Essex V Wellness
Essex Angel Capital, Inc. v. Wellness Indicators, Inc.
Plaintiff: Essex Angel Capital, Inc.
Defendant: Wellness Indicators, Inc.
Case Number: 2:2013cv11549
Filed: April 5, 2013
Court: Michigan Eastern District Court
County: Oakland
Presiding Judge: Paul D. Borman
Referring Judge: David R. Grand
Nature of Suit: Contract - Other Contract
Jurisdiction: Diversity
A summary of Wellness by Essex in July 2011.
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Wellness
Corporate Structure
Wellness Indicators, Inc. was incorporated as “Dianomics Inc.” on January 25, 2002 as a Michigan “C” corporation.
On April 25, 2008, the company changed its name to “Wellness Indicators, Inc.”. Its current registered address is 2165 Avon Industrial Drive, Rochester Hills, Michigan, 48309 and its head office is located at 1200 Karl Court, Wauconda, Illinois, 60084.
General Description of the Business of Wellness
Wellness is a private company based in Michigan, United States, which develops, manufactures and markets non - invasive urinary wellness tests (the “Wellness Assessment Tests”). These proprietary, first-to-market tests provide individuals the information and opportunity to optimize their health and identify future health risks; and provide insurers, employers and healthcare providers timely information to intervene with wellness programs, fitness regimes, preventative measures or medical intervention.
The Wellness Assessment Tests strips are in pre-production prototype stage for the paid field trial and subsequently will go into full production prototype for final changes before being released for mass production. Further, Wellness is positioning its test panel as an objective indicator for metabolic syndrome,
a precursor to diabetes. This is significant because millions
of North Americans are affected by diabetes and an early indicator of pre-conditions favorable to the onset of diabetes can trigger prevention and intervention measures to dramatically
decrease the risk or onset of this disease. Wellness is an independent spinoff from Oxford Biomedical Research,Inc., a US provider of life science tools utilized by some of North America’s
most prominent medical research institutions. Wellness protects
its intellectual property with patent applications, license agreements and trade secrets. It is anticipated that Wellness will sell its test products through a contracted sales organization directly to insurers, large employers, as well as wellness consultants, representatives or third party administrators contracted by such insurers and large employers. Once that revenue stream is well-established, it is intended that
Wellness will expand sales through a value-added reseller
network and international sales channels.
Products
The Wellness Assessment Tests are designed to serve as primary, pre-clinical screens for both healthy and unhealthy metabolic processes, thereby providing insight into an individual’s overall health. Therapies and intervention may then be tailored to an individual’s test results. As a result, healthcare or wellness providers would no longer need to rely solely on statistics or generalized regimens to assess an individual’s health status or to manage wellness. Also, unlike traditional blood tests, which are more costly and intrusive, the Wellness Assessment Tests are developed as non-invasive, urine-based tests that can be performed and recorded at the point of care, whether that setting is an employer’s clinic, a wellness center, the shop floor or an office environment. Wellness Assessment Tests can be administered by less skilled individuals at lower cost and with less complexity than administering blood -based tests. The Wellness Assessment Tests are also designed to be used as an objective indicator for metabolic syndrome, the pre-cursor to full
-blown diabetes. Sufficient scientific data and publications exist to support its use in such an application along with established biometrics and a health risk assessment protocol. The
Wellness Assessment Tests provide rapid, non-invasive, on -site method for improved assessment of metabolic syndrome, which to date has involved only the Body Mass Index performed onsite, or the inclusion of expensive blood tests performed offsite. The metabolic syndrome is extremely prevalent in the United States and, according to the Centers for Disease Control and Prevention (CDC), in 2009 was present in an estimated 34% of adult Americans.
In particular, very high rates of metabolic syndrome are present in certain populations, such as African Americans, Hispanics, Native Americans, and persons of Asian or Arab descent.
The Wellness Assessment Test panel is comprised of six (6) different chemistry tests on a single urine test strip. The test strip results are measured by a dedicated, custom reader device. The results of the test strip chemical reactions are transmitted directly from the reader device to a personal computer loaded with
Wellness’ proprietary software.
This test panel will measure:
Oxidative stress biomarkers (2 indices);
Total antioxidant power;
Inflammatory biomarkers (2 indices); and
Creatinine (to normalize test results).
The Wellness Assessment Test, from saturating the test strip with a urine sample through the production of a test report, is anticipated to take less than five (5) minutes. Dedicated software will provide a report that outputs the normalized individual results of the different tests, along with a range of values that have been observed for healthy, normal subjects.
Future or follow -on products may include the addition of tests for proper hydration, electrolyte balance, cardio or autoimmune risk and other urine -based tests integrated into the overall
system. Further, the analytic/reporting software can be modified to address the informational needs for differing applications, such as military training, athletics competition, rehabilitation and the like.
From an economic comparative, the Wellness Assessment Test will likely be priced in the US$25 range, as compared to a range of US$30 -$60 for a single blood -based test for inflammation, such as C-reactive protein testing (CRP). The price range is derived from an average in the United States for reimbursement by insurers across the country. <SNIP>
<SNIP>
Directors Officers and Advisors of Wellness
The directors of Wellness are Denis CallewaertFounder), Harry Silverman (former CFO of Dominoes Pizza) and Tim Sell (Thoracic Surgeon).
The officers of Wellness are Frank Lyman (President), Andrew Dahl (Secretary, Chief Marketing Officer) and Phil Rice (Chief Financial Officer).
<SNIP>
Wellness contract sales organization Flagship Sails Rx (“Flagship”). Flagship’s Chief Executive Officer, Jeff Zavada, former Chief Sales Officer of Walgreen Co., and Senior Vice - President, Sales and Account Management for United Health Group, Inc.
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Most recent mgmt data from Wellness .....
Denis Callewaert
Founder and Chief Science Officer. Since obtaining his Ph.D. in biochemisty in 1973, Denis performed academic research for over 35 years and has founded four biotechnology companies. He has authored multiple scientific publications and textbooks and has several patented inventions. He is an international expert in biochemistry and immunology, with a focus on biomarkers for oxidative stress and inflammation.
Frank Lyman
President and Chief Executive Officer. Frank has 20 years experience in the medical device industry. In addition to general management, his experience includes marketing, regulatory and R&D positions in the medical device industry. Frank managed a start-up team that built a successful medical device company from the ground up and sold it to a large public acquirer. He has been both an investor and the senior manager for start-up ventures.
Michael Sutcliffe
CPA, Chief Financial Officer. With over 20 years experience, Michael has held various positions from staff accountant to CFO in start-up to large manufacturing and distribution companies. His background includes raising capital, implementing accounting systems, developing comprehensive financial reports, cash flow forecasting, budgeting, product costing, and implementing company risk management and benefits plans.
Robert Smith
Director of Logistics and Information Technology. Robert has expertise in operations manufacturing biochemicals, biotechnology vaccines, radiopharmaceutical drugs and medical devices, supply chain, procurement, logistics, production planning, project management and budget process. He is skilled in lean manufacturing principles, FDA, GMPs, ISO9000/13485 programs and implementation of ERP system.
Donald VerLee
Director of Research and Development. Don has over 20 years of research and development experience at Abbott Laboratories in the diagnostics, cardiovascular and hospital product groups. His research experience includes invention and development of immuno-chromatographic diagnostic assays and the fluid metering and jetting systems for manufacturing assays, such as the Fact Plus pregnancy test. Don has taken multiple medical devices from concept to commercial introduction. He has experience with both large companies and start-ups.
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Amigo Mike
PS ... Liquid, I don't have PM access .... but your list .... top 3 bottom 3 ... no kidding. 1 of the remaining 7, duh. The rest ..... something you have dreamt up as you've been told before.
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