Next Safety (West Jefferson, North Carolina), focused on developing powered respirators, has developed a device that it expects to alter the landscape of pulmonary drug delivery. What’s more, one of those “drugs” — and the first for which it will seek approval — is nicotine, as a strategy to provide an aerosol designed to help smokers stop inhaling smoke, but still get the “fix” of the drug.

That plan is not without critiques who protest that use of a drug delivery device, saying it promotes addiction to nicotine, acknowledges Lyndell Duvall, director of technology and product development and corporate VP for Next Safety.

“The pulmonary delivery device kind of sprang out of an idea that we had during the development of the respirator,” Duvall told Biomedical Business & Technology. “Essentially our device is — we call it a mandible port — inserted between the respirator and the unit that delivers the air.”

But he believes such a delivery device for nicotine would be more effective, and therefore more marketable, than other options such as nicotine gum or patches because it delivers a more concentrated dose. It is also expected to fulfill an unmet need for other drugs, particularly drugs now off-patent and considered generic in order to “revive their use.” And though he said that the “jury is still out on nicotine,” the device would require a prescription for some of the other drugs being considered for use with it.

When the company begins clinical testing under an Institutional Review Board protocol, the drugs slated to be tested with the device will be antiobiotics such as tobramycin, the anti-nausea drug phenergen, albuterol and morphine. “[The device] would be applicable to use similar to an inhaler,” Duvall said. “The other embodiment of it, if you will, is including it in the air flow between the respirator and the wearer.”

The company’s hope is that it will be able to license the technology with a prototype and early test results, expected in July, Duvall said, since medical devices “that require FDA qualification” are not considered the company’s “core business.” Patents are pending on the delivery device currently.

Tom Stern, MD, assistant professor of medicine in the Department of Internal Medicine at Carolinas Medical Center (Charlotte), a member of Next Safety’s Medical advisory board, said, “To date, laboratory data suggests applications such as childhood asthma or home delivery of medicines previously requiring an IV will be equally benefited.” He said “this fundamental breakthrough may eventually be seen as important as the invention of the syringe.”

As for those drugs expected to undergo testing in the device, Duvall said “an easy example” where someone would prefer inhaling to an IV is morphine. Morphine delivered via the pulmonary delivery device would also “offer the potential for home healthcare. Things like metered dose inhalers and nebulizers... typically generate a massive cloud of droplets instantly, and it’s a bulk process, which means that you have some variation in the droplet size with perhaps very small droplets that can be delivered deep in the lung to larger droplets that get deposited higher up in the airways,” Duvall said.

Rather than that approach, the Next Safety-developed device uses a technology “to eject the droplets essentially one at a time, and those droplets are ejected through a nozzle that generates essentially the same droplet size every time.”

The company is now taking orders for its bPure8000 respirator over the company website, with manufacturing scheduled to begin later this month or in early July. The respirator is Next Safety’s first project, Duvall said. “Essentially, what we did is design it to have the best run time, best filter efficiency and best air flow on the market.”

Elsewhere in the product pipeline:

• AcroMetrix (Benicia, California) reported receiving FDA clearance for the VeriSure Pro HBV DNA external quality control. This control is for use on Chiron’s procleix ultrio assay for the detection of HBV DNA using nucleic acid amplification. AcroMetrix is the only Chiron approved provider of controls for the Chiron Procleix and Ultrio assays. The VeriSure Pro line of external quality controls is intended to provide a means of estimating accuracy and detecting systematic deviations of nucleic acid test procedures for the qualitative determination of HIV-1 RNA, HBV DNA, HCV RNA, and WNV RNA. AcroMetrix makes products for clinical diagnostic and blood testing laboratories.

• Boston Scientific (Natick, Massachusetts) reported the publication of an article in the April 24 Journal of American College of Cardiology reviewing the Taxus ATLAS clinical trial, which evaluates the company’s second-generation Taxus Liberte paclitaxel-eluting stent system. The article concluded that the shorter procedure time and lower bailout rate of the Liberte stent system compared to the Taxus Express2 stent system may represent a clinical surrogate for the improved deliverability and conformability of the Taxus Liberte stent as compared to the Taxus Express stent. ATLAS is a trial comparing the Taxus Liberte paclitaxel-eluting stent system to a case-matched control group of patients from the Taxus IV and Taxus V de novo studies that received the Taxus Express2 paclitaxel-eluting stent system. Data reported in the JACC article showed the TAXUS Liberte stent was associated with significantly shorter procedural times. Boston Scientific seeks to make less-invasive medical devices and procedures.

• Bruker Daltonics (Indianapolis, Indiana) launched its ImagePrep sample preparation device for automated matrix deposition onto tissue slices at the 55th ASMS Conference on Mass Spectrometry. MALDI mass imaging of tissue samples with Bruker’s MALDI Molecular Imager (for research use only) solution allows color-coded visualization of the distribution of peptide or small protein biomarkers, or of drugs and their major metabolites for the direct analysis of molecular distributions in tissue sections. The ImagePrep device provides reproducible sample preparations for MALDI imaging in a fully automated, push-button process. Another unique advantage of ImagePrep is the combination of excellent spectra quality at high image resolution of 50 m at the same time. Bruker Daltonics makes tools based on mass spectrometry and ion mobility spectrometry.

• Cook Medical (Bloomington, Indiana) reported the availability of the Cook Turbo-Flo 8 French Double Lumen Central Venous Catheter designed to produce increased flow rates. The catheter employs Cook’s antibiotic-impregnation process, infusing minocycline and rifampin on both the internal and external surfaces of the catheter to provide increased protection against catheter-related bloodstream infections. The Turbo-Flo catheter’s “double-D” lumen configuration provides maximum flow rates for whole blood product delivery and sampling or to deliver medication and nutrients. The catheter is introduced by mini-puncture, marked by a smaller puncture site and a decrease in complications. Additionally, it is available with the Cook EchoTip echogenic needle to improve visibility by enhancing the needle’s appearance during ultrasound imaging. The catheter is available in 15, 20 and 25 centimeter lengths and is now available with the Cook Full Spectrum tray, catheter tray and the cap, mask, gown and large drape maximum barrier precaution tray. Cook Medical makes interventional devices.

• Digirad (Poway, California) reported the introduction of nSPEED, an advanced 3D SPECT image reconstruction technique. This algorithm provides the clinicians with significant image quality improvement over existing 2-D reconstruction techniques by producing clearer and more accurate images to help improve physicians’ interpretation confidence. nSPEED models the depth-dependent point response function in an iterative reconstruction algorithm (OSEM), thus enabling depth-dependent resolution recovery and improving chamber contrast in cardiac SPECT images. Such improvement may further enable the reduction of acquisition time while maintaining image quality as compared to conventional reconstruction without depth-dependent resolution recovery, while adhering to ASNC imaging guidelines. With this product, Digirad said it is attempting to obtain ASNC and other society acceptance in order to meet accreditation requirements. Digirad provides diagnostic imaging products for use in cardiology, internal medicine, and general imaging applications.

• Immersion Medical (San Jose, California) has introduced the LaparoscopyVR Surgical Simulation System. The LapVR system, including hardware and software designed by Immersion, comes in a self-contained cart and provides a tool to assist in training of minimally invasive laparoscopic procedures. The base laparoscopy surgical simulator includes an essential skills module with 15 skill exercises, a laparoscopic cholecystectomy (LapChole) module with 18 cases, and an administration module. The essential skills module includes exercises for developing camera navigation, cutting, clipping, adhesiolysis, and hand transfer skills. The LapChole module provides a simulated environment for removal of the gall bladder. Immersion makes digital touch technology, and Immersion Medical makes computer-based surgical simulation training systems.

• Immucor (Norcross, Georgia) reported that Galileo Echo has been cleared by the FDA for marketing in the U.S. The company describes the device as a third generation automated assay instrument, is a compact bench-top, automated walk-away instrument for the small to medium sized hospital blood bank transfusion laboratory. The Echo offers small to medium sized hospitals and laboratories a full test menu and promises labor reduction while increasing productivity and patient safety, the company said. Immucor manufactures reagents and systems used by hospitals, reference laboratories and donor centers to detect and identify certain properties of the cell and serum components of blood prior to transfusion.

• Innocoll (Ashburn, Virginia) said that its subsidiary, Innocoll Technologies, has filed an investigational new drug (IND) application for its CollaRx gentamicin surgical implant, under development for the prevention of surgical site infections as an adjunct to standard infection prophylaxis. This is the third IND that Innocoll has filed in the last 6 months following similar submissions for the topical use of CollaRx gentamicin in the treatment of infected diabetic foot ulcers and for its CollaRx bupivacaine implant in the management of post-operative pain, both of which are already approved. CollaRx is Innocoll’s lead technology platform for the site specific targeted delivery of a wide variety of drugs with particular emphasis on antibiotics and anesthetics. The CollaRx technology also forms the basis of Innocoll’s lead product, Gentamicin surgical implant, a biodegradable leave-behind implant indicated for the treatment and prevention of post-surgical acquired infection in both hard and soft tissues. Innocoll is a privately held pharmaceutical company.

• Iris International (Chatsworth, California) showcased its new iChem Velocity automated Urine Chemistry System at the EUROMEDLAB 2007, the 17th IFCC-FESCC European Congress of Clinical Chemistry and Laboratory Medicine, in Amsterdam. The system utilizes the company’s Kinetic Imaging technology. The iChem Velocity with Kinetic Imaging leverages the company’s core image analysis technology to provide a complete and unique benchtop urinalysis solution. The iChem System is designed for medium to high volume laboratories that typically process more than 100 urine samples per day. The Velocity is scheduled for international launch in 4Q07 and is pending FDA 510(k) submission and CE-mark approval. Iris develops medical devices, diagnostic systems and consumables.

• Life Spine (Hoffman Estates, Illinois) said that the FDA has given 510(k) marketing clearance to Neo-SL, its new static anterior cervical plating system with an integrated lock that allows bone screws to be securely fixated without any additional locking components. The self-retaining screw capture mechanism prevents screw rotation and backout, while still allowing screw angulation. The Neo-SL features a 2mm profile, 16mm plate width, a large graft window, similar to the original Neo plate, providing increased intra-operative and post-operative views of the graft site. Life Spine makes spinal replacement products.

• Misonix (Farmingdale, New York), reported the acceleration of patient enrollment relating to the FDA clinical trials for the Sonablate 500, a medical device using high intensity focused ultrasound (HIFU) for non-invasive treatment of prostate cancer. The Sonablate 500 is approved by the FDA as an investigational device for clinical trials in the U.S. With the SB500 being used in 6,000 treatments in over 100 clinics in six years, interest in and usage of the HIFU medical device for prostate cancer treatment is gaining momentum. Misonix makes products for treatment of cancer.

• MIV Therapeutics (MIVT; Vancouver, British Columbia) reported the first human implantation of a hydroxyapatite-coated stent and the launch of a pilot test. The trial will evaluate the safety and efficacy of MIVT’s polymer-free nanoscale microporous hydroxyapatite drug-eluting stent (DES) for the treatment of single de novo lesions in native coronary arteries. MIVT has developed polymer-free, nanoscale microporous HAp DES that uses the company’s GenX coronary stent system coated with one of the company’s proprietary polymer-free systems that is 700 nanometers thin. It says that this ultra-thin coating, designed to protect surrounding tissue from harmful interactions with bare metal stents, is derived from an organic material called hydroxyapatite which MIVT says has demonstrated safety and biocompatibility in in vivo animal studies. It believes its coatings are applicable to a range of other implantable devices. MIVT makes biocompatible coatings and drug delivery systems for cardiovascular stents and implantable devices.

• NOVX Systems (Toronto) received clearance from the FDA to market iMDx system for point-of-care screening for drugs of abuse. NOVX provides drug screening solution that allows on-site screening and real-time access to results. When paired with PatientVu, the drug screening results and complete patient records are securely accessible from anywhere via the internet. NOVX Systems makes diagnostic productivity solutions with an initial focus on on-site drugs of abuse testing.

• Nuance Communications (Providence, Rhode Island) reported the availability of PowerScribe workstation 4.8, a speech recognition reporting solution for radiology. PowerScribe 4.8 delivers enhanced functionality including new features based on two previously announced partnerships, Vocada Veriphy and Amirsys STATdx. In this new version of PowerScribe, Vocada’s Veriphy is embedded in PowerScribe creating a simplified user interface for radiologists. Veriphy is a communications solution for critical test result management that allows physicians to send critical messages to ordering clinicians instantly via pager, cell phone or email. This integration between PowerScribe and Veriphy eliminates delays and inaccuracies in communication, improving patient safety and streamlining reporting. Nuance Communications is a supplier of speech and imaging solutions.

• OmniGuide (Cambridge, Massachusetts) said that the initial patients have been treated in a clinical study evaluating patient quality of life and airway patency. The patient’s quality of life and airway patency will be measured during the time of treatment and then at select post-operative intervals for four weeks, as well as during follow up treatments. The patients will be partially treated with the OmniGuide BeamPath system and then partially treated with the Pulse Dye Laser. Patients treated recently with the OmniGuide BeamPath CO₂ laser fiber that have previously been treated with the Pulse Dye Laser, report that the BeamPath fiber therapy provided a less frequent recurrence as well as less pain and a faster recovery. OmniGuide offers the BeamPath flexible fiber for CO₂ lasers. The CO₂ laser offers precision and a high degree of control over penetration into soft tissue. It says that these attributes are critical in soft tissue procedures in otolaryngology, head and neck surgery and pulmonology, for which the potential damage to delicate untargeted structures and possible rupture of underlying blood vessels is a risk. The key to OmniGuide’s technology is a photonic bandgap fiber that was originally invented and developed at MIT.

• Omni-Tract Surgical (St. Paul, Minnesota) reported the introduction of its Speed-Tract system. The system is made up of just two parts: a cam-activated coupler mounted on a sterile field post, along with a 360 degree adjustable cam-activated arm. Speed-Tract is designed to allow surgeons to set up their ring-type table mounted retractors, like Bookwalter and equivalent retractors. Speed-Tract is available through Omni-Tract Surgical and is designed to be compatible with most table-mounted ring retractor systems. Omni-Tract is a privately held medical device manufacturer.

• Paradigm Medical Industries (Salt Lake City) reported the introduction of a new software package for the P60 ultrasound biomicroscope (UBM). The software uses greater image resolution, a database management system and networking capabilities that allow the patient image data to be transferred within a user’s network for efficient patient record management. The P60 UBM is a microprocessor-based, multi-frequency UBM that allows practitioners to acquire and view high-resolution images of the anterior segment of the eye. The P60 is used for imaging of vital structures of the eye, primarily the anterior chamber of the eye. Imaging of the anterior chamber angle is one of the principal areas studied in the detection of closed angle glaucoma pathologies and related surgical filtering. Paradigm Medical makes ultrasound devices for the ophthalmic and medical industries.

• Sigma-Aldrich (St. Louis) reports the launch of the PhosDecor fluorescent phosphoprotein in-gel detection kit, a sensitive and selective tool for the identification of phosphorylated proteins. The PhosDecor kit includes a phosphate specific PhosDecor Stain, specially formulated buffers and a positive control to validate system performance. Interaction of the PhosDecor stain with protein-bound phosphate groups results in a selective chemiluminescence detectable with commonly available instruments. Some components are also available separately allowing for custom applications. Sigma-Aldrich is a life science and high technology company.

• Smith & Nephew’s (S&N; Andover, Massachusetts) Endoscopy Division announced the launch of the 560 Series 3-CCD High Definition Camera System. It is a surgical camera system capable of capturing and displaying broadcast quality HD images in arthroscopic and other minimally invasive surgeries. Smith & Nephew is a global medical technology business, specializing in orthopaedic reconstruction, orthopedic trauma and clinical therapies, endoscopy and advanced wound management products.

• Sono-Tek (Milton, New York) reported the release of the MediCoat PSI. The MediCoat PSI offers the same stent coating features as the MediCoat DES systems used for coating cardiac stents. The new PSI model is ideal for coating large peripheral stents, and it is capable of coating, in one cycle, multiple stents up to a cumulative length of 8 inches. MediCoat PSI incorporates Sono-Tek’s MicroMist ultrasonic atomizing nozzle, and provides stent motion that assures complete coverage of large vascular stents. Sono-Tek makes liquid spray products based on its ultrasonic nozzle technology.

• Swissray International (Elizabeth, New Jersey) reported receiving FDA clearance to market the ddRCompact sSeries of DR systems. The system was specifically designed to meet the needs of certain markets such as orthopedics, smaller hospitals, imaging centers, veterinary, chiropractic, and all emerging countries requiring a lower cost DR system with high image quality. The ddRCompact series offers exceptional image quality at low radiation dose. It comes with Swissray’s APS (automated positioning system) for fastest, most convenient and precise patient positioning. It also features autostitching for orthopedic examinations, proactive remote monitoring

• Teleflex Medical (Research Triangle Park, North Carolina) reported the launch of the Bravo nasal pillow mask for use with sleep therapy systems in the treatment of obstructive sleep apnea. The ergonomic design of the Bravo produces a higher level of comfort for the sleep apnea patient, promoting greater acceptance and compliance. The Bravo joins Teleflex Medical’s existing family of Hybrid and Nasal-Aire II sleep therapy interfaces. The Hybrid interface is designed to be a universal interface for patients, clinicians and providers. The Hybrid serves as a nasal interface, an oral interface, and a combination of the two. Its proprietary design enhances patient comfort and compliance by eliminating pressure points on the forehead and across the bridge of the nose. Teleflex Medical, a division of Teleflex Incorporated, makes disposable medical products, surgical instruments and medical devices.

• Thermage (Hayward, California) reported that the FDA has provided a first-time-ever 510(k) clearance for the treatment of periorbital wrinkles and rhytids, including upper and lower eyelids. Thermage’s technology provides a non-invasive procedure designed to tighten and contour skin, expanding the aesthetic applications physicians can offer to the rapidly growing anti-aging market. The treatment reduces hooding, improves texture and tone and smoothes the eye area. To date, more than 20,000 procedures have been completed worldwide. Thermage says that its technology provides “a unique, non-invasive procedure designed to tighten and contour skin, significantly expanding the non-invasive aesthetic applications physicians can offer to the rapidly growing “anti-aging” market.

• Verathon (Bothell, Washington) reported the introduction of the GlideScope cobalt, a single-use video laryngoscope that provides a real-time view of the patient’s airway, enabling quick intubation. The GlideScope Cobalt single-use design, which eliminates the need for disinfecting the “blade,” is ideal for fast-paced intubation settings. The video laryngoscopes provide a real-time view of the airway and of endotracheal tube placement, minimizing the need for a “blind” intubation procedure. GlideScope cobalt consists of a slim video baton which houses a high-resolution camera with a patented anti-fogging mechanism to resist lens contamination; a non-glare color monitor; and single-use, sterile GVL stats in large and small sizes that offer a patented 60-degree blade angulation. GlideRite tracheal tubes and a 90 degree rigid stylet, both used to facilitate intubation, are provided, along with a protective cradle for the video baton. Verathon makes medical devices and services that offer improvement in patient care to the health care community.