Reproductive Health Devices Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Published: February 27, 2024 Report Code: GDME1714EPD-ST

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Reproductive Health Devices Pipeline Market Report Overview

Endometrial ablation devices, female sterilization devices, reversible contraceptive devices, and assisted reproductive technology devices are the main categories of reproductive health devices. The reproductive health devices pipeline report provides comprehensive information about the main products with their comparative segment-wise analysis at various stages of development.

The report also covers the regional and country-wise reproductive health devices clinical trials outlook. The regulatory paths followed for conducting the reproductive health devices pipeline research are also highlighted in the report. Leading companies involved in the reproductive health devices pipeline development are also enlisted in this research report to aid clients in effective decision-making.

Key Segments ·        Reversible Contraceptive Devices

·        Intrauterine Devices (IUDs)

·        Copper IUDs

·        Hormonal IUDs

·        Endometrial Ablation Devices
Key Territories ·        The US

·        Europe

·        Japan

·        Mexico

·        New Zealand
Key Regulatory Paths ·        510(k)

·        CE

·        PMA

·        TGA

·        Ninsho
Leading Companies ·        AdneXXA LLC

·        Agile Therapeutics Inc

·        AltaScience Limited

·        Bayer AG

·        Bioceptive Inc

·        Biorings LLC
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Reproductive Health Devices Pipeline Market by Segments

The key segments in the reproductive health devices pipeline market are reversible contraceptive devices, intrauterine devices (IUDs), copper IUDs, hormonal IUDs, and endometrial ablation devices among others. As of February 2024, the reversible contraceptive devices segment was the leading segment accounting for the highest number of products in the pipeline.

Reproductive Health Devices Pipeline Market Analysis by Segments, 2024 (%)

Reproductive Health Devices Pipeline Market Analysis by Segments, 2024 (%)

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Reproductive Health Devices Pipeline Market Segmentation by Territories

A few of the key territories for reproductive health devices pipeline products are the US, Europe, Japan, Mexico, and New Zealand among others. As of February 2024, the US accounted for the highest number of pipeline products.

Reproductive Health Devices Pipeline Market Analysis by Territories, 2024 (%)

Reproductive Health Devices Pipeline Market Analysis by Territories, 2024 (%)

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Reproductive Health Devices Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths followed by the reproductive health devices pipeline market are 510(k), PMA, CE, TGA, and NMPA. As of February 2024, 510(k) was the most followed pathway for pipeline products in the market.

Reproductive Health Devices Pipeline Market Analysis by Regulatory Paths, 2024 (%)

Reproductive Health Devices Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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Reproductive Health Devices Pipeline Market – Competitive Landscape

A few of the key companies associated with the reproductive health devices pipeline market are AdneXXA LLC, Agile Therapeutics Inc, AltaScience Limited, Bayer AG, Bioceptive Inc, and Biorings LLC among others.

Agile Therapeutics Inc (Agile):  Agile is headquartered in Princeton, New Jersey, the US. The company develops and commercializes prescription contraceptive products for women. The company offers contraceptive patch containing the active ingredients levonorgestrel and ethinyl estradiol and progestin-only birth control patch. Its pipeline product candidate includes Twirla also known as AG200-15, is a prescription combination hormonal contraceptive patch.

Bayer AG: Bayer is headquartered in Leverkusen, North Rhine-Westphalia, Germany. The company is engaged in the discovery, development, manufacturing, and commercialization of products for human health, and agriculture. It provides medicines for cardiovascular diseases, women’s health, cancer, hematology, ophthalmology, and other indications.

Reproductive Health Devices Pipeline Market Analysis by Companies, 2024

Reproductive Health Devices Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

Reproductive Health Devices Pipeline Market Segments Outlook

  • Reversible Contraceptive Devices
  • Intrauterine Devices (IUDs)
  • Copper IUDs
  • Hormonal IUDs
  • Endometrial Ablation Devices

Reproductive Health Devices Pipeline Market Territories Outlook

  • The US
  • Europe
  • Japan
  • Mexico
  • New Zealand

Reproductive Health Devices Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • PMA
  • CE
  • TGA
  • NMPA

Scope

This report provides:

  • Extensive coverage of the reproductive health devices under development.

  • Exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.

  • Reviews of major players involved in the development of reproductive health devices and lists all their pipeline projects.

  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.

  • Key clinical trial data of ongoing clinical trials specific to pipeline products.

  • Recent developments in the segment/industry.

Reasons to Buy

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.

  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage.

  • Identify and understand important and diverse types of reproductive health devices under development.

  • Develop market-entry and market-expansion strategies.

  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.

  • Carry out an in-depth analysis of the product’s current stage of development, territory, and estimated launch date.

3Daughters Inc
Ablatus Therapeutics Ltd
AdneXXA LLC
Agile Therapeutics Inc
AltaScience Limited
Alydia Health Inc
Autoivf Inc
Bayer AG
Bioceptive Inc
Biorings LLC
BioTex Inc
Ceragenix Pharmaceuticals, Inc. (Inactive)
Contrel Europe NV
Dare Bioscience Inc
Dartmouth College
Emblation Ltd
EVE Medical Systems Ltd
Evestra Inc
Evofem Biosciences Inc
Femasys Inc
FemSuite LLC
Ghent University
Healthcare Enterprise Group PLC (Inactive)
Hemosquid SAS
Hera Health Solutions
HLL Lifecare Ltd
Idoman Teoranta
Impres Medical, Inc.
INVO Bioscience Inc
Japanese Organization for Medical Device Development Inc
Johns Hopkins University
Keratin Biosciences Inc
Laboratoire HRA Pharma SAS
Lubrizol Life Science Health
May Health
Memorial Sloan Kettering Cancer Center
Memphasys Ltd
Menorrx LLC
Merck & Co Inc
Merck Serono SA
NextGem Inc
Nipro Corp
Novomedics L L C
OCON Medical Ltd
OncoGenesis
Otago Innovation Ltd
Pfizer Inc
Sebela Pharmaceuticals Inc
Shandong Junxiu Biotechnology Co Ltd
Teva Pharmaceuticals USA Inc
Teva Women's Health
University of California San Diego
University of Cape Town
University of Minnesota
University of Oxford
University of Texas at Austin
University of Texas Health Science Center at San Antonio
University of Washington
Womed
Yale University
ZR-Operculum, Inc.

Table of Contents

1 Table of Contents 3

1.1 List of Tables 7

1.2 List of Figures 12

2 Introduction 13

2.1 Reproductive Health Devices Overview 13

3 Products under Development 15

3.1 Reproductive Health Devices – Pipeline Products by Stage of Development 15

3.2 Reproductive Health Devices – Pipeline Products by Segment 16

3.3 Reproductive Health Devices – Pipeline Products by Territory 17

3.4 Reproductive Health Devices – Pipeline Products by Regulatory Path 18

3.5 Reproductive Health Devices – Pipeline Products by Estimated Approval Date 19

3.6 Reproductive Health Devices – Ongoing Clinical Trials 20

4 Reproductive Health Devices – Pipeline Products under Development by Companies 21

4.1 Reproductive Health Devices Companies – Pipeline Products by Stage of Development 21

4.2 Reproductive Health Devices – Pipeline Products by Stage of Development 24

5 Reproductive Health Devices Companies and Product Overview 27

5.1 3Daughters Inc Company Overview 27

5.1.1 3Daughters Inc Pipeline Products & Ongoing Clinical Trials Overview 27

5.2 Ablatus Therapeutics Ltd Company Overview 28

5.2.1 Ablatus Therapeutics Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

5.3 AdneXXA LLC Company Overview 29

5.3.1 AdneXXA LLC Pipeline Products & Ongoing Clinical Trials Overview 29

5.4 Agile Therapeutics Inc Company Overview 30

5.4.1 Agile Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.5 AltaScience Limited Company Overview 33

5.5.1 AltaScience Limited Pipeline Products & Ongoing Clinical Trials Overview 33

5.6 Alydia Health Inc Company Overview 34

5.6.1 Alydia Health Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.7 Autoivf Inc Company Overview 37

5.7.1 Autoivf Inc Pipeline Products & Ongoing Clinical Trials Overview 37

5.8 Bayer AG Company Overview 38

5.8.1 Bayer AG Pipeline Products & Ongoing Clinical Trials Overview 38

5.9 Bioceptive Inc Company Overview 41

5.9.1 Bioceptive Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.10 Biorings LLC Company Overview 42

5.10.1 Biorings LLC Pipeline Products & Ongoing Clinical Trials Overview 42

5.11 BioTex Inc Company Overview 43

5.11.1 BioTex Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.12 Ceragenix Pharmaceuticals, Inc. (Inactive) Company Overview 44

5.12.1 Ceragenix Pharmaceuticals, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 44

5.13 Contrel Europe NV Company Overview 45

5.13.1 Contrel Europe NV Pipeline Products & Ongoing Clinical Trials Overview 45

5.14 Dare Bioscience Inc Company Overview 48

5.14.1 Dare Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.15 Dartmouth College Company Overview 52

5.15.1 Dartmouth College Pipeline Products & Ongoing Clinical Trials Overview 52

5.16 Emblation Ltd Company Overview 54

5.16.1 Emblation Ltd Pipeline Products & Ongoing Clinical Trials Overview 54

5.17 EVE Medical Systems Ltd Company Overview 55

5.17.1 EVE Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

5.18 Evestra Inc Company Overview 56

5.18.1 Evestra Inc Pipeline Products & Ongoing Clinical Trials Overview 56

5.19 Evofem Biosciences Inc Company Overview 59

5.19.1 Evofem Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 59

5.20 Femasys Inc Company Overview 62

5.20.1 Femasys Inc Pipeline Products & Ongoing Clinical Trials Overview 62

5.21 FemSuite LLC Company Overview 65

5.21.1 FemSuite LLC Pipeline Products & Ongoing Clinical Trials Overview 65

5.22 Ghent University Company Overview 67

5.22.1 Ghent University Pipeline Products & Ongoing Clinical Trials Overview 67

5.23 Healthcare Enterprise Group PLC (Inactive) Company Overview 68

5.23.1 Healthcare Enterprise Group PLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 68

5.24 Hemosquid SAS Company Overview 69

5.24.1 Hemosquid SAS Pipeline Products & Ongoing Clinical Trials Overview 69

5.25 Hera Health Solutions Company Overview 70

5.25.1 Hera Health Solutions Pipeline Products & Ongoing Clinical Trials Overview 70

5.26 HLL Lifecare Ltd Company Overview 71

5.26.1 HLL Lifecare Ltd Pipeline Products & Ongoing Clinical Trials Overview 71

5.27 Idoman Teoranta Company Overview 72

5.27.1 Idoman Teoranta Pipeline Products & Ongoing Clinical Trials Overview 72

5.28 Impres Medical, Inc. Company Overview 73

5.28.1 Impres Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 73

5.29 INVO Bioscience Inc Company Overview 74

5.29.1 INVO Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 74

5.30 Japanese Organization for Medical Device Development Inc Company Overview 75

5.30.1 Japanese Organization for Medical Device Development Inc Pipeline Products & Ongoing Clinical Trials Overview 75

5.31 Johns Hopkins University Company Overview 76

5.31.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 76

5.32 Keratin Biosciences Inc Company Overview 77

5.32.1 Keratin Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 77

5.33 Laboratoire HRA Pharma SAS Company Overview 78

5.33.1 Laboratoire HRA Pharma SAS Pipeline Products & Ongoing Clinical Trials Overview 78

5.34 Lubrizol Life Science Health Company Overview 80

5.34.1 Lubrizol Life Science Health Pipeline Products & Ongoing Clinical Trials Overview 80

5.35 May Health Company Overview 81

5.35.1 May Health Pipeline Products & Ongoing Clinical Trials Overview 81

5.36 Memorial Sloan Kettering Cancer Center Company Overview 85

5.36.1 Memorial Sloan Kettering Cancer Center Pipeline Products & Ongoing Clinical Trials Overview 85

5.37 Memphasys Ltd Company Overview 86

5.37.1 Memphasys Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

5.38 Menorrx LLC Company Overview 90

5.38.1 Menorrx LLC Pipeline Products & Ongoing Clinical Trials Overview 90

5.39 Merck & Co Inc Company Overview 91

5.39.1 Merck & Co Inc Pipeline Products & Ongoing Clinical Trials Overview 91

5.40 Merck Serono SA Company Overview 93

5.40.1 Merck Serono SA Pipeline Products & Ongoing Clinical Trials Overview 93

5.41 NextGem Inc Company Overview 94

5.41.1 NextGem Inc Pipeline Products & Ongoing Clinical Trials Overview 94

5.42 Nipro Corp Company Overview 96

5.42.1 Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 96

5.43 Novomedics L L C Company Overview 98

5.43.1 Novomedics L L C Pipeline Products & Ongoing Clinical Trials Overview 98

5.44 OCON Medical Ltd Company Overview 99

5.44.1 OCON Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 99

5.45 OncoGenesis Company Overview 104

5.45.1 OncoGenesis Pipeline Products & Ongoing Clinical Trials Overview 104

5.46 Otago Innovation Ltd Company Overview 105

5.46.1 Otago Innovation Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

5.47 Pfizer Inc Company Overview 106

5.47.1 Pfizer Inc Pipeline Products & Ongoing Clinical Trials Overview 106

5.48 Sebela Pharmaceuticals Inc Company Overview 107

5.48.1 Sebela Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 107

5.49 Shandong Junxiu Biotechnology Co Ltd Company Overview 111

5.49.1 Shandong Junxiu Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 111

5.50 Teva Pharmaceuticals USA Inc Company Overview 112

5.50.1 Teva Pharmaceuticals USA Inc Pipeline Products & Ongoing Clinical Trials Overview 112

5.51 Teva Women’s Health Company Overview 114

5.51.1 Teva Women’s Health Pipeline Products & Ongoing Clinical Trials Overview 114

5.52 University of California San Diego Company Overview 115

5.52.1 University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 115

5.53 University of Cape Town Company Overview 116

5.53.1 University of Cape Town Pipeline Products & Ongoing Clinical Trials Overview 116

5.54 University of Minnesota Company Overview 117

5.54.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 117

5.55 University of Oxford Company Overview 118

5.55.1 University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 118

5.56 University of Texas at Austin Company Overview 119

5.56.1 University of Texas at Austin Pipeline Products & Ongoing Clinical Trials Overview 119

5.57 University of Texas Health Science Center at San Antonio Company Overview 120

5.57.1 University of Texas Health Science Center at San Antonio Pipeline Products & Ongoing Clinical Trials Overview 120

5.58 University of Washington Company Overview 121

5.58.1 University of Washington Pipeline Products & Ongoing Clinical Trials Overview 121

5.59 Womed Company Overview 122

5.59.1 Womed Pipeline Products & Ongoing Clinical Trials Overview 122

5.60 Yale University Company Overview 123

5.60.1 Yale University Pipeline Products & Ongoing Clinical Trials Overview 123

5.61 ZR-Operculum, Inc. Company Overview 124

5.61.1 ZR-Operculum, Inc. Pipeline Products & Ongoing Clinical Trials Overview 124

6 Reproductive Health Devices- Recent Developments 125

6.1 Feb 06, 2024: Alife Health Partners with Ovation Fertility on Cutting-Edge AI Technology for Embryo Image Capture and Cataloguing 125

6.2 Jan 26, 2024: Femasys Begins Fembloc Pivotal Trial Enrollment at UC Davis Medical Center, a Hub for Innovation and Groundbreaking Research in Health Care for Women 125

6.3 Jan 23, 2024: Femasys Begins FemBloc Pivotal Trial Enrollment at University of Utah, an Internationally Recognized Center in Obstetrics and Gynecology 126

6.4 Jan 16, 2024: Pherdal, the First and Only Sterile At-Home Insemination Kit, Awarded FDA Clearance; Now Accepting Pre-orders 127

6.5 Jan 04, 2024: Hannah Life Technologies Receives 510(K) Clearance For Twoplus Applicator 127

6.6 Jan 04, 2024: Daree Bioscience’s Dare-LARC1 Platform Technology Achieves Proof-of-Concept Device That Has Transformative Potential for Women’s Health as Well as in Treating a Broad Range of Diseases 128

6.7 Jan 02, 2024: Distribution Agreement with Vitrolife Expands – Agreements now in place for Canada & NZ 129

6.8 Dec 26, 2023: PherDal Fertility Science Receives 510(k) Clearance for PherDal At-Home Insemination Kit 130

6.9 Dec 18, 2023: Femasys starts birth control solution trial at Stanford Medicine 130

6.10 Dec 16, 2023: Mosie Receives FDA 510(k) Clearance for Mosie Baby Kit 131

6.11 Dec 06, 2023: Mosie Baby Becomes the First Company to Receive FDA Clearance for At-Home Intravaginal Insemination 131

6.12 Dec 06, 2023: Artificial Insemination Kit Granted FDA Clearance 132

6.13 Dec 04, 2023: Dare Bioscience Announces Commencement of Phase 3 Study of Ovaprene, an Investigational Hormone-Free Monthly Intravaginal Contraceptive 133

6.14 Nov 29, 2023: Start-up Competition Winners Develop Innovative Tumor Antibody Penetration Technology 134

6.15 Nov 06, 2023: Celanese Announces New Leadership Appointments to Enhance Value Creation 134

6.16 Nov 06, 2023: NN Reports Financial Results for Third Quarter 2023 135

6.17 Nov 06, 2023: Celanese Corporations Q3 2023 Earnings Report Strong Profitability and Revenue Growth with Room for Improvement 137

6.18 Oct 30, 2023: Sebela Women’s Health Announces Further Positive Data From the Pivotal Phase 3 Study of the Investigational Copper 175 mm² Intra-Uterine Device (IUD) 137

6.19 Oct 25, 2023: Femasys to Showcase FemBloc and its other Novel Products Advancing Women’s Health at the American Association of Gynecologic Laparoscopic Surgeons 139

6.20 Sep 27, 2023: Femasys Expands FemBloc Pivotal Trial Enrollment Securing First Academic Site to Participate 139

6.21 Sep 21, 2023: Dare Bioscience Announces Grant Funding Installment to Support Further Development of Novel Contraceptive Technology Dare-LARC1 140

6.22 Sep 20, 2023: Femasys Announces First-Patient-In for Pivotal Clinical Trial Evaluating its FemBloc Permanent Birth Control 141

6.23 Sep 14, 2023: First Real-World Observational Study of the JADA System, a Medical Device to Control Postpartum Hemorrhage (PPH), Published in ACOG’s Obstetrics & Gynecology 142

6.24 Aug 22, 2023: NN Announces David Harrison as Chief Procurement Officer 144

6.25 Aug 18, 2023: DonneVie Medical Technology Receives 510(k) Clearance for Dewin Blastocyst Medium 144

6.26 Aug 03, 2023: Femasys Initiates Enrollment in Pivotal Trial of its Permanent Birth Control Candidate FemBloc 144

6.27 Jul 27, 2023: Femasys Announces Notice of Allowance for New U.S. Patent Application Covering Use of FemBloc for Female Permanent Birth Control 145

6.28 Jul 26, 2023: A Study Postulates Vaginal Self-Sample and Urine as Applicable Tools for Endometrial Cancer Diagnosis and Prognosis 145

6.29 Jul 13, 2023: Memphasys Granted Two New Australian Patents for the Felix System 146

6.30 Jun 27, 2023: NN Promotes Verlin Bush to Chief Commercial Officer 146

6.31 Jun 26, 2023: Femasys Announces FDA Approval of Its IDE for the Pivotal Clinical Trial of Fembloc Permanent Birth Control, a Non-surgical Alternative for Women 147

6.32 Jun 26, 2023: May Health Announces Data From Feasibility Studies of its Novel Ovarian Rebalancing Treatment and Receives Approval From FDA for Pivotal Trial 147

6.33 Jun 21, 2023: Revolutionising Reproductive And Sexual Health: LifeCell Launches Advanced Self-Collection Healthcare Services 148

6.34 Jun 06, 2023: Study Shows Felix System Offers Significant Advantages Over Alternative Sperm Separation Techniques on Cryopreserved Semen 150

6.35 May 25, 2023: Zhejiang Horizon Medical Technology receives 510(k) clearance for CryoX Vitrification Freeze Kit / Thaw Kit 150

6.36 May 18, 2023: Sebela Women’s Health announces positive phase 3 data for its investigational, next-generation, hormone-free, low-dose copper intrauterine device (IUD) 150

6.37 May 11, 2023: Femasys to showcase four products at the American College of Obstetricians and Gynecologists Annual Clinic & Scientific Meeting 151

6.38 Mar 16, 2023: Aspivix announces the publication, in contraception, an international reproductive health journal, of the first-in-women study results using its novel cervical stabilizer in IUD procedures 152

6.39 Mar 09, 2023: NN Reports Financial Results For Fourth Quarter and Full Year 2022 152

7 Appendix 156

7.1 Methodology 156

7.2 About GlobalData 159

7.3 Contact Us 159

7.4 Disclaimer 159

Table

Reproductive Health Devices – Pipeline Products by Stage of Development 15

Reproductive Health Devices – Pipeline Products by Segment 16

Reproductive Health Devices – Pipeline Products by Territory 17

Reproductive Health Devices – Pipeline Products by Regulatory Path 18

Reproductive Health Devices – Pipeline Products by Estimated Approval Date 19

Reproductive Health Devices – Ongoing Clinical Trials 20

Reproductive Health Devices Companies – Pipeline Products by Stage of Development 21

Reproductive Health Devices – Pipeline Products by Stage of Development 24

3Daughters Inc Pipeline Products & Ongoing Clinical Trials Overview 27

3D-001 – Product Status 27

3D-001 – Product Description 27

Ablatus Therapeutics Ltd Pipeline Products & Ongoing Clinical Trials Overview 28

Luna – Product Status 28

Luna – Product Description 28

AdneXXA LLC Pipeline Products & Ongoing Clinical Trials Overview 29

Reusable Contraception Device – Product Status 29

Reusable Contraception Device – Product Description 29

Agile Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 30

AG200-ER Patch – Product Status 30

AG200-ER Patch – Product Description 31

AG200-SP Patch – Product Status 31

AG200-SP Patch – Product Description 31

AG890 Patch – Product Status 32

AG890 Patch – Product Description 32

AltaScience Limited Pipeline Products & Ongoing Clinical Trials Overview 33

AltaSeal – Product Status 33

AltaSeal – Product Description 33

Alydia Health Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Jada System – Product Status 34

Jada System – Product Description 34

Alydia Health Inc – Ongoing Clinical Trials Overview 35

Jada System – Novel Vacuum-induced Hemorrhage Control for Postpartum Hemorrhage: A Multicenter Randomized Trial 36

Jada System – Potential Approach to Treat Postpartum Hemorrhage Using InPress Postpartum Hemorrhage Intrauterine Device 36

Autoivf Inc Pipeline Products & Ongoing Clinical Trials Overview 37

OvaSafe – Product Status 37

OvaSafe – Product Description 37

Bayer AG Pipeline Products & Ongoing Clinical Trials Overview 38

LNG-IUS16 – Product Status 38

LNG-IUS16 – Product Description 38

Next-Generation Essure Device – Product Status 39

Next-Generation Essure Device – Product Description 39

One-Handed IUD Insertion Device – Product Status 39

One-Handed IUD Insertion Device – Product Description 40

Bioceptive Inc Pipeline Products & Ongoing Clinical Trials Overview 41

IUD Insertion System – Product Status 41

IUD Insertion System – Product Description 41

Biorings LLC Pipeline Products & Ongoing Clinical Trials Overview 42

Vaginal Ring – Product Status 42

Vaginal Ring – Product Description 42

BioTex Inc Pipeline Products & Ongoing Clinical Trials Overview 43

3D Printed Pediatric Vaginal Stent – Product Status 43

3D Printed Pediatric Vaginal Stent – Product Description 43

Ceragenix Pharmaceuticals, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 44

CeraShield Intravaginal Silicone Ring – Product Status 44

CeraShield Intravaginal Silicone Ring – Product Description 44

Contrel Europe NV Pipeline Products & Ongoing Clinical Trials Overview 45

Femilis – Product Status 45

Femilis – Product Description 45

FibroPlant – Product Status 46

FibroPlant – Product Description 46

Omega-Shaped IUS – Product Status 46

Omega-Shaped IUS – Product Description 47

Dare Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 48

DARE-LARC1 – Product Status 48

DARE-LARC1 – Product Description 48

Ovaprene – Product Status 49

Ovaprene – Product Description 49

Dare Bioscience Inc – Ongoing Clinical Trials Overview 50

Ovaprene – A Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene 51

Dartmouth College Pipeline Products & Ongoing Clinical Trials Overview 52

Magnetic Particle Heating System – Product Status 52

Magnetic Particle Heating System – Product Description 52

Nanotherapeutic Device – Product Status 53

Nanotherapeutic Device – Product Description 53

Emblation Ltd Pipeline Products & Ongoing Clinical Trials Overview 54

Microwave System – HPV – Product Status 54

Microwave System – HPV – Product Description 54

EVE Medical Systems Ltd Pipeline Products & Ongoing Clinical Trials Overview 55

EVE System – Premenstrual Syndrome – Product Status 55

EVE System – Premenstrual Syndrome – Product Description 55

Evestra Inc Pipeline Products & Ongoing Clinical Trials Overview 56

EVE112 – Vaginal Ring – Product Status 56

EVE112 – Vaginal Ring – Product Description 56

EVE116 – Vaginal Ring – Product Status 57

EVE116 – Vaginal Ring – Product Description 57

Progestin Vaginal Ring – Product Status 57

Progestin Vaginal Ring – Product Description 58

Vaginal Ring For Preterm Labor – Product Status 58

Vaginal Ring For Preterm Labor – Product Description 58

Evofem Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 59

Phexxi Pre-filled Applicator – Product Status 59

Phexxi Pre-filled Applicator – Product Description 59

Evofem Biosciences Inc – Ongoing Clinical Trials Overview 60

Phexxi Pre-filled Applicator – Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome 61

Femasys Inc Pipeline Products & Ongoing Clinical Trials Overview 62

FemBloc – Product Status 62

FemBloc – Product Description 62

Femasys Inc – Ongoing Clinical Trials Overview 63

FemBloc – BLOC: Prospective, Multi-center, Study of Subjects Undergoing FemBloc Permanent Contraception with Two Confirmation Procedures (FemBloc with FemChec and Fluoro HSG) 64

FemBloc – FINALE: Prospective Multi-Center Trial for FemBloc Intratubal Occlusion for Transcervical Permanent Birth Control 64

FemBloc – Prospective Multi-center Office Based Bi-lateral Tubal Occlusion Trial for Female Permanent Contraception: BLOC 64

FemSuite LLC Pipeline Products & Ongoing Clinical Trials Overview 65

FemGuage – Product Status 65

FemGuage – Product Description 65

FemSeal – Product Status 66

FemSeal – Product Description 66

Ghent University Pipeline Products & Ongoing Clinical Trials Overview 67

Vaginal DL-Lactic Acid Releasing Ring – Product Status 67

Vaginal DL-Lactic Acid Releasing Ring – Product Description 67

Healthcare Enterprise Group PLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 68

CerDilator – Product Status 68

CerDilator – Product Description 68

Hemosquid SAS Pipeline Products & Ongoing Clinical Trials Overview 69

ILITEE – Product Status 69

ILITEE – Product Description 69

Hera Health Solutions Pipeline Products & Ongoing Clinical Trials Overview 70

Eucontra – Product Status 70

Eucontra – Product Description 70

HLL Lifecare Ltd Pipeline Products & Ongoing Clinical Trials Overview 71

Coated Copper T – Product Status 71

Coated Copper T – Product Description 71

Idoman Teoranta Pipeline Products & Ongoing Clinical Trials Overview 72

Thermablate EAS – Product Status 72

Thermablate EAS – Product Description 72

Impres Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 73

Elate System – Product Status 73

Elate System – Product Description 73

INVO Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 74

INVOcell System – 5-Day Continuous Vaginal Incubation – Product Status 74

INVOcell System – 5-Day Continuous Vaginal Incubation – Product Description 74

Japanese Organization for Medical Device Development Inc Pipeline Products & Ongoing Clinical Trials Overview 75

AI-Assisted Automatic Sperm Sorting Device – Product Status 75

AI-Assisted Automatic Sperm Sorting Device – Product Description 75

Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 76

Bioimpedance Probe – Product Status 76

Bioimpedance Probe – Product Description 76

Keratin Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 77

DARE-LARC1 – Product Status 77

DARE-LARC1 – Product Description 77

Laboratoire HRA Pharma SAS Pipeline Products & Ongoing Clinical Trials Overview 78

UPA C-IUS – Product Status 78

UPA C-IUS – Product Description 78

UPA C-Ring – Product Status 79

UPA C-Ring – Product Description 79

Lubrizol Life Science Health Pipeline Products & Ongoing Clinical Trials Overview 80

Contraceptive Vaginal System – Product Status 80

Contraceptive Vaginal System – Product Description 80

May Health Pipeline Products & Ongoing Clinical Trials Overview 81

Ovarian Rebalancing – Product Status 81

Ovarian Rebalancing – Product Description 81

May Health – Ongoing Clinical Trials Overview 82

Ovarian Rebalancing – A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue Under Ultrasound Guidance in Women With Infertility Due to Polycystic Ovary Syndrome 83

Ovarian Rebalancing – ULTRA Study: a Feasibility, Prospective, Multicenter, Single-arm Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualisation in Women With Polycystic Ovary Syndrome (PCOS) 83

Memorial Sloan Kettering Cancer Center Pipeline Products & Ongoing Clinical Trials Overview 85

Barakat Automated Uterine Manipulator Device – Product Status 85

Barakat Automated Uterine Manipulator Device – Product Description 85

Memphasys Ltd Pipeline Products & Ongoing Clinical Trials Overview 86

Felix – Product Status 86

Felix – Product Description 87

Memphasys Ltd – Ongoing Clinical Trials Overview 88

Felix – Clinical Assessment Study of Felix Device 89

Felix – Comparison of Clinical Outcomes of Infertile Men Candidate for ICSI Between Two Methods of Sperm Separation: Felix Device Based on Surface Electric Charge and Density Gradient Centrifugation (DGC) 89

Felix – The Felix Study: Assessing the Felix System Vs Swim-up and Discontinuous Gradient Centrifugation to Isolate Spermatozoa for Use in Assisted Reproductive Technology 89

Menorrx LLC Pipeline Products & Ongoing Clinical Trials Overview 90

Endometrial Ablation Device – Menstrual Bleeding – Product Status 90

Endometrial Ablation Device – Menstrual Bleeding – Product Description 90

Merck & Co Inc Pipeline Products & Ongoing Clinical Trials Overview 91

ENG-CVR – Product Status 91

ENG-CVR – Product Description 91

NOMAC-CVR – Product Status 92

NOMAC-CVR – Product Description 92

Merck Serono SA Pipeline Products & Ongoing Clinical Trials Overview 93

MK-8342 Medicated IUS – Product Status 93

MK-8342 Medicated IUS – Product Description 93

NextGem Inc Pipeline Products & Ongoing Clinical Trials Overview 94

NGX-004A – Product Status 94

NGX-004A – Product Description 94

NGX-004B – Product Status 95

NGX-004B – Product Description 95

Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 96

IVF – Embryo Transfer Catheter – Product Status 96

IVF – Embryo Transfer Catheter – Product Description 96

Oocyte Aspiration Needle – Product Status 97

Oocyte Aspiration Needle – Product Description 97

Novomedics L L C Pipeline Products & Ongoing Clinical Trials Overview 98

NovoSeal Catheter System – Product Status 98

NovoSeal Catheter System – Product Description 98

OCON Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 99

IUB SCu300B – Product Status 99

IUB SCu300B – Product Description 99

IUB SCu300C – Product Status 100

IUB SCu300C – Product Description 100

IUB SEAD – Product Status 100

IUB SEAD – Product Description 101

IUB Sphera – Product Status 101

IUB Sphera – Product Description 101

OCON Medical Ltd – Ongoing Clinical Trials Overview 102

IUB SEAD – Phase IIa Clinical Study to Evaluate Intrauterine Drug Delivery Platform IUB SEAD 103

IUB SEAD – PHASE IIB PRE-PIVOTAL STUDY TO ASSESS THE SAFETY AND EFFICACY OF THE IUB SEAD DEVICE IN WOMEN SUFFERING FROM HEAVY MENSTRUAL BLEEDING (HMB) 103

IUB SEAD – Phase IIc (Protocol 55P127): Addition of up to 10 Women to Explore Silver Systemic Absorption as a Continuation Study to: Phase IIb (Protocol 55P140) 103

OncoGenesis Pipeline Products & Ongoing Clinical Trials Overview 104

CerCap HIV – Product Status 104

CerCap HIV – Product Description 104

Otago Innovation Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

IUD Insertion Device – Product Status 105

IUD Insertion Device – Product Description 105

Pfizer Inc Pipeline Products & Ongoing Clinical Trials Overview 106

Sayana Press – Automated Filling Line – Product Status 106

Sayana Press – Automated Filling Line – Product Description 106

Sebela Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 107

LevoCept – Product Status 107

LevoCept – Product Description 107

VeraCept – Product Status 108

VeraCept – Product Description 108

Sebela Pharmaceuticals Inc – Ongoing Clinical Trials Overview 109

VeraCept – A Phase III, Prospective, Multi-center, Single-arm, Open-label Study to Evaluate VeraCept, a Long-acting Reversible Intrauterine Contraceptive for Contraceptive Efficacy, Safety, and Tolerability 110

VeraCept – A Randomized, Single-blind, Comparative Bioavailability Study to Assess the Pharmacokinetic Properties of VeraCept Intrauterine Contraceptive Versus ParaGard in Healthy, Post-menarcheal Women 110

Shandong Junxiu Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 111

Implantable Device – Reproductive Health – Product Status 111

Implantable Device – Reproductive Health – Product Description 111

Teva Pharmaceuticals USA Inc Pipeline Products & Ongoing Clinical Trials Overview 112

BREVARING – Product Status 112

BREVARING – Product Description 112

ONIVIX – Product Status 113

ONIVIX – Product Description 113

Zolaring – Product Status 113

Zolaring – Product Description 113

Teva Women’s Health Pipeline Products & Ongoing Clinical Trials Overview 114

Finzala – Product Status 114

Finzala – Product Description 114

University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 115

Biodegradable Porous Silicon Contraceptive – Product Status 115

Biodegradable Porous Silicon Contraceptive – Product Description 115

University of Cape Town Pipeline Products & Ongoing Clinical Trials Overview 116

FlexiGyn – Product Status 116

FlexiGyn – Product Description 116

University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 117

Adjustable Vaginal Spacer – Product Status 117

Adjustable Vaginal Spacer – Product Description 117

University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 118

Dual-Channel Needle – Product Status 118

Dual-Channel Needle – Product Description 118

University of Texas at Austin Pipeline Products & Ongoing Clinical Trials Overview 119

Postpartum Intrauterine Contraceptive Device – Product Status 119

Postpartum Intrauterine Contraceptive Device – Product Description 119

University of Texas Health Science Center at San Antonio Pipeline Products & Ongoing Clinical Trials Overview 120

Advanced Cervical Ripening System – Product Status 120

Advanced Cervical Ripening System – Product Description 120

University of Washington Pipeline Products & Ongoing Clinical Trials Overview 121

Copper Intrauterine Device – Product Status 121

Copper Intrauterine Device – Product Description 121

Womed Pipeline Products & Ongoing Clinical Trials Overview 122

Womed-03 – Product Status 122

Womed-03 – Product Description 122

Yale University Pipeline Products & Ongoing Clinical Trials Overview 123

Biodegradable Contraceptive Implant – Product Status 123

Biodegradable Contraceptive Implant – Product Description 123

ZR-Operculum, Inc. Pipeline Products & Ongoing Clinical Trials Overview 124

ZRO Device – Product Status 124

ZRO Device – Product Description 124

Glossary 158

Figures

Reproductive Health Devices – Pipeline Products by Stage of Development 15

Reproductive Health Devices – Pipeline Products by Segment 16

Reproductive Health Devices – Pipeline Products by Territory 17

Reproductive Health Devices – Pipeline Products by Regulatory Path 18

Reproductive Health Devices – Pipeline Products by Estimated Approval Date 19

Reproductive Health Devices – Ongoing Clinical Trials 20

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