Staff Writer

Traveling through the sea of med-tech mergers and acquisitions, financings, and regulatory news, it appears that innovation and collaboration is still alive and well, though not as much as in previous years. It also seems that one can't stop innovation and the quest for knowledge, as indicated in the numbers of company agreements and contracts our staff covers on a daily basis.

Medical Device Daily closed out the second quarter of our 2014 coverage of the med-tech industry's agreements and contracts with a slight up-tick from 1Q14. MDD reported 108 separate items in 2Q14, up from 103 the previous quarter. This time a year ago, in 2Q13, the number stood at 167.

While space limitations dictate that we can't list all of those 108 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 second quarter started off with a brain stimulation trial, a contract extension with the VA, and an integration of computer guidance technology for cataract and refractive surgery into ophthalmic microscopes.

Clinipace will manage Nexstim
clinical trial for NBT system

Clinipace Worldwide (Morrisville, North Carolina), a digital clinical research organization (dCRO), said Nexstim (Helsinki, Finland), a leader in navigated stimulation of the brain, has selected the company to manage the U.S.-based clinical trial for its Navigated Brain Therapy (NBT) System.

Nexstim makes Navigated Brain Stimulation (NBS) Systems for use in diagnostics and pre-surgical mapping. In 2012, Nexstim launched a novel NBT device for the treatment of brain injury and disease using repetitive transcranial magnetic stimulation (rTMS) guided by a patient's own MRI scan. While initial results show great promise in helping stroke patients regain lost motor control, the NBT System also enables personalized non-drug treatment for people suffering from major depressive disorder (clinical depression). The NBT System and therapeutic use for stroke and depression are not cleared indications in the U.S.

The NBT System meets the requirements of the European Medical Devices Directive (MDD) and has been CE marked accordingly. Nexstim's non-invasive NBT System is not yet approved by the FDA for therapy in commercial use in the U.S. and is available to select physicians for investigational use only.

"Building a strategic partnership with a CRO with proven global expertise managing regulatory submissions and approvals is critical to the success of our U.S.-based trial," said Rainer Harjunpää, VP, Quality Assurance and Regulatory Affairs. "Clinipace brings the right balance of regulatory and strategic development experience, working with global regulatory agencies to ensure we are compliant based on regional standards of care, standards of diagnosis, and other factors such as global marketing approval processes."

Nexstim makes image-guided transcranial magnetic stimulation (TMS). The Nexstim NBS System is the first and only FDA-cleared and CE-marked integrated navigated TMS (nTMS) mapping device, according to the compnay. Adjunct to physiotherapy in stroke rehabilitation, Nexstim´s Navigated Brain Therapy (NBT) System enables personalized, non-drug treatment of brain injury and disease using accurate and repeatable 3D-guidance of the therapeutic electric field.

SBG Technology Solutions awarded
VA contract extension for VistA

SBG Technology Solutions (Alexandria, Virginia) said it was recently awarded a contract extension with the Department of Veterans Affairs to continue to support the execution of the VistA Evolution Program by providing Program Management Office (PMO) support, technical consulting, financial, acquisition and strategic communications support.

VistA Evolution is one of the largest enhancements to an IT healthcare system to ever be undertaken, and will provide interoperability and modernized clinical capabilities to the VA electronic health record. The updated VA system will be interoperable with the electronic health systems of the Department of Defense and other healthcare partners to enhance patient-centered, team- and evidence-based care.

"As a 27-year Navy Veteran myself, I am thrilled to be part of a program designed to bring the VA's health IT system to the forefront of advanced technology and further advance healthcare for our Veterans," said Carlos Del Toro, CEO of SBG.

SBG Technology Solutions provides technology solutions to federal agencies and commercial clients including the Army, Army National Guard, Defense Threat Reduction Agency, Department of Veterans Affairs, Department of Defense, Department of Homeland Security, Federal Voting Assistance Program and the Navy.

TrueVision 3D Surgical and Leica expand into ophthalmic microscopes

TrueVision 3D Surgical (Santa Barbara, California), a specialist in neuro and ophthalmic 3-D surgical visualization and guidance, and Leica Microsystems (Wetzlar, Germany), a developer of microscopes and scientific instruments, reported a global agreement to integrate computer guidance technology for cataract and refractive surgery into ophthalmic microscopes.

The two companies, whose 2012 alliance resulted in what they termed the first 3-D integrated microscope for neurosurgery, recently expanded their relationship to incorporate TrueVision's 3-D intelligent visualization into Leica's ophthalmic microscopes. TrueVision and Leica Microsystems will expand their relationship to add computer-guided microsurgery assistance capabilities to ophthalmic microscopes, including the Leica M822 and Leica M844 models. The new platform, marketed and supported through Leica Microsystems' distribution channel, will be available in late 2014.

"Adding TrueVision's software guidance applications to our microscopy platform is the next logical step in the expansion of the collaboration between Leica Microsystems and TrueVision," said Heinrich Dreyer, MD, VP Leica Microsystems, Medical Division. "Patients will benefit from the application for astigmatic correction during cataract surgery, as they have the potential to see better, but only undergo surgery once. The goal is for patients to experience an improvement of their eyesight and a resulting improvement in quality of life."

Leica Microsystems is organized in three divisions: the Life Science Division, Industry Division and Medical Division.

TrueVision's real-time, 3-D surgical visualization and computer-guided software platform enables surgeons to view and record surgery in 3-D and to stream live video of the surgical field.

May brought us an extension of radiation dose monitoring services, an implantable drug delivery pump partnership, and more molecular diagnostic access.

Sectra secures an order with
Cleveland's University Hospitals

Sectra (Shelton, Connecticut) has secured a large order with University Hospitals (UH; Cleveland). The order includes a radiation dose monitoring solution and a five-year extension of the hospital's service and support contract for its medical IT solutions provided by Sectra.

UH Case Medical Center, at the core of the UH system, is the primary affiliated hospital of Case Western Reserve University School of Medicine and has been using Sectra PACS since 2003.

University Hospitals, the second largest employer in Northeast Ohio, serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians in 16 counties.

Sectra was founded in 1978 and has its roots in Linköping University in Sweden.

Palyon Medical to make CORE's delivery pumps

Palyon Medical (Santa Clara, California) and CORE Manufacturing (Valencia, California) have entered into a strategic partnership for the manufacturing of Palyon's line of implantable drug delivery pumps.

Palyon, a developmental stage company, has a pump portfolio that includes programmable devices for maximum clinical flexibility and constant flow devices for lower cost steady drug delivery. CORE is an ISO 13485, ISO 9001 and FDA approved manufacturer of implantable devices. CORE Manufacturing will provide manufacturing services, procurement coordination and dual quality control oversight, reducing Palyon's time to market introduction.

Palyon says its implantable infusion pump platform will offer accurate drug delivery rates and incorporate safety features including sensor-based feedback flow control, refill error detection capability, a non-motorized pumping mechanism that is less susceptible to wear and tear, catheter occlusion detection and a highly favorable MRI profile.

Palyon Medical is a privately held medical device company focused on creating treatment systems to alleviate symptoms of chronic pain, spasticity, diseases of the central nervous system and chronic metabolic diseases. CORE Manufacturing makes implantable, minimally invasive, and peripheral medical devices.

N-of-One set to provide molecular
diagnostic access to Mayo Clinic

N-of-One (Lexington, Massachusetts), a provider of clinical interpretation for oncology medicine, reported an agreement with Mayo Clinic (Rochester, Minnesota) to provide access to clinical interpretation information to aid in complex molecular diagnostics.

In select cases, N-of-One solutions will assist in the identification of biological and clinical knowledge, therapeutic options, and potential clinical trials for patients who undergo next-generation cancer sequencing. N-of-One says this will help to translate state-of-the-art knowledge specifically related to individual patients' tumors into molecularly informed, personalized treatment decisions. Mayo will use the clinical interpretation services for Mayo Medical Laboratories, a global reference laboratory operating within Mayo Clinic's department of laboratory medicine and pathology, as well as in its Center for Individualized Medicine, which discovers and integrates the latest in genomic, molecular and clinical sciences into personalized care for each Mayo Clinic patient.

"With the rapidly increasing volume of clinical and scientific data, and hundreds of drugs currently in clinical trials, the task of interpreting molecular test results has become increasingly challenging," said Chris Cournoyer, CEO of N-of-One. "We are committed to providing scalable, cost effective genomic clinical decision support that delivers valuable analysis and interpretation of the relevant clinical data to support oncologists in making molecularly informed treatment decisions for their patients."

The quarter rounded out with DNA and RNA biomarker development, companion diagnostic assay research, the introduction of a new cancer test, and a radioisotope contract.

Qiagen, Eli Lilly strike accord to
develop modular cancer assay panel

Qiagen (Hilden, Germany) reported a collaboration with Eli Lilly (Indianapolis) to co-develop universal and modular assay panels for the simultaneous analysis of DNA and RNA biomarkers targeting multiple cellular pathways involved in common cancer types. The agreement includes the development of tests that will be based on Qiagen's multi-modal, multi-analyte Modaplex analysis platform, which can process multiple sample types and biomarkers in a single test.

The new collaboration is the fourth project in the two companies' long-standing partnership. Qiagen's therascreen KRAS RGQ PCR Kit has been widely adopted by laboratories since its 2012 approval by the FDA as a companion diagnostic to detect KRAS gene mutations in metastatic colorectal cancer patients.

The test indicates which patients would benefit from a tailored oncology therapy marketed by Lilly and Bristol-Myers Squibb. In 2011, Qiagen and Lilly partnered to develop a companion diagnostic that evaluates a gene mutation which plays a role in some blood cancers. In 2013, Qiagen announced a third project, building on a master collaboration agreement, to create a companion diagnostic to guide use of an undisclosed Lilly oncology compound.

NanoString collaborates with
Celgene for companion diagnostic

NanoString Technologies (Seattle), a provider of life science tools for translational research and molecular diagnostic products, has entered into a collaboration with Celgene (Summit, New Jersey) to make a companion diagnostic assay using the nCounter analysis system to support the clinical validation of Revlimid for treatment of diffuse large B-cell lymphoma (DLBCL).

NanoString will develop, seek regulatory approval for, and commercialize the diagnostic test and is eligible to receive payments totaling up to $45 million, of which $5.75 million is an upfront payment, $17 million is for potential success-based developmental and regulatory milestones, and the remainder is for potential commercial payments.

DLBCL is a heterogeneous group of cancers classified together on the basis of morphology, immunophenotype, genetic alterations and clinical behavior, and represents the most common form of non-Hodgkin lymphoma. According to the National Cancer Institute, DLBCL will represent approximately 37% of the 70,000 new cases of non-Hodgkin lymphoma this year.

Under the collaboration agreement with Celgene, NanoString will work to develop an in vitro diagnostic (IVD) companion test to Revlimid that will be used to screen patients who are enrolling in a pivotal study of Revlimid for the treatment of DLBCL. Upon successful completion of the study, NanoString will pursue regulatory approval of the IVD. NanoString retains the flexibility to independently develop and commercialize additional indications for the IVD assay.

The upfront payment and a portion of the success-based milestone payments are intended to cover NanoString's costs for clinical development of the IVD. Included in the $45 million, NanoString may receive potential commercial payments in the event sales of the IVD do not exceed certain pre-specified minimum annual revenues during the first three years following regulatory approval.

Quest to distribute new THxID
bioMerieux cancer diagnostic

Quest Diagnostics (Madison, New Jersey), a provider of diagnostic information services, introduced a new cancer test service based on the FDA-approved THxID-BRAF test from bioMerieux (Durham, North Carolina), a specialist in the field of in vitro diagnostics.

The THxID-BRAF test is a companion diagnostic for two treatments for melanoma. The test is intended to be used as an aid in selecting patients with melanoma whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist].

Dermatologists, oncologists, hospital pathologists and other physicians may order the test through Quest Diagnostics, including its AmeriPath and Dermpath businesses, which specialize in anatomic and dermatologic pathology testing.

"Because of this relationship with Quest, many more doctors will have access to THxID-BRAF test. This means that more patients with advance melanoma will benefit from the optimized treatment that results when the THxID-BRAF test is used in designing their regimens," said Samuel Bozzette, VP, medical affairs – Americas, bioMerieux.

The THxID-BRAF kit is an In Vitro Diagnostic device intended for the qualitative detection of the BRAF V600E and V600K mutations in DNA samples extracted from formalin-fixed paraffin-embedded human melanoma tissue. The THxID-BRAF kit is a real-time PCR test on the ABI 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist].

NorthStar Radioisotopes works
with Triad in Mo-99 research

NorthStar Medical Radioisotopes (Madison, Wisconsin) has signed a non-exclusive letter of intent with Triad Isotopes (Orlando, Florida) marking what it calls a significant step toward achieving the U.S. Department of Energy's mandate to establish the first commercially viable domestic source of molybdenum-99 (Mo-99), the most widely used radioisotope in medical diagnostic imaging.

NorthStar will work with Triad to bring non-uranium-based Mo-99 produced with its RadioGenix isotope separation system to market. Triad Isotopes, the second-largest radiopharmacy chain in the U.S., will buy and lease the products once the technology has been approved by the FDA and is commercially available.

NorthStar is developing a domestic source of Mo-99 produced without the use of highly enriched uranium (HEU) to help alleviate chronic shortages of the vital medical isotope. This will help meet the goals of the National Nuclear Security Administration's Global Threat Reduction Initiative to reduce and protect vulnerable nuclear and radiological material located at civilian sites worldwide, and to minimize the use of HEU in civilian applications.

Mo-99 is the parent isotope of technetium-99m (Tc-99m), which is used in more than 13 million nuclear medicine procedures annually in the U.S. alone. Key applications include myocardial perfusion imaging (testing how well blood flows through the heart), sentinel node mapping (detecting whether breast cancer cells have spread to the sentinel lymph nodes), hepatobiliary imaging (evaluating the liver, gallbladder and ducts that are part of the biliary system), and inflammation and infection imaging.

Currently, almost all Mo-99 is produced using HEU at aging facilities located outside of the U.S., leading to product shortages and creating safety and national security concerns. NorthStar has two methods of producing Non-HEU Mo-99, both of which produce only a benign waste stream.

Triad Isotopes operates 60 locations that provide customized unit dose service nationwide. It was the first radiopharmacy company to demonstrate interest in working with NorthStar to bring this opportunity to fruition. Triad Isotopes has made key staff members and facilities available for testing, review and assessment of early versions of the technology.

NorthStar Medical Radioisotopes' technologies include non-uranium based molybdenum-99 production methods, a novel separation chemistry system and tools for the nuclear medicine market.

Triad is a nuclear pharmacy company.

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