 when using a vaginal cylinder, however eBx allows increased sparing of the bladder and rectum.

Dickler A, Kirk MC, Coon A et al. Dosimetric Comparison of Xoft Electronic Brachytherapy and Ir-192 HDR Brachytherapy In the Treatment of Endometrial Cancer. Brachytherapy 2008; 7;351-354.

Current Publications Over 75 abstracts on Xoft technology accepted for publication or poster and/or oral presentations

at national and international meetings since May 2004



Publication Summary Reference

Physics & Dosimetry

Electronic Source Will Ultimately Replace Ir-192 as the source for HDR Brachytherapy

Holt RW, Thomadsen BR, Orton CG. Mini-X-ray Tubes Will Ultimately Displace Ir-192 As The radiation Source for High Dose Rate Brachytherapy. Medical Physics 2008. 35: 815-817.

Measurements of x-ray spectra and half value layers for the Axxent source operating at 40 and 50 kV are compared with Monte Carlo calculations using Geant4.

Reniers B, Liu B, Rusch T, et al. Calculation of RBE of a low-energy electronic brachytherapy source; Physics in Medicine and Biology 2008. 53: 7125-7135.

Calculations and measurements of TG-43 Source parameters

Mahesh M, Detorie N, Holt R, et al. Electronic Brachytherapy: Comparisons With External Beam and High Dose Rate 192Ir Brachytherapy. Journal American College Radiology 2008; 5: 221-223.

Procedures used at Rhode Island Hospital to commission the Xoft system.

Hiatt JR, Cardarelli GA, Hepel J, et al. A Commissioning Procedure for Breast Intracavitary Electronic Brachytherapy Systems. Journal of Applied Clinical Medical Physics 2008; 9: 58-68.

The Xoft system is described along with calculations and measurements of TG-43 Source parameters.

Rivard M, Davis S, DeWerd L, et al. Calculated and Measured Brachytherapy Dosimetry Parameters for the Xoft AXXENT X-ray Source: An Electronic Brachytherapy Source; Med Phys 2006; 33:4020-32.

Dosimetric Comparison of eBx versus Ir-192 in APBI Application

Mille MM & Xu XG. Comparison of organ doses for patients undergoing balloon brachytherapy of the breast with HDR 192Ir or electronic sources using Monte Carlo simulations in a heterogeneous human phantom. Med Phys 2010; 37; 662-671

Measurements of x-ray spectra and half value layers for the Axxent source operating at 40 and 50 kV are compared with Monte Carlo calculations using Geant4.

Liu D, Poon E, Bazalova M et al. Spectroscopic characterization of a novel electronic brachytherapy system. Physics in Medicine and Biology 2008; 53: 61-78.

Point-counterpoint discussion

Sternick E, Todor D, Orton C. Intensity modulated electronic brachytherapy will soon become the brachytherapy treatment of choice for irregularly shaped tumor cavities or those closely bounded by critical structures. Medical Physics 2009. 36:681-683.

Current Publications (Cont’d)



Study

Design Study Overview Publication Status and Timelines

# Papers

Post Market APBI

1st experience with Xoft system, 6 month, 1, 2, 3, 4, 5 year follow-up. 1 year follow-up complete; 2 yr follow up in progress. N=44

Jan 2010: Peer reviewed publication accepted in major journal May 2010: Target date to publish 44 patient study May 2010: Target date to publish dosimetry focused paper Sep 2010: Target date to publish surgical focused paper Oct 2010: 2011, 2012, 2013: Target date to publish 2,3,4,5 year data

7

EXIBT Registry

APBI registry, 6 month and 1, 2, 3, 4, 5 year follow-up. N=67

Oct 2010: Target date publish through 1-year follow-up (25/ 69) Feb 2011: Publication target date to publish 1 year follow-up on all Feb 2012: Publication target date to publish 2 year follow-up on all Feb 2013, 2014, 2015:Publication target dates for 3,4,5 year follow-up

6

Chart Review

Multi-center retrospective study of APBI patients. N=60

Sep 2010: Publication target date 1

Chart Review

Single-center APBI, N=35 Aug 2010: Target date to publish single-center APBI experience 1

Breast Cancer

Breast IORT

Physician sponsored multi-center study. N=50

Apr 2010: Present abstract at ASBrS Apr 2010 on first 10 patients 1 1

1

Post Market

Treatment feasibility and acute safety through 3-month follow up. N=15

Oct 2010: Publication target date 1 Endometrial

Cancer Chart Review

Retrospective data collection study. N=40 Oct 2010: Publication target date 1

Post Market

Report safety and efficacy through 5-year follow up. N=50

Dec 2011: Publish all patients after 3 month follow-up Apr 2012: Publish all patients after 1 year follow-up May 2012, 2013, 2014, 2015: Target dates to publish annual follow-up

6 Skin

Cancer Chart Review

Retrospective data collection study report safety, cosmesis. N=25

Oct 2010: Publication target date 1

Multi-indication

IORT

Post Market

Xoft following surgical resection of pancreatic, stomach, head neck cancer, retroperitoneal sarcomas; follow-up through 3 years. N=15

Oct 2010: Publication target date of feasibility intra-op (5 of 15) Jul 2011: Publication target date of feasibility acute results, N=15 Dec 2012: Publication target date for 1 year follow-up, N=15

3

Clinical Publication Strategy Xoft currently executing 10 studies which will yield 17 papers to be published over the next two years



Recent Publication in Medical PhysicsXoft gives dramatically less dose to healthy tissue, particularly heart and lung, when compared to HDR Ir 192

during 5 day breast treatment

Comparison of organ doses for patients undergoing balloon brachytherapy of the breast with HDR Ir192 or electronic sources using Monte Carlo simulations in a heterogeneous human phantom

Matthew M. Mille and X. George XubNuclear Engineering and Engineering Physics Program, Rensselaer

Polytechnic Institute, Troy,New York 12180

Mark J. RivardDepartment of Radiation Oncology, Tufts University School of Medicine, Boston,

Massachusetts 02111

"As some studies have suggested, there may be a link between low doses to the heart and lungs during radiotherapy to heart disease and lung cancer, dose-reductions to these organs afforded by eBx could prove clinically relevant. Regardless, the ALARA or “as low as reasonably achievable” precautionary principle of radiation protection suggests that eBx optimizes dose to nearby healthy soft tissue, even though this principle does not technically apply to patients whose irradiation is medically justified. Issues associated with irradiation of healthy organs by scattered radiation outside the treatment volume for external beam and image-guided procedures (e.g., cone-beam CT) have become a topic of discussion."

"The significantly lower doses to many nearby healthy organs delivered by eBx, as reported here, suggest that eBx may be superior in terms of normal tissue sparing for some patients."

copyright © 2010 xoft, inc. mc107 r9 03/2010. copyright © 2010 xoft, inc. - 2 - confidential mc107...

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