BB&T Senior Staff Writer and Staff Reports

Allergist Thomas Beller, founder and CEO of TCB Medical (Bluffton, South Carolina) just might have designed a better alternative to large auto injectors used by patients suffering from allergies. Beller said that he has seen his fair share of allergies throughout the last 15 years, and one thing that often surprises and frustrates him, is the number of patients who leave their epinephrine, a treatment for allergies, behind simply because the auto injector is too cumbersome to carry.

“Very frequently patients will forget their epinephrine,“ he said. “I'll ask them do you have your epinephrine with you – and the answer is no. “Most epinephrine injectors are bulky, pen-shaped devices that are awkward to carry. Consequently, most patients do not carry them.“

Beller came up with the idea to shrink down most epinephrine auto injector devices and pitched it to pharma sales reps who he encountered.

“Why not make [the auto injectors]smaller,“ he said, of the devices, which are about six inches long and are about the size of markers.

The response from company reps was equally frustrating. Usually there was silence met with a slight nod of acknowledgement – but that was all.

“It seems like no one really cared,“ Beller said. “[But] when you have a dominating product in the market, who wants to change?“

Beller, however, saw it as a chance to break out from the norm and create a more convenient product, the Epinephrine Key.

“The Epinephrine Key goes everywhere your keys go and is more likely to be available for emergency use when the need arises. The size of the device significantly reduces the burden of carrying epinephrine, and the revolutionary concept of carrying the Epinephrine Key on a key chain facilitates access to potentially life-saving epinephrine.“

In late 2009, Beller located an engineering firm in North Carolina and throughout a period of several months, this firm took Beller's drawings and turned them into a functioning prototype. The prototype is undergoing tests in preparation for a submission to the FDA for approval. The company said that it expects the FDA approval process to proceed fairly quickly as similarly functioning devices have already been given approval.

In fact, Beller is hoping the device is available to go on the market for allergy patients within the next eight months.

The device is just three inches long and has a strong safety feature that distinguishes it from other auto injectors on the market.

The company touts that for those who have difficulty using pen-shaped auto-injectors, the Epinephrine Key is a perfect alternative. Confusion regarding the proper use of pen-shaped epinephrine auto-injectors to often results in accidental injections in the thumb.

The Epinephrine Key, in contrast, is ergonomically designed to fit in the hand just like a syringe. The user simply removes the cap, presses the safety buttons, and presses the tip of the device against the leg in one smooth motion. Epinephrine is delivered safely and efficiently with little risk of improper injections.

He said that there has been some interest in the device from Europe, but plans are to primarily stay in the U.S.

Elsewhere in the product pipeline:

• Bioject Medical Technologies (Portland, Oregon) said that Bioject's needle-free injection delivery technology was used to successfully demonstrate that intradermal administration of fractional doses of inactivated poliovirus vaccine given to infants is safe and effective (using seroconversion as an indication of effectiveness), and is preferred by both healthcare administrators and parents over typical full-dose needle and syringe. The study results also demonstrated a significant cost savings in use of the fractional-dose intradermal injection as compared with a full-dose vaccination course of treatment using an auto-disable needle and syringe. The intradermal fractional-dose was given with Bioject's Biojector 2000 needle-free injection delivery device and the full-dose was delivered with an auto-disable syringe and needle. The study was designed to assess the safety and efficacy of, and preference for, the needle-free intradermal fractional-dose and the potential to use a needle-free intradermal fractional-dose vaccine option with infants in order to prevent polio infection. The results of the study demonstrate that needle-free intradermal administration of fractional doses of the polio vaccine was safe, effective and lower cost than a similar cours e treatment with full dose needle-syringe option. In addition, both health caregivers and parents expressed a preference for the needle-free option because “the baby does not cry.“

• BioMimetic Therapeutics (Franklin, Tennessee) said the FDA has accepted for review its PMA application for Augment Bone Graft for use in foot and ankle fusions in the U.S. “Receipt of the PMA filing letter from the FDA is an important step in the process for approval of Augment Bone Graft in the U.S.,“ said Samuel Lynch, president/CEO of BioMimetic Therapeutics. “We expect to have the 100-day meeting with the FDA in the third quarter, at which time we will get more detailed feedback and questions from the agency related to the PMA application. We hope at that time to be able to agree with the Agency on a date for an advisory panel meeting for review of Augment.“ BioMimetic uses purified recombinant human platelet-derived growth factor (rhPDGF-BB) in combination with tissue-specific matrices as its primary technology platform for promotion of tissue healing and regeneration. rhPDGF-BB is a synthetic form of one of the body's principal agents to stimulate and direct healing and regeneration. The mechanism of action of this platform technology suggests it may be effective in a broad array of musculoskeletal applications, including the repair of bone, ligament, tendon and cartilage.

• Cambridge Heart (Tewksbury, Massachusetts) reported the first patient enrollments in the MTWA-CAD study. The study is designed to determine if Cambridge Heart's MTWA testing can enhance current diagnostic methods for detecting ischemia in patients with underlying coronary artery disease. Ischemia is defined as inadequate blood supply to the coronary arteries, which can lead to myocardial infarction or what is commonly referred to as a heart attack. The non-invasive test works like a stress test. Fourteen electrodes are put on a patient who walks moderately on a treadmill for about 30 minutes. The test analyzes for subtle variations in electrical activity.

• Cardiac Science (Bothell, Washington) expanded its ECG and cardiac stress product lines with CareCenter MD, a multimodality PC-based diagnostic workstation designed for today's physician practices. “CareCenter MD delivers superior ease-of-use and efficiency,“ said Rene Mitchell, Cardiac Science director of marketing. “It's the first PC-based diagnostic workstation that supports both resting ECG and stress testing with a wireless data acquisition module. And, it allows physicians to comply with pending electronic record mandates even if they have not yet chosen an electronic medical record (EMR) partner.“ The CareCenter MD diagnostic workstation features: Wireless data acquisition: A Bluetooth connection between the patient and the diagnostic workstation removes the need for cables, providing the opportunity for physicians to perform testing in a wider range of settings. Advanced connectivity: Physicians can read, analyze, and confirm patient tests from anywhere with a secure internet connection. While no EMR is required to view data with CareCenter MD, records can be easily transferred to an EMR if desired. Shared patient database: Data for both ECG and stress tests are stored in the same database and can be easily accessed and reviewed, allowing physicians to make real-time comparisons of historical versus current patient data.

• Concert Medical (Norwell, Massachusetts) reported the launch of the Conductor family of interventional coronary guidewires to the U.S. market. These guidewires are designed to address an extensive range of coronary disease cases at a superior value, the company said. Concert Medical is an integrated device manufacturer, directly controlling all design and critical manufacturing processes for its interventional products. Concert's Conductor guidewires offer enhanced trackability and crossability, with an increased reliable strength and superior torque response, it said. Performance-enhancing design features include a proprietary hydrophilic coating to improve tactile feel and shaft markers at 90 cm and 100 cm for precise insertion measurement. Howard Donnelly, president of Concert Medical, said the Conductor is the firm's second guidewire product released in 2010. “Earlier this year we launched a private-labeled neurological guidewire, co-developed with a leading medical device company,“ said CEO Howard Donnelly. “The Conductor, which we spent two years developing, is an outstanding addition to our interventional guidewire business.“

• Ecolab (St. Paul, Minnesota) reported the launch of Virasept, Ecolab's first ready-to-use (no mixing required) hard surface disinfectant approved by the U.S. Environmental Protection Agency to be effective against Clostridium difficile spores. Clostridium difficile is a highly drug-resistant bacterium that causes diarrhea and severe lower intestinal inflammation, which can be life-threatening. It is very difficult to clean and can remain on hard surfaces for months.

• Iris International (Chatsworth, California) said that its diagnostics division submitted a 510(k) pre-market notification application to the FDA requesting regulatory clearance for its iChem Velocity Automated Urine Chemistry Analyzer and iRICELL Urinalysis Workstation. The iChem Velocity system is designed to deliver improved productivity and clinical utility in the medium to high volume hospital and clinical reference labs. “The iChem Velocity represents a critical element of Iris's strategy to provide both stand-alone automated urine chemistry analyzers and our fully integrated urinalysis workstation, iRICELL, globally,“ said Tom Warekois, president of the Iris diagnostics division.

• LifeScan (Milpitas, California), makers of the OneTouch brand blood glucose monitoring systems, has introduced the new OneTouch Delica Lancing System. For many individuals, regular blood glucose monitoring, as recommended by their healthcare professional, is a key part of their daily diabetes management and can help prevent or delay serious complications. But the pain of lancing – which involves piercing the skin with a needle (lancet) to draw a small blood sample – can be a barrier. In fact, of those people who quit testing their blood glucose each year, nearly 1 in 6 cite the pain of lancing as the reason. To provide improved comfort, the OneTouch Delica System features a 33-gauge lancet that is 40% thinner than current industry standard 28 gauge lancets. In addition, the system's Advanced Glide Control System is designed to precisely guide the lancet in a swift, straight motion that reduces vibration for a smoother lancing experience. It also features seven adjustable depth settings to allow for shallower fingertip punctures that may be less painful.

• Peak Surgical (Palo Alto, California) reported the launch of the Peak PlasmaBlade 3.0S dissection device. This product features a 3.0 mm wide blade for even greater cutting precision, integrated suction for enhanced visibility, and a telescoping shaft that extends from 5.5 cm to 15 cm for improved surgical access. The PlasmaBlade 3.0S is cleared by the FDA for use in general, plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures in the U.S. Peak describes the PlasmaBlades as a family of disposable cutting devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without extensive collateral damage. These surgical devices come together with the Pulsar Generator, which supplies pulsed plasma radiofrequency energy to the PlasmaBlades, to form the Peak Surgery System.

• Raydiance (Petaluma, California) reported that it has demonstrated the ability to machine precise, micron-resolution features in gold and platinum, two of the more difficult-to-process materials used in advanced medical devices. Raydiance engineers achieved the results using the company's Smart Light 50 femtosecond pulse laser integrated into a Rofin StarCut Tube workstation. Due to their resistance to corrosion, and high electrical conductivity, gold and platinum, in particular, are showing increasing utility in medical devices, including heart rhythm leads, cardiovascular stents, and guide wires used for cardiovascular procedures. In the latter two applications, the precious metals are used as X-ray markers to better enable surgeons to see devices during procedures.

• Spectranetics (Colorado Springs, Colorado) said it has initiated a voluntary recall of specific lots of its thrombus extraction catheter (product number 60090-01) manufactured since October 2009. The FDA has been informed of this action and communication to various competent authorities outside of the U.S. has begun. While Spectranetics has received and confirmed customer complaints on this issue, no adverse events have been reported to the company. Customers who have received the affected lots of product will receive a letter from Spectranetics with requested actions and product replacement instructions. A manufacturing process improvement to correct the issue has been implemented and product is available for shipment. The occurrence of this issue is very low and may result in a blocked guidewire lumen that restricts the loading of the thrombus extraction catheter onto the guidewire prior to insertion of the catheter into the patient. “We are committed to deliver high-quality devices to our customers and their patients. We will endeavor to complete this voluntary action and the replacement of affected product in an expedient manner,“ said Emile Geisenheimer, president/CEO.

• Vicor Technologies (Boca Raton, Florida) said it submitted a 510(k) premarket notification to the FDA for its PD2i algorithm and software to secure a claim for identifying, in conjunction with patient medical history and other tests, congestive heart failure patients at elevated risk of cardiac mortality. This filing is based on findings obtained from “Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure,“ a study conducted under a collaborative agreement with the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona. The goal of the study was to evaluate the ability of Vicor's PD2i nonlinear algorithm to predict cardiac events in the 537 chronic heart failure patients. The conclusion of the researchers who conducted the study is that the PD2i nonlinear algorithm and software is predictive of total mortality, cardiac death, and heart failure death in patients with left ventricular ejection fraction of less than or equal to 35%. Vicor Technologies is focused on the development of non-invasive medical devices using its PD2i nonlinear algorithm and software.