industry news

04 MAY 2020

Venus Medtech and Opus Medical partner for TMVR and TTVR in China

Venus Medtech has partnered with Opus Medical Therapies to develop, manufacture and sell the latter’s transcatheter mitral valve replacement (TMVR) and transcatheter tricuspid valve replacement (TTVR) products in China.

The partnership will benefit physicians and patients undergoing transcatheter mitral and tricuspid valve replacement.

In China, the prevalence of mitral regurgitation (MR) above the age of 60 is 13.4% and the number of patients requiring treatment is estimated to be ten million. Tricuspid regurgitation (TR) is also not uncommon in the population, the company noted.

Currently, cardiac surgery is the mainstream way of treatment for patients with significant MR. However, the number of mitral valve surgeries in the country is approximately 40,000 cases a year. This means the majority of patients do not receive necessary treatments.

Venus Medtech CEO Eric Zi said: “It is the utmost importance to us that our devices can save more patients and improve their quality of life.

“The cooperation with Opus Medical Therapies will enable Venus Medtech to achieve full coverage from functional mitral regurgitation to degenerative regurgitation on the basis of its own product line and will greatly accelerate the clinical use of tricuspid valve replacement technology. No other company offers this all-valves solution in China and Asia.”

Opus Medical Therapies founder and CEO Vivek Rajagopal said: “With the depth of our experience and Venus’ support, we believe that this partnership will result in the furtherance of Venus’ pipelines, which have great potential market size globally.

“This partnership also provides us with the opportunity to make an impact in the fast-growing structural heart space in an extraordinarily important geographic market. With Venus as our partner, we also hope to make an impact in the rest of the world.”

Through the partnership, both companies also plan to lead China to the forefront of global TMVR and TTVR research field.

04 MAY 2020

US FDA grants emergency use authorisation for Roche’s Covid-19 test

Roche has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for an Elecsys Anti-SARS-CoV-2 antibody test for the coronavirus (Covid-19).

The test is expected to help identify patients who have been exposed to Covid-19 and assess patients’ immune response to the SARS-CoV-2 virus. It is said to have specificity higher than 99.8% based on the measurement of 5,272 samples.

It also detected 100% sensitivity in samples taken 14 days after a PCR-confirmed infection.

As more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up immunity to the virus, the company noted.

The test is available on Roche’s cobas e analysers, which are widely available across the hospitals and reference laboratories around the world.

The fully automated systems provide SARS-CoV-2 test results in 18 minutes with a test throughput of approximately 300 tests an hour.

Roche Group CEO Severin Schwan said: “Thanks to the enormous efforts of our dedicated colleagues, we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the Covid-19 health crisis.

“I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support healthcare systems around the world with a reliable tool to better manage the Covid-19 health crisis.”

Meanwhile, Roche has started shipping the new antibody test to laboratories worldwide. The company plans to scale up its manufacturing capabilities to supply several million tests a month.

01 MAY 2020

FDA grants emergency use authorisation for new Nasa’s ventilator

30 APRIL 2020

Cerus Endovascular’s neurovascular system secures CE Mark approval

Medical device company Cerus Endovascular has developed 021 Contour Neurovascular System for the treatment of saccular intracranial aneurysms.

The device is compatible with smaller commercially available 021 microcatheters and was developed to provide a combination of flow diversion and flow disruption through a single device implant.

It is a fine mesh braid that targets the neck of the aneurysm away from the vulnerable dome. In addition, the device is designed to be self-anchored for stability, re-sheathable for precise placement.

The new, lower profile system will enable physicians to access more distally challenging vascular anatomies.

Cerus Endovascular president Dr Stephen Griffin said: “In response to numerous requests from the clinical community and physicians we work closely with, we continue to aggressively expand our product portfolio to offer an even more comprehensive suite of products to meet market needs, complementing our Contour 027 device and Neqstent platform, which recently received CE Mark approval.”

The company’s CE-Marked Neqstent Coil Assisted Flow Diverter device was designed for the treatment of a range of aneurysm morphologies, including wide-necked bifurcation and bifurcation aneurysms.

Cerus Endovascular chairman Dr Sam Milstein said: “This latest approval testifies to the strength of our product pipeline and represents another critical step in our go-to-market strategy via a controlled roll-out.

“We look forward to initiating sales later this year and are pleased to be able to offer the medical community additional, key solutions that will meaningfully benefit patient care.”

Earlier this year, the company raised $19m in a Series B financing from institutional investors to implement its go-to-market strategy and expand product portfolio.

29 APRIL 2020

Biotecon Diagnostics unveils microproof kits for Covid-19

Biotecon Diagnostics has launched microproof SARS-CoV-2 Screening / Identification kits to assist the diagnosis of Covid-19 through the in vitro qualitative detection of the virus.

The screening kit detects the E gene (E) for Betacoronavirus, while the identification kit targets the SARS-CoV-2 specific RNA-dependent RNA polymerase (RdRp) gene.

While the E gene assay is advised for screening for SARS-CoV-2, SARS-CoV and other SARS-related CoVs, the RdRp gene assay is used for the specific confirmation of SARS-CoV-2.

Conducting large-scale testing has proven effective in stemming the spread of the coronavirus in many of the hardest-hit countries, the company noted.

Biotecon Diagnostics CEO Dr Kornelia Berghof-Jäger said: “I am extremely proud of our team of scientific researchers and experts, who in a short space of time have managed to develop, manufacture and market such high-quality real-time PCR tests for the qualitative detection of SARS-CoV-2.

“It is the latest addition to a whole coronavirus product portfolio we have aimed at expanding the availability of diagnostic testing and supporting the massively impacted healthcare systems.

“In addition to our own kits and analytical instruments, we have entered into agreements with several partners worldwide to be able to meet the growing demand for viral RNA extraction and identification of the coronavirus.”

The company developed the assays for Covid-19 diagnosis based on the World Health Organization (WHO) reference methods and adapted it according to the Charité protocol for the detection of SARS-CoV-2.

Biotecon’s microproof SARS-CoV-2 Screening / Identification kits are available immediately for purchase and are approved ‘for research use only’.

They are yet to receive CE-IVD in the EU and emergency use authorisation (EUA) from the Food and Drug Administration (FDA) in the US.

27 APRIL 2020

FDA grants EUA for ALung’s respiratory system for Covid-19 treatment

ALung Technologies has received EUA from the US FDA for its Hemolung Respiratory Assist System (RAS) for Covid-19 treatment.

Currently, the system is being used in the FDA-approved VENT-AVOID trial for the study of extracorporeal carbon dioxide removal (ECCO2R) technology to treat acute exacerbation of chronic obstructive pulmonary disease (AE-COPD).

Additionally, Hemolung RAS is evaluated for the treatment of moderate to severe acute respiratory distress syndrome (ARDS) in the UK REST trial.

The company said that the system has been used in the treatment of a number of Covid-19 patients in the US under existing FDA emergency use provisions and in the EU, where it is CE-marked since 2013.

The FDA reviewed in vitro and in vivo information in support of ALung’s ongoing US VENT-AVOID clinical trial for the Hemolung RAS.

In addition, it also considered information about the clinical use of the system outside the US and additional biocompatibility, cytotoxicity and performance testing.

ALung Technologies chairman and CEO Peter DeComo said: “We are pleased with the FDA’s recognition that the Hemolung may be beneficial in the treatment of Covid-19 by removal of CO₂ directly from the blood during extracorporeal therapy.

“Many of the academic medical centres involved with our clinical trial have already requested the use of the Hemolung RAS for treatment of their Covid-19 patients.”

Hemolung RAS is believed to have the potential to treat lung failure as an adjunct to noninvasive or invasive mechanical ventilation.

It can reduce hypercapnia and hypercapnic acidosis and maintain normalised levels of the partial pressure of carbon dioxide (pCO₂) and pH in patients suffering from acute, reversible respiratory failure due to Covid-19.

24 APRIL 2020

Australian researchers develop ultrasound biosensor

23 APRIL 2020

Cerus Endovascular receives CE Mark for aneurysms treatment devicE

Cerus Endovascular has received CE Mark approval for its Neqstent Coil Assisted Flow Diverter device designed for the treatment of intracranial aneurysms.

Neqstent is an adjunctive intrasaccular flow diverter device intended for the treatment of a range of aneurysm morphologies, including wide-necked bifurcation and bifurcation aneurysms.

It allows stable aneurysm neck coverage for the placement of embolisation coils within the sac and long-term occlusion of the aneurysm.

Cerus Endovascular president Dr Stephen Griffin said: “Many physicians already have firsthand experience using embolisation coils and the Neqstent will serve as an intrasaccular flow diverting device, which will work in combination with embolisation coils.

“Our goal is to offer a breadth of solutions for the treatment of these aneurysms. Physicians who have used the Neqstent comment on its ease of use through its controlled deliverability and deployment.”

The company’s new device is a further expansion of its portfolio of implant technologies, which target the neck of the aneurysm sac.

Cerus Endovascular plans to launch the device through a controlled market release across the EU. It is expected to be commercially available towards the end of this year.

Cerus Endovascular chairman Dr Sam Milstein said: “Once again, our remarkable team of dedicated professionals continue to widen and diversify our product portfolio to bring critical products to market, helping to position Cerus as a key solution provider within the industry.

“On behalf of the entire Cerus team, we would like to acknowledge the heroic and extraordinary sacrifices being made on a daily basis by healthcare workers, first-responders and the public at large, during this devastating pandemic.”