Announcement

Huma receives world’s first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform

March 23, 2023
Announcement

Huma receives world’s first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform

March 23, 2023

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  • Huma’s platform is ready to use, reducing the time and cost for other companies to bring regulated SaMD products to market, democratising digital health innovation across the industry
  • Class IIb certification expands the patient population and level of disease severity that can be managed; allowing delivery of personalised care through the use of predictive algorithms
  • Clinical evidence from over 20 peer-reviewed publications and studies were submitted for regulatory assessment of clinical safety and efficacy

NEW YORK & LONDON, March 23, 2023 Huma Therapeutics (“Huma”), a leading global digital health company, today announced that it has become the only company in the world to receive EU MDR 2017/745 Class IIb certification for a disease agnostic Software as a Medical Device (SaMD)1. This level of regulatory certification makes Huma’s technology the highest classified configurable disease agnostic platform in the sector today.

The company’s SaMD platform powers digital health pathways through which data are collected from patients for self-management or to be assessed centrally by clinicians. These include remote patient monitoring (RPM) systems, companion apps, risk assessment tools, dose calculators, algorithms.

Achieving Class IIb certification means that the SaMD platform is permitted to monitor patients of all ages with any condition - including infants and in pregnancy - and can connect with a range of external devices, such as heart rate, blood sugar monitors or smart inhalers. In addition to enabling disease self-management by patients, it can also support clinicians to manage serious and critical conditions such as heart failure, COPD exacerbations, surgical recovery, cancer, immunodeficiency, asthma attacks and more. The platform is now able to host machine learning algorithms that can support risk prediction, diagnosis and prognostication.

The platform can reduce burden on HCPs and healthcare systems by:

  • Offering enhanced decision-making tools for clinicians, such as treatment and diagnostic recommendations for serious conditions
  • Delivering proactive care through advanced triage alerts, filters and flags personalised to individual patients and communicated to clinicians via a customisable dashboard
  • Providing advanced personalised insights generated from a patient’s medical history and health data, to optimise care and outcomes
  • Hosting biomarkers to diagnose and monitor conditions that require frequent clinical observations

Dan Vahdat, CEO & Founder of Huma, said: “We have spent more than a decade advancing our platform and we are delighted to see this validated by achieving Class IIb certification which is a breakthrough for the entire digital health industry. Now, instead of spending years developing a regulated app at a cost sometimes running into tens of millions of dollars, companies can configure our Class IIb-approved platform to their specific needs, thus reducing risk and democratising innovation in digital health.”

Jeanne Kehren, Senior Vice President, Digital & Commercial Innovation and Chief Information Officer Pharmaceuticals, Bayer AG, said: “By rigorously working towards this high standard of certification for its technology platform, Huma has demonstrated its commitment to providing an evidence-based, patient-centred and scientifically robust solution, and to making digital health technology a driver of the healthcare ecosystem transformation”. Bayer is a long-time investor in Huma through its venture capital arm, Leaps by Bayer.

Dr Mert Aral, Chief Medical Officer at Huma, said: “Demonstrating the clinical efficacy and safety of our technology through this level of regulatory certification is essential for the trust needed to provide accurate, real-time insights to aid clinical decision-making in disease management. Clinicians can now deliver personalised treatment plans based on individual patient needs, medical history and digital biomarkers to optimise health outcomes and tailor the experience to patient preferences.” 

Speaker shot.

Dan Vahdat, CEO & Founder of Huma

“We have spent more than a decade advancing our platform and we are delighted to see this validated by achieving Class IIb certification which is a breakthrough for the entire digital health industry. Now, instead of spending years developing a regulated app at a cost sometimes running into tens of millions of dollars, companies can configure our Class IIb-approved platform to their specific needs, thus reducing risk and democratising innovation in digital health.”

Speaker shot.

Jeanne Kehren, Senior Vice President, Digital & Commercial Innovation and Chief Information Officer Pharmaceuticals, Bayer AG

“By rigorously working towards this high standard of certification for its technology platform, Huma has demonstrated its commitment to providing an evidence-based, patient-centred and scientifically robust solution, and to making digital health technology a driver of the healthcare ecosystem transformation”. Bayer is a long-time investor in Huma through its venture capital arm, Leaps by Bayer.

Speaker shot.

Dr Mert Aral, Chief Medical Officer at Huma

“Demonstrating the clinical efficacy and safety of our technology through this level of regulatory certification is essential for the trust needed to provide accurate, real-time insights to aid clinical decision-making in disease management. Clinicians can now deliver personalised treatment plans based on individual patient needs, medical history and digital biomarkers to optimise health outcomes and tailor the experience to patient preferences.”

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About Huma

Huma Therapeutics is a global digital health technology company that advances digital-first care delivery and research to help people live longer, fuller lives.

Huma's award-winning modular platforms are used by more than 3,000 hospitals and clinics, with 1.8+ million active users in healthcare and 650,000+ participants across research. Huma's regulated Software as a Medical Device is the only platform to hold Class IIb certification status. It powers:

  • Digital first care for health systems
  • Companion apps to support patients through treatment and drug therapies
  • Virtual clinical trials to accelerate research

Please visit www.huma.com and follow us on LinkedIn at Huma

Media contact:

Karen Birmingham PhD
Head of PR & Communications, Huma
karen.birmingham@huma.com
+44 (0) 7866 609314

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Making an impact

3000+

3000+ hospitals and clinics supported across Huma platforms to secure the most sustainable impact for patients1

×2

Our platform can almost double clinical capacity and reduce readmission rates by >30%3

27m+

Huma's digital-first health platforms support a network of 27m patients1

1m+

Over 1 million devices have been shipped in support of our projects and we know what it takes to deploy at scale1

Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4

Selected as one of 'The Most Important Healthcare Design of 2021' by Fast Company5

Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4

Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4

Announcement

Huma receives world’s first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform

March 23, 2023
Announcement

Huma receives world’s first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform

March 23, 2023

Huma joins digital pioneers to advance health equity in care and research

Chief Executive Officer and Founder, Dan Vahdat, is returning to the annual World Economic Forum’s main conference where he will join a panel discussion devoted to improving care for non-communicable disease and tackling health equity. Accompanied by Chief Financial and Strategy Officer, Ingeborg Oie, Dan is looking forward to connecting with other attendees to explore how Huma’s digital health platform can make healthcare more equitable, and advances proactive, predictive care.

Huma joins digital pioneers to advance health equity in care and research

Date:Wednesday, January 18, 2023
Time:4:15 - 5:15 p.m. CET
Location:Ice Village, Eisbahnstrasse 5, Davos, Switzerland
Dan will join the Digital Health Action Alliance panel at Davos to discuss Turning the Tide in Non-Communicable Disease Care Through Digital Health and Community Connection. Huma has a long history of advancing the care of non-communicable diseases (NCDs) such as heart disease, cancer, diabetes and lung conditions. Huma’s innovative remote patient monitoring platform enables broad patient recruitment, reduces reliance on in-person clinic visits and increases health system efficiency.
*This session is open to registered Annual Meeting 2023 participants and Affiliate badge holders.

Huma is one of the first to sign the Zero Health Gaps Pledge

Huma is one of the first signatories to the Zero Health Gaps Pledge, the World Economic Forum’s Global Health Equity Network’s (GHEN) initiative. Huma supports GHEN’s ambition to build a future without disparities in health or wellbeing outcomes. Huma’s digital platform has been built on a deep clinical knowledge of complex patient needs and how people engage with technology and we are committed to ensuring our technology promotes health equity. We are proud to work with governments, hospital groups, universities, life science and technology companies to bring greater scale and impact and help all people live longer, fuller lives.

Huma at World Economic Forum

Global Innovators and Tech Pioneers
Dec 2022: Huma selected to join 100 innovative companies on a two-year journey as part of the World Economic Forum’s initiatives, activities and events, bringing their cutting-edge insight and fresh thinking to critical global discussions.
Learn more
Working Together, Restoring Trust
May 2022: With the aim to address economic, environmental, political, and social fault-lines exacerbated by the COVID-19 pandemic, Dan Vahdat speaks at WEF annual meeting about the importance of scientific collaboration.
Learn more
Accelerating innovation and breaking new ground
October 2022: Dan joined the WEF Biotech Future Forum 2022 to discuss how start-ups are breaking new ground in biotech and changing the way we interact with the world, but also how the sector can earn trust, scale successfully and spot the brightest innovations.
Learn more
Making connections at Davos
Jan 2019: Dan attended WEF as an unofficial attendee and spoke to CNBC about the importance of meeting in-person to make connections.
Learn more

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Announcement

Huma receives world’s first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform

March 23, 2023
Media contact
A headshot of Karen Birmingham PhD
Karen Birmingham PhD
Head of PR & Communications
karen.birmingham@huma.com
Announcement

Huma receives world’s first and only multi-condition EU MDR Class IIb regulatory approval for its configurable SaMD disease management platform

March 23, 2023
Media contact
A headshot of Karen Birmingham PhD
Karen Birmingham PhD
Head of PR & Communications
karen.birmingham@huma.com
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About Huma

Huma began its journey in 2011, when the company was founded in London. Since then, Huma has grown to become a global healthcare company, spanning across multiple geographies and operating across four continents.

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