Femasys Inc

Invention:	Non-surgical permanent contraceptive
Trademark:	FemBloc®
Patents:	130
NYSE:	FEMY

The invention

FemBloc is a non-surgical, in-office permanent birth control method. It involves a procedure for delivering a biopolymer to block the fallopian tubes, preventing pregnancy. An ultrasound is conducted after the procedure using the company's FemView technology to confirm closure (occlusion). The biopolymer degrades after around 3 months and is expelled naturally, leaving naturally forming scar tissue to block the fallopian tubes. 

Performance advantages

FemBloc offers a non-surgical non-implant alternative to tubal ligation, providing a potentially safer and less invasive option for permanent birth control. Compared to tubal ligation, the FemBloc procedure can be performed in a physician’s office with no anesthesia, no incisions or cannulation, no specialty skill set or capital equipment and minimal pain and recovery time, and no residual implant remaining in the patient’s body after the scar tissue develops. 

Futhermore, unlike IUDs, which are temporary and require periodic replacement, FemBloc is designed for permanent contraception without the need for surgery or hormones. Compared to Essure, a now-discontinued device with surgical implantation, FemBloc aims to offer a safer profile by avoiding metal implants and the complications associated with them, focusing on a natural, biodegradable material for tubal occlusion.

Across three clinical trials, physicians observed that their subjects found the procedure to be highly tolerable, with subject self-reported pain scores similar to placement of IUDs. Almost every case (96%) was assessed by the physician to be extremely satisfied or very satisfied with the procedure and 96% found it easier than tubal ligation surgery. 

Cost advantages

FemBloc offers a ~50% cost advantage over surgical tubal ligation by potentially reducing the need for hospitalization, anesthesia, and surgery. The total cost of surgical tubal ligation is ~$6,000. Fembloc's projected total costs are ~$2,500 ($1,500 for the Fembloc system and $1,000 for the physician/practice).

There will be no cost to patients under the Affordable Care Act (ACA), and notable reimbursement is expected for physicians/practices. 

Intellectual property

As of December 31, 2022, the company owned 40 issued U.S. patents and 122 issued foreign patents, 13 pending U.S. patent applications and 17 pending foreign patent applications. It should be noted that some of these patents cover other products in the company's portfolio, such as:

• FemaSeed: intratubal insemination (treatment)
• FemView: contrast-generating device (diagnostic)
• FemCath: selective delivery catheter (diagnostic)
• FemCerv: endocervical tissue sampler (diagnostic)

Addressable market

The company values Fembloc's near-term annual market in the USA at USD$2bn, which includes the 1.3m patients choosing permanent birth control annually (800,000 women for tubal ligation and 500,000 men for vasectomy), and a total market expansion opportunity of USD$20bn, which includes the 12m  women who no longer intend to have children and are using non-permanent options, such as:

• LARCs (IUDs and hormonal contraceptive implants): 35% (4m)
  
• Pills: 25% (3m)
  
• Condoms: 18% (2m)
  
• Other hormone: 8% (1m)
  
• Other method: 14.5% (2m)

Regulatory status

On the 26th June 2023, the FDA approved the company's Investigational Device Exemption (IDE) to evaluate the safety and efficacy of FemBloc® in a pivotal clinical trial (the “FINALE” trial).

According to the company's annual report for 2022, the company has studied FemBloc in three clinical trials (a pilot safety study, a pivotal trial, and a validation study) pursuant to an FDA approved investigational device exemption (IDE) for each study with evaluation of safety in a total of 228 subjects. Subjects are being followed for five years for safety, and for the initial 49 subject pilot study, four years of follow-up have been completed. There have been no serious safety events reported to date in any of the subjects and over 90% of the events reported that were classified as related to the device, procedure or both, were on the day of the procedure or within seven days after the procedure. The reported events were anticipated and the majority of these events were bleeding or spotting and/or pain or cramps and over 75% were classified by the physician as mild.

During the conduct of the first two clinical studies, unintended pregnancies occurred in subjects who were told to rely on FemBloc (six pregnancies for the pilot study and three pregnancies for the pivotal trial). These pregnancies were due to misinterpretation of the ultrasound test using the FemChec device, as reviewed and confirmed by an independent clinical events committee. FDA viewed these unintended pregnancies as a safety concern and, as a result, in February 2019 the company paused the pivotal clinical trial for FemBloc (although subjects are still followed for safety through 5 years). Subsequently, the agency recommended conducting a small clinical study in a new cohort of subjects to evaluate the adequacy of certain proposed mitigations and validate the ultrasound confirmation test. The study enrollment concluded in September 2022, in which 45 subjects at five U.S. sites received two confirmation tests (ultrasound and traditional radiology). Subjects were informed to rely on FemBloc only if both tests confirm procedure success. There were no pregnancies in subjects told to rely on FemBloc. We plan to use the study data to support which of the two confirmation tests (ultrasound or radiology) should be studied in a new pivotal trial to support a potential future application for PMA for FemBloc. Results of the small study along with the trial design for the pivotal clinical trial is planned for submission to the FDA in the first quarter of 2023.

Commercialisation 

If approved, the company expect to recruit, hire and train sales representatives for a direct sales force in the United States for FemBloc. The company intend to focus the significant majority of sales and marketing efforts in the United States and continue to utilize distribution partners for international markets. Through a specialized and dedicated direct sales organization, the company plan to target the approximately 41,000 gynecologists who are trained and have experience performing gynecologic procedures and offering family planning. Over 60% of the practices representing over 60% of reproductive-aged women are located in 13 states, which will be prioritized.

Switching costs

The company believes that physicians and sonographers experienced in intrauterine procedures, such as IUD, will require minimal training to start utilizing the FemBloc system. Capital equipment expenditures are extremely low. 

Product category adoption risk

In the 2022 annual report, the company acknowledges a significant product category adoption risk.  Physicians may choose not to adopt the company's permanent birth control solution and products for women’s healthcare for a number of reasons, including:

• Lack of availability of adequate third-party payor coverage or reimbursement
• Lack of experience with our products and with permanent birth control and sonography as treatment alternatives
• The company's inability to convince key opinion leaders to provide recommendations regarding the company's permanent birth control solution, or to convince physicians, patients and healthcare payors that the company's permanent birth control solution is an attractive alternative to surgical tubal ligation or other contraception options
• Perceived inadequacy of evidence supporting clinical benefits, safety or cost-effectiveness of the company's permanent birth control solution over existing alternatives
• Liability risks generally associated with the use of new products and procedures
• The training required to use new products

Financials

For the years ended December 31, 2022 and December 31, 2021, the company had net losses of $11,394,170 and $7,537,845, respectively. As of December 31, 2022, the company had an accumulated deficit of $94,134,505.

Upside

The company's current market cap (USD$16.9m) is equivalent to less than 1% of its TAM ($2bn). 


Sources

Femasys Annual Report 2022

Femasys corporate presentation Sept 2023: 
https://s28.q4cdn.com/748976242/files/doc_presentations/2023/Sep/27/femasys_corporate_presentation_sep-2023.pdf