The U.S. medical-imaging market — including ultrasound, magnetic resonance imaging [MRI], radiography and mammography, and computed tomography [CT] — will be worth an estimated $11.4 billion by 2012, according to a new report by BCC Research, Medical Imaging: Equipment and Related Products.

CT currently accounts for the largest share of the market — worth an estimated $2.3 billion in 2007 — and is predicted to top $3.2 billion by 2012. But MRI scanners, now with the second-most market share, are the fastest-growing segment, with a projected CAGR of 9.8 percent. Currently valued at over $1.8 billion, the MRI scanner market is expected to exceed $2.8 billion in 2012.

Ventana Medical Systems (VMSI), in the midst of a hostile takeover bid by Roche, finally has something to smile about: The firm is the highest-ranking med tech firm, at number 17, on Forbes’ 200 Best Small Companies in America list, released last week.

The Tuscon, AZ-based company markets automated diagnostic systems to the anatomical pathology market. In early 2007, Ventana received FDA approval for the use of its PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Antibody as an aid in the assessment of breast cancer patients for whom Herceptin treatment is an option. According to Forbes, Ventana had sales of $261 million for the latest 12 months. The firm made a significant jump from last year, when it was ranked number 115.

SurModics will pay $11.3 million at closing and up to an additional $11.4 million at specified revenue targets for BioFX Laboratories, an Owings Mills, MD, manufacturer of substrates, which detect and signal that a reaction has taken place.

“The acquisition of BioFX Laboratories allows us to broaden our product and technology offerings in the important and growing in vitro diagnostics market,” said Bruce Barclay, CEO of SurModics, in a statement. BioFX offers both colorimetric and chemiluminescent substrates, as well as other products for use in in vitro diagnostic tests, a market estimated to exceed $20 billion.

Integra LifeSciences (IART), of Plainsboro, NJ, has announced plans to acquire Irvine, CA-based IsoTis (ISOT) in a $51 million deal that would create one of the largest orthobiologics companies in the world.

Upon closing, IsoTis will become a wholly owned subsidiary of Integra. The combined company will operate in North America and Europe with more than 2,000 employees, including about 300 sales and service professionals.

“We are especially pleased with this order, as the DoD has exceeded our original estimate for procurement of RSDL in the government’s 2007 fiscal year,” said Anthony Lombardo, E-Z-EM’s CEO, in a statement. The Department of Defense placed its first order — worth $5.07 million, for both RSDL and training packets — back in April.

RSDL is a broad-spectrum decontamination product intended to remove or neutralize chemical warfare agents or T2 toxins from the skin. It was originally developed by Defense Research and Development Canada, an agency within the Canadian Department of National Defense, for use by the Canadian Forces. But RSDL has since been adopted by several military services around the world, including the U.S. Army.

The device was approved for the treatment of right atrial flutter, a condition where the upper chambers of the heart beat too fast. Unlike other devices on the market that use heat to treat atrial flutter, the Cryoablation System uses extreme cold to destroy damaged cardiac tissue. This videoshows how it works.

For CryCor, the approval comes after a somewhat tumultuous wait. In June, the company learned that an FDA advisory panel was not convinced of the Cryoablation System’s longterm efficacy or safety profile, only to find out two days later that the panel had approved the device. The initial negative review in June was the second time FDA had found fault with CryoCor’s device. The agency rejected the company’s PMA application last year, prompting CryoCor to amend and resubmit in November 2006.

The money will go toward continued development of EOS’s flagship product, MelaFind, a point-of-care hand-held imaging device that emits multiple wavelengths to capture images of pigmented skin lesions, and extracts data. Using classifier algorithms trained on a proprietary database of melanomas and benign lesions, the data gathered from the images are analyzed to determine whether the lesion should be biopsied.

Coiling procedures involve the delivery of platinum coils to the aneurysm via a small microcatheter. While still maintaining normal blood flow, the coils are threaded through the catheter into the aneurysm until the ballooned area is completely filled.

Founded in 2000, Trans1 is a 60-person firm that makes surgical devices for treating degenerative disc disease affecting the lower lumbar region of the spine. The company’s AxiaLIF product is a percutaneous access and fusion system that enables lumbar fusion to be performed with complete preservation of the annulus and all paraspinal soft tissue structures. This video shows how it works.

Plymouth, MN-based ev3 has offered to pay $780 million for FoxHollow, of Redwood City, CA, which represents a 20% premium to the 30-day average trading price for FoxHollow’s shares. Both boards, and ev3’s shareholders, have signed off — pending approval by FoxHollow shareholders, the deal is expected to close in the 4th quarter of this year. Assuming successful completion, 2008 net sales are expected to be between $585 to $615 million.

ev3, whose name stands for the three endovascular markets it occupies — peripheral vascular, cardiovascular and neurovascular — would emerge with a majority stake, 59 percent, in the combined company.

Under the terms of the agreement, Inverness will help drive commercialization of Diamics’ products. It will provide strategic and hands-on assistance with assay development, product design, and manufacturing and distribution.

Diamics is developing products to improve the effectiveness of cervical cancer screening and to make the procedure less painful. Its FDA-cleared CerCol Cervical Cancer Collection System collects cellular and fractional histological material from the entire cervix with a single, soft-tipped device. The system is used together with Diamics’ Pap-Map system, which provides a “map” of the collected sample, to help guide physicians’ subsequent decisions about colposcopy and biopsy procedures.

Roughly a year after a corporate restructuring that separated its bioscience and communications units, Bothell, WA-based Lumera ((LMRA)) has formed a wholly owned subsidiary for its bioscience business. Called Plexera Biosciences, the subsidiary formalizes the nanotechnology company’s commitment to evolving from R&D startup to commercial enterprise.

“The formation of Plexera clarifies the purpose, business requirements and market opportunities of both Plexera and Lumera to our investors, customers, and prospective partners,” said Lumera CEO Tom Mino, in a statement. Along with launching the new subsidiary, Lumera hired financial advisory firm Robert W. Baird & Co. to help with evaluating partnering and financing alternatives over the coming months.

In exchange for an upfront payment of $500,000 and additional milestone payments of up to $6 million, PreMD is turning over U.S. marketing and distribution rights for the test, called PREVU, to AstraZeneca (AZN). PreMD will retain rights to future applications of the technology under the PREVU brand, and to promote PREVU to the life-insurance industry; AstraZeneca will exclusively market to healthcare professionals.

In addition to the upfront and milestone payments, PreMD, an 18-person company with a $26 million market cap, will receive 20% royalties on the first $30 million in sales, after which the royalty rate bumps up to 25%. AstraZeneca, which plans to start selling the test in 2008, will fund future clinical trials as well.

Leveraging its NanoChip technology, which allows for easy implementation of customized assays, Nanogen struck the deal with the Co-operative Research Centre for Diagnostics and Queensland University of Technology in Australia. The acquired markers will be used to create diagnostic tests for schizophrenia and related conditions; some may also help predict adverse drug reactions and guide therapeutic decision making.

Through a similar partnership initiated back in 2005, Nanogen is collaborating with Jurilab, a Finnish firm, to investigate genetic markers associated with Acute Myocardial Infarction, hypertension and type-2 diabetes.

Used in combination with Spectranetics’ existing TURBO elite laser catheters, the TURBO-Booster functions as a guiding catheter that facilitates ablation of blockages in the main arteries at or above the knee.

Back in March, Spectranetics stopped enrolling patients in its trial for the device after the company and FDA agreed that data gathered from 61 patients was sufficient for FDA review. [Original plans called for 85 enrollees.] The firm filed a 501[k] application in May.

San Diego-based CryoCor is seeking an approval for atrial flutter, a condition where the upper chambers of the heart beat too fast. Unlike other devices on the market that use heat to treat atrial flutter, the Cryoablation System uses extreme cold to destroy damaged cardiac tissue.

This is CryoCor’s second go-around with trying to gain approval for the Cryoablation System. FDA rejected the company’s application last year, prompting CryoCor to amend and resubmit in November 2006.

The device, cleverly named Celution System, automates a process that releases stem and regenerative cells residing within adipose (fat) tissue. The adipose tissue is taken from the patient using a minor liposuction-like procedure, placed into the system and, with the touch of a button, the processing begins. About an hour later, following a tissue wash, cell separation and concentration — also performed by the device — a meaningful dose of stem and regenerative cells may be delivered back to the patient. According to TheStreet.com, at $2,500 to $10,000 per treatment, the procedure “looks downright cheap for stem cell-based therapy.”

Eric Daniels, senior director of business development for Cytori, tells TheStreet.com that the company is addressing a real unmet need: “After a complete mastectomy, an implant is a very viable reconstruction option. But with partial breast removal, that isn’t the case. There are zero options for these patients.”

ATS will pay $22 million in cash at closing, followed by $2 million at certain manufacturing transition milestones, $2 million two years after closing, and up to $4 million based on future sales of Surgifrost XL, a treatment for cardiac arrhythmias that’s FDA cleared and CE Marked, and planned for commercial release in the second half of 2007. The agreement includes all products under the SurgiFrost and FrostByte names.

The transition should be a relatively smooth one for ATS, as the company has been serving since November 2004 as the exclusive representative of CryoCath for U.S. sales of these products and as the exclusive distributor in certain international markets.

As such, “From day one, this transaction is accretive to the company,” said ATS CEO Michael Dale, in a statement.

“The reason they work is they’re very steady in their performance, and many generate cash and have good barriers to entry,” Quintin Lai, a research analyst with Robert W. Baird & Co., tells the paper.

Sontra already has one FDA-approved product under its belt: SonoPrep is an ultrasound-mediated skin permeation technology, used with topical lidocaine, for achieving rapid (within five minutes) skin anesthesia before patients get injections and IV insertions.