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Medera

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uuid003vwga

Namestring
Medera
Legal namestring
Medera Inc.
Websiteurl
medera.bio
Company typeenum
Private
Founded yearint
2014
Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
51–100
akta.pro rankint
HeadquartersBoston, United States
HQ citystring
Boston
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices2 records

Each record includes

City, Country, Type, Description, Source

Keyword5 values
cardiac gene therapy, AAV-based therapeutics, heart failure treatment, preclinical disease modeling, regenerative medicine
Industry3 codes
1Cardiometabolic & Other Systemic Gene Therapies
CodeHLAAACAIPrimaryYes
2In Vitro Model Systems & Organoid Platforms (iPSC/organoids, microphysiological systems)
CodeHLAAAIAJPrimaryNo
3Pulmonary Hypertension & Rare Pulmonary Disease Therapies
CodeHLAIAIAGPrimaryNo
NAICS code2 codes
  • Biological Product (except Diagnostic) Manufacturing325414
  • Scientific Research and Development Services5417
SIC code2 codes
  • Pharmaceutical Preparations2834
  • Surgical & Medical Instruments & Apparatus3841
Product category
Cardiovascular Gene Therapy
GTM motion2 records

Each record includes

Type, Description, Source

Revenue model2 records
1Gene Therapy Development and Commercialization
TypeOne Time License
Description

As a clinical-stage biopharmaceutical company, Medera's primary revenue model is developing and commercializing gene therapy candidates. The company has three clinical-stage AAV-based cardiac gene therapy programs targeting heart failure and DMD-associated cardiomyopathy.

medera.bio
2Technology Platform Licensing and Services
TypeLicensing Royalties
Description

Novoheart provides disease modeling and drug screening services to pharmaceutical companies using its human mini-Heart platform, including partnerships with AstraZeneca for CTScreen technology and disease model development.

medera.bio
Marketing channels4 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels3 records

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components5 values
Personnel, Technology or R&D, Operations, Marketing or Sales, Others
GTM typeB2B
B2B
Offering typeServices
Services
Core offering1 text field

Medera is a clinical-stage biopharmaceutical company that develops gene- and cell-based therapeutic candidates for cardiovascular diseases through two wholly-owned divisions. Novoheart provides preclinical disease modeling and drug discovery services using a proprietary human mini-Heart platform of cardiac screening assays, while Sardocor advances clinical-stage AAV1/SERCA2a gene therapy candidates for heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), and Duchenne muscular dystrophy-associated cardiomyopathy (DMD-CM), administered via a proprietary minimally invasive intracoronary delivery methodology.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 4 values shown
  • Up to 100x lower viral vector doses compared to conventional systemic IV methods
+3 more records
Product overview1 text field

Medera operates through two complementary business units: Novoheart and Sardocor. Novoheart provides the pre-clinical human mini-Heart platform (including Heart-in-a-Jar and CTScreen screening technology) for disease modeling and drug discovery. Sardocor leverages this platform to advance clinical-stage gene therapy candidates, including SRD-002 for HFpEF, SRD-001 for HFrEF, and AAV-SERCA2a for DMD-CM, all delivered via the company's proprietary intracoronary delivery methodology. The integrated approach spans from discovery through clinical development.

Product and service5 records
1SRD-002 (MUSIC-HFpEF)
CategoryCardiac Gene Therapy Product
Description

Investigational AAV1/SERCA2a gene therapy for heart failure with preserved ejection fraction (HFpEF), designed to restore cardiac calcium handling by increasing SERCA2a expression in cardiomyocytes, delivered via Medera's proprietary targeted intracoronary catheter-based outpatient procedure. Holds FDA Fast Track Designation.

2SRD-001 (MUSIC-HFrEF)
CategoryCardiac Gene Therapy Product
Description

Investigational AAV1/SERCA2a gene therapy for heart failure with reduced ejection fraction (HFrEF), currently in Phase 1b/2 clinical trial evaluating efficacy and safety in patients with NYHA class III/IV symptoms using Medera's targeted intracoronary delivery approach.

3AAV-SERCA2a (MUSIC-DMD)
CategoryCardiac Gene Therapy Product
Description

Investigational AAV1/SERCA2a gene therapy for cardiomyopathy secondary to Duchenne muscular dystrophy (DMD-CM), delivering the SERCA2a gene via AAV1 vector to restore calcium handling in cardiac muscle cells. Holds FDA Orphan Drug Designation and Fast Track Designation.

4Novoheart Preclinical Disease Modeling & Drug Discovery Service
CategoryPreclinical Research Service
Description

Pre-clinical disease modeling and drug discovery service offering using proprietary human mini-Heart platform (Heart-in-a-Jar) to generate human-specific preclinical drug safety, efficacy, and dosing data for pharmaceutical and biotech partners. Supports FDA Modernization Act 2.0 submissions.

5CTScreen v1.5
CategoryDrug Screening Platform / Hardware
Description

High-throughput automated cardiac screening platform supporting Novoheart's mini-Heart platform, accommodating up to 96 tissue samples in 96-well format for rapid screening with reduced cell requirements and costs. Licensed to pharmaceutical companies for automated cardiac drug screening.

Scale indicator7 records

Each record includes

Type, Value, Description, Source

Partnership5 partners
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2025-07-15
Description

First patient treated in MUSIC-DMD Phase 1b clinical trial for DMD-associated cardiomyopathy gene therapy. Dr. Pradeep Mammen serves as principal investigator at the institution.

Strategic tierMajorTypeStrategic or Co-development PartnerAnnounced on2025-06-24
Description

Collaboration to develop first human mini-Heart models of hypoplastic left heart syndrome (HLHS) using patient stem cells. Mayo Clinic contributes biobank of 800+ HLHS patient samples; UC San Diego contributes clinical expertise with Dr. Paul Grossfeld leading pediatric cardiology.

Strategic tierMajorTypeStrategic or Co-development PartnerAnnounced on2025-02-10
Description

CTScreen installation at UMC Utrecht's Regenerative Medicine Center for human cardiac disease modeling and therapeutic screening. Partnership enables study of disease-specific mechanisms and drug safety using human-based assays.

Strategic tierCoreTypeTechnology or IntegrationAnnounced on2024-12-18
Description

Strategic partnership integrating Novoheart's human Heart-in-a-Jar technology with Curi Bio's Pulse analytics platform for accelerated human-based cardiac drug development. Initial focus on adapting Pulse to process pressure-volume data from Heart-in-a-Jar.

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2024-12-10
Description

AstraZeneca installed CTScreen v1.5 for advancing human heart-based R&D for investigational cardiovascular therapies. Multi-year collaboration including co-development of HFpEF disease model that contributed to FDA IND clearance and Fast Track Designation.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight6 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Clinical-stage AAV gene therapy company with a cardiac-focused program (RP-A601) for Danon disease cardiomyopathy. Directly comparable as a small-cap AAV gene therapy developer with a cardiac indication and similar regulatory designations (Orphan, Fast Track).

TypeBroad incumbent
Description

Large, established AAV gene therapy platform acquired by Bayer with deep cardiovascular and rare disease pipelines. Comparable as a broad incumbent in AAV gene therapy manufacturing and delivery, though larger and more diversified than Medera's focused cardiac pipeline.

TypeDirect peer
Description

Clinical-stage gene therapy company focused on heart failure and cardiomyopathies, with programs targeting both rare (genetic) and prevalent forms of heart disease using AAV-based approaches. Directly competes in the cardiac gene therapy space.

TypeEmerging player
Description

Late-stage rare disease biopharmaceutical company with pulmonary programs (e.g., brensocatib for bronchiectasis) that overlap with Medera's preclinical pulmonary hypertension pipeline. Comparable for the rare-disease biopharma business model rather than direct therapeutic competition.

TypeBroad incumbent
Description

Commercial-stage gene therapy leader with Duchenne muscular dystrophy programs (Elevidys) and AAV manufacturing expertise. Overlaps with Medera on DMD-associated cardiomyopathy and AAV vector CMC, though broader in scope.

TypeBroad incumbent
Description

Late-stage cardiovascular company developing cardiac myosin modulators for HFrEF and HFpEF (e.g., aficamten). Comparable as a competitor in the heart failure therapeutic space Medera is targeting with gene therapy.

TypeEmerging player
Description

Pre-clinical/early clinical gene therapy company that was developing AAV-based therapies for cardiomyopathy associated with BAG3 mutations (acquired by Lexeo Therapeutics in 2024). Comparable as a small-cap cardiac gene therapy player with similar modality.

TypeBroad incumbent
Description

Large pharmaceutical company with significant cardiovascular franchise including heart failure drugs (e.g., acquired MyoKardia for cardiac genetic medicines). Competes broadly in heart failure therapeutics where Medera is developing its gene therapy pipeline.

TypeBroad incumbent
Description

Large pharmaceutical company with growing cardiovascular and heart failure franchises (e.g., semaglutide CV outcomes). Comparable as a large incumbent with deep pockets pursuing heart failure therapeutics where Medera is developing gene therapies.

TypeDirect peer
Description

Clinical-stage gene therapy company developing AAV-based cardiac therapeutics, including a SERCA2a program (LX2006) for Friedreich's ataxia cardiomyopathy and other cardiovascular gene therapies. Most directly comparable peer given overlapping cardiac AAV gene therapy approach and similar target indications.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks1 record

Each record includes

Headline, Details, Source

Key highlights7 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Named customers7 records

Each record includes

Name, Industry, Type, Use case, Source, UUID

Segment4 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile3 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

Integration3 records

Each record includes

Title, Type, Description, Source

AI capability3 records

Each record includes

Type, Description, Source

AI maturity
App detail

Has app

Feature4 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles12 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

Subsidiaries2 records

Each record includes

Name, Acquired on, Relationship type, Type, Business focus

Compliance4 records

Each record includes

Name, Class, Description

Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Medera

Cardiovascular Gene Therapymedera.bio

Medera firmographics

Firmographics
Name
Medera
Legal name
Medera Inc.
Website
https://medera.bio
Company type
Private
Founded year
2014
Operating status
Operating
Headcount range
51–100 employees
Ownership category
akta.pro rank

Medera industry classification

Industry
Product category
Cardiovascular Gene Therapy
NAICS
Biological Product (except Diagnostic) Manufacturing (325414), Scientific Research and Development Services (5417)
SIC
Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841)
akta.pro primary industry
Cardiometabolic & Other Systemic Gene Therapies (HLAAACAI)
akta.pro secondary industries
In Vitro Model Systems & Organoid Platforms (iPSC/organoids, microphysiological systems) (HLAAAIAJ), Pulmonary Hypertension & Rare Pulmonary Disease Therapies (HLAIAIAG)

Keywords

  • Cardiac gene therapy
  • AAV-based therapeutics
  • Heart failure treatment
  • Preclinical disease modeling
  • Regenerative medicine

Where Medera is headquartered

Location

Headquarters

HQ city
Boston
HQ country
United States
HQ region
North America

Offices2 records

Markets served

Medera business model

Business model
GTM type
B2B
Offering type
Services
Cost components
Personnel, Technology or R&D, Operations, Marketing or Sales, Others

Revenue model

  1. Gene Therapy Development and Commercialization: As a clinical-stage biopharmaceutical company, Medera's primary revenue model is developing and commercializing gene therapy candidates. The company has three clinical-stage AAV-based cardiac gene therapy programs targeting heart failure and DMD-associated cardiomyopathy.
  2. Technology Platform Licensing and Services: Novoheart provides disease modeling and drug screening services to pharmaceutical companies using its human mini-Heart platform, including partnerships with AstraZeneca for CTScreen technology and disease model development.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Medera product offering

Product offering

Core offering

Medera is a clinical-stage biopharmaceutical company that develops gene- and cell-based therapeutic candidates for cardiovascular diseases through two wholly-owned divisions. Novoheart provides preclinical disease modeling and drug discovery services using a proprietary human mini-Heart platform of cardiac screening assays, while Sardocor advances clinical-stage AAV1/SERCA2a gene therapy candidates for heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), and Duchenne muscular dystrophy-associated cardiomyopathy (DMD-CM), administered via a proprietary minimally invasive intracoronary delivery methodology.

Product overview

Medera operates through two complementary business units: Novoheart and Sardocor. Novoheart provides the pre-clinical human mini-Heart platform (including Heart-in-a-Jar and CTScreen screening technology) for disease modeling and drug discovery. Sardocor leverages this platform to advance clinical-stage gene therapy candidates, including SRD-002 for HFpEF, SRD-001 for HFrEF, and AAV-SERCA2a for DMD-CM, all delivered via the company's proprietary intracoronary delivery methodology. The integrated approach spans from discovery through clinical development.

Differentiator

Problem solved

Functional benefit

Products and services

  • SRD-002 (MUSIC-HFpEF) Investigational AAV1/SERCA2a gene therapy for heart failure with preserved ejection fraction (HFpEF), designed to restore cardiac calcium handling by increasing SERCA2a expression in cardiomyocytes, delivered via Medera's proprietary targeted intracoronary catheter-based outpatient procedure. Holds FDA Fast Track Designation.
  • SRD-001 (MUSIC-HFrEF) Investigational AAV1/SERCA2a gene therapy for heart failure with reduced ejection fraction (HFrEF), currently in Phase 1b/2 clinical trial evaluating efficacy and safety in patients with NYHA class III/IV symptoms using Medera's targeted intracoronary delivery approach.
  • AAV-SERCA2a (MUSIC-DMD) Investigational AAV1/SERCA2a gene therapy for cardiomyopathy secondary to Duchenne muscular dystrophy (DMD-CM), delivering the SERCA2a gene via AAV1 vector to restore calcium handling in cardiac muscle cells. Holds FDA Orphan Drug Designation and Fast Track Designation.
  • Novoheart Preclinical Disease Modeling & Drug Discovery Service Pre-clinical disease modeling and drug discovery service offering using proprietary human mini-Heart platform (Heart-in-a-Jar) to generate human-specific preclinical drug safety, efficacy, and dosing data for pharmaceutical and biotech partners. Supports FDA Modernization Act 2.0 submissions.
  • CTScreen v1.5 High-throughput automated cardiac screening platform supporting Novoheart's mini-Heart platform, accommodating up to 96 tissue samples in 96-well format for rapid screening with reduced cell requirements and costs. Licensed to pharmaceutical companies for automated cardiac drug screening.

Quantifiable outcome

  • Up to 100x lower viral vector doses compared to conventional systemic IV methods
  • +3 more outcomes

Companies that use Medera

Customer profile

Named customers7 records

Segments4 records

Ideal customer profiles3 records

Medera technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Integration3 records

AI capability3 records

Feature4 records

Medera partnerships and signals

Strategic signal

Partnerships

Five partnerships are on record, tiered core and major.

  • University of Kansas Medical CentercoreStrategic or Co-development Partner · 15 July 2025First patient treated in MUSIC-DMD Phase 1b clinical trial for DMD-associated cardiomyopathy gene therapy. Dr. Pradeep Mammen serves as principal investigator at the institution.
  • Mayo Clinic and UC San Diego School of MedicinemajorStrategic or Co-development Partner · 24 June 2025Collaboration to develop first human mini-Heart models of hypoplastic left heart syndrome (HLHS) using patient stem cells. Mayo Clinic contributes biobank of 800+ HLHS patient samples; UC San Diego contributes clinical expertise with Dr. Paul Grossfeld leading pediatric cardiology.
  • University Medical Center UtrechtmajorStrategic or Co-development Partner · 10 February 2025CTScreen installation at UMC Utrecht's Regenerative Medicine Center for human cardiac disease modeling and therapeutic screening. Partnership enables study of disease-specific mechanisms and drug safety using human-based assays.
  • Curi BiocoreTechnology or Integration · 18 December 2024Strategic partnership integrating Novoheart's human Heart-in-a-Jar technology with Curi Bio's Pulse analytics platform for accelerated human-based cardiac drug development. Initial focus on adapting Pulse to process pressure-volume data from Heart-in-a-Jar.
  • AstraZenecacoreStrategic or Co-development Partner · 10 December 2024AstraZeneca installed CTScreen v1.5 for advancing human heart-based R&D for investigational cardiovascular therapies. Multi-year collaboration including co-development of HFpEF disease model that contributed to FDA IND clearance and Fast Track Designation.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Medera competitors and assessment

Company assessment

Direct peers

  • Rocket Pharmaceuticals: Clinical-stage AAV gene therapy company with a cardiac-focused program (RP-A601) for Danon disease cardiomyopathy. Directly comparable as a small-cap AAV gene therapy developer with a cardiac indication and similar regulatory designations (Orphan, Fast Track).
  • Tenaya Therapeutics: Clinical-stage gene therapy company focused on heart failure and cardiomyopathies, with programs targeting both rare (genetic) and prevalent forms of heart disease using AAV-based approaches. Directly competes in the cardiac gene therapy space.
  • Lexeo Therapeutics: Clinical-stage gene therapy company developing AAV-based cardiac therapeutics, including a SERCA2a program (LX2006) for Friedreich's ataxia cardiomyopathy and other cardiovascular gene therapies. Most directly comparable peer given overlapping cardiac AAV gene therapy approach and similar target indications.

Broad incumbents

  • AskBio (Bayer): Large, established AAV gene therapy platform acquired by Bayer with deep cardiovascular and rare disease pipelines. Comparable as a broad incumbent in AAV gene therapy manufacturing and delivery, though larger and more diversified than Medera's focused cardiac pipeline.
  • Sarepta Therapeutics: Commercial-stage gene therapy leader with Duchenne muscular dystrophy programs (Elevidys) and AAV manufacturing expertise. Overlaps with Medera on DMD-associated cardiomyopathy and AAV vector CMC, though broader in scope.
  • Cytokinetics: Late-stage cardiovascular company developing cardiac myosin modulators for HFrEF and HFpEF (e.g., aficamten). Comparable as a competitor in the heart failure therapeutic space Medera is targeting with gene therapy.
  • Bristol Myers Squibb: Large pharmaceutical company with significant cardiovascular franchise including heart failure drugs (e.g., acquired MyoKardia for cardiac genetic medicines). Competes broadly in heart failure therapeutics where Medera is developing its gene therapy pipeline.
  • Novo Nordisk (Heart Failure Programs): Large pharmaceutical company with growing cardiovascular and heart failure franchises (e.g., semaglutide CV outcomes). Comparable as a large incumbent with deep pockets pursuing heart failure therapeutics where Medera is developing gene therapies.

Emerging players

  • Insmed: Late-stage rare disease biopharmaceutical company with pulmonary programs (e.g., brensocatib for bronchiectasis) that overlap with Medera's preclinical pulmonary hypertension pipeline. Comparable for the rare-disease biopharma business model rather than direct therapeutic competition.
  • Renovacor: Pre-clinical/early clinical gene therapy company that was developing AAV-based therapies for cardiomyopathy associated with BAG3 mutations (acquired by Lexeo Therapeutics in 2024). Comparable as a small-cap cardiac gene therapy player with similar modality.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks1 record

Key highlights7 records

Customer concentration

Medera social profiles

Digital presence

Medera compliance and trust

Trust signal

Compliance4 records

Medera financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Medera leadership team

Management profile

Number of profiles

Profiles12 records

Medera subsidiaries and ownership

Company hierarchy

Subsidiaries2 records

Medera funding detail

Funding detail

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Medera M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Medera

What does Medera do?

Medera is a clinical-stage biopharmaceutical company that develops gene- and cell-based therapeutic candidates for cardiovascular diseases through two wholly-owned divisions. Novoheart provides preclinical disease modeling and drug discovery services using a proprietary human mini-Heart platform of cardiac screening assays, while Sardocor advances clinical-stage AAV1/SERCA2a gene therapy candidates for heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), and Duchenne muscular dystrophy-associated cardiomyopathy (DMD-CM), administered via a proprietary minimally invasive intracoronary delivery methodology.

Is Medera a public or private company?

Medera is a private company. It is classified as venture growth investor backed and is currently operating.

When was Medera founded?

Medera was founded in 2014. It employs 51 to 100 people.

Where is Medera based?

Medera is headquartered in Boston, United States, in the North America region.

How does Medera make money?

Two revenue lines are on record. Gene Therapy Development and Commercialization is the primary driver. The others are technology Platform Licensing and Services.

Who are Medera's main competitors?

Direct peers on record are Rocket Pharmaceuticals, Tenaya Therapeutics and Lexeo Therapeutics. Broad incumbents are AskBio (Bayer), Sarepta Therapeutics, Cytokinetics, Bristol Myers Squibb and Novo Nordisk (Heart Failure Programs). Emerging players are Insmed and Renovacor.

Does Medera have an API?

No public API is recorded for Medera.

What industry is Medera in?

Medera's product category is Cardiovascular Gene Therapy. Its primary akta.pro industry code is HLAAACAI, Cardiometabolic & Other Systemic Gene Therapies, with a secondary code of HLAAAIAJ, In Vitro Model Systems & Organoid Platforms (iPSC/organoids, microphysiological systems). Its NAICS code is 325414 and its SIC code is 2834.

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Live signals
BioSpaceMedera Presents Late-Breaking Clinical Trial Data at ESC Congress 2026 Demonstrating Durable Improvement in HFpEF Cardiac Filling Pressures Following SRD-002 Gene TherapyMedera presented 12-month data from its MUSIC-HFpEF trial at ESC Congress 2026, showing 80% of patients normalized cardiac filling pressures and a 30% reduction in peak exercise PCWP after a single intracoronary SRD-002 dose. The improvements were durable and dose-dependent, with no serious adverse events. The company plans to advance to a randomized Phase 2b trial.Simply Wall StHow IQVIA’s Medera Cardiac Gene Therapy Alliance and Raised 2026 Outlook Will Impact IQV (IQV) InvestorsIQVIA Inc. and Medera Inc. announced a collaboration in late July/early August 2026 to advance cardiac gene therapies and human-based drug discovery, integrating IQVIA's trial execution and regulatory infrastructure with Medera's Sardocor gene therapy programs and Novoheart's mini-Heart platform. Simultaneously, IQVIA reported second-quarter results, updated its share buyback activity, and raised full-year 2026 revenue guidance to US$17.28–US$17.48 billion, with third-quarter outlook set at US$4.32–US$4.39 billion. The alliance positions IQVIA to deepen its role in advanced cardiovascular research while navigating ongoing pricing pressure and margin strain across its CRO contracts.citybizMedera Partners with IQVIA to Accelerate Cardiac Gene Therapies and Human-Based Drug Discovery PlatformsIQVIA has partnered with clinical-stage biotechnology company Medera to accelerate cardiac gene therapies and human-based drug discovery technologies. Under the agreement, IQVIA will provide clinical trial execution, patient recruitment, data management, and regulatory support to Medera's Sardocor gene therapy division, while also assisting with FDA designation applications for its AAV-based cardiovascular gene therapy programs. The collaboration also encompasses Medera's Novoheart subsidiary, whose mini-Heart engineered human cardiac tissue platform has already supported IND applications and FDA Fast Track designations under the FDA Modernization Act 2.0.MorningstarIQVIA and Medera to Advance Cardiac Gene Therapy and Human-Based Drug DiscoveryIQVIA and Medera announced a strategic collaboration to advance cardiac gene therapies and human-based drug discovery. The partnership combines IQVIA's clinical trial infrastructure with Medera's Sardocor gene therapy programs and Novoheart's mini-Heart platform, which has already secured FDA IND and Fast Track designations.GlobeNewswireMedera Announces Independent Data Monitoring Committee (DMC) Recommends Continued Advancement of Lead HFpEF Gene Therapy ProgramMedera Inc. announced that an independent Data Monitoring Committee completed its scheduled review of the ongoing MUSIC-HFpEF clinical trial evaluating SRD-002 gene therapy for heart failure with preserved ejection fraction, recommending the study continue without protocol modification after identifying no safety concerns. All ten patients across two dose cohorts have been successfully treated, with no gene therapy-related serious adverse events reported to date and Cohort A showing clinical improvements at 12-month follow-up. The company now prepares for discussions with the FDA regarding the next randomized stage of development and expects to report Cohort B 12-month data in the last quarter of 2026.BioSpaceMedera Announces Independent Data Monitoring Committee (DMC) Recommends Continued Advancement of Lead HFpEF Gene Therapy ProgramMedera's independent Data Monitoring Committee recommended continued conduct of its MUSIC-HFpEF trial without protocol modification after reviewing accumulated clinical data. No safety concerns were identified, and the committee also reviewed the MUSIC-HFrEF Phase 1/2a trial. The company expects to report 12-month data from Cohort B patients in the last quarter of 2026.GlobeNewswireMedera Announces Independent Data Monitoring Committee (DMC) Recommends Continued Advancement of Lead HFpEF Gene Therapy ProgramMedera's independent Data Monitoring Committee reviewed its MUSIC-HFpEF trial of SRD-002 gene therapy and recommended continuing the study without protocol changes. No safety concerns were identified, and all ten patients have been treated across two dose cohorts. The company expects to report 12-month data from Cohort B in the last quarter of 2026.GlobeNewswireMedera Expands Scientific Advisory Board with Leading Heart Failure and Cardiopulmonary Physiology Experts to Advance HFpEF Gene Therapy ProgramMedera Inc., a clinical-stage biopharmaceutical company, announced the appointment of three leading heart failure and cardiopulmonary physiology experts—Gregory Lewis, Marat Fudim, and Rajeev Malhotra—to its Scientific Advisory Board to support advancement of its HFpEF gene therapy program. The appointments strengthen Medera's clinical and physiological framework as its lead program SRD-002, targeting heart failure with preserved ejection fraction, shows consistent improvements in cardiac hemodynamics and functional measures. Medera operates through two business units, Novoheart and Sardocor, and is developing AAV-based cardiac gene therapies targeting fundamental drivers of heart failure.BioSpaceMedera Expands Scientific Advisory Board with Leading Heart Failure and Cardiopulmonary Physiology Experts to Advance HFpEF Gene Therapy ProgramMedera appointed Gregory Lewis, Marat Fudim, and Rajeev Malhotra to its Scientific Advisory Board to advance its HFpEF gene therapy program. The company's lead program, SRD-002, has shown consistent improvements in cardiac hemodynamics and functional measures. Medera expects to share additional clinical updates in the near term.BioSpace4 spaces primed for the next wave of gene therapiesThe FDA approved Regeneron Pharmaceuticals' Otarmeni as the first gene therapy for congenital hearing loss last month, validating the broader potential of genetic medicines beyond oncology. Researchers and companies including Eli Lilly, UniQure, Lexeo, AskBio, Taysha Gene Therapies, and Passage Bio are now advancing gene therapies targeting central nervous system diseases such as Alzheimer's, Parkinson's, and Huntington's, with UniQure reporting Phase 1/2 data showing its AMT-130 therapy slowed Huntington's disease progression by 75% after three years. The therapeutic expansion extends into eye diseases, cardiovascular conditions, and neuromuscular disorders, with companies like REGENXBIO, AbbVie, 4D Molecular Therapeutics, Tenaya, Medera, Sarepta, and Novartis developing pipeline candidates across wet AMD, heart failure, and Duchenne muscular dystrophy.