The FemBloc Solution

Femasys is developing a permanent contraceptive solution (FemBloc) that will provide a safe and effective family planning option
for women who want to be free from temporary methods.





FemBloc has been designed for widespread acceptance by physicians and their patients:

Every gynecologist can perform in-office

Simple, quick, non-surgical placement that is similar to an IUD.

Safe and natural approach for patients

Pregnancy prevention by the body’s natural response to a temporary biopolymer with no intrusive implants or hormones.

Least expensive convenient permanent option

This office based procedure eliminates all extra costs to the practice and patient, such as; anesthesia, hospital/equipment fees, and radiology referrals.

FemBloc Permanent Contraceptive System is not commercially available for sale.

50+% of all women using contraceptives no longer want more children*

*Source: Daniels K., et al. Current contraceptive status among women aged 15-44; United States, 2011-2013: National Center for Health Statistics. Dec 2014

Products
Currently making a Difference

Femasys has expanded options for women with its two commercially available products for diagnosis of infertility (FemVue® Saline-Air device) and cervical cancer (FemCerv® Endocervical Sampler).

About FemVue

The FemVue device is used during the fallopian tube evaluation part of the Sono HSG, to introduce a saline and air mixture through the catheter. These bubbles are highly visible allowing the tubes to be evaluated for patency with ultrasound, saving physicians time and reducing patient cost associated with the x-ray HSG.

About SonoHSG

Sono HSG, also called sonographic hysterosalpingogram, is a transvaginal ultrasound technique that involves assessment of fallopian tube patency with a mixture of air and saline delivered through an intrauterine catheter, as well as, detection of abnormalities of the uterus.


* Gynecology in Practice: Infertility edited by Emre Seli, Chapter 3 Diagnosis and management of tubal factor infertility, Amanda N. Kallen and Peter H. Kodaman/span>

 

Learn more about FemCerv at www.femcerv.com

About Us

Femasys Inc. is a privately held corporation committed to transforming women's healthcare worldwide by expanding options
for women with innovative medical devices and next generation advancements providing significant clinical impact.

Our products have been organically conceived, researched and developed by the Company and all manufacturing activities are conducted to ensure compliance with the
U.S. Food and Drug Administration (FDA) per the requirements of 21 CFR 820, as well as ISO 13485.

Femasys has achieved significant milestones to date, including numerous issued patents and filings, clearance of multiple regulatory filings by the U.S. FDA, European Union,
Canada, and Japan with other select countries in process.

Our Process

1

INVENT

2

DEVELOP

3

TEST

4

APPROVE

5

BUILD

6

MARKET

Leadership

Founder of Femasys Inc., has served as President & CEO overseeing the development of the Company since its inception. She has over 20 years experience in medical device management, directing product development, operations and commercialization efforts in medical product regulated markets globally and is the inventor on more than 60 patents and patent applications.
Practicing obstetrician/gynecologist, has served as the company's CMO, influencing product development, including intellectual property and commercialization efforts. He has over 20 years of experience as a physician and was a founding member of Atlanta Women's Health Group. He has served as a principal investigator of numerous clinical trials and as a member of medical advisory and speaker boards.
Has served as CFO since 2015 and is responsible for the Company's financing, accounting, corporate development and investor activities. He has over 20 years of experience where he has structured, placed and managed capital investments, raising millions in debt and equity financing for emerging companies, such as ZS Pharma, SARcode Bioscience, Sirion Therapeutics, NovaQuest and Centice.
Has served as head of Operations developing the Company's infrastructure, product development program and quality system foundation since its inception. He has over 25 years of operational experience in the medical device industry, working closely with research and development teams, implementing and managing quality systems, and developing fully compliant manufacturing operations both domestically and internationally.
Has served as VP overseeing global regulatory product approvals since 2009. She has over 20 years of experience in medical device development, compliance, and global regulatory product approvals and has led product strategy and development initiatives for Class III medical devices that have successfully achieved PMA approval and managed pre-clinical and quality aspects for groundbreaking technologies.
Has served as VP overseeing global clinical trial requirements since 2016. She has over 20 years of consulting experience in women's health and contraception, developing medical education, pharmacovigilance and safety analysis & reporting, clinical trial development and conducting training. She was the Director of Family Planning at Emory Hospital for 10 years.
Has served as VP since 2011, overseeing strategic partnerships, including distribution arrangements. Mr. Damon has over 25 years of experience in pharmaceutical and medical device business management in the U.S. and Europe with a track record of securing several key partnerships with pharmaceutical companies resulting in more than $45 million of non-dilutive financing.
Has served as VP since 2010 and has over 30 years of finance and management experience in the medical device and pharmaceutical industries and public accounting as a CPA for both growth and revenue generating stage companies. He uniquely served as head of finance for a emerging unit within C.R. Bard and was responsible for budgeting, strategic plans and reporting.

News

Femasys Appoints Fred Aslan and Charles Larsen to its Board of Directors

Atlanta, GA, March 22, 2016 Femasys Inc., a developer of innovative medical devices for the women's healthcare market today announced that Fred Aslan, Founder and Chief Executive Officer of Advance Medical, Inc. and Vice President of Venrock and Charles E. Larsen, Managing Director of Accuitive Medical Ventures, have been appointed to the Femasys Board of Directors. Both new directors bring significant leadership, operations and commercial experience to Femasys as the Company prepares to commence its pivotal trial of FemBloc™ which is designed to provide women with the first non-surgical permanent contraception option delivered exclusively in the office.

read more

Femasys Announces Todd Creech as Chief Financial Officer

ATLANTA, GA, December 14, 2015 - Femasys Inc., a developer of innovative medical devices for the women's healthcare market today announced the appointment of Todd A. Creech as Chief Financial Officer. Mr. Creech will serve as Femasys' principal financial and accounting officer, will report to Kathy Lee-Sepsick, President and CEO, and will be responsible for all financing, accounting, corporate development and investor activities.

read more

Femasys Secures Term Loan Facility from Silicon Valley Bank

ATLANTA, GA, July 9, 2015 - Femasys Inc., a developer of innovative medical devices for the women's healthcare market, announced today that it has secured a term loan facility from Silicon Valley Bank. Under the loan facility, the company received initial funding and a conditional option to receive additional funding. The Company will use the funds for working capital as it supports the advancement of its groundbreaking non-surgical female sterilization device.

read more

Femasys Completes $10.2 Million Series B Financing Round

ATLANTA, GA, April 29, 2015 - Femasys Inc., a developer of innovative medical devices for the women's healthcare market has raised a $10.2 million financing round. The investor group was led by Legacy Capital Partners and Mario Family Partners, the family offices of life sciences industry veterans John Adams, Jr. and Dr. Ernest Mario. Joining the Company's board of directors is Mr. Adams, former CEO of Adams Respiratory Therapeutics. Salem Partners, a Los Angeles based investment bank focused on life sciences, advised the Company on the transaction and participated as a principal investor.

read more


Corporate Contacts:

General information:


Employment:


Business Development:
Steve Damon 

Media & Public Relations:
Jerry Fink 

FemVue Orders & Customer Service

United States Orders | Femasys (Mon-Fri, 8:30 am - 5:30 pm ET)

Japan Orders | Bayer Healthcare

FemCerv Orders & Customer Service

United States | McKesson Medical-Surgical

  • Toll free: +1.866.625.2679


Corporate Headquarters

Femasys Inc.
3950 Johns Creek Court, Suite 100
Suwanee, GA 30024
P: 1.770.500.3910 F: 1.770.500.3980

Femasys Announces Todd Creech as Chief Financial Officer

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Atlanta, Ga. --- December 14, 2015 --- Femasys Inc., a developer of innovative medical devices for the women's healthcare market today announced the appointment of Todd A. Creech as Chief Financial Officer. Mr. Creech will serve as Femasys' principal financial and accounting officer, will report to Kathy Lee-Sepsick, President and CEO, and will be responsible for all financing, accounting, corporate development and investor activities.

"Todd has a tremendous amount of financial and corporate development experience in the Life Sciences industry. We are honored to welcome Todd to the Femasys team as we enter the next critical phase of growth while pursuing our vision of expanding healthcare options for women with our innovative medical devices," said Kathy Lee-Sepsick, Femasys' President and CEO. "Todd's proven track record and financial leadership is exemplified by his success with numerous debt and equity financings to support the development of late-stage programs, regulatory approvals as well as commercial activities."

Mr. Creech previously served as the Chief Financial Officer of ZS Pharma, Inc., from August 2013 until June 2015 and was part of the team responsible for taking the company public, completing a successful secondary offering, disseminating key clinical data, and positioning the company for M&A discussions and eventual acquisition. During his tenure at ZS Pharma, Mr. Creech helped raise approximately $360 million in debt and equity financing.

Prior to ZS Pharma, Mr. Creech was CFO and Vice President of Business Development at SARcode Bioscience, where he led all financing, legal, accounting, and corporate development activities. Shire Pharmaceuticals acquired SARcode in April 2013. Prior to SARcode, Mr. Creech was CFO of Sirion Therapeutics, an ophthalmic pharmaceutical company. During his tenure, he raised $100 million in debt and equity financing to support the development of six late-stage clinical programs and two NDA approvals, and he also helped lead the sale of Sirion's drug assets to Alcon and Bausch & Lomb.

Mr. Creech worked with NovaQuest, the investment group within Quintiles, Inc., where he structured, placed, and managed capital investments into US-emerging biotech and specialty pharmaceutical companies. Prior to his work with NovaQuest, he cofounded Centice, an optical sensor spin out from Duke University, in 2003. Mr. Creech has an additional 10 years of experience consulting to biotech and high-tech companies while at SRI International and Andersen Consulting. Mr. Creech holds bachelor's degrees in finance and accounting from Miami University of Ohio and an MBA from Duke University.

"This is an extremely exciting time to be joining Femasys especially as the company prepares to commence its pivotal trial of FemBloc™ which is designed to provide women with the first non-surgical permanent contraception option delivered in exclusively in the office.," said Mr. Creech. "I look forward to working closely with the Femasys team to achieve its financial and strategic goals."


Femasys Secures Term Loan Facility from Silicon Valley Bank

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Atlanta, GA -July 9, 2015 - Femasys Inc., a developer of innovative medical devices for the women's healthcare market, announced today that it has secured a term loan facility from Silicon Valley Bank. Under the loan facility, the company received initial funding and a conditional option to receive additional funding. The Company will use the funds for working capital as it supports the advancement of its groundbreaking non-surgical female sterilization device.

"We are pleased to build a relationship with Silicon Valley Bank, a leader in financial services for the healthcare industry. This loan facility will provide greater financial flexibility as we aggressively pursue the regulatory milestones of our highly promising FemBloc™ Permanent Contraceptive System and expansion of commercialization efforts for our novel medical devices," remarked Kathy Lee-Sepsick, President & CEO of Femasys Inc.

"The opportunity to work with innovative medical device companies like Femasys is what excites us on the life science side of the SVB portfolio," said Scott McCarty, Director of Life Science and Healthcare for Silicon Valley Bank's Atlanta office. "We have confidence in the Femasys team and it has been a pleasure working with them throughout the implementation of the loan facility. Our partnership is intended to increase the Company's probability of success as it develops and delivers solutions that are transforming women's healthcare."

"Femasys fills an important and significant gap in the women's healthcare continuum," said John Q. Adams, Jr. Legacy Capital Partners. "We believe that both physicians and patients will have great interest in the innovative new technologies and that we can provide value to the company through our highly experienced investor syndicate."



ABOUT SILICON VALLEY BANK | www.svb.com

For more than 30 years, Silicon Valley Bank (SVB) has helped innovative companies and their investors move bold ideas forward, fast. SVB provides targeted financial services and expertise through its offices in innovation centers around the world. With commercial, international and private banking services, SVB helps address the unique needs of innovators. Forbes named SVB one of America's best banks (2015) and one of America's best-managed companies (2014). Learn more at svb.com.

Silicon Valley Bank is the California bank subsidiary and commercial banking operation of SVB Financial Group (Nasdaq: SIVB), and a member of the FDIC. Silicon Valley Bank and SVB Financial Group are members of the Federal Reserve System.


Femasys Completes $10.2 Million Series B Financing Round

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Atlanta, GA -April 29, 2015 - Femasys Inc., a developer of innovative medical devices for the women's healthcare market has raised a $10.2 million financing round. The investor group was led by Legacy Capital Partners and Mario Family Partners, the family offices of life sciences industry veterans John Adams, Jr. and Dr. Ernest Mario. Joining the Company's board of directors is Mr. Adams, former CEO of Adams Respiratory Therapeutics. Salem Partners, a Los Angeles based investment bank focused on life sciences, advised the Company on the transaction and participated as a principal investor.

Femasys has developed a groundbreaking non-surgical female sterilization device (FemBloc™ Permanent Contraceptive System) that allows physicians to deliver exclusively in their office a biomaterial through a catheter based system to permanently block the fallopian tubes that substantially reduces patient risks and costs by eliminating the use of anesthesia and permanent implants. The company has also expanded options for women with its two commercially available products for diagnosis of infertility (FemVue® Saline-Air device) and cervical cancer (FemCerv® Endocervical Sampler) that present significant advantages for the patient, physician and healthcare system.

"We are pleased to have the support and confidence of this esteemed group of investors," said Kathy Lee-Sepsick, Femasys' President and CEO. "This round of funding will enable Femasys to invest in the people and programs necessary to achieve the Investigational Device Exemption (IDE) milestone for FemBloc and expand commercialization globally for our diagnostic products to allow women access to better options when it comes to managing their health needs."

"Femasys fills an important and significant gap in the women's healthcare continuum," said John Q. Adams, Jr. Legacy Capital Partners. "We believe that both physicians and patients will have great interest in the innovative new technologies and that we can provide value to the company through our highly experienced investor syndicate."

ABOUT LEGACY CAPITAL PARTNERS

John Adams, Jr. was the former CEO of Adams Respiratory Therapeutics, developer of the Mucinex brands. Adams was sold to Reckitt Benckiser in 2008 for $2.3 billion. Mr. Adams has been in the pharmaceutical industry for over 30 years and has made investments in a number of development-stage companies. Legacy Capital Partners is based in Southlake, TX.

ABOUT MARIO FAMILY PARTNERS

Mario Family Partners is the private equity arm of Dr. Ernest Mario's family office. Dr. Mario was the former CEO of Alza Corporation which was sold to Johnson & Johnson for $12 billion in 2001, the largest-ever M&A deal for J&J at the time. He was previously CEO of Glaxo and currently sits on the boards of Boston Scientific Corporation and Celgene Corporation among others.

ABOUT SALEM PARTNERS LLC | www.salempartners.com

Salem Partners is a boutique investment bank and wealth management firm based in Los Angeles that specializes in raising growth capital and executing M&A assignments for companies in the media, life sciences and industrial sectors. Salem has a strong track record in life sciences, having raised substantially all of the private capital for Adams Respiratory Therapeutics, ZS Pharma, Inc. and Neos Therapeutics.


Femasys Appoints Fred Aslan and Charles Larsen to its Board of Directors

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-- Aslan and Larsen are seasoned healthcare executives who have successfully developed emerging technologies to advance the practice of medicine --

Atlanta, GA March 23, 2016 - Femasys Inc., a developer of innovative medical devices for the women's healthcare market today announced that Fred Aslan, Founder and Chief Executive Officer of Advance Medical, Inc. and Vice President of Venrock and Charles E. Larsen, Managing Director of Accuitive Medical Ventures, have been appointed to the Femasys Board of Directors. Both new directors bring significant leadership, operations and commercial experience to Femasys as the Company prepares to commence its pivotal trial of FemBloc™ which is designed to provide women with the first non-surgical permanent contraception option delivered exclusively in the office.

"We are extremely honored to have Fred and Charlie join our Board of Directors – they are proven executives who have been successful starting new businesses, developing and commercializing emerging technologies, building organizations and delivering value to shareholders,” said Kathy Lee-Sepsick, President and CEO of Femasys. “Their considerable experience will be invaluable to our team as we embark on the next phase of development with FemBloc™.”

Dr. Aslan has over 15 years of strategic management and direct investment experience in the medical device, diagnostics, and biotechnology sectors. Dr. Aslan is currently the Founder and Chief Executive Officer of Advance Medical, a Venrock portfolio company that is focused on the commercialization of medical device and diagnostics technologies in Brazil, and he is also a Vice President at Venrock. Dr. Aslan has served on the Board of Directors of Receptos, a company recently acquired by Celgene, and has been a Board observer for a number of other companies including Zeltiq and PowerVision. Dr. Aslan was the Director of Business Development and Investor Relations at CuraGen Corporation. Prior to CuraGen, he worked at Boston Consulting Group where he advised biotechnology and pharmaceutical companies on a number of strategic initiatives. Dr. Aslan received his B.S. in Biology from Duke University, M.D. from Yale University School of Medicine and M.B.A. from the Harvard Business School.

Mr. Larsen has over 35 years of operating and technical experience in the medical device industry. He co-founded Novoste Corporation and The Innovation Factory and through his role at The Innovation Factory, he co-founded additional companies including: Acufocus, AqueSys, Halscion, LipoSonix, Neuronetics and Sebacia. He holds over 30 issued U.S. and international patents on medical devices. Before joining Novoste, Mr. Larsen held positions with Novoste Puerto Rico, Cordis Corporation, Key Pharmaceuticals and Parke-Davis/Warner Lambert in executive, senior engineering and project management roles. Mr. Larsen received a B.S. in Mechanical Engineering from the New Jersey Institute of Technology. Mr. Larsen currently is member of the Board of Directors for Acufocus, CardioFocus, Intuity, and Torax.

ABOUT FEMASYS

Femasys Inc., based in Atlanta, GA, is a privately held corporation committed to transforming women's healthcare worldwide by expanding options for women with innovative medical devices and next generation advancements providing significant clinical impact. Additional information about Femasys and the Company’s products can be found at www.femasys.com

Femasys has developed a groundbreaking non-surgical female sterilization device (FemBloc™ Permanent Contraceptive System) that allows physicians to deliver exclusively in their office a Biopolymer through a catheter-based Delivery System to permanently block the fallopian tubes in a procedure that substantially reduces patient risks and costs by eliminating the use of anesthesia and permanent implants. The company has also expanded options for women with its two commercially available products for diagnosis of infertility (FemVue® Saline-Air device) and cervical cancer (FemCerv® Endocervical Sampler) that present significant advantages for the patient, physician, and healthcare system.

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Femasys may modify the Terms and Conditions at any time, and such modifications will be effective immediately upon posting to the website. Please review the Terms of Use and Privacy Policy each time you visit the Femasys website.

Purpose

This is a World Wide Web site for information about Femasys Inc. products: FemBloc, FemCerv, and FemVue, and Sono HSG. The purpose is to provide information to healthcare providers, patients, and all interested parties.

Copyright

All rights, including copyright, in the content of the web pages contained in this website are owned or controlled for these purposes by Femasys Inc. In accessing Femasys' web pages, you agree that you may only download the content for your personal non-commercial use. You are not permitted to copy, reproduce, republish, distribute, broadcast, download, store (in any medium), transmit, show or play in public, adapt or change in any way the content of these Femasys web pages for any other purpose whatsoever without the prior written permission of Femasys Inc.

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Trademark Notice

Femasys is a trademark of Femasys Inc. Other trademarks, logos, brand names and slogans registered or used by Femasys in the United States and/or other countries include, but are not limited to, the following: FemBloc, FemCerv, FemChec, FemaSeed, and FemVue. All other trademarks and registered trademarks are the property of their respective owners.

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