Femasys Stock

Femasys Inc. operates as a biomedical company. The company focuses on transforming women's healthcare by developing novel solutions and next-generation advancements providing significant clinical impact to address severely underserved areas.

The company is a woman-founded and led company with an expansive, internally created intellectual property portfolio with over 150 patents globally, in-house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to develop and commercialize products. The company's suite of products and product candidates addresses multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive and expose women to harm. With an initial focus in the area of reproductive health, the company's two lead product candidates offer solutions for two ends of the spectrum: FemBloc for permanent birth control and FemaSeed as an artificial insemination infertility treatment.

FemBloc - Permanent Birth Control Solution

The company's permanent birth control solution in development includes its proprietary FemBloc system, which features dual intrauterine directional delivery targeting both fallopian tubes simultaneously with a degradable biopolymer followed by an ultrasound confirmation test to confirm procedure success.

FemBloc is a procedure that can be completed 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, which will likely be at half the cost.

The company's permanent birth control solution combines FemBloc with an ultrasound in-office diagnostic test, which uses saline and air contrast to permit the same physician to evaluate the fallopian tubes in-office to confirm the success of FemBloc approximately three months after the FemBloc procedure, rather than requiring the patient to visit another provider for a radiology-based exam, exposing the patient unnecessarily to radiation and the use of x-ray dye.

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.

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. The company plans 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 Premarket Approval (PMA) for FemBloc. Results of the small study along with the trial design for the pivotal clinical trial is planned for submission to the U.S. Food and Drug Administration (FDA) in the first quarter of 2023.

FemaSeed - Artificial Insemination Solution

The company's artificial insemination solution in development includes its proprietary FemaSeed product candidate for artificial insemination, which features single intrauterine directional delivery with sperm, offering significant advantages over existing artificial insemination solutions, including being the only approach that allows selective delivery of sperm locally and directly to the fallopian tube where conception occurs. The company's artificial insemination solution combines FemaSeed with a diagnostic companion product, its FDA-cleared and marketed FemVue device, which, creates saline and air contrast to safely assess the fallopian tubes for patency prior to treatment with FemaSeed. FemVue can be used with the company's FDA-cleared and marketed FemCath device, which allows for selective evaluation of the fallopian tube. Fallopian tube patency is necessary for successful fertilization, and FemVue offers significant advantages over other existing procedures, including being able to provide ultrasound evaluation of a woman's fallopian tubes as part of a diagnostic infertility assessment. The safety profile of FemaSeed as of December 31, 2022, is supported by data from the company's FemBloc clinical trials and a post-market study of an identical single intrauterine directional delivery device design, for which it received FDA clearance for another indication. The FemaSeed pivotal trial began in July 2021, pursuant to an FDA-approved IDE received in April 2021, at multiple U.S. sites. In October 2022, the company announced an updated study design for the pivotal trial, which will focus on couples experiencing male factor infertility. This update reflects a revised strategy to address this underserved population experiencing infertility with a goal of facilitating accelerated enrollment. Completion of enrollment is expected in the second quarter of 2023 followed by a planned submission of the results from the trial to FDA in the support of a future de novo classification request for FemaSeed. The company's FemVue product, a companion diagnostic to FemaSeed, has marketing clearances or authorization in the United States, Canada, and Japan. The company's FemCath product, has marketing clearance in the United States.

Additional Women's Health Solutions

The company has also developed a novel technology platform for tissue sampling intended to be marketed alongside its other women-specific medical products in the physician's office setting. The company's FDA-cleared FemCerv product is a biopsy device for endocervical curettage that can be used to sample cervical cells and tissue circumferentially with sample containment within the device to minimize contamination. The company sponsored a post-market study of FemCerv where subjects found the procedure to be relatively pain-free and the sample obtained was complete for analysis, which may aid in reliable diagnosis. There were no adverse events reported. The company began commercializing the FemCerv product in September 2022. Its FemEMB product candidate in development is designed to obtain a comprehensive and uncontaminated sample of the endometrial cells and tissue in an office procedure. There is a market opportunity for use of FemEMB in continuous monitoring by multiple sampling procedures that may be employed by physicians during and after treatments for cancers, abnormal bleeding, or other uterine treatments, such as prior to an endometrial ablation. In addition, the company plans to explore expanded indications for the single or dual intrauterine directional delivery to instill therapeutic drugs for the treatment of ailments of the fallopian tubes, for which it has issued patents.

Intellectual Property and Production Capabilities

The company has designed and developed the proprietary methods utilized in its women's health solutions so that they are protected by patents, know-how, and trade secrets. Each product and product candidate in its portfolio is covered by both design and utility patents in the U.S. and significant ex-U.S. markets. 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. These issued patents, and any patents granted from such applications, are expected to expire between 2023 and 2046, without taking potential patent term extensions or adjustments into account.

All of the company's products are manufactured or assembled at its facility, and manufacturing activities are conducted to ensure compliance with the FDA and good manufacturing practices with significant chemistry, manufacturing, and controls (CMC) and device manufacturing infrastructure in compliance with QSR. The company has passed numerous manufacturing audits, including those by the FDA and international notified bodies.

Strategy

The key elements of the company's strategy are to address unmet clinical needs in multiple large markets for women; execute on its clinical program to achieve FDA approval to advance its FemBloc system for use together with its companion diagnostic device for ultrasound confirmation as the preferred option for permanent birth control for women; continuously innovate to introduce additional product offerings for women; penetrate the addressable markets by promoting patient and practice awareness; build a commercialization infrastructure with a specialized direct sales and marketing team; and expand gynecologists' practice capabilities by diversifying products and services to include artificial insemination with FemaSeed.

Clinical Development

The company is developing a growing body of compelling clinical evidence for its intrauterine directional delivery product candidates.

Permanent Birth Control Solution - FemBloc and Ultrasound Confirmation

Preclinical Studies

The company completed two animal studies to support efficacy of the occlusion, or blockage, created by the biopolymer tissue adhesive, a degradable blend of cyanide derivatives of acrylates, it uses in its FemBloc system. The first was an exploratory study of efficacy in the rabbit model, where the rabbit oviducts mimic human female fallopian tubes. The second animal study assessed the degree and nature of the tubal occlusion created by the biopolymer by microscope assessment of tissue sampling, or histopathology, at various time points up to 52 weeks. It also assessed safety by evaluation of local tissue reaction to the biopolymer and degradation and characterization of the degradation profile.

Clinical Trials

The company conducted a number of clinical trials in 93 patients to evaluate various aspects of the development program. With respect to biopolymer effectiveness, the company conducted a clinical trial on ten patients pending a planned hysterectomy procedure, which is not an indicated population for FemBloc.

The company has studied FemBloc in three clinical studies pursuant to FDA-approved IDEs to evaluate safety in 228 subjects. The first clinical study consisted of 49 subjects enrolled at five U.S. study sites, the second clinical trial consisted of 134 subjects enrolled at 14 U.S. study sites, and the third consisted of 45 subjects enrolled at five U.S. study sites. As part of the second clinical trial, the company sponsored subjects in a control arm for surgical tubal ligation of 105 subjects for future comparison of safety events only. Subjects are being followed for five years for safety, with the first subjects enrolled approaching five-year follow-up.

The company has observed that the patients found the procedures in both studies to be highly tolerable, with pain scores similar to placement of other intrauterine devices, such as IUDs. In its clinical trials, the company has used ultrasound confirmation with the FemChec device three months after FemBloc treatment and have observed that no remaining biopolymer was detected in patients, which suggests that the biopolymer completely degraded and likely exited the patient with possible menstruation. The company recorded data on the patients for safety and additional performance measures at time of FemBloc procedure, seven days post procedure, three months post procedure for confirmation test, three months post confirmation test, and annually through five years. Enrollment ended in February 2019.

During the conduct of these two clinical studies, unintended pregnancies occurred in patients 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 confirmation test, as verified by an independent clinical events committee. In February 2019 the company paused the ongoing pivotal clinical trial for FemBloc (although subjects are still followed for safety through 5 years). The FDA recommended that the company conducts a small IDE clinical study in a new cohort of patients to evaluate the adequacy of improvements that were made to the procedures, products and training to mitigate the risk of unintended pregnancies, while validating the ultrasound confirmation test. The design for the small IDE trial (stage II validation study) included performance of two confirmation tests (ultrasound and radiology) and subjects were informed to rely on FemBloc only if both tests confirm procedure success. There were no pregnancies in patients who were told to rely on FemBloc in this study. In September 2022 enrollment was concluded and the company plans to submit the results to FDA in an IDE for a pivotal trial planned to support future PMA approval of FemBloc in the first quarter of 2023.

Planned Clinical Trial

The company anticipates initiating a pivotal clinical trial after FDA approval of an IDE, which it expects to be a multicenter, unblinded prospective clinical trial. The clinical trial will be designed to evaluate the safety and effectiveness of the company's FemBloc system for permanent birth control in order to obtain PMA approval in the United States. The company anticipates building in an interim analysis of the data into the clinical trial design, subject to FDA approval. Although there can be no assurance that the FDA will approve its trial design, FDA-approved third-party study designs for other permanent birth control product candidates included primary endpoint of pregnancy rate at one year after the confirmation test and safety follow-up for two to five years post-market approval.

Artificial Insemination Solution

The company received FDA 510(k) clearance for its FemCath Cornual Balloon Catheter, a single intrauterine directional delivery product, like FemaSeed, but for a different indication. A post-market study in 23 subjects (45 tubes) was conducted with the product and FemVue Saline-Air device to assess selective tubal infusion with the observation of saline-air contrast. 89% had contrast observed entering the proximal portion of the fallopian tube combined with sustained flow or exit into the peritoneal cavity. This is the same intended location of delivery for the FemaSeed product. The company began commercializing the FemCath product in December 2022.

FemVue Saline - Air device, a contrast-generating product, is authorized for marketing in the United States, Canada and Japan. There have been multiple publications and abstracts presented with clinical evidence in the support of FemVue, a diagnostic companion product to the company's artificial insemination solution. It has been concluded that tubal patency assessment with FemVue is comparable to fluoroscopic hysterosalpingogram (HSG) and it appears to be a convenient and well-tolerable method that may be performed alongside conventional ultrasound and uterine cavity assessment as part of an infertility evaluation. Other publications have stated that FemVue is an accurate test for diagnosing tubal occlusion and performs similarly to a fluoroscopic HSG and it could potentially replace fluoroscopic HSG.

The FemaSeed pivotal trial began in July 2021, pursuant to an FDA-approved IDE received in April 2021, at multiple U.S. sites. In October 2022, the company announced an updated study design for the pivotal trial, which will focus on couples experiencing male factor infertility. This update reflects a revised strategy to address this underserved population experiencing infertility with a goal of facilitating accelerated enrollment. The ongoing clinical trial is designed to evaluate the safety and effectiveness of the company's FemaSeed product for localized directional intrauterine insemination in order to obtain a de novo classification in the United States. The prospective unblinded trial consists of up to 214 enrolled subjects and subjects are to be followed for up to 7 weeks to evaluate for clinical pregnancy, the primary effectiveness endpoint. If unsuccessful, subjects can receive another procedure. There is no long-term follow-up. Enrollment for the FemaSeed pivotal trial is expected to be completed in the second quarter of 2023 followed by submission of the results to FDA in the support of a future de novo classification request for FemaSeed.

Endocervical Tissue Sampler

FemCerv is cleared to market in the United States. The company sponsored a post-market study for FemCerv in 112 patients undergoing further evaluation of an abnormal cervical tissue result. The company began commercializing the FemCerv product in September 2022.

Sales and Marketing

FemaSeed - Artificial Insemination Solution

The company will seek to recruit representatives with strong sales backgrounds and experience in infertility product sales, and with relationships with reproductive endocrinologists and gynecologists. The company intends to focus the significant majority of its sales and marketing efforts in the United States and continue to utilize distribution partners for international markets. While the company has received regulatory clearance and marketing authorization in United States, Europe, Canada, and Japan for the FemVue device, the company's main commercial priority is the United States where it expects to begin to commercialize and market its FemaSeed product and generate revenue from product sales if and when its request for de novo classification of the FemaSeed product is granted by the FDA.

Through a specialized and dedicated direct sales organization, the company plans to target the approximately 1,300 reproductive endocrinologists at 450 practices who are trained and have experience performing infertility procedures. Specifically, the company intends to initially target the approximately 50 practices that are customers purchasing the FemVue device. Over 50% of the practices representing approximately 60% of the assisted reproduction cycles performed are located in 8 states, which will be prioritized.

The company plans to engage in awareness raising activities, highlighting the benefits of its FemaSeed product in jurisdictions where it is approved to market. The company also intends to promote broader awareness of the FemaSeed product as the first localized directional intrauterine insemination option for artificial insemination among patients and physicians.

FemBloc - Permanent Birth Control Solution

The company ultimately plans to use its gynecologist-focused sales force for FemBloc, if approved, to introduce those doctors to FemaSeed and broaden its sales force reach for its infertility treatment beyond its initial focus on reproductive endocrinologists. The company will seek to recruit representatives with strong sales backgrounds and experience in gynecology product sales, and with relationships with gynecologists. The company intends to focus the significant majority of its sales and marketing efforts in the United States and continues to utilize distribution partners for international markets. Through its specialized and dedicated direct sales organization, the company plans 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.

Based on the company's clinical experience as of December 31, 2022, physicians experienced in intrauterine procedures, such as intrauterine device (IUD), will require minimal training to start utilizing its FemBloc system as is the case for its FemaSeed product. Additional sonographic training will be required for the healthcare practitioners or sonographers that will support the ultrasound confirmation test. Based on the company's clinical experience as of December 31, 2022, physicians and sonographers will require minimal training and it can be accomplished largely online.

The company plans to engage in awareness raising activities, highlighting the benefits of its FemBloc system in jurisdictions where it is approved to market. The company also intends to promote broader awareness of the FemBloc system as the first non-surgical, non-implant option for permanent birth control among patients and physicians.

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. These issued patents, and any patents granted from such applications, are expected to expire between 2023 and 2046, without taking potential patent term extensions or adjustments into account. The patents expiring in 2023 are not material to the company's business.

In the United States, the company's FemBloc patent portfolio includes two patent families. They include granted utility and design patents providing protection until at least 2025 and 2030, including any eligible patent term adjustments and extensions. The utility patent family includes a pending patent application, which if granted, could result in a patent expiring in 2025, plus any eligible patent term adjustments and extensions. The company's FemVue patent portfolio includes five patent families. The five patent families include granted utility and design patents providing protection until at least 2026 and 2028. The two utility patent families include pending patent applications, which if granted, could result in patents expiring in 2028, plus any eligible patent term adjustments and extensions. The company's FemChec patent portfolio includes five patent families. The five patent families include granted utility and design patents providing protection until at least 2026, 2028, 2029 and 2032. The utility patent family and one of the design patent families include pending patent applications, which if granted, could result in patents expiring in 2030 and 2035, plus any eligible patent term adjustments and extensions. The company's FemaSeed patent portfolio includes three patent families. Two patent families include granted utility and design patents providing protection until at least 2025 and 2026. The third (design) patent family includes a pending patent application, which if granted, could result in a patent expiring in 2035. The company's FemCerv patent portfolio includes two patent families. The two patent families include granted utility and design patents providing protection until at least 2027, 2032, and 2033. The utility patent family includes a pending patent application, which if granted, could result in a patent expiring in 2033. The company's FemEMB patent portfolio includes one patent family. The one patent family includes granted utility patents providing protection until at least 2033. The utility patent family includes a pending patent application, which if granted, could result in a patent expiring in 2033. The company's biopolymer patent portfolio includes one patent family. The one patent family includes a pending utility patent application, which if granted, could result in a patents expiring in 2038. The company's controlled delivery device patent portfolio includes two patent families. The two patent families include pending utility and design patent applications, which if granted, could result in patents expiring in 2035 and 2039. The company's syringe lock patent portfolio includes one patent family. The one patent family includes a pending design patent application which if granted, could result in a patent expiring in 2034. There can be no assurance that the pending patent application will be granted. The company's material international patents and patent applications include granted design and utility patents, as applicable, with similar overview detail as with the U.S. patent application, including in Canada, China, Hong Kong, European Union, India, Japan, South Korea and Brazil.

Research and Development

For the year ended December 31, 2022, the company's research and development expenses were $5,813,755.

Government Regulation

The company's products are medical devices subject to extensive and ongoing regulation by the FDA under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations, as well as other federal and state regulatory bodies in the United States and comparable authorities in other countries under other statutes and regulations.

Each medical device the company seeks to commercially distribute in the United States will require either a prior 510(k) clearance, unless it is exempt, a granted request for de novo classification, or a pre-market approval from the FDA.

When a 510(k) clearance is required, the company must submit a pre-market notification to the FDA demonstrating that its proposed device is substantially equivalent to a predicate device, which may be a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976, or a device that that was de novo classified under section 513(f)(2) of the FDCA.

Th company's products are regulated in the European Union as medical devices under Directive 93/42/EEC on Medical Devices, also known as the Medical Devices Directive. The Medical Devices Directive requires medical devices to meet the essential requirements which are enumerated in the annexes to the Directive. Compliance with these requirements is a prerequisite to be able to affix the Conformite Europeene, or CE, mark to the company's products, without which they cannot be sold or marketed in the European Economic Area (EEA).

FDA regulations require the company to register as a medical device manufacturer with the FDA. Additionally, the California Department of Health Services, or CDHS, requires the company to register as a medical device manufacturer within the state. The company's manufacturing processes are required to comply with the applicable portions of the Quality System Regulation (QSR), which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. As a manufacturer, the company's facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA and the CDHS.

The Medical Device Reporting laws and regulations require the company to provide information to the FDA when it receives or otherwise become aware of information that reasonably suggests its device may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

History

Femasys Inc. was founded in 2004. The company was incorporated in Delaware in 2004.