BB&T and Staff Reports

In just a few short months patients are going to be able to do something fairly unique with their eye glasses. They're going to be able to switch between vision settings, thanks in part to a technology created by start-up PixelOptics (Roanoke, Virginia).

The firm said that its emPower line of electronic eyeglasses lets wearers switch between two prescriptions, with settings for close-up and distance vision.

“We chose the name [emPower] because we felt it would capture the essence of what we're trying to do for the patient and the consumer,“ PixelOptics president/CEO Ron Blum, MD, told BB&T. “We wanted, for the very first time, to empower [patients] to be able to gain control of their eyeglasses.“

The company has been working on this project for 12 years and, according to Blum, it has been “quite a journey.“

He briefly described the concept of the technology, which has been touted by some as being disruptive to the way bifocals are designed.

“It's important to understand that when our glasses are turned off they're distinctively designed so a person can see far away and all the way up to what we call intermediate vision,“ Blum said. “And when they're turned on it allows you to see near.“

He added, the advantage of that is significant because now for the first time if a person has a bifocal if they stand up and look at their feet its like they're looking through a blur, because the bifocals are focused at 14 inches and their feet are much further out.“

The device works a bit like this, after powering up for six to eight hours the glasses can run for roughly three days. The company said the emPower lenses have a thin layer of liquid crystal located between two layers of plastic.

Once the electrical charge hits the liquid crystal the molecules realign, changing the prescription.

According to Blum, the company will first launch the glasses in Virginia and then follow up in North Carolina. Since eyeglasses are a Class I device there was no need to seek 510(k) approval, he said.

“Our goal is to be across all the states before year's end,“ he told BB&T. He added that there would be plans to take the device to Europe.

Investors seem to be sold on the company's idea. Most recently Safeguard Scientifics (Wayne, Pennsylvania) a holding company that builds value in growth-stage life sciences and technology companies reported that it led a $45 million financing for PixelOptics The financing is comprised of $35 million in equity, of which Safeguard provided $25 million, and $10 million in venture debt.

“I have to tell you I'm not surprised by the dollars that we've raised,“ Blum said. “I want to say honestly, and I don't want to be cocky, but this is a billion dollar opportunity and it could be a multi-billion dollar opportunity. It's so significant and the investors, I believe, see that.“

Investors said the reason PixelOptics was so attractive was because of emPower's potential to become a disruptive technology.

But could it really replace bifocals?

“It's not going to happen overnight,“ Blum answered. “Before 1784 people had two pairs of glasses, then Benjamin Franklin came along and showed them that they didn't have to have two pairs of glasses anymore and then bifocals came about. Now some 50 years ago progressive lens were developed and people started using them. EmPower is no different. It is a disruptive technology and we believe that it's the first of a breed of many different types of dynamic lenses.“

Although funding isn't a surprise to Blum, the attention is.

“This is not my first company, I've done this several times,“ he said. “[But] I've never been associated with a product where there is so much human interest and so much media interest.“

Blum pointed out that the device has been featured in media outlets across the world. He said that the product has been featured on CNN, NBC, and ABC just to name a few stations. He also added that the product has been discussed overseas, in Chile and Japan.

“When you have this kind of attention on a [global scale], which is at least in our industry unprecedented, it's tremendous pressure on a company like PixelOptics to make sure its product lives up to the promise that we deliver what it is we say we're going to deliver.“

Elsewhere in the product pipeline:

• Abbott (Abbott Park, Illinois) reported FDA approval of the RX Acculink carotid stent system for the treatment of patients with carotid artery disease who are at standard risk of adverse events from carotid endarterectomy (surgery). RX Acculink was previously indicated for patients at high risk of adverse events from surgery. This expanded indication is supported by the results of the CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) study. RX Acculink, used with the RX Accunet Embolic Protection System, represents an important option for standard-risk patients for the treatment of carotid artery disease. The RX Acculink, used in conjunction with the RX Accunet Embolic Protection System, is indicated for the treatment of patients at high risk and standard risk of adverse events from carotid endarterectomy who require carotid revascularization (a procedure to restore blood flow) and meet certain criteria.

• Alliqua (New York) has commenced work on an investigational new drug application for the company's PHN patch project for submission to the FDA. The company also announced that it had received encouraging results from a new in vitro test related to the company's drug delivery platform. Richard Rosenblum, president of Alliqua, said, “We are extremely pleased with the continued progress of our transdermal delivery platform.“ AquaMed makes custom hydrogels used for transdermal drug delivery, wound care, medical diagnostics, and cosmetics.

• Boston Scientific (Natick, Massachusetts) reported several milestones in the adoption of its SpyGlass Direct Visualization System since its launch in July 2007. The SpyGlass System guides visualization and accessory devices for diagnostic and therapeutic procedures in the pancreatico-biliary system, including the hepatic ducts. It was developed to overcome limitations of traditional cholangioscopes and ERCP (endoscopic retrograde cholangio-pancreotography) while reducing the need for exploratory surgery, potentially reducing cost and procedure time. During nearly four years of clinical practice, the system has been: installed in approximately 600 medical facilities worldwide; used globally in more than 25,000 patient procedures; supported by published clinical data in more than 60 abstracts and articles in peer-reviewed medical journals. The SpyGlass System features a miniature 6,000-pixel fiber optic probe attached to a camera that permits direct visualization of the pancreatico-biliary system.

• Charisela Technologies (Menlo Park, California) claims it has developed an adiponectin assay with major advantages over existing technologies, including the elimination of dilutions. Adiponectin (Acrp30), an adipocytokine, is important in many therapeutic arenas, including type 2 diabetes, obesity, atherosclerosis, and rheumatoid arthritis. The new assay's advantages represent major breakthroughs in the testing of adiponectin. While ELISA tests typically require dilutions of 1,000 to 1, the Charisela assay can directly quantitate adiponectin at normal levels naturally occurring in serum. This saves time, increases accuracy, and decreases costs. Charisela's assay is ready for analysis in about one hour and requires only one wash step.

• Clear Catheter Systems (Bend, Oregon) said the PleuraFlow Active Tube Clearance system was featured at the annual American Association of Thoracic Surgery Meeting in Philadelphia. Chest tubes are used after every heart and lung procedure. The PleuraFlow Active Tube Clearance System is a novel chest tube clearance accessory developed to maintain chest tube patency after heart and lung surgery. Clogging of a chest tube with a clot in the setting of continued postoperative drainage can contribute to impaired patient outcomes and increased costs of care. Chest tube clearance with the PleuraFlow Active Tube Clearance System is achieved by advancing the specially designed clearance member back and forth within the chest tube under sterile conditions, breaking down and pulling clots back out of the tube, thereby leaving the inner portion of the chest tube clear of any obstructing material.

• Copan (Murrieta, California) reported the launch of WASPLab, a barcode-driven and conveyor-connected specimen processing system, which uses robotic plate management to automate specimen workflow in Microbiology. WASPLab can manage various aspects of specimen processing and workup including planting and streaking, Gram slide preparation, enrichment broth inoculation, robotic incubation and storage, plate image analysis, AST/ID inoculum preparation, Kirby-Bauer disk application, and even MALDI-TOF target plate seeding.

• Guided Therapeutics (Norcross, Georgia) unveiled the new name and new industrial design for its non-invasive and painless test for the early detection of cervical precancer. LuViva was on display at The American College of Obstetricians and Gynecologists (ACOG) Clinical Meeting in Washington. LuViva Advanced Cervical Scan is the full name for the new cart design. The name for the single-use calibration and patient interface is the LuViva Cervical Guide. The technology, which consists of a base unit and single-patient-use calibration disposable, scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively. Guided Therapeutics' biophotonic technology is able to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level.

• Idaho Technology (Salt Lake City) received FDA clearance for the FilmArray instrument and the FilmArray Respiratory Panel. The FilmArray Respiratory Panel (RP) is a multiplexed nucleic acid test designed for the simultaneous detection of 15 respiratory viruses in 1 hour. The FilmArray RP detects viral nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The FilmArray system represents a significant advancement in user friendliness and multiplex infectious disease testing capability for hospital clinical labs. The FilmArray requires only two minutes of hands-on time, has a 1 hour turnaround time, and simultaneously tests for the following virus types and subtypes: Adenovirus, Coronavirus HKU1, Cornonavirus NL63, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1 2009, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus and Respiratory Syncytial Virus

• Lantheus Medical Imaging (North Billerica, Massachusetts) completed a successful meeting with the FDA Cardiovascular and Renal Drugs Advisory Committee and Risk Management Advisory Committee to review safety data of ultrasound contrast agents from three manufacturers. Lantheus Medical Imaging presented safety data for Definity vial for injectable suspension. “Definity is an important diagnostic cardiovascular imaging tool with a well-characterized safety profile,“ said Don Kiepert, president/CEO. Definity Vial For (Perflutren Lipid Microsphere) injectable suspension is an ultrasound contrast agent for use in patients with suboptimal cardiograms. Activated Definity is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

• Maquet Cardiovascular (Wayne, New Jersey) reported the launch of its Quadrox-i Neonatal and Pediatric oxygenators and reservoirs in the U.S. Oxygenators are an integral part of a cardiopulmonary bypass system and function as an artificial lung during surgical procedures. Maquet says the Quadrox-i Neonatal and Pediatric oxygenators offer significant improvements over currently comparable oxygenators. During open-heart surgery on neonatal and pediatric patients, the integrated arterial filter, low pressure drop and minimal priming volume of the Maquet oxygenators contribute to improved quality of perfusion.

• Medigus (Omer, Israel) has made what it calls the world's smallest video camera – just 0.99 mm in diameter. These miniature cameras are manufactured from materials suitable for human medical procedures. They are designed specifically for small-diameter disposable endoscopic devices, used in diagnostic and surgical procedures in regions of the anatomy where larger scopes are not viable, the company said. Medical fields in which such tools are required include: cardiology; orthopedics; gastroenterology; gynecology; otolaryngology, bronchoscopy and robotic surgery. These cameras will be integrated into endoscopic devices developed and manufactured by the company, and also sold to third-party medical device manufacturers. The cameras use advanced technology, notably the TSV (Through Silicon Via) method which enables miniaturization and reduction of mass-production costs. A dedicated 0.66x0.66 mm CMOS sensor provides resolution at 45,000 pixels.

• Nihon Kohden America (Foothill Ranch, California) has introduced its new CNS-6200 Central Station. The new central station simultaneously monitors up to 32 patients. The CNS-6200 features a new user interface that enables the user to fully customize the screens and display the data needed to make better clinical assessments on every patient. The CNS-6200 is compatible with all existing Nihon Kohden monitors and its next generation of ambulatory transmitters.

• Retina Implant (Reutlingen, Germany) reported the presentation of initial findings from their second clinical trial. Results showed that the first seven patients who were permanently implanted with the company's subretinal implant restored useful visual function enabling them to improve activities of daily living. Previous data presented on the success of their subretinal microchip included the use of an external power source and this data is the first time patients have been able to restore vision using a power supply implanted under the skin.

• Sectra (Linköping, Sweden) reported FDA clearance of its digital mammography system, Sectra MicroDose Mammography. Sectra says the MicroDose photon counting technology reduces the radiation dose by half of that used by other digital or film based systems. Sectra MicroDose Mammography is based on the company's photon counting technology. Sectra MicroDose Mammography detects X-ray photons individually. Images are delivered with 25 megapixles, which is two to four times higher resolution than that of other digital systems. The high resolution of the images aids detection of early changes that occur with breast cancer.

• SI-Bone (San Jose, California) said the FDA approved a major modification to its existing product label. The approval targets the use of iFuse Implant System for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The FDA-OSDB worked with SI-Bone to arrive at a more accurate description of the intended use of the iFuse system. The communications were helpful in differentiating the iFuse system from fracture fixation devices, the company noted. The iFuse Implant System is intended for treatment of conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The iFuse procedure uses a minimal incision for delivery and implantation of small, titanium implants. The implants are coated with a porous plasma spray that acts as an interference surface, designed to help decrease implant motion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional pins or screws used to surgically fix boney structures.

• Solta Medical (Hayward, California) received FDA clearance of its new Clear + Brilliant laser aesthetic treatment. Clear + Brilliant is a treatment based on fractional laser technology that is performed in a professional setting. Clear + Brilliant provides a new offering for physicians and skin care providers to address evolving consumer needs and expand their patient base. In-depth research with patients and their skin care providers revealed an unmet need in the skin care continuum that lies between over the counter or spa treatments and more aggressive laser offerings such as Fraxel.

• Sorin Group (Arvada, Colorado) reported the U.S. launch of XTRA, the next-generation of Sorin's autotransfusion (ATS) device family. An autotransfusion system is a piece of medical equipment that allows collection, processing and reinfusion of autologous blood during and after surgical interventions in many applications including cardiac, orthopedic, vascular, obstetrics, trauma and others, as well as preoperative sequestration of whole blood components. Sorin claims the XTRA builds on state-of-the-art technology, introducing innovative solutions through functional design, graphic color operator's interface and advanced data management. Building on the design of Sorin's C5 and S5 heart lung machines, the XTRA is an intuitive and powerful system, providing high quality end-product, fast processing and quietness during operation. A small volume disposable option also handles low blood volume loss typical in pediatrics and orthopedic cases, the company said.

• SwabCap (Neptune, New Jersey) said recent trial results showed its device reduced central-line associated bloodstream infection (CLABSI) rates by more than 79% in a four-hospital system. SwabCap is a twist-on device that is intended to be used between catheter-line accesses as a supplement to manual disinfection. The device passively disinfects the connector top and threads. It can only be attached to the connector one way, which helps eliminate variation. As the cap is twisted onto the threads, a foam pad inside the cap is compressed, releasing 70% isopropyl alcohol that continually bathes the top and threads while the cap is in place. The twisting action and the patent-pending thread cover design help focus the alcohol on the targeted areas. The cap also acts as a physical barrier to touch and airborne contamination, lasting up to 96 hours under normal conditions if not removed.

• Technology Commercialization Group (TCG; Durham, North Carolina) said that Acousticon, one of its portfolio companies, received FDA clearance for its ACAM-5 product, allowing the company to begin US commercialization activities for the first time. The ACAM-5 helps hearing professionals understand the scope and depth of a patient's hearing loss in order to optimize the performance of hearing aids. Technology Commercialization Group is a business development strategy and implementation firm.

• Zimmer (Warsaw, Indiana) reported the launch of the next generation of its Wallis posterior dynamic stabilization system, the UniWallis System, in Europe and Asia Pacific. The principles of the UniWallis and Wallis implants are the same: the spacer controls movements in extension and the band controls movements in flexion. In addition to the advantages it shares with the Wallis implant, the UniWallis implant offers surgeons the ability to perform surgery from a unilateral approach, preserving the supraspinous ligament. Interspinous dynamic stabilization first appeared in 1987, establishing the need for posterior dynamic stabilization to treat lower back pain due to degenerative instability