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Surgical device for ureter identification granted FDA designation

The device can be used to help locate and identify ureters through electrical stimulation

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The US healthtech company Allotrope Medical has received FDA Safer Technologies Program (STeP) designation for its surgical device for ureter identification.

StimSite is the company’s first product which was designed to assist surgeons in the critical step of ureter identification in lower abdominal and pelvic procedures.

The device has been used by surgeons to help locate and identify ureters through electrical stimulation. It can be installed in operating rooms and can help surgeons elicit visible, full-length ureteral movement using their existing laparoscopic and robotic instruments.

Millions of lower abdominal and pelvic procedures are performed every year including hysterectomies, endometriosis excisions and colon resections.

Surgeons across the US started using Allotrope’s technology in 2020 after it was cleared by the FDA and noticed an improvement in their operative experience through rapid ureter verification.

Additionally, they observed an increased predictability and decreased duration of their post-procedure cystoscopies.

“Surgeons are constantly learning new techniques, either robotics or laparoscopic, and safety is always front and centre,” said Dr Craig McCoy, a urogynecologist and one of the technology’s early adopters.

“StimSite allows a surgeon to rapidly verify its identity, create ureteral awareness during the case, and potentially have a substantial impact on shortening cystoscopies at the end of the case.

“All these benefits align with the FDA’s Safer Technologies Program and are well-deserved.”

Dr Richard Farnam, an expert in robotic gynaecologic surgery, added: “StimSite is a game changer. I now have ‘on-demand’ ureter identification with induced vermiculation.

“The technology is seamlessly integrated into my surgical procedure and robotic workflow. How much is your time worth? I use StimSite to facilitate ureter efflux, and have observed a significant reduction in my post-procedure cystoscopy time.”

Dr Albert Huang, founder and CEO of Allotrope Medical, said: “We are both excited and honoured to be part of the FDA’s Safer Technologies Program.

“I created StimSite to advance efficiency and safety for those operating in the pelvis, and these advancements now in the post-procedure cystoscopy space continue to show how we are improving the surgical experience for the OR team, surgeons and most importantly, the patients in a way that no other technology out there is able to.”

The new designation, along with a proposed additional indication for use, reflects StimSite’s value that while performing cystoscopy during open or minimally invasive surgical procedures, the device may decrease the time for functional urodiagnostic tests to confirm intact ureters, the Texas-based company explained.

 

Sorina Mihaila is the Femtech World editor, covering technology, research and innovation in women's health. Sorina is also a contributor for the neuro-rehabilitation magazine NR Times.

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Lawyers warn of discrimination risks around lack of menstrual health support in the workplace

Employers should consider proactively supporting women in managing menstruation at work, lawyers have argued

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Employers should consider the potential discrimination risks around menstrual health in the workplace, lawyers have warned, as research shows that most women in the UK feel unsupported.

According to the Chartered Institute of Personnel and Development (CIPD), the majority of women in the UK do not feel a strong sense of support in their organisation in relation to their menstrual cycle.

Figures show women are more likely to feel supported by colleagues than by their employer or manager, with only one in 10 reporting that their organisation provides support for menstruation and menstrual health.

Annisa Khan, employment lawyer at Farrer & Co who has previously raised the alarm over the lack of practical measures to support women with their periods, told Femtech World that employers should be mindful of the legal risks related to managing menstruation.

“Under the Equality Act 2010, it is unlawful to discriminate against employees based on sex, age, or disability,” she said.

“Employers should therefore consider the potential discrimination risks in relation to managing mensuration in the workplace and implement measures to reduce these risks.”

A lack of workplace period policies has been estimated to cost businesses over £6bn per year, as menstrual symptoms cause women to miss an average of 8.4 days per year due to lower productivity.

Khan said organisations should consider proactively supporting employees in managing menstruation at work by reviewing existing policies, including sickness absence and health and wellbeing policies, to ensure they effectively address menstrual-related concerns.

“Creating an open and supportive environment is crucial for employees to feel comfortable discussing periods at work,” she explained.

“This involves raising awareness among all staff, including senior-level managers and male colleagues, to foster an understanding of how colleagues may be affected by menstruation, the relevant policies and how to have open and empathetic conversations.

“Implementing practical measures is also essential to create a supportive environment. Practical steps can include having accessible bathroom facilities with sanitary bins, providing free period products to employees, offering additional breaks and providing a quiet space for rest.”

In line with CIPD’s findings, Khan said workplaces should also consider implementing more flexible working practices and giving women more breaks when needed.

“Employers should be open to employees adjusting their work pattern on the days they are experiencing menstruation symptoms by, for example, offering employees the opportunity to work from home.

“Additionally, they should consider the needs of employees with disabilities or those with medical conditions, and how they may be affected by managing mensuration at work.”

Heidi Watson, employment partner at Clyde & Co, said employers should ensure they avoid breaching discrimination laws when approaching issues like menstrual health.

“As awareness of menstrual issues such as endometriosis grows and as employees are more willing to discuss their symptoms at work, employers will need to consider whether employees are disabled under the legal definition and therefore entitled to protection from less favourable treatment and subject to the duty of the employer to make reasonable adjustments for them,” she told Femtech World.

“Employees may also be able to establish sex or age discrimination claims. We can expect more claims to come before the Employment Tribunal in the not too distant future, in a similar way as we have seen with cases involving menopause in recent years.

“Adopting a flexible approach to managing those with menstrual symptoms which are impacting their work, and creating an open and supportive culture around the issue, will help to reduce the risk of such claims being brought,” she added.

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OB/GYN-founded vitamin company pledges US$10m to improve women’s health research

Perelel aims to close the divide on women’s reproductive health research and improve access to nutritional support

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Alex Taylor and Victoria Thain Gioia, co-founders of Perelel

The US OB/GYN-founded vitamin company Perelel has pledged US$10m to Magee-Womens Research Institute and Good+ Foundation to fund women’s health research and address gaps in maternal healthcare.

The vitamin company said the US$10m would be distributed as both in-kind product donations and funding grants through 2027 focused on advancing women’s reproductive health.

Magee-Womens Research Institute is the largest US research foundation focused exclusively on women’s health, reproductive biology and infant research and care.

Good+Foundation is a national nonprofit working to dismantle multi-generational poverty by pairing tangible goods with innovative services for under-resourced individuals.

“As the only female OB/GYN-founded women’s vitamin company, Perelel is committed to ensuring that all women have access to medically backed care,” said Victoria Thain Gioia, co-founder and co-CEO of Perelel.

“This is why we are devoted to furthering women’s research in partnership with Magee-Womens Research Institute and creating more equity in the way underserved communities receive critical prenatal micronutrients that would otherwise be inaccessible thanks to Good+Foundation.”

Research shows that medical studies have historically excluded female participants and data have been collected from males and generalised to females.

The exclusion of women of “childbearing potential” from clinical research studies has meant that women’s diseases are often missed, misdiagnosed or remain a total mystery.

Alex Taylor, co-founder and co-CEO and of Perelel, said: “We recognise how wildly complex women’s bodies are — bodies that have historically been oversimplified, objectified and shamefully under-researched in medicine.

“Unfortunately, it’s not as simple as ’12 essential nutrients.’ In founding Perelel, we hope to shine a light on how dynamic our bodies are by supporting them with targeted solutions made by the doctors and experts who know best.

“Core to what we stand for is the need to keep fighting for our fundamental rights and help close the women’s health research gap and improve body literacy.”

Perelel’s pledge comes at a time of intensified focus on women’s health as efforts start to reach new levels, including the White House, after President Joe Biden announced the first-ever initiative on Women’s Health Research in 2023.

“It is critical that there is more in-depth medical research done to support women at every hormonal life stage,” said Michael Annichine, CEO at Magee-Womens Research Institute and Foundation.

“Perelel has committed to a cash donation to further advance research into women’s reproductive health and to ensure that this research is made more accessible to doctors everywhere.”

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New treatment could ‘disrupt’ growth of breast cancer tumours

A new type of immunotherapy could lead to pioneering treatment for breast cancer

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A breakthrough injection could “disrupt” the growth of breast cancer tumours, paving the way for a pioneering new treatment.

Breast cancer is the most common cancer in the UK with one woman diagnosed every 10 minutes. Around 55,000 women in the UK are diagnosed with breast cancer every year and 11,500 die from the disease each year.

Researchers from the Institute of Cancer Research have found that a new type of immunotherapy that targets non-cancer cells could help prevent the growth and spread of breast cancer tumours.

The discovery, published in The Journal for ImmunoTherapy of Cancer, has found that an immunotherapy approach targeting a protein, called endosialin, disrupts the tumour’s blood supply and, as a result, can hinder its growth and spread.

Unlike most cancer treatments, this innovative treatment does not target cancer cells directly but attacks the cells that support the disease instead.

Researchers used a type of immunotherapy called CAR-T therapy, which involves removing a patient’s healthy immune cells and genetically modifying them to attack specific targets.

CAR-T therapies are already being used to treat some blood cancers, and scientists are trying to find ways to make them effective for other types of cancer, including breast cancer.

However, CAR-T cell therapy does not always work on tumours because their environment suppresses the immune response, and it can also be challenging to find specific features on the breast cancer cells to target.

To work around these challenges, the team directed the CAR-T cells to cells surrounding the tumour’s blood supply that make the endosialin protein, rather than actual cancer cells. In experiments in mice, scientists found that targeting endosialin successfully reduced the breast cancer’s growth and spread.

The team, based at the Breast Cancer Now Toby Robins Research Centre at The Institute of Cancer Research (ICR), also tested the treatment on lung cancer tumours in mice and saw similarly successful results, suggesting patients with other types of cancer could benefit from this new treatment too.

In addition, researchers found that the CAR-T therapy did not affect cells without endosialin, indicating this could work as a cancer-specific treatment with potentially fewer side effects for patients.

“This is the very first study that demonstrates the effectiveness of using endosialin-directed CAR-T cells to reduce breast cancer tumour growth and spread,” said Dr Frances Turrell, study co-leader and postdoctoral training fellow in the division of breast cancer research at the Institute of Cancer Research.

“Immunotherapy has had limited success in treating breast cancer but by targeting the cells that support the tumour and help it to survive, rather than the cancer cells directly, we’ve found a promising way to overcome the challenges posed by the tumour environment and develop a more effective and targeted treatment for breast cancer.

“We could not have done this project without funding to the Molecular Cell Biology group from Breast Cancer Now and we hope that further research will help translate these findings into targeted therapies for breast cancer patients.”

Dr Simon Vincent, director of research, support and influencing at Breast Cancer Now, said: “This exciting research could lead to much-needed targeted treatments for people with breast cancer, and with one person dying from breast cancer every 45 minutes in the UK, new treatments like these are urgently needed.

“Now we know that the treatment works in principle in mice, Breast Cancer Now researchers can continue to develop this immunotherapy to make it suitable for people, as well as to understand the full effect it could have and who it may benefit the most.”

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