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I'm planning a BLOG posting
on the move up in HESG based on yesterday's QVC announcement.
I'll get to it over the weekend. If you want a technical comment on the
way the stock is behaving, you will find it by Monday morning. I am choosing
to wait until the market closes today so we can see how the stock performed.
Your comments and questions are welcome.
Also, for those with an interest-
myself included- BPTR is releasing Q3 earnings Monday before the
open. A conference call will be held Monday at 5:00 Eastern, 2:00 Pacific
for any interested parties. Investors can access the call by dialing toll
free 800-901-5217 and use pass code 81797204.
To use the BLOG, simply go
to the home page at www.otcjournal.com
- the BLOG will scroll down automatically on the right side of your
screen. The most current journal entries appear in the middle of your screen.
Check back frequently for updates particularly when stocks are moving to
overbought or oversold levels or in volatile markets. Your questions and
postings do not automatically appear, so don't bother posting the same
question multiple times. I personally go through to moderate and respond
to every question.
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First
Coming Attraction: Exciting New Drug Delivery Technology Targeting Diabetes |
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Here's the first of three new ideas
I have coming in the next two weeks. The second will probably come Monday
after the close. This is our second idea associated with the diabetes epidemic.
It is early stage, but the technology is very exciting and has potential
applications far beyond the delivery of insulin. A second diabetes related
idea is coming within the next two weeks.
Monday, after the close, I expect
to deliver another new idea in the telecommunications industry. It's a
pure numbers play. The company is growing, delivering north of $20 million
in annual sales, cash flow positive, and simply undervalued.
Despite the nice seasonal rebound
in the broader markets, interest in microcap stocks is still very lackluster.
I view 2005 as the year of the "Energy Shock". The plethora of negative
news has investors stuffing their mattresses with money they otherwise
might be willing to commit to speculation.
Volume will come back and small stocks
will move off oversold and undervalued levels. The energy shock is running
its course. Oil and natural gas prices more than doubled in one year. This
kind of energy shock only happens once every 30 years. The economy has
absorbed the blow, and it's once again back on track. Micros are due to
perk up. Be there ahead of the crowd in the right stocks.
For your consideration:
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Dermisonics
(OTC BB: DMSI): Revolutionizing Transdermal Drug Delivery |
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Type II Diabetes is an epidemic in
the US- here are the hard numbers: 21 million Americans suffer from diagnosed
diabetes; 90% or 18 million have Type II Diabetes- Type II being less complex
version. Their bodies produce insufficient insulin, and they can be treated
with insulin injections.
Dermisonics is developing
a method for delivery of insulin transdermally- another words with a patch
rather than a needle. Transdermal delivery means through the skin- specifically
through a patch on the skin. Hence the image of a cross section of the
human skin for your benefit.
Few drugs beyond birth control are
available in transdermal version for a very simple reason: The skin can
only absorb molecules with a molecular weight less than 500. Molecular
weights from 500 to 1,000 require some kind of enhancement to open the
pores. Currently, drugs with a molecular weight over 1,000 cannot be delivered
transdermally.
There are only 14 FDA approved drugs
with a molecular weight of less than 500- Insulin has a molecular weight
of 6,000. Hence, the limitations of transdermal delivery for commonly taken
drugs despite the benefit of not having to use any needles or upset your
stomach.
Enter Dermisonics (DMSI from
here forward). DMSI has a solution to the problem of transdermal
drug delivery. The company has discovered that the combination of a transdermal
patch and the application of very sophisticated ultra wave will open the
skin pores enough to allow the delivery of 82% of all drugs.
Using heat to open the skin pores
might seem like an obvious solution. However, with heat there are two problems:
1. The heated area can lead to skin irritation and 2. once exposed to heat,
the molecular structure of many drugs can change, making them ineffective.
DMSI has discovered a way
to open the skin pores without heating the area. There are two components
to the skin patch. The white part you see in the picture is the transdermal
patch that contains the insulin. There is an adhesive around the outer
ring. This design prevents the adhesive from mixing with the medication.
Once applied in the abdomen area
(the same place diabetics give insulin injections), the black component
snaps into place on the transdermal patch. This component provides the
ultrasonic signal which opens to skin pores and accepts the medication.
The ultrasonic component is attached
by wire to the unit you see pictured here. It will more likely be worn
on the belt like a cell phone rather than on the arm.
This unit can be programmed to activate
the delivery of insulin either on command or on a regular schedule. It
has data memory, and can be hooked up to a computer so that the user can
send the usage data to his or her doctor over the internet.
The unit also has an RFID port so
that future applications could include wireless commands.
On Friday after the market closed,
DMSI
announced it would be starting Phase I clinical trials on this product
in the first qtr of '06. After lengthy deliberations with the FDA on the
design of a trial, the company is taking its first major step towards commercialization
of the technology.
For the purposes of the regulatory
approval, their product is not considered a new drug and therefore the
process will not be as lengthy. It is considered a medical device. The
company will only have to prove the device delivers the drug effectively
without harming the user.
DMSI will self finance the
study in Phase I clinical trials. A small sampling of patients with Type
II Diabetes will participate. In Phase II, a much larger sampling of at
least 250 patients will be used. Since this is a medical device, the company
can petition for its PMA (pre market approval) after the Phase II study
has been completed.
DMSI's timeline goals through
the first half of 2006 are as follows:
-
Commence the Phase I clinical trial
-
Complete and Compile Data from Trial
in the March/April time frame
-
Get peer review publication on data
from Associates- specifically hoping for Princeton University Medical
-
Unveil the product at the American Diabetes
Association annual convention in June
-
Seek out a major biotech or pharmaceutical
giant to partner up with the company for the Phase II clinical trial.
While there are no guarantees any or
all of the goals can be attained, the time line makes sense if they can
get the Phase I trial started in early 2006.
On the fundamental side, DMSI
has 40 million shares I&O, leading to a $40 million market valuation
at $1. The company has $1.5 million in convertible debt, which converts
into a maximum of 600,000 shares based on the terms of the note and is
therefore, non toxic.
It is certainly early stage and should
be looked at with a long term perspective. However, when one considers
the possibility for drug delivery of not only insulin, but the other 175
commonly used drugs that could be delivered transdermally with the DMSI
technology, the $40 million starting level offers an enormous upside.
Patents also add value to the story.
DMSI
has filed for 15 patents on this process. One has been granted, and they
are closing in on a second. This will insure a "first to market" valuation
if and when the market prices in an approval.
Technically there is nothing remarkable
about the chart. This is a weekly chart going back to mid summer. Like
so many of its micro brethren, the stock has been in a down trend early
August. The stock should reverse course on Friday's announcement of the
commencement of the first clinical trial.
I would expect the stock to start
getting traction as the company's unique transdermal/ultrasound delivery
system begins to get publicity in the medical community. This is very exciting
technology with unlimited upside. I don't know how long it will take, but
I can easily see this company being acquired by a major pharma or biotech
company.
Here is the complete text of today's
news for your review:
| Press Release Source:
Dermisonics, Inc.
Dermisonics Receives
IRB Approval to Expand Human Pilot Clinical Trials of U-Strip(TM) Insulin
Patch in Diabetes Patients
Friday November 11, 4:01
pm ET
Patented Ultrasonic Technology
Platform Designed to Be Painless, Safe Method of Delivery for Insulin and
Other Drugs
WEST CONSHOHOCKEN, Pa.--(BUSINESS
WIRE)--Nov. 11, 2005--Dermisonics, Inc. (OTCBB:DMSI - News; FWB:FQC), a
developer of painless, injection-free, ultrasonic transdermal drug-delivery
patches and technologies with broad pharmaceutical and consumer applications,
announced today that it has received approval from the Chesapeake Research
Review Investigative Review Board to enter into the next stage of human
pilot trials of its proprietary U-Strip(TM) Insulin Patch drug-delivery
system in patients with Type-2 diabetes.
The approval is a major
step toward identifying Dermisonics as the front-runner in securing federal
regulatory approval for injection-free transdermal (through the skin) drug-delivery
technologies and positions the Company to become a leader in the $19 billion
drug-delivery market segment. Approval for the Company's HPT-2 trials came
from the Investigative Review Board (IRB) of the Chesapeake Research Review,
an independent biomedical research review organization.
The trials, expected
to begin in the first quarter of 2006, will evaluate the use of Dermisonics'
proprietary U-Strip (TM) transdermal patch device as an insulin delivery
system for Type-2 diabetics. Currently, people with diabetes rely on regular,
frequent needle injections of insulin to control blood glucose levels.
Dermisonics' patented U-Strip(TM) system employs proprietary microelectronics
and ultrasonic technologies with a drug-carrying patch to enable the painless
delivery of large-molecule drugs through the skin's natural pores and hair
follicles.
"The IRB approval to
begin this significant trial provides an important opportunity to validate
our proprietary ultrasonic drug-delivery technology," said Bruce Haglund,
CEO of Dermisonics. "The Company's U-Strip system is being designed to
serve as a safe and painless alternative to injections for delivering a
broad range of drugs transdermally, that is, through the skin. Should our
trials be successful, we believe Dermisonics' platform technology has the
potential to emerge as a leading force in the creation of breakthrough
methods to deliver at least 175 existing drugs that would otherwise require
uncomfortable, inconvenient or painful injections."
*
About the Human Pilot Trial 2 (HPT-2) -- The trial will involve a small
group of volunteers, Type-2 diabetes patients, to compare the performance
of the Dermisonics U-Strip(TM) Insulin Patch system with an existing FDA-approved
insulin pump delivery system. The test will run for approximately three
months. The study will evaluate the effectiveness of the Insulin Patch
in comparison to conventional pump therapy, with one significant advantage;
the U-Strip(TM) Insulin Patch will be totally non-invasive. The results
of the study will be presented for publication by peer reviewed medical
journals in 2006.
*
About Diabetes Sufferers -- When final regulatory approval has been obtained,
the U-Strip(TM) Insulin Patch technology has the potential to improve the
lives of both Type-1 and insulin dependent Type-2 diabetics, reaching 55
million diabetics, or nearly 30% of the total 185 million diabetic population
worldwide, who endure painful needle injections to survive this debilitating
disease.
About Dermisonics, Inc.
Dermisonics is an intellectual
property company and advanced technology incubator that is primarily focused
on the ongoing development, testing and eventual commercialization of a
transdermal patch that has been designed to facilitate the efficient and
needle-free delivery of drugs with large molecular structures into the
bloodstream. Its breakthrough system, called the U-Strip, is based on a
radical integration of microelectronics and ultrasonic science with a product-carrying
patch, and represents a quantum leap in non-invasive, transdermal delivery
technology. Tests have shown that this system facilitates the transdermal
delivery of insulin as well as potentially at least 175 other existing
drugs that at present cannot be effectively delivered through the pores
of the skin using conventionally available transdermal technology due to
their large molecular size. The Company has also developed other portable
ultrasonic systems for applications in the medical (Antiseptic Wand) and
skin care (U-Wand) fields. For more information visit http://www.Dermisonics.com.
For more investor-specific
information about Dermisonics, please visit http://www.trilogy-capital.com/dmsi_summary.aspx.
To read or download an Investor Fact Sheet about the Company, visit http://www.trilogy-capital.com/tcp/dermisonics/factsheet.html.
For stock price quotes, visit http://www.trilogy-capital.com/tcp/dermisonics/quote.html.
Forward-Looking Statements
This release contains
forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that
are based upon current expectations or beliefs, as well as a number of
assumptions about future events. Although the Company believes that the
expectations reflected in the forward-looking statements and the assumptions
upon which they are based are reasonable, it can give no assurance that
such expectations and assumptions will prove to have been correct. The
reader is cautioned not to put undue reliance on these forward-looking
statements, as these statements are subject to numerous factors and uncertainties,
including but not limited to adverse economic conditions, intense competition,
lack of meaningful research results, entry of new competitors and products,
adverse federal, state and local government regulation, inadequate capital,
unexpected costs and operating deficits, increases in general and administrative
costs, termination of contracts or agreements, technological obsolescence
of the Company's products, technical problems with the Company's research
and products, price increases for supplies and components, litigation and
administrative proceedings involving the Company, the possible acquisition
of new businesses that result in operating losses or that do not perform
as anticipated, unanticipated losses, the possible fluctuation and volatility
of the Company's operating results, financial condition and stock price,
losses incurred in litigating and settling cases, dilution in the Company's
ownership of its business, adverse publicity and news coverage, inability
to carry out research, development and commercialization plans, loss or
retirement of key executives and research scientists, changes in interest
rates, inflationary factors, and other specific risks. In addition, other
factors that could cause actual results to differ materially are discussed
in the Company's most recent Form 10-QSB and Form 10-KSB filings with the
Securities and Exchange Commission.
Contact:
Dermisonics, Inc.
Bruce Haglund
Toll Free: 888-401-DERM
(3376)
Phone: 610-543-0800
Fax: 610-543-0688
bruce.haglund@dermisonics.com
or
Trilogy Capital Partners
(Financial Communications)
Paul Karon, 800-592-6067
paul@trilogy-capital.com
or
European Investor Relations
Contact:
Michael Drepper
Phone: +49-621-430-6130
investor-germany@dermisonics.com
Source: Dermisonics,
Inc. |
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