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BioWorld - Sunday, July 20, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Self-amplifying mRNA technology underscored for next big pandemic
  • Heartflow FFRCT analysis Credit: Heartflow Inc.

    Heartflow pumps up med tech IPOs

    Heartflow Inc. continued the steady rhythm of med-tech companies filing to go public, with an S-1 submitted to the U.S. SEC on July 17. The company joins 15 others that have completed IPOs in 2025 and one other in process – Carlsmed Inc., which a company spokesperson told BioWorld is expected to begin trading on the Nasdaq on July 22.
  • Xeltis sees encouraging preliminary data for Xabg coronary artery bypass conduit

    Xeltis BV is seeing encouraging preliminary data for Xabg, its coronary artery bypas conduit, from two clinical trials underway in Europe and South America. The data shows positive safety and patency in patients with multi-vessel atherosclerotic coronary artery disease.
  • Heartflow pumps up med tech IPOs

    Heartflow Inc. continued the steady rhythm of med-tech companies filing to go public, with an S-1 submitted to the U.S. SEC on July 17. The company joins 15 others that have completed IPOs in 2025 and one other in process – Carlsmed Inc., which a company spokesperson told BioWorld is expected to begin trading on the Nasdaq on July 22.
  • Xeltis sees encouraging preliminary data for Xabg coronary artery bypass conduit

    Xeltis BV is seeing encouraging preliminary data for Xabg, its coronary artery bypas conduit, from two clinical trials underway in Europe and South America. The data shows positive safety and patency in patients with multi-vessel atherosclerotic coronary artery disease.
  • US states continue to move deeper into FCA legislation

    The U.S. False Claims Act (FCA) is not the only statute governing the submission of false claims to federal agencies thanks to the more than 30 states with their own versions of the FCA. However, the federal government is providing states with more incentives to amplify their FCA-related activities, a development that raises the stakes for companies in the life sciences.
  • 34 mainland China biotechs file for Hong Kong IPO in H1 2025

    Thirty-six biotechnology, pharmaceutical and medical device companies sought a capital raise on the Hong Kong Stock Exchange in the first half (H1) of 2025, a review by BioWorld found. Of those, 34 companies were from mainland China.
  • Australia awards AU$100M in grants to biopharma/med-tech incubators

    The Australian government has awarded nearly AU$100 million (US$64.65 million) in grant funding to three biopharma/med-tech incubators to support emerging Australian biopharma and med-tech startups.
  • Today's news in brief

    BioWorld MedTech briefs for July 18, 2025.

BioWorld Insider Podcast

Play buttonRobert Williamson, CEO of Triumvira Immunologics, and Hernan Bazan, CEO of South Rampart Pharma, discuss bracing for tariffs, NIH grant cuts and gifting China a biopharma leadership position.
Listen now

Digital health

  • Telehealth illustration

    CMS takes aim at skin substitutes, telehealth in 2026 doc fee draft

    Regulatory
    The U.S. Centers for Medicare & Medicaid Services (CMS) has pulled off the gloves when it comes to spending on skin substitutes in the draft Medicare physician fee schedule for 2026, proposing a payment methodology that would slash spending by 90%. However, the doc fee draft also proposes to...
  • Lunit

    Lunit, Microsoft to codevelop cloud-based clinical AI solutions

    Deals and M&A
    Lunit Inc. reported a new collaboration with Microsoft Corp. July 2 to jointly develop medical AI programs accessible on Microsoft’s Azure cloud platform.
  • MHRA logo

    MHRA tackles risk classification for digital mental health tech

    Regulatory
    The U.K. Medicines and Healthcare Products Regulator Agency dropped a guidance for digital mental health technologies that clarifies several key points, such as when the DMHT qualifies as software as a medical device.
  • Reset Moves action shot

    Reset Moves to promote well-being in children with neurodivergence

    Neurology/psychiatric
    Focused on promoting well-being amongst children with neurodivergence, Reset Moves Pty Ltd. created app-based games to help children not only focus with greater clarity, but also to better help them re-engage in certain settings.
More in Digital health

Today's news in brief

  • Appointments and advancements July 18, 2025

  • Financings for July 18, 2025

  • In the clinic for July 17, 2025

  • Other news to note for July 18, 2025

  • Regulatory actions for July 17, 2025

Regulatory

  • Uromems gets OK for Uroactive stress urinary incontinence trial

  • Impulse Dynamics inches closer to Medicare coverage for CCM

  • Life sciences strategy to reduce UK approval costs by 25%

  • Caranx Medical gets FDA nod for TAVR software Tavipilot Soft

  • CMS proposes again to end IPO list in outpatient draft

  • NICE endorses pulsed field ablation for atrial fibrillation

  • Synchrony receives FDA OK for Libairty airway clearance system

  • CMS lists 6 specialists as part of hypertension team in RDN memo

  • Preemption of state privacy law on tap in cybersecurity hearing

  • US FDA posts raft of early device alerts in June, July

Financings

  • Going public ticker

    Carlsmed aims for $100M+ IPO

    Deals and M&A
    Carlsmed Inc. launched its IPO at a price of $14 to $16 per share for 6.7 million shares, which would raise just over $100.5 million at the midpoint. The spinal surgery technology company could well pull in more money, if recent history provides guidance. Most med-tech IPOs this year have settled...
  • Comphya secures $8.4M for implantable neurostimulation ED therapy

    Urology
  • Plasmacure secures funding for Plasoma wound healing tech

    Dermatologic
  • Nuclidium’s radiopharma approach draws $99M in series B

    Clinical
  • Actithera raises $75M series A for FAP-targeted radiopharmaceuticals

    Newco news
More in Financings

Newco news

  • 3D illustration of a chain of amino acid or biomolecules called protein

    Alphadesign: AI creating proteins from scratch

    Science
    The Alphafold machine learning system for predicting a protein’s structure from its amino acid sequence has been adapted to make it possible to design de novo proteins that fold in a particular way and bind to prespecified target proteins. The sister system, called Alphadesign, works by generating...
  • Zip Diagnostics develops first rapid POC test for scabies

    Infection
    Zip Diagnostics Pty Ltd., Menzies School of Health Research and Axxin Pty Ltd., a Melbourne, Australia-based diagnostic instrumentation manufacturer, partnered to develop a rapid diagnostic test for scabies, a skin parasite that affects more than 200 million people each year.
  • Wearoptimo’s hydration sensor outperforms gold standard tests

    Clinical
    Health care technology company Wearoptimo Ltd. developed a next-generation microwearable sensor that accurately detects hydration levels, outperforming the needle-based gold standard.
  • Patent filed for multiweek, multitarget CGM-like wearable sensor

    Cardiovascular
  • Updoc patents AI-powered diabetes management platform

    Diabetes
  • Trio of neuro disease-focused firms highlighted at KIMES 2025

    Cardiovascular
  • Researchers develop visual prosthetic to restore sight

    Neurology/psychiatric
More in Newco news

Deals and M&A

  • Handshake, money, calculator, MA-letters

    Med-tech M&A value drops to $12M in June after strong Q2

    Analysis and data insight
    Med-tech publicly disclosed deal value reached just $5 million in June 2025, capping a weak quarter for the sector. Total deal value for the first half of the year came to just $320.14 million, with no single month crossing the $200 million mark.
  • Lumos’ Febridx rapid POC test

    Lumos stock rockets 162% on commercialization deal worth $317M

    Infection
    Lumos Diagnostics Inc.’s stock shot up 162% Wednesday morning on news that it signed a pivotal commercial deal with Phase Scientific International Ltd to expand its reach into the U.S. market for its Febridx rapid, point-of-care test for bacterial infections.
  • Merger-arrows-black-white.png

    BD’s biosciences & diagnostics unit in $17.5B merger with Waters

    Merger
    Three months earlier than an expected update on a deal, Becton, Dickinson and Co. reported its biosciences and diagnostic solutions business will combine with Waters Corp. in a transaction valued at $17.5 billion. The resulting enterprise will operate under the Waters name and use its trading...
  • Stock merger illustration

    Zimmer Biomet in $168M buy of ortho robotics maker Monogram

    Merger
    Zimmer Biomet Holdings Inc. reported it is buying orthopedic robotics maker Monogram Technologies Inc. for an upfront payment of $4.04 per share in cash, corresponding to an equity value of approximately $177 million and an enterprise value of about $168 million.
  • Close up of eye and vision test

    Alcon sees the light with Lumithera buy for dry AMD

    Ophthalmic
    Alcon AG plans to acquire Lumithera Inc., adding its photobiomodulation (PBM) device designed to treat early and intermediate dry age-related macular degeneration (AMD) to the Alcon portfolio. The financial terms of the deal were not disclosed. The move continues Alcon’s strategic expansion in eye...
More in Deals and M&A

U.S.

  • Abbott med tech bumps up Q2 results

  • Med tech helps boost J&J to strong 2Q beat

  • OIG won’t oppose drugmaker payment for companion diagnostic

  • PTAB hands Exact a loss in Geneoscopy patent dispute

  • FDA’s MDUFA report suggests pre-sub interactions increasing

  • Edwards seeks to add three months to Ultra Resilia patent

  • HELP sends CDC nominee on her way to Senate vote

  • Insightec gains FDA approval for Exablate Neuro use in Parkinson’s

  • Iancu: Patent reform undone by multinationals’ apathy over IP rights

  • CMS formally proposes to terminate ESRD choices program

Europe

  • Carotid ultrasound

    UK Biobank project complete, supports research with 100,000 scans

    Science
    After a 10-year project and a £60 million (US$80 million) investment, the UK Biobank has completed the whole body scans of 100,000 volunteers and is making the 1 billion images available for researchers worldwide.
  • UK’s NICE recommends pulsed field ablation to treat atrial fibrillation

    Regulatory
  • Glucomodicum reports positive data from its needle-free CGM

    Clinical
  • UK industry encourages renewal of rare disease framework

    Science
  • Accunea’s Renosure device can save kidneys from being discarded

    Clinical
More in Europe

Asia-Pacific

  • Cochlear Nuclea Nexa system

    FDA green lights Cochlear’s smart cochlear implant

    Regulatory
    Cochlear Ltd. heard good news from the U.S. FDA, as the agency approved its next-generation cochlear implant, the Nucleus Nexa System, the first smart cochlear implant system. Cochlear expects to launch the new products in the U.S. in the next few months, Brendan Murray, vice president for Cochlear...
  • UDI mandates kick in for devices in Australia

    Regulatory
    Australia’s Therapeutic Goods Administration reported June 30 several new regulatory requirements are in effect, including a new mandate regarding the use of unique device identifiers for implanted medical devices.
  • Med-tech IPOs gain steam going into Q3

    Deals and M&A
    The IPO market for med-tech companies continues to set new records. With one IPO closed the last week of June, two slated for the first week of July and another pending, 2025 will shortly exceed the total number of IPOs closed in the previous two years combined as well as the number completed in 2022.
  • Tetratherix lists on ASX in $25M IPO

    Financings
  • Multiple multianalyte sensors for diabetes on horizon

    American Diabetes Association
  • MFDS clears world’s first ECG-based AI kidney disease software

    Regulatory
  • European Commission clamps down on Chinese med tech

    Europe
More in Asia-Pacific

Clinical

  • Serac Imaging sees clinical value of gamma imaging camera

    Cancer
    Serac Imaging Systems Ltd. reported encouraging data from two clinical trials demonstrating the effectiveness of its Seracam portable hybrid gamma-optical camera as a point-of-care imaging solution. The studies show the camera’s value in nuclear...
  • In-patient BYOD still troublesome for CGM makers

    American Diabetes Association
    With a growing number of people wearing continuous glucose monitors and an ever-shrinking number of hospital-based nurses, bringing your own device or using personal CGMs to measure glucose levels during hospitalizations seems like a no-brainer.
  • UK Women to be offered home-testing kits for cervical screening

    Cancer
    The U.K. government will offer women home-testing kits for cervical screening as part of an effort to tackle barriers and get more of them taking this potentially life-saving test.
  • AID system improves glycemic control in pregnancy

    Diabetes
    Pregnant women with type 1 diabetes who used a hybrid closed loop automated insulin delivery system averaged more than three additional hours per day in their recommended glucose range than those who managed their diabetes with insulin injections...
  • Fractyl pursues dual track to cure T2 diabetes

    American Diabetes Association
    At the American Diabetes Association 85th Scientific Sessions in Chicago June 20-23, Fractyl Health Inc. presented results from two studies evaluating very different approaches to treating – and possibly curing – type 2 diabetes.
  • Fineheart pursues FIH study of Flowmaker fully implanted heart pump

    Cardiovascular
    Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to...
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:

  • The importance of balancing AI and people in drug development
  • Two CEOs discuss bracing for tariffs, NIH grant cuts and
    gifting China biopharma leadership position
  • As biopharma investments stumble, med tech surges
  • Mega money well spent? Mammoth mergers fall short of the dream
  • Healing the health divide for women
  • Modifi gets creative on the rocky road to a multibillion-dollar buyout
  • A quantum leap into the future of drug development
  • Gene and cell therapies will propel innovation, says Astellas CCO
  • Capricor’s CEO pursues a BLA and talks rare disease
  • The first half of 2024 was strong as M&As and financings dominate

View all

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