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Novel PCOS treatment shows ‘great promise’ in clinical trials

The Ovarian Rebalancing treatment aims to lower androgen production through targeted ovarian ablation

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A French medical device company has unveiled promising clinical trial results for a “novel” polycystic ovary syndrome treatment.

May Health has announced preliminary data supporting the safety and effectiveness of its Ovarian Rebalancing treatment for inducing ovulation in women with PCOS-related infertility at the this year’s ESHRE meeting in Copenhagen.

The company has received the US FDA’s approval of its REBALANCE study, designed to evaluate the safety and effectiveness of Ovarian Rebalancing in women with PCOS-related infertility.

PCOS is a common condition affecting around one in 10 women in the UK.

Women with PCOS may experience symptoms such as irregular periods, high levels of “male” hormones, known as androgens, and a cystic appearance of the ovaries on ultrasound caused by the ovarian follicles becoming arrested in their development towards releasing an egg.

The “novel” one-time treatment aims to lower androgen production, which can often restore ovulation, through targeted ovarian ablation.

Saad Amer, professor of gynaecology and reproductive medicine at the University of Nottingham and lead investigator, said: “Infertility is an emotional journey, and current options available to achieve pregnancy are often expensive, invasive, and do not work for all women, adding burden to the experience.

“The new data shows great promise for Ovarian Rebalancing as a safe and effective office-based treatment to induce ovulation in women who have not achieved results from first-line medications.”

To date, a pregnancy rate of 35 per cent was observed for the 23 participants who received Ovarian Rebalancing and completed six months of follow-up, including some patients who re-started first-line ovulation induction medication between three and six months, the trials found.

Results showed 44 per cent of women ovulated spontaneously during the first three months after undergoing Ovarian Rebalancing.

The trials also showed the ovulation rate increased to 65 per cent between three and six months, with the re-introduction of first-line medication at three months post procedure.

In 100 per cent of patients, ablation was achieved successfully in at least one ovary, the studies found, with 84 per cent of patients receiving the targeted ablation in both ovaries.

No serious adverse events related to the device were reported. The most common adverse events related to the procedure were mild and included vaginal bleeding, pain, and headache.

Anne Morrissey, CEO of May Health, said: “In addition to being the leading cause of infertility, PCOS causes other major health challenges and women lack options to address the needs of this disorder.

“Our team recognises the need for innovative treatments for PCOS, and the data from our trials show that Ovarian Rebalancing has the potential to shift the treatment landscape for this patient population.

“We are eager to continue our research with the US pivotal trial and explore additional endpoints in future studies to assess the potential of Ovarian Rebalancing as a treatment for other symptoms of PCOS.”

Antoine Papiernik, chairman and managing partner of Sofinnova Partners, said: “The inception of May Health within our medtech accelerator was fuelled by a firm belief in the transformative potential of its technology.

“The success of these feasibility studies and the FDA’s approval of the pivotal REBALANCE study only serve to reinforce our initial conviction. We look forward to seeing this technology revolutionise the field of infertility treatment.”

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New survey to ‘amplify’ marginalised voices in healthcare decision-making

UK charities enter partnership to address gender gap and advocate for inclusive healthcare policies

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The gynaecological health charity Cysters and Endometriosis UK have announced a partnership to amplify women’s voice in healthcare decision-making.

Despite progress in healthcare data collection, there remains a gap in representing the experiences of marginalised groups, particularly for those impacted by conditions and diseases like endometriosis.

Decision-makers in Parliament and the NHS often rely on data and statistics to inform policy and resource allocation. However, these datasets may not accurately reflect the experiences of marginalised communities.

A recent report from Endometriosis UK that gathered data on the experiences of being diagnosed with endometriosis in the UK found that whilst the ethnicity of respondents who identified as ‘white’ was proportionate to the data collected in the Census 2021, the remaining data was not illustrative of the ethnic diversity of the UK, with 15 per cent of respondents choosing not to respond to the ethnicity question.

To address this gap and advocate for inclusive healthcare policies, Cysters and Endometriosis UK are launching a new survey initiative aimed at amplifying the voices of marginalised groups in healthcare decision-making.

“We know that the current statistics are not inclusive of all communities, particularly marginalised groups,” said Neelam Heera-Shergill, founder of Cysters.

“By encouraging those from marginalised communities to share their experiences through this survey, they will be helping us to advocate for the changes that are needed, backed by evidence from their communities.

“In addition to delving into the diagnosis journey for people of colour and the unique barriers they encounter. We aim for this research and findings to pave the way for additional funded research on all menstrual-related conditions affecting people of colour.”

The survey seeks to gather insights into the experiences of marginalised communities, particularly concerning conditions and diseases like endometriosis.

Participants are encouraged to share their experiences openly and honestly, knowing that their responses will contribute to shaping more inclusive healthcare policies.

Sarah Harris, a researcher at Cysters, said: “We urge everyone to participate in this survey and share it far and wide. Together, we can ensure that all voices are considered in the conversation surrounding healthcare policy and resource allocation.”

The survey is anonymous and takes approximately 15 minutes to complete. To participate, visit Delayed Diagnosis of Endometriosis Among People of Colour in the UK Survey.

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Menstrual care start-up launches period equity initiative across college campuses

The initiative is hoped to facilitate access to period care and educate students on the use of more sustainable products

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Cherie Hoeger, founder and CEO of Saalt

The US menstrual care start-up Saalt has launched a new initiative aimed at addressing period poverty and environmental sustainability.

The Period Equity Initiative aims to reduce 100 million tampons from the environment while combatting period poverty.

Institutions, including Harvard University, Vanderbilt University, Northwestern University, the University of Utah and the University of Nebraska, are already participating in the programme.

One in five female college students in the US have had to decide between buying period products and paying for other basic essentials like food and other bills according to a nationwide survey.

The initiative, a direct response to the demand for more units for student populations, underscores the issue of period poverty, which affects students across America, challenging the misconception that it is solely an “overseas problem”.

Saalt aims to make period care accessible and affordable through the subsidisation of reusable period products, such as cups, discs, and period underwear, to participating universities and their campus affiliates.

The project is hoped to not only facilitate access to period care, but also educate students on the use of more sustainable products, which are designed to be reused rather than discarded.

“Every day we hear from customers about how life-changing Saalt cups are for them,” said Cherie Hoeger, founder and CEO of Saalt.

“Creating period equity and managing the environmental impact created by disposables are pressing matters that demand urgent attention and innovative solutions.

“Through our Period Equity Initiative, we’re taking a proactive approach to tackle these challenges by leveraging our expertise and aligning with universities across America to make a big impact closer to home.”

The Period Equity Initiative, Hoeger added, furthers Saalt’s commitment to making period care more affordable, accessible and sustainable.

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Medical device start-up enters partnership with Bayer Switzerland

The collaboration is hoped to help “transform” gynaecological examinations

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The medical device start-up Aspivix has announced a partnership with Bayer Switzerland in an effort to “modernise” gynaecological procedures.

Aspivix has developed an innovative, suction-based cervical device designed as an alternative to the tenaculum, a surgical instrument commonly used in gynaecology for over a century.

The device aims to reduce pain and bleeding during transcervical procedures, including IUD placement.

Through the partnership with Bayer, Aspivix is now officially introducing Carevix in an effort to “transform” gynaecological examinations.

The collaboration is hoped to help bring the tool to market and offer women a more comfortable gynaecological experience, reducing the cases of pain associated with IUD procedures.

“We are excited to enter this partnership with Bayer (Schweiz) AG that truly emphasise the goal of empowering women to select the best contraceptive solution without worrying about potential pain and bleeding,” said Mathieu Horras, co-founder and CEO of Aspivix.

“The thorough research and clinical data behind Carevix guarantee a notable decrease in pain and bleeding, enhancing the experience of IUD adoption and placement, as well as various other gynaecological procedures for millions of women.”

The device, Horras added, provides an appealing alternative to the currently available tenaculum, filling an “important” unmet need.

Marco Gierten, Bayer Switzerland women’s healthcare lead, said: “As a globally trusted brand, Bayer remains committed to advancing solutions that provide significant benefits to patients.”

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