CURRENT
ACTIVITIES
The
Company has retained the services of an FDA consulting firm to assist
in the review of patient data documents from the approximately 500 women
tested in clinical trials as well as to review the development
process of the First Warning System's computer based interpretive software.
These processes and their documentation will form the basis for the Company’s
anticipated preparation and filing of a 510 (k) with the FDA.
We will be seeking marketing clearance for this medical device designed
to assist in the early discovery of breast tissue abnormalities.
Some portions of these tissue abnormalities may indicate the presence of
cancers or pre-cancerous lesions.
Management
anticipates the FDA consulting firm’s report will be completed near
term. Once the report is available a plan for the preparation
and submission of a 510 (k) application shall commence.
Concurrently,
the Company has retained an experienced medical marketing company to
conduct a marketing assessment survey of physicians and patients, the
anticipated target markets for the First Warning System™.
The marketing company report is expected to be completed before the
end of May 2010.
Updated
information is available from time-to-time in press releases on this
website under the Investor Relations section.
MANAGEMENT DISCUSSION AND
ANALYSIS - OPERATIONS
The
current priority of Management is to focus on the preparation and submission
of a 510 (k) medical device application to the FDA seeking approval
of marketing clearance within the United States. Although the Company
has spent time and resources developing the First Warning System‘s
proprietary technology and testing approximately 500 women with the
System, there can be no assurance the FDA will approve the 510(k) application.
Management estimates it will take several months to prepare the 510(k)
application and submit it the the FDA. It is not possible to estimate
the time it will take the FDA to respond and what their response may
be.
Management
estimates, based on the current rate of monthly operating expenditures,
without any additional patient testing or pursuing additional product
development, the current cash on hand should support operations for
approximately the next 12 months.
BUSINESS DESCRIPTION
The
Company has engineered and developed the First Warning System™, (FWS)
a process designed to assist in the early discovery of breast tissue
abnormalities Over 500 women have been tested with the FWS in
various clinical trials. The system attained a 90+% range for
sensitivity and specificity. The FWS process is noninvasive, non-compressive
and uses no radiation. The FWS is much more accurate than mammography
which historically has a sensitivity in the range of 70% and involves
both compression and radiation. In other words, the FWS can identify breast tissue abnormalities much earlier and more accurately than other existing modalities.. If, in the process, an abnormality has
been identified, further investigation such as MRI, Ultrasound or Biopsy
may be appropriate, depending on the attending physician’s opinion.
HISTORY
The
technology developed to assist in the early discovery of breast tissue
abnormalities began in the mid-nineteen eighties by company founder,
Dr. William Reeves (then working in Dayton, Ohio together with engineers
from Wright Patterson Air Force Base). The original process involved
collecting discrete temperature measurements via 16 minaturized sensors,
eight located on various portions of each breast. The temperature data
was then stored in a miniature device developed by the Company. The
collected data was then ready for analysis.
The process was clinically tested over a period of years at three different sites: 1) Department of Oncology
at Ohio State University under the direction of Dr. William Farrar;
2) Green Memorial Hospital, Dayton, Ohio under the direction of Dr.
Ronald Fletcher; 3) Clemplam Breast Clinic, La Plata, Argentina under
the direction of the late Dr. Martin Laguens who was then Professor
of Pathology at the University of La Plata. At all three testing sites
a total of 500+ patients were tested.
The methods of analysis of
the patient data has evolved over time as the developed software became
more sensitive and accurate. It was obvious from the beginning that
the over 9,000 discrete temperature measurements from each patient did
not lend themselves to visual analysis as is done in mammography and
thermography. Accordingly, computerized analytical methods were selected,
initially utilizing two separate neural nets in conjunction with a variety
of statistical manipulations. Although these efforts were rewarding,
they did not provide sufficient accuracy to support a commercially viable
product. More recently, the Company has greatly increased the interpretative
efficiency in conjunction with members of the faculty of the Division
of Thermal and Fluid Engineering, School of Mechanical and Product Engineering,
Nanyang Technological University, Singapore.
The Company was originally
located in Dayton, Ohio, then moved to Fort Lauderdale, Florida, and
now has located all corporate offices in Reno, Nevada.
MANAGEMENT, PRIMARY CONSULTANTS,
PROFESSIONALS
MANAGEMENT
JIM
HOLMES, Chairman of the Board, Chief Executive Officer and Treasurer
Mr.
Holmes has been involved in Lifeline Biotechnologies, Inc. since 1994.
Since that time he has assisted in providing financing of over $10 million
for the Company. These funds have been primarily utilized for
the development and patient testing of the First Warning System™.
He was acting as CFO until mid 2000. In 2001, Dr. Reeves, then
CEO of Lifeline experienced a significant health challenge. During
the ensuing years his day-to-day involvement became less and less until
his doctor advised that he retire. At that time Mr. Holmes became
acting CEO. The focus at that time was to complete the Argentina
patient study. Shortly thereafter, the Lifeline headquarters was
moved from Florida to Nevada. Here, the focus became the completion
of revisions in the interpretive technology (software) as it related
to patient testing. The goal is preparation and submission to
the FDA for 510(k) marketing clearance.
Mr. Holmes’ background
includes financing and managing of numerous companies, public and private,
in a variety of industries. He is a CPA, formerly with PricewaterhouseCoopers.
His education includes a BS in Business, MBA Studies, emphasis in accounting
and the Advanced Management College, Stanford University.
Dr.
LOUIS KEITH, Director, Vice President, Secretary and Medical Director
Dr.
Keith has worked closely with Lifeline’s founder, Dr. William Reeves
for almost two decades. Beginning as a consultant, he ultimately became
the company’s Medical Director, assisting other company officers in
understanding the computerized analytic system now in place. He also
assists in the evaluation of the other products in the company’s portfolio.
His publications relating to the breast can be found under “Publications
and Whitepapers” on Lifeline’s website.
Dr. Keith currently
is Professor Emeritus of Obstetrics and Gynecology and former Director
of the Section of Undergraduate Education and Medical Student Affairs
at Northwestern University, Feinberg School of Medicine in Chicago.
He received certification by the American Board of Obstetrics and Gynecology
in 1967, a Ph.D. degree from the Karol Marchinkowski University of Medical
Sciences in Poznan, Poland in 2002, and has been elected
to fellowship or membership in numerous American and international medical
societies and colleges. He was awarded an Honorary Fellowship in the
Indian College of Obstetrics and Gynecology in 2004, an honorary Doctor
of Science by the Medical Academy of Lublin, Poland in 2007 , and was
elected to Honorary Fellowship in the Royal College of Obstetricians
and Gynecologists of London, UK in 2010. He has authored or co-authored
more than 600 scientific treatises and edited or co-edited more than
30 monographs in the discipline of Obstetrics and Gynecology. His textbooks
on Multiple Gestation and Obstetric Hemorrhage are regarded as definitive
in the English language.
FRED
SCHIEMANN, CPA, Controller
Mr.
Schiemann received his degree from the University of Illinois, Chicago
Circle Campus. Additionally, he obtained his MBA in taxation from Golden
Gate University, Sacramento campus. Mr. Schiemann had his own certified
public accounting firm for over fourteen years, until he sold the business
at the end of 1993. During his years of practice, his main areas of
focus were taxation, auditing and public securities work. He has been
involved with many public registrations and structuring of mergers and
acquisitions. He assisted in the financing of a nutrition company that
was doing in excess of $8.5 million dollars a year in sales. Additionally,
he recently assisted a nutrition company that he organized to public
through a reverse merger with a pink sheet company. Mr. Schiemann currently
has established a new accounting practice in Reno, Nevada with an emphasis
on public registrations, administration and consulting to small and
micro-cap public companies. He was the interim assistant CFO for American
Leisure Holdings, Inc. from December 2002 through June 2006. He was the
CFO for Xtreme Oil & Gas, Inc. from December 2006 through February
2010.
He currently is the treasurer
of Biz2Biz.Com, Powerlean USA, Web Business Relations and Interactive
Health Network.
PRIMARY CONSULTANTS
Dr.
William H. Reeves, Founder of Lifeline Biotechnologies.
Dr.
Reeves has been involved in the founding of three medical start-ups,
two public and one private. They include Vectra Corporation, Lifeline
Biotechnologies and Chronodynamics, Ltd. He began his career with
Sandoz Pharmaceuticals working with federal and state psychiatric hospitals
doing clinical studies with phenothiazing drugs. He joined Davis
& Geck Division of American Cyanamid as a market analyst and served
as a group product manager before joining International Paper Company
as Director of New Product Development. He assisted IP’s entry
into the medical products field with the development of Confil, a disposable
paper medical product. IP acquired Davol, Inc as its marketing
arm. Dr. Reeves joined Sherwood Medical Industries and became
National Sales Manager for surgical products. He has been involved
in the development of a variety of medical devices with both domestic
and foreign manufacturers. Dr. Reeves holds seventeen patents
on medical or medically related products, with four patents presently
pending.
NANYANG
TECHNOLOGICAL UNIVERSITY, Division of Thermal and Fluid Engineering,
School of Mechanical and Product Engineering, Nanyang Technological
University, Singapore.
LSS
GROUP
LSSG
is an experienced medical marketing firm assisting Lifeline/First Warning
in gathering market information by conducting a marketing assessment
of physicians and patients in the use of First Warning System™.
The assessment survey is expected to further define prospective marketing
aspects of the target customers and the prospective end users.
PROFESSIONAL
Robert
Laskowski, Esq. Corporate and Securities Counsel
Principal practice areas involve
all aspects of business and corporate law, with a special emphasis on
federal and state securities law matters, involving the SEC, FINRA and
state securities administrators for issuers, broker-dealers and investment
advisers. We represent development-stage, start-up and emerging
businesses, as well as seasoned companies, in public and private equity
and debt financing, venture capital transactions, mergers and
acquisitions, proxy solicitations, and SEC periodic reporting compliance.
Clients have also been represented before federal and state regulatory
agencies in securities law enforcement matters.