Noninvasive Chart

| Jan 1, 1998

Noninvasive

Futrex

Skin

This hand-held monitor sends infra-red light through the finger.

At this point it is uncertain when the Dream Beam will be put on the market.

One positive aspect of the DreamBeam is that it has opened up market awareness of non-invasive technology.

Some disadvantages are the alleged Security Exchange Committee (SEC) violations and investor lawsuits.

Financing for the Dream Beam was $1.8 million in 1994. In 1995, the Individual Public Offering (IPO) resulted in alleged SEC violations.

Solid State Farms

Skin

The meter works by transmitting radio frequency waves through the skin of the finger. The device is expected to be battery operated and about the size of a calculator. The cost will be about $500.

The company is currently doing clinicals in preparation for the FDA.

Solid State Farms also is currently focusing on an HbA1c monitor.

Solid State Farms has signed a joint marketing agreement with Bio-Tech Industries of Parsippany, New Jersey and Biophile of Minden, Nevada. They and other private sources are providing financing for the research.

CME Telemetrix

Skin

This monitor will measure glucose levels in the finger using a near infrared spectroscopy technology.

Clinicals are being conducted in Canada and the United States in preparation for a 510 (k) application to the FDA in 1998.

CME Telemetrix has been working with MediSense, a wholly owned subsidiary of Abbott Laboratories, since 1995 on the development of the device.

Abbott funds the project on an ongoing basis. CME and its partners have invested over seven million on the development of the device. CME is a public company.

Technical Chemicals and Products Inc. (TCPI)

Skin/Interstitial fluid (ISF)

A patch is placed on the skin which collects the ISF. A meter is then placed on the patch to interpret the BG measurement.

Pre-clinical trials were done during 1997. Launch was anticipated in 1998. However, TCPI is currently involved in a legal battle with Americare Diagnostics.

TCPI recently signed a standstill agreement with Smith-Kline Beecham for evaluation of blood glucose products. Financing consists of $25.6 M in private offerings, $4.2 M in initial public offerings and $21.4M in secondary offerings.

Instrumentation Metrics

Skin

This portable handheld monitor will use near infrared reflective measurement to measure blood glucose.

Scheduled to be released in 1999.

Instrumentation Metrics is funded by venture capital and private institutional investors.

Americare Diagnostics (American Transtech)

Skin/interstitial fluid (ISF)

This meter will use a patch and chemical BG measurement.

There has been no formally announced date for launching this meter.

Because of the break up with TCPI, Americare Diagnostics is now involved in legal skirmishes with TCPI.

Financing is private.

RetiTech, Inc.

This monitor works by analyzing the glucose-sensitive cells of the retina in the eye.

Computer driven test box conducts a visual test which determines the concentration of glucose in the retina.

The meter is expected to be released in the year 2000.

The technique works in patients with diabetic retinopathy or uncorrected myopia, hyperopia, astigmatism or presbyopia. However, the device will not work for those who have severe vision loss, blindness or for very young children.

Research and development has been funded by private money and grants. RetiTech is actively seeking a corporate partner to license its technology for commercialization.

 

Bioject Medical Technologies/ELAN Corporation

Skin/interstitial fluid (ISF)

The ISF is sampled through the pores of the skin by a micro probe and transmitted to a disposable patch. The patch collects, analyzes and transmits the results of the analysis to a small portable LCD unit, which can be worn as a wrist watch.

Human clinical testing is expected to begin in the second quarter of 1998 with commercial introduction expected in 2001.

Funding is shared jointly between Bioject at 81.1 percent and ELAN at 19.9 percent for the next two years. Afterwards the company will be publicly offered.

Optiscan

Skin/ interstitial fluid (ISF)

This meter looks for specific wavelengths of heat coming off of the body.

There has been no formally announced date for the release of Optiscan's meter, however clinicals are scheduled to start in 1998.

Funded by venture capital.

Biocontrol

Skin

Near infrared technology is used in the Diasensor 1000.

Biocontrol resubmitted the 510 (k) for its Diasensor 1000 noninvasive glucose sensor to the FDA in October 1996. The FDA withdrew the 510 (k) in November 1995 and requested that more in-home testing be conducted. Biocontrol plans to market the Diasensor 1000 in the Far East and the Philippines.

Two disadvantages are: the price may be as high as $8,000. And it will require individual patient calibrations.

Financing has largely been from offshore funds from foreign banks and investment groups.

Semi-Invasive monitoring

Cygnus

Skin/interstitial fluid (ISF)

Reverse iontophoresis is used to employ an electrical charge on the skin to pull interstitial fluid (ISF) through the pores of the skin. A disposable patch which collects the ISF is attached to the bottom of a watch which gives a blood sugar read out.

Pivotal clinicals anticipated in the fourth quarter of 1997 - a 510K will be submitted in the second quarter of 1998.

Some positive aspects of the GlucoWatch are: automatic frequent measurements that provide an abundance of data for better disease management. Plus, the wristwatch design is portable and discreet.

Thirty million in financing came from Becton Dickinson and Yamanouchi Pharmaceutical (Tokyo). Cygnus is publicly held.

Mercury Diagnostics, Inc.

Skin

This minimally invasive monitor measures a very small amount of blood.

Because this system measures blood, therapy adjustments can be made on the same basis as current measurement systems.

Clinicals are planned for 1998.

Financing includes venture capital and private funds.

MiniMed Inc.

Interstitial fluid (ISF)

A subcutaneous micro sensor canula is inserted into the skin with a needle.

The market launch for this meter is estimated for 1999.

MiniMed already has a franchise business in diabetes with its insulin infusion pumps. It also has a marketing agreement with Boehringer Mannheim.

This is a publicly held company with a dedicated research and development budget. This technology is part of a platform intended to be tied into MiniMed's implantable pump as well as a potentially stand-alone product.

SpectRx

Interstitial fluid (ISF)

Laser technology is used to drill a very shallow hole about the size of a human hair into the skin.

The expected market launch is unknown.

SpectRx's relationship with Abbott Laboratories, a division of MediSense affords them a marketing partner. They are likely to be tied into Abbott Laboratory's biosensors.

Financing consists of some venture capital and private funds from Abbott. Also, 12 million from IPO.

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Categories: A1c Test, Blood Glucose, Blood Sugar, Diabetes, Insulin, Meters, Noninvasive Monitors


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