BB&T Staff Writer and Staff Reports

Inovio Pharmaceuticals (Blue Bell, Pennsylvania) reported that its new generation DNA vaccine delivery technology was highlighted in a paper published in the scientific journal Human Vaccines.

The paper, “Piezoelectric permeabilization of mammalian dermal tissue for in vivo DNA delivery leads to enhanced protein expression and increased immunogenicity,“ authored by Inovio scientists, describes an electroporation method optimized for delivery into skin. This new method is based on piezoelectricity, which is the generation of an electric field or electric potential by certain materials in response to applied mechanical stress.

While current Inovio electroporation devices have been shown to be safe and well-tolerated in multiple human studies, Inovio said it has been advancing research to achieve the most optimal device characteristics to facilitate mass vaccinations.

Inovio's electroporation delivery device uses controlled, brief electrical pulses to create permeability in cell membranes, which can dramatically increase cellular uptake of a DNA vaccine and resulting gene expression. Data achieved in animal and human studies has indicated that electroporation based delivery enables potent immune responses, which are considered vital to tackling challenging infectious diseases and cancers.

“The technology is still several years away before it reaches commercialization,“ Joseph Kim, MD, Inovio's president/CEO said. “Our next step will be to test larger animal models – then, eventually we will get to test the device in human trials. It's probably seven years away before you see this on the market.“

He added, “we don't envision getting approval of the device alone – but rather as a combination device with the vaccine.“

In the study, Inovio researchers investigated whether the electrical field strength generated by piezoelectricity alone could elicit gene transfer in the skin of an animal.

To demonstrate this, researchers injected a plasmid encoding a type of protein that generates fluorescence into guinea pig skin and delivered electrical pulses using the contactless electroporation device. Three days following treatment, researchers observed protein expression on the skin of pulsed animals.

Furthermore, study results show superior immune responses were achieved when a DNA vaccine expressing an influenza antigen was delivered and pulsed using this novel device, in contrast to a lack of immune response when the antigen was injected but not pulsed.

If this “contactless“ vaccine delivery method were to be approved by the FDA, it could conceivably “revolutionize“ the way drugs are delivered by device, Kim said.

To date drug delivery into skin, or dermal tissue, is the most attractive method given that the skin is the largest, most accessible, and most easily monitored organ of the human body, and it is highly immunocompetent (able to recognize antigens and mount an immune response to them).

But traditional means of drug delivery aren't without risks. Kim said that the firm's device negates a lot of safety concerns and risks that come with using a syringe or needle for drug delivery.“

According to the company, using piezoelectricity in this new technology also provides a desirable amount of benefits. By taking away the insertion of needles used in the conventional electroporation process and reducing the electrical pulsing to nanoseconds makes this contactless device even more tolerable than current and emerging electroporation device designs, the company said.

“You don't pierce the tissue – you have less safety concerns,“ he said. “When you're using a syringe or needle you run the risk of having blood splash. You can also eliminate any pain the patient might feel.“

Kim likened the feeling once the vaccine is absorbed using the firm's device as something similar to static electricity. In addition, the nature of piezoelectricity preempts the need for a battery or electrical power source, which would be beneficial for mass vaccinations in the field, particularly in developing countries.

“Inovio continues to raise the bar in terms of technological innovation that will further optimize electroporation-based delivery of DNA-based therapeutics and vaccines for patients of all ages,“ Kim said. “While still enabling levels of vaccine potency that we have observed with our existing electroporation devices, this new contactless delivery method is non-invasive and amenable to the design of devices that are low-cost, portable, and extremely easy to use.“

Elsewhere in the product pipeline:

• Atherotech Diagnostics Lab (Birmingham, Alabama) is introducing its VAP Cholesterol Test and cardiometabolic test at PriMed South conference. Atherotech's VAP Test is a lipid test that routinely reports directly measured LDLc, which is included in the 22 reported cholesterol components. These components include Lp(a), apoB, apoA1, and the apoB/apoA1 ratio, making the VAP Test the only lipid profile that routinely reports all three lipid parameters — LDL, non-HDL and apoB, the company said.

• BioMimetic Therapeutics (Franklin, Tennessee) said the FDA has tentatively scheduled an Orthopedic and Rehabilitation Devices Panel meeting on May 12 to review the company's PMA application for Augment Bone Graft for the treatment of foot and ankle fusions in the U.S. All products developed by BioMimetic are based upon recombinant human platelet-derived growth factor (rhPDGF-BB) platform technology, which is a synthetic form of PDGF, one of the body's principal agents to stimulate and direct healing and regeneration.

Covidien (Boulder, Colorado) said that Mallinckrodt, a Covidien company, received FDA approval of its Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System (FTS) patch. Covidien's FTS is a generic alternative to the branded Duragesic patch. FTS, a Class II controlled substance, is an opioid analgesic indicated in opioid-tolerant patients for management of persistent, moderate-to-severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time, and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.

• Covidien (Boulder, Colorado) reported the integration of its Nellcor OxiMax platform with SatSeconds technology into the Welch Allyn Connex Vital Signs Monitor (VSM). The same OxiMax technology is featured in the Nellcor OxiMax N-600x pulse oximeter, the company's flagship oximeter that delivers reliable readings even during low perfusion and signal interference. The OxiMax platform monitors oxygen saturation (SpO2) levels – a critical measure of respiratory function. The SatSeconds feature alerts healthcare providers when patient saturation drops below the established SpO2 threshold – this helps minimize nuisance alarms by providing clinicians with the ability to differentiate between serious desaturations and minor transient events so they can intervene promptly to alarms that matter. The Connex VSM provides patient documentation on a single display, including such critical information as heart rate, blood pressure, temperature and pulse oximetry; manual parameters such as respiration, height, weight and pain level; and modifiers such as body position and O2 therapy details.

Davol (Warwick, Rhode Island), a subsidiary of C. R. Bard, said that a study published in February's American Surgeon showed patients undergoing complex abdominal wall repair with the implantation of the XenMatrix Surgical Graft demonstrated low levels of recurrence and post operative complications an average of two-and-a-half years after abdominal wall reconstruction. The study is a retrospective analysis of 57 consecutive patients who underwent high risk hernia repairs by five different surgeons using the XenMatrix Surgical Graft as an underlay between March 2006 and January 2008. With an average follow up of two-and-a-half years, the data in this peer reviewed clinical study provides the longest existing post operative view of patients following the implantation of a non-cross-linked porcine dermis product in abdominal wall reconstruction.

• Hypertronics (Hudson, Massachusetts) reported the release of their new Shielded HyperGrip connector. More sophisticated medical equipment with increased data transfer rates have given rise to a need for shielded connectors to protect medical interconnect from dangerous signal interruptions caused by EMI and RFI. In addition to its uniquely medical appearance and proprietary features, the Hypertronics Shielded HyperGrip circular, plastic, push-pull medical connectors series provides continuous shielding through the connector with an attenuation of -50db at 3 GHz, the company said. The Shielded HyperGrip series is suited for operating in sterile hospital environments and embodies the features and functionality required to make certain that the highest level of performance and quality are maintained across key disciplines that include homecare cardiac devices, patient monitoring, imaging, and electrophysiology catheter systems.

• Isabel Healthcare (Ann Arbor, Michigan) reported the release of v4 of Isabel, its diagnosis decision support system. Isabel says the v4 provides significant improvements in speed, quality and specificity. In addition, Isabel v4 has streamlined usability and enhanced accessibility features to support physicians within their normal workflow. Extensive testing of Isabel v4 has shown improvement in quality and specificity of over 20% and response times improved by 25%. The increase in speed allows Isabel v4 to handle current and new features in the tool with ease. New features of Isabel v4 extend access to the iPhone, iPad and Android and include a more robust suite of integration capabilities into existing EMR systems.

• Maquet Cardiovascular (Wayne, New Jersey) has launched its new Acrobat-i Stabilizer and Positioner System. Developed for use in performing off-pump coronary artery bypass (OPCAB) procedures on coronary artery bypass graft (CABG) patients, this next-generation Acrobat-i system, the latest in the Acrobat family, has a significantly lower profile design and tubing management features that allow increased access to and visibility of the surgical field. With 180° side-to-side range of motion and the stabilizer's ability to vertically drop into the chest cavity, its maneuverability and arm strength help cardiovascular surgeons gain better access and control for hard-to-reach vessels during CABG surgery. In a CABG procedure, a healthy blood vessel, such as the saphenous vein, from the leg, or the radial artery, from the arm, is used to bypass a blockage in the heart.

• Mederi Therapeutics (Greenwich, Connecticut) has received FDA clearance for its new MDRF1 Generator. The Mederi RF Generator powers the Stretta System for treatment of Gastroesophageal Reflux Disease as well as the Secca System for Bowel Incontinence or Bowel Control Disorder. “Mederi's new RF generator dramatically reduces the user's capital spending requirements by combining two power generators into one. The MDRF1 is a smaller, lighter and highly portable radio frequency generator with a more intuitive user interface than its predecessors,“ said Will Rutan, Mederi's CEO. “The MDRF1 combines the functionality of these earlier models into one system that powers both the Stretta and Secca devices.“

• Miramar Labs (Sunnyvale, California) has received FDA clearance for the new miraDry System for the treatment of primary axillary hyperhidrosis, commonly known as excessive underarm sweat. miraDry is a non-invasive, outpatient procedure that provides a lasting solution for this debilitating condition. The miraDry procedure entails delivering electromagnetic energy to the area beneath the underarm skin where the sweat glands reside, resulting in thermolysis of the sweat glands. The effect can be seen almost immediately. The miraDry procedure will be available later in 2011 through miraDry-certified dermatologists.

• NMS Labs (Willow Grove, Pennsylvania) has launched a test suitable for the evaluation of toxicity vs. efficacy and helping physicians with therapeutic drug monitoring (TDM) of patients for the therapeutic agent, Methotrexate. NMS Labs is the only known commercial laboratory to perform this test using the highly specific and sensitive technique of liquid chromatography/tandem mass spectrometry (LC-MS/MS). This test expands upon the group of chemotherapeutic TDM tests already offered by NMS Labs which includes Busulfan, Mercaptopurine, Mitotane, Platinum and Tamoxifen and metabolites.

• Ornim (Santa Clarita, California) reported the receipt of 510(k) clearance from the FDA to market the CerOx 3210F monitor. Additionally to its previous clearance for non-invasive monitoring of regional hemoglobin oxygen saturation in the brain or skeletal muscle, the CerOx 3210F is now also intended for use as a non-invasive monitor of blood flow in tissue of adults. The CerOx 3210F is currently the only device to use a single, non-invasive probe for simultaneously and independently measuring both oximetry and blood flow parameters, together providing a clear indication of tissue perfusion.

• PerkinElmer (Waltham, Massachusetts) reported the launch of the Frontier Infrared Spectrometer, a high-performance infrared (FT-IR) spectrometer built using PerkinElmer's spectroscopy expertise. Part of a new family of spectrometers, the Frontier analytical platform meets diverse FT-IR challenges ranging from everyday measurements to the most advanced, complex analyses. The instrument combines best-in-class sensitivity with flexibility for many diverse sectors, from polymers and chemicals to consumer goods and pharmaceuticals, helping to protect consumers and the environment across the world, the company said. Frontier is a powerful, configurable FT-IR spectrometer that can be expanded as research goals develop.

• Rcadia Medical Imaging (Newton, Massachusetts) received FDA clearance for an enhanced version of its COR Analyzer System to assess coronary branch vessels in addition to main coronary arteries in patients with suspected coronary artery disease (CAD). The COR Analyzer System is a clinical decision support tool that automatically detects significant (50% and more) stenotic lesions in coronary arteries from Coronary CT Angiography (cCTA) studies.

• Revolutions Medical (Charleston, South Carolina) reported a breakthrough in automatic retractable prefilled safety syringe technology. Building on the company's vacuum-based technology, important improvements in performance have been made that will set a new gold standard for safety in automatic prefilled syringes. Revolutions Medical's products include the RevVac Safety Syringe, safety blood drawing device; and the RevColor, RevDisplay and Rev3D software tools that are compatible with standard MRIs and standard PACS.

• Stryker's (Mahwah, New Jersey) Orthopedics Division reported FDA clearance for its MDM X3 Modular Dual Mobility Mobile Bearing Hip System. MDM X3 is an addition to the company's portfolio of next-generation technologies designed to minimize the risks traditionally associated with hip replacement surgery and address a broader patient population, including both primary and revision total hip arthroplasty candidates. MDM X3 is a third-generation dual mobility device that allows surgeons to offer the benefits associated with Stryker's dual mobility technology to a broader patient population, including those who may benefit from advanced fixation. The dual points of articulation in dual mobility constructs help accommodate multi-directional movement, which provides the potential for greater range of motion and reduced wear compared to competitive fixed implant designs, based on laboratory testing, the company said.

• Wright Medical Group (Arlington, Tennessee) reported the release of the Evolve Elbow Plating System (EPS). Developed by a team of elbow surgeons, the Evolve EPS is an anatomic plating system designed to treat fractures of the distal humerus and proximal ulna. Composed of polished stainless steel, the system was designed to accurately match the patient anatomy to reduce the need for intra-operative bending while providing a low profile design to minimize post-operative irritation.

Xytos (Carson City, Nevada) has introduced their Cancer Diagnostic Fluorescent Scanning Technique. Xytos is able to illuminate cancer cells years before the cancer would be detectable by current diagnostic procedures such as the mammogram. This early diagnostic technique allows Xytos to fight cancer at the very earliest stages, before a lump can develop, the company said. Fluorescent Scanning works best on Breast and Skin Cancer because the cancer is near the surface of the body. Xytos Fluorescent Scanning has the ability to detect cancer at its earliest stages well before it becomes a tumor. At present, the mammogram is the accepted diagnostic tool for detecting breast cancer. From day one through 3 years cancer is undetectable using a mammogram. Cancer cells could possibly be present 3 years before they are detectable by a mammogram, and by the time the cancer is detected by mammogram in the form of a lump/tumor the cancer has been present for 6 plus years. In time Xytos expects their fluorescent scanning technique to become the standard for diagnosing Breast and Skin Cancer.