Financing

Exact Sciences: Lower Guidance, But Payer Care Gap Programs Plan Shows Promise

 

Exact Sciences lowered its full-year 2024 midpoint guidance by $90m. Commercial adjustments to the sales force are being made "to fix the basics," senior company executives told the Jefferies London Healthcare Conference.

Guardant Health Eyes Earlier Breakeven As Liquid Biopsy Boosts Outlook

 

Guardant Health expects to break even by 2028. A positive pricing outlook for the Guardant 360 lab test could bring this forward by maybe one year, CFO Mike Bell told the Jefferies London Healthcare Conference.

SVB Report Finds 2024 Resurgence In Healthtech Investment, Driven Largely By Investments In AI

 
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Venture capital investment in healthtech is showing signs of early recovery in the first half of 2024 after the long hangover of a downturn that followed booming investments during the pandemic years, according to a new report from Silicon Valley Bank (SVB). Despite ongoing challenges, healthtech is on a positive trajectory and hovers between $3.5bn and $4.5bn per quarter, surpassing pre-pandemic levels.

Marabio Systems Raised $19M In Series A For Blood Test To Detect Autism

 
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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.


News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

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.  

Route 92 To Drive FreeClimb Neurointervention Sales With Extended Series F Funding

 

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.

News We’re Watching: New OPEQ Head, Constructive Bio Funding Round, Natera Wins Injunction In Patent Suit

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.

News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

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.


2024’s Medtech Venture Investment Climate Warmer Than 2023. Will It Last?

 

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.

Deals Shaping The Medtech And Diagnostics Industries, August 2024

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

Deals Shaping The Medtech And Diagnostics Industries, July 2024

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

Amferia Aims To Bring Peptide Hydrogel To Fight Against Antimicrobial Resistance

 

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.


Curio Prepares To Launch Postpartum Depression Digital Therapeutic With $10M In New Funding

 

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.

Truvian CEO Confident Blood-Testing Benchtop Could Be ‘Any Place You Go’

 
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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.

PreciseDX Aims To ‘Enrich’ Standard Of Care For Breast Cancer Recurrence Prediction

 

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.

News We’re Watching: AMP Sues FDA To Block Lab-Developed Test Rule; FDA Guidances; ICU Medical Infusion Pump Correction

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 Acquires Heart Failure Implant Company V-Wave For Up To $1.7Bn, Expanding Its Medtech Portfolio In Cardiology

 
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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 Secures $91M To Scale Commercialization Of MISHA Knee System

 

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.

Neptune Medical Leans Into GI Robotics, Spins Out Jupiter Endovascular

 

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 Secures $180M In Series C To Build Out AI-Enabled Surgical Software

 
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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.