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BioWorld - Thursday, September 28, 2023
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  • Ossdsign Catalyst

    Ossdsign plots new future as pure play for US-focused orthobiologics business

    Ossdsign AB will abandon its 3D-printed cranial reconstructive implant business to focus on U.S. sales of its Ossdsign Catalyst, an off-the-shelf nanosynthetic bone graft that offers gross margins of 90% or better. The new strategy sharply reduces the capital required before the company projects achieving a cash-flow positive position.
  • Advisory panel urges FDA to reclassify three in vitro diagnostic tests

  • Today's news in brief

  • Ossdsign plots new future as pure play for US-focused orthobiologics business

    Ossdsign AB will abandon its 3D-printed cranial reconstructive implant business to focus on U.S. sales of its Ossdsign Catalyst, an off-the-shelf nanosynthetic bone graft that offers gross margins of 90% or better. The new strategy sharply reduces the capital required before the company projects achieving a cash-flow positive position.
  • Advisory panel urges FDA to reclassify three in vitro diagnostic tests

    The U.S. FDA recently convened an advisory hearing to discuss whether three in vitro diagnostics should be reclassified from class III to class II, including tests for the pathogens responsible for Hepatitis B and tuberculosis. The panel agreed that all three of the test types should be reshuffled to the lower-risk class II category, suggesting that test developers now have an opportunity to jump into a market with lower-cost tests that won’t need expensive and drawn-out clinical studies to obtain the FDA’s seal of approval.
  • Today's news in brief

    BioWorld MedTech briefs for September 27, 2023.
  • Proteomics develops new blood test for esophageal cancer

    Proteomics International Pty Ltd has developed a new blood-based diagnostic test called the Promarkereso that identifies patients with esophageal adenocarcinoma as well as patients with a pre-malignant condition called Barrett’s esophagus that can arise from chronic acid reflux.
  • UK’s NICE keen to develop evidence for the use of AI in radiotherapy contouring

    Artificial intelligence (AI) is an increasingly common matter of medical practice and thus not just another buzzword, and the U.K. National Institute for Health and Care Excellence (NICE) has opened a program for evidence generation for the use of AI to contour external beam radiotherapy to the tumor of treatment.
  • Patent update: Total Flow designs cannulas for reducing ischemic conditions in cannulated limbs

    The co-founder and CEO of Total Flow Medical Ltd, Hilary Pierce, reported the filing of a patent for bidirectional flow cannulas configured and designed to replace conventional femoral arterial cannulas for extracorporeal circulation during cardiopulmonary bypass procedures and that provide an optional dedicated blood flow to the ipsilateral limb.

BioWorld Insider Podcast

Google’s Scott Penberthy joins the podcast for a visionary discussion that scans the horizon for startling changes artificial intelligence will bring to drug development in the relatively near future.

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Digital health

  • Art concept for gene therapy research

    Machine learning tool Alphamissense analyzes human mutations to predict diseases

    Science
    Proteome analysis with artificial intelligence has made it possible to create a catalog of all possible missense mutations in the human genome to predict diseases.
  • Ceribell mobile patient monitoring

    Ceribell scores win with FDA clearance of bedside Claritypro

    Neurology/Psychiatric
    At the same time it reported U.S. FDA clearance for bedside software to diagnose electrographic status epilepticus (ESE) seizures, Ceribell Inc. declared Claritypro the first ICU monitoring device to receive an NTAP reimbursement from the Centers for Medicare and Medicaid Services. The clearance of...
  • Stethoscope, hand, health care icons

    France overhauls framework for digital health app reimbursement

    Diagnostics
    The French National Insurance Fund, known as La Caisse Nationale d’Assurance Maladie, a division reporting to the Ministry of Health and the Ministry of Economics and Finance in France, has released its annual report containing proposals aimed at achieving financial balance in the nation’s health...
  • Imeka white matter tracking

    FDA clearance, reimbursement codes greet Imeka’s white matter tracking tool

    Regulatory
    Imeka Solutions Inc. has received U.S. FDA 510(k) clearance for the Advanced Neuro Diagnostic Imaging system designed to provide neurologists and radiologists with vital reference information on cerebral white matter for better management of brain diseases such as Alzheimer’s. This comes on the...
More in Digital health

Today's news in brief

  • Appointments and advancements for Sept. 27, 2023

  • Financings for Sept. 27, 2023

  • In the clinic for Sept. 27, 2023

  • Other news to note for Sept. 27, 2023

  • Regulatory actions for Sept. 27, 2023

Regulatory

  • ITCA-650 beaten down by safety issues at EMDAC hearing

  • FDA clearance enables Femaseed to help families grow

  • Zap Surgical prevails over Elekta in Federal Circuit patent scrum

  • FDA’s premarket cybersecurity guidance encodes legislative imperatives

  • Medtronic gets CE mark for Simplera continuous glucose monitor

  • Medtech Europe presses Brussels for ‘accountable structure’ for oversight of regulation

  • Patients urge FDA to work with CMS on coding issues for health equity purposes

  • US FDA advises sponsors on conducting trials in the face of disasters, PHEs

  • US FDA advises sponsors on conducting trials in the face of disasters, PHEs

  • Med-tech harmonization plan is a study in regulatory incrementalism

Financings

  • CMRs Versius robotic surgery system

    CMR Surgical rakes in $165M to hit $1B in funding

    Robotic surgery
    CMR Surgical Ltd. raised $165 million in financing from its existing investors that will allow the company to continue to innovate its portable robotic surgery system, Versius, and grow its position in existing and new markets. The latest financing takes CMR’s total capital raised since its...
  • A good day for Day Zero with new $16M financing

    Diagnostics
  • Briya raises $11.5M to expand health care data exchange platform

    Series A
  • Stimvia raises funds for Uris system to manage overactive bladder

    Urology
  • Awak raises $20M series B to take portable kidney dialysis device to pivotal trials

    Nephrology
More in Financings
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Newco news

  • Digital brain and silhouette

    Brainaurora files for Hong Kong IPO to develop digital therapeutics

    Financings
    Brainaurora Medical Technology Ltd. has filed for an initial public offering (IPO) in Hong Kong to develop its digital therapeutics for the treatment of cognitive impairment diseases. The company claims to be the first in China to launch a digital therapeutics (DTx) product for cognitive...
  • A born listener: CNS startup Violet hones in on cellular cross-talk

    Financings
    The identification of new targets in diseases of the central nervous system (CNS) such as Alzheimer’s and Parkinson’s – conditions which continue to have significant unmet needs – has taken a small step forward as one company, Violet Therapeutics Inc., plans to put $10.6 million in seed funding...
  • Flow Medical nears completion of catheter to treat venous thromboembolic disease

    Cardiovascular
    University of Chicago spinoff Flow Medical Inc. is finalizing its design of a multi-function catheter to diagnose and treat venous thromboembolic disease – boosted by a $1 million private investment to commercialize the device.
  • Orakl developing in vitro diagnostic test using organoids for colorectal cancer

    Cancer
  • Startup Enhanc3D raises £10M for high-res genome mapping platform

    Medical devices and technologies
  • Spinoffs keep up dizzying pace with Medtronic separation

    U.S.
  • Axoft launches with $8M for brain-machine interface implants

    Financings
More in Newco news

Deals and M&A

  • Vaxxas HD-MAP

    SK Bioscience, Vaxxas partner to develop needle-free typhoid vaccine

    Infection
    SK Bioscience Co. Ltd.  and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid.
  • No deal dice

    On the SPAC track: Slowdown continues with Ross/Aprinoia sputter

    Neurology/Psychiatric
    The first special purpose acquisition company (SPAC) merger announced in 2023 has fallen apart. Aprinoia Therapeutics Inc. and Ross Acquisition Corp. II mutually agreed to call off the merger that had been valued at $280 million. The failed deal is part of a larger trend that has gained momentum in...
  • US FTC taps Covington’s Liu for director of Bureau of Competition

    Regulatory
    The U.S. Federal Trade Commission has picked Henry Liu of the law firm of Covington & Burling to run the agency’s Bureau of Competition, a seat that was vacated earlier this year when Holly Vedova retired.
  • Tandem Control-IQ system

    Tandem Diabetes secures French reimbursement for semi-closed loop system

    Medical devices and technologies
    Tandem Diabetes Care Inc. obtained reimbursement in France for its Control-IQ technology, an advanced hybrid closed loop system for patients with type 1 diabetes that uses an algorithm to automatically adjust insulin in response to predicted glucose levels.
  • Green arrow up red arrow down

    Med-tech deals reach $8.63B and M&As total $37.33B in first 7 months of 2023

    Analysis and data insight
    Med-tech deal values the first seven months of the year are up more than 50% from last year. Meanwhile, M&As decreased almost 70% from the same time period in 2022.
More in Deals and M&A

U.S.

  • Patent update: Zig develops system for at home diagnosis and treatment of acute respiratory exacerbations

  • Enovis to buy orthopedic implant maker Lima for €800M

  • Boston Scientific aims high with new long-range plan

  • Attorney forecasts more US DOJ dismissals of False Claims Act cases thanks to Supervalu

  • Dexcom simplifies calorie and nutrient tracking with Rxfood partnership

  • FDA converts conformity assessment pilot into a full-fledged program

  • Adcom a make-it-or-break-it hearing for combo diabetes product

  • Boston Scientific to acquire Relievant Medsystems in $850M+ deal

  • Bipartisan momentum gathering for reforms of US Medicare program

  • FDA eyes overhaul of IT system with an emphasis on agency-wide integration

Europe

  • The CUE1 device on Parkinsons disease patient

    Charco’s vibration device ‘fundamentally’ reduces symptoms of Parkinson’s Disease

    Neurology/Psychiatric
    With a waiting list of some 90,000 people, startup company Charco Neurotech Ltd. is seeing growing demand for its Cue1 device which has shown to reduce the symptoms of Parkinson’s disease in patients suffering from the condition. The Cue1 is a non-invasive device that can literally change the...
  • NICE says cryotherapy for chronic rhinitis not ready for prime time

    Regulatory
  • Insightec secures additional CE mark for Exablate Neuro to treat essential tremors

    Regulatory
  • Selection based on blastocysts size nearly doubles IVF transfer success

    Obstetrics
  • UK looks to turn the tide against cancer with funding for AI projects

    Oncology
More in Europe
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Asia-Pacific

  • Annalise Enterprise CTB

    Annalise.ai software improves radiologists’ diagnostic accuracy and speed

    Neurology/Psychiatric
    An artificial intelligence (AI) tool developed by Annalise.ai Pty Ltd. was able to improve radiologists’ accuracy in detecting abnormalities on non-contrast computed tomography brain (CTB) scans. According to a study published in European Radiology, the Annalise Enterprise CTB module improved...
  • Researchers develop wearable sensor for continuous detection of solid-state biomarkers in skin

    Diagnostics
    Researchers at Singapore’s Agency for Science Technology & Research Bioprocessing Technology Institute (also known as A*STAR BTI) saw publication of their patent application for a wearable electronic system for solid-state epidermal biomarkers (SEB) that enables in situ, continuous, multiplexed,...
  • Vergent’s imaging agent reveals previously undetected tumors

    Oncology
    A fluorescent imaging agent developed by Vergent Bioscience Inc. enables visualization of elusive and previously undetected tumors, a phase II study presented last week at the 2023 World Conference on Lung Cancer (WCL23) demonstrated. The ability of the tumor-targeting agent, Vgt-309, to illuminate...
  • KIW 2023: Lunit moves from AI-imaging cancer diagnostics to I/O success prediction

    Conferences
  • Two med-tech IPOs in August bring 2023 total to five

    Analysis and data insight
  • Japan’s PMDA sees a role for e-consent in clinical trials

    Regulatory
  • Challenges in China spell trouble for Illumina, 10x and others

    Proteomics
More in Asia-Pacific

Clinical

  • Humacyte’s phase II/III tissue graft data prompt talk of a BLA

    Immune
    Regenerative tissue developer Humacyte Inc. has posted positive top-line phase II/III results for its Human Acellular Vessel, a tissue-engineered graft consisting entirely of decellularized extracellular matrix, for vascular trauma repair. The...
  • Neuraxis looks beyond gut to apply IB-Stim in post-concussion syndrome

    Gastrointestinal

    Neuraxis Inc. has initiated a clinical study to evaluate the efficacy of its IB-Stim neuromodulation system in treating children with post-concussion syndrome (PCS). The aim is to see whether IB-Stim can ease the constellation of symptoms that...

  • EDEN trial shows DBS improves movement in stroke patients

    Medical devices and technologies
    A first-in-human clinical trial conducted by researchers at the Cleveland Clinic demonstrated that deep brain stimulation (DBS) applied to the dentate nucleus region of the cerebellum could help patients recover function in their upper extremities...
  • Headset could improve safety of return-to-play decisions after concussion

    Neurology/Psychiatric
    For many sports injuries, return-to-play decisions are pretty straightforward: pain and swelling have dissipated, or an X-ray confirms that a bone has healed. For concussion, it’s not so clear. Though symptoms may resolve after a few days, the...
  • Personadx predicts treatment outcomes for metastatic CRC patients

    Oncology
    Personadx Inc. and researchers from the University of Chicago Medicine Comprehensive Cancer Center have developed a method to accurately predict which patients with metastatic colorectal cancer will have a favorable treatment outcome following...
  • Spinex neuromodulation technology ‘game-changing’ for children with cerebral palsy

    Neurology/Psychiatric
    In game-changing news for parents of children with cerebral palsy, researchers demonstrated significant clinical improvement in the sensorimotor function of children who underwent sessions using Spinex Inc.’s Spinal Cord Innovation in Pediatrics...
More in Clinical

BioWorld Insider Podcast

One-on-one with medical innovators

podcast microphone, sound waves on purple backgroundBreakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.


Recent episodes:

  • AI: driving drug development from effective to remarkable
  • The struggle is real: The first half of 2023 was an uphill climb
  • The biosimilars challenge to Humira revs up
  • Preventing opioid overdoses with a smart patch
  • Better times ahead for the biopharma sector? Could be, the new numbers say
  • Radiopharmaceuticals: The next big disrupter?
  • Cambrian carves out a new niche as it works to keep people from getting sick
  • Rethinking obesity: Fitness may be more directly linked to health than weight
  • Looking ahead to 2023: CEOs contemplate the new normal
  • $1B+ biopharma deals keep values afloat, even amid muted volume

View all

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