Archive: Company News
Company News: NEO New Oncology AG closes financing round
NEO New Oncology AG, a Cologne based cancer diagnostics company, today announced the closing of a financing round with a total investment of app. EUR 5 Million.
“I am pleased by the strong interest that NEO New Oncology AG has received from the investment community,” commented Dr Andreas Jenne, CEO of NEO New Oncology AG. “Together with the proceeds from the first closing earlier this year, the funds will help us to make NEOliquid, a genomic diagnostics test that identifies all therapeutically actionable genome alterations from a simple blood sample, available to patients even faster.”
Company News: Curetis and Acumen to Collaborate on Unyvero Sepsis Test and ASEAN Distribution
– Curetis licenses Acumen’s proprietary sepsis biomarker panel for use with Unyvero Platform
– Diagnostics Development (DxD) Hub in Singapore to support Acumen in development and clinical validation of the panel
– Acumen to distribute Unyvero product line in ASEAN countries
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has obtained a world-wide, non-exclusive license to AcuSept, a proprietary biomarker panel from Acumen Research Laboratories Pte Ltd. (Singapore). The panel is in advanced clinical development and will be used by Curetis and Acumen for the joint development and clinical validation of a sepsis host response test on the Unyvero Platform. Acumen’s activities in Singapore will be supported by NUS Enterprise and the Diagnostics Development (DxD) Hub, a national initiative led by the Agency for Science, Technology and Research (A*STAR), which aims to accelerate diagnostics innovations into market-ready products.
Separately, Curetis and Acumen have signed an exclusive, multi-year distribution agreement for the Unyvero product line in ASEAN markets, which will initially include Singapore, Malaysia, Thailand and Indonesia. The agreement, effective immediately, comprises Unyvero Systems and P55 and i60 ITI Application Cartridges. Acumen will seek product registration in these markets. This agreement, through which Acumen will act as a commercial hub for Curetis in the ASEAN markets, will complement the recently announced Greater China distribution partnership between Curetis and Beijing Clear Biotech, giving Curetis a strong sales and marketing presence in Asia.
The AcuSept biomarker panel is designed to accurately detect changes in a patient’s immune system indicative of pathogens in the blood stream and of a systemic inflammatory response syndrome (SIRS) caused by these microorganisms. The presence of both SIRS and infections are the medical criteria for sepsis, a severe disease with poor prognosis and an often fatal outcome: approximately 50% of people with severe sepsis and 80% of people with septic shock die. With an estimated incidence of 26 million cases worldwide per year, sepsis is among the most frequent severe medical conditions and a significant economic burden to the healthcare systems. A fast and clear distinction between patients with sepsis and those who only have either infections or SIRS by appropriate tests is key to an effective therapy and survival.
Curetis expects to launch a sepsis host response test in Europe in late 2017 at the earliest. The registration process for the current Unyvero Systems and Application Cartridges in ASEAN countries is expected to take up to one year.
Company News: Curetis Enters into Distribution Agreement to Expand Commercial Activities into Greater China
– Exclusive Unyvero distribution agreement with Beijing Clear Biotech Co., Ltd. for Mainland China, Hong Kong and Taiwan
– Clinical trials for CFDA regulatory approval in preparation
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has signed an exclusive distribution agreement (the “Agreement”) for China, Hong Kong and Taiwan (collectively “Greater China”) with Beijing Clear Biotech Co. Ltd. The Agreement, effective from September 25, 2015, comprises the Unyvero Systems and P55 and i60 ITI Application Cartridges. Based in Beijing and founded in 2001, Beijing Clear Biotech is an experienced and prominent distributor of prime medical technology brands throughout Greater China. In the in vitro diagnostics market, Beijing Clear Biotech focuses on the distribution of point-of-care diagnostics, in particular European products and PCR devices.
Under the terms of the Agreement, Beijing Clear Biotech will conduct and fully fund all prospective multi-center clinical trials required for approval of the Unyvero System and its P55 and i60 ITI Application Cartridges by the China Food and Drug Administration (“CFDA”), including funding the systems and application cartridges required for the trials. Beijing Clear Biotech’s responsibilities also include leading the registration and approval process, inclusive of paying all fees, on behalf of Curetis. The anticipated CFDA license will be owned by Curetis. Curetis will pay Beijing Clear Biotech certain milestone payments upon clinical trial initiation and CFDA approval, respectively, and grant a commercial exclusivity for distribution in China, Hong Kong and Taiwan. Under the terms of the Agreement, Beijing Clear Biotech has agreed to certain minimum purchase numbers of Unyvero Systems as well as P55 and i60 ITI Application Cartridges per year.
Upon CFDA approval, Curetis will support commercialization through Chinese-language marketing materials and regular product training for the distributor’s sales force. Beijing Clear Biotech will be responsible for managing all local marketing and sales activities as well as handling storage and logistics support. Marketing in Taiwan will start earlier than in China and Hong Kong, as specific trials are not required for product registration there.
For the commercialization of the Unyvero i60 implant and tissue infection (“ITI”) Application Cartridge, Beijing Clear Biotech will partner with LandMover Medical Technologies Co. Ltd. (Beijing, China), the exclusive Chinese distributor of Heraeus Medical, one of the leading companies in the field of bone cement and biomaterials for elective orthopedic and trauma surgery. The i60 ITI Application Cartridge was co-developed by Curetis with Heraeus Medical to improve the management of patients with implant and tissue infections, including prosthetic joint and other orthopedic infections, to support an early and informed decision on the choice of antibiotic-supplemented bone cement in revision surgery.
Company News: EMC to assume costs of tumor analysis for employees and relatives with cancer
– The “Corporate Oncology Program for Employees” with Molecular Health –
As of September 1, 2015, EMC in Germany will be joining forces with Molecular Health to launch a Corporate Oncology Program for Employees (COPE). If an EMC employee or the spouse, partner, or child of an EMC employee are diagnosed with cancer, the program will fund an analysis of the patient’s tumor genome so that the most promising treatment options can be identified.
“Every day we spend many intense hours working together. No one is left unmoved when they hear that cancer has touched the life of a colleague or a colleague’s family member,” says Sabine Bendiek, managing director of EMC Germany, about the new program. Gabriele Schickel, the director of human resources at EMC, adds, “We asked ourselves what we as an employer could do in situations like these. We offer a great deal to healthy employees. But how can we support colleagues who get sick?” The answer for EMC Germany employees and their families is COPE. EMC, an IT compan with headquarters near Boston, Massachusetts (USA), employs some 70,000 people around the world; its main German office is located in Schwalbach am Taunus.
EMC is Molecular Health’s second COPE customer. “There’s been a lot of interest in COPE over the past few months. Typically it is forward-thinking companies like EMC that make special efforts to look after their employees,” said Lutz Voelker, CEO of Molecular Health.
Part of the COPE program involves Molecular Health’s TreatmentMAP™: the tool analyzes and interprets the tumor genome and the ways in which it differs from healthy tissue in a clinical context. TreatmentMAP compares patient-specific genetic information with the latest international biomedical knowledge. This allows treating physicians to manage the incredibly complex masses of data so they can match the tumor profile to a suitable treatment. As a result, they can identify the therapeutic option with the highest potential benefit while also avoiding side effects as much as possible. Confidentiality is a natural component of our process. The patient remains anonymous. All patient-relevant data remains confidential and is never given to third parties or the employer.