|Hansen Announces Completion of World's First Intravascular Robot-Assisted IVC Filter Retrieval; Alexza Initiates Phase 2a Study of AZ-002|
|By Marilyn Mullen|
|Thursday, 22 January 2015 19:58|
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, announced the completion of the world's first intravascular robot-assisted retrieval of an Inferior Vena Cava (IVC) Filter. Dr. Alan Lumsden, Vascular Surgeon and Director of the Methodist DeBakey Heart & Vascular Center, performed the procedure at Houston Methodist Hospital in Houston, Texas using the Magellan™ Robotic System to remove a filter manufactured by Cook® Medical.
"We are pleased to report the success of this initial procedure," said Dr. Lumsden. "This is another great example of how the precision, stability and control of the Magellan robotic catheters are being applied to help improve the predictability of many of the complex endovascular procedures that we perform on a daily basis."
An IVC filter is implanted in the inferior vena cava (the large vein that carries blood from the lower part of the body to the heart) to trap blood clots. IVC filters are placed in patients with contraindications to systemic anticoagulation who are at high risk for Deep Vein Thrombosis (DVT). DVT is a blood clot formed in the veins of the legs or pelvis that can have life-threatening consequences if it travels to the lungs, known as Pulmonary Embolism (PE). Estimates of the incidence of nonfatal PE range from 400,000 to 630,000 cases per year in the US, and 50,000 to 200,000 fatalities per year are directly attributable to PE1. It is estimated that more than 250,000 IVC filters are placed annually in the United States.2
Retrievable IVC filters can be removed from the body when the risk of PE has subsided or when the patient is able to tolerate blood thinning medications. The filter is retrieved via an endovascular procedure in which a hook on the filter is "snared" by a specially designed wire and pulled back into a catheter, and then removed from the body. Retrieval may be technically challenging or fail when a filter has tilted inside the body. By enabling a physician to change the angle and direction of the robotic catheter inside the blood vessel, Magellan may help a physician to more precisely target the hook of a tilted filter.
"We would like to extend our congratulations to Dr. Lumsden and his team at Houston Methodist for continuing to identify promising new applications for the Magellan Robotic System in the treatment of vascular disease," said Cary Vance, President and Chief Executive Officer of Hansen Medical. "We are hopeful that as more experience is gained, intravascular robot-assisted IVC filter retrieval with Magellan can help a large number of patients benefit from a more predictable procedure."
The Magellan Robotic System is an advanced technology that drives the Magellan Robotic Catheters during endovascular procedures. Magellan is designed to offer procedural predictability, control, and catheter stability to physicians as they remotely navigate the robotic catheter through the vasculature. Magellan's remote workstation allows physicians to navigate through the vasculature while seated away from the radiation field, potentially reducing physicians' radiation exposure and procedural fatigue.
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced it has initiated a Phase 2a study of AZ-002 (Staccato® alprazolam), which is being developed for the management of epilepsy in patients with acute repetitive seizures (ARS). ARS occurs in a subset of patients with epilepsy who regularly experience breakthrough seizures, despite treatment with a regular regimen of anti-epileptic drugs.
"Our team has been working with some of the leading opinion leaders in the field of epilepsy to finalize our development strategy for AZ-002," said James V. Cassella, PhD, Executive Vice President, Research and Development, and Chief Scientific Officer of Alexza. "We believe that AZ-002, if approved, could greatly benefit epilepsy patients who experience seizure emergencies like ARS."
Dr. Cassella continued, "In previous clinical studies where we have dosed more than 100 subjects, Staccato alprazolam demonstrated excellent dose-proportionality, exhibited a median Tmax (time to peak plasma concentration) of 2 minutes, and was safe and well-tolerated."
Acute Repetitive Seizures (ARS) -- Epilepsy, a disorder of recurrent seizures, affects approximately 2.5 million Americans, making it the third most common neurological disorder in the United States. ARS refers to seizures that are serial, clustered or crescendo, and ones that are distinct from the patient's usual seizure pattern. Typically there is recovery between the seizures in the cluster1.
Among the implications of ARS are concerns for patient safety. Seizure effects generally correlate directly with seizure duration. Prolonged or recurrent seizure activity persisting for 30 minutes or more may result in serious injury, health impacts or death. If left untreated, ARS has been reported to evolve into status epilepticus, a life-threatening condition in which the brain is in a state of persistent seizure which has a mortality rate of 3% in children and 26% in adults.2
Benzodiazepines are considered to be medications of first choice for the treatment of ARS. The most immediate treatment for out-of-hospital care and the only U.S. Food and Drug Administration-approved product for acute repetitive seizures is rectal diazepam gel. This treatment may produce central nervous system depression. Oral, buccal, and sublingual benzodiazepines (lorazepam, diazepam), which are not approved for patients with ARS, are sometimes used for treatment, but only if the risk of aspiration is not a concern and it is recognized that the absorption time will be increased. Nasal benzodiazepine products, available in some countries, are not yet available in the United States. Intravenous benzodiazepines are rapidly acting, but must be administered by a healthcare professional in a medical facility.
The ability to treat a patient quickly is clinically imperative to avoid the epilepsy becoming status epilepticus or causing other serious complications3. Alexza believes that a product that can be administered easily in the home setting to effectively treat ARS may result in avoiding a trip to the hospital for treatment or diminish the use of the rectal formulation of diazepam. AZ-002 could be administered after the first seizure in a cluster, with the aim of preventing further seizures. The caregiver could provide dosing assistance between seizures. The product could also be used in a healthcare facility, thus avoiding the use of an IV or a rectal formulation of a benzodiazepine.
AZ-002 Study Design -- Alexza's AZ-002 Phase 2a study is an in-clinic, randomized, placebo-controlled, double-blind evaluation of patients with epilepsy using the intermittent photo-stimulation model. The primary aim of this study is to assess the safety and the pharmacodynamic electroencephalographic effects of a single dose of AZ-002 at different dose strengths vs. placebo. Data from this clinical trial are expected to serve as the basis for dose selection in potential future efficacy and safety clinical studies and will be collected from three clinical trial sites.
While there are not firm incidence and prevalence numbers in the literature, there are estimated to be about 150,0004 people with ARS in the United States, which could make AZ-002 eligible for orphan product status.
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1 clinical study of ADXS-HER2 (ADXS31-164) for the treatment of patients with metastatic HER2 expressing solid tumors.
Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR), a clinical-stage biopharmaceutical company, announced today that the underwriters of its previously announced public offering of common stock have exercised in full their option to purchase an additional 900,000 shares of common stock.
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Applied Genetic Technologies Corporation (Nasdaq:AGTC), a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced that company management will participate in the Phacilitate Cell & Gene Therapy Forum 2015.
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CollabRx, Inc. (Nasdaq:CLRX) and Medytox Solutions, Inc. (OTCQB:MMMS) have entered into a non-binding letter of intent to negotiate a potential business combination.
Dehaier Medical Systems Ltd. (Nasdaq:DHRM), which develops, markets and sells medical devices and wearable sleep respiratory products in China, today announced that representatives from the Company recently participated in the Jiangxi Province Sleep and Health Forum (the "Jiangxi Sleep Forum") to promote the Company's wearable sleep respiratory product and solution.
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, announced that their leading work on the first phase of the TALOS project resulted in a grant to expand their involvement into the second phase of the project.
Intersect ENT, Inc. (Nasdaq:XENT) today announced that management will present an overview of the company's business at the Leerink Partners 2015 Global Healthcare Conference.
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NeoStem, Inc. (Nasdaq:NBS), a leader in the development and manufacturing of cell therapy products and regenerative medicine, today announced the addition of Peter G. Traber, MD, to its Board of Directors.
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Relypsa, Inc. (Nasdaq:RLYP), today announced that Helen Torley, M.B. Ch.B., M.R.C.P., has been appointed to the company's board of directors, bringing the number of directors to nine.
ScripsAmerica, Inc. (OTCBB:SCRC) today announced that the Company is featured in the January 2015 monthly newsletter published by SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies.