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[IP] Fwd: E-News 02/19/02
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>Date: Tue, 19 Feb 2002 02:30:00 -0800
>To: (Recipient list suppressed)
>From: "Dr. Joe, The Diabetes Doctor" <email @ redacted>
>Subject: E-News 02/19/02
>Dr. Joe and the team have been involved in development of this new product
>and delighted to see it out there.
>SpectRx, Inc. Announces FDA Clearance of New Minimally Invasive Insulin
>Delivery Patch for Insulin Pumps
>Monday February 4, 6:30 AM EST NORCROSS, Ga., Feb 4, 2002
>/PRNewswire-FirstCall via COMTEX/ -- SpectRx, Inc. (SPRX
>today announced it received U.S. Food and Drug Administration (FDA)
>clearance to market a new minimally invasive insulin infusion patch set
>for use with insulin pumps. The new patch infusion set brings to 19 the
>number of FDA clearances supporting SpectRx's insulin delivery product
>These products were added to SpectRx's diabetes franchise through its
>recent acquisition of Sterling Medivations. The new insulin patch infusion
>set, which is expected to be on the market in 2003, will address a U.S.
>insulin pump infusion set disposable market estimated at $200 million
>annually and growing approximately 25 percent per year.
>The patch infusion set, designed for use with all makes of insulin pumps,
>delivers insulin through five microneedles that are less than half the
>length of ordinary insulin pump infusion needles. The reduced penetration
>is designed to improve comfort and wearability. "We believe that the
>novel design of this new groundbreaking product will provide people who
>use insulin pumps with a more comfortable, secure, easy to use and
>discreet option," said SpectRx President and COO, Keith D. Ignotz.
>"This latest FDA clearance is an indication of the strength and depth of
>our insulin delivery products pipeline," said Mark A. Samuels, SpectRx
>Chairman and CEO. "After our initial product introductions of the Simple
>Choice(TM) insulin pump infusion sets scheduled for later this year, we
>expect to roll out new insulin delivery products at regular intervals,
>providing innovation for people with diabetes and excellent growth
>opportunities for SpectRx."
>In addition to the insulin patch infusion set, SpectRx has received FDA
>clearance for soft catheter insulin pump infusion sets, an insulin pump
>reservoir and a multi-purpose insulin pen. The first of these products,
>the Simple Choice(TM) Soft and Simple Choice(TM) Quick insulin pump
>infusion sets, are expected to launch by the third quarter of this year.
>The Company's additional proprietary insulin delivery products under
>development are designed to improve the quality of life for people with
>diabetes who use insulin, most of whom still use conventional syringes.
>Insulin infusion sets, when attached to external pumps, provide a steady
>stream of insulin for people with diabetes, helping them to better control
>their disease. The disposable infusion sets are changed about every three
>days. This is a growing market, with about 160,000 people with diabetes
>using insulin pumps in the U.S in 2001. That number is expected to
>increase to about 225,000 in 2002.
>SpectRx is a medical technology company providing innovative detection,
>monitoring and treatment solutions for diabetes, cancer and other niche
>healthcare markets. SpectRx is developing and will market the Simple
>Choice(TM) line of innovative insulin delivery products for people with
>diabetes. These products will complement SpectRx's consumer device for
>continuous glucose monitoring being developed with partner Abbott
>Laboratories. SpectRx is also developing, along with partner Welch Allyn,
>a product for the non-invasive detection of cervical cancer based on its
>biophotonic technology. SpectRx also developed and currently markets the
>BiliChek(TM), a non-invasive, painless monitor for infant jaundice.
>SpectRx was developed around its leading-edge biophotonic detection and
>monitoring technology, which uses light and spectral energies to develop
>painless alternatives to blood-based and tissue-based procedures. For more
>information, visit SpectRx's web sites at www.spectrx.com and
>www.bilicheck.com, or use Internet keyword spectrx.
>"Safe Harbor" Statement under the Private Securities Litigation Reform Act
>of 1995: A number of the matters and subject areas discussed in this press
>release that are not historical or current facts deal with potential
>future circumstances and developments. The discussion of such matters and
>subject areas is qualified by the inherent risks and uncertainties
>surrounding future expectations generally and also may materially differ
>from SpectRx's actual future experience involving any of or more of such
>matters and subject areas.
>SpectRx has attempted to identify, in context, certain of the factors that
>they currently believe may cause actual future experience and results to
>differ from SpectRx's current expectations regarding the relevant matter
>or subject area. Such risks and uncertainties include: unexpected
>difficulties in integrating the operations of Sterling Medivations, the
>early stage of products in development, the uncertainty of market
>acceptance of its products, the intense competition in the medical device
>industry, the uncertainty of capital to develop products, as well as those
>that are more fully described from time to time in SpectRx's reports under
>the heading "Risk Factors" filed with the SEC, including SpectRx's Annual
>Report on Form 10-K for the fiscal year ended December 31, 2000 and in the
>Forms 10-Q for the first, second and third quarters of 2001 filed by SpectRx.
> MAKE YOUR OPINION COUNT - Click Here
>SOURCE SpectRx, Inc.
>CONTACT: media, Bill Wells, or financial, Thomas H. Muller, Jr.,
>both of SpectRx, Inc., +1-770-242-8723; Alison Ziegler, General Contact,
>or Julie Tu, Analyst Information, or Judith Sylk-Siegel, Media Contact,
>all of FRB|Weber Shandwick, +1-212-445-8400, for SpectRx, Inc.
>Copyright (C) 2002 PR Newswire. All rights reserved.
>SpectRx gets FDA clearance for new insulin set
>Monday February 4, 6:59 AM EST
>NEW YORK, Feb 4 (Reuters) - Medical products maker SpectRx Inc. (SPRX
>said on Monday it had received U.S. regulatory clearance to market a new
>insulin infusion kit that delivers insulin to diabetes patients through
>five mini-needles designed to improve the comfort of such infusions. The
>"microneedles" in the infusion patch set are less than half the length of
>ordinary insulin pump infusion needles.
>Diabetics often do not have enough of the hormone insulin, which regulates
>sugar levels in the blood, or their insulin does not work properly. A
>majority of diabetes patients receive insulin injections or
>infusions. SpectRx said the new infusion patch set would likely be on the
>market in 2003. The U.S. insulin pump infusion set disposable market is
>estimated at $200 million and is growing by about 25 percent each
>year. The Norcross, Georgia-based company, which specializes in diabetes
>products, said it acquired the new product as part of its Jan. 2 takeover
>of privately held Sterling Medivations Inc.
>)2001 Reuters Limited.
>Dr. Joe, The Diabetes Doctor
>E-News is written by Dr. Joe Prendergast and his staff at Endocrine
>Metabolic Medical Center. It is sent out Monday through Friday
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