From devices and diagnostics to digital health, these femtech companies breathe innovation.

Femtech is finally getting its well-deserved time in the limelight as innovative women-led products hit the medtech stage. There are many reasons behind the boom, including awareness of once taboo topics around female reproductive health, understanding that women’s healthcare affects healthcare for all, and acknowledgement of previously poor care for female patients surrounding sex-specific health conditions or how sex affects how one diagnoses conditions.

“We see a de-stigmatization,” Brittany Barreto, Ph.D., founder of FemHealth Insights, and host of Femtech focus podcast, told MD+DI in a recent interview. “This has a lot to do with the younger generations being open and loud and questioning sex and gender but also just a society that says, ‘Hey if we can have Game of Thrones on tv showing very violent gore, why do we still have fake blue liquid in a menstrual pad commercial.’ People are finally talking about their menopause, endometriosis, and incontinence. With the knowledge of how common it is, they’re saying, ‘And there’s no solution? That’s unacceptable.”

And investors should take notice. Valued at $50.97 billion in 2023, the global femtech market is projected to grow at a CAGR of 15.38% from 2024 to 2032 ($177.05 billion). Additionally, according to FemTech Analytics, venture capital (VC) investments in femtech companies have quadrupled since 2015, rising from $600 million to nearly $2.4 billion in 2021. By July 2022, VC funding for the market had already reached $840 million.

One factor impacting the data, according to Barreto, is women in finance. “What I mean by that is angel investors,” she said. “To get that first check, you really have to convince somebody of the problem you’re trying to solve and when you’re trying to pitch about hot flashes to a room full of men who have never had one, they may not be as passionate about investing in that first round.”

During a recent video interview with Barreto, she highlighted some of the many femtech companies innovating the space.

Since then, I have also added to this not-even-close-to-exhaustive list.

Aspivix

Aspivix is a femtech company focused on modernizing gynecology and have developed Carevix™ for the 120 million women every year that are afflicted by the tenaculum in gynecological procedures. Carevix™ uses suction technology through its anatomical soft lip to stabilize the cervix. The 510(k) cleared device is indicated for IUD procedures, hysterometry, hysterscopy, and fertility procedures and is clinically proven to reduce pain and bleeding during transcervical procedures without compromising on performance.

“Aspivix’s ambition is to create multiple simple solutions in women’s healthcare, always coming from unmet patients’ needs and modernizing a space which has remained underserved for too long… and the potential is unfortunately humongous,” Ikram Guerd, vice president of global marketing and managing director US for Aspivix, told MD+DI in a previous article. “Aspivix is committed to conducting rigorous clinical research, collaborating with key opinion leaders, and striving for affordability and accessibility to make a positive impact on global women's healthcare.”

“Aspivix is a game changer,” Barreto said. “We’ve been using the tenaculum since the Civil War to remove bullets from men and they thought this little clamping medical device would be great to clamp the cervix to stabilize it when entering the uterus, most commonly for IUD insertion. The real blasphemy here is that doctors have not told women how painful the procedure will be. Aspivix is using a slight suctioning device that looks like a little smiley face that goes onto the bottom of the cervix you pull the edge of the device, and it creates a suction of air… stabilizing the cervix. FDA approved, billing code exists, for sale already in the US.”

Hyivy

Hyivy is developing Floora, its pelvic rehabilitation vaginal dilator, for the one in three women who experience pelvic health problems in their lifetime, like it’s founder, Rachel Bartholomew, who started the company after receiving a cervical cancer diagnosis.

Its pelvic floor rehab system includes a vaginal dilator, patient app, and clinical software. The Floora dilator is the first oelvic health rebab vaginal dilator that performs gentile auto dilation with air chambers, so there is no need fore reinsertion. It uses hot and cold therapy, lubrication, and is equipped with biosensors to collect data on the pelvic floor. The patient app allows patients to track progress, connect with clinicians, and set personal goals. The clinician app then allows healthcare providers to monitor their patients in real-time, set prescribed protocol, and provide personalized care.

“Hyivy was created by a cancer survivor, Rachel,” according to Barreto. “She had cervical cancer in her early 20s and radiation treatment for gynecological cancer can cause a lot of scar tissue. She was given a dilator set which essentially was a cylinder like device that she was told to go home and insert into her vagina to break up the scar tissue on her own, which is incredibly painful. She’s created this device that uses air to increase and decrease in size, it’s self-lubricating, it can have medicine inside of it, it uses heat and has this awesome dashboard that sends the data to your pelvic floor therapist.”

Nua Surgical

Based in Galway, Ireland, Nua Surgical is aiming to make C-sections safer and easier with its SteriCision device. Developed by CEO Barry McCann after the company and BioInnovate programme came together, the SteriCision C-section retractor is designed so that obstetricians and surgical staff can gain hands-free unobstructed access to the uterus during surgery.

“When you’re getting a cesarian, today’s standard of care is that you have a nurse on either side of the table holding your abdomen open with their hands,” Barreto told MD+DI. “[The SteriCision] looks like a very deep oval that can be inserted into the abdomen and it is in a shape that allows for a baby to be removed from the abdomen. It’s going to decrease infection and decrease the pain during recovery.”

Molli Surgical

Molli Surgical answered the call when a patient spoke up about her breast cancer treat experience, creating a wire-free, easier, and more precise way to locate lesions during surgery, while also offering more precise removal. Its technologies, Molli 2 and Molli re.markable, are wire, and radiation free.

“As surgeons, we don’t have X-ray vision, so we need something to guide us to the tumor and help us remove it as precisely as possible,” said Dr. Nicole Look Hong, a breast cancer surgeon at Sunnybrook and co-inventor of MOLLI, on the company website. “It’s so detailed and precise but also so simple. Instead of getting more complicated, the concept has gotten simpler — not to underestimate the years of work that have gone into it.”

“For women who have had doctors identify a lump in the breast and need to go in for a biopsy, usually what she has to do is go to the hospital early in the morning, and has a little metallic wire inserted into the side of her breast where the tip of it is pointing directly at where it needs to be biopsied,” according to Barreto. “This woman then needs to lay still until her surgical time and it’s not an emergency so sometimes she can be there literally all day with this wire hanging out of her that she can’t move. Molli Surgical is this little tiny bullet that is inserted next to the lump and the women can actually go home and doesn’t even have to stay in the hospital.”

Aavia

Founded at MIT, Aavia is a daily hormone health tracking app to help patients track and monitor 30+ physical, mental, and emotional hormone health indicators. The app utilizes user-input data and advanced algorithms to assess vast historical and communal datasets, enabling precise daily system prediction for a personalized and scientifically informed experience, according to the company. It also delivers research-based education on nutrition, exercise, and self-care to “equip patients with effective management strategies.”

“I recommend patients use Aavia to track their menstrual cycle, remind them to take their birth control, and track mood and other symptoms,” Dr. Uma Lerner, MD, reproductive health psychiatry, UCSF and Aavia medical advisor, said on the website. “This helps patients be more aware of their body and hormonal fluctuations. They can also bring this data into their appointments with me to help me better diagnose and treat their symptoms.”

Endodiag

Endodiag’s vision is to radically improve endometriosis management through earlier and easier diagnosis. Currently, the average diagnosis delay for endo is about seven to 10 years. In part, this is due to the diagnostic method used to confirm the condition — laparoscopy: removal of endometriosis tissue which is then assessed in a lab. Endodiag, however, is developing a non-invasive and reliable diagnostic test based on disease-specific biomarkers circulating in the blood.

“Endodiag believes that the development of a non-invasive and reliable diagnostic test based on disease-specific biomarkers will allow a simpler, earlier and more systematic screening of patients,” according to the company. “This would enable physicians to make informed medical decisions to prevent disease progression and potentially safeguard fertility.”

EndoDTect is a blood test that analyses changes in biomarker expression levels that indicate if a subject has endometriosis or not. The test is highly sensitive, specific, and “has the potential to dramatically reduce diagnosis delays,” according to Endodiag.

The company is currently conducting validation studies to confirm the predictive value of EndoDTect for disease detection.

Watch the full interview with Dr. Brittany Barreto here.

See Feature on Medical Device and Diagnostic Industry (MD+DI)