ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer

A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease

This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: Gemcitabine; Drug: Carboplatin; Drug: Eribulin; Drug: Pumitamig; Drug: Nab-paclitaxel/Paclitaxel; Drug: Matching placebo

Detailed Description

The study consists of a:

1. Screening period (up to 28 days);
2. Treatment period, during which participants will receive pumitamig or placebo in combination with chemotherapy (until disease progression, the occurrence of intolerable toxicity, withdrawal, death, or trial termination [whichever comes first]);
3. Safety follow-up (FU) period (for up to 90 days after administration of the last dose of trial treatment) and survival follow-up (until the participant dies, withdraws consent for survival status follow-up, loss of contact, or sponsor decision, whichever occurs first).

Participants will be randomized 1:1 to receive either pumitamig in combination with the treatment of physician's choice (TPC) chemotherapy (Arm 1) or placebo in combination with TPC chemotherapy (Arm 2). Chemotherapy will be administered per standard of care. The randomization will be stratified based on the following factors:

• Prior treatment with cancer immunotherapy (yes versus no)
• On-trial chemotherapy regimen (paclitaxel/nab-paclitaxel versus gemcitabine plus carboplatin versus eribulin)
• Geography (East Asia versus the rest of the world [ROW])
• PD-L1 status (combined positive score [CPS] less than [<] 1 versus 1 less than or equal to [<=] CPS <10).

• Study Type: Interventional
• Enrollment (Estimated): 558
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: BioNTech clinical trials patient information; Phone Number: +49 6131 9084; Email: patients@biontech.de

Study Locations

• Australia
  • Westmead, Australia, 2145
    • Recruiting
    • Westmead Hospital
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • St Vincent's Hospital - The Kinghorn Cancer Centre
  • South Australia
    • Adelaide, South Australia, Australia, 50000
      • Recruiting
      • GenesisCare St Andrew's Precinct
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Recruiting
      • Peninsula & South Eastern Hematology and Oncology Group
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter Maccallum Cancer Centre
    • Melbourne, Victoria, Australia, 3168
      • Recruiting
      • Monash University - Monash Medical Centre (MMC) - Clayton
• Belgium
  • Brussels, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel)
  • Gilly, Belgium, 6060
    • Recruiting
    • Grand hospital de Charleroi
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospitals Leuven
  • Woluwe-Saint-Lambert, Belgium, 1200
    • Recruiting
    • Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
• China
  • Changde, China, 415003
    • Recruiting
    • Changde First People's Hospital
  • Jinan, China, 250117
    • Recruiting
    • Shandong Cancer Hospital and Institute
  • Shanghai, China, 200032
    • Recruiting
    • Fudan University - Shanghai Cancer Center (FUSCC)
  • Zhengzhou, China, 450052
    • Recruiting
    • The First Affiliated Hospital of Zhengzhou University
• Czechia
  • Prague, Czechia, 150 06
    • Recruiting
    • Fakultni nemocnice Motol a Homolka
• Georgia
  • Batumi, Georgia, 6000
    • Recruiting
    • High Technology Hospital MedCenter Ltd
  • Tbilisi, Georgia, 112
    • Recruiting
    • Llc Todua Clinic
  • Tbilisi, Georgia, 186
    • Recruiting
    • Caucasus Medical Centre
  • Tbilisi, Georgia, 0168
    • Recruiting
    • Multiprofile Clinic Consilium Medulla
• Germany
  • Augsburg, Germany, 86150
    • Recruiting
    • Hämatologische-Onkologische Praxis Augsburg
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • Praxis Fuer Interdisziplinaere Onkologie & Haematologie
  • Koblenz, Germany, 56068
    • Recruiting
    • Institut fuer Versorgungsforschung in der Onkologie
• Italy
  • Aviano, Italy, 33081
    • Recruiting
    • Centro di Riferimento Oncologico (CRO)
  • Lucca, Italy, 55100
    • Recruiting
    • Azienda Unità Sanitaria Locale 2 (USL2) Lucca
  • Milan, Italy, 20133
    • Recruiting
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milan, Italy, 20141
    • Recruiting
    • IRCCS-Istituto Europeo di Oncologia
  • Milan, Italy, 20132
    • Recruiting
    • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
  • Roma, Italy, 00128
    • Recruiting
    • Fondazione Policlinico Universitario Campus Bio-medico
  • Torrette, Italy, 60126
    • Recruiting
    • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
• Japan
  • Chiba, Japan, 260-8717
    • Recruiting
    • Chiba Cancer Center
  • Fukushima, Japan, 960-1295
    • Recruiting
    • Fukushima Medical University Hospital
  • Gifu, Japan, 501-1112
    • Recruiting
    • Gifu University Hospital
  • Hiroshima, Japan, 730-8518
    • Recruiting
    • Hiroshima City Hiroshima Citizens Hospital
  • Kumamoto, Japan, 860-8556
    • Recruiting
    • Kumamoto University Hospital
  • Kyoto, Japan, 606-8507
    • Recruiting
    • Kyoto University Hospital
  • Matsuyama, Japan, 791-0280
    • Recruiting
    • National Hospital Organization Shikoku Cancer Center
  • Nagoya, Japan, 467-8602
    • Recruiting
    • Nagoya City University Hospital
  • Sendai, Japan, 980-8574
    • Recruiting
    • Tohoku University Hospital
  • Shinjuku-Ku, Japan, 162-8655
    • Recruiting
    • National Center for Global Health and Medicine
• Poland
  • Lodz, Poland, 90-752
    • Recruiting
    • IP Clinic Sp. z o.o.
  • Warsaw, Poland, 02-781
    • Recruiting
    • Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy Instytut Badawczy
• South Korea
  • Cheonan, South Korea, 31151
    • Recruiting
    • Soon Chun Hyang University Cheonan Hospital
  • Cheongju-si, South Korea, 28644
    • Recruiting
    • Chungbuk National University Hospital
  • Goyang-si, South Korea, 10408
    • Recruiting
    • National Cancer Center
  • Seongnam-si, South Korea, 13620
    • Recruiting
    • Seoul National University Bundang Hospital (SNUBH)
  • Seoul, South Korea, 6351
    • Recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 3722
    • Recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 5505
    • Recruiting
    • Asan Medical Center (AMC)
  • Seoul, South Korea, 2841
    • Recruiting
    • Korea University Anam Hospital
  • Suwon, South Korea, 16499
    • Recruiting
    • Ajou University Hospital
• Spain
  • Badajoz, Spain, 6006
    • Recruiting
    • Hospital Universitario de Badajoz
  • Barcelona, Spain, 8003
    • Recruiting
    • Parc de Salut Mar - Hospital del Mar
  • Barcelona, Spain, 8195
    • Recruiting
    • Institut Oncologic Rosell - Hospital General De Catalunya
  • Córdoba, Spain, 14004
    • Recruiting
    • HOSPITAL Universitario REINA SOFIA
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28050
    • Recruiting
    • Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)
  • Madrid, Spain, 28007
    • Recruiting
    • IOB Institute of Oncology - Beata Maria Ana Hospital
  • Madrid, Spain, 28027
    • Recruiting
    • Universidad de Navarra - Clínica Universidad de Navarra (CUN)
  • Murcia, Spain, 30008
    • Recruiting
    • Hospital General Universitario Morales Meseguer
  • Murcia, Spain, 30120
    • Recruiting
    • Hospital Universitario Virgen De La Arrixaca (Huva)
  • Pamplona, Spain, 31008
    • Recruiting
    • Universidad de Navarra - Clínica Universidad de Navarra (CUN)
  • Sabadell, Spain, 8208
    • Recruiting
    • Hospital Universitari Parc Tauli
  • Valencia, Spain, 46009
    • Recruiting
    • Fundacion Instituto Valenciano de Oncologia
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Recruiting
    • Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
  • Bristol, United Kingdom, BS2 8ED
    • Recruiting
    • University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre
  • Cottingham, United Kingdom, HU16 5JQ
    • Recruiting
    • Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
  • Edinburgh, United Kingdom, EH4 2LF
    • Recruiting
    • Edinburgh Cancer Centre-Western General Hospital
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • St James's University Hospital - Leeds Teaching Hospitals NHS Trust
  • London, United Kingdom, W1G 6AD
    • Recruiting
    • Sarah Cannon Research Institute
  • London, United Kingdom, NW3 2QG
    • Recruiting
    • The Royal Free Hospital - Royal Free London NHS Foundation Trust
  • London, United Kingdom, NW2 1PG
    • Recruiting
    • University College London Hospitals NHS Foundation Trust
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • St Bartholomew's Hospital - Barts Health NHS Trust
  • Oxford, United Kingdom, OX3 7LE
    • Recruiting
    • Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
  • Rhyl, United Kingdom, LL18 5UJ
    • Recruiting
    • North Wales Cancer Treatment C - Glan Clwyd Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • Recruiting
    • Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
  • Torquay, United Kingdom, TQ2 7AA
    • Recruiting
    • Torbay Hosptial, South Devon Healthcare NHS Foundation Trust
  • Wolverhampton, United Kingdom, WV10 0QP
    • Recruiting
    • New Cross Hospital - The Royal Wolverhampton NHS Trust
• United States
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Recruiting
      • Highlands Oncology Group
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • University Of California - San Diego Moores Cancer Center
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedar Sinai - Samuel Oschin Cancer Center
    • Palo Alto, California, United States, 94304-2201
      • Recruiting
      • Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center
  • Florida
    • Pensacola, Florida, United States, 32504
      • Recruiting
      • Sacred Heart Medical Oncology Group
  • Illinois
    • Decatur, Illinois, United States, 62526
      • Recruiting
      • Cancer Care Specialists
    • O'Fallon, Illinois, United States, 62269
      • Recruiting
      • Cancer Care Specialists of Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • Carle Foundation Hospital d/b/a Carle Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center
  • Maine
    • Westbrook, Maine, United States, 04092
      • Recruiting
      • New England Cancer Specialists
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Recruiting
      • Saint Agnes Hospital, Clinical Research Center
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Recruiting
      • Lahey Hospital & Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Center
    • Royal Oak, Michigan, United States, 48073
      • Recruiting
      • Profound Research LLC at Michigan Hematology and Oncology Consultants
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Saint Luke's Hospital of Kansas City
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Recruiting
      • Oncology Hematology West, PC dba Nebraska Cancer Specialist
    • Omaha, Nebraska, United States, 68310
      • Recruiting
      • Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Recruiting
      • Summit Medical Group PA
  • New York
    • Rochester, New York, United States, 14621
      • Recruiting
      • Rochester General Hospital Lipson Cancer Institute
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Medical Center
    • The Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Medical Center
  • Oregon
    • Salem, Oregon, United States, 97301
      • Recruiting
      • Oregon Oncology Specialists
  • Tennessee
    • Germantown, Tennessee, United States, 38002
      • Recruiting
      • The West Clinic, P.C. dba West Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Oncology Consultants PA
    • Houston, Texas, United States, 77024
      • Recruiting
      • Oncology Consultants PA
  • Washington
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Northwest Medical Specialties, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.
• Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and/or progesterone receptor [PgR]) 1% to 10%, HER2 immunohistochemistry [IHC] 0, 1+, or 2+ with fluorescence in situ hybridization [FISH] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care.
• Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.
• Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial).
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

• Have received any of the following therapies or drugs prior to the initiation of trial:

  • Have received prior systemic anticancer therapy for advanced disease.
  • Have received prior treatment with a PD(L)-1/vascular endothelial growth factor (VEGF) bispecific antibody.
  • Have received systemic corticosteroids (at a dosage greater than 10 milligrams [mg]/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (<= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens).
  • Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment.
  • Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.
• Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.
• Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed.
• Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy; Participants will be administered with pumitamig (BNT327) plus chemotherapy regimen.	Drug: Gemcitabine; IV infusion; Drug: Carboplatin; IV infusion; Drug: Eribulin; IV infusion; Drug: Pumitamig; Solution for intravenous (IV) infusion; Other Names: BNT327; PM8002; BMS-986545; Drug: Nab-paclitaxel/Paclitaxel; IV infusion
Placebo Comparator: Arm 2: Placebo + TPC Chemotherapy; Participants will be administered with matching placebo plus chemotherapy regimen.	Drug: Gemcitabine; IV infusion; Drug: Carboplatin; IV infusion; Drug: Eribulin; IV infusion; Drug: Nab-paclitaxel/Paclitaxel; IV infusion; Drug: Matching placebo; IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to death from any cause.	Up to approximately 49 months
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)	PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR per response evaluation criteria in solid tumors [RECIST] v1.1), or death from any cause, whichever occurs first.	Up to approximately 32 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) as Assessed by BICR	ORR is defined as the percentage of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) as per RECIST v1.1 is assessed by BICR as best overall response.	Up to approximately 49 months
PFS	PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by investigator per RECIST v1.1), or death from any cause, whichever occurs first.	Up to approximately 32 months
ORR	ORR is defined as the percentage of participants in whom a confirmed CR or confirmed PR (per RECIST v1.1) is observed as best overall response.	Up to approximately 49 months
Duration of Response (DOR)	DOR is defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.	Up to approximately 49 months
Disease Control Rate (DCR)	DCR is defined as the percentage of participants in whom a confirmed CR or confirmed PR or stable disease (SD) (per RECIST v1.1, SD assessed at least 6 weeks after randomization) is observed as best overall response.	Up to approximately 32 months
PFS Rate as Assessed by BICR		At 6, 12, 18, and 24 months
PFS Rate as Assessed by Investigator		At 6, 12, 18, and 24 months
OS Rate		At 6, 12, 18, and 24 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs) Including Grade Greater than or Equal to (>=) 3, Serious, and Fatal TEAEs by Relationship	TEAEs graded according to United Stated (US) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)	From the first dose of study treatment to the 90-days after last dose of study treatment (up to approximately 57 months)
Occurrence of Dose Interruption, Reduction, and Discontinuation of Trial Treatment due to TEAEs (including related TEAEs)		From the first dose of study treatment to the 90-days after last dose of study treatment (up to approximately 57 months)
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 Questionnaire (QLQ-C30) Global Health Status/Quality-of-Life score (Items 29 and 30)	Global health status or quality of life (QoL) scale ranges in score from 0 to 100 with a high scale score representing a higher response level (for example, high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems).	Baseline up to approximately 49 months
Change from Baseline in EORTC QLQ-C30 Physical Functioning	Physical functioning scale ranges in score from 0 to 100 with a high scale score representing a higher response level (for example, high score for functional scale is high/healthy level of functioning).	Baseline up to approximately 49 months
Change from Baseline in Arm Symptoms Scale of EORTC QLQ-Breast Cancer (BR)42	Arm symptom scale ranges in score from 0 to 100 with a high scale score representing a higher level of symptoms or problems.	Baseline up to approximately 49 months
Change from Baseline in Breast Symptoms Scale of EORTC QLQ-BR42	Breast symptom scale ranges in score from 0 to 100 with a high scale score representing a higher level of symptoms or problems.	Baseline up to approximately 49 months
Change from Baseline in Functional Assessment of Cancer Therapy-General Version (FACT-G) Overall Bother Item (FACT-GP5)	The single-item GP5, that is "I am bothered by side effects of treatment," is rated on a 5-point Likert scale (where 1=not at all and 5=very much) by the participants. A high scale score represents worse outcome.	Baseline up to approximately 49 months

Collaborators and Investigators

• Sponsor: BioNTech SE
• Collaborators: Bristol-Myers Squibb
• Investigators: Study Director: BioNTech Responsible Person, BioNTech SE

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: September 8, 2025
• First Submitted That Met QC Criteria: September 8, 2025
• First Posted (Actual): September 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Bispecific antibody; Metastatic TNBC; Programmed death-ligand 1 (PD-L1); Immunotherapy in combination with chemotherapy; Combination with other investigational agents
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; Carboplatin; 130-nm albumin-bound paclitaxel; eribulin
• Other Study ID Numbers: BNT327-05; 2025-521884-12-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No