2012 Media Placements - The Abbi Agency

First Warning SystemsTable Of Contents

Date Publication Title

12/20/2012 KRNV News 4Bra May Be Able To Detect Early Stages Of

Breast Cancer

12/10/2012 Clarion Ledger New 'Smart Bra' Would Screen For Cancer

12/8/2012 Gillette News RecordReno Company's 'Smart Bra' Would Screen

For Cancer

12/6/2012 10tv.comReno Company's 'Smart Bra' Would Screen

For Cancer

12/6/2012 Cancer KickReno Company's 'Smart Bra' Would Screen

For Cancer

12/6/2012 KOAAReno Company's 'Smart Bra' Would Screen

For Cancer

12/6/2012 NorthJersey.comReno Company's 'Smart Bra' Would Screen

For Cancer

12/6/2012 NECN.comReno Company's 'Smart Bra' Would Screen

For Cancer

12/6/2012 Seattle PIReno Company's 'Smart Bra' Would Screen

For Cancer

12/6/2012 SF GateReno Company's 'Smart Bra' Would Screen

For Cancer

12/2/2012 Reno Gazette Journal - OnlineReno Company's 'Smart Bra' Would Screen

For Cancer

11/5/2012 KOLO News 8 Can This Bra Detect Cancer?

RENO, Nev. (KRNV & MyNews4.com) -

Next to skin cancer breast cancer is

the most common cancer among

women in the United States and it's

the second leading cause of cancer

death in women.

About one in 36 people will die from breast cancer this year. Breast cancer death rates have been going down,

but this is probably due to earlier detection and better treatment over the years.

Now a company in Reno believes they have found to take earlier detection to a whole new level.

The Smart Bra by First Warning Systems, Inc. has completed three clinical trials of 650 women.

The bra is used to detect very early stages of breast cancer. Especially in young women and dense breasted women.

The Smart Bra looks like a sports bra, but has a dynamic thermometer device embedded in it. The device looks for heat signatures in the breast by looking for changes in the breast tissue.

The patient puts it on and sets out on their normal day wearing the sports bra for at least 12 hours. The data is then sent back to First Warning Systems, Inc. and they will decide between four categories: normal, benign, suspicious, or positive.

First Warning Systems, Inc. does not give a diagnosis. Instead, they pass the data on to the patient's doctor who then makes a recommendation to the patient and they can go from there.

The Smart Bra is not on the market yet, but News 4 sat down with First Warning Systems, Inc. chief of operations Matt Benardis and he believes the system through early detection will save lives.

"To identify the disease at its earliest stages and allow us to treat it more efficiently more cost effectively and with better success rates and we know that if we're catching the disease in stage two or earlier we're approaching 100-percent survival rates and treatment therapies," Benardis says.

Mammograms are still considered the gold standard in technology, but Benardis believes screening is a very reactive approach to the disease. He says by the time they start screening women the disease maybe in generation and harbor for anywhere from 10 to 20 years.

News 4 also met with Cindy Lain, a cancer survivor who stressed early detection helped save her life and she wants her daughter to be able to use the best form of early detection out there.

She hopes soon her daughter will be able to use the Smart Bra.

The Smart Bra is expected to to go through its fourth and final clincal trial in spring of 2013 and will hopefully be on the market in 2014. However, the bra will be available in some European markets starting as early as this spring.

RENO, NEV. — It’s been more than 15 years in the making, but Reno-based First Warning Systems is close to bringing a new type of breast cancer screening tool to the market: the Smart Bra.

The device makes it easier and more economical to detect breast cancer in younger women, who usually have denser breast tissue, making traditional mammogram results hard to read.

Women as young as 18 can be monitored for abnormal tissue growth, and cancer can be detected earlier.

“There are a number of studies out over the past 10 years that say the earlier we can identify this disease, the more success we have at treating it,” Matt Bernardis, chief operating officer for First Warning, told the Reno Gazette-Journal. “So much so that we are approaching 100 percent survival rates when we are catching pre-cancer, stage 1 or early stage 2.”

Dr. Sanford Barsky, pathology chair at the University of Nevada Medical School and breast cancer researcher, agrees that there is a need for better early detection of breast cancer, especially in young women and pre-menopausal women.

“There is a great need to develop technologies that can make progress in the war against breast cancer,” he said.

The bra also can be used to track how well treatment is helping women already diagnosed with breast cancer.

Smart Bra Design

The product is designed to look like a sports bra, but it is embedded with 16 small temperature sensors that take deep-tissue temperature readings of the breast during a 24-hour testing period.

Bernardis said his company’s No. 1 goal is to implement screening starting at age 18.

The bra is different than the usual mammograms and biopsies because it doesn’t compress the tissue, it doesn’t use radiology and it’s noninvasive.

“We’re not an imaging technology,” he said. “What we are ‘looking’ for is the disruption in the cell cycle over a 24-hour period.”

The Smart Bra relies on temperature readings during the test period. It detects the higher temperature that signals blood vessel growth that preceded abnormal breast tissue growth. Disease cells start destroying healthy tissue around it.

“The device itself is a contact thermal tool,” he said. “It’s essentially a dynamic thermometer.”

The sensors within the bra recorded the difference in temperature between healthy cells and diseased tissue.

The device would be prescribed by the doctor to a patient. She then would be outfitted at the office with the garment and a removable flash drive that records the data. The patient can then go about her daily routine and remove the garment after the prescribed time period.

The patient can then mail or return the recording device back to the physician’s office, where the data would be uploaded to First Warning Systems’ data center in Reno.

She can keep the garment for the next annual exam.

The doctor uploads the data gathered by the bra to First Warning Systems’ bioinformatics software program. It analyzes and processes the information through First Warning Systems’ proprietary algorithm to identify the condition of breast.

This process should take less than 30 seconds to generate a report for the doctor.

The report has four different readings: normal, benign, suspected for breast tissue abnormalities or probable for breast tissue abnormalities.

The results then are sent to the doctor to handle the diagnosis and treatment, if needed.

The device has had three clinical trials with more than 650 women. It has a 90 percent accuracy rate, according to First Warning. The trials used a screen mammogram as a comparison.

“We are not looking to take out the mammogram,” Bernardis said. “We are just looking to provide a tool that does a better job in a population that is currently underserved.”

The Smart Bra comes out in Europe in 2013. Meanwhile, it will undergo another trial in the United States before release in 2014.

First Warning is projecting that the clinical Smart Bra would cost about $200, while each report would be $10 to $20 per exam. As more people use the device, the prices would decrease.

The company also is working on a direct-to-consumer version of the Smart Bra that could replace the self-breast exam, but it is not as advanced as the professional version. It would be a subscription-based fee.

“Our goal has been — really in a nebulous sense — to try to change the approach to health care in Western countries from that of a reactive nature to a proactive nature,” Bernardis said.

RENO, Nev. — It's been more than 15 years in the making, but Reno-based First Warning

Systems is close to bringing a new type of breast cancer screening tool to the market: the Smart

Bra.

The device makes it easier and more economical to detect breast cancer in younger women,

who usually have denser breast tissue, making traditional mammogram results hard to read.

Women as young as 18 can be monitored for abnormal tissue growth, and cancer can be

detected earlier.

"There are a number of studies out over the past 10 years that say the earlier we can identify

this disease, the more success we have at treating it," Matt Bernardis, chief operating officer for

First Warning, told the Reno Gazette-Journal (http://on.rgj.com/UkRHu8). "So much so that we

are approaching 100 percent survival rates when we are catching pre-cancer, stage 1 or early

stage 2."

Dr. Sanford Barsky, pathology chair at the University of Nevada Medical School and breast

cancer researcher, agrees that there is a need for better early detection of breast cancer,

especially in young women and pre-menopausal women.

"There is a great need to develop technologies that can make progress in the war against breast

cancer," he said.

The bra also can be used to track how well treatment is helping women already diagnosed with

breast cancer.

SMART BRA DESIGN

The product is designed to look like a sports bra, but it is embedded with 16 small temperature

sensors that take deep-tissue temperature readings of the breast during a 24-hour testing

period.

Bernardis said his company's No. 1 goal is to implement screening starting at age 18.

The bra is different than the usual mammograms and biopsies because it doesn't compress the

tissue, it doesn't use radiology and it's noninvasive.

"We're not an imaging technology," he said. "What we are 'looking' for is the disruption in the

cell cycle over a 24-hour period."

The Smart Bra relies on temperature readings during the test period. It detects the higher

temperature that signals blood vessel growth that preceded abnormal breast tissue growth.

Disease cells start destroying healthy tissue around it.

"The device itself is a contact thermal tool," he said. "It's essentially a dynamic thermometer."

The sensors within the bra recorded the difference in temperature between healthy cells and

diseased tissue.

The device would be prescribed by the doctor to a patient. She then would be outfitted at the

office with the garment and a removable flash drive that records the data. The patient can then

go about her daily routine and remove the garment after the prescribed time period.

The patient can then mail or return the recording device back to the physician's office, where

the data would be uploaded to First Warning Systems' data center in Reno.

She can keep the garment for the next annual exam.

The doctor uploads the data gathered by the bra to First Warning Systems' bioinformatics

software program. It analyzes and processes the information through First Warning Systems'

proprietary algorithm to identify the condition of breast.

This process should take less than 30 seconds to generate a report for the doctor.

The report has four different readings: normal, benign, suspected for breast tissue

abnormalities or probable for breast tissue abnormalities.

The results then are sent to the doctor to handle the diagnosis and treatment, if needed.

The device has had three clinical trials with more than 650 women. It has a 90 percent accuracy

rate, according to First Warning. The trials used a screen mammogram as a comparison.

"We are not looking to take out the mammogram," Bernardis said. "We are just looking to

provide a tool that does a better job in a population that is currently underserved."

The Smart Bra comes out in Europe in 2013. Meanwhile, it will undergo another trial in the

United States before release in 2014.

The company is close to commercialization of its product after 15 years of research and

development.

First Warning is projecting that the clinical Smart Bra would cost about $200, while each report

would be $10 to $20 per exam. As more people use the device, the prices would decrease.

The company also is working on a direct-to-consumer version of the Smart Bra that could

replace the self-breast exam, but it is not as advanced as the professional version. It would be a

subscription-based fee.

"Our goal has been — really in a nebulous sense — to try to change the approach to health care

in Western countries from that of a reactive nature to a proactive nature," Bernardis said.

INVESTING IN RENO

First Warning Systems is vested in Reno and committed to growing its medical device software

firm in Northern Nevada.

"It would be much, much easier and much less expensive to offshore, if you will, but that is the

last thing on our agenda," Bernardis said. "We very much want to support Nevada: grow jobs

here, help put a new face on Reno in the tech and medical sector."

Even though the company receives most of its funding from Silicon Valley and gets requests to

move closer to its investors, core management is headquartered in a building near the Reno-

Tahoe International Airport.

The company finds the business startup climate to be more friendly and supportive, Bernardis

said. As it moves from research-and-development stage to commercialization, the company will

be adding more jobs to the area. It currently employs seven people.

Currently, most of its consultants and advisers are located around the world, but First Warning

is using local firms for building and engineering of its device. It also is building up its in-house

software development department, which would raise the level of jobs offered in the area.

Meanwhile, the fourth-and-final trial of the Smart Bra will occur later next year with about 300

participants. The firm is putting together a medical and management team.

"One of our greatest hopes is that we can do a multisite study throughout the United States,

mostly on the West Cost," Bernardis said. "We want to base it right here in Reno."

RENO, Nev. (AP) — It's been more than 15 years in the making, but Reno-based First Warning

Systems is close to bringing a new type of breast cancer screening tool to the market: the Smart

Bra.

The device makes it easier and more economical to detect breast cancer in younger women, who

usually have denser breast tissue, making traditional mammogram results hard to read.

Women as young as 18 can be monitored for abnormal tissue growth, and cancer can be detected

earlier.

"There are a number of studies out over the past 10 years that say the earlier we can identify this

disease, the more success we have at treating it," Matt Bernardis, chief operating officer for First

Warning, told the Reno Gazette-Journal (http://on.rgj.com/UkRHu8). "So much so that we are

approaching 100 percent survival rates when we are catching pre-cancer, stage 1 or early stage

2."

Dr. Sanford Barsky, pathology chair at the University of Nevada Medical School and breast

cancer researcher, agrees that there is a need for better early detection of breast cancer, especially

in young women and pre-menopausal women.

"There is a great need to develop technologies that can make progress in the war against breast

cancer," he said.

The bra also can be used to track how well treatment is helping women already diagnosed with

breast cancer.

SMART BRA DESIGN

The product is designed to look like a sports bra, but it is embedded with 16 small temperature

sensors that take deep-tissue temperature readings of the breast during a 24-hour testing period.

Bernardis said his company's No. 1 goal is to implement screening starting at age 18.

The bra is different than the usual mammograms and biopsies because it doesn't compress the

tissue, it doesn't use radiology and it's noninvasive.

"We're not an imaging technology," he said. "What we are 'looking' for is the disruption in the

cell cycle over a 24-hour period."

The Smart Bra relies on temperature readings during the test period. It detects the higher

temperature that signals blood vessel growth that preceded abnormal breast tissue growth.

Disease cells start destroying healthy tissue around it.

"The device itself is a contact thermal tool," he said. "It's essentially a dynamic thermometer."

The sensors within the bra recorded the difference in temperature between healthy cells and

diseased tissue.

The device would be prescribed by the doctor to a patient. She then would be outfitted at the

office with the garment and a removable flash drive that records the data. The patient can then go

about her daily routine and remove the garment after the prescribed time period.

The patient can then mail or return the recording device back to the physician's office, where the

data would be uploaded to First Warning Systems' data center in Reno.

She can keep the garment for the next annual exam.

The doctor uploads the data gathered by the bra to First Warning Systems' bioinformatics

software program. It analyzes and processes the information through First Warning Systems'

proprietary algorithm to identify the condition of breast.

This process should take less than 30 seconds to generate a report for the doctor.

The report has four different readings: normal, benign, suspected for breast tissue abnormalities

or probable for breast tissue abnormalities.

The results then are sent to the doctor to handle the diagnosis and treatment, if needed.

The device has had three clinical trials with more than 650 women. It has a 90 percent accuracy

rate, according to First Warning. The trials used a screen mammogram as a comparison.

"We are not looking to take out the mammogram," Bernardis said. "We are just looking to

provide a tool that does a better job in a population that is currently underserved."

The Smart Bra comes out in Europe in 2013. Meanwhile, it will undergo another trial in the

United States before release in 2014.

The company is close to commercialization of its product after 15 years of research and

development.

First Warning is projecting that the clinical Smart Bra would cost about $200, while each report

would be $10 to $20 per exam. As more people use the device, the prices would decrease.

The company also is working on a direct-to-consumer version of the Smart Bra that could

replace the self-breast exam, but it is not as advanced as the professional version. It would be a

subscription-based fee.

"Our goal has been — really in a nebulous sense — to try to change the approach to health care

in Western countries from that of a reactive nature to a proactive nature," Bernardis said.

INVESTING IN RENO

First Warning Systems is vested in Reno and committed to growing its medical device software

firm in Northern Nevada.

"It would be much, much easier and much less expensive to offshore, if you will, but that is the

last thing on our agenda," Bernardis said. "We very much want to support Nevada: grow jobs

here, help put a new face on Reno in the tech and medical sector."

Even though the company receives most of its funding from Silicon Valley and gets requests to

move closer to its investors, core management is headquartered in a building near the Reno-

Tahoe International Airport.

The company finds the business startup climate to be more friendly and supportive, Bernardis

said. As it moves from research-and-development stage to commercialization, the company will

be adding more jobs to the area. It currently employs seven people.

Currently, most of its consultants and advisers are located around the world, but First Warning is

using local firms for building and engineering of its device. It also is building up its in-house

software development department, which would raise the level of jobs offered in the area.

Meanwhile, the fourth-and-final trial of the Smart Bra will occur later next year with about 300

participants. The firm is putting together a medical and management team.

"One of our greatest hopes is that we can do a multisite study throughout the United States,

mostly on the West Cost," Bernardis said. "We want to base it right here in Reno."

Published on December 6, 2012, in Breast Cancer.

RENO, Nev. (AP) — It’s been more than 15 years in the making, but Reno-based First Warning Systems is close to bringing a new type of breast cancer screening tool to the market: the Smart Bra.

The device makes it easier and more economical to detect breast cancer in younger women, who usually have denser breast tissue, making traditional mammogram results hard to read.

Women as young as 18 can be monitored for abnormal tissue growth, and cancer can be detected earlier.

“There are a number of studies out over the past 10 years that say the earlier we can identify this disease, the more success we have at treating it,” Matt Bernardis, chief operating officer for First Warning, told the Reno Gazette-Journal (http://on.rgj.com/UkRHu8). “So much so that we are approaching 100 percent survival rates when we are catching pre-cancer, stage 1 or early stage 2.”

Dr. Sanford Barsky, pathology chair at the University of Nevada Medical School and breast cancer researcher, agrees that there is a need for better early detection of breast cancer, especially in young women and pre-menopausal women.

“There is a great need to develop technologies that can make progress in the war against breast cancer,” he said.

The bra also can be used to track how well treatment is helping women already diagnosed with breast cancer.

SMART BRA DESIGN

The product is designed to look like a sports bra, but it is embedded with 16 small temperature sensors that take deep-tissue temperature readings of the breast during a 24-hour testing period.

Bernardis said his company’s No. 1 goal is to implement screening starting at age 18.

The bra is different than the usual mammograms and biopsies because it doesn’t compress the tissue, it doesn’t use radiology and it’s noninvasive.

“We’re not an imaging technology,” he said. “What we are ‘looking’ for is the disruption in the cell cycle over a 24-hour period.”

The Smart Bra relies on temperature readings during the test period. It detects the higher temperature that signals blood vessel growth that preceded abnormal breast tissue growth. Disease cells start destroying healthy tissue around it.

“The device itself is a contact thermal tool,” he said. “It’s essentially a dynamic thermometer.”

The sensors within the bra recorded the difference in temperature between healthy cells and diseased tissue.

The device would be prescribed by the doctor to a patient. She then would be outfitted at the office with the garment and a removable flash drive that records the data. The patient can then go about her daily routine and remove the garment after the prescribed time period.

The patient can then mail or return the recording device back to the physician’s office, where the data would be uploaded to First Warning Systems’ data center in Reno.

She can keep the garment for the next annual exam.

The doctor uploads the data gathered by the bra to First Warning Systems’ bioinformatics software program. It analyzes and processes the information through First Warning Systems’ proprietary algorithm to identify the condition of breast.

This process should take less than 30 seconds to generate a report for the doctor.

The report has four different readings: normal, benign, suspected for breast tissue abnormalities or probable for breast tissue abnormalities.

The results then are sent to the doctor to handle the diagnosis and treatment, if needed.

The device has had three clinical trials with more than 650 women. It has a 90 percent accuracy rate, according to First Warning. The trials used a screen mammogram as a comparison.

“We are not looking to take out the mammogram,” Bernardis said. “We are just looking to provide a tool that does a better job in a population that is currently underserved.”

The Smart Bra comes out in Europe in 2013. Meanwhile, it will undergo another trial in the United States before release in 2014.

The company is close to commercialization of its product after 15 years of research and development.

First Warning is projecting that the clinical Smart Bra would cost about $200, while each report would be $10 to $20 per exam. As more people use the device, the prices would decrease.

The company also is working on a direct-to-consumer version of the Smart Bra that could replace the self-breast exam, but it is not as advanced as the professional version. It would be a subscription-based fee.

“Our goal has been — really in a nebulous sense — to try to change the approach to health care in Western countries from that of a reactive nature to a proactive nature,” Bernardis said.

INVESTING IN RENO

First Warning Systems is vested in Reno and committed to growing its medical device software firm in Northern Nevada.

“It would be much, much easier and much less expensive to offshore, if you will, but that is the last thing on our agenda,” Bernardis said. “We very much want to support Nevada: grow jobs here, help put a new face on Reno in the tech and medical sector.”

Even though the company receives most of its funding from Silicon Valley and gets requests to move closer to its investors, core management is headquartered in a building near the Reno-Tahoe International Airport.

The company finds the business startup climate to be more friendly and supportive, Bernardis said. As it moves from research-and-development stage to commercialization, the company will be adding more jobs to the area. It currently employs seven people.

Currently, most of its consultants and advisers are located around the world, but First Warning is using local firms for building and engineering of its device. It also is building up its in-house software development department, which would raise the level of jobs offered in the area.

Meanwhile, the fourth-and-final trial of the Smart Bra will occur later next year with about 300 participants. The firm is putting together a medical and management team.

“One of our greatest hopes is that we can do a multisite study throughout the United States, mostly on the West Cost,” Bernardis said. “We want to base it right here in Reno.”

RENO, Nev. (AP) - It's been more than 15 years

in the making, but Reno-based First Warning

Systems is close to bringing a new type of breast

cancer screening tool to the market: the Smart

Bra.

The device makes it easier and more economical

to detect breast cancer in younger women, who

usually have denser breast tissue, making

traditional mammogram results hard to read.

Women as young as 18 can be monitored for

abnormal tissue growth, and cancer can be detected earlier.

"There are a number of studies out over the past 10 years that say the earlier we can identify this

disease, the more success we have at treating it," Matt Bernardis, chief operating officer for First

Warning, told the Reno Gazette-Journal. "So much so that we are approaching 100 percent

survival rates when we are catching pre-cancer, stage 1 or early stage 2."

Dr. Sanford Barsky, pathology chair at the University of Nevada Medical School and breast

cancer researcher, agrees that there is a need for better early detection of breast cancer, especially

in young women and pre-menopausal women.

"There is a great need to develop technologies that can make progress in the war against breast

cancer," he said.

The bra also can be used to track how well treatment is helping women already diagnosed with

breast cancer.

RENO, Nev. (AP) — It's been more than 15 years in the making, but Reno-based First Warning

Systems is close to bringing a new type of breast cancer screening tool to the market: the Smart

Bra.

The device makes it easier and more economical to detect breast cancer in younger women, who

usually have denser breast tissue, making traditional mammogram results hard to read.

Women as young as 18 can be monitored for abnormal tissue growth, and cancer can be detected

earlier.

"There are a number of studies out over the past 10 years that say the earlier we can identify this

disease, the more success we have at treating it," Matt Bernardis, chief operating officer for First

Warning, told the Reno Gazette-Journal (http://on.rgj.com/UkRHu8). "So much so that we are

approaching 100 percent survival rates when we are catching pre-cancer, stage 1 or early stage

2."

Dr. Sanford Barsky, pathology chair at the University of Nevada Medical School and breast

cancer researcher, agrees that there is a need for better early detection of breast cancer, especially

in young women and pre-menopausal women.

"There is a great need to develop technologies that can make progress in the war against breast

cancer," he said.

The bra also can be used to track how well treatment is helping women already diagnosed with

breast cancer.

SMART BRA DESIGN

The product is designed to look like a sports bra, but it is embedded with 16 small temperature

sensors that take deep-tissue temperature readings of the breast during a 24-hour testing period.

Bernardis said his company's No. 1 goal is to implement screening starting at age 18.

The bra is different than the usual mammograms and biopsies because it doesn't compress the

tissue, it doesn't use radiology and it's noninvasive.

"We're not an imaging technology," he said. "What we are 'looking' for is the disruption in the

cell cycle over a 24-hour period."

The Smart Bra relies on temperature readings during the test period. It detects the higher

temperature that signals blood vessel growth that preceded abnormal breast tissue growth.

Disease cells start destroying healthy tissue around it.

"The device itself is a contact thermal tool," he said. "It's essentially a dynamic thermometer."

The sensors within the bra recorded the difference in temperature between healthy cells and

diseased tissue.

The device would be prescribed by the doctor to a patient. She then would be outfitted at the

office with the garment and a removable flash drive that records the data. The patient can then go

about her daily routine and remove the garment after the prescribed time period.

The patient can then mail or return the recording device back to the physician's office, where the

data would be uploaded to First Warning Systems' data center in Reno.

She can keep the garment for the next annual exam.

The doctor uploads the data gathered by the bra to First Warning Systems' bioinformatics

software program. It analyzes and processes the information through First Warning Systems'

proprietary algorithm to identify the condition of breast.

This process should take less than 30 seconds to generate a report for the doctor.

The report has four different readings: normal, benign, suspected for breast tissue abnormalities

or probable for breast tissue abnormalities.

The results then are sent to the doctor to handle the diagnosis and treatment, if needed.

The device has had three clinical trials with more than 650 women. It has a 90 percent accuracy

rate, according to First Warning. The trials used a screen mammogram as a comparison.

"We are not looking to take out the mammogram," Bernardis said. "We are just looking to

provide a tool that does a better job in a population that is currently underserved."

The Smart Bra comes out in Europe in 2013. Meanwhile, it will undergo another trial in the

United States before release in 2014.

The company is close to commercialization of its product after 15 years of research and

development.

First Warning is projecting that the clinical Smart Bra would cost about $200, while each report

would be $10 to $20 per exam. As more people use the device, the prices would decrease.

The company also is working on a direct-to-consumer version of the Smart Bra that could

replace the self-breast exam, but it is not as advanced as the professional version. It would be a

subscription-based fee.

"Our goal has been — really in a nebulous sense — to try to change the approach to health care

in Western countries from that of a reactive nature to a proactive nature," Bernardis said.

INVESTING IN RENO

First Warning Systems is vested in Reno and committed to growing its medical device software

firm in Northern Nevada.

"It would be much, much easier and much less expensive to offshore, if you will, but that is the

last thing on our agenda," Bernardis said. "We very much want to support Nevada: grow jobs

here, help put a new face on Reno in the tech and medical sector."

Even though the company receives most of its funding from Silicon Valley and gets requests to

move closer to its investors, core management is headquartered in a building near the Reno-

Tahoe International Airport.

The company finds the business startup climate to be more friendly and supportive, Bernardis

said. As it moves from research-and-development stage to commercialization, the company will

be adding more jobs to the area. It currently employs seven people.

Currently, most of its consultants and advisers are located around the world, but First Warning is

using local firms for building and engineering of its device. It also is building up its in-house

software development department, which would raise the level of jobs offered in the area.

Meanwhile, the fourth-and-final trial of the Smart Bra will occur later next year with about 300

participants. The firm is putting together a medical and management team.

"One of our greatest hopes is that we can do a multisite study throughout the United States,

mostly on the West Cost," Bernardis said. "We want to base it right here in Reno."

RENO, Nev. (AP) — It's been more than 15 years in the making, but Reno-based First Warning

Systems is close to bringing a new type of breast cancer screening tool to the market: the Smart

Bra.

The device makes it easier and more economical to detect breast cancer in younger women, who

usually have denser breast tissue, making traditional mammogram results hard to read.

Women as young as 18 can be monitored for abnormal tissue growth, and cancer can be detected

earlier.

"There are a number of studies out over the past 10 years that say the earlier we can identify this

disease, the more success we have at treating it," Matt Bernardis, chief operating officer for First

Warning, told the Reno Gazette-Journal (http://on.rgj.com/UkRHu8). "So much so that we are

approaching 100 percent survival rates when we are catching pre-cancer, stage 1 or early stage

2."

Dr. Sanford Barsky, pathology chair at the University of Nevada Medical School and breast

cancer researcher, agrees that there is a need for better early detection of breast cancer, especially

in young women and pre-menopausal women.

"There is a great need to develop technologies that can make progress in the war against breast

cancer," he said.

The bra also can be used to track how well treatment is helping women already diagnosed with

breast cancer.

SMART BRA DESIGN

The product is designed to look like a sports bra, but it is embedded with 16 small temperature

sensors that take deep-tissue temperature readings of the breast during a 24-hour testing period.

Bernardis said his company's No. 1 goal is to implement screening starting at age 18.

The bra is different than the usual mammograms and biopsies because it doesn't compress the

tissue, it doesn't use radiology and it's noninvasive.

"We're not an imaging technology," he said. "What we are 'looking' for is the disruption in the

cell cycle over a 24-hour period."

The Smart Bra relies on temperature readings during the test period. It detects the higher

temperature that signals blood vessel growth that preceded abnormal breast tissue growth.

Disease cells start destroying healthy tissue around it.

"The device itself is a contact thermal tool," he said. "It's essentially a dynamic thermometer."

The sensors within the bra recorded the difference in temperature between healthy cells and

diseased tissue.

The device would be prescribed by the doctor to a patient. She then would be outfitted at the

office with the garment and a removable flash drive that records the data. The patient can then go

about her daily routine and remove the garment after the prescribed time period.

The patient can then mail or return the recording device back to the physician's office, where the

data would be uploaded to First Warning Systems' data center in Reno.

She can keep the garment for the next annual exam.

The doctor uploads the data gathered by the bra to First Warning Systems' bioinformatics

software program. It analyzes and processes the information through First Warning Systems'

proprietary algorithm to identify the condition of breast.

This process should take less than 30 seconds to generate a report for the doctor.

The report has four different readings: normal, benign, suspected for breast tissue abnormalities

or probable for breast tissue abnormalities.

The results then are sent to the doctor to handle the diagnosis and treatment, if needed.

The device has had three clinical trials with more than 650 women. It has a 90 percent accuracy

rate, according to First Warning. The trials used a screen mammogram as a comparison.

"We are not looking to take out the mammogram," Bernardis said. "We are just looking to

provide a tool that does a better job in a population that is currently underserved."

The Smart Bra comes out in Europe in 2013. Meanwhile, it will undergo another trial in the

United States before release in 2014.

The company is close to commercialization of its product after 15 years of research and

development.

First Warning is projecting that the clinical Smart Bra would cost about $200, while each report

would be $10 to $20 per exam. As more people use the device, the prices would decrease.

The company also is working on a direct-to-consumer version of the Smart Bra that could

replace the self-breast exam, but it is not as advanced as the professional version. It would be a

subscription-based fee.

"Our goal has been — really in a nebulous sense — to try to change the approach to health care

in Western countries from that of a reactive nature to a proactive nature," Bernardis said.

INVESTING IN RENO

First Warning Systems is vested in Reno and committed to growing its medical device software

firm in Northern Nevada.

"It would be much, much easier and much less expensive to offshore, if you will, but that is the

last thing on our agenda," Bernardis said. "We very much want to support Nevada: grow jobs

here, help put a new face on Reno in the tech and medical sector."

Even though the company receives most of its funding from Silicon Valley and gets requests to

move closer to its investors, core management is headquartered in a building near the Reno-

Tahoe International Airport.

The company finds the business startup climate to be more friendly and supportive, Bernardis

said. As it moves from research-and-development stage to commercialization, the company will

be adding more jobs to the area. It currently employs seven people.

Currently, most of its consultants and advisers are located around the world, but First Warning is

using local firms for building and engineering of its device. It also is building up its in-house

software development department, which would raise the level of jobs offered in the area.

Meanwhile, the fourth-and-final trial of the Smart Bra will occur later next year with about 300

participants. The firm is putting together a medical and management team.

"One of our greatest hopes is that we can do a multisite study throughout the United States,

mostly on the West Cost," Bernardis said. "We want to base it right here in Reno."

RENO, Nev. (AP) — It's been more than 15 years in the making, but Reno-based First Warning

Systems is close to bringing a new type of breast cancer screening tool to the market: the Smart

Bra.

The device makes it easier and more economical to detect breast cancer in younger women, who

usually have denser breast tissue, making traditional mammogram results hard to read.

Women as young as 18 can be monitored for abnormal tissue growth, and cancer can be detected

earlier.

"There are a number of studies out over the past 10 years that say the earlier we can identify this

disease, the more success we have at treating it," Matt Bernardis, chief operating officer for First

Warning, told the Reno Gazette-Journal (http://on.rgj.com/UkRHu8). "So much so that we are

approaching 100 percent survival rates when we are catching pre-cancer, stage 1 or early stage

2."

Dr. Sanford Barsky, pathology chair at the University of Nevada Medical School and breast

cancer researcher, agrees that there is a need for better early detection of breast cancer, especially

in young women and pre-menopausal women.

"There is a great need to develop technologies that can make progress in the war against breast

cancer," he said.

The bra also can be used to track how well treatment is helping women already diagnosed with

breast cancer.

SMART BRA DESIGN

The product is designed to look like a sports bra, but it is embedded with 16 small temperature

sensors that take deep-tissue temperature readings of the breast during a 24-hour testing period.

Bernardis said his company's No. 1 goal is to implement screening starting at age 18.

The bra is different than the usual mammograms and biopsies because it doesn't compress the

tissue, it doesn't use radiology and it's noninvasive.

"We're not an imaging technology," he said. "What we are 'looking' for is the disruption in the

cell cycle over a 24-hour period."

The Smart Bra relies on temperature readings during the test period. It detects the higher

temperature that signals blood vessel growth that preceded abnormal breast tissue growth.

Disease cells start destroying healthy tissue around it.

"The device itself is a contact thermal tool," he said. "It's essentially a dynamic thermometer."

The sensors within the bra recorded the difference in temperature between healthy cells and

diseased tissue.

The device would be prescribed by the doctor to a patient. She then would be outfitted at the

office with the garment and a removable flash drive that records the data. The patient can then go

about her daily routine and remove the garment after the prescribed time period.

The patient can then mail or return the recording device back to the physician's office, where the

data would be uploaded to First Warning Systems' data center in Reno.

She can keep the garment for the next annual exam.

The doctor uploads the data gathered by the bra to First Warning Systems' bioinformatics

software program. It analyzes and processes the information through First Warning Systems'

proprietary algorithm to identify the condition of breast.

This process should take less than 30 seconds to generate a report for the doctor.

The report has four different readings: normal, benign, suspected for breast tissue abnormalities

or probable for breast tissue abnormalities.

The results then are sent to the doctor to handle the diagnosis and treatment, if needed.

The device has had three clinical trials with more than 650 women. It has a 90 percent accuracy

rate, according to First Warning. The trials used a screen mammogram as a comparison.

"We are not looking to take out the mammogram," Bernardis said. "We are just looking to

provide a tool that does a better job in a population that is currently underserved."

The Smart Bra comes out in Europe in 2013. Meanwhile, it will undergo another trial in the

United States before release in 2014.

The company is close to commercialization of its product after 15 years of research and

development.

First Warning is projecting that the clinical Smart Bra would cost about $200, while each report

would be $10 to $20 per exam. As more people use the device, the prices would decrease.

The company also is working on a direct-to-consumer version of the Smart Bra that could

replace the self-breast exam, but it is not as advanced as the professional version. It would be a

subscription-based fee.

"Our goal has been — really in a nebulous sense — to try to change the approach to health care

in Western countries from that of a reactive nature to a proactive nature," Bernardis said.

INVESTING IN RENO

First Warning Systems is vested in Reno and committed to growing its medical device software

firm in Northern Nevada.

"It would be much, much easier and much less expensive to offshore, if you will, but that is the

last thing on our agenda," Bernardis said. "We very much want to support Nevada: grow jobs

here, help put a new face on Reno in the tech and medical sector."

Even though the company receives most of its funding from Silicon Valley and gets requests to

move closer to its investors, core management is headquartered in a building near the Reno-

Tahoe International Airport.

The company finds the business startup climate to be more friendly and supportive, Bernardis

said. As it moves from research-and-development stage to commercialization, the company will

be adding more jobs to the area. It currently employs seven people.

Currently, most of its consultants and advisers are located around the world, but First Warning is

using local firms for building and engineering of its device. It also is building up its in-house

software development department, which would raise the level of jobs offered in the area.

Meanwhile, the fourth-and-final trial of the Smart Bra will occur later next year with about 300

participants. The firm is putting together a medical and management team.

"One of our greatest hopes is that we can do a multisite study throughout the United States,

mostly on the West Cost," Bernardis said. "We want to base it right here in Reno."

RENO, Nev. (AP) — It's been more than 15 years in the making, but Reno-based First Warning

Systems is close to bringing a new type of breast cancer screening tool to the market: the

Smart Bra.

The device makes it easier and more economical to detect breast cancer in younger women, who

usually have denser breast tissue, making traditional mammogram results hard to read.

Women as young as 18 can be monitored for abnormal tissue growth, and cancer can be

detected earlier.

"There are a number of studies out over the past 10 years that say the earlier we can identify this

disease, the more success we have at treating it," Matt Bernardis, chief operating officer for First

Warning, told the Reno Gazette-Journal (http://on.rgj.com/UkRHu8). "So much so that we are

approaching 100 percent survival rates when we are catching pre-cancer, stage 1 or early

stage 2."

Dr. Sanford Barsky, pathology chair at the University of Nevada Medical School and breast

cancer researcher, agrees that there is a need for better early detection of breast cancer, especially

in young women and pre-menopausal women.

"There is a great need to develop technologies that can make progress in the war against breast

cancer," he said.

The bra also can be used to track how well treatment is helping women already diagnosed with

breast cancer.

SMART BRA DESIGN

The product is designed to look like a sports bra, but it is embedded with 16 small temperature

sensors that take deep-tissue temperature readings of the breast during a 24-hour testing period.

Bernardis said his company's No. 1 goal is to implement screening starting at age 18.

The bra is different than the usual mammograms and biopsies because it doesn't compress the

tissue, it doesn't use radiology and it's noninvasive.

"We're not an imaging technology," he said. "What we are 'looking' for is the disruption in the

cell cycle over a 24-hour period."

The Smart Bra relies on temperature readings during the test period. It detects the higher

temperature that signals blood vessel growth that preceded abnormal breast tissue growth.

Disease cells start destroying healthy tissue around it.

"The device itself is a contact thermal tool," he said. "It's essentially a dynamic thermometer."

The sensors within the bra recorded the difference in temperature between healthy cells and

diseased tissue.

The device would be prescribed by the doctor to a patient. She then would be outfitted at the

office with the garment and a removable flash drive that records the data. The patient can then go

about her daily routine and remove the garment after the prescribed time period.

The patient can then mail or return the recording device back to the physician's office, where the

data would be uploaded to First Warning Systems' data center in Reno.

She can keep the garment for the next annual exam.

The doctor uploads the data gathered by the bra to First Warning Systems' bioinformatics

software program. It analyzes and processes the information through First Warning Systems'

proprietary algorithm to identify the condition of breast.

This process should take less than 30 seconds to generate a report for the doctor.

The report has four different readings: normal, benign, suspected for breast tissue abnormalities

or probable for breast tissue abnormalities.

The results then are sent to the doctor to handle the diagnosis and treatment, if needed.

The device has had three clinical trials with more than 650 women. It has a 90 percent accuracy

rate, according to First Warning. The trials used a screen mammogram as a comparison.

"We are not looking to take out the mammogram," Bernardis said. "We are just looking to

provide a tool that does a better job in a population that is currently underserved."

The Smart Bra comes out in Europe in 2013. Meanwhile, it will undergo another trial in the

United States before release in 2014.

The company is close to commercialization of its product after 15 years of research

and development.

First Warning is projecting that the clinical Smart Bra would cost about $200, while each report

would be $10 to $20 per exam. As more people use the device, the prices would decrease.

The company also is working on a direct-to-consumer version of the Smart Bra that could

replace the self-breast exam, but it is not as advanced as the professional version. It would be a

subscription-based fee.

"Our goal has been — really in a nebulous sense — to try to change the approach to health care

in Western countries from that of a reactive nature to a proactive nature," Bernardis said.

INVESTING IN RENO

First Warning Systems is vested in Reno and committed to growing its medical device software

firm in Northern Nevada.

"It would be much, much easier and much less expensive to offshore, if you will, but that is the

last thing on our agenda," Bernardis said. "We very much want to support Nevada: grow jobs

here, help put a new face on Reno in the tech and medical sector."

Even though the company receives most of its funding from Silicon Valley and gets requests to

move closer to its investors, core management is headquartered in a building near the Reno-

Tahoe International Airport.

The company finds the business startup climate to be more friendly and supportive, Bernardis

said. As it moves from research-and-development stage to commercialization, the company will

be adding more jobs to the area. It currently employs seven people.

Currently, most of its consultants and advisers are located around the world, but First Warning is

using local firms for building and engineering of its device. It also is building up its in-house

software development department, which would raise the level of jobs offered in the area.

Meanwhile, the fourth-and-final trial of the Smart Bra will occur later next year with about 300

participants. The firm is putting together a medical and management team.

"One of our greatest hopes is that we can do a multisite study throughout the United States,

mostly on the West Cost," Bernardis said. "We want to base it right here in Reno."

It’s been more than 15 years in the making, but Reno-based First Warning Systems is close to bringing a new type of breast cancer screening tool to the market: the Smart Bra. First Warning Systems is vested in Reno and committed to growing its medical device software firm in Northern Nevada. “It would be much, much easier and much less expensive to offshore, if you will, but that is the last thing on our agenda,” said Matt Bernardis, chief operating officer for First Warning. “We very much want to support Nevada: grow jobs here, help put a new face on Reno in the tech and medical sector.” Even though the company receives most of its funding from Silicon Valley and gets requests to move closer to its investors, core management is headquartered in a building near the Reno-Tahoe International Airport. The company finds the business startup climate to be more friendly and supportive, Bernardis said. As it moves from research-and-development stage to commercialization, the company will be adding more jobs to the area. It currently employs seven people. Currently, most of its consultants and advisers are located around the world, but First Warning is using local firms for building and engineering of its device. It also is building up its in-house software development department, which would raise the level of jobs offered in the area.

Meanwhile, the fourth-and-final trial of the Smart Bra will occur later next year with about 300 participants. The firm is putting together a medical and management team. “One of our greatest hopes is that we can do a multisite study throughout the United States, mostly on the West Cost,” Bernardis said. “We want to base it right here in Reno.” The company has talked to University of Nevada Medical School officials about running a study about the Smart Bra, he said. The device makes it easier and more economical to detect breast cancer in younger women. Women, as young as 18, can be monitored for abnormal tissue growth, and cancer can be detected earlier. It is recommended that women 40 and older get yearly mammograms because it is more effective after menopause. Younger women usually have denser breast tissue, making results hard to read. “There are a number of studies out over the past 10 years that say the earlier we can identify this disease, the more success we have at treating it,” he said, “so much so that we are approaching 100 percent survival rates when we are catching pre-cancer, stage 1 or early stage 2.” Dr. Sanford Barsky, pathology chair at the University of Nevada Medical School and breast cancer researcher, agrees that there is a need for better early detection of breast cancer, especially in young women and pre-menopausal women. Mammograms and MRIs have a hard time detecting the cancer in young women in the early stages, when it is more treatable. “There is a great need to develop technologies that can make progress in the war against breast cancer,” he said. The bra also can be used to track how well treatment is helping women already diagnosed with breast cancer. The product is designed to look like a sports bra, but it is embedded with 16 small temperature sensors that take deep-tissue temperature readings of the breast during a 24-hour testing period. “Our No. 1 goal with this tool that we developed is to implement a 21st-century objective, clinical approach to breast cancer screen starting at age 18,” Bernardis said. The bra is different than the usual mammograms and biopsies because it doesn’t compress the tissue, it doesn’t use radiology and it’s noninvasive. “We’re not an imaging technology,” he said. “What we are ‘looking’ for is the disruption in the cell cycle over a 24-hour period.” The Smart Bra relies on temperature readings during the test period. It detects the higher temperature that signals blood vessel growth that preceded abnormal breast tissue growth. Disease cells start destroying healthy tissue around it. “The device itself is a contact thermal tool,” he said. “It’s essentially a dynamic thermometer.” The sensors within the bra recorded the difference in temperature between healthy cells and diseased tissue. The device would be prescribed by the doctor to a patient. She then would be outfitted at the office with the garment and a removable flash drive that records the data. The patient can then go about her daily routine and remove the garment after the prescribed time period.

The patient can then mail or return the recording device back to the physician’s office, where the data would be uploaded to First Warning Systems’ data center in Reno. She can keep the garment for the next annual exam. The doctor uploads the data gathered by the bra to First Warning Systems’ bioinformatics software program. It analyzes and processes the information through First Warning Systems’ proprietary algorithm to identify the condition of breast. This process should take less than 30 seconds to generate a report for the doctor. The report has four different readings: normal, benign, suspected for breast tissue abnormalities or probable for breast tissue abnormalities. The results then are sent to the doctor to handle the diagnosis and treatment, if needed. The device has had three clinical trials with more than 650 women. It has a 90 percent accuracy rate, according to First Warning. The trials used a screen mammogram as a comparison. “We are not looking to take out the mammogram,” Bernardis said. “We are just looking to provide a tool that does a better job in a population that is currently underserved.” The Smart Bra comes out in Europe in 2013. Meanwhile, it will undergo another trial in the United States before release in 2014. Barsky, who was not involved in the development of the Smart Bra, warns that consumers and medical professionals must scrutinize any new technology on the market for effectiveness. He can’t comment on the Smart Bra because he has reviewed the reports, trials and research about the medical device. But, he is interested in learning more about the product. The company is close to commercialization of its product after 15 years of research and development. First Warning is projecting that the clinical Smart Bra would cost about $200, while each report would be $10 to $20 per exam. As more people use the device, the prices would decrease. The company also is working on a direct-to-consumer version of the Smart Bra that could replace the self-breast exam, but it is not as advanced as the professional version. It would be a subscription-based fee. “Our goal has been — really in a nebulous sense — to try to change the approach to health care in Western countries from that of a reactive nature to a proactive nature,” Bernardis said.

Nov 05, 2012

Can This Bra Detect Cancer?

RENO, Nev. -- Bras can do a lot of miraculous

things for women, but is detecting cancer one of

them?

The Reno-based company has been getting

international and national attention about its

one-of-a-kind claim.

The idea is for women to put on a bra for about

12 hours, and based on the temperature of the

breast tissue, it should be able to tell them, if

they have breast cancer.

For 20 years, First Warning Systems has been working on a smart bra that will give an accurate

screening for breast tissue abnormalities.

The company says the three trials have shown the bra can detect abnormalities with a 90 percent

and higher accuracy rating in women of all ages.

Matthew Bernardis, the project manager of the smart bra, says the bra is

"We are identifying lesions or abnormalities up to six years or earlier than any imaging

technology we currently have, can do...this is not diagnostic. We do not tell you that you

absolutely have cancer and you need to go do something about it," he said.

The results from the bra come in four forms: normal, benign, suspected for breast tissue

abnormalities, or probable for breast tissue abnormalities.

Thus far, a mammogram is the leading technology for women over 40 years old to screen for

breast cancer.

The bra is based off the idea of thermography. IT uses a series of sensors embedded in the cups

that can pick up temperature changes related to the disease. That information is later used to alert

doctors of malignant cells.

"First Warning Systems takes that foundational science and takes it a step further," Bernardis

said. "One in that we aren't just taking skin surface temperatures. we're looking deep into the

breast and we're doing that through our sensor technology."

Breast cancer specialist say the bra is a little ahead of its time.

"Though the theory sounds plausible, there's really not enough clinical trial evidence to show that

it's helpful," Bobbi Gillis, RN Renown Breast Program Coordinator said.

Even if the claims are true and tumors can be detected at their earliest stages, it is still unclear

what doctors can do at that point.

"The American College of Radiology looked at thermography throughout the years and does not

find it to be a screening tool that is helpful to detect breast cancer," Gillis said.

Patients will still have to go to a specialist to get properly diagnosed.

Mammograms in Northern Nevada are about 300 dollars without insurance and the bra will be

about 1000 dollars at market price.

First Warning Systems is currently in its fourth trial of testing before they can submit the smart

bra for FDA approval. The product will not be available in the United States until at least 2014.