By Robert Kimball, Staff Writer

Medical Device Daily closed out the third quarter of our 2014 coverage of the med-tech industry's agreements and contracts down slightly from 2Q14. MDD reported 101 separate items in 3Q14, up from 108 the previous quarter. This time a year ago, in 3Q13, the number stood at 157.

While space limitations dictate that we can't list all of those 101 items, we have sought to provide a glimpse into a few that stood out. Rest assured, the staff at MDD will keep working to provide the most up-to-date and comprehensive daily med-tech news to our readers.

With full disclosure in mind, the staff at MDD defines an agreement (or contract) as simply as this: two or more entities coming to a mutual understanding and, in effect, sharing something with each other. An agreement could be two med-tech companies sharing intellectual property, technology, or a customer service team. Perhaps a company licenses technology or innovation from a university lab? Most often, two companies will join together in a group effort to produce or improve upon a device or technology.

The third quarter started off in July with a combination of personalized medicine and genomic testing, endocervical cancer product distribution, and an extension of protein quantitation, biomarker and proteomic services

CompanionDx Reference partners with RegenWell

CompanionDx Reference Lab (Houston), a CLIA certified laboratory specializing in pharmacogenomics, cancer companion diagnostics, targeted next generation sequencing (NGS) and epigenomics testing, is joining forces with RegenWell Holdings (Acworth, Georgia), an integrated healthcare provider. The partnership will bring CompanionDx Lab's personalized medicine and precision therapy genomic testing to the point of care to deliver reduced healthcare costs and improved patient outcomes by optimizing drug selection and dosing based on the genetic makeup of each individual patient.

CompanionDx Lab says it is committed to the next evolution in cancer care where comprehensive genetic data is delivered in an actionable format, thereby enabling the physician to make treatment decisions and choose healthcare strategies based on unique cancer type and the genetic makeup of each patient.

RegenWell Holdings and its operating subsidiaries are an integrated healthcare delivery system consisting of a network of healthcare organizations that provides a continuum of care in healthcare services under a parent holding company.

McKesson Medical to sell Femasys' Femcerv sampler

Femasys (Atlanta), an emerging medical device developer of women's healthcare solutions, has entered into a distribution agreement with McKesson Medical-Surgical (Minneapolis) to sell and distribute Femasys' Femcerv endocervical sampler. Femcerv collects a tissue sample of a woman's endocervical canal for histological analysis when cervical cancer is suspected.

Femcerv is intended for women who have received an abnormal pap smear result or have other factors that require a sampling of the cervical canal (i.e. cervical lesions extending into the canal or when there is undiagnosed uterine bleeding). The device minimizes the risk of incomplete sampling and optimizes diagnostic acuity by collecting a complete 360 degree sample while protecting the sample from contamination. Endocervical curettage has the potential to decrease the number of unnecessary surgical treatments and to play a role in reducing the number of undiagnosed cases of cervical cancer.

McKesson Medical-Surgical says it helps its customers improve their financial, operational, and clinical performance with solutions that include pharmaceutical and medical-surgical supply management, healthcare information technology, and business and clinical services.

Agilent extends collaboration with MRM for proteomics kits

Agilent Technologies (Santa Clara, California) has extended a co-marketing agreement with MRM Proteomics (Victoria, British Columbia), a provider of advanced protein quantitation, biomarker and proteomic services. The agreement expands on an existing collaboration established in 2012 and will allow both organizations to bolster their combined proteomics solutions, comprising reagent kits, hardware and software.

Proteomics is the study of the structure and function of proteins and how they interact within a complex biological system. Agilent's integrated proteomics workflow provides analytical performance and features plug-and-play flexibility. Interchangeable workflows simplify setups and let researchers quickly switch between different methodologies. Offering what it claims is the industry's highest sensitivity and highest throughput quantitation, the Agilent 6495 Triple Quadrupole MS/MS provides targeted MRM peptide quantitation at attomole detection levels.

MRM Proteomics's key technology, targeted quantitative proteomics by MRM-MS, is suitable for biomarker discovery/validation, clinical studies, diagnostics and toxicology.

Agilent Technologies is a measurement company and a technology leader in chemical analysis, life sciences, diagnostics, electronics and communications.

August brought us assurance that integrated care would be brought to all health communities, a continued execution of cell therapy for thermal burn injuries, a logistical renewal of spinal products, and a hydrogel for the treatment of vocal fold scarring.

Netsmart, Allscripts collaborate on integrated solutions technology

Netsmart (Overlook Park, Kansas) and Allscripts (Chicago) will partner to help ensure integrated care is achieved for all heath communities. The companies say collaboration will focus on further enhancing clinical workflows, optimizing outcomes and reducing costs.

Netsmart and Allscripts share clients that use the Allscripts Sunrise electronic health record (EHR) for physical health and the Netsmart myAvatar CareRecord EHR for behavioral health.

One collaborative initiative will enable Allscripts Sunrise users to view behavioral health records within an Allscripts Sunrise workflow, and myAvatar users to view physical health records in a myAvatar workflow. These capabilities will help lead to improved care, a streamlined user experience for clinicians and reduced costs.

A second initiative will integrate Netsmart's behavioral EHRs with Allscripts ambulatory EHR platforms. This will allow for improved care coordination for the 26% of the population who will have a mental illness diagnosis this year.

"Healthcare providers need innovative, pragmatic technology partners that can equip them to grow and thrive as they serve increasingly diverse clients in complex settings," said Michael Valentine,CEO, Netsmart. "Allscripts and Netsmart are well-positioned to equip providers with scalable solutions so they can focus on their own core growth and serve their clients in a coordinated care environment."

Netsmart is committed to helping health and human services providers deliver effective, outcomes-based care with Netsmart's CareFabric solution, a tightly woven framework of innovative clinical and business solutions and services that supports integrated, coordinated delivery of health services across the spectrum of care.

Cytori and BARDA continue cell development for thermal burns

Cytori Therapeutics (San Diego) and the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services (Washington) reported the execution of a contract option to fund the continued investigation and development of Cytori Cell Therapy for use in thermal burn injuries. The current extension is valued at approximately $12.1 million. Upon investigational device exemption (IDE) approval by the FDA, BARDA anticipates funding to cover costs associated with execution of the clinical trial, currently estimated at around $8.3 million, bringing the combined value to up to $20.4 million.

The execution of this option funds the remaining research and development activities required to enable a pilot clinical trial of Cytori Cell Therapy in thermal burn. It also funds approximately two years of preclinical studies in other burn-related areas that could lead to broadening of the use of Cytori technology to burn centers and in wound healing more generally. The immediate focus of contract activities is directed at preclinical, clinical and regulatory activities leading to FDA IDE approval for the trial. The contract retains two additional options in the original contract to fund a pivotal clinical trial and additional work in thermal burn complicated by radiation exposure valued at up to $45 million and $23 million respectively.

In September 2012, Cytori was awarded a contract with BARDA for the development of Cytori Cell Therapy for thermal burns combined with radiation injury. The initial base period of the contract covered three contract milestones which were achieved to the government's satisfaction. These milestones included: Preclinical studies demonstrating improved healing parameters using Cytori Cell Therapy in a thermal burn model; Preliminary design and development of Cytori's next generation Celution System, and; demonstration of feasibility of obtaining viable, functional regenerative cells from adipose tissue samples from burn patients.

Cytori is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions.

MNX Global Logistics renews multi-year contract with NuVasive

MNX Global Logistics' (Irvine, California) Medical Device transportation division reported that it has renewed a multi-year contract providing time- and mission-critical logistics services for NuVasive (San Diego), the third largest spinal device company in the world. The precision and responsive nature of the medical device industry is well suited to MNX's main business competencies. MNX's specialized services team understands that every shipment involves a surgeon, surgical team and patient, who rely on MNX to deliver the spinal device with full product integrity in a timely manner.

MNX's medical device supply chain solutions are designed with its customers in mind. Services include storing and managing inventory, just-in-time deliveries of devices and equipment, and managing sterilization and restocking.

MNX is a provider of specialized, expedited transportation and logistics services serving the medical device, biopharmaceutical, life sciences, aviation, secured documents and entertainment industries.

BioTime collaborates with Louvain for HyStem hydrogel

BioTime (Alameda, California) has entered into a collaboration with Susan Thibeault, of the University of Wisconsin and Marc Remacle, of Louvain University (Belgium) to evaluate BioTime's HyStem-based hydrogel for the treatment of vocal fold scarring. Preclinical studies published by Thibeault and colleagues have demonstrated that localized delivery of HyStem into injured vocal folds resulted in a significant improvement in function.

Under a sponsored research agreement, Thibeault's laboratory will evaluate HyStem-based hydrogels to identify formulations with optimum properties for reducing scarring. Upon completion of these preclinical studies, an investigator-initiated clinical trial in patients with vocal fold scarring due to disease or prior surgical interventions is planned, under the direction of Remacle, at the Cliniques Universitaires UCL Mont-Godinne in Belgium, subject to institutional and regulatory approval.

Scarring of the vocal folds is the most common cause of undesired changes in the voice (dysphonia) following injury, disease, or surgical procedures. Current treatments are limited to microsurgical treatments including scar lysis/excision, medialization laryngoplasty, or engraftment of tissue flaps/grafts. Since the region of the vocal fold affected by scarring is rich in hyaluronic acid, nonclinical studies of HyStem-based hydrogels have been performed which indicate that localized injection of a HyStem hydrogel during surgical release of the adhesions provides an environment for improved tissue viscoelasticity vital for vocal fold function. Because vocal fold scarring remains one of the most challenging problems for otolaryngologists using the available technology, continued successful preclinical studies could lead to investigator-initiated clinical investigations, and efforts for regulatory approval for this indication.

The quarter rounded out with heart valve therapy, a 3-D printing opportunity, and a collaboration for an oncology test for solid tumors that will serve as a companion diagnostic for multiple drug programs.

Novation enters heart valve category along with Edwards

Novation (Irving, Texas) and Edwards Lifesciences (Irvine, California) have entered into a three-year, sole-source strategic relationship that provides heart valve therapies to the more than 100,000 members and affiliates of VHA, UHC, Children's Hospital Association and Provista.

The new agreement with Edwards for its heart valve product portfolio enables Novation to enter the heart valve category for the first time, and expands on the previous relationship between the companies for critical care technologies, Novation said.

"This heart valve agreement enables Novation to provide marked additional value to hospitals and their patients with Edwards Lifesciences' clinically proven, life-saving heart valve devices," said David Richman, VP, Sourcing Operations, Novation. "We are proud that Edwards believes in Novation's unique capabilities and we look forward to working with them to deliver value to the members we serve."

Novation awards product agreements to suppliers by using member-driven criteria and a weighted award decision tool that considers product specification, quality and patient safety, as well as financial factors.

Stratasys partners with FirstBuild for 3-D printing

Stratasys (Minneapolis), a maker of 3-D printing and additive manufacturing solutions, reported its partnership with FirstBuild (Louisville, Kentucky), a GE affiliate. The partnership combines co-creation and micro-manufacturing to build and commercialize various GE appliances and accessories by leveraging 3-D printing, and other advanced manufacturing processes in an open innovation approach to engineering.

GE Appliances, in collaboration with Local Motors, established FirstBuild, a new model for the appliance industry aimed to allow concepts to rapidly reach the marketplace. Individuals design and submit ideas, and a community of home enthusiasts, designers, engineers, and makers tests out the ideas and creates the products with the help of Stratasys 3-D printing technology. FirstBuild will then manufacture and deliver the next generation of major home appliances to customers.

"We believe that the prospects of tapping into the hardware innovation scene are very promising," said Gilad Gans, president of Stratasys North America. "This is an outstanding opportunity to help revolutionize the way things are made. This is an open-innovation environment where FirstBuild users will be able to use our cutting-edge technology to accelerate product development phases and create real products."

Stratasys 3-D Printers will go to work in the FirstBuild micro-factory located in Louisville, Kentucky, which is where ideas may come to grow into real products. 3-D printing along with woodworking, welding, and other tools will be used to test and build the initial products. The micro-factory will produce products and sell them through FirstBuild's website and retail store located at the micro-factory, and through traditional retail channels.

Stratasys's patented FDM, PolyJet, and WDM 3-D Printing technologies produce prototypes and manufactured goods directly from 3-D CAD files or other 3-D content. Systems include 3-D printers for idea development, prototyping and direct digital manufacturing.

FirstBuild, a partnership between GE and Local Motors, the open-source hardware innovator, harnesses what it calls the expertise and creativity of an online and offline global community that is dedicated to conceiving, engineering and building the next generation of major home appliances.

Thermo Fisher, GSK, Pfizer look into NGS oncology testing

Thermo Fisher Scientific (Minneapolis), GlaxoSmithKline (Brentford, UK) and Pfizer (New York) have entered into an agreement to develop a universal next-generation sequencing (NGS) oncology test for solid tumors that will serve as a companion diagnostic for multiple drug programs. Thermo Fisher intends to submit this test for premarket approval to the FDA and other global regulatory authorities, following successful development and validation of the test. The test will be developed using Thermo Fisher Scientific's Ion Personal Genome Machine (PGM) Dx Platform, Ion AmpliSeq technology, and content from the Oncomine Cancer Research Panel.

Companion diagnostics refers to tests that help identify those patients who are most suitable for treatment with targeted therapies. For many cancer types, patient tumor samples are tested to ascertain the presence or absence of actionable genetic markers, information that can help physicians choose a course of action best suited for each patient. Since cancer is known to be complex and highly heterogeneous, up to hundreds of genetic markers must be interrogated to fully understand the genetic profile of an individual tumor. Current genomic analysis technologies, however, interrogate only one or a few genetic markers at a time, requiring large amounts of sample input and taking weeks to deliver all of the relevant information for therapy selection.

Using the Ion PGM Sequencing Platform combined with Ion AmpliSeq technology, hundreds of genes can be simultaneously analyzed from tumor samples via next-generation sequencing, with high reproducibility and rapid turnaround time. Furthermore, due to AmpliSeq technology's uniquely low DNA and RNA sample input requirements from FFPE tissue (10ng extracted nucleic acid per reaction), the Ion PGM-based sequencing platform can enable comprehensive sequence analysis of a larger range of tumor samples, including small biopsies and fine needle aspirates, in conjunction with other required pathology tests. Ultimately enabling standardization while working within the current pathology workflow, this technology also has the potential to provide more cancer patients the benefit of actionable information afforded through next-generation sequencing for therapy selection and clinical trial matching in the future.

The development of this new universal companion diagnostic test will include markers from the Oncomine Cancer Research panel, which enables simultaneous testing of single nucleotide variants (SNVs), copy number variants (CNVs), gene fusions, and indels across 143 unique cancer genes. Among the genes within the new panel, 26 of these are targeted by oncology drugs currently on the market and an additional 44 are used in determining eligibility for current clinical trials. Developed using the industry's most robust oncology database containing more than one billion data points of curated oncology data, this panel capitalizes on the investments made by Thermo Fisher Scientific over the last two years.

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