This new mammogram alternative has no compression, which means no pain. SARASOTA, Fla. - You hear all the time, especiall...
Problem
Most mammograms miss more than 30% of cancers
Breast cancer is the most diagnosed cancer in women in the US and the second leading cause of cancer death in American women. It is treatable if detected early, but current mammograms miss more than 30% of cancers, which increases to 70% in women with dense breasts. Diagnosis and treatment are limited by current 2D mammogram technology, causing breast cancer to go undetected until it's in its later stages.
Almost half of women don't get their yearly mammogram
A survey conducted by the Society for Women’s Health Research showed that four out of five women believe mammograms are necessary for overall wellbeing. However, only 54% of those women got their yearly mammogram.
Solution
No compression, low dose, real isotropic 3D imaging
The Koning Breast CT (KBCT) produces real, high-contrast 3D images of the breast with exceptional spatial resolution, no painful compression, in a rapid 10-second exposure—all at radiation levels in the range of diagnostic mammograms. We excel at diagnostic work ups, post-op monitoring, 3D guided biopsy, neoadjuvant monitoring, implant evaluation, contrast enhancement, and density measurements, especially when it comes to imaging small, dense breasts.
Product
KBCT is the only commercially available device with 360-degree scanning technology
KBCT is our proprietary breast imaging device and technology built to detect Stage 0 and Stage 1 cancers, finding tumors as small as 2mm and calcifications as small as 200 microns. With prone positioning and no compression of the breasts, KBCT allows for a better patient experience. Each output of the scan is a 3D image, allowing for an evaluation of tissue from any angle, eliminating overlapping structures.
The Koning difference
Traction
Projected global revenue is $16.6M by EoY 2021
Koning is a pioneer in the breast imaging space with a commercialized breast CT scanner for cancer detection. Our parent company owns 12 and, from the University of Rochester, has exclusive license rights to over 120 patents globally. We also now have 6 additional patents filed and pending. We are now FDA-certified for commercial diagnostic use, and have regulatory approval in North America, Australia, and across countries in Asia. Our projected global revenue is $16.6M by EoY 2021.
Customers
Providing benefits to all in the healthcare ecosystem
KBCT provides significant clinical and economic benefits to all parties in the healthcare ecosystem, particularly insurance providers, doctors, and of course, patients.
65%+ of the US patient population is covered for breast CT under current diagnostic indication approval.
Business model
Multiple revenue streams
Our initial market entry is focused on a small set of luminary site partners who will foster early adoption. Ultimately, we will have multiple revenue streams through software sales, consumables, add-on accessories, and service and parts fees.
Market
US market poised for rapid expansion after receiving breast CT CPT codes
Koning’s AMA application was directly submitted by the American College of Radiology with broad-based support. The US market is poised for rapid expansion with 6 dedicated breast CT CPT codes approved as of May 2020. These codes were published in October 2020 and went live January 2021. Since then, both private and public payers have received reimbursements.
Attractive financial advantage to clinics
Below is a realistic reimbursement ROI based on the average rate confirmed by KBCT users.
38,537,340 screening exams were performed from May 2020 - May 2021 in breast centers across the US with an average call back rate of 10%. This means there were 3,853,734 potential callbacks for a diagnostic work up. Although there are 8697 centers performing screening exams, it is estimated that only one third provide comprehensive diagnostic services beyond screening. Therefore, 3,853,734 diagnostic work ups are managed by 2,899 facilities.
Averaged out, each facility performs 1,329 diagnostic exams per year. With 260 working days per year, that's 5 diagnostic exams per day per center.
Competition
The only independent, commercial, dedicated breast CT company
Koning is the only independent and dedicated breast CT company, with compelling advantages over existing modalities. Our competition is focused on making incremental improvements in CT, MRI, X-ray tomosynthesis and ultrasound, whereas we use novel technology to get a clearer picture of each patient. Given the historical precedent set by DBT, we believe that KBCT will soon dominate the medical landscape for breast imaging.
Vision and strategy
Creating a revolution in medical imaging
Koning wants to change the world's perspective on breast imaging. We believe our KBCT will dramatically improve the way clinicians visualize and evaluate breast tissue. Current and future versions of the Koning Breast CT are expected to optimize early disease detection, diagnosis, intervention, and treatment.
Our hope is to improve survival rates and outcomes for millions of patients around the world. We believe that the power, versatility, and lower cost of KBCT will serve as a viable substitute for many traditional imaging applications.
Funding
Raised more than $50M to date
Prior to our Republic campaign, Koning has raised more than $50M from venture funding and high net-worth individuals. $20M of that was raised from NIH/government grants. We are now raising to provide support for our mass-market scaling in 2022. We plan to spend this next year performing 50-75 installs to improve industry acceptance.