Daily Newsletter

08 August 2023

Daily Newsletter

08 August 2023

Femasys opens trial to test non-surgical permanent birth control device

A biopolymer delivered to the fallopian tubes triggers scar tissue formation, which causes permanent occlusion.

Robert Barrie August 04 2023

US-based medical device company Femasys has initiated enrolment in a pivotal clinical trial investigating the use of its biopolymer that helps permanently close the fallopian tubes to prevent pregnancy.

The company will use the prospective, multi-centre FINALE trial to evaluate pregnancy rates in women who have used the device for one year. The analysis will be conducted once 401 participants have used the device, though the company will also perform an earlier readout at a 50-participant checkpoint for safety data.

The non-surgical, non-implant is delivered in-office as a biopolymer into each fallopian tube via balloon catheters. Once the biopolymer touches the tissue within the tubes, it solidifies, triggering wound healing and eventual scar tissue formation. The resulting scar tissue blocks the tube while the biopolymer degrades and is expelled within three months.

The device, which is limited only to investigational use currently, has been tested in previous clinical studies (NCT03433911) that evaluated 228 women aged 21 to 45.

Though Femasys has not openly published results from the research, founder, president and CEO Kathy Lee-Sepsick said the earlier studies “demonstrated the safety and tolerability profile of FemBloc”. The company will use the previous trials and FINALE for a premarket application (PMA) to the US Food and Drug Administration (FDA) to allow the product to be marketed.

Currently, tubal ligation – which involves the surgical tying, cutting, or blocking of fallopian tubes –is the only available form of permanent birth control.

On the opposite side of the spectrum is the company’s other lead product FemaSeed – a flexible catheter that delivers sperm into the ovulating fallopian tube to help fertilisation. 

Lee-Sepsick stated: “We are very pleased to have quickly initiated the pivotal clinical trial phase for FemBloc, which is an important milestone for Femasys.

“As this landmark pivotal trial progresses, we look forward to providing enrolment updates and preliminary data results.”

“Femasys is striving to provide a safe and accessible permanent birth control alternative for women who today must choose between elective surgery and its associated risks or remain on temporary contraception, which can carry the risk of implants or hormones.”

Healthcare companies are hesitant to invest in the metaverse

The COVID-19 pandemic pushed the healthcare industry to rapid digitalization. Increased use of telehealth, telepresence systems, remote diagnostics, predictive AI, and wearable technology is changing how healthcare is delivered and improving patient outcomes. Emerging technologies such as AR and VR are becoming increasingly routine for professional training, surgical assistance, and treatment of psychological and neurological disorders. In the pharma and medical devices industries, AR, VR, and AI are rapidly accelerating drug discovery and manufacturing and generating supply chain efficiencies. New digital opportunities will look to build upon disruptive technologies. However, affordability is a limiting factor to widespread adoption. Per GlobalData estimates, the metaverse market is expected to grow at a CAGR of more than 33% between 2023 and 2030. Although metaverse technologies could reinvent healthcare approaches and bring new experiences to healthcare providers and patients, adoption is still at an early stage. There are currently few use cases in the healthcare industry. The metaverse needs to overcome major challenges for healthcare, including regulation and data privacy concerns. Evidence of proven use cases and participation by a critical mass of users are imperative to drive a shift in metaverse investment.

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