A Natural Contrast Media

for fallopian tube patency evaluations.

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A meta analysis of 1000 women concluded that
SonoHSG used for tubal evaluation is superior to fluoroscopic HSG

and comparable to laparoscopic chromopertubation*

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

About Sono HSG

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.

Sono HSG Clinical Literature

Sono HSG is an accurate test for diagnosing tubal occlusion and performs similarly to a fluoroscopic HSG. Sono HSG should replace fluoroscopic HSG*
in the initial workup of subfertile couples because it also allows for visualization of the ovaries and myometrium, better sensitivity and specificity for the diagnosis of uterine cavity abnormalities, absence of radiation and risk of iodine allergy, while being comparable for patient tolerability. An economic study comparing cost-utility of Sono HSG and fluoroscopic HSG would add an interesting perspective to these considerations.

*S. Maheux-Lacroix et al. Hum Reprod 2014;29(5):953-63.

Hysterosalpingosonography for diagnosing tubal occlusion in subfertile women: a systematic review with meta-analysis

S. Maheux-Lacroix et al. Hum Reprod 2014;29(5):953-63.

Current methods of tubal patency assessment

Saunders RD, Shwayder JM, Nakajima ST. Fertil Sterili 2011;95:2171–79.

Transvaginal sonographic patency testing using air and saline as contrast media in a routine infertility clinic setting

Volpi. Ultrasound Obstetrics Gynecology. 1996;7:43-48.

Hysterosalpingo-Contrast Sonography Compared with Hysterosalpingography and Laparoscopic Dye Pertubation to Evaluate Tubal Patency

Exacoustos. The Journal of the American Association of Gynecologic Laparoscopists. 2003;10(3):367-372.

Saline and Air Bubbles

History as Contrast for Ultrasound Tubal Evaluation

Using saline and air as a contrast for sonographic imaging of the fallopian tubes was found to be highly concordant to laparoscopic chromopertubation (LC) and fluoroscopic hysterosalpingography (fluoroscopic HSG) as evidenced by the studies below.



Sono HSG Compared to LC
  Number of Tubes   Sensitivity (%)   Specificity (%)   Concordance (%)
Allahbadia Fertility and Sterility. 1992;58(5):901-907. 134   Not Reported   94
Heikkinen et al. Fertility and Sterility. 1995;64(2):293-298. 61   82   86   85
Volpi et al. Ultrasound Obstetrics Gynecology. 1996;7:43-48. 56   85   92   89
Spalding et al. Human Reproduction. 1997;12(11):2461-2464. 29   63   100   90
Inki et al. Acta Obstetricia et Gynecologica Scandinavica. 1998;77:978-982. 53   90   83   89
Jeanty et al. Journal Ultrasound Medicine. 2000;19:519-527. 29   86   77   79
Exacoustos et al. The Journal of the American Association of Gynecologic Laparoscopists. 2003;10(3):367-372. 30   75   91   87

  • As was stated by Spalding et al., not even LC is 100% reliable for testing tubal patency.
  • According to the American Society for Reproductive Medicine (Optimal evaluation of the infertile female. Fertility and Sterility. 2006; 86(4).): "All available methods for evaluation of tubal factors have technical limitations that must be considered when any one technique yields abnormal results." Accurate diagnosis and effective treatment of tubal obstruction often requires more than one evaluation method.

Sono HSG Compared to Fluoroscopic HSG
  Number of Tubes   Sensitivity (%)   Specificity (%)   Concordance (%)
Allahbadia Fertility and Sterility. 1992;58(5):901-907. 134   Not Reported   88
Chenia et al. The British Journal of Radiology. 1997;70:833-836. 142   Not Reported   88
Spalding et al. Ultrasound Obstetrics Gynecology. 1999;14:205-209. 31   50   97   94
Exacoustos et al. The Journal of the American Association of Gynecologic Laparoscopists. 2003;10(3):367-372. 67   80   94   90

  • These studies included numerous patients where Sono HSG detected patency and fluoroscopic HSG incorrectly determined blockage.

Sono HSG Articles

Sono HSG is being used by hospitals and physicians as an alternative test to the fluoroscopic HSG

Air Apparent: Using Bubbles to Reveal Fertility Problems

New ultrasound procedure can identify blockages in fallopian tubes.

Shedding Light on Fallopian Tube Blockages

You could have blockage in your fallopian tubes.

FemVue: The HSG Alternative Test

Using Sono HSG, patency can be tested with minimal discomfort to the patient.

Tests for Infertility

To diagnose the cause of infertility, experts at the NYU Langone Fertility Center may perform several different tests.

FemVue SAline - Air Device

The FemVue Saline-Air Device delivers a consistent alternating pattern of saline and air for fallopian tube patency evaluation during a Sono HSG.

Learn more about the FemVue Saline-Air Device

FemVue Sono HSG Patient Information



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.


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