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Start-up announces clinical trial to evaluate treatment for endometriosis

The study will evaluate cannabinoids-based formulations intravaginally, raising hopes for millions of women with endometriosis

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The biotech start-up Gynica has announced the submission of a first-in-human clinical trial to evaluate its “novel” endometriosis treatment.

The study will take place at Careggi University Hospital in Florence, Italy and will evaluate the safety, tolerability, and pharmacokinetics of the IntraVag intra-vaginal drug delivery platform and two proprietary drug candidates, S-301 and S-302.

Endometriosis is a debilitating disease characterised by abnormal growth of uterine-like tissue outside the uterus.

The condition, which affects one in 10 women and girls of reproductive age, has a devastating impact on the lives of over 190 million women globally, disrupting careers, relationships and overall quality of life.

Despite its widespread prevalence representing an estimated US$180bn annual market, according to the World Economic Forum and Mckinsey’s Health Institute, the disease continues to be an underserved and underfunded area, lacking effective treatment solutions.

Gynica’s clinical study aims to assess the company’s cannabinoids-based formulations intravaginally, raising hopes for millions of women with endometriosis.

“After four years of rigorous pre-clinical research and development efforts, we are thrilled to announce this upcoming milestone during Endometriosis Awareness Month,” said Yotam Hod, CEO of Gynica.

“This trial represents a significant step forward in our mission to revolutionise care and provide a better quality of life for the millions of women worldwide suffering from endometriosis. In this enormous unmet need, patients urgently seek efficient solutions.”

The trial will be led by endometriosis expert Professor Felice Petraglia, former president and founding member of the Society for Endometriosis and Uterine Disorders (SEUD) and will evaluate the safety, tolerability, and pharmacokinetics of the IntraVag platform and drug candidates.

According to Gynica, the team will examine the potential of cannabinoids as they engage with the endocannabinoid system (ECS), which is extensively distributed in women’s reproductive organs, such as the uterus and ovaries.

This positioning, the start-up said, makes the ECS a crucial target for addressing conditions like endometriosis. In this context, cannabinoids may possess the capability to alleviate various types of endometriosis-associated pain.

Further, it could mitigate the inflammatory microenvironment associated with endometriosis, the company added.

Professor Petraglia said: “Endometriosis is now recognised as a chronic disease.

“To have a non-hormonal treatment for endometriosis-associated pain is an absolute priority for many patients who require long-term management and for gynaecologists who need new therapeutic options with multiple mechanisms of action.”

Gynica aims to pursue registration of its solutions with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Pending positive Phase 1 results, the company plans to soon advance into Phase 2 efficacy trials.

Sorina Mihaila is the Femtech World editor, covering technology, research and innovation in women's health and wellbeing.

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Singapore-based fertility centre sets up grant for couples struggling to conceive

This grant aims to support eligible Singaporean couples facing financial and family planning challenges

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A Singapore-based fertility centre is to set up a grant to support couples struggling to conceive.

Virtus Fertility Centre Singapore (VFCS) announced that it would set up a grant to support aspiring parents on their IVF journey.

The initial grant is set for at $50,000 SGD and, depending on the take-up rate over the next 12 fiscal months, VFCS plans to increase the pool to benefit more couples in the subsequent years.

The grant will cover the main costs associated with IVF treatments and procedures, including embryo retrieval and transfer, laboratory services and embryo prep. It will also be applicable to fresh and frozen egg transfers.

As grant recipients, their samples will similarly be given a radio frequency identification (RFID) tag, a service VFCS provides for all its patients. It locks the patient’s identity with the respective sample. The RFID identifies gametes—eggs, sperms, or embryos—at every stage of the IVF treatment.

According to VFCS, the grant will also include access to counselling services and wellness resources.

“I’ve witnessed firsthand the emotional toll and occasional frustration that infertility can take on individuals and couples, especially for some who are still young and healthy,” said Dr Roland Chieng, medical director at VFCS.

“The common deterrent of going for fertility treatment is always associated with the cost, more so in a private care setting where their only source of funds is through Medisave.

“By alleviating their financial concerns, we hope ReadyBaby Fertility Grant empowers patients to approach their IVF journey, focusing on their clinical needs and working towards a healthy pregnancy and less on financials.

“With access to the necessary treatments and support, patients can embark on their path to parenthood with renewed confidence, knowing they have the clinical resources and guidance they need to navigate this journey,” he added.

Tim Kwan, VFCS’s managing director, said: “We believe every couple deserves the opportunity to experience the profound joy of parenthood.

“With the ReadyBaby Fertility Grant, we aim to support aspiring couples on their IVF journey and help them bring new life into the world.”

To be eligible for the grant, applicants must be married Singaporean couples diagnosed with medical infertility by a fertility specialist and first-time parents who have not tried IVF before.

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Canadian insurer launches partnership to support women’s health

Members of the Canadian insurer Medavie Blue Cross will have access to a dedicated women’s health platform

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Angela Johnson, co-founder and CEO of sanoLiving

The Canadian insurer Medavie Blue Cross (MBC) has partnered with the virtual health platform sanoLiving to support women on their menopause journey.

Currently, more than 10 million Canadian women are navigating menopause, often with little support and misinformation about treatments.

With sanoMidLife, sanoLiving’s online menopause platform, Medavie Blue Cross members will have access to a national women’s health platform tailored to provide care and services for women going through the menopause.

The service includes personalised assessments, access to clinicians, treatments, educational content, peer support and AI assistance.

“Many women lack support for their menopause transition due to the misunderstandings of what is ‘normal’ and misinformation about treatments,” said Angela Johnson, co-founder and CEO of sanoLiving.

“Women are seeking solutions that allow them to thrive during midlife. We are thrilled about our alliance with Medavie Blue Cross, and our shared commitment to providing access to care that empowers women.”

Anita Swamy, senior vice president operations at Medavie Blue Cross, added: “We’ve heard first-hand from our members about the need for more menopause-related services.

“Our partnership with sanoLiving creates an innovative way to increase access to care for our members as we continue to focus on the support women need to navigate their benefits and provide forward-thinking options to support their health.”

Studies report one in 10 women exit the workforce due to unmanaged symptoms. Early onset of menopause and symptoms before age 45 can elevate the risk of health issues like heart disease, diabetes, dementia and osteoporosis.

With this new service, Medavie Blue Cross and sanoLiving are aiming to open up the conversation around menopause, reduce stigma and work towards giving women the access to the care they need.

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US start-up raises US$2.32m to address pelvic health concerns

The Flyte intravaginal device aims to treat stress urinary incontinence and strengthen pelvic floor muscles

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The US women’s health start-up Pelvital has raised US$2.32m in funding to address “unanswered” pelvic health issues.

Minnesota-based Pelvital aims to restore pelvic health with its first product Flyte, an FDA-cleared intravaginal treatment for stress urinary incontinence (SUI) and weakened pelvic floor muscles.

The device, originally developed by physicians from the Arctic University of Norway, uses mechanotherapy, a treatment modality that when paired with an active pelvic floor contraction stimulates tissue regeneration and the creation of neuromuscular memory.

The company will use the funding to speed up the commercialisation of Flyte and raise awareness of pelvic health issues.

“Completing this round is an important step in continuing Pelvital’s unwavering dedication to provide women with innovative solutions for pelvic health, including the treatment of SUI,” said Lydia Zeller, president and CEO of Pelvital.

“This funding will play a crucial role in accelerating our commercialisation of Flyte with a strong emphasis on expanding payor coverage and enhancing clinical education and clinician awareness.”

With this final close, Zeller said, Pelvital would welcome new investors including Pier 70 Ventures, Life Science Angels, Tech Coast Angels Orange County, and Blue Pacific Fund.

Preetha Ram, managing partner at Pier 70 Ventures, would join the Pelvital board of directors.

“Joining Pelvital’s board alongside this investment round is truly an honour,” Ram shared.

“Pier 70 and I are thrilled to be part of this transformational opportunity, as Pelvital’s mission aligns beautifully with our dedication to support disruptive technologies that shake up the status quo in healthcare.

“Pelvital’s pioneering work is shaping a future where women’s health receives the attention and innovation it deserves with novel medical devices like Flyte.”

Oscar Moralez, founder and managing partner of Boomerang Ventures who led the investment round, said: “We are thrilled for the successful completion of this round as we aim to tackle the most pressing healthcare challenges.

“Our participation aims to address the chronic underfunding in women’s healthcare. Investing in Flyte, a truly groundbreaking treatment, addresses underserved pelvic health issues like SUI and contributes to raising vital awareness.”

Two published clinical trials have validated Flyte’s safety, efficacy and durability of treatment effect for women with SUI.

Most recently Pelvital published a paper in Therapeutic Advances in Urology, showing that 71 per cent of study participants achieved dry or near dry conditions as evidenced by a reduction in 24-hour pad weight after using Flyte for between two and 12 weeks.

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