Medtronic Completes $20 Million Second Tranche Investment In Mazor Robotics

Mazor Robotics Ltd. announced the completion of the second tranche of the equity investment by Medtronic pursuant to a previously executed agreement between the parties. The Company issued new securities representing 3.40% percent of Mazor’s issued and outstanding share capital, on a fully diluted basis, at a price per ADS $21.84, which is equal to the volume weighted average price of the ADS’s for the trailing 20-day period ending on and including August 9, 2016, for an aggregate purchase price of $20 million. The triggering milestone for this second tranche investment was the July 12, 2016 unveiling by the Company of Mazor X, a transformative Surgical Assurance Platform to enhance predictability of spine surgeries for the benefit of patients and those who treat them.

“Since signing the agreements in May our two organizations have been working closely to ensure a successful partnership,” commented Ori Hadomi, Chief Executive Officer. “This investment by Medtronic reflects a key operating achievement – the unveiling of the Mazor X Surgical Assurance Platform – and in just a few short weeks we have received many inquiries from new surgeons, as well as interest from our existing Renaissance user base. The feedback is overwhelmingly positive and we plan to launch Mazor X at the NASS conference this October. I am confident it will advance and change the way spine surgery is performed.”

Following the completion of the second tranche investment, Medtronic has purchased a total of 1.96 million ADS’s, representing 7.27% of Mazor’s issued and outstanding share capital, on a fully diluted basis, for a total of $31.9 million.

As of June 30, 2016, cash, cash equivalents and investments totaled $47.5 million. Following the completion of the second equity investment, the Company’s cash, cash equivalents and investments will total approximately $65 million and the fully diluted share count will be approximately 53.9 million.

A press release can be found from Mazor Robotics website.

Aggressive cancer’s aggressiveness may prove its Achilles’ heel

Researchers at the School of Medicine have discovered a flaw in the armor of the most aggressive form of lung cancer, a weakness that doctors may be able to exploit to slow or even stop the disease. Remarkably, this vulnerability stems from the very aggressiveness that makes the cancer so deadly.

Using an existing drug, the scientists were able to halt the progression of small cell lung cancer tumors in genetically engineered mice. This was a notable achievement because small cell lung cancer (SCLC) is known for spreading quickly throughout the body. The finding raises the hope that the drug, which is being tested in people overseas for several types of cancers in clinical trials, might prove to be an effective way to control or prevent small cell tumor growth – possibly keeping the cancer as harmless tiny lesions.

Even if the drug does not prove effective for that purpose, the researchers have identified a tantalizing target in the battle against a particularly deadly form of cancer. They believe their approach could lend itself to the development of new drugs that would target the cancer progression while sparing healthy cells.
Small cell lung cancer

Small cell lung cancer makes up approximately 15 percent of all lung cancer cases. However, it spreads much more quickly than non-small cell lung cancer, and once it has spread, it is extremely difficult to treat. Five-year survival for people whose small cell lung cancer has metastasized (spread) is only about 2 percent.

Notably, small cell lung cancer is seen almost exclusively in smokers. UVA’s Kwon Park, PhD, of the Department of Microbiology, Immunology and Cancer Biology, was seeking to better understand why that is when he and his team discovered the potential way to undercut tumor development.

Park was investigating whether a mutation in the gene MYCL was what is known as an oncogene – a gene that drives tumor development. His team determined that the gene did, in fact, have an important role to play. Amplifying its effect spurred tumor growth in genetically engineered mice, while blocking it suppressed tumor growth. Unfortunately, there is no known drug that could be used to target the gene in people.

So Park took another approach. He looked at what the gene was doing, to see if it would be possible to target the results of the gene’s activity, rather the gene itself. “It turns out that this master oncogene regulates these protein assembly machines called ribosomes,” he said. “For a cell to divide faster, you need everything faster. Not just DNA but also the proteins. By making more machinery at a faster speed, [the oncogene] actually promotes tumorigenesis.”

Maybe there’s no way to get at the oncogene, Park thought, but perhaps there’s a way to stop the amped-up protein production it causes. Through a stroke of luck, there was a drug available to do just that. And it worked: Tumor growth was inhibited significantly.

It’s important to note that the drug used in what Park called his “proof-of-concept pharmaceutical experiment” is not yet available to patients. It’s being evaluated for other forms of cancer in Australia and Canada, but it’s not being tested in patients in the U.S., so much work would need to be done to determine if it would be safe and effective for this purpose. Regardless, the research has identified a potential back-door way to block a critical aspect of the tumor-production process in small cell lung cancer.

Park noted that the finding could potentially lead to a preventative strategy involving food and nutrition, so that people could modify their diets to reduce their chances of developing the disease.

A press release can be found from University of Virginia website.

Cook Medical Issues Global Recall of Hydrophilic Wire Guides

DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner® Uniglide® Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016. Cook is taking this action as a precautionary measure, because it cannot exclude the possibility that glass particles passed through during processing and could be present in the coating of the recalled wire guide units.

Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system. Cook Medical has not received any reports of adverse events of these types to date.

The Roadrunner UniGlide Hydrophilic Wire Guide is intended for use in the delivery of percutaneous catheters into the peripheral vasculature.

A full list of affected products and lot numbers is available for download: Roadrunner® UniGlide® Hydrophilic Wire Guide product list. Products can be identified by the part number and lot number on the outer label of the package. Products in this recall were distributed globally.

Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all recalled units and return the affected products to Cook as soon as possible for credit.

The FDA and other regulatory agencies around the world have been notified of this action.

A press release can be found from Cook Medical website.

Siemens and INSIGHTEC sign agreement to expand access to Exablate Neuro technology

INSIGHTEC announced the signing of a strategic agreement with the global leader in Magnetic Resonance Imaging, Siemens Healthineers. The strategic collaboration will involve the development of compatibility between Exablate Neuro and Siemens leading 1.5T and 3T clinical MRI systems, MAGNETOM Aera and Skyra. With this agreement, Siemens Healthineers follows its strategy of broadening and complementing its diagnostic imaging portfolio with advanced therapy solutions. Both parties will work towards providing access to Exablate Neuro for installed base, as well as new product installation customers.

Exablate Neuro is the world’s first and only CE and FDA-approved device for the non-invasive application of MR guided focused ultrasound to treat essential tremor and other conditions. Clinical research, development and regulatory approvals are ongoing for additional neurosurgical applications and markets.

“Our agreement with Siemens Healthineers will allow us to significantly expand Exablate Neuro’s market presence. Siemens has embraced our technology and together we will bring our therapy to significantly more patients and providers,” said Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board. “INSIGHTEC is committed to continue investing in research and development of MRgFUS technology. The strategic collaboration with Siemens Heathineers will allow more patients and researchers globally to benefit from the unique MRgFUS technology,” he concluded.

Christoph Zindel, MD, Senior Vice President and General Manager of SIEMENS Healthineers’ Magnetic Resonance business further highlights the importance of the agreement: “This strategic partnership of two leading organizations is exciting and further underlines Siemens Healthineers’ strategy of enabling better patient outcomes by broadening its diagnostic imaging portfolio into advanced therapies in the area of neurological and other disorders. Together with INSIGHTEC and its innovative technology, we will jointly drive healthcare further together with our strong research and clinical customer network worldwide.”

Exablate Neuro uses focused ultrasound waves to precisely target and accurately ablate tissue deep within the brain with no incisions, and while minimizing damage to adjacent healthy tissue. Siemens MR imaging plans to provide patient-specific treatment planning and continuous temperature monitoring for assessing treatment outcome in real-time during Exablate Neuro procedures.

A press release is available from Siemens website.

Major study evaluates use of antibiotics against diarrhea

Scientists at the University of Washington and Kenya Medical Research Institute are working to discern whether antibiotics could help prevent thousands of child deaths from diarrheal disease.

A four-year, $2.5 million grant from the World Health Organization is supporting UW’s role in the largest clinical trial to date examining diarrhea-management. It aims to determine potential benefits of antibiotics as well as potential harms, such as antibiotic resistance.

Diarrhea remains a leading cause of death in children, mostly affecting children under 2 years in sub-Saharan Africa and Asia. More than a half-million children under 5 died from diarrheal disease in 2013, according the UW Institute for Health Metrics and Evaluation.

“That children continue to die from diarrhea is unacceptable,” said Patty Pavlinac, UW acting assistant professor of global health and one of the lead researchers. Although interventions have greatly reduced diarrhea deaths attributed to dehydration, “young children with bacterial causes of diarrhea experience other severe consequences, including malnutrition, gastrointestinal dysfunction, and death, which are unaddressed with existing interventions,” she said.

The researchers hope to build on earlier findings that three of the four leading infectious causes of diarrhea may be treatable with antimicrobial agents. Specifically, a double-blind, placebo-controlled clinical trial will determine the ability of two antibiotics to reduce risk of death in children under 2 with diarrhea and dehydration or malnutrition.

Some 15,000 children will be enrolled at study sites in Kenya, Mali, Malawi, Tanzania, Bangladesh, India, and Pakistan. Each child will be randomly assigned to a three-day course of azithromycin, ciprofloxacin or a placebo. Patients will be followed for 90 days to assess risk of death or chronic malnutrition.

A subset of children will be followed for an additional three months, along with another child in their household, to monitor for development of antimicrobial resistance and to evaluate potential impact on their intestinal health.

The study’s ambitious scope is designed to provide clear evidence for or against using antibiotics to treat diarrhea, in order to inform an update of WHO guidelines created more than 20 years ago. The current guidelines do not recommend antibiotics unless blood is present in the stool, an indicator for bacterial infection that misses a large number of treatable diarrhea cases.

Many experts have questioned why the guidelines do not recommend antibiotics as a common practice for treating high-risk children with diarrhea, especially when they are readily prescribed to healthy American travelers who have little to no risk of death from diarrhea.

Investigators from the University of Washington Center for Women, Children and Adolescent Health and Kenya Medical Research Institute will lead the Kenya field site of this multicountry trial under leadership of the WHO Maternal, Newborn, Child, & Adolescent Health Research and Development Team. Researchers also include Judd Walson, Benson Singa and Christine McGrath.

Full story can be found from University of Washington website.

BD Cited As Infusion Pump EMR Integration Leader In KLAS Report

BD announced that its Alaris™ System infusion platform was cited as having the most customers live with bidirectional electronic medical record (EMR) integration, which health care providers said is the most important next step for improving safety to help reduce pump-programming errors in the Smart Pumps 2016: The Quest for Patient Safety report issued by KLAS.

The report from KLAS, an organization that independently monitors health care information technology performance through the active participation of thousands of health care organizations, also stated that BD has the “most comprehensive pump platform.” The Alaris System from BD has the most customers live with EMR integration and is reported to be the only infusion platform to achieve EMR integration with syringe pumps.

“This recognition is important because it comes directly from the health care providers who use our products every day,” said Mike Garrison, vice president and general manager of worldwide Infusion Solutions for BD. “We continue to invest in innovation to ensure our products are at the forefront of technology to help improve patient safety and care efficiency.”

The report also states that a large number of BD customers achieve high drug library compliance, which many credit to BD’s reports and guidance. In addition, the report shows that actionable insights are more highly valued over basic reporting, and BD is leading in this transformation. More customers use BD reports and analytics to drive outcomes than any other infusion pump vendor.

Earlier this year, the Alaris System was named Best in KLAS for Smart Pumps in The 2015 Best in KLAS: Medical Equipment report that stated that providers believe that BD is better positioned for the future in regard to interoperability with electronic medical records (EMRs), and customers appreciate the added benefit of having patient-controlled analgesia (PCA) pumps and syringe pumps on a single platform.

A press release can be found from BD website.