Medical Device Link.

Originally Published MX May/June 2005

BUSINESS NEWS

GlucoWatch G2 Biographer, the only noninvasive glucose monitor with FDA approval. (click to enlarge)

In late March, insulin pump manufacturer Animas Corp. (West Chester, PA) completed its purchase of Cygnus Inc. (Redwood City, CA), maker of the only completely noninvasive glucose monitor approved by FDA. Animas paid $10 million in cash for the intellectual property rights, production equipment, license agreements, and inventory belonging to Cygnus.

The sale of Cygnus left some wondering if this may be the death knell for the company's approach to noninvasive glucose monitoring. "The purchase by Animas is an acknowledgment that the Cygnus device remains a specialty product, as opposed to the mainstream glucose monitoring solution originally envisioned by Cygnus," says Mark S. Vreeke, PhD, partner and cofounder of Rational Systems LLC (Houston), a technology consulting firm.

Cygnus's GlucoWatch G2 Biographer is a glucose monitor worn like a wristwatch. An electric current applied by the device extracts glucose molecules from interstitial fluid surrounding cells, circumventing the need for finger pricks. After considerable hesitation over the performance standards that should be applied to noninvasive glucose monitors, FDA approved the GlucoWatch as an adjunctive device in March 2001. At the time, the agency's approval was widely hailed as a breakthrough for the marketplace.

However, the agency also imposed significant restrictions on the use of the GlucoWatch. Under the terms of the approval, the device has to be used in conjunction with a traditional blood glucose monitor to make treatment decisions. The complexity of using the GlucoWatch under close physician supervision, and the requirement that its measurements be confirmed daily with more-traditional fingerstick testing, doubtless limited the desirability of the device.

Meanwhile, the GlucoWatch also suffered from a number of technical problems that slowed adoption. Problems such as skin irritation and inaccurate readings dogged the device, making it difficult for Cygnus to advance beyond the status of an adjunct diagnostic.

Kathy Crothall, PhD

In announcing its acquisition of Cygnus, Animas acknowledged some of the setbacks that the GlucoWatch had encountered. "We believe many of these issues can be addressed and are evaluating the commercial feasibility of these improvements," said Animas president and CEO Kathy Crothall, PhD. "Longer term, we are looking to substitute reverse electroiontophoresis extraction with microneedle extraction, using the microneedle technology that we recently licensed from Debiotech SA (Lausanne, Switzerland)."

In recent filings with the Securities and Exchange Commission (SEC), Animas discussed the possibility of such an amalgamation of technologies, nicknaming it the MicroWatch. Although the company said it had developed prototypes of modified GlucoWatch technologies, it was lukewarm about the success of the improvements.

However, implementing the company’s technology improvements would make the modified device invasive, effectively ending the company's quest to create a workable noninvasive glucose monitor. Despite this blow to Cygnus's noninvasive technology, Vreeke believes that in vitro diagnostics (IVD) companies will continue to search for a noninvasive approach to meet the needs of the $4 billion market in glucose monitoring. "Because there are significant patient benefits from tightly controlled glucose levels—and a desire to minimize intrusion into a patient's lifestyle—the quest for a viable noninvasive glucose strategy will continue," says Vreeke. "The market has sustained previous false starts, such as noninvasive strategies involving near-infrared optical technologies, and yet has continued the pursuit."

A few IVD companies have remained active in pursuing the goal of a completely noninvasive monitor, employing a variety of experimental technologies. Sontra Medical Corp. (Franklin, MA) is developing a technology that uses sonication to extract the interstitial fluid from which glucose measurements are made. BioTex Inc. (Houston) is employing a technology involving a 'glucose tattoo,' implanted beads that enhance the glucose signal in order to make it readable using optical technologies. Other companies are said to be pursuing technologies involving ocular or saliva-based measurement of glucose levels, so far with little success.

Meanwhile, most IVD companies have turned their research in other directions. "The strategies being investigated today mostly involve a mix of implantable, minimally invasive, and continuous-monitoring approaches, rather than a strictly noninvasive strategy," says Vreeke. In its recent SEC filings, for instance, Animas affirmed its long-term goal of developing implantable continuous glucose sensors. Similar strategies are also being followed by several other IVD companies. Abbott Laboratories (Abbott Park, IL), Medtronic Inc. (Redmond, WA), DexCom (San Diego), Roche Diagnostics (Basel, Switzerland), and TheraFuse Inc. (Carlsbad, CA) are all investigating the coupling of electrochemical detection with implanted or transdermal sensors.

Despite the ambitions of Animas, the company's plans come at a time when it has been under considerable market pressure. During inspections of Animas's manufacturing plant last October, FDA found that the company had failed to take proper corrective action following complaints of infusion pump failures. More recently, in April, a software bug led Animas to voluntarily recall 2000 of its IR 1250 insulin infusion pumps—launched just three months earlier—at a cost of $300,000.

Animas went public in 2004, raising $65.7 million from its initial public offering. The company spent $18 million to license microneedle technologies from Debiotech last year, and now another $10 million to acquire Cygnus.

Considering the cost of the company's recent regulatory issues, some are wondering whether this is a spending pattern that Animas can maintain. But whatever the company's expenses may be, it's a pretty fair bet that further spending to develop a truly workable noninvasive glucose monitor isn't going to be among them.

Copyright ©2005 MX