Reflexion, Telix Pharmaceuticals to collaborate to treat high-risk cancers
Reflexion Medical Inc. appears to be on a roll. A little more than a month after unveiling a tie up with Merck & Co. Inc., it now has reported a collaboration with Telix Pharmaceuticals Ltd., a radiopharmaceutical company developing molecularly targeted radiation products.

Reflexion, Telix Pharmaceuticals to collaborate to treat high-risk cancers
Reflexion Medical Inc. appears to be on a roll. A little more than a month after unveiling a tie up with Merck & Co. Inc., it now has reported a collaboration with Telix Pharmaceuticals Ltd., a radiopharmaceutical company developing molecularly targeted radiation products.
Doctor On Demand raises $75M in series D
Virtual care provider Doctor On Demand has scooped up $75 million in a series D round led by General Atlantic, with participation from existing investors. The funds are earmarked to fuel the company’s growth and expand access to comprehensive telehealth services across the U.S. Combined with earlier financings, the San Francisco-based company has raised nearly $240 million to date.
U.S. FDA urges test developers to amend EUAs for pooled sample testing
The U.S. FDA’s priorities for testing for the SARS-CoV-2 virus have shifted as circumstances have changed, and the agency is putting more emphasis into testing of pooled samples. Toby Lowe, the associate director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said on the July 8 diagnostic town hall that the agency wants to encourage test developers to work on their existing EUAs for pooled sampling.
Today's news in brief
BioWorld MedTech's briefs for July 8.
Partisan votes on U.S. federal agency appropriations foreshadow showdown between House, Senate
Two subcommittees of the U.S. House Appropriations Committee have moved their respective appropriations proposals for the FDA and the NIH, restarting a process that has worked smoothly over the past couple of years. Still, Republicans in both committees objected to the use of emergency funding mechanisms in lieu of more routine appropriations.
Nonin nabs FDA nod for wireless handheld for first responders to monitor oxygen indicators
Plymouth, Minn.-based Nonin Medical Inc. gained a U.S. FDA 510(k) clearance for its Co-Pilot wireless hand-held multiparameter system (H500). The system is expected to be used by first responders to evaluate various oxygenation and respiratory-related parameters in patients after incidents such as cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation.
BioWorld MedTech’s Orthopedics Extra for July 8, 2020
Keeping you up to date on recent developments in orthopedics, including: Buzzing to rebuild broken bone; Tiny mineral particles are better vehicles for promising gene therapy; New trial results question standard treatment plan for rheumatoid arthritis.

Digital health

AI-powered stroke imaging solution nabs CADx clearance
Neurology/Psychiatric
RapidAI, which focuses on imaging for stroke, has received the U.S. FDA’s nod for Rapid ASPECTS. According to the company, it is the first neuroimaging analysis device to gain clearance in the computer-assisted diagnostic software category.
FDA gives breakthrough nod to Dascena’s predictive algorithm for acute kidney injury
Nephrology
Machine learning-based diagnostics startup Dascena Inc. has won the U.S. FDA’s breakthrough device designation for its Previse algorithm, which is designed to predict acute kidney injury (AKI) before clinical symptoms. In early validation tests, Previse detected AKI more than a day before patients...
FDA’s artificial intelligence paper prompts concerns regarding practicability
Artificial intelligence
The comment period has closed on the U.S. FDA’s discussion draft for artificial intelligence (AI) in medical devices, a paper that attracted the attention of medical societies and regulated industry. One of the questions posed by industry was whether the FDA is in a position to deal with the...
Study finds AI improves accuracy of stroke prediction by 70% over standard methods
Clinical
Elucid Bioimaging Inc. has already gained an FDA clearance and a CE mark for its Vascucap artificial intelligence-based software that analyzes CT angiograms (CTA) to characterize and quantify atherosclerotic plaque to predict a patient’s stroke risk. But recent interim data presented on July 2,...

Financings

Court approves first step in Endologix reorganization, agreement with Deerfield Partners to take company private
Cardiovascular
On Tuesday, July 7, Judge Stacey Jernigan of the U.S. Bankruptcy Court in Dallas ruled that Endologix Inc. could take an initial draw of $10 million from a Chapter 11 loan from its largest lender, Deerfield Partners. A day earlier, Endologix filed a voluntary Chapter 11 case and a consensual plan of reorganization supported by Deerfield.

Newco news

Protaryx Medical raises $8.3M to help with left-heart interventions
Cardiovascular
Protaryx Medical has picked up $8.3 million to develop its device for precision transseptal access to the left atrium for use during structural heart and catheter ablation procedures. The funding includes nondilutive grants and a seed round totaling $3.2 million, as well as the recently closed $5.1...

Canadian, U.S. investors boost the fortunes of long-term transcatheter heart pump
Cardiovascular
TORONTO – Once he’d enrolled in an entrepreneurial engineering course, third-year medical school student Gabriel Georges’ task was deceptively simple: come up with a device to meet an unmet medical need. Before long, Georges had pulled two other students with engineering and investor relations...
Sirakoss scores FDA nod for nanoparticle synthetic bone graft substitute
Orthopedics
LONDON – Sirakoss Ltd. has received FDA 510(k) clearance for its nanoparticle synthetic bone graft substitute, after showing the ready-to-use putty is equivalent to the CE-approved dry formulation. Rather than granules that are mixed with a patient’s blood before administration, the inorganic...

Deals and M&A

Abbott, Tandem nail down agreement for automated insulin delivery systems
Diabetes
Abbott Laboratories and Tandem Diabetes Care Inc. have finalized an agreement related to integrated diabetes solutions. Specifically, the duo is planning to combine Abbott's Freestyle Libre continuous glucose monitoring (CGM) technology with San Diego-based Tandem's insulin delivery systems, with an eye toward providing more options for diabetes management.
Thermo Fisher expands CDx agreements with Daiichi Sankyo and Agios
Cancer
Thermo Fisher Scientific Inc. is working with Daiichi Sankyo Co. Ltd. to develop a companion diagnostic (CDx) to identify non-small-cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who could be eligible for the Tokyo-based company's cancer drug, Enhertu.
Vuno seeks more markets after entering the Japanese arena via M3 tie-up
Diagnostics
Hong Kong – Vuno Inc. is looking to access more markets after inking a partnership with Japan’s M3 on June 19. The partnership with M3, a medical data platform which is 34% owned by conglomerate Sony Corp., allows Vuno to tap into the Japanese market. The M3-Vuno tie-up aims to encompass all Vuno’s existing products.
Invitae hits bull’s-eye with blockbuster $1.4B Archerdx buy
Acquisition
Invitae Corp. (NYSE:NVTA) saw its stock flying high June 22 on the news of its agreement to buy Archerdx Inc., with an eye toward enhancing cancer genetics and precision oncology. Investors appear to approve of the deal, with the company’s stock closing at $27.05, up $8.34 or 44.58%.
Illumina acquires Dutch cloud software startup Bluebee to enhance genomic data analysis
Diagnostics
San Diego-based Illumina Inc. is synonymous with next-generation sequencing (NGS) equipment. But when it comes to dealmaking, the genomics giant is focused largely on software to make its results more useful, accessible and affordable. It has acquired cloud-based software startup Bluebee Holding BV in its latest move on this front.

Europe

COVID-19: Trying for herd immunity without vaccine ‘unethical’ and ‘unachievable’
Science
A large epidemiological study published in the July 6, 2020, advance online issue of The Lancet found that most individuals who became infected with SARS-CoV-2 developed antibodies to the virus, confirming that infection usually results in at least a short-term immune response.

Asia-Pacific

Kangji soars in HKEX debut
Financings
Hong Kong – China’s Kangji Medical Holdings Ltd. has made a memorable debut on the Hong Kong Stock Exchange (HKEX), with shares jumping 98.84% from their opening price of HK$13.88 (US$1.79) to close at HK$27.60 (US$3.56) on the first day of trading on June 29.

Precision model allows accurate cancer therapy testing
Science
Chinese scientists at Peking University (PKU) in Beijing have developed a new in vitro patient-derived tumor-like cluster (PTC) model, which predicted the outcomes of neoadjuvant and conventional chemotherapies in colon, gastric and breast cancer patients, with a clinical consistency of >93%.
Study in South Korea makes case for ablation for atrial fibrillation
Clinical
Makers of devices for ablation for atrial fibrillation (AF) have struggled at times to overcome clinician skepticism, but a new report in a respected medical journal might persuade some of those cardiologists. A study of nearly 28,000 AF patients in South Korea demonstrated that device therapy...

Clinical

Radiology research alliance adds algorithm for reliable blood flow data via 3D ultrasound
Diagnostics
Researchers working as part of the Quantitative Imaging Biomarkers Alliance (QIBA) have recently validated an open-source algorithm that can be used to measure blood flow using existing 3D ultrasound technology from major manufacturers. They published their results in the June 30, 2020, issue of Radiology.
Ancora Heart gets FDA nod for Accucinch pivotal trial
Cardiovascular
The U.S. FDA has greenlighted Ancora Heart Inc.’s IDE request to conduct the Corcinch-HF pivotal clinical trial. The study is intended to demonstrate the safety and effectiveness of the Accucinch ventricular restoration system in patients with heart failure and reduced ejection fraction (HFrEF).
Elixir Medical sees positive data for adaptive remodeling coronary stent technology
EuroPCR
Elixir Medical Corp., reported positive 12-month results for its Dynamx Coronary Bioadaptor System, with no target vessel revascularization (TVR) or stent thrombosis and adaptive remodeling of the artery to sustain healthy blood flow. The findings, from a multisite European trial, were presented during a late-breaking trials session at the PCR e-Course virtual meeting in Paris.
Abbott rolls out slew of data on minimally invasive structural heart implants
EuroPCR
Minimally invasive structural heart implants are moving from mitral into tricuspid valve repair, as well as mitral valve replacement. Abbott Laboratories is presenting its latest data on all these fronts at the virtual PCR e-Course held by the European Association of Percutaneous Cardiovascular Interventions from June 25 to 27.
Affluent Medical kicks off first-in-human trial of Epygon valve
Cardiovascular
French startup Affluent Medical SA has launched a European pilot study in humans of its native-like transcatheter mitral valve technology. The Epygon valve is designed to restore the normal blood flow vortex in the left side of the heart and treat left ventricle disease, particularly in so-called “functional” patients.
CAR T cells target senescence marker, ameliorate cancer, fibrosis
Science
By targeting chimeric antigen receptors (CARs) to a senescence marker, researchers at Memorial Sloan-Kettering Cancer Center have developed a CAR T cell that had beneficial effects in mouse models of both liver fibrosis and lung cancer.

BioWorld MedTech Perspectives

The demise of the device tax and other fun med-tech stories
It’s mighty tempting to run a little play on words with regard to eyesight in this new year, but I need reading glasses, so far be it from me to pepper a...
Missed Opportunity: The epidemic of poor sleep
BioWorld MedTech
There are a lot of ways to save money without going bankrupt in the process, but health care in the U.S. certainly has not lent itself to that sort of...
Next up for TAVR; bicuspid valve
BioWorld MedTech
Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low...
Cabanas and commissioners; med tech in the news
BioWorld MedTech
We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two...
FDA’s new man of regulatory mystery
BioWorld MedTech
Life has a lot of unknowns, and one of the big unknowns for 2019 is what the FDA will look like now that Scott Gottlieb has returned to the American...
Scott Gottlieb and the FDA’s revolving door problem
BioWorld MedTech
Now that the dust is still swirling over the news that Scott Gottlieb will leave the FDA, it’s time to conduct a hasty post-mortem on his tenure at the...
Four “Spooky” ways to fix the 510(k) dilemma
BioWorld MedTech
A now-little known band called the Classics IV made a big splash in 1968 when their Hallowe’en love song “Spooky” charted at #3 on the U.S. Billboard Hot...

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