Cardica Issues MicroCutter XCHANGE 30 510(k) Application; Cadence Comments on USPTO's Reexamination of Patent Print E-mail
By Staff and Wire Reports   
Friday, 16 August 2013 18:31
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 16, 2013.

Cardica, Inc. (Nasdaq: CRDC)
announced it filed regulatory documents with the U.S. Food and Drug Administration (FDA) for marketing clearance of the MicroCutter XCHANGE™ 30, a cutting and stapling device designed to be used in multiple open and minimally invasive surgical procedures. The XCHANGE 30 has a cross-sectional area six times smaller than conventional surgical staplers and articulates up to 80 degrees in each direction. The lower profile provides greater access through a 5 mm trocar.

The submission to the FDA includes the results of Cardica's recently completed MicroCutter European Trial (MET1). In the MET1 study, the MicroCutter XCHANGE 30 met the primary endpoint, freedom of MicroCutter-related severe adverse events when compared to historical controls from the medical literature, with only one event in 160 patients enrolled and 423 deployments.



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Cadence Pharmaceuticals, Inc. (NASDAQ:CADX)
announced tht the United States Patent and Trademark Office (USPTO), has issued a non-final, initial office action in the Ex Parte Reexamination of US Patent No. 6,028,222, or the '222 patent, one of the two licensed patents covering OFIRMEV® (acetaminophen) injection.  Although the USPTO made an initial determination to reject certain claims, all of the claims of the '222 patent remain valid and in force until the USPTO issues a final action in this reexamination.

"This initial office action by the USPTO is not a final decision, rather, it's just one step in the reexamination process, which can take many years to complete. It's very common for the USPTO to reject some or all of the claims of a patent in an initial office action, however, claims that are initially rejected may be subsequently allowed. Importantly, we don't expect this action to have an adverse impact on the pending litigation against Exela," said Ted Schroeder, President and CEO of Cadence. "We strongly believe that the scope and validity of the patent claims in the '222 patent are appropriate and that the USPTO's prior issuance of the patent was correct."

The '222 patent covers the formulation of OFIRMEV, and expires in August 2017, and US Patent No. 6,992,218, covers the process used to manufacture OFIRMEV, and expires in June 2021. Upon completion of the company's ongoing pediatric clinical trial of OFIRMEV, both patents will be eligible for an additional six months of marketing exclusivity. In September 2012, a third party filed with the USPTO a Request for Ex Parte Reexamination of the '222 patent, and in December 2012, Cadence received notice that the USPTO had granted the Request for Reexamination. The reexamination process requires the USPTO to consider the scope and validity of the patent based on substantial new questions of patentability raised by a third party or the USPTO.

Cadence intends to continue with the reexamination of all of the rejected claims of the '222 patent and the company is confident in its ability to make a strong case for the patentability of the rejected claims as the process continues.  Additionally, as permitted under USPTO rules, Cadence plans to file additional claims under the '222 patent. From this point forward, third parties are barred from providing additional information in this reexamination.



Also Friday:



Aastrom Biosciences, Inc. (Nasdaq:ASTM)
, the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, announced today the closing of the previously announced underwritten public offering of 29,000,000 shares of its common stock, and warrants to purchase up to an aggregate of 29,000,000 shares of common stock, at a price to the public of $0.30 per share.

Accuray Incorporated (Nasdaq: ARAY)
, announced today its participation in the 22nd China International Medical Instruments and Equipment Exhibition and Seminar (CHINA-HOSPEQ), taking place from Friday, August 16 to Sunday, August 18, 2013.

The Alkaline Water Company Inc. (OTCBB: WTER)
, developers of an innovative, state of the art, proprietary electrolysis beverage process, packaged and branded as Alkaline84, a premier alkaline drinking water for balanced lifestyles, is pleased to announce an agreement and immediate placement with Bashas' Supermarkets throughout Arizona.

Alkame Water, Inc., a wholly-owned subsidiary of Pinacle Enterprise, Inc. (OTCBB: PINS) (OTCQB: PINS), is pleased to announce that Alkame's multi-patented ultra-hydration bottled water will be sold at Albertsons locations in Southern California, Arizona, Nevada, and New Mexico ("Albertsons Southwest").

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
today announced that its abstract, PARP inhibition with BMN 673 in ovarian and breast cancer patients with deleterious mutations of BRCA1 and BRCA2 has been selected as a late breaking abstract by the 17th ECCO – 38th ESMO – 32nd ESTRO European Cancer Congress in Amsterdam, The Netherlands and will be presented in an oral presentation on September 29, 2013.

Brazil Interactive Media, Inc. (OTCQB: BIMI)
, a Brazil-based, interactive TV entertainment, production and broadcasting Company, today announced its second quarter results for the period ended June 30, 2013, as reported in its most recent Form 10-Q filing.

Cellular Biomedicine Group, Inc. (OTCQB: CBMG)
, a developer of proprietary cell therapies for the treatment of degenerative diseases and cancers, this week reported financial results and business highlights for the quarter and six months ended June 30, 2013.

Clean Coal Technologies, Inc. (OTCQB: CCTC)
is a cleaner-energy technology company that holds patented process technology and other intellectual property that converts raw coal into a cleaner burning fuel.

Covalon Technologies Ltd. (TSXV: COV)
, an advanced medical technologies company, today announced that it intends to complete, subject to the approval of the TSX Venture Exchange, a non-brokered private placement comprised of 750 units (the "Units") at a price of $1,000 per Unit for gross proceeds of $750,000. Each Unit will consist of $1,000 principal amount of 12% senior secured convertible debenture (the "Debentures" and each a "Debenture") and 6,452 warrants (each, a "Warrant").

eHealth, Inc. (NASDAQ: EHTH)
, the nation's leading private online health insurance exchange for individual and family health insurance, today announced that it has entered into an agreement with the Centers for Medicare and Medicaid Services (CMS) that relates to its ability to enroll individuals into qualified health plans (QHPs) through the Federally-Facilitated Health Insurance Exchange ("FFE").

Liberator Medical Holdings, Inc. (OTCQB: LBMH)
is recognized for offering a simple, reliable way to purchase medical supplies needed on a regular, ongoing, repeat-order basis, with the convenience of direct billing to Medicare and private insurance.

MannKind Corporation (Nasdaq: MNKD)
today announced that, pursuant to a Facility Agreement dated July 1, 2013 between Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (collectively, “Deerfield”) and MannKind, the conditions that obligate Deerfield to purchase the second $40 million tranche of 9.75% senior secured convertible notes (the “Convertible Notes”) have now been satisfied.

MediSwipe Inc. (OTCQB: MWIP)
, the leader in Compassionate Care Technology Solutions for the medicinal marijuana industry, today announced that the Company has received a purchase order through its' Washington state distributor for over 10,000 units of "Chillo," the Company's Hemp based energy drink.

Medytox Solutions Inc. (OTCQB: MMMS)
announces it has filed its 10-Q with the SEC for the 2nd Quarter of 2013 and for the 6 months ended June 30, 2013.

MIT HOLDING, INC. (OTCQB: MITD)
announces that it has begun negotiations with a leading South Eastern US private duty care services company.

Remedent, Inc. (OTCBB: REMI)
, an international company specializing in research, development, and manufacturing of oral care and cosmetic dentistry products, reported results for the first quarter ended June 30, 2013.

SK3 Group, Inc. (PINKSHEETS: SKTO) (SK3)
announces that it has signed a definitive agreement to acquire Sovereign International, Inc., a full service medical cannabis consulting firm specializing in advising on cultivation techniques.



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