BB&T s

Common sense would hold that surgeons fix torn tissue, rather than making it worse. But that's exactly what happens when orthopedists endeavor to fix partial articular sided tendon avulsion (PASTA) tears – a type of rotator cuff tear that commonly causes shoulder pain. The remaining attached supraspinatus tendon is usually fully torn from its natural position and then reattached.

"When it's 50% torn, the clinician tears the rest away in order to repair it," Tate Scott, chairman/CEO of KFx Medical (Carlsbad, California), told Biomedical Business & Technology. "As you can imagine, clinicians don't like to tear away good tissue. But it's a degenerative disease and they know what the end of the story is. It's going to go on to become a full-thickness tear eventually; most do."

KFx has just launched PASTAFx Anchor System, which is designed to repair partial rotator cuff tears, avoiding the need to fully tear the tendon first.

"The PASTAFx system enables you to put the anchor through the tendon and then into bone without removing the tendon," Scott said. "That's why it's different. It makes the doctor more comfortable with repairing early because they don't have to tear the tendon."

Surgeons have been using anchors to do repairs for decades. But the problem with most anchors comes down to size. Most are about 4 mm.

"If you screw that through the tendon, you've just further denigrated the tendon," he said. "Yet if they don't remove the tendon to repair it, then they can't get a big enough anchor in place to be worthwhile. Our system goes in through the tendon at 3 mm. Once it's under the bone, it expands to a 10 mm wingspan."

Picture a hollow-wall expanding anchors, such as a molly bolt or toggle screw, and you get the idea.

"We saw the need for this product and we believe PASTAFx will become a new standard of care," Scott said.

FDA 510(k) clearance for PASTAFx was obtained several years ago, but the company has made some modification so that it's more user-friendly before commercially launching the product this month.

PASTAFx will be the second flagship product for this small company. The first, SutureCross Knotless Fixation System, is used for arthroscopic, double-row rotator cuff and some PASTA repairs.

Privately held KFx is venture-backed. Investors include Alloy Ventures, Charter Life Sciences, Arboretum Ventures, Montreux Equity Partners, and MB Venture Partners.

For now, it intends to produce PASTAFx independently.

"We manufacture it ourselves in Carlsbad," Scott said. "Our focus and dream here is true treatment of disease states. We're not a product company. We're a procedures company."

He added, "We're sufficiently funded and we've got a great team of venture investors; we follow a capital-efficient model. We're not a company built on putting 60 direct sales people in the field. We are focused on disease states and proving, with good clinical results, that we can manage that," he said.

Just back from the American Academy of Orthopaedic Surgeons (Rosemont, Illinois) meeting in Las Vegas, Tate said the launch of PASTAFx went well. "You always feel like you've done things right when clinicians take a look and say 'Gosh, I've been searching for a product for PASTAs' and you identify an unmet need," he said. "They really light up, because their goal is to do right by their patients."

Elsewhere in the product pipeline:

• Aethlon Medical (San Diego) said it has initiated a research program to test the capabilities of the Aethlon Hemopurifier to identify and capture Cytomegalovirus (CMV). The Hemopurifier assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins from the entire circulatory system. Safety of the Hemopurifier has been demonstrated in multi-site human studies, with robust viral load reductions observed in enrolled Hepatitis-C (HCV) infected patients. Safety and efficacy data resulting from the first use of the Hemopurifier in an individual infected with Human Immunodeficiency Virus (HIV) is forthcoming.

• Alcon (Huenenberg, Switzerland) reported FDA approval of its aspheric AcrySof IQ Toric intraocular lens (IOL). The new lens offers an enhanced aspheric optic that improves image quality and increases contrast sensitivity in cataract surgery patients with astigmatism. Alcon says that the AcrySof Intraocular lenses are the most frequently implanted lenses in the world, with more than 40 million implants since their introduction in the early 1990s. Alcon's AcrySof IOL platform offers cataract patients a variety of benefits and is available with a variety of optics designed to help patients achieve the best possible vision. The AcrySof family of IOLs includes the AcrySof IQ, AcrySof IQ Toric and AcrySof IQ ReSTOR IOLs.

• BioImagene (Cupertino, California) reported the launch of Virtuoso the company's new digital pathology solution. Virtuoso is a comprehensive suite of web-based software applications that work with BioImagene's iScan slide scanners to provide an end-to-end workflow solution. It is a role-based system and it enables the various stakeholders, or roles – pathologist, histo-technologist, lab administrator, clinician, etc – to improve the efficiency and quality of the various steps in the anatomical pathology workflow. It allows the user to scan glass slides and then perform a wide range of functions view, manage, manipulate, analyze, report and collaborate – in the digital form.

• Bone Biologics (Thousand Oaks, California) said it has successfully completed the initial primate trials validating the efficacy of the proprietary bone growth regeneration UCB-1 (NELL-1) protein in spinal fusion surgery. 100% fusion was obtained in a 3-month period. No cystic lesion was observed. The successful primate surgical outcomes used the DBX demineralized bone matrix (scaffold) produced by the Musculoskeletal Transplant Foundation (MTF). MTF is a non-profit service organization dedicated to providing quality tissue through a commitment to excellence in education, research, recovery and care for recipients, donors and their families.

• Bovie Medical (Melville, New York) said it has submitted a 510(k) pre-market notification application to the FDA requesting regulatory clearance for its ICON GS electrosurgical generator and handpiece (J-Plasma system). The technology uses a gas ionization process producing a stable thin focused beam of ionized gas that can be controlled in a wide range of temperatures and intensities, providing the surgeon greater precision, minimal invasiveness and an absence of conductive currents during surgery. Recent engineering improvements include increases in power and efficiency and component miniaturization, making manufacturing easier and more efficient.

• Celerus Diagnostics (Carpinteria, California) has introduced new products for use on the Celerus Wave System, a solution to deliver precise, standardized IHC results in 15 minutes. Some of the new products are the D10, a cell surface antigen also known as CALLA (common acute lymphoblastic leukemia antigen), is expressed on a variety of cell types, including immature and germinal center B cells, as well as lymphoblastic leukemia cells; the CD34, a marker of lymphatic and vascular endothelium (antibodies to CD34 can be used to study tumors of endothelial origin and CD34 also is a useful marker for quantifying micro-vascular density in a variety of other tumor types); and Tyrosinase, a copper-glycoenzyme involved in the synthesis of melanin pigments. The melanin pigments can serve as markers for cells of melanocytic lineage, including malignant melanomas.

• Curexo Technology (Sacramento, California) said it has submitted a premarket notification 510(k) application to the FDA for U.S. market clearance of its Robodoc Surgical System for total knee arthroplasty. The Robodoc Surgical System includes two components; Orthodoc, a computer workstation equipped with proprietary software for 3-D preoperative surgical planning, and the Robodoc Surgical Assistant, a computer-controlled surgical robot utilized for precise cavity and surface preparation for hip and knee replacement surgeries.

• Dale Medical Products (Plainville, Massachusetts) has introduced a new Foley catheter for short-term patient use. The Dale Hold-n-Place Foley Catheter Holder is an adhesive patch which has a clear, base and a locking tab that features a dual holding system of adhesive and hook-and-loop to secure the indwelling catheter. Stabilizing the catheter to prevent movement and dislodgment helps reduce the likelihood of metal irritation, bladder spasms and urethral erosion. The re-sealable system allows the catheter to be repositioned multiple times.

• Derma Sciences (Princeton, New Jersey) reported FDA clearance for the Biogurad Barrier Dressings. Derma Sciences says that along with a superior rate of target-specific kill, what makes Bioguard different from other infection control dressings is the permanent, non-leaching bond between the dressing substrate and the active agent. The Nimbus cationic biocide is permanently bonded to the gauze, keeping it from depleting in the presence of wound fluid and bacteria, while killing microbes that are drawn into the absorbent dressing.

• DSM Biomedical (Berkeley, California) said it has launched ComfortCoat, a lubricious hydrophilic coating designed to enhance maneuverability of metal guidewires in minimally invasive procedures. Metal guidewires are more easily maneuvered within a patient's vasculature when the friction between the walls of the vessel and the intravascular guidewire is reduced by coating the device with a hydrophilic compound that becomes slippery after adsorbing water – for example, when the coated device is exposed to water prior to insertion into a patient or into a patient's blood during use. However, it is important to note that, typically, hydrophilic coatings cannot be applied to metal guidewires because their adhesion to metal is poor, especially in the case of coiled guidewires. DSM says that with ComfortCoat, adhesion to metal is not a problem; lubricity is maintained on the metal guidewire, which may enhance neurovascular maneuverability.

• GE Global Research (Niskayuna, New York) said it has developed sophisticated signal processing algorithms for a wireless sensor that can classify different types of motion and closely monitor a person's breathing and heart rate. The company says this type of sensor could have advantages in monitoring premature babies in a neonatal intensive care unit. Premature infants have very sensitive and fragile skin, which can make it difficult to directly attach sensors to them. GE said the new sensor could wirelessly monitor an infant's movements, including breathing and heart rate. Similarly, this sensor could be installed in a home for elder care or other outpatient monitoring.

• Hospira (Lake Forest, Illinois) reported the introduction of the GemStar SP infusion system with GemStar Infusion Suite software, an advanced version of the GemStar pump. The GemStar SP infusion system is designed to help caregivers better incorporate patient safety best practices right at the patient's bedside. GemStar SP uses GemStar Infusion Suite software, a stand-alone PC-based application designed to enhance safe and efficient medication administration.

• IntraOp Medical (Sunnyvale, California) reported the launch of DermaBeam, a new paradigm in radiation therapy for office-based dermatology applications. DermaBeam is an office-based electron beam radiation therapy solution. While radiation therapy has long been the preferred standard-of-care for many types of skin cancers, the logistics of radiation delivery have made its benefits impractical and inaccessible for most dermatologists and their patients.

• Itamar Medical (Caesarea, Israel) reported the use of the company's Endo-PAT2000 in the Carolinas HealthCare System's study of the potential benefits of flavonoid supplementation on endothelial function. The Endo-PAT2000 was used to measure participants' endothelial function in a study designed to evaluate how flavonoid supplementation can prevent the adverse impact on endothelial function caused by a high-fat meal. Study results indicate that flavonoid supplementation can reduce the acute impairment of endothelial function caused by a high-fat meal, adding to the growing medical literature on the long-term benefits of flavonoid supplementation on endothelial dysfunction and cardiac health.

• Kensey Nash (Exton, Pennsylvania) said it has submitted an Investigational Device Exemption (IDE) application to the FDA to study the use of the company's unique biomaterials technology for treating articular cartilage defects of the knee. The clinical trial will use the company's Cartilage Repair Device (CRD), which consists of a proprietary bi-phasic, bioresorbable implant designed to treat chondral lesions. The CRD is a composite of several bioresorbable biomaterials, using collagen technology, and beta-tricalcium phosphate mineral suspended in a synthetic polymer Porous Tissue Matrix (PTM). This device architecture is designed to repair damaged articular cartilage in the knee or other articulating joints.

• Luminex (Austin, Texas) reported the commercial release of xPONENT 3.1 data acquisition software. Launched for use on Luminex 100 and Luminex 200 systems, xPONENT 3.1 includes more than 65 new features designed to benefit scientists and laboratory professionals across research and clinical diagnostic markets in simplifying laboratory workflow and increasing productivity. Luminex said it has added xPONENT 3.1 to its FDA-cleared Luminex 100 and 200 systems for use in clinical diagnostic applications.

• Meta Biomed (Horsham, Pennsylvania) reported the launch of BoneMedik-S and BoneMedik-DM, a biocompatible bone graft substitute based on natural coral. Meta Biomed says that the natural coral-based hydroxyapatite provides framework to promote strong and faster regeneration and healing. It is of the highest product quality and most compatible with the human bone structure, the company said.

• Metabolon (Research Triangle Park, North Carolina) reported the release of the mFocus TST (Tissue-based Sarcosine Test), a research-use-only assay that measures the level of sarcosine in a biological sample. Based on biomarkers identified in a study conducted by Metabolon to better understand the metabolic changes associated with prostate cancer progression, the assay reports a biochemistry-based measurement of prostate cancer aggressiveness. mFocus TST is the first in a series of new research tool offerings developed using Metabolon's proprietary biochemical profiling technology which is able to identify and measure hundreds of biochemicals and metabolites in a biological sample.

• Nephros (River Edge, New Jersey) said it has received initial responses from the FDA's review of the company's 510(k) submissions for dialysis devices. Nephros submitted a 510k application to the FDA for approval to market its leading-edge hemodiafiltration products for end-stage renal disease in the U.S. Nephros's OLpur MD220 filter is designed expressly for HDF therapy that employs Nephros's proprietary Mid-Dilution Diafiltration technology. Nephros's OLpur H2H Hemodiafiltration module enables existing dialysis machines to be used for HDF therapy. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, particularly with respect to substances known collectively as "middle molecules."

• Neuisys Imaging System Solutions (Greensboro, North Carolina) received FDA clearance of the NeuViz 16 Multi-Slice computed tomography (CT) system. "The NeuViz 16 is a state-of-the-art CT system that provides superior performance for the price and provides the clinical benefits of routine, sub-millimeter resolution, volume imaging and low-dose protocols," said President/CEO Kim Russell. "The NeuViz 16 packs a tremendous amount of technology into a very economical footprint and is the perfect solution for diagnostic imaging centers and community hospitals that plan to upgrade from older single or multi-slice CT systems to 16-slice CT as well as a wide array of specialist physician groups considering in-office CT including urologists, gastroenterologists, pulmonologists, surgeons, and oncologists."

• A case study from Neuro Kinetics (Pittsburgh) suggests that tests using its I-Portal NOTC (Neuro-Otologic Test Center) system can generate results that may indicate mild traumatic brain injuries (mTBI) that are not detected by other evaluation technologies. The case study features unique pre- and post-accident neuro-otologic test data gathered from one individual, a NKI employee who had undergone various I-Portal NOTC evaluations as part of routine product testing and then again after he suffered a bicycle accident last year.

• Oridion Systems (Needham, Massachusetts) reported FDA clearance for the Capnostream 20 Monitor with Integrated Pulmonary Index. The Integrated Pulmonary Index uses sophisticated algorithms to integrate the real time measures and interactions of four complex parameters – end tidal CO2 (EtCO2), respiration rate, pulse rate and SpO2 (oxygen saturation) – into a single index value. The result is displayed on a scale from 1-10, where 10 indicates optimal pulmonary status. The company claims that by using the Integrated Pulmonary Index, clinicians can quickly and easily assess a patient's ventilation status and monitor a patient's changing condition, thus facilitating more timely interventions to reduce patient risk and improve outcomes.

• Paieon (Wynnewood, Pennsylvania) reported FDA approval of its Guidance application. The Guidance application is now available as part of the second generation of the IC-PRO, an imaging workstation that supports the interventional cardiologist in all phases of the catheterization procedure. The Guidance application is a navigation system that is used in interventional cardiology procedures. Paieon says the Guidance application allows the user to take advantage of the existing captured images and add a new dimension of planning a roadmap and navigating the device to the desired location.

• Quick-Med Technologies (Gainesville, Florida) said it has received FDA clearance for its Nimbus barrier gauze wound care dressings. The company says that what makes Nimbus-treated gauze different from other antimicrobial dressings are its permanent bond and its ability to be effective even in the presence of large amounts of serum and exudate. The active agent is permanently bonded to the gauze, keeping the biocide from depletion, while killing microbes (such as MRSA, VRE, and many others) that are drawn into the absorbent dressing. Nimbus is non-toxic, long-lasting and not blocked by organics such as blood, urine and perspiration.