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Rithem Life Sciences Joins Innovators’ Network at American Heart Association Center for Health Technology & Innovation

The Center is focused on building and fostering health technology relationships to develop innovative and scalable solutions.

1st Patients Enrolled in STEM Trial for `Treatment of Chronic Subdural Hematoma

This marks the first patients enrolled in a prospective, randomized, international trial of a liquid embolic agent for the treatment of chronic subdural hematoma (cSDH), a common disease affecting primarily older adults.

Genius AI Detection Receives FDA Clearance – New Deep Learning-based Software Designed to Help Radiologists Detect Subtle Potential Cancers in Breast Tomosynthesis Images

This new technology, represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius® 3D Mammography™ exam.

Passio Pump Drainage System Granted 510(k) for Additional Indication for Home Use

The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, which includes a redressing kit, for drainage of recurrent and symptomatic pleural effusion.

Boston Scientific Signs Definitive Agreement to Divest BTG Specialty Pharmaceuticals Business

Boston Scientific notes SERB, backed by private equity firm Charterhouse Capital Partners since 2017, owns a diversified portfolio of prescription medicines focused on rare and life-threatening diseases.

Kypha Acquires Biosensia

July 13, 2018: Kypha, a medical diagnostics company developing specialized biomarker testing solutions for precision monitoring of immune status and inflammation, has acquired Biosensia, a diagnostics platform and contract development company that strengthens Kypha’s product commercialization.

This acquisition demonstrates Kypha’s commitment to meet the need for universally accessible, reliable and timely immune status results in virtually any setting from acute hospital care, to centralized laboratories, physician offices and home use.  The combined first-in-class platforms promise to quickly and accurately detect meaningful changes in immune-mediated disease activity for more effective treatment decisions and patient care.

Kypha’s innovative diagnostics platforms measure Complement and other important immune status biomarkers accurately, and reliably. Kypha’s Comp act® testing platform, analytically validated and GMP-manufactured includes a small portable instrument with multiple single-use rapid assay cassettes designed to quantitatively measure Complement activation biomarkers, from a small volume of blood in either laboratory or point-of-care settings. Biosensia’s RapiPlex is a proprietary diagnostic system designed to support CLIA-waived protocols and is capable of producing laboratory quality quantitative and qualitative results with a disposable cartridge for up to 24 analytes in a multiplex format.

“The proprietary technologies and core competencies of each company are perfectly synergistic. Blending them enhances and accelerates the delivery of our products to health care practitioners, researchers and pharmaceutical companies seeking to more precisely assess and monitor immune status dynamics. The addition of Biosensia’s EU-based ISO-certified facilities and deeply experienced core team allows us to bring product development, quality control and test manufacturing in house and continue to provide contract assay development and manufacturing services to Biosensia clients around the world,” according to Chad Stiening, Ph.D., Chief Executive Officer, Kypha.

“We are very excited about bringing our advanced platform together with Kypha’s specialized biomarker testing and achieving the clinical impact that we designed RapiPlex to fulfill,” stated Niamh O’Luanaigh, Chief Operating Officer, Biosensia.

“With continued growth in biologic and cellular therapies targeting Complement- and immune-mediated mechanisms, the need for these solutions is growing rapidly. This acquisition reinforces our position as the ideal diagnostic partner for stratifying patient populations and tailoring treatment for each patient suffering from immune-mediated conditions,” enthused Martin Schmidt, Ph.D., Chief Scientific Officer, Kypha.

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Rithem Life Sciences Joins Innovators’ Network at American Heart Association Center for Health Technology & Innovation

The Center is focused on building and fostering health technology relationships to develop innovative and scalable solutions.

1st Patients Enrolled in STEM Trial for `Treatment of Chronic Subdural Hematoma

This marks the first patients enrolled in a prospective, randomized, international trial of a liquid embolic agent for the treatment of chronic subdural hematoma (cSDH), a common disease affecting primarily older adults.

New England Biolabs Announces Further Expansion of Their RNA Depletion Product Portfolio with the Launch of the NEBNext Custom RNA Depletion Design Tool and NEBNext RNA Depletion Core Reagent...

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New England Biolabs Announces Further Expansion of Their RNA Depletion Product Portfolio with the Launch of the NEBNext Custom RNA Depletion Design Tool and NEBNext RNA Depletion Core Reagent...

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INTERCEPT Blood System for Cryoprecipitation Receives FDA Approval States Cerus Corporation

The system is used to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. 

Genetron Health Provides Update on HCCscreen™ for Liver Cancer Early Screening in China

Establishes joint venture with Wuxi municipal government; Expects the commercialization and revenues of HCCscreen to accelerate in China.

Research Paper Showing ProtoKinetix AAGP® Enhanced Stem Cell Derived Retina Precursor Cells Restoration of Vision

ProtoKinetix notes the research paper has been submitted to a prestigious journal specializing in tissue regeneration for peer review and editing.

OrganaBio to Expand Its cGMP Cell and Gene Therapy Manufacturing Facility: 19,000 Sq. Ft. Slated to Commence Operations In Q3 2021

OrganBio, a Miami-based cGMP facility, will include process development space, ISO 7 cleanrooms, state-of-the-art scientific equipment, analytics and QC laboratories, and a suite of support services to enable OrganaBio and its partners to rapidly and economically self-manufacture clinical materials.