Brainsway (TASE:BRIN) has received the Frost & Sullivan 2012 Global New Product Innovation Award in neuro-psychiatric devices for its Deep TMS system.

“Brainsway’s deep Transcranial Magnetic Stimulation (TMS) is the only innovative, noninvasive technique that can be used for treatment of depression and other neuro-psychiatric disorders without causing any significant side effects,” the Frost & Sullivan Best Practices Research Report said.

“The system has shown high efficacy compared to the conventional treatment methods for depression and also the standard TMS systems that are currently used in the market. The key opinion leaders across Europe and United States are already using this device and the clinical evidence so far suggests that deep TMS system of Brainsway is highly efficient and is very promising for the treatment of neuro-psychiatric disorders,” the reported added.

Brainsway’s initial focus is the treatment of major depression.

The Frost & Sullivan Best Practices Research Report evaluated available neuro-psychiatric devices using five business performance categories: innovative element of the product, ability to leverage leading-edge technologies in the product, value-added features and benefits, ability to increase customer ROI and customer acquisition/penetration potential.

Deep TMS is a novel, noninvasive medical devices for treatment of a wide range of neurological and psychopathological disorders.  In principle, any brain-related disorder that is associated with pathological activity of specific brain sites may be treated by this method.  Potential applications include addiction, schizophrenia, obesity, eating disorders, Parkinson’s disease, Alzheimer’s disease, autism and post-traumatic stress disorder.

TearLab (NASDAQ:TEAR; TSX:TLB) has entered into a consulting agreement with one of its directors, Dr. Adrienne Graves, who will oversee identifying and leading discussions with potential partners for the commercialization of the TearLab Osmolarity System in Japan.

Dr. Graves has been a member of TearLab’s board since April 2005. She was CEO of Santen Inc., the U.S. subsidiary of Japan’s Santen Pharmaceutical Co. from 2002 to 2010. Under her leadership, Santen’s R&D team successfully developed and obtained FDA approval for three ophthalmic products in major therapeutic areas.

“Like in the U.S. and Europe, the dry eye disease patient population in Japan is large and growing,” TearLab CEO Elias Vamvakas said in a statement.

“Adrienne’s extraordinary international executive experience, broad network of industry contacts and special knowledge of the Japanese ophthalmic corporate culture make her the ideal person to help us explore commercial partnership opportunities for the TearLab Osmolarity System in this important market.”

Dry eye disease is a common condition in which the eye does not produce enough tears to keep the surface of the eye sufficiently lubricated. It affects some 22 million people in Japan and 100 million people worldwide. Recent studies have found the incidence of dry eye disease in high schools in Japan to be about 5%, and among office workers, using visual display terminals, the incidences reported were 10% of men and 20% of women.

The TearLab Osmolarity System uses a novel lab-on-a-chip approach that requires less than 50 nanoliters of tear fluid in order to measure tear osmolarity.  The system eliminates the challenges that previously prevented point-of-care osmolarity testing and can produce a sample-to-answer result in less than 30 seconds

Final results of a clinical trial using Brainsway’s (TASE:BRIN) high-intensity Deep TMS treatment protocols have induced a “temporary but significant” opening of the blood-brain barrier in 10 of 12 patients with brain tumors, compared with a control group.

The clinical trial confirms and extends findings of a previous animal study conducted at Ben-Gurion University.

Blood-brain barrier opening was observed in patients immediately following the stimulation protocol, which included magnetic field intensities higher than those used in other Deep TMS clinical trials, and was quantified using magnetic resonance imaging and special protocols for blood-brain barrier permeability measurement developed at the Zlotowski Center for Neuroscience at Ben-Gurion University.

Brainsway said that timing this transient opening to coincide with drug delivery could focus and enhance drug delivery, thereby increasing the effectiveness of existing drugs.

The researchers hope that this new method will prove effective in enhancing delivery of chemotherapy drugs to brain tumors, and perhaps even in the treatment of other central nervous system diseases. In addition, the prospect of timed opening of the barrier opens possibilities for the development of new drugs.

“The final results, which support the interim results of the study, attest to a novel non-invasive technique to safely and efficiently open the blood-brain barrier,” principal investigator Dr. Alon Friedman said in a statement.

“We, therefore, recommend that a multi-center trial be initiated in patients with glioblastoma multiforme and other brain tumors in which the efficacy and safety of this novel method for blood-brain barrier opening in combination with drug delivery would be investigated,” he added.

In parallel to this clinical effort, animal experiments are being carried out in Ben-Gurion University in order to further characterize the method and its potential mechanisms.

Cipher Pharmaceuticals (TSX: DND) is actively pursuing out-licensing agreements for its current products in other territories and is also seeking products in development or approved for the Canadian market to complement its Canadian commercialization plans for CIP-Isotretinoin, a patented formulation of the acne medication isotretinoin.

Cipher's CIP-Isotretinoin

The company made the disclosure in its financial results for 2011, which saw royalty revenue from its Lipofen fenofibrate product climb 8% over 2010. Cipher ended 2011 with no debt and cash of $9.6 million, up from $9.2 million at the end of the third quarter last year.

CIP-Isotretinoin has a PDUFA date of this May 29 from the FDA

Once CIP-Isotretinoin is launched in the U.S. by marketing partner, Ranbaxy Pharmaceuticals, Cipher said that it “expects that future revenue from this product has the potential to significantly exceed the revenue generated from the company’s other current products.” Pre-commercial manufacturing planning is also underway for a possible U.S. launch in the fourth quarter this year.

Cipher also expects a marketing decision from Health Canada in the first quarter of 2013 and, if approved, the company plans to market the acne treatment in Canada through its own specialty sales team.

“It was a successful year for Cipher with multiple commercial and regulatory milestones, highlighted by two marketing agreements for our once-daily tramadol, the launch of ConZip in the U.S. market, and completion of the comprehensive Phase 3 study of our high-potential acne product,” CEO Larry Andrews said in a statement.

“With growing revenues from our two commercial products and an upcoming PDUFA date in May for CIP-Isotretinoin, 2012 is shaping up to be an eventful and exciting year for the company,” he added.

GeneNews (TSX:GEN) announced that Enzo Clinical Labs, a division of Enzo BioChem (NYSE:ENZ), has received approval from New York State’s Department of Health to market ColonSentry, a blood-based test to assess an individual’s current risk for colorectal cancer.

Enzo has exclusive rights to market the GeneNews ColonSentry test in the states of New York and New Jersey.

“The New York State review process is widely regarded to be amongst the most stringent in the clinical lab industry and provides important validation for the robustness of the ColonSentry test and underlying Sentinel Principle technology,” President Gailina J. Liew said in a statement.

“We are pleased that with this approval, the US population, representing the single largest established market for molecular diagnostic tests, will now have access to this clinically-actionable, innovative, and patient-friendly blood test,” she added.

Dr. Robert Burakoff, clinical chief of gastroenterology and director of the Center for Digestive Diseases and of the Crohn’s and Colitis Center at Brigham and Women’s Hospital, Harvard Medical School, said there is no question that the greatest barrier to reducing mortality arising from colorectal cancer is patient compliance with screening.

“The approval of blood tests to facilitate colorectal cancer screening is very much welcomed as we attempt to significantly increase compliance with screening colonoscopy at the appropriate age as there is still, unfortunately, a significant percentage of the US population that has not undergone screening for colorectal cancer, “ he added.

Ms. Liew concluded, “As a risk stratification test providing information about an individual’s current risk of having colorectal cancer, ColonSentry may facilitate a decision to undergo colonoscopy for those who would otherwise refuse the procedure.  Importantly, it can also help prioritize patients at greater current risk for colorectal cancer in healthcare systems with limited colonoscopy capacity. Widespread adoption of the test could lead to earlier detection of colorectal cancer, improved patient outcomes and reduced healthcare costs.”

Colorectal cancer is the second leading cause of cancer deaths in the US. Each year, there are approximately 154,000 colorectal cancer cases diagnosed and 52,000 deaths due to this disease. The American Cancer Society recommends that all men and women age 50 and older be regularly screened for colorectal cancer. However, only about half of this population is up-to-date on screening as many patients regard recommended tests such as colonoscopy and stool-based tests to be invasive or unpleasant, and consequently, refuse or delay testing.

According to the U.S. Centers for Disease Control and Prevention, or CDC, this low level of patient compliance with recommended colorectal cancer screening tests results in less than 40% of colorectal cancers being detected early. The CDC estimates that close to one-third of colorectal cancer-related deaths could be avoided if more people underwent regular screening. When colorectal cancer is found early and treated, the 5-year relative survival rate is 90%.

SafeStitch Medical (OTCBB:SFES) has closed on the issuance of approximately 21 million of its common shares at a price of 40 cents a share under a stock purchase agreement with about 35 private investors for total proceeds of about $8.3 million. The issued shares are restricted securities, and no registration rights have been granted.

“We appreciate the confidence investors have shown in SafeStitch,” CEO Jeffrey Spragens said in a statement. “This infusion of capital is to support the launch of the improved AMID Stapler for Lichtenstein hernia repairs and to advance the development of proprietary, trans-orally delivered gastroplasty devices for the treatment of obesity and gastro-esophageal reflux disease to clinical trials. ”

Among the investors purchasing shares were Frost Gamma Investments Trust, an entity controlled by Dr. Phillip Frost, the largest beneficial owner of SafeStitch common stock, Dr. Jane Hsiao, chairman of SafeStitch, Mr. Spragens and Kwang Shun Co., a Taiwan-based investment company.

CytoSorbents (OTCBB:CTSO) plans to exhibit its CytoSorb technology this week at the 2012 Symposium of Intensive Medicine and Intensive Care in Bremen, Germany.

CytoSorb

The conference attracts an estimated 4,000 participants, including key German thought leaders and physicians, and is the largest independent German association event to focus on critical care and intensive care medicine. The CytoSorbents booth is located at A7.

“We continue to increase the market visibility and availability of our CytoSorb extracorporeal cytokine filter ahead of our broader market launch in Germany planned for this spring,” CEO Dr. Phillip Chan said in a statement.

There continues to be strong physician interest in the ability to reduce cytokine storm in a variety of serious conditions, including sepsis, burn injury, trauma, lung injury and pancreatitis, he said. “This interest has extended into a number of new additional applications where cytokines are elevated, which we will detail in the future as they continue to develop. We remain very excited about the new critical care treatment options that CytoSorb may provide.”

Novadaq Technologies (TSX:NDQ) narrowed its loss for the fourth quarter last year to $2 million from $3.1 million a year earlier as revenue rose 119% to $5 million.

SPY Imaging System

“Last year in collaboration with our partners, LifeCell and Intuitive Surgical, we advanced our goal of becoming a leader in providing imaging technology for surgeons,” Novadaq CEO Dr. Arun Menawat said in a statement.

“In the fourth quarter, we estimate that nearly 8% of breast reconstruction surgeries performed in the U.S. involved the use of SPY imaging, effectively tripling penetration into our lead application over the period of one year,” he added. “Exiting 2011, more than 10% of mid-to-large U.S. hospitals were users of Novadaq’s imaging systems.”

Looking ahead into 2012, he said the company anticipates continued expansion of the SPY Elite and FIREFLY installed bases, increased penetration in breast reconstruction, and launches of new applications, including colorectal and vascular surgeries. Novadaq also is moving towards a direct launch of its PINPOINT Endoscopic Fluorescence Imaging System in the second half of 2012.

Dr. Menawat said the company’s main performance metric in 2011 was “system shipments.” In the fourth quarter, Novadaq shipped 150 SPY and FIREFLY systems and at year-end, the number of U.S. hospitals with installed SPY and FIREFLY systems exceeded 300.

Approximately 175 SPY systems are in use for breast reconstruction surgery, our lead indication, he said, adding that during the fourth quarter, the average annualized run rate for each of these systems was approximately 50 procedures.

During the fourth quarter, the company shipped 2,700 SPY procedure kits for open surgical applications to hospitals, up 128% from the same period in 2010, and a 21% sequential increase, compared with the third quarter of 2011. In total, 7,838 SPY procedure kits were shipped to hospitals during all of 2011, up 110% from 2010.

BioSante Pharmaceuticals (NASDAQ: BPAX) has entered into a privately-negotiated securities exchange agreement with a holder of BioSante 3.125% convertible senior notes, due May 1, 2013.

Under the accord, BioSante is exchanging $4 million principal amount of notes, including accrued and unpaid interest, for 4,485,159 of its common shares. Following the transaction, $11.8 million principal amount of notes will remain outstanding.

“This transaction further extends BioSante’s cash runway and is important as we reported FDA approval of Bio-T-Gel, continue to analyze the best path forward for LibiGel, investigate alternative strategies and explore new product development projects through in-licensing and mergers and acquisitions,” CFO Phillip Donenberg said in a statement. “

“We appreciate the flexibility and continued support of our note holder as we rebuild BioSante to maximize value for our stockholders,” he added.

The U.S. Patent & Trademark Office has denied a request brought by the current market leader for livestock sexed semen to re-examine fundamental claims in Microbix Biosystems’ (TSX:MBX) patent for its LumiSort technology.

LumiSort, the next-generation instrument-based technology, is expected to enter the $3 billion market for sexed semen in the second half of 2013. It will provide livestock producers around the world with a three-fold increase in yield and a 10-fold increase in speed.

The Patent Office found that there was no basis for the re-examination of broad claims directed to the LumiSort method and system. As a result, claims in Microbix’ patent embracing aspects of this contribution to the field remain enforceable.

To further support its patent estate, Microbix has filed a new patent application for second-generation LumiSort technology, representing significant advances in ease of use, construction, speed and accuracy of the instrument.

Microbix has established agreements for licensing its LumiSort technology with more than one-third of the U.S. livestock semen collection centers and also has agreements with collection centers in Canada, Australia, Europe, South America, and China, representing more than 40 million straws of the dairy semen sold annually and a market of $900 million.

William Gastle, CEO of Microbix, said the company is in advanced discussions with a number of strategic partners to fund the final development and commercialization steps of LumiSort technology, which has no regulatory barriers to market entry.