New technologies — not just new but rather different and not easily understood — can cause considerable anxiety, and considerable resistance against uptake, as a result. It is a reaction that has been termed "bioconservatism" by James Hughes, executive director of the Institute for Ethics and Emerging Technologies (Hartford, Connecticut). As just one example, Hughes cites the recent debate concerning reports of sarcomas in four animals implanted with the radio frequency identification (RFIC) device manufactured by VeriChip (Delray Beach, Florida).

Millions of people have had their pet dogs and cats implanted with the device, used to track and identify them if they become lost. But an Associated Press article reported four sarcomas in these animals. By some accounts, veterinarians are being deluged with requests to have the chips removed, and the reaction to human use is likely to be even more aggressive. In humans, the use is for implantation in those with cognitive disorders, such as dementia and Alzheimer's, at risk for wandering off and getting lost and at high risk for complications when injured or ill.

The company also advertises the VeriChip for use in maternity wards as a means of preventing accidental or deliberate child swap, which is said to occur as often as 20,000 times each year, leaving 40,000 children in the wrong homes.

Overall, the reports of "fast-growing" tumors in pets and lab animals served to reinforce previous concerns by privacy advocates who have linked the chip's ability to carry a large amount of private information to apocalyptic "mark of the Beast" signs. These privacy activists passed along these reports to the AP, and one result of the subsequent stories was that the company's shares dropped by 20% on the Nasdaq, though that only totaled about $1.

Scott Silverman, CEO of Verichip, said that the AP article "and the alleged research cited [in the article] make no link whatsoever to malignant tumor formation in dogs and cats but for one unsubstantiated report" and that "over the past 15 years, millions of dogs and cats have safely received an implantable microchip with limited or no reports of adverse health reactions."

The chip's supporters would argue that in human uses of the chip, its benefits overshadow its risks, and several physicians have weighed in on the issue. Robert Benezra, MD, head of the cancer biology genetics program at the Memorial Sloan-Kettering Cancer Center (New York), said, "There's no way in the world, having read this information, that I would have one of those chips implanted in my skin, or in one of my family members."

Lawrence McGill, DVM, a veterinary pathologist at Animal Reference Pathology (Salt Lake City), told Biomedical Business & Technology that the incidence of tumors in lab mice and rats is not that relevant since these animals are genetically predisposed to express tumors more rapidly. McGill also said that the studies cited by opponents of RFID implantation included no controls, and hence no comparisons.

McGill said that epidemiological evaluations "have noted no association with microchips," and that some of the fear-provoking data comes from "veterinary diagnostic labs that combined data for sarcomas with other data on other types of tumors." McGill added that a needle and syringe also constitute a risk factor for lab rodents. "Most pathologists agree that injection sites have their own" risk profile for sarcoma formation, he said.

"Veterinarians found many years ago that when cats got into fights, many of those cats had sarcomas in their eyes" when their opponents landed a claw in the eye, he said, adding that he and many others have "never seen what we thought was a microchip-only" source for a sarcoma. However, he recommended that veterinarians implant the Verichip in a site other than the site for an injection.

He said that even if the incidence of sarcoma formation in animals holds up in humans, a patient, for instance with Alzheimer's is likely to pass away before there is any reaction to the chip. This difference in the rate of tumor acquisition is predicated on a difference in the metabolic rates of rodents and humans.

"One year in the rat's life equals about 12 or more" in humans, he said, adding that the lifespan ratio is roughly paralleled by the comparative rates of tumor formation. McGill also said that this is not a speculative line of thinking. "There is data that says mice and rats acquire tumors much more quickly than humans," he said

McGill was wary about the possibility of widespread use of implanted chips, however. "I think we're going to where our kids might be microchipped one day," he said, adding that he is not keen on the idea unless there is some compelling reason. However, for someone who suffers from recurrent bouts of amnesia, "I'd put one in him in a heartbeat," he said. As for patients with Alzheimer's, who are prone to leave the house and get lost, "I'd put a chip in them even if they were 50."

Emphasys, Mako Surgical both file with SEC to go public

Emphasys Medical (Redwood City, California) last month filed with the Securities and Exchange Commission to raise up to $86.3 million in an initial public offering. The number of shares to be offered and the price range for the offering have not yet been determined. The company registered to sell its stock on the NASDAQ Global Market under the symbol EMPH.

Emphasys develops devices for the treatment of patients with emphysema and other breathing disorders. The company recently completed a pivotal clinical trial to demonstrate the efficacy and safety of its first product, the Emphasys Bronchial Valve (EBV) in patients with emphysema and has submitted its pre-market application to the FDA. It said it expects FDA approval for the EBV in late 2008.

Emphasys said it will use about $25 million of the proceeds for sales, marketing and administrative activities; $20 million for R&D activities; $15 million for capital equipment and commercial scale-up of manufacturing; and the balance for working capital and other general corporate purposes.

In its SEC filing, the company said it has incurred "substantial net losses" since its inception in 2000. As of June 30, it had accumulated a deficit during development stage of $64.4 million. In the six months ended June 30 the company said it has narrowed its loss to $4.6 million compared to $7.6 million in the same period last year. The company's revenue jumped in that same period to $570,000 from $61,000.

Also filing for an IPO was Mako Surgical (Fort Lauderdale, Florida), for up to $86.25 million. The number of shares to be offered and the price range of the offering have not yet been determined. The company will apply to have its common stock approved for quotation on the NASDAQ Global Market under the symbol MAKO.

The company said it will use the proceeds for the expansion of its sales and marketing organizations, continuation of its R&D efforts and general corporate purposes, including working capital. It also intends to use a portion of the proceeds to make a $4 million payment to IBM (Armonk, New York), as required under the terms of its licensing agreement with IBM. It may also may use a portion of the proceeds for acquisitions of products and technologies.

Mako is the developer of a robotic solution and implants for minimally invasive orthopedic knee procedures. Its Haptic guidance system includes an interactive haptic robotics platform that utilizes tactile-guided robotics and patient-specific visualization to prepare the knee joint for the insertion and alignment of resurfacing implants through a keyhole incision. The FDA-cleared surgeon-interactive haptic robotic system allows surgeons to provide a tissue-sparing bone resurfacing therapy that the company calls MAKOplasty.

In its filing, the company noted that it has sustained net losses in every fiscal year since its inception in 2004, including a net loss of $10.6 million for the year ended Dec. 31, 2006 and a net loss of $7.5 million for the six months ended June 30.

Nanogen eyes alternatives for microarray business

Nanogen (San Diego) reported that it is evaluating alternatives for its microarray business. The unit includes the company's NanoChip instrument system and related multiplexed reagents and consumables. Nanogen has retained Credit Suisse to evaluate alternatives which may include a sale, partnering or closure of the array business.

The company said it expects to complete its evaluation in 60 to 90 days.

The company said the goal is to create a restructured business that can reach profitability"faster and with greater predictability." The restructured business will continue to focus on clinical diagnostic markets with emphasis on real-time molecular and rapid point of care products.

"Financial expectations for the restructured business have not been completed and are dependent on the outcome of the strategic evaluation," said Robert Saltmarsh, Nanogen's CFO. "We expect that sale or closure of the microarray business will decrease expenses and improve cash flow by at least $15 million annually. We also expect the restructured business will show revenue growth on a year over year basis."

"In taking this course of action, we recognize that our microarray technology is very good and customer reception is positive. However, multiplex molecular testing remains an early stage market with slower growth and lower testing volumes than we expected," said Howard Birndorf, Nanogen's chairman/CEO. "

Nanogen's products include real-time PCR reagents, the NanoChip400 electronic microarray platform and a line of rapid, point-of-care diagnostic tests.

Carnegie Mellon wins $5M to create computational biology center

Carnegie Mellon University (CMU; Pittsburgh) reported that it has received a $5 million gift from Ray and Stephanie Lane to establish the Ray and Stephanie Lane Center for Computational Biology.

The gift also will endow a professorship and provide support for doctoral and post-doctoral training in this field. Biological Sciences and Biomedical Engineering Professor Robert Murphy will direct the center and has been appointed the first Ray and Stephanie Lane Professor of Computational Biology, recognizing Murphy's leadership in computational biology research, education and administration.

"We are extremely pleased that the Lanes have supported these initiatives, which collectively provide critical momentum in our growth as a leader in life sciences research and education," said Carnegie Mellon President Jared Cohon.

He added: "Bob Murphy's work epitomizes our university's strength in cultivating scientific achievement at the intersection of disciplines, such as computer science and biology."

NanoSensors parts ways with CEO, will restructure

NanoSensors (Santa Clara, California) reported that it is parting ways with Dr. Ted Wong, its president/CEO, CFO and chairman and will become a shell company as the vehicle for the possible acquisition a new operating business.

Wong's departure coincides with a decision by the company's board to terminate its operations, position it as a shell company and use its assets to acquire an operating business.

The company said it does not have any specific merger, stock exchange, asset acquisition, reorganization or other combination under consideration or contemplation, other than what it termed "two initial, exploratory conversations." The company said it will not limit itself to any particular industry or geographic location in these efforts.

The board also dissolved the company's Technical Advisory Board and terminated certain of the company's consulting and license agreements. Its non-binding letter of intent to acquire DKL International (Vienna, Virginia) expired Aug. 31.

The restructured company will be led by Robert Baron as acting president/CEO and chairman. Josh Moser has been appointed interim CFO.

NanoSensors agreed to make a severance payment to Wong equal to six months of his salary, about $72,000, plus another $5,125 for unused vacation benefits. The company also granted him a restricted stock award of 1,364,629 shares.

NanoSensors was a developer of instruments and sensors to detect explosives, chemical and biological agents, principally a sensor device to detect e.coli and salmonella in food and water.