Changing the Standard of Care for Fibroid Treatment and Fertility

Over 5.9% of women (226 million) have Uterine Fibroids world wide

0%

70%-80%

Of women will develop uterine fibroid by the age of 50

0%

20%-30%

Of women with fibroids are symptomatic

0%

>70%

Of women with fibroids are on therapeutic plan

+0%

70%-75%

Of surgeries performed in US are hysterectomies

Symptoms

Menstrual
cramps and pain

Heavy menstrual
bleeding & anemia

Problems with
fertility or pregnancy

Bladder or bowel
symptoms

Body illustration

Uterine Fibroids are benign muscle tumors

Fibroids are classified by their size, shape and location

Myomectomy is The Golden Standard of Care for Uterine Preservation and Future Pregnancy Option.

Minimally Invasive or Laparoscopic Myomectomy Was First Described in the Late 1970’s
It is a Difficult Technique which has not Developed since the early 1990’s

Pressure Induced Fibroid Ischemia

The Empress system is intended to treat symptomatic uterine fibroids, in a laparoscopic procedure, by inducing fibroid tissue ischemia.

Sutures wrapped around the fibroid increases the intra-tumoral pressure which leads to fibroid Ischemia – blockage of intra- and peri-fibroid blood flow and, eventually, necrosis of the fibroid tissue.

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EMPRESS System Ease-of-Use Features

Simple Steps Battery Operated

Simple Steps Battery Operated

Semi-Automated Advancement

Semi-Automated Advancement

Controlled Suture Technique

Controlled Suture Technique

Guided Needle Path

Guided Needle Path

Hand-held Untethered

Hand-held Untethered

No Thermal Energy.

No Thermal Energy

Published in Reproductive Sciences August 2022

Results from our First In Man Study Demonstrated Safety and Feasibility Of the Empress Procedure

Follow this link for the full article

First In Human Feasibility Study Summary

21 uterine fibroids were treated in 16 symptomatic pre-menopausal black women. Pelvic magnetic resonance imaging (MRI) was performed before the procedure, and at 1, 3, 6, and 12 months.
Results suggest the device is safe and can be effective for its intended purpose

VOLUME REDUCTION.

36.3% treated fibroid volume reduction @ 3 months (p=.002)

60.4% treated fibroid volume reduction @ 12 months (p=.008)

100% procedural Success

100% procedural Success

Patients reported improvements in Energy/Mood, Control, and Sexual Function

Patients reported improvements in Energy/Mood, Control, and Sexual Function

ZERO

Zero Adverse Events

Short Surgery Time

Short Surgery Time

Positive Safety Profile

Positive Safety Profile

Improved Quality of Life at 3 months

Improved Quality of Life at 3 months

Case Study

Before Empress Treatment

Before Empress Treatment

Fibroid Volume = 46cm3
0 %
Fibroid Volume Decrease
After 1 Year

After 1 Year

Fibroid Volume = 8.6cm3

Empress is a technology company changing the standard of care for women with uterine fibroids

Who we are

Empress Medical is changing the standard of care for fibroid treatment – one of the highest prevalence painful conditions amongst women especially black and ethnic women. Incorporated in Delaware, United States in 2019, our team is international and preparing rapidly to enter a pivotal clinical phase in the US

What we do

We are focused on changing the standard of care for women worldwide and reducing the number of hysterectomies by introducing an easy-to-use laparoscopic technology designed for gynecologists operating in average settings, making it accessible to more underserved women, and delivering on the promise to offer a broader base of women a safe uterus preserving fibroid treatment option and preserving fertility

Why we do it

We are on a mission to reduce hysterectomies and give women with Uterine Fibroids a safe uterine preserving treatment option. When we succeed, more women with fibroids will be empowered to make better decisions about their treatment choice for preserving their uterus and future pregnancy options

BOARD OF DIRECTORS

Michael Tal, M.D

Empress’ Founder & Chairman
Interventional Radiologist Former Associate Clinical Professor of Radiology at Yale University School of Medicine, US

Travis Sessions

Biomerics CEO
Managing Partner of Med Venture Holdings

Keren Leshem

OCON Therapeutics CEO
Aspivix BOD

CLINICAL ADVISORY

Kevin Stepp, M.D

Kevin Stepp, M.D

Head of Advisory Board
FACOG, Female Pelvic Medicine and Reconstructive Surgery, Urogynecology

Ran Keidar, M.D

Ran Keidar, M.D

Advisory Board Member
OBGYN Surgeon, Specializing in advanced Endoscopy

MANAGEMENT TEAM

Angela Dotson

CEO
A seasoned executive with over 20 years of experience in the medical device space. The majority of her career has been working within the med tech start-up space in various sales roles where she has helped deliver on successful exits

Ron Livne

VP BD
Experienced manager and business consultant of medical device funds and startups

Yuval Yona

VP R&D
Deep technical experience and background in development and production of medical devices

Hila

Hila Ravid

QA/RA Manager
Vast experience in regulation and certification of medical devices

Sigal Shachar

Sigal Shachar

CFO
Over 15 years as a CFO in startups and corporations

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