News

BioMérieux Inc., a subsidiary of a France-based diagnostics company that has its U.S. corporate headquarters in Durham County, is planning to invest $48.3 million in an expansion project here that would create 44 jobs.
Gov. Pat McCrory and N.C. Commerce Secretary Sharon Decker announced Thursday an incentive award of up to $220,000 for the project.
The performance-based grant is contingent on the company’s getting a matching grant from the local government, according to the news release from the state officials. The money would be paid out only as the company meets certain performance targets.
BioMérieux provides diagnostic instruments, software and other products used to determine the source of disease or contamination.
Its products are used for diagnosing infectious diseases, as well as for detecting micro-organisms in agri-food, pharmaceutical and cosmetic products.

Cook Medical is bringing its Flexor Parallel Rapid Release Ureteral Access Sheath to the U.S. market. Unlike traditional ureteral access devices that require the use of two guidewires, the Flexor Parallel is the first that combines the function of both into one. Moreover, if a physician prefers the old approach, the new sheath supports that option as well. More from Cook:
The Flexor Parallel has a slit on the dilator that guides the wire outside of the sheath. When the dilator is withdrawn, the sheath and the wire guide remain parallel to each other, which leaves a clear working channel through the sheath.
The physician can also choose to place the Flexor Parallel in the same manner as a traditional Flexor sheath.

nContact said it's received FDA clearance for modifications made to its cardiac ablation device.The Research Triangle Park, N.C.-based device medical device company won 510(k) clearance from the federal watchdog agency for the next generation of its VisiTrax cardiac ablation device, EPi-Sense. The company says this product includes new sensors, generating electrical feedback to assist electrophysiologists with device positioning during cardiac ablation procedures.
 
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The North Carolina Eye Bank expanded its research reach for a second time this month, this time through a $1 million donation to UNC School of Medicine.
The donation to the school’s ophthalmology department will create the N.C. Eye Bank Multidisciplinary Surgical Skills Laboratory, which will be shared by two other neuroscience departments, neurosurgery and otolaryngology/head and neck surgery .
The company, based in Winston-Salem, and the medical school will hold a grand-opening ceremony for the laboratory at 2 p.m. Wednesday in the Thurston Bowles building, 104 Manning Dr. in Chapel Hill.
The 3,500-square-foot laboratory will have 19 stations, a conference room and a simulation lab with access to high-fidelity simulators, such as robotic stations and anatomic computer-based simulators. The simulators allow controlled proctoring and progressive educational scoring of surgical skills.

Durham-based Tryton Medical has closed on $24 million in financing.Tryton develops medical stents and the financing should see the company through the U.S. approval of its latest product, the TrytonSide Branch Stent, CEO Shaw McCarthy says.“The funds will be used to support the company’s U.S. Food & Drug Administration submission this year, to expand the company’s platform portfolio with a new stent system designed to address left main disease, and to accelerate access into critical global markets, specifically in Asia.”The new Branch Stent addresses what’s called “bifurcated lesions,” which can develop in coronary artery disease patients.Investors participating in the round included PTV Sciences, RiverVest Venture Partners, Spray Venture Partners and the 3x5 Special Opportunity Fund, all existing investors.

Bioventus, Smith & Nephew's semi-spun-out biologics healing business, is launching its products in Italy, expanding its presence in Europe after getting a foothold in the Netherlands last year.

In 2012, S&N turned its active orthopedic healing unit into a joint venture, retaining 49% ownership and selling the remainder to venture capital firm Essex Woodlands. Bioventus, the resulting JV, sells devices, therapies and diagnostics. "Launch," in this case, is relative, as much Bioventus' work is in relabeling existing S&N products, including the Exogen ultrasound bone-healing system and Durolane osteoarthritis treatment.
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BioDelivery Sciences International announces that it has received definitive commitments from institutional investors (including existing investors of the company) for an at market registered direct financing yielding gross proceeds of $40 million to BDSI. The financing is expected to close on December 3, 2012, subject to customary closing conditions. Under the terms of subscription agreements entered into with the investors, BDSI will sell an aggregate of 6,791,887 shares of its common stock at a price equal to $4.21 per share, and 2,709,300 shares of newly designated Series A Convertible Preferred Stock (Series A Preferred) at a price of $4.21 per share. The shares of common stock and Series A Preferred are being sold at the consolidated closing bid price of BDSI's common stock on November 27, 2012.
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The FDA today approved Cook Medical’s Zilver PTX stent. It is the first drug-eluting stent  approved for the treatment of peripheral arterial disease (PAD) in the superficial femoral and proximal (i.e., above the knee) popliteal artery. The new stent will provide a new treatment option for treating patients with PAD. Current treatments include exercise, drug therapy, balloon angioplasty, bare-metal stents, and surgical bypass.
“The clinical study demonstrated that the Zilver is more effective than balloon angioplasty for the treatment of symptomatic peripheral artery disease in above-the-knee femoropopliteal artery,” said Christy Foreman, of the FDA’s Center for Devices and Radiological Health, in an FDA press release. “This approval expands the treatment options for patients suffering from symptomatic peripheral artery disease to include the Cook Zilver PTX drug eluting stent.”

Bioptigen Inc. is relocating its headquarters to a larger facility, in part to accommodate expanded production of its Envisu ophthalmic imaging system, which the U.S. Food and Drug Administration cleared for use in patients earlier this year.
Bioptigen’s relocation to Keystone Technology Park within the Research Triangle Park culminates a year in which the company has successfully gained regulatory clearance to commercially market Envisu in the United States, Canada, Europe and Australia.
“This year has been positively monumental for Bioptigen,” said Dr. Eric Buckland, president and CEO. “Now that we’ve been cleared to market Envisu practically worldwide, we’re seeing increased demand from clinicians and researchers who appreciate the convenience and flexibility our hand-held scanner provides for patients who can’t be imaged using traditional, tabletop devices.”

Micell Technologies, Inc. today announced that the United States Patent and Trademark Office (USPTO) has issued a patent covering the company's surface and polymer modification technology. This intellectual property protection is related to Micell's investigational MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES™), as well as potential additional biomedical products. The patent rights are assigned to and wholly owned by Micell.