PhyBa Catheter – Medical Device for Women

Industry

Healthcare/Technology

Company Type

Medical Devices

Location

U.S.

Size

$25 Million

Investment Type

Equity/Debt
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Contact: Tina Vital, Managing Director

Email: tvital@castleplacement.com

Cell (917) 432-8474 

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OVERVIEW

nGyne Technologies is a U.S. based surgical research and device company seeking +/-$25 million equity (excluding $3 million of sponsor contributed equity) for FDA/CE application processing, prototype development, manufacturing, and sales of the PhyBa intrauterine expander (UTE) catheter.

  • State-of-the-art intrauterine (balloon) catheter for the prevention (or primary prophylaxis) of adhesions after intrauterine surgery and/or other affections
  • Replaces inferior options currently in use; lower rates of adhesion compared with Foley or Kan-Ji catheter, Cooper’s anti-adhesion gel and/or IUD catheters
  • Expands market by use with endometriosis procedures where there are currently no good options; helps to prevent walls of uterus from touching on natural contraction which reduces endometriosis (pain)
  • Proprietary technology – invented by renowned gynecologists – international patents granted and/or pending
  • Management team has expertise in medical and surgical device development and marketing, with deep surgical and research experience in reproductive medicine and fertility
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GLOBAL MARKET FOR UTERINE CATHETERS EXPANDING

Multi-billion global gynecological market for uterine catheters is expanding, reflecting use to prevent complications from uterine surgery such as intrauterine adhesions and post-surgical bleeding.

  • Three main pathologies in which catheters are currently in use
    • pregnancies and abortions – after removal of retained intracavitary remains (incomplete abortion or after delivery/caesarean section)
    • Asherman’s Syndrome procedure
    • hysteroscopic myomectomies – myomas are a common pathology estimated to affect up to 50% of women of reproductive age
  • Specialty catheters – fast-growing segment due to increased prevalence of targeted diseases and demand for minimally invasive procedures
    • Asherman’s Syndrome – largest segment
  • Balloon catheters – global market was valued near $2.6 billion in 2021, and projected to top $9.92 billion by 2030
    • Post-Partum Hemorrhage (PPH) – world’s leading cause of maternal mortality, responsible for an estimated 127,000 deaths of the 14 million cases that occur each year
    • PPH balloon catheter market is expected to exceed $1.2 billion by 2025 worldwide, driven by increased incidence of PPH in high- and low-income countries
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SOLUTION/STRATEGY

nGyne Technologies was formed to acquire medical device technology and patents developed by gynecologists Haimovich and Alonso and robotics engineer Sabaris.

  • PhyBa UTE Catheter is an expander (balloon) catheter for intrauterine placement with special anatomical features which helps to prevent the formation of intrauterine adhesion
    • eliminates almost all pain
    • 100% internal; easily removed 5 days after insertion without a surgical procedure
    • works better than the Foley and Kan-Ji catheters
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PHYBA INTRAUTERINE EXPANDER (UTE) CATHETER – BETTER DESIGN AND FUNCTION

PhyBa (intrauterine balloon) catheter for intrauterine placement with special anatomical features – first Tampon Catheter ever designed.

  • Enhanced adaption to different morphologies presented by the inner cavities of the uterine organ
  • Efficiently allows for dilation and separation of the inner walls of the uterine cavity previously scraped in the endometrial curettage surgical procedure
  • Acts as a separator and insulator in the prevention of intrauterine adhesions, facilitating drainage in both inside the device and perimetral in various operative approaches
  • Positioned in the uterus with the help of a pushing element, which is discarded together with the sheath once the catheter is placed
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KEY USES

Primary prophylaxis (prevention) of intrauterine adhesions after intrauterine surgery.

  • Dilation & Curettage (D&C) – most frequent procedure worldwide; responsible for 90% of intrauterine adhesions
  • Intrauterine surgery (also called hysteroscopy surgery) – myomectomy, uterine anomalies and malformations (such as septate uterus, dysmorphic uterus)
  • Secondary prophylaxis after surgery of adhesions
  • Asherman’s Syndrome and PPH
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COMPETITIVE ADVANTAGES

DESIGN

  • Device has its own inserter, which significantly facilitates its placement and reduces discomfort; no tubes out of body
  • Top inner placement for filling cavities and seven (7) main draining channels
  • Increased perimeter drainage capacity of accumulated secretions
  • Multi-chamber configuration allows for greater expansion along the lateral edges
  • Hypoallergic materials and fixed expanders to prevent rejection

FUNCTION

  • Adaption – an anatomical shape that adapts to the uterine cavity
  • Separation – wide distension capacity which increases the separation of the walls exerting hemostatic action by compression
  • Movement – intra-vaginal tubes avoiding external shut-off valves and external longer tubes that limit freedom of movement in the patient
  • Robust – different sizes and types to customize demand and expand use to other applications such as PPH by the hemostasis effect
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MANAGEMENT

Leon Levy Truzman – Chief Executive Officer and Co-Founder

Over 30 years of global business development, product manufacturing and physical commodity trading. Co-founder of AWE Medical Group LLC (2020) and nGyne Technologies, Inc (2019). Owner of import/export companies, 26 Collections (New York) and Textiles Globaltex (Panama). Past Broker, Symmetry Financial Group; and Director of Physical Commodity Trading, Capital Export (Panama). B.S., Yeshiva University (New York).  

Sagil Haimovich, MD, PhD – Team Coordinator and Co-Founder

Over 30 years of surgical and research experience within Obstetrics and Gynecology. Director of Gynecology Department, Laniado University Hospital (Netanya, Israel). Head of Reproductive Surgery Unit at the Embriogyn Clinic (Tarragona, Spain). Director and Founder of the International School of Laser in Gynecology (ISLaH), Del Mar Hospital (Barcelona, Spain). Chair and Founder of the Global Community of Hysteroscopy; and Chair of the AAGI Hysteroscopy SIG. Co-Founder and Team Coordinator of the Group of Interest in Hysteroscopy of the Israeli Gynecology Endoscopy Society. National Award by Diario Medico (2013); Annual Award for best investigative work by National Congress of the Spanish Contraception Foundation (2009); and Best Communication Award by the National Congress of the Spanish Society of Contraception (2009, 2004). Numerous patents and publications. MD/PhD in Obstetrics and Gynecology (cum laude), Universidad Autonoma de Barcelona (Spain). Specialty in Obstetrics and Gynecology (MIR), Vail d’Hebron University Hospital, Universidad Autonoma de Barcelona (Spain). B.S. in Medicine and Surgery, Universidad Central de Barcelona (Spain).

Joaquin Vilas Sabaris, MS, MBA – Chief Technology Officer and Co-Founder

Over 30 years of engineering and marketing support for medical systems and devices. Co-founder of AWE Pharma (Spain); AWE Medical Group LLC; nGyne Technologies, Inc; and Respira, Inc (U.S.) focused on the development of medical and surgical devices in association with VHIR (Vall d’Hebron Research Institute; Barcelona, Spain). Previously served as RDI Associated Scientist at AWE4; Head of Marketing POCT at Danaher Group Product Specialist Radiology at Siemens; Product Manager/Head of Point Care POCT at Roche Global; Product Specialist Radiology at Siemens A.G. (Germany); Bioengineering Surgery at Werfen Group; and FSE Field Service Engineer at Izasa S.A. Multiple patents and publications. International MBA, ESADE University. ADE EADA Business School. PGDigp from, Roche’s Cathedra University in Microbiology, Sale Lake University. M.S.  in Tech Engineering, Nuclear Energy, UCM University of Madrid (Spain). PGDip in Cardiology Surgery Systems, Tel Aviv University (Israel). M.S. in Robotics, Polytech University. B.A. in Telematic and Electronic, Polytech University. 

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FOOTNOTES:

Overview
Opportunity
Global Market for Uterine Catheters Expanding
Solution/Strategy
PhyBa Intrauterine Expander (UTE) Catheter – Better Design and Function
Key Uses
Competitve Advantages

(1) nGyne Technologies – Offering Memo 6.0 – 2022
(2) BJOG – Prevention of postoperative adhesion reformation by intermittent intrauterine balloon therapy a radomized clinical trial – 190617
(3) Journal of Obstetrics and Gynecology – The use of intrauterine balloon in preventing adhesion recurrence after hysteroscopic adhesiolysis – 221221

Global Market for Uterine Catheters Expanding

(4) Grandview Research.com – PTA Balloon Catheter Market Size Share and Trends Analysis 2022-2030 – 2021
(5) Allied Market Research – Postpartum Hemorrhage PPH Devices Market – April 2022
(6) Grandview Research.com – Catheter Market Size Share and Trends Analysis By Product Type 2022-2030 – 2021
(7) Reprod Biol Endocrinol – The management of Asherman syndrome a review of literature – 131227

Key Uses

(8) nGyne Technologies Inc – Spain – Intrauterine Expander Device – Patent WO 2020-094903-AI- Spanish – 200514
(9) BJOG – Prevention of postoperative adhesion reformation by intermittent intrauterine balloon therapy a radomized clinical trial – 190617
(10) Journal of Obstetrics and Gynecology – The use of intrauterine balloon in preventing adhesion recurrence after hysteroscopic adhesiolysis – 221221.pdf
(11) Sevinç F, Oskovi-Kaplan ZA, Çelen Ş, Ozturk Atan D, Topçu HO. Identifying the risk factors and incidence of Asherman Syndrome in women with post-abortion uterine curettage. J Obstet Gynaecol Res. 2021 Apr;47(4):1549-1555. doi: 10.1111/jog.14667. Epub 2021 Jan 18. PMID: 33462894.
(12)  Li S. Study on Risk Factors Related to Intrauterine Adhesion Based on Meta-Analysis. Comput Math Methods Med. 2022 Oct 11;2022:4667679. doi: 10.1155/2022/4667679. PMID: 36267305; PMCID: PMC9578867.
(13) Hooker AB, de Leeuw RA, Twisk JWR, Brölmann HAM, Huirne JAF. Reproductive performance of women with and without intrauterine adhesions following recurrent dilatation and curettage for miscarriage: long-term follow-up of a randomized controlled trial. Hum Reprod. 2021 Jan 1;36(1):70-81. doi: 10.1093/humrep/deaa289. PMID: 33320197; PMCID: PMC7801791.
(14) Freedman MF, Schlaff WD. Avoiding Asherman’s syndrome: refining our approach to uterine evacuation. Fertil Steril. 2021 Oct;116(4):961-962. doi: 10.1016/j.fertnstert.2021.06.037. Epub 2021 Jul 28. PMID: 34330428.
(15)  Lee WL, Liu CH, Cheng M, Chang WH, Liu WM, Wang PH. Focus on the Primary Prevention of Intrauterine Adhesions: Current Concept and Vision. Int J Mol Sci. 2021 May 13;22(10):5175. doi: 10.3390/ijms22105175. PMID: 34068335; PMCID: PMC8153321.
(16) Takasaki K, Henmi H, Ikeda U, Endo T, Azumaguchi A, Nagasaka K. Intrauterine adhesion after hysteroscopic myomectomy of submucous myomas. J Obstet Gynaecol Res. 2023 Feb;49(2):675-681. doi: 10.1111/jog.15499. Epub 2022 Nov 20. PMID: 36404131.
(17) Bortoletto P, Keefe KW, Unger E, Hariton E, Gargiulo AR. Incidence and risk factors of intrauterine adhesions after myomectomy. F S Rep. 2022 May 28;3(3):269-274. doi: 10.1016/j.xfre.2022.05.007. PMID: 36212555; PMCID: PMC9532880.
(18) Giouleka S, Tsakiridis I, Kalogiannidis I, Mamopoulos A, Tentas I, Athanasiadis A, Dagklis T. Postpartum Hemorrhage: A Comprehensive Review of Guidelines. Obstet Gynecol Surv. 2022 Nov;77(11):665-682. doi: 10.1097/OGX.0000000000001061. PMID: 36345105.
(19)  Leleu A, Ghesquiere L, Machuron F, Caudrelier C, Devouge P, Subtil D, Houflin-Debarge V, Garabedian C. Intrauterine balloon tamponade in the management of severe postpartum haemorrhage after vaginal delivery: Is the failure early predictable? Eur J Obstet Gynecol Reprod Biol. 2021 Mar; 258:317-323. doi: 10.1016/j.ejogrb.2021.01.030. Epub 2021 Jan 20. PMID: 33498006.
(20) Guo Y, Hua R, Bian S, Xie X, Ma J, Cai Y, Sooranna SR, Cheng W. Intrauterine Bakri Balloon and Vaginal Tamponade Combined with Abdominal Compression for the Management of Postpartum Hemorrhage. J Obstet Gynaecol Can. 2018 May;40(5):561-565. doi: 10.1016/j.jogc.2017.08.035. Epub 2017 Oct 19. PMID: 29056469.
(21) Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi:
(22) Shi X, Saravelos SH, Zhou Q, Huang X, Xia E, Li TC. Prevention of postoperative adhesion reformation by intermittent intrauterine balloon therapy: a randomised controlled trial. BJOG. 2019 Sep;126(10):1259-1266. doi: 10.1111/1471-0528.15843. Epub 2019 Jul 18. PMID: 31207009.
(23)  Zhang X, Liu W, Zhou Y, Qiu J, Sun Y, Li M, Ding Y, Xi Q. Comparison of therapeutic efficacy of three methods to prevent re-adhesion after hysteroscopic intrauterine adhesion separation: a parallel, randomized and single-center trial. Ann Palliat Med. 2021 Jun;10(6):6804-6823. doi: 10.21037/apm-21-1296. PMID: 34237979.
(24) Steffi van Wessel, Lieselot Wauters, Steven Weyers & Tjalina Hamerlynck (2022): The use of an intrauterine balloon in preventing adhesion recurrence after hysteroscopic adhesiolysis: a feasibility study, Journal of Obstetrics and Gynaecology, DOI: 10.1080/01443615.2022.2158320
(25) Zhao J, Zhang L, Liang J, Zhao H, Wang Z, Pang Y. The effect of the combined use of an intrauterine device and a Foley balloon in the prevention of adhesion following hysteroscopic adhesiolysis. Women Health. 2023 Jan

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Thanks, Ken

Ken Margolis | Managing Partner Castle Placement, LLC
1460 Broadway Street, Rte 400
New York, New York 10036
(212) 418-1188 | C: (516) 712-7784
kmargolis@castleplacement.com

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