3M Health Care (St. Paul, Minnesota) last month rolled out a new Medical Diagnostics business unit that will focus on developing and commercializing rapid diagnostics for the detection of what it called "key" infectious pathogens. Those pathogens include methicillin-resistant Staphylococcus aureus (MRSA) and other treatment-resistant microbes.

"We're making it known . . . that we're entering this diagnostics area specifically in infection prevention diagnostics to give customers what they're asking for, which are easier tests [that are] very rapid compared to what's on the market today," Angela Dillow, PhD, global business manager, 3M Medical Diagnostics, told Biomedical Business & Technology. The company will be offering three different platforms, Dillow said, all of which are "a combination of internal development — organically developed platforms — and technologies to which [3M has] gained access through acquisition," she said. The first three tests in the U.S., which still require a green light from the FDA, are expected to be launched later this year. Some of them will be point-of-care and others will be lab-based, she said.

Dillow called the 3M Medical Diagnostics unit a "natural extension" of its existing infection prevention business, one that began 30 years ago with the development of loban incise antimicrobial surgical drapes. 3M Health Care, one of 3M’s six major business segmen, is a provider of products for not only medical, but also dental, orthodontic and health information markets, the company said.

With this new diagnostics business unit, 3M said it will offer hospitals new rapid diagnostic tests to detect the presence of potentially destructive microbes before they spread and potentially infect other patients.

Dillow said the medical diagnostics unit will address the "many market trends pointing to the need" for such infection control tests both in the U.S. and abroad. For example, the Medical Diagnostics unit will be launching its first product this month in Europe, where its first test already has the CE mark.

In the U.S., the Centers for Disease Control and Prevention (CDC; Atlanta) estimates that annually about 90,000 deaths are due to hospital-acquired, or so-called nosocomial, infections. In December 2006, the CDC issued new guidelines outlining strategies to prevent the spread of drug-resistant infections in healthcare facilities. Those guidelines specifically called for the screening of patients at high risk for carrying drug-resistant bacterial infections in hospitals that do not improve their healthcare-associated infection rates.

The company said that in the U.S., current infection prevention patient screening activities include no screening at all, traditional cultures that require 48 hours to provide results, or molecular diagnostics, which the company said are more costly.

3M said its tests will "simplify the diagnostic testing process and provide more rapid results than traditional microbiology tests for the detection of key microbes such as Staphylococcus aureus, MRSA and influenza A and B. The company expects its tests to allow physicians to make faster decisions regarding their patients and the possibility of infection. It also expects labs to be able to reduce the amount of time conducting the tests, which it said could lead to "reduced healthcare costs and improved laboratory profitability."

Dillow told BB&T that while at the moment 3M is "sticking to [its] strategy" to offer diagnostics in infection control, the market ultimately can expect the company to "fill out [its] product portfolio and offer total solutions in infection prevention."

Boston Sci eyes Endosurgery IPO/spin to raise up to $1B

Faced with large debt and eroding confidence on the part of investors, Boston Scientific (Natick, Massachusetts) said last month that it is considering the spin-off, via IPO, of a minority share of a group of endosurgical businesses manufacturing products for endoscopy, urology, gynecology and oncology. It said the IPO could raise up to $1 billion.

Boston Scientific said its board gave it the go-ahead to explore selling of about 20% of the Endosurgery group — its main endosurgery facility located in Marlborough, Massachusetts — and establishing a separately traded public company. The new company would remain a majority-owned Boston Sci subsidiary.

(In reporting on the potential offering, The New York Times noted that the partial spin would be the biggest in the medical device sector since Nestle sold about 23% of eye care firm Alcon for $2.3 billion in 2002.)

The company would use the funds to help pay the $9 billion in debt it acquired with the purchase of Guidant last year. But that debt is just one of many difficulties for the company, ranging from a flattening of its sales of the Taxus drug-eluting stent and its defibrillator products, to an FDA warning letter that blocks approval of new products, to the continued filing of class action and product liability lawsuits, currently heading toward the one-thousand mark.

The result has been significant paring of customer confidence and, worse, loss of investor confidence, the company's share price having fallen about 37% since its 52-week high of $23.98.

Lexie Code, endosurgery department manager at Millennium Research Group (Waltham, Massachusetts), told Biomedical Business & Technology, that the proposed spin is "exciting and creative," while adding a proviso: "I think it will be a very positive move as long as they can find the right partner with the right managers."

Code said she thought that consideration of this initiative was a response both to a longer-term analysis of the endosurgery division by Boston Scientific on how to improve operations, and also a response to the shorter-term issues related to the Guidant purchase.

Boston Scientific, she said, had "definitely done a good job with [the endosurgery business] and it could be a star company on its own." An "outside party," she said, "isn't going to be distracted in some cases."

Boston Scientific said that its endosurgical offerings have produced "consistent revenue and earnings growth over the past eight years" with a compound annual growth rate in revenues of about 12% during that period. The group is expected to generate more than $1.4 billion in revenue in 2007.

But in a press statement, the company acknowledged that the endosurgical businesses have been over-shadowed — specifically, "less visible to the investment community" — by the Guidant purchase last year and its "increased presence in the cardiovascular market."

Boston Scientific said that reorganizing the endosurgical business as a private entity would have a variety of benefits including improved visibility and improved focus — as well as providing the $1 billion for debt repayment and providing funds for beefed-up salary offerings.

Lawrence Biegelsen, an analyst for Prudential Financial, in a report said the move "signals that [Boston Sci management] acknowledges that the challenges in its core DES and CRM businesses are making it increasingly difficult for the company to achieve its debt repayment targets."

In a conference call, Jim Tobin, president/CEO of Boston Scientific, emphasized the consistency of its performance in the endosurgical sector but said that these businesses were "not getting credit" for their track record because they are hidden in the larger corporate operations.

Tobin said that a minority-interest IPO for the business group "would highlight its success and stability and create a direct investment vehicle in these specialty device markets, while giving us greater financial flexibility."

The company said it would take from six to 12 months to evaluate the proposal and that, if approved for going forward, would be made in made late this year or early 2008.

Corin’s hip resurfacing system wins ortho panel go-ahead

What do you do when you need a control group but can't develop one? This is a problem facing an increasing number of device makers these days as their products become more leading edge and so have no comparators — or, alternatively, when potential enrollees are becoming better acquainted with the benefits of the newest technologies.

The bigger problem then, of course, is how to approach an FDA panel minus a control.

That was a difficulty overcome in late February by the Corin Group (Cirincester, UK), in pursuing efforts to get its Cormet 2000 hip resurfacing system into U.S. commercialization. Fortunately for the company, the agency's orthopedics panel decided that the benefits of the Cormet outweigh such concerns, and panelists voted 4-1 to recommend approval, though a final agency decision is yet to come.

Hip resurfacing is an invasive procedure, but much less invasive then total hip replacement, and patients increasingly are convinced that less-invasive is always better. Ian Paling, Corin's CEO, told Biomedical Business & Technology, "we didn't realize at the time" of trial launch that subjects would not be interested in enrolling in a total hip replacement. Additionally, he noted the advantage for younger patients: that the less traumatic hip resurfacing leaves the option of a total hip replacement at some later point.

Richard Mott, MD, president/CEO of Wright Medical (Arlington, Tennessee), speaking for the sponsor — apparently because Wright will be seeking a hip resurfacing product approval — said, "I'm coming here as someone who has done a lot of resurfacing," totaling about 1,200 such procedures over the past 18 years. He said of those, "about 650 resurfacings were of metal-on-metal," adding that "all these resurfacings are fairly similar, and if you approve one, you have to approve them all."

"My main message is to urge education. I believe that if companies . . . urge surgeons to use the appropriate procedures . . . you can reduce these complications to a very low level." Mott said that it is up to the companies to enforce educational requirements and that each surgeon's first five procedures should be monitored.

Thomas Schmaltzreid, MD, associate director of the Joint Replacement Institute (Los Angeles), supported the company's argument that patient selection for a control group was difficult. Patient selection, he said "has truly evolved," partly because some reports indicate that short-term, femoral neck fracture is more common among women, and because age and gender "are surrogates for bone density."

He noted that the Internet blunts the prospect of enrolling subjects in control study arms. Because of the volume of information available online, "[t]he level of pressure coming from the patients" is driven partly by perception of benefits with sometimes little regard for risk, he said.

Michael Mayor, MD, professor of orthopedics at Dartmouth Medical School (Hanover, New Hampshire), said, "efficacy [trial] endpoints appear to have been maintained in a reasonable manner" but the change from a concurrent to historical controls constituted "a near-tragic compromise" of such requirements. He also argued that the changes to various criteria for outcomes "optimized the chances for success."

If the Cormet is approved, it will enable Stryker (Kalamazoo, Michigan) — which will market the product in the U.S. — to compete with Smith & Nephew (London) in this technology sector.

Variety of new med-tech ventures get roll-out

A variety of new companies and new company offerings have been rolled out over the past month, ranging from disease monitoring to medical education. Following is a sampling of these:

• A new business out of the Cleveland Clinic (Cleveland) will develop technology enabling physicians to monitor chronically ill patients remotely, from watching blood pressure via telephone lines to one day keeping tabs on heart rhythms from a distance.

The business has teamed with a venture capital firm, Glengary (Cleveland); Dan Carlin, MD, a telemedicine physician in New Hampshire; and someone that it termed an information technology veteran” in Massachusetts to form VitalStream Health, the latest out of the Clinic's spin-out arm, CCF Innovations.

The system will be used to gather health information from afar to generate online patient report cards that doctors will use to help treat people. The idea belongs to Glengary and Carlin, founder of telemedicine practice WorldClinic (New London, New Hampshire) in 1998.

Drawing from his experience as a medical officer in the Navy and as an expatriate volunteer, Carlin said he designed WorldClinic to be a "teledoctor" for patients who are far from modern medical care. "My patients who are scattered around the world are getting older," Carlin said. "I needed a way to do a better job of taking care of them."

Marc Penn, MD, director of the Clinic's Bakken Heart-Brain Institute and medical director of its coronary intensive care unit, will be the lead clinical researcher on the project.

The partners are raising money and hiring a management team to run VitalStream Health, Rosenfeld said. Glengary also will invest in the startup.

• The American College of Radiology (ACR; Reston, Virginia) has launched ACR Image Metrix, a contract research organization (CRO) that will leverage ACR's experience in large-scale clinical research to accelerate advances in radiologic care and fund future research.

ACR Image Metrix said it will offer a menu of imaging CRO services, from study design to image interpretation and quantitation. ACR Image Metrix is headquartered in the college's Philadelphia office, alongside the ACR clinical research division, a radiology research organization.

The ACR and the American College of Radiology Imaging Network (ACRIN) develop trials that standardize the use of imaging technologies, image transmission and archive, and quantification of image data to reduce variability, reduce the size and cost of trials and produce more reliable results. The organizations said that revenue from the research projects by ACR Image Metrix will be used to fund future ACRIN, Radiation Therapy OncologyGroup, and Quality Research in Radiation Oncology (Q-RRO) studies.

• Infuse Media Group (Salt Lake City) reported launch of Infuse Medical, a medical education agency offering training and education using interactive media and measurement tools.

Infuse Medical focusing primarily on training and education and online digital marketing.

“Educators and marketers partner with Infuse Medical to produce interactive learning experiences and marketing tools that are both memorable and measurable," said James Norton, Infuse Media Group, creative director.