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.

SafeStitch Medical (OTCBB:SFES) plans to introduce its AMID Stapler, a repair system for inguinal and ventral hernias, at a joint meeting of the American and European Hernia Societies on March 28, 2012 in New York City.

Jeffrey Spragens

“We see the AMID Stapler as a new and innovative device in the treatment of hernias that can promote faster patient turnaround in the operating room,” co-founder and CEO Jeffrey Spragens said in an interview with BioTuesdays.com. “Fast procedure time and less tissue manipulation are expected to provide patients with a more comfortable recovery and the potential to return to work in less time.”

The AMID Stapler, which was developed with direct involvement from Dr. Parvis Amid, who pioneered and teaches the widely used Lichtenstein hernia procedure, is pre-loaded with titanium staples. The staples secure a mesh screen in the hernia sac, as part of a Lichtenstein repair, which helps prevent the recurrence of a hernia.

There are over 600,000 Lichtenstein inguinal, or groin, hernia procedures performed in U.S. annually, with an annual growth rate of 5%, and virtually all of them are sutured. “The stapler is designed for ventral (abdominal) hernias as well but our initial focus will be on hernias in the groin,” Mr. Spragens says. “With a Lichtenstein repair, patients leave the hospital on the same day as the procedure because treatment is minimally invasive.”

SafeStitch’s premarket evaluations have identified approximately 250 hernia surgeons who collectively perform some 40,000 procedures a year. “They have tried the stapler in various non-human models and the feedback we have is that they like the device and they’re ready for the sales introduction,” he adds. SafeStitch’s initial marketing plans will focus on these early adopters.

“Our competition is hand suturing,” he says, noting that the “stapler will cost more than suturing but has many offsetting advantages. These 250-plus doctors seem to agree.”

SafeStitch anticipates deploying a sales team of eight employees, 14 independent contracted sales reps, and one distributor, with 10 sales people, to market the AMID Stapler.

SafeStitch's AMID Stapler(R)

Mr. Spragens says that the second phase of the company’s sales and marketing strategy, running from 2014 through 2016, will target formulary acceptance by Group Purchasing Organizations (GPOs), which currently cover approximately 480,000 hernia procedures a year.

SafeStitch was founded by Dr. Charles Filipi, Dr. Phillip Frost, Dr. Jane Hsiao and Jeffrey Spragens in 2006 largely to develop medical devices that manipulate tissues for the treatment of obesity, gastroesophageal reflux disease (GERD), esophageal obstructions, Barrett’s Esophagus, upper gastrointestinal bleeding, and other intraperitoneal abnormalities through endoscopic and minimally invasive surgery. SafeStitch’s offices and manufacturing facilities are located in Miami, Florida and its animal laboratories in Omaha, Nebraska.

The company’s gastroplasty (GST) system is under development to treat GERD and obesity, using a device that passes through the mouth, with moderate sedation in an outpatient setting.

SafeStitch GERD Procedure

GERD is a condition where stomach contents, food or liquid, leak from the stomach into the esophagus, which is the tube from the mouth to the stomach. GERD results not only in heartburn but can led to ulcers as well as development of Barrett’s Esophagus, a precancerous condition where cells lining the esophagus turn into stomach-lining cells because of the continued presence of stomach juices in the esophagus.

Mr. Spragens explains that there are surgical procedures to narrow the opening around the esophageal sphincter valve and stop reflux, but they are invasive operations with corresponding recovery time. “Our GST system has a full surgical array of transoral tools,” he says.

Dr. Filipi, SafeStitch’s chief medical officer, said that after 17 months, “GERD and obesity patients from our first human trial are doing well. We demonstrated that our GST devices can perform the intended procedure safely at the gastroesophageal junction. The patients are continuing to do well with the procedures displaying the necessary durability.”

SafeStitch Obesity Procedure

To treat obesity, Mr. Spragens explains that the GST device can make a mini-pouch below the esophageal sphincter, using the body’s own tissue rather than a prosthetic device such as a lap band. Food goes down through the opening into the stomach and hits the mini-pouch that has been made internally with the GST system.

“We have the only transoral procedure that uses endogenous tissue formation for optimal efficacy and durability,” he contends. “This is what differentiates us.”

Many people suffering from obesity resort to adjustable lap bands, which are placed around the top portion of the stomach. In 2010, the number of gastric bypass and banding procedures totalled 370,000 in the U.S. and 79,000 in the EU, with expected growth rates of 10% to 15% a year, respectively.

But complications from gastric banding have led to a reported 20% to 30% removal rate in the first year. “This trend is expected to continue,” Mr. Spragens says, adding that this could be an “additional marketing opportunity for our GST product. Our procedure also may expand the market because it is transoral and is expected to require moderate sedation in an outpatient setting.”

Even though the same SafeStitch GST device can perform both procedures, the company will need to conduct two separate trials for GERD and obesity, and seek FDA clearance and approval for two indications. “The plan now is to move into feasibility trials in the U.S. for both indications sometime next year,” he says.

Mr. Spragens says the company also is evaluating commercialization options for its Smart Dilator and Bite Blocks products.

Esophageal dilations are performed to expand the esophagus, which has narrowed often because of GERD-induced ulcers. There are over one million dilations performed in the U.S. each year, with studies pointing to a nearly 1% perforation rate. Untreated perforation of the esophagus is fatal, usually within two days. Research also indicates that during dilation, a physician should place no greater than two pounds of pressure on the dilator.

“Our Smart Dilatorhas an indication on the handle that provides a physician with a cost effective, visual indicator before reaching the recommended two-pound limit,” Mr. Spragens says.

“While there are numerous dilators on the market, we believe none include a feedback mechanism similar to that contained in the Smart Dilator,” he adds, noting that the device was cleared by the FDA in February, 2009.

Mr. Spragens says a bite block is used to keep patients from biting down on an endoscope and damaging it during GI procedures. “In fact, more money is spent each year repairing endoscopes than on buying new endoscopes,” he says.

Airway Bite Block

SafeStitch’s Airway Bite Block, contains a built-in airway that assists breathing in patients with larger tongues or smaller throats, usually because of obesity, during an endoscopic procedure.

“This is probably a commodity product but the fact is no one has ever tried to incorporate an airway and a bite block in the same device, and with more and more obese patients undergoing endoscopic procedures, there is a need for such a device,” he adds.

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.

The FDA has approved a new testosterone gel developed by BioSante Pharmaceuticals (NASDAQ:BPAX), Bio-T-Gel, as a once-daily transdermal gel for the treatment of male hypogonadism, or low testosterone levels.

The drug is licensed to Teva Pharmaceuticals, which is responsible for all regulatory and marketing activities, and BioSante is entitled to milestones and royalties of 5% to 7.5% on sales, according to Rodman & Renshaw analyst Elemer Piros.

“As BioSante recovers from the LibiGel Phase 3 setback, we believe the company’s current and future pipeline may drive shareholder value,” he writes in a new report.

With an estimated cash position at the end of 2011 of about $56 million, and an expected decreased cash burn, BioSante is in a position to search for potential licensing opportunities, he added. He rates the stock “market perform,” without a price target.