Med-tech financings on track to match 2020’s record-breaking year
More than doubling the amount raised by this point last month, med-tech financings are coming out strong in 2021, beating by 67% the early months of last year. The full year of 2020 broke med-tech financings records, reaching $59.7 billion. With $10.63 billion already raised this year, 2021 is well on its way to at least match last year’s amount.

Med-tech financings on track to match 2020’s record-breaking year
More than doubling the amount raised by this point last month, med-tech financings are coming out strong in 2021, beating by 67% the early months of last year. The full year of 2020 broke med-tech financings records, reaching $59.7 billion. With $10.63 billion already raised this year, 2021 is well on its way to at least match last year’s amount.
Thermal imaging systems not appropriate for COVID-19 mass screenings
The FDA issued an advisory about the use of thermal imaging systems as screening instruments for the COVID-19 pandemic landing the same day as a warning letter to Certify Global Inc. The agency’s concern is that these systems are being used without consideration for the limitations, including that they are not appropriate for mass screenings due to inaccurate findings that could elevate the risk of spread of the SARS-CoV-2 virus.
Genetic Technologies pairs up with Infinity Biologix for COVID-19 risk test
PERTH, Australia – Genetic Technologies Ltd. signed a co-exclusive licensing deal with U.S.-based central lab Infinity Biologix LLC (IBX) for the production, sale and distribution of Genetic Technology’s COVID-19 serious disease risk test in the U.S. Branded as Genetype, the genotyping test combines a patient’s clinical profile with their genetic information to compute a patient’s risk of developing severe disease from COVID-19.
4D bioprinting developer, Rokit, preps for IPO
HONG KONG – Rokit Healthcare Inc. is working toward its goal of listing on the Korean stock exchange by July or August 2021. The Seoul, South Korea-based company will issue 12 million shares and targets setting the price range as early as July 2021. KB Securities Co. Ltd. and Mirae Asset will serve as organizers for the IPO.
Today's news in brief
BioWorld MedTech's briefs for March 5.
Median developing early lung cancer detection technology
PARIS – Median Technologies SA has unveiled a new clinical development plan for its Ibiopsy platform to provide early diagnosis of lung cancer in at-risk populations using low dose CT scans. Median executives said they hope to demonstrate the potential of deep learning in identifying lung lesions and characterizing them as malignant or benign.
Med-tech gainers and losers for March 1-5, 2021
The top 10 med-tech stock gainers and losers for the week.
BioWorld MedTech’s Neurology Extra for March 5, 2021
Keeping you up to date on recent developments in neurology, including: AI reveals drugs that may be repurposed for Alzheimer’s disease; Treating Parkinson’s disease symptoms with brain cell grafts; Astrocytes are more inflammatory in bipolar disease; Pain on the brain.
BioWorld MedTech Patent Highlights: Week 8
BioWorld MedTech presents Patent Highlights, an excerpt of the most important med-tech patents from this week's Cortellis Patents Gazette.

Digital health

Corvista advancing heart disease tech with $65M series C
Financings
Corvista Health Inc. has raised $65 million in a series C equity financing led by Ambix Life Science Fund I LP. The new funds are earmarked for ongoing research, product development and commercialization of the company’s noninvasive, point-of-care (POC) solution for rapid detection of heart...
Telehealth takeaway: Don’t forget about the patient
Coronavirus
A bad patient experience with telehealth can blunt adoption regardless of the incentives for developers and doctors. Griffin Mulcahey, chief compliance officer at Wheel Health Inc., of Austin, Texas, said during a recent webinar that users of these digital health apps and telemedicine programs may...
Skepticism of telehealth cost, utilization in the U.S. aired in hearing
Telehealth
Several telehealth bills are in circulation on Capitol Hill, but U.S. federal government agencies have expressed concerns about the potential for fraud and abuse, and the impact on Medicare spending. Despite those concerns, two key members of the House Energy and Commerce (E&C) Committee, Reps....
Fifth Eye launches ML-based tool to predict hemodynamic instability
Regulatory
The FDA has granted de novo authorization to Fifth Eye Inc. for its Analytic for Hemodynamic Instability (AHI), a machine learning (ML)-based, real-time indicator of patient deterioration. Commercialization of the software device, which continuously monitors patients with an electrocardiogram (ECG)...

Financings

Bionaut lands $20M to develop microscale robots to treat CNS disorders
Newco news
Bionaut Labs emerged from five years in stealth mode raising $20 million to develop Bionauts, microrobots designed to deliver therapies to treat brain disorders. The financing will support the company’s therapeutic program in glioma through preclinical development and further research and...

Newco news

Nanomedic's wound care system spins out skin-like dressing
Wound closure
If Marvel’s Peter Parker had chosen to apply his graduate work in biochemistry and his web-shooters to medicine, he might have created something like Nanomedic Technologies Ltd.’s Spincare system. The system uses a hand-held medical gun that prints a flexible, transparent layer of artificial skin...

Newco news: Ellen Medical develops portable and affordable dialysis machine
Regulatory
PERTH, Australia – About seven years ago, Australia’s George Institute for Global Health conducted a study to find out how many people require dialysis for end-stage kidney failure compared to how many people receive treatment.
Opticyte plans trial of cellular oxygen monitor to detect sepsis
Clinical
Opticyte Inc., a medical device startup, is planning the first clinical trial of its cellular oxygen monitor, a new device that could help emergency physicians diagnose sepsis faster and prevent organ failure. The prospective, observational trial is set to launch in mid-2021.

Deals and M&A

Boston Scientific buying Lumenis’ urology business for $1.07B
Urology
Boston Scientific Corp. has inked an agreement with an affiliate of Baring Private Equity Asia to acquire the global surgical business of Lumenis Ltd. for $1.07 billion up front. The med-tech giant has had a relationship with Lumenis for more than two decades and currently sells its urology laser...
Agilent snags Resolution Bioscience in deal valued up to $695M
Acquisition
Agilent Technologies Inc. will acquire Resolution Bioscience Inc. for $550 million in cash at closing and up to an additional $145 million based on performance milestones. The deal will expand Agilent’s cancer diagnostics offerings and its presence in next-generation sequencing (NGS) technology for...
Luye signs over Japan rights for dementia patch to Towa Pharmaceutical
Neurology/Psychiatric
HONG KONG – Looking to improve treatment outcomes for Alzheimer’s patients, Shanghai-based Luye Pharma Group has inked a deal to hand the Japanese rights for its leading treatment to Japan’s Towa Pharmaceutical Co. Ltd. Made through Luye’s subsidiary Luye Pharma Switzerland AG, the agreement gives...
Hologic snaps up Diagenode for $159M
Diagnostics
Hologic Inc. continues to strengthen its diagnostics businesses via tuck-ins, this time with the acquisition of Diagenode SA for $159 million. The Belgium-based developer of molecular assays and epigenetics products counts more than 30 real-time polymerase chain reaction (PCR) tests in its...
Med-tech M&As leap into 2021 with sharp rise in values; deals up, too
Analysis and data insight
While the new year has recorded a similar number of completed med-tech deals and M&As in comparison with the early months of 2020, the projected values of those transactions are up by 78% and 418%, respectively. Through this week, BioWorld has tracked 204 deals worth $144.65 million, and 62 M&As...

Europe

Withings unveils cellular-connected home health monitors
Digital health
Withings Health Solutions, the business-to-business division of the connected health company Withings SA, is launching two cellular-connected devices that allow patients to measure their weight and blood pressure at home and immediately transmit the results to a health care provider. The products –...

Asia-Pacific

Vuno soars in $33.4M IPO as investors affirm AI’s potential
Financings
HONG KONG – Vuno Inc. saw its shares soar on their first day of trading on the Kosdaq board with a $33.4 million IPO. The shares closed at ₩32,150 (US$28.89) on Feb. 26. Vuno had priced the 1.8 million new shares on offer at ₩21,000, exceeding its desired range of ₩15,000 to ₩19,500 and raising...

Wuxi Diagnostics raises $150M in series B financing
Financings
HONG KONG – Wuxi Diagnostic Investment (Cayman) Ltd. has raised $150 million in a series B financing round, while netting a number of new investors along the way. The new investors to come on board include Thermo Fisher Scientific Inc., Shiyu Capital, ABC International Holdings Ltd., Sunland...
Australian researchers identify potential treatment for fatal brain cancer in children
Science
PERTH, Australia – The fight against diffuse intrinsic pontine glioma may finally see some progress, after experiments using 3D models of the tumor in animal studies showed that a combination therapy of the polyamine inhibitor AMXT-1501 (Aminex Therapeutics Inc.) and the ornithine decarboxylase 1...

Clinical

Histosonics tests sonic beam therapy for liver tumors
Cancer
Histosonics Inc. is testing its investigational histotripsy technology to destroy liver tumors in two clinical trials in the U.S. and Europe, with the goal of seeking regulatory clearance for the platform in 2022. The technology uses the science...
Researchers ID new method to monitor schizophrenia drug in blood
Neurology/Psychiatric
HONG KONG – Researchers at Ben-Gurion University of the Negev (BGU) in Israel have developed a way to instantly monitor blood levels of the antipsychotic drug clozapine. BGU’s solution is based on an electrochemical microsensor developed by Hadar...
Patensee launches first-in-human trial of integrated surveillance system for fistula stenosis
Nephrology
Patensee Ltd. initiated a first-in-human trial of its machine vision-based surveillance system for stenosis in hemodialysis patients. The trial will evaluate the imaging system's ability to perform contact-free surveillance of the access points or...
Study underscores effectiveness of Caption Health's AI-guided ultrasound software
Cardiovascular
Last year, artificial intelligence (AI)-focused Caption Health Inc. won the U.S. FDA’s nod for software that guides untrained clinicians step-by-step in providing a cardiac ultrasound exam, a process normally performed by a highly skilled...
Emitbio seeks EUA for light-based COVID-19 treatment to be used at home
Infection
Emitbio Inc., a life science company developing light-based therapies, is seeking emergency use authorization (EUA) from the U.S. FDA for its investigational device to treat mild to moderate COVID-19 infection at home. The portable, hand-held...
Geisinger AI accurately predicts mortality risk
Cardiovascular
An artificial intelligence (AI) algorithm developed by Geisinger researchers that uses echocardiogram videos predicted all-cause mortality at one year more accurately than three out of four expert cardiologists and other predictors commonly used...

BioWorld MedTech Perspectives

U.S. politicking threatens public trust in the FDA and CDC
BioWorld MedTech
The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to...
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...

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