MammoGRIP® — The Invisible Glove
Mammography technologist and patient — MammoGRIP® in practice

The Missing Link
in Modern
Breast Imaging

Despite advances in digital mammography, tomosynthesis, and AI-assisted interpretation, one fundamental element remains unchanged: breast tissue must first be properly positioned. MammoGRIP® is designed to deliver exactly that.

The MammoGRIP® Principle

Better GripBetter PositioningBetter Tissue InclusionBetter Image QualityBetter DetectionBetter Outcomes
FDA-Cleared · United StatesANVISA Approved · BrazilCE Mark · European UnionClinically Studied
The Challenge

The Numbers Behind
39 Million Mammograms a Year

Despite remarkable advances in digital mammography, tomosynthesis, and AI-assisted interpretation, one fundamental moment remains unchanged and underserved — the physical contact between the technologist's hands and the patient.

Patient
5 of 10 women
25–46%

of women cite pain

as the reason they don't return for annual screening. Fear of discomfort is not a comfort issue — it is a cancer detection issue.

Whelehan et al., Breast 2013

20%

of ALL image failures

caused by positioning deficiencies — the #1 cited category across ACR-accredited centers

Bassett et al., Radiology 2000

49%

of all retakes

traced directly to positioning errors — nearly 1 in 2 avoidable with proper technique

Prieto et al., RPD 2015

52.4%

global IMF average

Half of all mammograms miss the inframammary fold — a critical anatomical landmark for complete imaging

Spuur et al., Eur J Radiol 2018

84%
optimal imaging
66.3%
poor positioning

Sensitivity drop for invasive breast cancer detection

When images fail positioning criteria, radiologists lose nearly 18 percentage points of diagnostic sensitivity — directly increasing the risk of missed cancers

Taplin et al., AJR 2002

Woman leaving mammography center

"Better positioning is not a technical problem.
It is a grip problem."

39 million mammograms annually in the United States alone. One moment that determines the quality of every image.

Estimated 60–90M mammograms performed globally each year (screening + diagnostic) · US: BRFSS / NHIS / NMD · Europe: EUNICE / Eurostat · Global: GLOBOCAN 2022

The Solution

MammoGRIP®: A Mammography-Specific
Positioning Technology

Applied to the mammography technologist's hands before breast positioning, MammoGRIP® is the only mammography solution of its kind — combining enhanced grip performance with antiseptic hand preparation in a single, workflow-integrated application designed to support breast imaging quality and patient comfort at the point of acquisition.

Positioning Technology

"The Invisible Glove"

The only mammography-specific positioning technology of its kind — applied to the technologist's hands, not the equipment.

Enhanced Grip Surface

Creates a gentle adhesive surface designed to improve tissue manipulation with less breast handling — intended to reduce the extent of contact needed for proper positioning.

Antiseptic Formulation

Benzalkonium chloride-based antiseptic formulation designed to replace examination gloves. Absorbs rapidly — no residue on patient or technologist.

Zero-Residue Formula

Alcohol-free, fragrance-free, water-free. Single-use per exam. No equipment modification. No training required. Immediate workflow integration.

Patented Technology

MammoGRIP® is the only mammography-specific positioning technology of its kind with clinical data supporting improved image quality.

Why Not Simply Use Gloves?

Standard examination gloves are barrier devices intended primarily for infection control. To the authors' knowledge, no published clinical studies have demonstrated improved mammographic positioning performance — improved IMF visualization, reduced retake rates, or improved image-quality metrics — through the use of standard examination gloves alone.

MammoGRIP® is not simply a grip aid and not simply an antiseptic product. It is a mammography-specific positioning technology — the only one of its kind with clinical data.

FormatSingle-use topical antiseptic solution
ApplicationHand-applied by technologist before positioning
Active IngredientBenzalkonium chloride-based antiseptic
PropertiesAlcohol-free, fragrance-free, water-free
IP StatusPatented product and methodology (MammoGRIP LLC)

The MammoGRIP® Principle

Better GripBetter PositioningBetter Tissue InclusionBetter Image QualityBetter DetectionBetter Outcomes
Clinical Evidence

Clinical Evidence
Supporting MammoGRIP®

Two independent clinical investigations report on MammoGRIP® performance — one measuring objective image quality metrics against ACR positioning criteria, one capturing patient-reported experience of comfort and procedural adherence.

Study 01 — Image Quality

Englewood Health Pilot Study

Goldfischer M, Weiselberg C, Kim H, Williams K

Within-subject comparison of 50 women (ages 40–75) undergoing routine screening mammography at a single center. Each participant's MammoGRIP® mammogram was compared to her own prior historical mammogram using McNemar's test — minimising inter-patient variability.

ACR CriterionMammoGRIP®p-value
IMF Visualization — Right66%0.029 ✓
IMF Visualization — Left91%0.014 ✓
Nipple Profile (bilateral)96%
Skin Fold Absence94%
Posterior Tissue66–96%

★ Statistically significant vs. each participant's own prior historical mammogram (McNemar's test, within-subject paired analysis). Peer-reviewed publication is planned following completion of the clinical investigation and final analysis. Ongoing single-center pilot investigation.

Study 02 — Patient Experience

Portugal Patient Experience Study

Bioflex and Akurey / MammoGRIP® · Lisbon Region

62 women underwent mammography with MammoGRIP®; 14 women consented to in-depth interviews. Pain is not merely a comfort issue — published systematic reviews demonstrate that 25%–46% of women who do not return for screening cite pain as the reason (Whelehan et al., Breast 2013).

93%

Recognized reduced discomfort and less breast manipulation

79%

Acknowledged fewer retakes compared to prior mammograms

57%

Recognized fewer retakes improved diagnostic confidence and reduced radiation exposure

100%

Felt confident undergoing the exam with MammoGRIP®

0%

of technologists identified any problem with MammoGRIP® use

IMF Visualization — Clinical Performance

Englewood Health Clinical Investigation

91%

Left IMF Visualization

vs. each participant's own prior historical mammogram · Within-subject paired analysis · p=0.014 · Englewood Health Pilot Investigation (n=50) · Ongoing single-center pilot

Published Benchmark — Clinical Literature

approx. 52.4%

Standard Mammographic Practice

Spuur KM et al. · European Journal of Radiology, 2018 · Independent published benchmark

Independent published benchmark

The Englewood Health clinical investigation compared each participant's MammoGRIP® examination with her own prior historical mammogram using a within-subject paired design. The approximately 52.4% value represents an independently published benchmark reported in the clinical literature (Spuur KM et al., European Journal of Radiology, 2018) and is presented solely to provide clinical context. It was not part of the study design and was not used as the study comparator.

Educational Disclaimer: Clinical findings presented on this website are derived from ongoing clinical evaluations at Englewood Health. Preliminary findings have been presented through scientific forums and continue to contribute to the clinical evaluation of MammoGRIP®. Additional healthcare institutions have expressed interest in evaluating the technology, and future collaborative studies remain under consideration, subject to institutional review and applicable regulatory and ethical approvals.

The AI Era

AI Has Raised the Stakes —
MammoGRIP® Is the Foundational Layer

The emergence of AI-assisted screening has increased the importance of image quality rather than reduced it. Every AI benefit assumes the image was properly acquired — and that assumption starts with MammoGRIP®.

01

AI Reads After Acquisition

AI-assisted screening tools analyze images after they are acquired. The MASAI trial demonstrated AI-supported screening achieved 80.5% sensitivity vs 73.8% with a 12% reduction in interval cancer rate.

MASAI trial, 2024

02

But AI Assumes Image Quality

Suboptimal images led to inaccurate AI risk scores with unexpectedly large variability. AI-driven feedback systems assess quality after acquisition — they cannot fix what was never captured.

Alström et al., Radiat Prot Dosimetry 2026

03

MammoGRIP® Works During Acquisition

MammoGRIP® is designed to improve the physical quality of image acquisition. It is not a replacement for AI — it is the foundational layer upon which every downstream technology depends.

The MammoGRIP® Principle

"MammoGRIP® is not a replacement for AI or advanced imaging technologies — it is a complementary foundational layer upon which every downstream technology depends."

ZERO-DISRUPTION ADOPTION

Innovation Without
Disruption.

MammoGRIP® integrates naturally into existing mammography workflows.

Equipment replacement
Software integration
Workflow redesign
Scheduling changes
Changes to mammographic positioning technique
Infrastructure modifications
Extensive staff retraining

Simply integrate MammoGRIP® into established clinical practice.

Benefits for Every Stakeholder

One Technology.
Transformative Impact Across Roles.

For Imaging Centers
For Imaging Centers

Efficiency, Quality, and ACR Compliance

Intended to reduce positioning-related retakes, MammoGRIP® may support ACR accreditation performance benchmarks, extended equipment longevity, and increased patient throughput — with estimated throughput improvements of approximately 1,000 additional patients per year at 10,000-exam facilities.

  • Designed to reduce retake rates
  • Supports ACR accreditation criteria
  • Extended X-ray tube life
  • Glove cost elimination
For Patients
For Patients

Dignity, Comfort, and Confidence

MammoGRIP® is designed to reduce the extent of breast manipulation required for positioning, which may support patient comfort and reduce anxiety. 93% of patients in the Portugal study recognized reduced discomfort. When women have better experiences, they return for screening.

  • Less breast manipulation
  • Reduced discomfort and anxiety
  • Increased screening adherence
  • Positive experience shared with others
For Technologists
For Technologists

Professional Confidence and Control

MammoGRIP® is designed to give technologists enhanced grip control during positioning — supporting more consistent results with less physical effort. In the Portugal study, 0% of technologists identified any problem with MammoGRIP® use.

  • Enhanced grip precision
  • Designed to reduce retake rates
  • No equipment changes required
  • Integrates into existing workflow instantly
For Healthcare Systems
For Healthcare Systems

Population Health and Earlier Detection

Improved positioning quality may directly support earlier cancer detection at the population level. At approximately $2 per patient, MammoGRIP® approaches cost-neutrality when operational savings are factored in — making adoption economically rational even before considering clinical benefits.

  • Earlier-stage cancer detection
  • Improved screening adherence metrics
  • Cost-neutral economics
  • Public health alignment
Patient Journey

A Better Experience
From First Contact to Final Image

01

Scheduling

Patient schedules routine screening mammogram. With appropriate pre-visit communication about the imaging process, anxiety and anticipation of pain may be reduced from the outset.

02

Check-In & Preparation

Patient arrives and completes routine intake. Staff provide information about the imaging procedure and what to expect during positioning.

03

MammoGRIP® Applied

MammoGRIP® Applied

The mammography technologist applies MammoGRIP® to their hands before the positioning exam. The antiseptic formulation replaces standard examination gloves — the single-use solution absorbs rapidly, leaving no residue.

04

Imaging with Precision

With MammoGRIP® applied, the technologist is designed to achieve enhanced control during breast positioning, supporting consistent tissue inclusion, IMF visualization, and overall image quality.

05

Positive Outcome

Fewer retakes. Reduced discomfort. A better experience — for both patient and technologist. When patients have positive experiences, they return for screening on schedule.

Patient testimonial — MammoGRIP® Clinical Program

Economics

A Compelling
Cost-Benefit Case

At approximately $2 per patient, MammoGRIP® has the potential to approach cost neutrality when operational efficiencies are considered, making adoption economically compelling even before considering its clinical and public-health benefits.

approximately $2
per patient
"May approach cost neutrality through operational efficiencies, depending on institutional workflow and utilization."
01

Reduction in Recalls & Repeat Examinations

Potential reduction in positioning-related recalls and repeat examinations may decrease technologist time, patient rescheduling, and film utilization where applicable.

02

Equipment Utilization & Preservation

More efficient and consistent examinations may reduce unnecessary equipment utilization associated with repeated positioning and prolonged examination times, potentially contributing to equipment preservation and improved operational efficiency.

03

Potential Productivity & Revenue Opportunity

Improved workflow efficiency and fewer repeat examinations may increase operational capacity, allowing departments to accommodate additional patients depending on scheduling, demand, and institutional workflow. This may also create opportunities for increased revenue.

04

Appropriate Examination Glove Utilization

Current evidence-based infection-control guidance generally does not require routine examination gloves for standard screening mammography involving intact skin. Appropriate glove utilization may contribute to operational savings while supporting modern clinical practice.

05

Potential Downstream Healthcare Cost Reduction

Earlier detection facilitated by high-quality mammographic imaging may contribute to reduced downstream treatment costs by increasing opportunities to diagnose breast cancer at earlier stages, where treatment is generally less complex and less costly than management of advanced disease. The magnitude of this benefit depends on multiple clinical and healthcare system factors and should not be interpreted as a direct outcome of MammoGRIP® alone.

EXAMINATION GLOVE UTILIZATION

Modern Infection-Control Practice
in Mammography

Current evidence-based infection-control guidance indicates that routine screening mammography involving contact only with intact skin does not routinely require examination gloves under Standard Precautions. MammoGRIP® naturally integrates into this evidence-based clinical workflow while supporting breast positioning consistency.

Hand hygiene remains the cornerstone of infection prevention and should always be performed in accordance with institutional policies and established clinical guidelines.

Gloves remain appropriate whenever clinically indicated — including situations involving nonintact skin, body fluids, contact precautions, equipment cleaning, or specific institutional requirements. Institutional policies and professional clinical judgment always take precedence.

View Scientific Evidence

Evidence-Based Practice

Aligns with CDC Standard Precautions guidance

Appropriate Glove Utilization

Supports clinically indicated glove use

Reduced Unnecessary Consumption

May reduce routine glove use where not clinically required

Operational Efficiency

May reduce associated supply costs

Environmental Responsibility

May reduce unnecessary medical waste

This educational content is intended for healthcare professionals. Institutional policies and professional clinical judgment always take precedence over general guidance.

The Vision Behind MammoGRIP®

Designed to Address a Persistent
Challenge in Breast Imaging

MammoGRIP® was developed to address one of the most persistent challenges in mammography and breast imaging: achieving reliable positioning while improving comfort, confidence, and consistency throughout the patient experience.

Today, MammoGRIP® is being introduced internationally as part of a broader effort to enhance mammography patient comfort, breast imaging workflow, and clinical efficiency — bringing meaningful innovation to every mammography exam, for every patient, in every screening environment.

Global Reach

A Coordinated
Global Commercialization Architecture

MammoGRIP® is positioned at an inflection point between early commercialization and broader international scale — with regulatory approvals in three major jurisdictions and active commercialization underway across multiple territories.

FDA-Cleared · United StatesANVISA Approved · BrazilCE Mark Certified · European Union
🇧🇷LAUNCHED · 2026

Brazil & Latin America

Alphattitude Capital

First major commercialization territory. 9.5–12M annual mammograms. Exclusive licensee focused on Brazil and full Latin American expansion. Pathway to PDP/PPP public-sector partnerships.

🇵🇹🇪🇸Market Rollout · Coming Next

Iberian Peninsula

Local Trade Partner · To Be Disclosed

European gateway providing CE Mark market access, institutional credibility, and strategic connectivity. Covers Spain's autonomous regions and Portugal's mature healthcare system.

🌍Framework Executed

Africa (Continental)

Confidential Principal + Regional Sublicensees

Performance-based continental licensing with two regional sub-licensees covering North Africa and Sub-Saharan Africa independently. Regulatory activities underway in selected jurisdictions.

🇺🇸Strategic Phase

United States

Controlled Commercialization

Most strategically significant long-term market. Pursuing carefully controlled commercialization strategy with exploratory discussions ongoing with a major global imaging industry participant.

🇪🇺Active Selection

Europe (Broader)

Licensee candidates under evaluation

Building on Iberian CE Mark foundation. Bioflex actively interviewing licensee candidates for additional European countries using a rigorous 12–24 month selection framework.

The Brazil–Iberian Axis

Brazil and the Iberian Peninsula were not selected as independent opportunities. They were selected because of the strategic relationship between them. The historical, cultural, linguistic, economic, and business connections linking Portugal, Spain, and Latin America create opportunities for knowledge transfer, partnership development, market intelligence sharing, and coordinated expansion strategies.

Clinical Development Journey

From Concept to
Global Commercialization

Innovative concept developed

Clinical studies completed

Regulatory pathway established

International commercialization initiated

Global expansion underway

Ongoing market development

Connect With Us

Connect With Our
Clinical Team

We welcome inquiries from healthcare providers, imaging center administrators, distribution partners, and clinical professionals interested in learning more about MammoGRIP® or exploring partnership opportunities.

Commercialization & Partnership Inquiries

MammoGRIP® is supported by Bioflex USA Life Technologies, a medical technology commercialization platform dedicated to advancing innovative healthcare solutions through strategic partnerships, licensing, clinical development, and international expansion.

Request Clinical Information

We'll respond within 1–2 business days

Bioflex USA Life Technologies · (213) 720-8330 · www.bioflex.us