First Commercial Application

Breast Cancer
Surgery

Our initial focus is on addressing a long-standing problem: one third of patients require a second or third procedure following breast conserving surgery (BCS) to fully remove the cancer. This is both highly stressful for the patients and a huge financial burden on the healthcare system. Our biochemical imaging modality is designed to provide the surgeon rapid intra-operative information to aid in complete resection of the cancer the first time.

First Commercial Application

Breast Cancer
Surgery

Our initial focus is on addressing a long-standing problem: one third of patients require a second or third procedure following breast conserving surgery (BCS) to fully remove the cancer. This is both highly stressful for the patients and a huge financial burden on the healthcare system. Our biochemical imaging modality is designed to provide the surgeon rapid intra-operative information to aid in complete resection of the cancer the first time.

Breast Cancer

Landscape

1 of 8 Women
Will be diagnosed with breast cancer in their lifetime.
75%
Of those diagnosed with breast cancer will choose to undergo a lumpectomy.
1 in 3 Patients
Who choose surgery will have to return for an additional operation.
Previous
Next

Breast cancer is the most common cancer in the US among women, and surgery is the treatment of choice.

Improved screening methods have allowed breast cancer to be detected in its earlier stages, providing the opportunity for the less invasive and more rapid surgical procedure known as breast-conserving surgery (BCS) or lumpectomy. Three out of four women choose BCS because it preserves more tissue and leads to fewer complications and a shorter recovery period.

Breast Cancer

Landscape

Breast cancer is the most common cancer in the US among women, and surgery is the treatment of choice.

1 of 8 Women
Will be diagnosed with breast cancer in their lifetime.
75%
Of those diagnosed with breast cancer will choose to undergo a lumpectomy.
1 in 3 Patients
Who choose surgery will have to return for an additional operation.
Previous
Next

Improved screening methods have allowed breast cancer to be detected in its earlier stages, providing the opportunity for the less invasive and more rapid surgical procedure known as breast-conserving surgery (BCS) or lumpectomy. Three out of four women choose BCS because it preserves more tissue and leads to fewer complications and a shorter recovery period.

Introducing Novel Technology to

The

Unresolved

Problem

During BCS, a section of tissue believed to have fully enclosed the cancer is removed and sent to a pathology lab. The lab will assess whether any cancerous tissue has been left behind by determining if cancer is touching the edges of the specimen. These results are typically available within three to five days, and if cancer is present at the margin, (positive margin) the patient is required to undergo additional surgery. In the US and developed world, this occurs in one out of every three BCS procedures, causing severe anxiety for the patient and representing a huge financial burden on the healthcare system.

Introducing Novel Technology to

The

Unresolved

Problem

During BCS, a section of tissue believed to have fully enclosed the cancer is removed and sent to a pathology lab. The lab will assess whether any cancerous tissue has been left behind by determining if cancer is touching the edges of the specimen. These results are typically available within three to five days, and if cancer is present at the margin, (positive margin) the patient is required to undergo additional surgery. In the US and developed world, this occurs in one out of every three BCS procedures, causing severe anxiety for the patient and representing a huge financial burden on the healthcare system.

Visible Image

TRF Scan

What We Are Doing Differently

An

Unprecedented

Solution

The BlackLight imaging system is designed to be used in the operating room to scan the tissue removed from the breast and immediately inform the surgeon whether cancer exists on the surface of the tissue. A positive result means that the surgeon was not able to contain all of the cancer within the excised tissue. The BLS system is intended to provide information that enables the surgeon to remove additional tissue, if necessary, thereby ensuring complete removal of the cancer and avoiding a repeat surgery.

Learn more

What We Are Doing Differently

An

Unprecedented

Solution

The BlackLight imaging system is designed to be used in the operating room to scan the tissue removed from the breast and immediately inform the surgeon whether cancer exists on the surface of the tissue. A positive result means that the surgeon was not able to contain all of the cancer within the excised tissue. The BLS system is intended to provide information that enables the surgeon to remove additional tissue, if necessary, thereby ensuring complete removal of the cancer and avoiding a repeat surgery.

Learn more

Results From

Preliminary

Clinical Studies

BLS has tested its prototype system in series of clinical studies conducted at Cedar-Sinai at Los Angeles. Thus far 121 patients have participated in these studies. The following summarizes the data gathered and analyzed to date.

Sensitivity: 99.8%

Specificity: 98.6%

Negative Predictive Value (NPV) 99.9%

Positive Predictive Value (PPV) 89.2%

The above data was submitted to FDA, on the basis of which the company received a “Breakthrough Device Designation”, a recognition of the huge unmet need in breast cancer surgery and the potential of the company’s technology to meaningfully address the problem. This is an important accomplishment that potentially facilitates the path to regulatory approval.

Results From

Preliminary

Clinical Studies

BLS has tested its prototype system in series of clinical studies conducted at Cedar-Sinai at Los Angeles. Thus far 121 patients have participated in these studies. The following summarizes the data gathered and analyzed to date.

NPV 99.9%

PPV 89.2%

Negative Predictive Value (NPV) 99.9%

Positive Predictive Value (PPV) 89.2%

The above data was submitted to FDA, on the basis of which the company received a “Breakthrough Device Designation”, a recognition of the huge unmet need in breast cancer surgery and the potential of the company’s technology to meaningfully address the problem. This is an important accomplishment that potentially facilitates the path to regulatory approval.

A section through the 

“Hot Spot”

on the lump.

TRF Scan

SurfaceScan Image

Histopathology Image

Interested in

Our Technology?

Find out what’s the next chapter in
biochemical imaging and how you can
become a part of it.
get in touch

Interested in

Our Technology?

Find out what’s the next chapter in
biochemical imaging and how you can
become a part of it.
get in touch
323 Sunny Isles Blvd, 7th Floor,
Sunny Isles Beach,
FL 33160
323 Sunny Isles Blvd, 7th Floor,
Sunny Isles Beach,
FL 33160