Transcript Title Slide

MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Xoft, Inc. – Basic Facts
 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
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Copyright © 2010 Xoft, Inc.
The Xoft System Evolution
BREAST
REST OF BODY
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5 of the Top 20 US Hospitals have eBx™
The Axxent System is being used at many marquee medical centers
including 5 hospitals ranked in the top 20 hospitals in the U.S.
Lead Physician
Ranking (1)
Special Interest
Michael Steinberg M.D.
3*
Multi-platform / IORT
Josh Yamada M.D.
2*
IORT-Spine
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
Academic Sites Treating
UCLA Medical Center
Memorial Sloan Kettering
New York-Presbyterian-Cornell
* Indicates ranking US News and World Report top 20 hospitals.
** indicates ranking top cancer hospitals. (1) Rankings per US News and World Report.
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Install Base
There are currently 53 Axxent systems installed in the U.S.
(1)
WA
ME
MT
ND
OR
VT
NH
MN
ID
NY
WI
SD
MI
WY
PA
IA
NE
NV
OH
IL
UT
CO
CA
MA
RI
CT
IN
WV
KS
MO
NJ
MD
DE
VA
KY
NC
OK
AZ
NM
TN
SC
AR
MS
TX
AL
GA
LA
FL
HI
AK
Represents site with an Axxent system installed
(1) One system has been installed internationally in Seoul, South Korea.
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Traditional RT Treatment Options & Limitations
Xoft’s eBx system addresses many of the shortcomings of traditional RT systems
Treatment Option
External Beam RT
Traditional HDR
Brachytherapy
Limitation






Cost: Typically >£2.5mm + £1.5mm bunker




Cost: Typically £0.3mm + £1.5mm bunker + isotope yearly contracts
Access: Limited treatment sites
Compliance: Typically 6 – 8 weeks of treatment
Does not allow for treatment during surgery
Costly service support infrastructure
Limited recurring revenue
Access: Limited treatment sites
Radioactive materials handling, storage and shipping
Difficult to treat during surgery – must have shielded OR
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Copyright © 2010 Xoft, Inc.
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
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Copyright © 2010 Xoft, Inc.
Electronic Brachytherapy (eBx)
A Next Step in the Evolution of Radiation Therapy
eBx has the potential to do to isotope therapy what linear accelerators did to cobalt therapies—a generation ago
Internal RT
Axxent
Isotope Needle and
Seed Implants
Isotope Based
HDR Afterloader
Orthovoltage
X-rays
Cesium-137
Cobalt-60
Digital Linear
Accelerator
External RT
Radium
Capsules
Combines the Benefits
of Brachytherapy with
Modern Electronic
Therapy Technologies
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Copyright © 2010 Xoft, Inc.
Why eBx™?
Xoft’s miniaturized eBx technology offers significant advantages over traditional brachytherapy
 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
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Equivalent Treatment at a Fraction of the Cost
Xoft delivers equivalent treatment at 1/6th – 1/10th the cost of alternative systems
LINAC System
Bunker
+
HDR Reloader
Cost
=
£3.5mm
=
£1.8mm
=
£0.3mm
Bunker
+
Axxent
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Copyright © 2010 Xoft, Inc.
Non-Radioisotope Source
Among numerous other advantages, public safety and environmental concerns will also drive eBx adoption
– Increasing regulatory control over use of radioactive
isotopes in medicine
eBx Source
– 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
Traditional Source
– 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
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Copyright © 2010 Xoft, Inc.
eBx Enabling Technology for IORT
KOL’s and soon to be released clinical data will accelerate IORT adoption
 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
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Copyright © 2010 Xoft, Inc.
eBx’s Superior Dose Profile Spares Healthy Tissue
 Unlike radioactive isotopes, eBx delivers
Dose Distribution eBx vs. Mammosite
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
eBx vs. HDR for Endometrial Cancer
 Significant patient comfort and
compliance benefits
(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.
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Copyright © 2010 Xoft, Inc.
eBx Safer for Medical Personnel
and Improving Patient Care
The ability to comfort patients during treatment is viewed as a significant quality of care improvement that
only eBx offers
 Low energy source spares medical
personnel coincidental exposure to
high-energy ionizing radiation
– Source non-radioactive when
switched “off”
 Medical staff can remain in the room
with the patient, as determined by the
facility Radiation Safety Officer
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Copyright © 2010 Xoft, Inc.
Portability Increases Potential
Axxent’s portability significantly increases Xoft’s addressable market opportunity
Radiation Following BCS vs. Distance from RT Facility (1)
100%
Choice of Mastectomy (2)
100%
Radiation follow ing BCS
% of Patients Opting for Mastectom y
86%
82%
78%
75%
75%
69%
58%
57%
53%
50%
50%
42%
47%
43%
25%
25%
0%
0%
< 10
10 – 25
25 – 50
50 – 75
75 – 100
> 100
≤10
10 to 25
25 to 50
>50
Miles from Radiation Therapy Facility
Miles from Radiation Therapy Facility
Strong correlation exists between distance to treatment center and percentage of patients receiving
radiation therapy
(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
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Copyright © 2010 Xoft, Inc.
Xoft System Overview
Copyright © 2010 Xoft, Inc.
The Xoft System Evolution
BREAST
REST OF BODY
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Copyright © 2010 Xoft, Inc.
Xoft System Overview
Axxent
Controller
 FDA Cleared:
– 2/29/2008
– General
radiation
therapy
indication
Axxent
X-ray Source
 FDA Cleared:
– 2/29/2008
– General
radiation
therapy
indication
Axxent Balloon
Applicator
 FDA Cleared :
– 12/22/2005
(breast)
– 7/16/2009
(everywhere)
– Intracavitary or
intraoperative
brachytherapy
wherever the
physician
chooses to
deliver radiation
treatment
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Axxent Vaginal
Applicator
 FDA Cleared:
– 5/9/2008
– Intracavitary
brachytherapy
in the vagina
and rectum
Axxent Surface
Applicator
 FDA Cleared:
– 2/11/2009
– Skin
brachytherapy,
including IORT
MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Xoft Controller
Controller
 The Axxent controller:
– Controls dose delivery
– User friendly interface
 FDA clearance breast:
– December 2005
 Cleared for general radiation therapy:
– February 2008
User Interface
 Weight 200lbs
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Xoft: Miniaturized X-ray Source Overview
Xoft’s miniaturized eBx technology
Miniaturized X-ray Source
 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
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Copyright © 2010 Xoft, Inc.
Miniature X-ray Source Dose – Energy Characteristics
The unique, proprietary non-radioisotope high dose – low energy source
Axxent Source and Dose Rate Comparison
Dose Rate vs. Energy Profile
 High dose rate – low energy source
Dose Rate
 Dose deposited locally, but sufficient to
Low
High
Radioactive
Seeds
Xoft
penetrate target tissue
Advantages
Low
 Outpatient treatment times same as fresh (7 Ci)
Energy
Ir192 source
 Source doesn’t decay over time therefore
maintains constant dose profile
 Minimal stray radiation to normal tissue, organs,
High
and medical personnel
 Minimal shielding required
–
Radioactive
Sources or
External
Beams
i.e. no bunker Portable
 Medical staff can remain in the room with the
patient, as determined by the facility Radiation
Safety Officer
 Enables IORT
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Source Depth-Dose Characteristics
(Balloon Applicator)
Xoft s miniaturized X-ray source delivers equivalent dose as Ir at the prescription point but
lower dose to critical structures
 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)
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Copyright © 2010 Xoft, Inc.
Use Stepping to Reduce Effect of Source Anisotropy
Single source position
Stepped source
•2.5 cm from distal tip (position 22.5)
•9 positions, 5 mm spacing,
active range 24.5 – 20.5 cm
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Note reduced anisotropy
Copyright © 2010 Xoft, Inc.
Xoft Controller Components
Source high voltage
cable attachment
Source connected
to source nest
Applicator hub
attachment
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Copyright © 2010 Xoft, Inc.
Xoft Controller Well Chamber and
Electrometer Components
Source in well chamber
for calibration
Well chamber connected
internally to electrometer
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Copyright © 2010 Xoft, Inc.
Transportable
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Axxent: Applicators
Balloon Applicator
Spine App. Sloan Kettering
Skin Applicator
HAM App. Beth Israel
Endometrial Applicator
Sterile Sheath - DaVinci
 Future development will
expand eBx indications
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Current Indications Treated
Copyright © 2010 Xoft, Inc.
Breast Cancer Overview
Xoft’s portability offers a unique advantage and opportunity to expand the current useage for APBI
 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).
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Treating Breast Cancer with eBx
eBx’s high-dose, low-energy source delivers less radiation to critical structures such as the heart and lung
 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
U.S. breast market:
U.S. lumpectomy market:
eBx market:
254,650 Cases in 2009
162,575 Eligible patients
70,000 Eligible patients
 Physician Driven:
– Increased utilization of BCT
– Decrease normal tissue toxicity
– Economics
Source: American Cancer Society; Cancer Facts and Figures 2008-9, SEER Incidence Data, 1999-2003. National Comprehensive Cancer Network (NCCN).
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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.
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Treating Endometrial Cancer with eBx
Axxent has significant competitive advantages due to its more optimal dose targeting that dramatically
reduces dose to the bladder and rectum
 Patient Driven:
– Increased access for the patient
– Medical personnel can stay in the
treatment room as determined by the
facility Radiation Safety Officer
 Physician Driven:
– Improved Dosimetry, Axxent source
does not show anisotropy like Iridium
– Doses outside PTV lower for Axxent
HDR Source due to steeper dose falloff; spares healthy tissue of the rectum
and bladder
Endomentrial market :
eBx market:
40,895 Cases in 2009
27,619 Eligible patients
– Applicator insertion and treatment setup similar
– No isotope handling
– Minimal shielding required
Source: American Cancer Society; Cancer Facts and Figures 2008-9, SEER Incidence Data, 1999-2003. National Comprehensive Cancer Network (NCCN).
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Copyright © 2010 Xoft, Inc.
Skin Cancer Market Overview
Xoft’s customers now say patients request a non surgical approach to treatment.
 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
Source: American Cancer Society; Cancer Facts and Figures 2007-8, SEER Incidence Data, 1999-2003. National Comprehensive Cancer Network (NCCN).
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Treating Skin Cancer with eBx
Xoft's unique dosimetric capabilities provided significant competitive advantages in treating skin cancer
 Patient Driven
– More convenient dose schedule
compared to external beam
– An option for those who can not
undergo surgery
– Medical personnel can stay in the
treatment room as determined by the
facility Radiation Safety Officer
Basal and Squamous Cell
►1 million cases (1)
Cancer Patients
 Physician Driven
– Xoft Electronic Brachytherapy using
surface applicator offers comparable
technique to Ir-192 HDR brachytherapy
with several advantages
Basal and Squamous Cell
Cancer Patients Receiving ► 26,000 cases per year (2)
Radiation Therapy
■ Isotope free
■ Dosimetric advantages compared to
electron beam
■ Superior dosimetry that allows for
reduced margin
(1) American Cancer Society; Cancer Facts and Figures 2007-8.
(2) SEER Incidence Data, 1999-2003 National Comprehensive Cancer Network (NCCN).
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Image courtesy of James S. Welsh MS, MD, FACRO
MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Case Study - Ajay Bhatnagar MD, MBA
Axxent enables significant improvement in cosmesis
 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
Images courtesy of Ajay Bhatnagar,MD
* 30 days post treatment
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Copyright © 2010 Xoft, Inc.
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
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
IORT - A New Frontier in Radiation Therapy
Delivering RT and lumpectomy (with reconstruction) all in a 1 day therapy regimen
 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
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Patient Discharged
The patient was in at 7:45 AM and out at 11:45 AM
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
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
Potential Areas for Research Include
 Lung
 Neck
 Brain
 Colon
 Spine
 Liver
 Head
 Can be used as a monotherapy or boost
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
IORT – Physician and Patient Perspectives
“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
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Copyright © 2010 Xoft, Inc.
IORT – Growing Clinical and KOL Support
IORT will become a significant growth driver and an important focus of sales and marketing efforts
 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
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Xoft eBx Competitive Matrix
Xoft enjoys numerous advantages over competitive Brachytherapy systems
Xoft Axxent
eBx
Nucletron
HDR
Afterloader
Varian HDR
Afterloader
APBI



Endometrial



Skin/Surface



No Cost to Build Shielded Room
Physician or therapist in room with patient
IntraOp
Mobetron
Zeiss
IntraBeam



(determined by RSO)



Lower dose to normal tissue beyond target

IORT for Breast


IORT for wide range of indications


Mobile (Tx Room to Tx Room or OR to OR)



Portable (Between sites)



Future intensity modulation capability

Feature
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


MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Customer Service & Support
Copyright © 2010 Xoft, Inc.
Service Support and Customer Service
What Service Support Provides
 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
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Customer Survey Results - "Would You Recommend Xoft?"
100% of 2009 survey respondents will recommend Xoft to their colleagues
“Most importantly, the
approach taken with the
treatment planning system by
having a trained individual to
help with the first few plans is
critical.”
“Quite impressed by the sales
and training group. Always
available to help with the
smallest issues.”
“Excellent product
with very good sales
and training support”
“I believe in the technology.
Your company is presenting
this technology in the right
direction.”
“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)”
Note: Statements are actual responses from Xoft customers.
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Clinical Publications
Copyright © 2010 Xoft, Inc.
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
Dosimetric Comparison Xoft versus
Ir-192
ASCO Breast Cancer SymposiumPreliminary Report of 44 Patient
Study Results, 2008
Dose Volume Characterisitcs of the
50 kV Source
Breast
Cancer
RSNA Preliminary Report of 44
Patient Study Results
Detailed description of how to treat
patients using the Xoft system intraoperatively at time of lumpectotmy
for the treatment of early stage
breast cancer.
APBI Initial Experience with Xoft for
the Treatment Breast Cancer & 1
Year follow-up
50 kV electronic brachytherapy
source can provide equivalent target
Endometrial volume coverage to Ir-192 when
Cancer
using a vaginal cylinder, however
eBx allows increased sparing of the
bladder and rectum.
Reference

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.

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.

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.

Mehta, VK. Early Experience with An Electronic Brachytherapy Technique For
Intracavitary Partial Breast Irradiation. RSNA 2009; Abstract.

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.

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.

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.
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Copyright © 2010 Xoft, Inc.
Current Publications (Cont’d)
Publication Summary
Electronic Source Will Ultimately
Replace Ir-192 as the source for HDR
Brachytherapy
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.
Calculations and measurements of
TG-43 Source parameters
Physics &
Dosimetry
Procedures used at Rhode Island
Hospital to commission the Xoft
system.
The Xoft system is described along
with calculations and measurements
of TG-43 Source parameters.
Dosimetric Comparison of eBx versus
Ir-192 in APBI Application
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.
Point-counterpoint discussion
Reference

Holt RW, Thomadsen BR, Orton CG. Mini-X-ray Tubes Will Ultimately Displace Ir192 As The radiation Source for High Dose Rate Brachytherapy. Medical Physics
2008. 35: 815-817.

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.

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.
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.
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.


 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

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.

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.
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Clinical Publication Strategy
Xoft currently executing 10 studies which will yield 17 papers to be published over the next two years
Study
Design
Study Overview
Publication Status and Timelines





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
EXIBT
Registry
APBI registry, 6 month and 1, 2, 3, 4, 5 
year follow-up. N=67

Chart
Review
Chart
Review
Breast
IORT
Multi-center retrospective study of
APBI patients. N=60
 Sep 2010: Publication target date
1
Single-center APBI, N=35
 Aug 2010: Target date to publish single-center APBI experience
1
Physician sponsored multi-center
study. N=50
 Apr 2010: Present abstract at ASBrS Apr 2010 on first 10 patients
1
Post
Market
Chart
Review
Treatment feasibility and acute safety
through 3-month follow up. N=15
Retrospective data collection study.
N=40
Post
Market

Breast
Cancer
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
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
#
Papers

7
6
1
1
Endometrial
Cancer
Skin
Cancer
Multiindication
IORT
 Oct 2010: Publication target date
1
 Oct 2010: Publication target date
1
Report safety and efficacy through 5year 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
Chart
Review
Retrospective data collection study
report safety, cosmesis. N=25
 Oct 2010: Publication target date
1
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
CONFIDENTIAL
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.
Recent Publication in Medical Physics
Xoft 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 Xub
Nuclear Engineering and Engineering Physics Program, Rensselaer
Polytechnic Institute, Troy,
New York 12180
Mark J. Rivard
Department 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."
CONFIDENTIAL
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MC107 R9 03/2010
Copyright © 2010 Xoft, Inc.