Univec believes that its 1cc difficult-to-reuse sy
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than competitive syringes and that they are competitively priced. Univec also
believes that it is the only company that markets an AD-Syringe with a 1cc
barrel, which is ideal for dispensing accurate dosages of medicine (e.g.,
allergy, immunization and insulin medicines). It is more difficult to deliver up
to a .95cc dosage accurately with a syringe barrel that is greater than 1cc.
Univec does not know of any other company that offers a lcc aspirating syringe
that can be locked. Healthcare workers need aspirating syringes to mix
medications in the syringe barrel and inject medications intravenously.
Furthermore, Univec believes that aspirating syringes are preferred by diabetes
patients and needle-exchange programs. Pursuant to programs of international
relief agencies, Univec has shipped its lcc AD-Syringes to over 80 countries.
Univec also manufactures and markets patented Sliding Sheath Syringes
designed to protect patients and healthcare workers from needle stick injuries,
in compliance with the Federal Needlestick Safety and Prevention Act of the
United States government, and requirements of the Occupational Safety and Health
Administration (OSHA). Univec has FDA approval for an extendible barrel sleeve
syringe used in the sliding sheath syringes based on technology licensed by
Univec.
In addition, Univec has developed a Bifurcated Needle Safety Syringe
specifically designed to comply with the Federal Needlestick Safety and
Prevention Act of the United States government. Univec has been granted 510(k)
clearance by the FDA. The device is intended for use in administering smallpox
vaccines in response to potential bio-terrorist threats. The Needlestick Safety
mandate requires all U.S. healthcare providers to evaluate and implement safer
medical devices under their OSHA "Exposure Control Plans". All healthcare
providers must now adopt safer devices to protect workers and others from
needles potentially contaminated with blood borne pathogens such as hepatitis B,
hepatitis C, and HIV.
Univec markets its AD-Syringes and Sliding Sheath Safety Syringes to
governments of developing countries, provided that such syringes are
manufactured in the United States, private hospitals and health facilities in
the United States, and distributors in the United States.
Problems Associated With Traditional Disposable Syringes
In developing countries, accidental or deliberate reuse of disposable
syringes poses a serious risk of transmitting HIV-AIDS, hepatitis and other
blood-borne pathogens. Relief agencies, including UNICEF and WHO, administered
almost a billion immunizations to women and children through immunization
programs in developing countries in 1998 and anticipate administering 3.5
billion immunizations by 2005. WHO reported that surveys carried out in four of
its six regions indicated that up to a third of immunization injections were
unsterile. Immunization injections account for less than 10% of injections
administered within the health sector. The United Nations estimates that more
than half of all non-immunization injections in developing countries are unsafe.
According to WHO, an estimated 40.0 million adults and children worldwide are
infected with HIV, 90% of who live in developing countries.
Needlestick Prevention
Needlestick prevention devices are designed to prevent accidental puncture
injuries to health care workers and patients before, during, and after the use
of hypodermic syringes and needles. Statistics indicate that less than 1% of all
reported HIV infections in the United States are attributed to needlestick
injuries. The most prevalent needle stick prevention device, the extendible
barrel sleeve, is not a substitute for features that render a syringe
difficult-to-reuse; however, it can be combined with devices that make a syringe
difficult-to-reuse. Needlestick prevention methods include:
Retracting Needles retract the needle into the barrel after use. These
devices are effective needlestick prevention devices; however, operators must
manually trigger the retraction of needles. Retracting needle devices that
automatically trigger with a single use of the syringe can render the syringe
design difficult to reuse. However, such devices are costly to manufacture due
to the complexity of the mechanics required to retract the needle.
Self-Destruct Needles permit the needle to be collapsed or deformed into a
shape, which cannot result in a needlestick injury. Although self-destruct needle
devices are mechanically simpler than retracting needle devices, less prone to
malfunction and less costly to manufacture, such devices are effective only if
the operator triggers the self-destruct feature.
Extendible Barrel Sleeves enclose the barrel of the syringe in a second
cylinder. The operator extends the sleeve before and after use to cover the tip
of the needle. The extendible barrel sleeves often lock in the extended position
after use. In virtually all designs, the operator of the syringe must manually
extend the barrel sleeve after use. The sleeve does not prevent multiple use of
the syringe before the operator encloses the barrel. However, extendible barrel
sleeves are more cost-effective than the other alternatives and can be combined
with a device that makes the syringe difficult to reuse.
UNIVEC Syringes
Univec has developed a 1cc AD-Syringe for aspirating and non-aspirating
applications, which are ideally suited for dispensing accurate dosages of
allergy, immunization and insulin medicines. The Company's 1cc AD-Syringe can
deliver dosages of up to .95cc. With the aspirating syringe, the UNIVEC locking
clip does not limit the user's ability to withdraw and depress ("to aspirate"
the plunger until the user locks the syringe voluntarily. With the
non-aspirating syringe, the UNIVEC locking clip limits the user's ability to
aspirate the plunger and locks the syringe passively.
When the non-aspirating syringes are assembled, the syringe clip is placed
on the ratcheted plunger in the position needed to limit dosage as desired. When
the operator depresses the plunger, the clip travels down the barrel by an equal
distance. Withdrawal of the plunger by any amount embeds the prongs into the
barrel and the user cannot retract the plunger.
Univec's 1cc non-aspirating syringe was developed for the needs of
immunization programs. Using existing components, the Company can limit its
non-aspirating syringe to any dosage between .05cc and .95cc.
Univec's 1cc aspirating syringe works similarly to the non-aspirating
model, except that the clip prongs do not engage the barrel until the operator
withdraws the plunger completely. Once the operator does so, the clip catches a
single ratchet and travels down the barrel as the plunger is depressed and the
operator cannot withdraw the plunger.
Univec's 1cc aspirating syringe was developed for healthcare workers, who
need to mix medications in the syringe barrel and inject medicines
intravenously. Furthermore, the Company believes that aspirating syringes are
preferred by diabetes patients and needle-exchange programs. The Company does
not know of any other company that offers an aspirating syringe that can be
locked.
Univec has licensed rights to a United States patent for a sliding sheath
to function on all standard syringes. The Company believes that its licensed
design for a safety syringe will compete successfully with the other safety
syringes on the market. This design can be used on barrels of various sizes.
Univec has shipped its lcc AD-Syringes to over 80 countries. Univec intends
to market its Safety-Shield syringes, as well as the Demolizer medical waste
disposal system to governments of developing countries, private hospitals and
health facilities in the United States, and distributors in the United States.
Univec is a licensee of products and proprietary manufacturing processes
relating to 1cc AD-Syringes. For manufacturing in our facilities. The Company
markets such syringes to governments of developing countries, private hospitals
and medical facilities. To stimulate demand for its safety syringes, Univec
plans to initiate promotional and educational campaigns directed at (i) public
health officers and other government officials responsible for public health
policies, (ii) doctors and administrators of healthcare facilities responsible
for treatment of HIV-AIDS and hepatitis patients, and (iii) liability insurance
companies.
Univec also markets its drug sampling services to pharmaceutical companies
desiring to maintain or expand market position.
In 1995, Univec was granted a United States patent for a locking clip
device not biased against the plunger. The patent is broad enough to include
several applications of the design covering the first series of products to be
marketed by Univec. Univec was granted a United States patent for a plunger
design which, in conjunction with its patented locking clip, results in a narrow
barrel, difficult-to-reuse syringe that allows for aspiration during use.
In the past, Univec has filed patent applications for its locking clip and
aspirating plunger in certain foreign countries participating in the Patent
Cooperation Treaty (Canada, Brazil, Mexico, certain European countries, Japan,
South Korea, China, Russia and Australia). However, patent applications filed in
foreign countries and patents granted in such countries are subject to laws,
rules and procedures that differ from those in the United States, and
accordingly, patent protection in such countries may be different from patent
protection provided by United States laws. In December 2003, to settle an
outstanding note with Syrinter, Ltd. (Switzerland), the Company assigned certain
patents for the 1cc auto-disabled syringe as in full payment of the note and
interest thereon. The Company in turn received relief from restrictive patent
payments and a perpetual license to exploit these patents provided manufacturing
occurs in the United States. In addition, the Company will continue to receive
15% of future royalties being earned from the licensing of these items.
IMO Doc still has this business going strong, you don't get as wealthy as he has become it's common since.
TOODLES