Robert,
Thought this might cheer you up.....it did me.
biz.yahoo.com
Wednesday April 16 8:46 AM EDT
FDA Grants Clearance on Laser Lancet(TM) to LaBarge and Venisect
ST. LOUIS, April 16 /PRNewswire/ -- LaBarge, Inc. of St. Louis, Mo., and Venisect, Inc. of Little Rock,
Ark., jointly
announced today that the U.S. Food and Drug Administration (FDA) has granted clearance to the companies
to manufacture
and market the Laser Lancet(TM), a portable, battery-powered laser device, to draw capillary blood for clinical
testing without
the use of sharp instruments such as needles.
The Laser Lancet provides a new alternative to needles or metal lancets commonly used to puncture the skin to
draw blood.
For healthcare workers, this procedure eliminates the risk of infections posed by sharp instruments, possibly
contaminated
with blood-borne diseases, such as HIV or hepatitis B. The new Laser Lancet is the first and only device to
receive FDA
clearance for the purpose of drawing blood, other than sharp metal instruments. The Laser Lancet may also
prove more
cost-effective for hospitals, medical laboratories, blood donor centers and doctors' offices than traditional
techniques.
The Laser Lancet draws blood from the patient by sending a laser pulse through a proprietary, disposable
plastic tube. The
laser pulse perforates the skin, making a small slit, normally in the fingertip, just deep enough to break
through the outer skin
layers and into the capillary bed. Clinical trials proved the Laser Lancet system is fast and effective for routine
blood
chemistry tests requiring small amounts of blood. The results of clinical trials indicated that patients generally
preferred the
Laser Lancet to traditional needle sticks and that the skin perforation heals normally.
Venisect will market and distribute the Laser Lancet, which will bear the Venisect name. LaBarge will
manufacture the device
at its Tulsa, Okla., facility under exclusive license from Venisect.
In a related matter, the U.S. Patent Office recently notified Venisect that many new and important patent claims
related to the
Laser Lancet will be allowed. Currently, Venisect has one issued U.S. patent and many other patents pending
on the laser
technology.
Charles H. Vestal, president of Venisect, Inc., commented: "We're very excited to receive clearance from the
FDA. Since we
began research and development on the Laser Lancet, we've received significant interest from the medical
community, both
here in the United States and from overseas. The Laser Lancet will make the job of the healthcare worker safer
and, with the
trend toward analysis of smaller and smaller blood samples, we believe we are positioned to quickly become
the preferred
method of blood sampling.
"In addition, we continue to be enthusiastic about future applications for the technology. One such promising
application
currently being tested in clinical trials is transdermal delivery of pharmaceuticals."
Craig E. LaBarge, chief executive officer and president of LaBarge, Inc., commented: "We are delighted the
FDA has given
clearance to market and manufacture the Laser Lancet. We are beginning initial production immediately and
will increase production as needed to meet market demand. The Laser Lancet offers a revolutionary alternative
to traditional blood-drawing techniques and LaBarge is pleased to partner with Venisect in bringing this
exciting new device to market."
Venisect, Inc. is a privately-owned firm headquartered in Little Rock, Ark.
LaBarge Inc , headquartered in St. Louis, provides engineered solutions and manufactures a wide range of
custom electronic
products and complex interconnect systems for the telecommunications, geophysical, medical, and aerospace
and defense
markets at its facilities in Missouri, Arkansas, Oklahoma and Texas.
Facts About the Laser Lancet(TM)
Name of Device Laser Lancet(TM)
Description Portable medical laser device that perforates the
skin to draw capillary blood for clinical testing
and screening; powered by a rechargeable battery
pack
Key Benefit Eliminates the risk to healthcare workers of
infections posed by sharp instruments possibly
contaminated with blood-borne diseases
Market/Typical Users Hospitals, clinics, blood banks, medical
laboratories, doctors' offices
Marketed By Venisect, Inc.; Little Rock, Ark.
Manufactured By LaBarge, Inc.; St. Louis, Mo. |
