The Principals of NorthStar Capital Advisors are pleased to announce the completion of the acquisition of a controlling interest in the Palo Alto, California headquartered Angiologix, Inc., by Ann Arbor, Michigan headquartered Everist Genomics Inc. As part of the acquisition Everist Genomics also completed a financing.
Everist Genomics, Inc. and Angiologix, Inc. combine to create a highly complimentary portfolio of proprietary, high-value prognostic tests targeting two of the disease areas with the greatest unmet medical needs; Cancer and Heart Disease. Commencing in Q1 of 2011 the Group now expects to launch three innovative tests over the next 18 months. The first, a breakthrough prognostic cancer test identifies patients likely to experience a recurrence of their cancer and therefore most likely to benefit from adjuvant therapy. This test will be launched in the United States in Q1 of 2011 and will be priced at ~$3,400.
Rapidly Growing Market: Breakthroughs in molecular testing and sensor technology are delivering a new class of reliable, predictive information (“Prognostics”) that are transforming the practice of medicine and medical outcomes. Consequently, the market for prognostic tests is experiencing rapid growth and is expected to continue to expand at over 3X the rate of the Clinical Diagnostics market as a whole. Because of the medical and financial value created by innovative prognostic tests they command premium prices and generate large profit margins. For example, proprietary prognostic tests which enable medical intervention or treatment (such as the Oncotype Dx breast cancer prognostic test) can command prices in excess of $3,000 per test. Companies with proprietary prognostic tests that deliver clinical value and help to reduce health-care costs realize significant valuations and are increasingly targets for acquisition by multi-national diagnostic and therapeutic companies.
Everist Genomics, Inc. Disease Area Targets: Everist Genomics is driving growth (through in-house R&D, acquisition, and in-licensing) in disease areas with substantial unmet medical needs and where innovative prognostics have the potential for the greatest impact on medical and financial outcomes, including:
- Cancer and Cancer Supportive Care
- Cardiovascular Disease
- Neurodegenerative Diseases (e.g. Alzheimer’s and Parkinson’s disease)
- Metabolic Disease (e.g. diabetes)
Colon Cancer Prognostic Breakthrough: Everist Genomics Inc. is successfully developing and commercializing a portfolio of innovative, high-value prognostic tests. Everist Genomics lead product is based on the Company’s proprietary (patent protected) platform technology called Evolver which accelerates the development of innovative prognostic cancer tests. Utilizing the Evolver technology, Everist Genomics is completing development of a breakthrough Colorectal Cancer Prognostic test (the ‘CRC Prognostic test’), which promises to provide clinicians with greatly improved prognostic accuracy. The CRC Prognostic test identifies patients likely to have a recurrence after surgical removal of a Stage I or II colorectal cancer tumor, helping physicians to select patients most likely to require adjuvant therapy. This is important because:
1. 23% of early stage colon cancer patients have recurrences…
2. …but recurrences have a high death rate…
3. …providing patients with adjuvant therapy (prior to a recurrence) greatly improve patient survival rates…
4. …but chemotherapy has severe side effects and is costly; patients and doctors want to avoid unnecessary treatment…
5. …consequently physicians want to identify those patients with the greatest risk of experiencing a recurrence of their colon cancer…
6. …the Everist Genomics CRC Prognostic test helps physicians identify patients most likely to experience a recurrence of their cancer and therefore most likely to benefit from adjuvant therapy
Not only will the CRC Prognostic test help save lives but it will save the health-care system money; every ~$1 spent on Genetics Squared’s colorectal cancer prognostic test results in ~$5.00 saved by the health-care system
- Each patient that has an unexpected recurrence of colorectal cancer will cost the health-care system ~$280,000
- Each patient receiving unnecessary preventative chemotherapy will cost the health-care system ~$53,000
- The CRC Prognostic test will be available to physicians during Q1 2011.
Acquisition of Angiologix, Inc. – Cardiovascular Disease Prognostic Breakthrough: Cardiovascular disease (CVD) is the leading cause of death of men and women in the United States, accounting for more than one-third (34.3%) of all U.S. deaths; every 25 seconds an American will have a coronary event and 81 million Americans have been diagnosed with one or more forms of CVD. A 2010 report by the American Heart Association (AHA) estimates that the treatment and management of CVD will cost the nation ~$503 billion this year.
Consequently, physicians, insurance companies, MediCare, and employers are highly motivated to improve early diagnosis; early medical intervention and life style modification has been proven to save lives and reduce the total cost of care. For example the AHA estimates that if 20% to 25% of Americans currently diagnosed with high blood pressure (hypertension) reduced their systolic blood pressure by 12 to 13 points it would result in ~25% reduction in the risk of death from heart disease and generate >$75 billion in annual cost savings for health-care payers and employers
The Unmet Need: Despite advances in diagnosis and treatment, cardiovascular disease is diagnosed too late; no diagnostic tool is available for early detection of blood vessel damage, when medical interventions are most effective. Multi-center clinical studies have shown that cardiovascular disease starts years before patients present with high blood pressure, elevated cholesterol levels or abnormal EKG’s. As a result diagnosis using legacy testing methods currently occurs after cardiovascular disease and atherosclerosis has started.
The Medical Insight: A single layer of cells called the endothelium lines the walls of every blood vessel in the body. These endothelial cells are often referred to by cardiologists as “the governing intelligence’ of vascular health. Healthy endothelial cells are essential to enabling blood to course through the body without clotting and helping to keep arteries healthy and flexible. Over time, the effects of diet, lack of exercise, stress, alcohol, smoking and genetics causes inflammation that damages endothelial cells, preventing them from performing their vital functions. Eventually this damage to the endothelial cells will show up as high blood pressure, elevated cholesterol levels, and fatty deposits in the vessels (atherosclerosis) but by then the vascular system may have undergone years of damage and cardiovascular disease will have taken root. Scientists have demonstrated that endothelial cell damage is a key biomarker and is the earliest detectable sign of cardiovascular disease. A non-invasive, low cost and easy to use method for the early identification of endothelial cell damage would enable physicians to prevent (or regress) cardiovascular disease years earlier than legacy diagnostic techniques. Such a test would also enable early diagnosis when medical interventions have been demonstrated to be most effective.
Limitations of Legacy Testing Techniques: Legacy testing methods have significant limitations; elevated blood pressure or cholesterol levels appear after vessel damage has started and they do not provide an assessment of endothelial cell health. The legacy testing methods of assessing endothelial dysfunction have substantial limitations. Brachial artery ultrasound requires expensive equipment and probes, a highly skilled operator, is costly and time consuming to perform. Intracoronary studies of endothelial dysfunction are invasive with high risk of complications; involves anesthesia and catheter insertion, requires an interventional cardiologist and is also costly to perform.
The Breakthrough: Angiologix Inc, has developed a proprietary, market-disruptive, non-invasive prognostic medical device (the ‘AngioEF3000’) for the early detection and monitoring of endothelial cell dysfunction; enabling prevention and early treatment when medical interventions are most effective. The Angiologix device has numerous advantages, including:
Mr. Worzel further explained, “Timing for this transaction was also good; Angiologix recently succeeded in validation of their innovative prognostic testing device, the AngioEF3000, which enables – for the first time - the early detection of sub clinical atherosclerosis and CVD, prior to the onset of high blood pressure or elevated lipid levels. The patented technology is a non-invasive test which can substantially improve medical outcomes by identifying patients at risk for atherosclerosis and CVD and thereby reduce health-care costs for insurance companies and MediCare.”
Mr. Worzel points out that the addition of the AngioEF3000 to the Group increases the anticipated regulatory approvals and product launches. The Group now expects to launch their Colorectal Cancer test during Q41 2011, to secure CE Mark European marketing clearance for the AngioEF3000 during Q1, 2011 and US regulatory marketing clearance during Q4, 2011.
Transaction terms were not disclosed.
The Unmet Need: Despite advances in diagnosis and treatment, cardiovascular disease is diagnosed too late; no diagnostic tool is available for early detection of blood vessel damage, when medical interventions are most effective. Multi-center clinical studies have shown that cardiovascular disease starts years before patients present with high blood pressure, elevated cholesterol levels or abnormal EKG’s. As a result diagnosis using legacy testing methods currently occurs after cardiovascular disease and atherosclerosis has started.
The Medical Insight: A single layer of cells called the endothelium lines the walls of every blood vessel in the body. These endothelial cells are often referred to by cardiologists as “the governing intelligence’ of vascular health. Healthy endothelial cells are essential to enabling blood to course through the body without clotting and helping to keep arteries healthy and flexible. Over time, the effects of diet, lack of exercise, stress, alcohol, smoking and genetics causes inflammation that damages endothelial cells, preventing them from performing their vital functions. Eventually this damage to the endothelial cells will show up as high blood pressure, elevated cholesterol levels, and fatty deposits in the vessels (atherosclerosis) but by then the vascular system may have undergone years of damage and cardiovascular disease will have taken root. Scientists have demonstrated that endothelial cell damage is a key biomarker and is the earliest detectable sign of cardiovascular disease. A non-invasive, low cost and easy to use method for the early identification of endothelial cell damage would enable physicians to prevent (or regress) cardiovascular disease years earlier than legacy diagnostic techniques. Such a test would also enable early diagnosis when medical interventions have been demonstrated to be most effective.
Limitations of Legacy Testing Techniques: Legacy testing methods have significant limitations; elevated blood pressure or cholesterol levels appear after vessel damage has started and they do not provide an assessment of endothelial cell health. The legacy testing methods of assessing endothelial dysfunction have substantial limitations. Brachial artery ultrasound requires expensive equipment and probes, a highly skilled operator, is costly and time consuming to perform. Intracoronary studies of endothelial dysfunction are invasive with high risk of complications; involves anesthesia and catheter insertion, requires an interventional cardiologist and is also costly to perform.
The Breakthrough: Angiologix Inc, has developed a proprietary, market-disruptive, non-invasive prognostic medical device (the ‘AngioEF3000’) for the early detection and monitoring of endothelial cell dysfunction; enabling prevention and early treatment when medical interventions are most effective. The Angiologix device has numerous advantages, including:
- Non-invasive; applicable to any patient, regardless of age, gender, ethnicity or pre-existing conditions
- Suitable for screening and periodic health assessment; will detect endothelial cell damage in patients presenting within normal blood pressure and cholesterol ranges
- Monitors disease progression and effectiveness of cardiovascular therapies, enabling personalized dosage and treatment regimens
- The test is easy to perform and can be done by a physician or a technician with results reported in ~15 minutes
- Clinical validation successfully completed: Clinical validation of the Angiologix prognostic device has been completed and has demonstrated a strong correlation to the current gold-standard, Brachial Artery Ultrasound
- Test is reimbursed by insurance companies and Medicare: The endothelial cell function testing performed by the AngioEF3000 benefits from reimbursement approval by insurance companies and MediCare
- Targeting market launch in EU during Q1, 2011 and in United States during Q4 2011 (510k approval path)
- A strong patent position exists for Angiologix; compelling clinical and economic advantages over potential competitors
Mr. Worzel further explained, “Timing for this transaction was also good; Angiologix recently succeeded in validation of their innovative prognostic testing device, the AngioEF3000, which enables – for the first time - the early detection of sub clinical atherosclerosis and CVD, prior to the onset of high blood pressure or elevated lipid levels. The patented technology is a non-invasive test which can substantially improve medical outcomes by identifying patients at risk for atherosclerosis and CVD and thereby reduce health-care costs for insurance companies and MediCare.”
Mr. Worzel points out that the addition of the AngioEF3000 to the Group increases the anticipated regulatory approvals and product launches. The Group now expects to launch their Colorectal Cancer test during Q41 2011, to secure CE Mark European marketing clearance for the AngioEF3000 during Q1, 2011 and US regulatory marketing clearance during Q4, 2011.
Transaction terms were not disclosed.