1. Don’t Cut It – Freeze It ! Cryoablation for Early Stage Breast Cancer
I am a passionate maverick about a non-surgical treatment for early stage breast cancer.
I am here today to tell you about a technology that immediately freezes and kills early stage breast cancer in under 30 minutes in a doctor’s office Let’s think about that – Breast Cancer Killed – in under 30 Minutes – in a Doctor’s Office There’s no scar, no tissue is removed, and the body heals the tumor site in the following months Patients generally takes a Tylenol after treatment, and return to normal activities the next day.
Innovation is truly a wonderful thing! And for patients with breast cancer, it’s about time!
Today, I’m here to inform you, to inspire you and to take the fear out of breast cancer.
Let’s watch….
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Innovation Nation
January 21, 2018

2. Play June 2016 cryoablation video
[ VIDEO ENDS ]
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3. What was my process?
3D or tomosynthesis mammogram is critical if dense
When tumor formed – immediately scheduled treatment
Images and biopsy in the morning, diagnosis by 1:00 and cryoablation in the afternoon
Back on the job the next day
18 months later – no sign of breast cancer
You’ve noticed that the patient in the video is ME -- This was MY experience:
Let me give you background:
50% of women DENSE & require 3D mammo for clear images; >3 yrs ago - my 1st 3-D Mammo discovered a Suspicious Abnormality; SMALL & we followed it with 3-D mammos every 6 months; 3x the SAME; but on the 4th mammo – there was a tumor forming
Time for a biopsy & knew likely ESBC; I also knew wanted to stop this thing NOW, while small, and cryo was my solution; I’m in the industry, so I made calls & and scheduled day for diagnosis and treatment
I told my team what was happening – Marketing wanted to video the day, and the Rest is now Online
Clearly, My experience is unique – this is NOT the current standard of care -- Women do not normally get imaging, a biopsy, a diagnosis and cryoablation treatment in 1 day
I’ve had No chemo and No radiation. It’s now 18 months later, and I have no sign of breast cancer -- AND … I still have my breast
Again, this is MY experience. Every patient’s experience is unique and is based on decisions made with their physician.
Some people have asked why I did that video on a deeply personal day? The answer is Simple -- Because Women need to know they have an option and a choice for their own treatment!
Let’s talk about the technology that makes this possible.
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4. The Visica® 2 Treatment System
Easy-to-use console
Sterile, single-use cryoprobes
Simple doctor training
FDA 510k clearance
Cancerous and malignant tissue, among other indications for use
11 patents
This is the Visica 2 Treatment System -- it’s an easy-to-use console, with a sterile, single-use probe
This is a low-pressure Liquid Nitrogen-based system. The R part of our R&D effort made that work – it wasn’t easy.
The training for physicians is Simple -- If a Dr. knows how to do an ultrasound-guided biopsy, they already have the skills needed. We can train them on the system’s use very quickly.
Procedure is similar to a breast biopsy – uses a local anesthetic, patient is awake, they may feel a little pressure during the treatment, leave with a small bandage and generally return to normal activities in a day.
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5. How Does It Work? I’ll walk you through the cryoablation process:
Tumor is identified through imaging or finding a lump, and the patient generally has a biopsy to identify the tumor type
They then have cryoablation of the tumor site:
Local anesthetic is used in the affected area
Using ultrasound guidance, the Probe is inserted into the center of the tumor
The system then uses extreme cold to freeze the entire tumor in ice
At the end of the procedure, the tip of the probe is warmed and the probe is removed
Because ice is a natural anesthetic, patients generally only need a Tylenol for any discomfort
Over the following months, the tumor site is healed and the dead tissue is replaced by healthy tissue
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6. Clinical Success 22 published clinical papers
Landmark National Cancer Institute sponsored clinical trial – results show 100% effectiveness within the cryoablation zone
We’ve now launched the FROST Study – to further advance the product’s usage and clinical evidence
Prestigious sites are now using Visica in the US
Our technology is Supported by:
FDA 510k clearance
Extensive clinical research showing that cryoablation destroys breast tumors
Landmark National Cancer Institute sponsored clinical trial – results show 100% effectiveness within the cryoablation zone [ Z1072 ]
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7. Breast Cancer Treatment Timeline
Trastuzumab, first targeted therapy
Sentinel node biopsies
Dr. Halsted develops radical mastectomy
Dr. Fisher et al start trials of less invasive surgery
Modified radical mastectomy (lumpectomy)
ACSOG Z1072 trial shows 100% success in ablation zone with cryoablation
1880
1900
1920
1960
1980
2000
2010
2020
Whole breast irradiation with conservative surgery and chemotherapy for ESBC
Breast conserving surgery
Tamoxifen, first endocrine therapy
ACSOG Z011 trial shows that axillary dissection can be safely omitted in postmenopausal women
I think we all know that Medical treatments have been steadily moving over the years from more radical surgical solutions to minimally invasive treatments
Let’s look at the evolution breast cancer treatment:
In the late 1800s, breast cancer treatment started with mastectomy – removing all or most of the breast tissue in an operating room
80 years later, early stage breast cancer started being treated with lumpectomies, which conserve part of the breast while removing the diseased tissue – again, a surgical procedure
I believe that Cryoablation, this minimally invasive procedure done in a doctor’s office in under 30 minutes, is simply the next step for breast tumor treatment
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Radical mastectomy extended in various ways
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8. Why Am I So Passionate About Cryoablation?
1 in 8 women will have breast cancer in there lifetime
1 in 100 breast cancers will be in a MAN ! You are not exempt!
Approximately 75% of breast cancer is found at <2cm
The standard treatment for early stage breast cancer is a surgical lumpectomy or mastectomy
Often followed by radiation, chemotherapy or other medical interventions
Often followed by additional reconstructive surgeries
It’s about time for women to be offered a minimally invasive treatment option for breast disease
First, 1:8 Women; But MEN – you are not immune to the disease! 1:100
We are all affected by breast cancer – patients, families, friends – we all know someone that’s dealt with BC.
THIS is the Size of Early Stage Breast Cancer – the size of a nickel or smaller – 2 cm or smaller
These tumors are small enough that you may not feel them – need imaging.
Nearly 8 out of 10 women diagnosed with breast cancer, will have ESBC and their tumor will be THIS size or smaller
Regular imaging – and particularly 3D Imaging for dense breasts – can reveal ESBC in time to treat it effectively.
Important note – a lump does NOT mean it’s breast cancer – for every breast cancer case discovered, 3 times more tumors discovered that are benign tumors, and they can also be easily cryoablated
How do we take some of the fear out of Breast Cancer? We actively Look for IT! Find when it’s still small – THIS SIZE or smaller – and know that there are now minimally invasive treatment options
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9. Innovators Be driven and be passionate! Dare to be a maverick!
Be fast and flexible!
Focus on the goal, and love your work!
MAKE A DIFFERENCE!
This conference is about innovation. It’s about YOU, and ME. It’s about innovating and inventing, and changing the world !!!
We CAN Make a Difference! It’s hard work, and sometimes it’s desperately hard.
Persevere, analyze, re-analyze, change it up and keep going. YOU can MAKE A DIFFERENCE!
I AM Making a Difference for patients with breast cancer and other breast tumors.
How will YOU make a difference?
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