Financing

Marabio Systems says the new funding will help accelerate efforts to bring a blood test to market in 2025 that will accurately determine if a mother is a carrier of antibodies that cause MARA, a subtype of autism that believe to cause more severe behavior.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

An additional $50m brings the neurovascular intervention specialist’s total Series F funding to $82m. Route 92 says it will use the capital to build its sales and support teams and pursue regulatory authorizations around the globe for its FreeClimb portfolio while advancing its SUMMIT MAX clinical trial for the investigational Monopoint Reperfusion System.

This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

Venture investment in medtech seems to be improving, particularly in diagnostics and tools, and down-value rounds have decreased. However, interest rates are still much higher than three years ago, and many tech investors continue to avoid the health care sector as a whole.

An interactive look at medtech and diagnostics deals made during August 2024. Data courtesy of Biomedtracker.

An interactive look at medtech and diagnostics deals made during July 2024. Data courtesy of Biomedtracker.

Amferia is developing an antimicrobial peptide hydrogel dressing to combat infections in acute wounds in humans and veterinary contexts. Supported by €1.2m of new venture capital financing, the company is planning pivotal clinical studies to support an FDA application later this year and CE mark submission in 2026-2027.

MamaLift Plus, 510(k)-cleared by the FDA in April as the first prescription digital therapeutic for treating postpartum depression, will soon be available for download on the App Store or Google Play. Announced 28 August, Curio has raised $10m in Series A funding to bolster commercial activities.

During a tour of Truvian’s San Diego headquarters, Medtech Insight spoke with the company’s top executives about their unique three-in-one blood-testing benchtop system, plans for FDA regulatory filing, and marketing strategy.

The New York-based augmented intelligence health care services provider has secured $20.7m in series B funding to support clinical validation and commercialization of its AI-powered breast cancer morphology diagnostic test PreciseBreast. The company intends for its test to advance current approaches to recurrence prediction comprising clinician histopathology assessment and genomic testing.

This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.

J&J buys heart failure implant company V-Wave, whose Ventura Interatrial Shunt could be the first device of its kind aimed to reach the roughly 800,000 patients in the US who experience heart failure and reduce ejection fraction every year.

Moximed aims to accelerate adoption of its MISHA Knee System, De Novo-approved by the US FDA in April 2023, with $91m in Series D funding. Chris Gleason, president and chief executive officer, offers perspective on the company’s innovative technology and commercial growth activities.

Announced in conjunction with a $97m Series D financing round, Neptune underscores its gastrointestinal focus and robotics aspirations by spinning out Jupiter Endovascular, which will leverage $21m of the funding to support ongoing development of its Endoportal Control technology.

Caresyntax said it will use the $180m it recently raised in a series C extension and debt financing round to build out its vendor-neutral surgery platform aimed to help surgeons with real-time and long-term decision support to improve patient outcomes and efficiencies.

Following FDA clearance of its Edison Histotripsy System in October 2023 for the non-invasive destruction of liver tumors using focused ultrasound, HistoSonics announces plans for $102m in new funding led by Alpha Wave Ventures. “Bubbles have never been so powerful,” the company says.

The nonprofit XLerator Network has announced eight life sciences start-ups, including five medtech concerns, that will benefit from its educational support and other resources. The NIH-funded program is designed to build entrepreneurial skills and promote commercialization of academic technologies in the US Southeast region. 

The Seattle-WA-based company’s latest capital raise follows study results published in July in which Know Labs’ proprietary non-invasive RF dielectric sensor and machine learning algorithms correctly classified participants’ glycemic status as hyperglycemic, normoglycemic, or hypoglycemic with 93.37% accuracy compared with venous blood glucose values. Know Labs' goal is to commercialize a diabetes screening device that could help to funnel undiagnosed patients into the health care system.