HistoSonics Inks VA Contract Worth $90M For Tumor-Fighting Tech
HistoSonics, a Plymouth-based start-up, which created an ultrasound system to destroy and liquefy liver tumors, announced on 28 October, it was awarded an exclusive contract to provide Veterans Affairs hospitals access to their Edison Histotripsy technology.
The contract establishes a $90m ongoing schedule to develop histotripsy programs at VA hospitals nationwide, the company said. Histotripsy is a single-setting, outpatient procedure for most patients and involves ultrasound that uses high-amplitude, very short pulses to create a “bubble cloud” designed to mechanically destroy and liquefy targeted liver tumors. For most patients, it is a single-setting, outpatient procedure.
HistoSonics, which has raised more than $300m, has received US Food and Drug Administration de novo clearance for its histotripsy system in October 2023. It has been put into US academic centers and integrated health systems and community hospitals and will now make its way to participating VA hospitals.
The FDA has not evaluated the Edison System for treating any other disease and should only be used by physicians who have been trained on HistoSonics, the company said.
NeuroOne Medical Technologies Amends Distribution Agreement With Zimmer Biomet
NeuroOne Medical, which developed what it calls the worlds-first FDA-cleared OneRF ablation system for diagnostic and therapeutic use, said on 31 October it will receive a $3m upfront payment with the potential to earn an additional milestone payment if certain performance criteria are met.
The company said the device has been used successfully to identify brain tissue triggering seizure activity and to ablate the targeted tisuse to reduce or eliminate brain-related seizure activity. NeuroOne believes the technology has the potential to reduce hospital stays, number of surgeries, and adverse events while offering temperature control to enhance patient safety.
Innoventric Gets $28.5M Boost To Fund Cross-Caval Prosthetic Tricuspid Valve
Innoventric announced it secured $28.5m in a series B funding round led by RA Capital with European Investment Committee (EIC) also joining the round.
The raised funding will be used to advance its cross-caval transcatheter tricuspid prosthetic valve to treat tricuspid regurgitation. In total, the company has raised $41 million in funding since it was founded in 2017.
Innoventric’s flagship device uses a unique heterotopic, cross-caval approach, the company says, restoring function of the triscuspid valve without directly interacting with the heart. By anchoring a prosthetic valve to the superior and inferior vena cava, the device achieves a complete seal, which eliminates risk of leakage or detachment while simplifying the implementation process.
With this approach, the device can be implanted without the use of echocardiography or general anesthesia, improving success rates and reducing patient recovery time. The device can also be used on patients who are ineligible for tricuspid procedures, says the Israeli company.
The company has completed a first-in-human clinical trial in Europe, treating 40 patients, and has started an Early Feasibility Study in the US.
Edwards Lifesciences One-Year TRISCEND II Trial Results Show Evoque Benefit
Edwards Lifesciences transcatheter tricuspid valve replacement system (TTVR) Evoque demonstrated superiority compared to medical therapy alone in the one-year endpoint of the TRISCEND II trial, presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting from 27-30 October.
The Evoque system is indicated for improvement of health status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical therapy for whom tricuspid valve replacement is deemed appropriate by a heart team.
The trial evaluated the Evoque TTVR system with optimal medical therapy (OMT) compared to OMT alone with 2:1 randomization. The Evoque valve was successfully implanted in 95.4% of the treatment cohort, which was 400 patients; 95.3% of the patients who received the value had almost complete elimination of (TR) with mild (or less than mild) TR at one year versus 2.3% of patients receiving medical treatment alone.
Edwards reported that the TR reductions came with significant improvements in symptoms, function, and quality of life at one year and favorable numerical outcomes in mortality and heart failure hospitalization.
The TRISCEND II trial, which started in April 2021, will continue for another five years until December 2029. The FDA approved Evoque earlier this year, based on the 30-day and 6-month results of the pivotal TRISCEND II trial evaluating the safety and efficacy of Evoque in comparison to optimal medical therapy. Evoque also received the CE mark.
The one-year outcomes from the TRISCEND II trial demonstrate the benefits of this therapy in these patients, and the favorable trends in all-cause mortality and heart failure hospitalization are encouraging, said Susheel Kodali, cardiologist and trial principal investigator. Evoque showed “near elimination of TR, which was sustained out to 1 year,” he said.
Blood Test For Colorectal Cancer Less Cost-Effective Than Alternatives
Blood-based liquid biopsy colorectal cancer (CRC) screening is more costly and less effective than alternatives, a study published in the Annals of Internal Medicine investigating the cost-effectiveness of available CRC tests suggests.
Cell-free DNA blood tests (cf-bDNA) prevented the fewest cancers and cancer deaths versus no screening, the study shows. The cf-bDNA test was the least cost-effective, with Guardant’s Shield costing $89,600 per quality of life (QALY) gained versus no screening. Colonoscopy and annual fecal immunochemical tests (FIT) were the most cost-effective tests, with an estimated cost per QALY of between $6,300 and $6,500 for the two tests.
The study concluded that “first-generation cf-bDNA have the potential to decrease meaningfully the incidence and mortality of CRC compared with no screening, but substantially less profoundly than screening colonoscopy or stool tests.”
The study authors suggested that cf-bDNA tests could help bring unscreened patients into practice. However, cf-bDNA should not be used as a substitute for other more effective strategies, such as colonoscopy and stool testing.
The study investigated seven different screening tests: the Guardant Shield cf-bDNA test, an investigational cf-bDNA test, Exact Sciences Cologuard stool DNA test, an investigational next-generation stool DNA, FIT testing, FIT DNA testing, FIT RNA testing, and colonoscopy.
Trinity Biotech Enters Oncology Space with Acquisition of EpiCapture
Irish firm Trinity Biotech announced on 25 October it acquired EpiCapture Limited, which developed a non-invasive test for assessing the risk of aggressive prostate cancer. With the acquisition, Dublin-based Trinity marks its expansion into the oncology diagnostics market.
The acquisition, valued at about $3m plus $0.5m based on achieving milestones, was paid through 1.7m American Depository Shares in Trinity Biotech. EpiCapture is a spin-out company of NovaUCD, part of University College-Dublin.
EpiCapture’s urine-based test, Trinity says, is designed to reduce the need for repeated invasive prostate biopsies for patients undergoing active surveillance for prostate cancer. The test features a breakthrough approach to monitoring disease progression by using epigenetic analysis to detect DNA methylation patterns that are indicative of high-grade cancer, the company says.
Trinity says a study published in The Journal of Clinical Oncology – Precision Oncology demonstrated that EpiCapture’s test “correctly predicted all high-grade cancers” when combined with a prostate-specific antigen, or PSA, test, a commonly used prostate diagnostic.
Prostate cancer is the most common non-skin cancer among men in the US, with about 1 in 8 diagnosed during their lifetime with a cost for diagnosis and treatment around $10bn a year.
Public/Private Partnership Aims To Develop At Home Flu And COVID Diagnostic Platform
The US government has teamed up with life sciences company Revvity to accelerate the development of an at-home molecular test for influenza and COVID-19.
The Biomedical Advanced Research and Development Authority, or BARDA, recently awarded Revvity with a $9.2m contract to develop the diagnostic tool, which Revvity says, will detect and distinguish between Influenza strains A and B and SARS-CoV-2 from nasal swabs.
The test features a reusable hub and disposable cartridge requiring only five minutes of user time. It is intended to provide results within 30 minutes. Results can be shared electronically with physicians or pharmacies to enable rapid treatment decisions.
Revvity says it plans to conduct multisite clinical studies to validate the test in pursuit of marketing authorization from the FDA. If successful, Revvity says the test could enable more rapid patient care and provide useful public health information.
Court Favors Apple In One Masimo Suit, With Another Upcoming
A Delaware federal jury found last week that a pulse oximetry tool in older versions of Masimo’s smart watches infringed on patents held by Apple. But the court awarded just $250 to the tech giant, which is the minimum amount possible under US law.
The jury also found that Masimo smart watches now on the market do not infringe upon Apple’s patents.
The split verdict left both sides claiming victory. Apple said in a statement that it appreciated that the court had protected its patents, while Masimo said the court sided with them on the key issue. “Apple primarily sought an injunction against Masimo’s current products, and the jury’s verdict is a victory for Masimo on that issue,” Masimo said in a statement.
The pause in the sprawling court battle between the two companies will be a short one. Apple and Masimo will face off on similar issues again next week in California, where Masimo filed suit in 2020 alleging that Apple had violated trade secrets law by hiring a chief Masimo scientist. This is the second time the case has gone to trial in California; a 2023 attempt ended in a mistrial.
FDA Approves Medtronic Ablation Catheter
Medtronic has landed FDA approval for its Affera mapping and ablation system with Sphere-9 catheter, an all-in-one tool that treats persistent atrial fibrillation (AFib) as well as cavotricuspid isthmus (CTI) dependent atrial flutter.
The Affera system integrates high-density mapping as well as pulsed field and radiofrequency ablation. It is the first system of its type to reach the market and also makes Medtronic the first company to have two pulsed field ablation technologies available for patients with AFib. The FDA approved the other device, the PulseSelect pulsed field ablation system, in December 2023.
In a pivotal trial, 73.8% of patients did not see a recurrence of AFib after treatment with Affera, compared to 65.8% of patients in the control arm. The device also met safety endpoints, with no reports of events including pulmonary vein stenosis, esophageal events or cardiac tamponade.
“The significance of this innovative technology should be underscored; Affera is a game-changer for treatment of Afib and atrial flutter,” said Vivek Reddy, director of cardiac arrhythmia services for New York City’s Mount Sinai Health System. “The Affera system provides physicians with one safe, effective and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients. With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of Afib.”
AFib is one of the most common and undertreated cardiac conditions, affecting more than 60 million people worldwide according to Medtronic.
FDA Approves First Antimicrobial Wound Dressing To Integrate Lidocaine
Imbed Biosciences announced on 31 October that the FDA cleared Microlyate Ag/Lidocaine, the first antimicrobial wound dressing to integrate lidocaine for managing painful skin wounds.
The synthetic matrix delivers ionic and metallic silver alongside lidocaine, providing antimicrobial protection and local anesthetic effects, the company said.
Standards Group Updates Guidelines On Hospital Ethylene Oxide Use
The Association for the Advancement of Medical Instrumentation (AAMI) has updated its standards for the sterilization of medical devices in hospital settings to address safety concerns over the use of ethylene oxide in device sterilization.
The document, ANSI/AAMI ST58:2024, Chemical sterilization and high-level disinfection in health care facilities, is a revision of ANSI/AAMI ST58:2013/(R)2018 and will supersede ANSI/AAMI ST41. It discusses topics such as how to select a sterilization method, processing methods for facilities that sterilize devices, transport and storage of sterilized devices, and safety and personnel concerns. It applies to liquid chemical sterilants, high-level disinfectants and gaseous chemical sterilizers.
The new version will help health care providers comply with current recommendations and improve patient safety, said Alpa Patel, director of scientific improvement at Nelson Laboratories and co-chair of AAMI’s chemical sterilants hospital practices working group.
