SEC dialing up scrutiny of special purpose acquisition companies
Special purpose acquisition companies (SPACs) have been making headlines recently in the life sciences, but these entities practice a business model that leaves some observers uneasy. Gary Gensler, chairman of the U.S. Securities and Exchange Commission (SEC), told a Senate committee recently that the risks to investors in SPACs has prompted him to ask his staff to come up with some proposals to increase transparency to investors, potentially leading to additional compliance costs for these entities.

SEC dialing up scrutiny of special purpose acquisition companies
Special purpose acquisition companies (SPACs) have been making headlines recently in the life sciences, but these entities practice a business model that leaves some observers uneasy. Gary Gensler, chairman of the U.S. Securities and Exchange Commission (SEC), told a Senate committee recently that the risks to investors in SPACs has prompted him to ask his staff to come up with some proposals to increase transparency to investors, potentially leading to additional compliance costs for these entities.
Opgen’s multiplex diagnostic panel found to reduce inappropriate antibiotic use
A multicenter study has found that a multiplex diagnostic panel developed by Opgen Inc. can reduce the use of inappropriate antibiotic therapy by 45.1%. Opgen’s Unyvero Hospitalized Pneumonia (HPN) panel uses PCR technology that can detect 21 pathogens and 17 antibiotic resistance markers in less than five hours. During the European Respiratory Society conference, Rockville, Md.-based Opgen presented data showing that combined with antibiotic stewardship, its HPN panel decreased time on inappropriate antibiotic therapy in hospitalized patients with pneumonia at risk for Gram-negative rods.
Rune Labs’ $22.8M in series A financing symbolizes confidence in its brain data platform
Rune Labs Inc. is on a mission to make the mysteries of the brain easier to read for both clinicians and biopharma companies. Having a fresh $22.8 million in a series A financing on the books will no doubt make the goal easier to reach. The new round pushed total funding for development of the San Francisco-based company’s brain data software platform to $30.1 million.
Today's news in brief
BioWorld MedTech's briefs for Sept. 16.
Sofinnova closes over-subscribed $75M med-tech accelerator fund
PARIS – Sofinnova Partners SAS reported the successful closing of its med-tech accelerator fund, Sofinnova MD Start III, at $75 million. The fund had been oversubscribed and exceeded its original quota, with new investors joining existing ones such as Medtronic plc, Liva Nova plc, Baxter International Inc., French national public investment bank Bpifrance and the European Investment Fund.
Startup Somne collars new solution for treating obstructive sleep apnea
Newly launched startup Somne Inc. plans to give CPAP machines a run for their money by replacing CPAP masks and hoses for treating obstructive sleep apnea with a gentler collar encircling the patient’s neck. The new device uses variable negative pressure to ensure users get a good night’s sleep instead of positive airway pressure employed by companies such as Resmed Inc. and Philips Respironics Inc.
ESMO 2021: Allarity shares edge up on post hoc analysis of dovitinib RCC data
DUBLIN – Allarity Therapeutics A/S plans to file an NDA with FDA for dovitinib in renal cell carcinoma (RCC) in the fourth quarter this year, after unveiling a new analysis at the European Society for Molecular Oncology’s virtual congress, which suggest that its companion diagnostic, DRP, can identify patients who obtain a survival benefit from the therapy.

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Digital health

FTC eyes streamlined enforcement for algorithm bias, drug patents and right to repair
Algorithm
The U.S. Federal Trade Commission (FTC) has taken a more assertive stance regarding enforcement of several considerations, most conspicuously about mergers and acquisitions. However, the agency’s push for less cumbersome processes has now been applied to a host of considerations pertinent to the...
Cureapp shares results for hypertension digital therapeutic app, seeks regulatory approval and U.S. partner
Clinical
Cureapp Inc. is ready to take the next step for its digital therapeutic app (DTA) for hypertension, after completing a late-stage clinical trial and publishing the results. The company said it is the first global trial for a therapeutic app, conducted to seek regulatory approval in the field of...
China an attractive market, but regulatory uncertainty a source of concern
Regulatory
The med-tech market in China has lured many device makers and investors into doing business there despite concerns about intellectual property (IP) theft. While some of those IP theft worries have eased, China’s National Medical Products Administration (NMPA) is still implementing an order that...
Medial Earlysign partners with Roche Diagnostics for early cancer detection tools
Deals and M&A
Startup company Medial Earlysign Ltd. and Roche Diagnostics International Ltd. are teaming up to bring to market artificial intelligence (AI) solutions for early detection of cancer. Founded in 2013, Tel Aviv-based Medial Earlysign uses machine learning tools to flag patients with a high...

Financings

Nectero Medical nets $19.5M from investors to develop AAA treatment
Cardiovascular
Nectero Medical Inc. has secured $19.5 million in a series C financing round, led by Boston Scientific Corp. The company is developing the Endovascular Aortic Stabilization Treatment (EAST) system, a treatment platform that reduces the growth rate of aortic aneurysms. EAST is currently in a...

Newco news

Fluid Biotech raises $4.7M for a world’s first in brain stent development
Financings
TORONTO – Fluid Biotech Inc. has raised $4.7 million in oversubscribed seed funding to further develop and commercialize the world's first hybrid polymer-metal flow-diverting brain stent for curing brain aneurysms that can lead to stroke. Following successful preclinical studies of the stent,...

Genieus builds neurodegenerative diseases platform to develop diagnostics, personalized medicines
Neurology/Psychiatric
PERTH, Australia – Bioinformatic and cell technology company Genieus Genomics Ltd. is using the power of the human genome to build a platform for neurodegenerative diseases to develop diagnostic tests for personalized medicines.
Device enables four patients to breathe on a single ventilator at the same time
Deals and M&A
Steven Roy, CEO of Convergence Medical Sciences Inc., has designed a low-cost device that boosts the number of patients on a single ventilator to four simultaneously. To do this, he is collaborating with Calgary-based consulting engineers, Exergy Solutions Inc., to take the international Red Dot...

Deals and M&A

Finnish companies combine to form IVD triple threat
Cancer
Three is the magic number for Finnish companies Abacus Diagnostica Oy, Kaivogen Oy and Labrox Oy as they link up to develop a new diagnostic solution combining antibody and PCR testing on a single device. The three Turku, Finland-based companies said they are joining forces to form a new...
Zoll continues its push in sleep apnea market with $538M Itamar buy
Zoll Medical Corp.’s plans to wake up the sleep apnea market segment advanced with the acquisition of Itamar Medical Ltd. for $538 million in cash. Itamar focuses on the diagnosis and treatment of sleep apnea, a common and complicating comorbidity of the cardiovascular patients served by Zoll. The...
Stereotaxis plans to tackle the Chinese ablation market via deal with Microport
Cardiovascular
Robotic technologies company Stereotaxis Inc. is scaling up its footprint in the Chinese med-tech market, with a deal to commercialize its robotic technology for heart rhythm therapy in China with Shanghai Microport EP Medtech Co. Ltd. The St. Louis-based Stereotaxis aims to introduce a...
ICU Medical displaces Trulli Bidco with $2.35B offer for Smiths Medical division
ICU Medical Inc. reached an agreement with Smiths Group plc to buy Smiths Medical division for $2.35 billion in cash and stock. The deal represents an improvement in the terms reached between Trulli Bidco Ltd. and Smiths Group in early August for the purchase of the same division. Trulli, a wholly...
Stryker boosts surgical unit with AI blood monitoring company Gauss Surgical
Obstetrics
Stryker Corp. has made its second acquisition of the year, picking up Gauss Surgical Inc. – the developer of an artificial intelligence (AI) platform for real-time monitoring of blood loss during surgery. Financial terms of the deal were not disclosed. Kalamazoo, Mich.-based Stryker’s shares...

Europe

Austro-Japanese team developing e-health patches that can monitor pulse and blood pressure
Science
PARIS – Researchers at the Institute for Surface Technologies and Photonics in Weiz, Austria, and the Institute of Scientific and Industrial Research Osaka University, Japan, have invented new ultra-flexible health monitoring patches that use harvested bio-mechanical energy. “These new devices...

Asia-Pacific

Metabolomics study reveals dementia-linked metabolites
Science
A comprehensive nontargeted metabolomics analysis has revealed previously unknown classes of disease-linked metabolites in whole blood samples from dementia patients, which may have significant therapeutic implications for managing the untreatable common cognitive disorder.

Tokyo University of Science develops urine sugar level monitoring diaper sensor
Diabetes
The Tokyo University of Science (TUS) has developed a self-powered diaper biosensor that can monitor urine sugar levels, which could be a boon for both diabetic patients and their caregivers. Caregivers at nursing homes currently open patients’ diapers every few hours to check for urination, thus...
Following A$90M IPO, Trajan doubles share price as it executes global strategy
Financings
PERTH, Australia – On the heels of a A$90 million (US$67.12 million) initial public offering on the Australian Securities Exchange, device company Trajan Group Holdings Ltd. has doubled its share price and is well poised for its next stage of global growth. Trajan makes precision consumable...

Clinical

Savicell touts high accuracy results for its liquid biopsy platform
Cancer
Savicell Diagnostics Ltd. has reported high accuracy results from a study validating its liquid biopsy platform Immunobiopsy. Haifa, Israel-based Savicell said the platform achieved high accuracy identifying lung cancer across stages I to IV. In a...
Abbott’s Amulet gives Watchman a run for its money in head-to-head trial
European Society of Cardiology
The race is on. After six years as the only FDA approved devices for left atrial appendage closure, Boston Scientific Corp.’s Watchman products face a challenger, Abbott Laboratories’ Amplatzer Amulet. With the Amulet’s FDA approval in mid-August...
FDA guidance update looks beyond pandemic
Regulatory
Although COVID-19 is still dictating how things are done in the U.S. and throughout the world, the FDA looked beyond the pandemic in an update to its guidance on conducting clinical trials of medical products during the public health emergency.
Case for COVID-19 booster shots strengthens with data from J&J and UK
Coronavirus
Johnson & Johnson has announced new data supporting use of its COVID-19 vaccine as a booster shot, after separate trial data from the U.K. showed effects of several vaccines waned after six months.
Lightpoint Medical and Telix unite for prostate cancer surgery trials
Deals and M&A
Lightpoint Medical Ltd. is stepping up commercialization activities and collaborating with Telix Pharmaceuticals Ltd. on radio-guided cancer surgery. The companies plan to initiate prostate cancer clinical trials evaluating Lightpoint’s Sensei...
Cardiac Dimensions launches pivotal trial for mitral regurgitation device
Cardiovascular
Cardiac Dimensions Inc. launched the Empower trial of its Carillon mitral contour system for the treatment of heart failure patients with early-stage functional mitral regurgitation. The company expects to enroll up to 300 patients at 75 sites in...

BioWorld MedTech Perspectives

Forward to the past: The FDA commissioner dilemma
BioWorld MedTech
As we’ve all undoubtedly noticed, the FDA commissioner’s chair is conspicuously absent a duly deputized occupant, and a number of reasons have been offered...
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...

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