Siemens Healthcare (Mountain View, California) unveiled its Acuson SC2000 volume imaging ultrasound system in mid-June, saying it is the first system to acquire non-stitched, real-time full-volume 3-D images of the heart in one single heart cycle.
The product announcement came during the 19th annual meeting of the American Society of Echocardiography (ASE; Raleigh, North Carolina) in Toronto.
Calling it "Echo in a Heartbeat," Siemens said the new technology marks "the greatest paradigm shift in ultrasound since the introduction of 2-D imaging in the late 1970s." Instantaneous, non-stitched full-volume imaging comes 55 years after echocardiography pioneers Inge Edler and Hellmuth Hertz acquired the world's first cardiac ultrasound recording using Siemens technology in 1953, the company said.
Louise Kruz, senior marketing manager for echocardiography solutions at Siemens Ultrasound business unit, told Biomedical Business & Technology that Siemens had to overcome a few technical challenges to make the Acuson SC2000 stand out from the competition.
"Currently the products on the market use a stitched image, because they are limited by how much information and the rate at which they can acquire it they stitch shorter images together to cover the entire cardiac structure," she said. "The Acuson SC2000 can acquire at such a rate that we can cover the whole heart, a 90-degree by 90-degree imaging angle, and an acceptable frame rate at 20 or greater."
"The heart is a moving organ, so if you have to stitch something together you're kind of corrupting the clinical information," Kruz said, noting that the Acuson SC2000 offers purer information because it images one cardiac structure on the same heartbeat.
Another challenge that all other systems that do stitched imaging face, she said, is that those images often are gated by the ECG, an electrical tracing of the heart, so when the patient has an arrhythmia it makes it difficult to image. Also, patients who cannot hold their breath is a problem for clinicians using a stitched-imaging ultrasound system. With the Acuson SC2000, the patient does not have to hold their breath.
"Innovation has always been the lifeblood of Siemens, and the Acuson SC2000 volume ultrasound system is delivering on this promise," said Klaus Hambuechen, CEO, ultrasound for Siemens Medical Solutions USA (Hoffman Estates, Illinois). "The system has unparalleled capabilities in information rate processing that allow us to acquire a full volume of the entire heart with 90 degree pyramids. With a high-volume acquisition rate like this in one second, every second acquisition time is dramatically reduced, improving the overall workflow in the echocardiography suite."
Siemens says that the Acuson SC2000 system "is Siemens' premier cardiology platform that will change the way echocardiography is practiced today."
The company says Acuson's architecture delivers vastly more information than conventional systems and is strengthened by Siemens' Coherent Volume Formation technology. Coupled with the system's high-volume acquisition rate, Coherent Volume Formation moves away from serial line-by-line acquisition towards simultaneous, multiple beams, delivering excellent image resolution, Siemens said.
Another challenge for competing ultrasound systems, Kruz told BB&T, is patients who are difficult to image, such as those who are obese, those who smoke, or a patient who has end-stage renal disease. Patients who are considered difficult to image make up about 30% of the patient population, which she said probably is understated.
"Siemens has a reputation for going after the difficult-to-image patient," Kruz said. "We target the hard ones, not the easy ones, because everyone can do the easy patients."
BSGI seen as better for cancer detection
Another interesting report from the imaging sector indicated that Breast-Specific Gamma Imaging (BSGI) is giving surgeons a much better way to detect breast cancer perhaps an even better method than MRI. The findings by a group of doctors from Legacy Good Samaritan Hospital (Portland, Oregon) were presented during the Society of Black Academic Surgeons' annual meeting in Cleveland in early June.
BSGI is a molecular breast-imaging technique used for the early detection of breast cancer and in the differentiation of malignant and benign tumors. It relies on advanced gamma imaging technology and mammographic positioning to optimize result.
The surgeons used Dilon Technologies' (Newport News, Virginia) high-resolution gamma camera, the Dilon 6800, which was given FDA approval in 1999. The device was marketed much later beginning only three years ago and received CE-mark status just this May. The Dilon 6800 is a high-resolution, small-field-of-view gamma camera, optimized to perform BSGI, a molecular breast-imaging procedure that images the metabolic activity of breast lesions through radiotracer uptake.
The device has been used on more than 25,000 patients in hospitals and private imaging centers nationwide, according to the company. "This device looks at how the tissue observed behaves and is a more physiological approach than standard MRIs," Nancy Morter, director of marketing and corporate communications for Dilon, told BB&T. "It's about the size of an ultrasound and it's mobile," she added.
The study, which used the device, evaluated 138 patients with a cancer diagnosis. In this group, additional disease was found in a total of 11% of patients. Some 6% were in the same breast and 5% were in the opposite breast. This finding is very similar to that of an MRI study conducted by Northwestern University; however, BSGI provided a significantly lower false positive rate of 7% compared to 78% with the MRI study.
"Cancer tests have two values," Morter said. "First is the sensitivity, and that tells you when there is an abnormality. Second is the specificity, and that tells you when there is no abnormality. Well, MRIs have about the same sensitivity as [BGSI, but also] has a higher rate of false positives or sensitivity than BGSI. The result is too many people are having biopsises which is an expensive process."
The study authors concluded that BSGI has comparable sensitivity and greater specificity than MRI for the detection of breast cancer in patients with equivocal mammograms. The smallest cancer detected by BSGI was 3 mm.
For difficult-to-diagnose patients, BSGI serves as a complementary diagnostic adjunctive procedure to mammography and ultrasound.
Evolution stent may 'shake up' market
Another potentially market-disrupting technology unveiled last month is Cook Medical's (Bloomington, Indiana) Evolution controlled-release esophageal stent system, a device Cook hopes will bring some long-overdue innovation to the market.
"This product is going to make a real difference; we think it's going to shake up the market, we think as a disruptive technology," Barry Slowey, VP of global sales and marketing for Cook's Endoscopy division, told BB&T following the company's receipt of FDA 510(k) clearance for the system.
The Evolution stent system, cleared for use in patients with esophageal cancer, is designed to reduce the risk of migration and give physicians more control over the placement of the stent.
Slowey said Boston Scientific (Natick, Massachusetts) has dominated the esophageal stent market. "10 years ago [Boston Sci's stent] was a pretty good, novel introduction system, better than what was out at the time," Slowey said. "Now doctors are saying that the stent doesn't give them much control," he said.
When treating patients with esophageal cancer, he said, doctors are trying to get the stents aligned within the tumor so they are trying to get part of the stent above and part of it below the tumor. Cook has been working on the Evolution stent for about three years, Slowey said, and designed the device using input from gastroenterologists who said they wanted a more controlled delivery system for precise placement and a stent with a low risk of migration.
The company came up with a device that has a pistol-grip deployment system so that the doctor can squeeze a trigger and only 8 mm of stent deploys at a time. The stent itself is about 8 cm to 15 cm long. "We've given them a very controlled-release stent," Slowey said.
Another complaint Cook heard from doctors about other esophageal stents is that sometimes they will get up to 50% into the deployment and find that the stent is not exactly where it needs to be. So the Evolution stent system features a button that allows doctors to retract the stent, 8 mm at a time, if they are unhappy with the placement.
"The problem we've best addressed is the issue of placement, which was our biggest concern when we heard back from gastroenterologists," Slowey said.
The ability to place the stent precisely the first time may reduce the need for repeat procedures, the company noted. "It gives [doctors] peace of mind ... they want sort of a Get-out-of-jail card," Slowey said.
He said the "dog bone" or "dumbbell" shape of the stent helps anchor it in place because the top and bottom parts are larger than the part of the stent within the structure.
$6.7B deal will net Applied Biosystems
Invitrogen (Carlsbad, California) and Applera (Foster City, California) plan to merge in a cash-and-stock deal valued at $6.7 billion, expected to close this fall.
Invitrogen will acquire all of the outstanding shares of Applera's Applied Biosystems group (ABI) to form a combined company, which will carry the Applied Biosystems name and will be located in Carlsbad.
During a conference call last month, Tony White, CEO and chairman of Applera, told investors that the Applera board authorized Morgan Stanley in January to consider options to enhance value for shareholders. White said Applera considered three options: continuing to make acquisitions and increase the company's portfolio; restructuring and remaining independent; and selling to another company.
"Today's transaction is a hybrid of the second and third options as we are combining with a very complimentary life science tools provider to create a new company that will have the strengths of each as well as synergies that will make the combination much more than the sum of its parts," White said.
Applera-Applied Biosystems shareholders will receive $38 for each share of Applera-Applied Biosystems stock they own in the form of Invitrogen common stock and cash. The expected split between cash and stock is 45% and 55%, respectively. Applera-Applied Biosystems shareholders will receive a value of $38 a share if the 20-day, volume-weighted average price of Invitrogen common stock is in the range of $43.69 to $46 three business days before the close of the transaction.
"I recognize that we had our issues a few years ago when we tried to integrate 15 acquisitions onto a very unstable company infrastructure," Greg Lucier, chairman/CEO of Invitrogen, said during the conference call. "Those investors and analysts that know us well know that our company is a radically different one today than it was three years ago. We have a very solid and stable infrastructure from people to processes to systems. We have a leadership team that has demonstrated that we can deliver upon a significant improvement to company performance in a very short period of time."
Lucier, who will be chairman/CEO of the new company, said that Invitrogen "could not be in a better position to take on something of this nature." He added, "Yes, it will be complex; yes, it will be time-consuming; and yes, there will be challenges. But our team and the ABI team are up for the challenge and I am extremely confident that we can deliver upon our commitment and then some."
Mark Stevenson, president/COO of Applied Biosystems, will be president/COO of the new company, which is expected to have about $3 billion in combined revenues, generating more than 70% of revenues from consumables and services. The deal is expected to generate about $125 million in annual cost savings by the third year of the combination.
Hologic riding Third Wave into HPV test sector
Diagnostics and imaging systems maker Hologic (Bedford, Massachusetts), a diagnostics and imaging systems provider, continued its drive into the women's health segment last month with its announced $580 million deal for human papillomavirus (HPV) test maker Third Wave Technologies (Madison, Wisconsin).
The $11.25-a-share offer represents a 24% premium to Third Wave's average trading price over the last three months.
"It's an outstanding opportunity for Hologic to enter the molecular diagnostics market," said Jack Cumming, Hologic's chairman/CEO, during a conference call with investors. "Third Wave's HPV tests, currently under FDA review, represent a highly strategic addition to our portfolio of products focused on women's health."
Third Wave makes molecular diagnostic reagents for a wide variety of DNA and RNA analysis applications based on its Invader chemistry for conditions such as cystic fibrosis, hepatitis C, cardiovascular risk and other diseases. The company recently submitted pre-market approval applications to FDA for two HPV tests.
Hologic is borrowing $600 million to finance a senior credit facility. "The new $600 million term loan is expected to be paid off in a 2.5-year time frame," said Hologic CFO Glenn Muir.
Cumming said that, with last year's $6.2 billion acquisition of Cytyc (Marlborough, Massachusetts), "We gained access to a completely new franchise with a strong distribution presence in key markets. This led us to seriously consider the molecular diagnostics market."
Muir reported that because Hologic is well ahead of plan, the remaining $90 million owed on that purchase was scheduled to be paid off at the end of June. "We continue to generate cash flow," he said.
A month after the Cytyc deal last May, Hologic agreed to acquire BioLucent (Aliso Viejo, California) and its MammoPad breast cushion business for $70 million.
Cumming said the Third Wave acquisition will help the company strengthen its diagnostics portfolio, provide near-term access to the HPV market and enable new growth in several non-HPV test areas. "We believe, when fully commercialized, Third Waves' Cervista for high-risk screening of HPV will provide a competitive alternative to existing HPV tests," he said. "This will allow Hologic to participate in the growing HPV market."
He added that buying Third Wave will strengthen Hologic's business internationally. "We plan to launch the high-risk test, which is CE-marked, internationally immediately after the transaction closes, beginning with the EU. Once approval is granted in the U.S., we will immediately begin to market here."
Strategically, Cumming said, "We view this acquisition as a critical step to maintaining Hologic's commitment to women's health and continuing our strong earnings growth into the future."
Datascope acquiring, Veridex divesting
Two other interesting deals reported in mid-June included the somewhat-surprising disclosure by Datascope (Montvale, New Jersey) that it is acquiring the Sorin Group's (Milan, Italy) Peripheral Vascular Stent business for an undisclosed sum. The surprise arises out of the fact that just a few days earlier, Datascope had said that it was considering strategic alternatives including the company's possible sale after receiving interest from several unnamed third parties.
Datascope said the planned acquisition is a result of its successful experience as exclusive distributor of the Sorin peripheral stent product line in Europe, in which sales have grown rapidly since the product launch in January 2007. In 4Q08, sales are expected to rise 27% above last year to an annualized level of $6.6 million. With the acquisition, Datascope said it gains the opportunity to market the product line throughout the world. Datascope estimates the worldwide market at $800 million annually, of which $200 million is in Europe, $500 million in the U.S. and $40 million in Japan.
While the Sorin acquisition appears to fly in the face of Datascope's earlier report that it was considering a sale, the deal might also increase the number of suitors for the company. Datascope said it had been approached by several third parties that were considering making a bid for the company after the $202 million sale of its patient monitoring business to Mindray Medical International (Shenzhen, China), which was disclosed in March and finalized in early June.
The sale comes as part of the Sorin Group's previously disclosed plan to divest its non-core assets in order to better focus on its strategic businesses, Cardiopulmonary, Heart Valves and CRM. Sorin's peripheral stent products are dedicated to the treatment of peripheral arterial disease (PAD) and use the company's Carbofilm technology. Datascope also has received exclusive, worldwide rights to the Carbofilm technology within the endovascular field as part of the deal. The product line includes balloon-expandable and self-expanding stent systems principally for use in the treatment of the iliac arteries, renal arteries and infrapopliteal lesions, as well as balloon systems for use in percutaneous transluminal angioplasty.
"We believe that Sorin's peripheral vascular stents will be an attractive addition to our product portfolio," said Datascope's COO, Dr. Antonino Laudani. "Peripheral vascular stents are in line with our strategic objectives to play a main role in the vascular and endovascular market."
The other interesting deal reported last month was the agreement by Immunicon (Huntingdon Valley, Pennsylvania) to sell most of its assets to Veridex (Raritan, New Jersey), a Johnson & Johnson (New Brunswick, New Jersey) unit, for $31 million.
Announcement of that deal followed Immunicon's filing for Chapter 11 bankruptcy protection. Immunicon sought protection from creditors with the U.S. Bankruptcy Court in Delaware. It said it had $9.2 million of assets and $24.3 million of debts, according to the filing.
The assets to be bought include intellectual property, product inventory and clinical data, and technologies related to Immunicon's CellSearch cancer test, the companies said. In March, Immunicon lost an arbitration ruling in a case in which it had alleged that Veridex did not devote "best efforts" to market CellSearch. The companies have been partners for various products since 2000.
Following the decision, Immunicon said it would cut 40% of its full-time staff. In April, the company said it had retained Stifel, Nicolaus & Co. to advise on strategic alternatives, including a possible sale. The deal is subject to approval by the bankruptcy court and is not expected to require antitrust review or shareholder approval, Veridex said.
LifeScan, ResMed in co-marketing accord
A this-makes-great-sense marketing agreement reported last month sees LifeScan (Milpitas, California), maker of the market-leading OneTouch Brand of blood glucose meters for people with diabetes, and ResMed (Poway, California), a manufacturer of devices for the diagnosis and treatment of sleep apnea, joining up in an exclusive co-marketing agreement designed to improve the lives of people with Type 2 diabetes and sleep-disordered breathing (SDB).
The two companies will focus on educational and cross-promotional efforts intended to benefit the patients and healthcare professionals served by both companies. The goal is to build awareness among healthcare professionals of the overlap of these two conditions, trigger new approaches to patient care, and ultimately improve the rate of treating patients suffering from both SDB and diabetes.
The agreement between the two companies comes on the heels of a recent announcement by the International Diabetes Federation (IDF) in which the organization issued a consensus statemen on Type 2 diabetes and obstructive sleep apnea (OSA), the most common form of SDB. Issued by an IDF working group, the new statement included an urgent call-to-action regarding the need to adopt new clinical practices with respect to monitoring, screening and treating patients who present with either condition.
"Through this agreement, it's our hope to make significant inroads into educating more physicians about the coexistence, identification and care of these two diseases, and getting more patients diagnosed, treated and on the road to a healthier future," said Tom West, president-North America, LifeScan.
While more research is needed to fully understand the correlation between diabetes and OSA, it is clear that the two conditions are often are linked. "Research shows that it is likely in people with Type 2 diabetes that more than 50% suffer from some form of sleep disorder including sleep apnea," said Paul Zimmet, MD, PhD, co-chair of the IDF working group that issued the consensus statement, and director of the International Diabetes Institute in Melbourne, Australia.