BB&Ts

Bladder cancer, which afflicts more than 400,000 people globally each year, has a 98% survival rate if caught in the earliest stages. Initial testing and survivors must undergo repeated cystoscopies, an uncomfortable test, to diagnose and then check for disease recurrence, which is fairly common.

Pacific Edge Biotechnology (Dunedin, New Zealand) has developed a rapid, urine test based on assaying RNA or proteins using multiple biomarkers with the potential to replace at least some of those cystoscopies. “It’s a very informative test and has great utility,” CEO David Darling told Biomedical Business & Technology. “It’s designed to replace the cytology used as an adjunct to cystoscopy, which is the current gold standard. It’s a test used to triage a patient and then following on to determine if that patient has a superficial or invasive cancer.”

Pacific Edge was recently issued a Singaporean patent for the test which enables the early detection of bladder cancer from a relatively small volume of urine – just 50 milliliters. Darling said he anticipates patents from other countries to be issued over the next 12 to 24 months.

“The idea is to minimize use of cystoscopes,” Darling said. “A patient often will receive a cystoscopy along with diagnosis. Then, European standard procedure is six follow-ups in the first year and then four per year thereafter. In the U.S., there are typically four follow-ups with cystoscopies and then two for the next four years. So that’s a total of 12 in the U.S. Those are all extremely invasive and rely on general anesthesia and it’s extremely expensive.”

Darling said the test won’t entirely replace the need for cystoscopy. “It’s an important test, but urologists have 85% of cases that test negative and then need to follow up with a new more accurate test that’s not invasive and is more cost effective,” he said. “A lot of patients don’t want the invasiveness and general anesthetic. We expect to see some behavioral changes with this test. Urologists may reduce the number of follow-up tests.”

While cystoscopy is the gold standard test, it presents challenges for patient compliance along with the fact that it’s relatively poor in efforts to actually assess tumors, Darling said.

“Bladder cancer has the highest total medical costs of all cancers driven by two things: a strong requirement for monitoring following detection and the cost of overall detection technology,” he said. “There is a very high recurrence rate: 78% of early stage tumors recur and, of those, 30% come back as late stage tumor. It’s a very persistent disease.”

Pacific Edge is currently conducting a 1,000-patient clinical trial – with sites in New Zealand and the Soviet Union – that is expected to be completed within a few months.

Darling said the FDA has indicated that an extra cohort is needed for approval in the U.S. “We’re currently talking to investigators in U.S. to put it together and then we will follow through with a PMA,” he said. “We’ve been talking to the FDA for a year and they are very happy with our trial design, but we need to add a cohort of American people. We’ve yet to design that but it will probably be 300 people.”

Pacific Edge intends to first offer the test – to be named uRNA – to Australasian urologists through its Dunedin-based lab following completion of clinical trials later this year. Following that, commercialization will proceed in Singapore, Europe and the U.S. Darling said that Pacific Edge anticipates partnering in several of these locations for lab resources.

Bladder cancer isn’t the only target for Pacific Edge, which also is developing colorectal and gastric cancer tests. The colorectal cancer prognostic test is nearing completion of commercial development and the company has licensed that technology to an as-yet-undisclosed German diagnostics firm. For gastric cancer, a prototype is currently undergoing validation rounds.

Elsewhere in the product pipeline:

• Results from a clinical study published in the New England Journal of Medicine reveal that ablative therapy using the HALO system, made by Barrx Medical (Sunnyvale, California) is highly effective for complete eradication of a pre-cancerous condition of the esophagus called Barrett’s esophagus. Additionally, ablative therapy using the HALO system reduced the risk of progression to cancer in the highest risk cohort studied (compared to control) from 19% to 2.4%.

• Bayer Diabetes Care (Tarrytown, New York) reported the launch of A1CNow Selfcheck, a new A1C monitor that enables people with diabetes to check their A1C level at home. Measurement of A1C provides an average assessment of blood sugar levels over the past three months — and is an indicator of how well diabetes is being managed. The Selfcheck enables patients to more closely watch their A1C level iin between healthcare provider visits so they may modify their diet and exercise, or have a more informed discussion with their healthcare provider based on the results. An A1C reading provides the average blood sugar level over the past three months and indicates how well blood sugar is being managed. A1C levels, for most people without diabetes, range from 4-6%. For most patients with diabetes, the American Diabetes Association recommends an A1C under 7%. A1C levels higher than 7% increase the risk of developing complications such as heart disease, stroke, kidney disease, eye disease, nerve damage, amputations and circulation problems. An A1C over 7% may prompt a physician to re-evaluate the diabetes management plan to help bring the A1C closer to normal.

• BioCardia (San Carlos, California) has introduced a new tool designed to help physicians refine minimally invasive treatment of peripheral artery disease (PAD). It could result in better outcomes for many of the 12 million Americans who suffer from an accumulation of plaque in arteries, which reduces blood flow. Clearing out that plaque has, for years, been performed via angioplasty that makes use of a catheter to reach the blockage. Even though those catheters are considered flexible, they aren’t always ideal for the curves of the human anatomy. Morph AccessPro has received FDA 510(k) clearance as a tool to refine this procedure. Surgeons currently use multiple preshaped catheters and scrape the soft curves up and down the aorta. The Morph AccessPro allows surgeons to use a single straight catheter. When they reach the target lesion, it deflects and takes on the needed shape in real time. “Better manipulation of a catheter in the vasculature could result in better outcomes,” said CEO Peter Altman, PhD. “It’s a steerable introducer that gives a clinician the advantage of a deflectable catheter that can take the shape of any geometry. Because it can be shaped in the patient, it can have better back-up support than other catheters that are very soft and floppy at the distal end. It can provide for customization of the distal shape of the presenting anatomy.”

• Boston Scientific (Natick, Massachusetts) released results from the multicenter, prospective, randomized controlled ISAT clinical trial, which was aimed at determining the safer procedure with better outcomes for an aneurysm patient – with coil embolization or standard surgical clipping. Results were published in The Lancet Neurology. Patients were primarily treated with the early generation of Boston Scientific’s Guglielmi Detachable Coils, some as far back as 14 years when technology, angiographic imaging equipment and physician experience differed significantly from today. The coils are bare-platinum and detachable according to the company. Results showed that patients with a ruptured intracranial aneurysm treated with endovascular coil embolization are 23% less likely to die within five years compared to patients who undergo surgical clipping. The study specifically looked at 2,143 patients with ruptured intracranial aneurysms who were enrolled between 1994 and 2002 at 43 neurosurgical centers. The findings were reported by Andrew Molyneux, MD, and Richard Kerr, MD, from the Neurovascular and Neuroradiology Research Unit of the John Radcliffe Hospital and the University of Oxford (both Oxford, UK). At five years’ post-treatment, 14% of surgically clipped patients had died compared to 11% of patients treated with endovascular coiling, representing a 23% relative reduction in risk of death for coiled patients. The percentage of patients characterized as independent in their daily activities at five years post-treatment was similar for both groups (82% for coiling vs. 81% for clipping). At five years, 11% (112 of 1,046) of the patients in the endovascular group and 14% (144 of 1,041) of the patients in the neurosurgical group had died. The risk of death at five years was significantly lower in the coiling group than in the clipping group, but the proportion of survivors at five years who were independent did not differ between the two groups: endovascular 83% (626 of 755) and neurosurgical 82% (584 of 713).

• Cook Medical (Bloomington, Indiana) has launched a line of high-definition EUS biopsy needles that it says are up to three times brighter than others on the market. With the addition of the 19 and 25 gauge EchoTip Ultra with High Definition Fine Needle Aspiration (HDFNA) needles, the EchoTip Ultra HDFNA represents the next level of precision in EUS, according to the company. During a EUS procedure, the endosonographer inserts an endoscope, which has a small ultrasound transducer at its tip, through the patient’s mouth into the esophagus, facilitating imaging from within the GI tract. EUS also enables tissue sampling through fine needle aspiration (FNA), a safer and less invasive alternative to open surgical biopsy. Under ultrasound guidance, a special needle inserted in the endoscope collects cells from targeted sites. Cook’s EchoTip Ultra with HDFNA is a single-use, disposable needle intended for sampling of targeted submucosal GI lesions through the accessory channel of an ultrasound endoscope.

• Conmed (Utica, New York) reported the full market release of the Zen Wireless Footswitch and adaptor by its Conmed Linvatec arthroscopy unit. The Zen Wireless Footswitch offers wireless operation of Conmed Linvatec powered handpieces and uses a low power communications protocol for a highly reliable two-way communication with unmatched control and responsiveness.

• Electro-Optical Sciences (Irvington, New York) submitted a PMA application for MelaFind, a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma. Positive top line data from the MelaFind pivotal study, the largest prospective clinical study ever conducted in melanoma detection, were announced in February and subsequently presented at several major international dermatology meetings. The company’s final analysis of the data demonstrated that for all subgroups analyzed, the sensitivity of MelaFind was greater than 95% (lower confidence bound) and MelaFind specificity was statistically significantly higher than that of study clinicians.

• Exagen Diagnostics (Albuquerque, New Mexico) reported the availability of two new genomic blood tests to assist physicians with diagnosing Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD). The eXaIBStest identifies patients with IBS, while the eXaIBD test identifies patients with IBD. Exagen’s tests are RNA-based, and require a single tube of peripheral blood.

• iCAD (Nashua, New Hampshire) said it has submitted data to the FDA seeking 510(k) clearance of its VeraLook computer-aided detection (CAD) technology for CT colonography (CTC), or “virtual” colonoscopy. CTC uses advanced visualization technology to produce three-dimensional images that permit a thorough and minimally invasive evaluation of the entire colorectal structure. iCAD’s VeraLook product uses advanced algorithms to detect and highlight potential polyps warranting closer review by a radiologist.

• iMedicor (Nanuet, New York) reported the introduction of its technology solution that addresses the inability of disparate electronic health records (EHRs) systems to communicate, collaborate and exchange medical records in a HIPAA-compliant environment. iMedicor says its technology provides physicians, healthcare providers and patients with the capability of transporting medical records in a manner that eliminates the risk of them being intercepted or altered. The portal, which also provides physicians with a social and professional referral network and access to continuing medical education programs, is available to healthcare organizations, professionals and patients free of charge at www.imedicor.com.

• Innovia (Miami) has received FDA clearance to market the InnoPort to facilitate single-port access laparoscopy. The InnoPort is inserted into the abdomen to perform laparoscopic surgery through one small incision – instead of multiple incisions – with the goal of minimizing scarring, pain, recovery time, and complication risk to the patient. The port is enabled by Quatromer, one of Innovia’s biopolymers.

• Interson (Pleasanton, California) reported the launch of the SeeMore USB Ultrasound Imaging probe. SeeMore probes plug directly into the USB port of a laptop, netbook, or desktop computer. General purpose and specialty probes are available for a wide range of clinical applications including: abdominal, OB/GYN, bladder scanning, emergency, vascular access, small parts, musculo-skeletal, nerve blocks, endocavity (prostate, transvaginal) and more, and range in frequency from 3.5 MHz to 24 MHz.

• Lantheus Medical Imaging (North Billerica, Massachusetts) said it has completed patient enrollment of CaRES (Contrast Echocardiography REgistry for Safety Surveillance), the first, multicenter Phase IV observational registry that evaluates the use of ultrasound imaging agents in routine clinical practice. The patients in the study required Definity Vial for (Perflutren Lipid Microsphere) injectable suspension-enhanced echocardiography because of a previous suboptimal, unenhanced echocardiogram. In patients with suboptimal echocardiograms, Definity enables physicians to visualize the borders of the heart more clearly.

• With the promise of more device programming options, Medtronic (Minneapolis) reported FDA approval of Activa RC and Activa PC, two deep brain stimulation (DBS) devices used to treat the symptoms of advanced Parkinson’s disease and essential tremor. Medtronic DBS therapy delivers small electrical pulses to precisely targeted areas within one or both sides of the brain to help patients achieve greater control over disabling body movements, according to the company. Both Activa RC and Activa PC devices provide bi-lateral stimulation (to both sides of the brain) and offer a more advanced approach to device programming, and additional tools for capturing history relevant to the patient’s therapy, Medtronic says. New programming options provide greater ability to fine tune the stimulation field and give patients more options to optimize their settings compared to previous DBS devices. Activa RC is the first rechargeable DBS neurostimulator in the world, Medtronic noted, and lasts for nine years before replacement is necessary.

• Merge Healthcare (Milwaukee) reported the addition of the eFilm archive to its portfolio of eCommerce diagnostic imaging solutions. This archive gives imaging centers, specialty clinics and rural hospitals an economical way to increase their storage capacity for medical images and enable efficient image routing.

• Meridian Bioscience (Cincinnati) said it has received FDA clearance for a new rapid test for Campylobacter, ImmunoCard STAT! CAMPY. This new test provides fast and accurate detection of Campylobacter bacteria, one of the most common causes of diarrheal illness and the most common bacterial cause of foodborne illness in the U.S. About 20 million stool culture tests are conducted each year in the U.S. to detect the illness, known as Campylobacteriosis. With culture, there is a potential for reduction in sensitivity due to variable culturing procedures, specimen viability, and inhibitory antibiotics in culture media. Meridian said ImmunoCard STAT! CAMPY “dramatically reduces these concerns with a consistent method that measures the bacterial antigen instead of measuring the viability of this fragile bacteria in an environment that is less inhibitory than current culturing procedures.”

• Neoprobe (Dublin, Ohio) said a second multi-center Phase III study of Lymphoseek (NEO3-06) has received investigational review board approval to begin enrollment of patients diagnosed with head and neck squamous cell carcinoma. The study will evaluate the efficacy of Lymphoseek to identify sentinel lymph nodes that may be predictive of determining whether a patient’s cancer has spread into the lymphatic system.

• Olympus America (Center Valley, Pennsylvania) reported the introduction of X-Suit NIR, a biliary metallic stent designed with exceptional anatomic conformability and superior radial support. The stent’s NIRflex cell design provides a physician support and flexibility; the company said, both critical to help relieve the symptoms associated with pancreatic, liver and bile duct cancers. Olympus said the NIRflex advanced cell design biliary metallic stent provides flexible construction to fit the shape of any biliary duct. Each strut is also rounded, helping to reduce stress to the tissue and prevent damage to the bile duct and duodenal walls.

• PhotoMedex (Montgomeryville, Pennsylvania) reported the availability of its Xtrac Velocity Excimer Laser, a device expected to redefine laser treatment options for patients suffering from psoriasis and vitiligo. The laser features an average laser power of up to 7.2 watts delivered to the patient. The company claims that because the innovative Velocity excimer laser can cover a much greater surface area in the average treatment session – up to 20% of the body surface in five minutes vs. only 2% to 4% for alternative lasers – it is the first practical alternative to potent pharmaceuticals or full-body UV irradiation for patients with severe psoriasis.ording to the company.

• Precision Therapeutics (Orlando, Florida) presented data demonstrating the use of ChemoFX, a chemosensitivity assay, to predict the effectiveness of cetuximab (ERBITUX) on the colorectal cancer cells of individual patients. Results from the study show that of the 54 primary colorectal cultures tested, 8% were responsive to cetuximab, a result that is consistent with the reported clinical response rate for cetuximab in colorectal carcinoma patients (11%). A predictive assay such as this could give physicians the edge they need to determine if cetuximab is appropriate for a patient before administering the biologic. ChemoFx measures an individual patient’s probable tumor response to various chemotherapeutic and biologic agents.

• Prescient Medical (Doylestown, Pennsylvania) reported that six months after placement of a vProtect Luminal Shield to treat a vulnerable plaque, a follow-up exam revealed reduced plaque burden and reduced stenosis in the target vessel. The exam was part of the SECRITT I trial, a randomized study designed to evaluate the vProtect Luminal Shield as a prophylactic treatment for non–flow-limiting vulnerable plaques. The follow-up exam indicated that the self-expanding vProtect Luminal Shield had stabilized the vulnerable lesion while gently expanding over time.

• Power Medical Interventions (Langhorne, Pennsylvania) said the FDA has cleared its 510(k) application for marketing its iDrive Intelligent Power Unit, detachable Intelligent Surgical Instruments and iConsole. The iDrive is designed to support a variety of minimally invasive procedures by offering surgeons a range of cutting and stapling configurations combined with flexibility, access and precision. The iDrive is a hand-held, computer-controlled power unit to which any of the company’s Intelligent Surgical Instruments can be attached. The iConsole is a wireless device that communicates directly with the iDrive during surgical procedures to output specific auditory and visual reference information via its speaker and liquid crystal display. Outputs provide surgeons with information regarding calibration, firing, and instrument and reload type, allowing surgeons to make real-time, critical decisions that may ultimately lead to an improved patient outcome.

• Roche Applied Sciences (Branford, Connecticut) said that a study published online in PLoS Pathogens reports that researchers at Columbia University, the South African National Health Laboratory Services, the U.S. Centers for Disease Control, and 454 Life Sciences have discovered a new virus that is responsible for a highly fatal hemorrhagic fever outbreak in Zambia and South Africa late 2008. The previously unknown arenavirus, which is distantly related to the Lassa virus and Lymphocytic choriomeningitis virus, was characterized using the rapid and sensitive sequencing technology of 454 Life Sciences.

• Data from a pre-clinical study to evaluate the silk-based, bioresorbable surgical scaffold made by Serica Technologies (Bedford, Massachusetts) in hernia repair surgery were recently published in the peer-reviewed journal, Hernia. Study results demonstrated that the silk-based scaffold bioresorbed at an ideal rate to support the regeneration of host tissue in a well vascularized area, and could potentially minimize any long-term complications associated with previously available, synthetic polymer mesh implants.

• Small Bone Innovations (SBI; Morrisville, Pennsylvania) said the FDA has approved a total ankle replacement system for arthritic or deformed ankles that may preserve some range of motion in the joint. The new prosthesis is a mobile-bearing device, which relies on bearings that move across a surface of polyethylene, a flexible plastic. The Scandinavian Total Ankle Replacement (STAR) System, made by SBI, is an alternative to fusion surgery and may allow for greater rotation and movement in the joint. Fusion surgery involves cementing the shin bone (tibia) – the thicker of the two bones in the lower leg – to the talus bone in the ankle. The procedure stabilizes the ankle, but significantly decreases the ability to move the foot up and down. Once arthritis or injury destroys the cartilage that cushions the ankle bone, the joints can become painful enough to warrant total ankle replacement.

• SPO Medical (New York) said it has expanded its product offering for the hand-held SPO Medical PulseOx 6100 device with the introduction of a new pediatric sensor. The pediatric sensor is designed to further enhance applications of the product in the professional medical sector. In addition, the PulseOx 6100 now supports the Six Minute Walk Test (6MWT) which is widely used for preoperative and postoperative evaluation and for measuring the response to therapeutic interventions for pulmonary and cardiac disease.

• Targeted Molecular Diagnostics (Research Triangle Park, North Carolina) reported the availability of two new laboratory tests used to develop more effective cancer treatments. These new tests are now being used in the clinical development of targeted therapies more likely to succeed in treating patients with cancer related to gene mutations.

• Transoma Medical (St. Paul, Minnesota) reported FDA clearance for its new Data Review feature on Sleuth AT. The Data Review feature allows any clinician to easily access up to 99 events stored on the patient’s Personal Diagnostic Manager (PDM). The PDM is a handheld device that retrieves and stores ECG data from the implanted device prior to automatic transmission to the 24/7 monitoring center. Each stored ECG strip is labeled with the time and date of the cardiac event making it easier for clinicians to correlate symptoms with rhythms. The system includes a small implanted device that incorporates a sensitive arrhythmia. The Sleuth AT captures ECG strips containing arrhythmias automatically, and also allows the patient to capture data by pressing a button on the handheld PDM after experiencing a symptom. All data captured by the implanted device is automatically transferred to the PDM, providing an additional 10.5 hours of ECG storage. Data stored on the PDM is automatically transmitted to a 24/7 monitoring center where certified cardiac technicians review the data and alert clinicians to clinically-significant events.

• Varian Medical Systems (Salt Lake City) has introduced its first digital imager specifically designed for interventional angiography procedures. “With speeds up to 30 frames per second, the PaxScan 3030+ allows the physician to monitor interventional procedures, including the placement of catheters within blood vessels, in real time,” said Carl LaCasce, VP of imaging products. “The PaxScan 3030+ provides highly detailed images with excellent contrast and spatial resolution, while delivering a low X-ray dose to the patient.” In addition to interventional angiography systems, the new PaxScan 3030+ multi-modality panel is designed for use in cardiovascular imaging systems and surgical C-arms.