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.

Deals


News We’re Watching: FDA Recalls Communication Pilot; Cardinal Buys Two Firms; Medtronic Diabetes App Cleared

This week, the US device center announced a pilot program to speed communications about high-risk recalls; Cardinal paid $3.9B for Advanced Diabetes Supply Group and GIA Alliance; a companion diagnostic for Merck lung cancer drug Tepmetko got FDA clearance; and more.

News We’re Watching: Medicare Payments For Renal Denervation; Acquisitions for Tempus And Boston Sci; LumiThera And Caris Land FDA Authorizations

 

This week, renal denervation systems from Medtronic and Recor won Medicare coverage; Boston Scientific bought cardiac-mapping firm Cortex; Veravas and Phanes Biotech teamed up on an Alzheimer’s diagnostic; and more.

Beta Bionics Launches iLet Bionic Pancreas With Abbott’s Latest-Generation CGM

 
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Beta Bionics’ automated insulin delivery system is now pairable with Abbott’s FreeStyle Libre 3 Plus CGM.

What's Next For Abbott Diabetes?

 
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Abbott’s Diabetes Care Division has recorded meteoric growth over recent years. Partnerships and a laser-focused strategy for driving patient access are at the core of its success, says Chris Scoggins, SVP of commercial operations and marketing.

R&D


Stakeholders Weigh In On UK’s Clinical Trials Diversity Draft

 
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As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.

When It Comes To Stroke Care, Spanish Start-Up Embodies ‘Time Is Brain’ Medical Principle To Save Neurons And Lives

 
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Medtech Insight spoke with executives from Spanish medtech firm Time is Brain about their wearable device that monitors stroke victims in real time, potentially saving lives.

News We’re Watching: Schwarzenegger ZB’s Chief Movement Officer; J&J Ottava Enters Clinical Trials; Dassault, FDA Develop First Guide For Virtual Twins

 

This week, Zimmer Biomet announced a new role of chief movement officer for Arnold Schwarzenegger, J&J MedTech receives IDE approval for Ottava, Dassault Systèmes with US FDA develop first guide for virtual twins, Mainz Biomed and Thermo Fisher team up to fight colorectal cancer.

Harbinger Health Enters New Collaboration With MSK On Validation Trials, Presents New Data

 
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Massachusetts-based Harbinger Health has partnered with Memorial Sloan Kettering Cancer Center in New York to accelerate the validation of its AI-driven blood test for early-stage cancer detection. The company also recently presented encouraging data at two conferences.

Strategy


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.

Boston Scientific’s Head Of Urology Says Axonics Acquisition ‘Brings A More Comprehensive Gender Balance’

 
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Medtech Insight spoke with Meghan Scanlon, president of Boston Scientific’s urology division, about integration plans for the recently acquired Axonics medtech. The purchase adds sacral neuromodulation to Boston Scientific’s portfolio, a global market that research reports valued at $1.6bn in 2023.

Companies Will Face Increased Regulatory Challenges In 2025, Pair Of Reports Say

 

Medical device manufacturers are among the companies that will face more regulatory challenges in the coming year. Two new reports look at the growing complexity of the regulatory landscape organizations will have to navigate.

News We’re Watching: Schwarzenegger ZB’s Chief Movement Officer; J&J Ottava Enters Clinical Trials; Dassault, FDA Develop First Guide For Virtual Twins

 

This week, Zimmer Biomet announced a new role of chief movement officer for Arnold Schwarzenegger, J&J MedTech receives IDE approval for Ottava, Dassault Systèmes with US FDA develop first guide for virtual twins, Mainz Biomed and Thermo Fisher team up to fight colorectal cancer.

Startups & SMEs


When It Comes To Stroke Care, Spanish Start-Up Embodies ‘Time Is Brain’ Medical Principle To Save Neurons And Lives

 
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Medtech Insight spoke with executives from Spanish medtech firm Time is Brain about their wearable device that monitors stroke victims in real time, potentially saving lives.

IMU Biosciences Joins £20M UK Government-Backed Cancer Immunoprofiling Project

 

IMU Biosciences joins a UK consortium of 27 academic and industry partners to undertake “immunoprofiling” of 6,000 cancer patients to assess their response to treatment.

University Of Cambridge Project Nimble Genomics Discusses Brain Cancer Liquid Biopsy

 

University of Cambridge's soon-to-be spun-out Nimble Genomics is among grant-winning projects in Capital Enterprise's Cancer Tech Accelerator. Medtech Insight spoke to clinical oncologist and Nimble founder Henno Martin and co-founder Radek Lach to learn more what about the brain cancer blood test’s prospects in an increasingly competitive liquid biopsy space.

7 Start-Ups At HLTH 2024: Shaking Up Medtech’s Business Model, ‘AI’ For Cancer Detection, MCI Assessment, Validation, Monitoring

 
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Medtech Insight was on the ground at HLTH looking for innovative companies. Learn about seven start-ups using AI to help physicians detect conditions including prostate and breast cancers, seizures and heart failure; assess patients for cognitive decline validate and deploy algorithms, and monitor patients in and out of the hospital.

Investor Eye


Investor Eye: Sofinnova Partners Are Redefining And Disobeying The Venture Investment Commandments

 

Sofinnova Partners has played an important role in defining the medtech investment space for the past 50 years, helping bring to market a plethora of life-saving technologies, even when they appear, initially, to be risky.

Investor Eye: Medtech Innovator’s Accelerator Is Catching Up With Pharma

 

Each year, Medtech Innovator whittles down a vast number of applicants to a relatively succinct shortlist of companies. Paul Grand, Medtech Innovator’s CEO, spoke to Medtech Insight about this process, as well as some of the broader trends impacting investment in medtech.

Investor Eye: Intuitive Surgical Hops, Skips, And Jumps Into VC

 

When a large medtech company sets up a venture fund, it typically invests in technologies that are adjacent to its pre-existing portfolio. Intuitive Surgical’s approach is different.

Investor Eye: A Licensing-Based Approach May Be Best For Revolutionary IP

 

Keeping a firm grip on one’s IP is a cornerstone of most innovative businesses. However, Robert Cote, CEO of Cote Capital, believes that if the idea is good enough to keep close, it’s good enough to license out.