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Cancer

Ark Surgical secures further institutional backing to accelerate US expansion

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Women’s health medical device company Ark Surgical has secured further institutional backing from JNF and the Israel Innovation Authority (IIA) as it accelerates the US commercial expansion of its surgical tissue containment technology.

Both organisations have previously backed Ark, making the renewed support a significant vote of confidence in the company’s technology, leadership team and commercial strategy as it moves into its next stage of growth.

The new backing comes alongside Ark Surgical’s ongoing Series A financing round, which has also attracted investment from physicians and experienced medical device executives, adding further industry validation as the company builds its US commercial presence.

The Israel Innovation Authority, Israel’s public agency supporting technological innovation, selected Ark Surgical for additional non-dilutive funding following an extensive evaluation process.

The assessment examined the unmet clinical need addressed by Ark’s technology, its clinical results, business and US go-to-market strategy, Israeli and US teams, execution against milestones and future product pipeline.

JNF, which supports economic development and community-building initiatives in Israel, has also increased its previous backing of Ark Surgical.

The relationship has particular significance given Ark’s roots in northern Israel. The company is headquartered near Nazareth in the Galilee and plans to continue strengthening its manufacturing capabilities in the region as its commercial presence in the US grows.

Together, the continued institutional support and investment from experienced healthcare leaders reflect growing confidence in Ark’s technology and its strategy for US expansion.

Stav Tori, CEO of Ark Surgical, said: “Having organisations that already know Ark, our technology and our team choose to support us again is particularly meaningful.

“It reflects our ability to consistently achieve the clinical, regulatory and commercial milestones we set and gives us additional resources to accelerate our expansion in the US.

“Our ambition goes beyond bringing another medical device to market.

“We want to help establish a higher standard of surgical safety for women undergoing minimally invasive procedures.”

Addressing an overlooked risk in women’s surgery

At the centre of Ark’s expansion is LapBox, the company’s FDA-cleared dual-wall tissue containment system developed to address an important safety challenge in minimally invasive gynecologic surgery.

Procedures such as hysterectomy and myomectomy can require large uterine specimens or fibroids to be divided into smaller pieces so they can be removed through small laparoscopic incisions.

This process, known as morcellation, carries a risk of disseminating tissue within the abdominal cavity.

In rare cases where an unsuspected malignancy is present, morcellation can spread malignant tissue and potentially worsen a patient’s prognosis.

But the risk is not limited to cancer.

Even benign uterine tissue can implant elsewhere in the abdominal cavity and grow, potentially resulting in complications such as parasitic fibroids and the need for additional treatment.

LapBox was developed as a dual-wall, bag-in-bag containment system that creates a secured chamber for tissue extraction. The device is FDA-cleared for use with both manual and power morcellation.

From clinical innovation to US adoption

Ark Surgical is now moving beyond its clinical and regulatory milestones to focus on broader commercial adoption.

LapBox™ has already been used in hundreds of procedures, while Ark has been expanding its presence within US hospitals and building relationships with leading minimally invasive gynecologic surgeons.

The latest institutional backing will support the next stage of that strategy, including additional hospital partnerships, key opinion leader engagement, sales leadership and clinical support.

Joseph LaBruzzo, President and CEO of U.S. Operations at Ark Surgical, said: “Ark has reached an important point in its development.

“We have the regulatory clearance, growing clinical experience and increasing engagement from US surgeons and hospitals.

“The focus now is execution and scale.

“What makes this continued backing particularly meaningful is that these are organizations that have followed Ark’s development and seen the team deliver against its objectives.

“Their decision to support the company again provides further validation as we build the commercial and clinical infrastructure needed for broader US adoption.”

That growing adoption is also being reflected in the experience of surgeons using LapBox.

Dr Ramon Yera, a minimally invasive gynecologic surgeon with more than 35 years of experience, said: “Once surgeons use LapBox, they realize this is the bag they should be using for their bread-and-butter procedures.”

Yera believes this reflects a broader shift in expectations around tissue containment in gynecologic surgery.

“Containment is no longer optional. It is an expectation.”

Ark Surgical is continuing its Series A financing round, with additional capital intended to support the next phase of US commercial expansion and development of its broader product pipeline.

Further information for prospective investors is available at ark-surgical.com/investment

Cancer

Trust to decide how far back to review unnecessary breast cancer surgeries

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A health trust will decide how far back to review breast cancer cases after more than 30 women were found to have undergone unnecessary surgery.

It has already been established that hundreds of patients came to harm during treatment at the breast unit at County Durham and Darlington Foundation Trust (CDDFT).

The trust has apologised and is using specialists from other hospitals to review cases to see if other women underwent unnecessary operations or received otherwise poor care.

An extraordinary trust board meeting in Durham will consider the scope of its Look Back Exercise.

Board papers recommend reviewing cases as far back as 2015, working backwards one year at a time.

Documents estimate that this could take five years and involve reviewing the care of approximately 4,500 patients.

Members of the Pink Justice Network, an online support group for women who have received breast cancer treatment from the trust, will attend the meeting.

Nadeen Lister, who runs the group of around 150 women with Amelia Green, said members were calling for a public inquiry into what went wrong.

Lister told the Press Association: “When we started the group, nobody was talking about compensation, they just wanted justice for what has been done.

“The Look Back Exercise has cost the trust more than £500,000 this year, with staff checking back over records, medical experts reviewing cases and psychological help offered to patients affected.”

Green said the trust could avoid the expense of the exercise “by backing our call for a public inquiry”.

Hayley Collinson, of Hudgell Solicitors, which represents many affected patients, said: “Given the scale of harm revealed so far, we can’t see how the Trust board can come to any other decision than to extend this lookback investigation given the findings of the first batch of cases to have been reviewed, and the high percentage of harm being identified.

“The reality is that any woman who had breast cancer treatment at this Trust from 2015 onwards is now going to be questioning whether their treatment was appropriate and if they were actually harmed.”

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Diagnosis

Breast cancer patients face ‘postcode lottery’ for new drug

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Breast cancer patients in Scotland face a postcode lottery that could limit access to two newly approved NHS treatments.

The Scottish Medicines Consortium has approved Elacestrant and Capivasertib, which could be life-extending for some people with metastatic breast cancer.

Eligibility depends on genetic testing to confirm gene mutations before treatment can be prescribed, but the necessary testing is not yet available through the NHS in Scotland.

The testing is available to patients in England and to those able to pay for it privately.

Claire O’Donnell, who was diagnosed with metastatic breast cancer at 37, has raised concerns about the difference in access.

Ten years after her diagnosis, O’Donnell is receiving a treatment that works for her but does not know when it may stop being effective.

She said: “I know how lucky I am. It’s certainly not been easy but I’m incredibly lucky and incredibly privileged to be in that position.

“I’ve watched a lot of my friends die, and a lot of the circumstances has been about not being able to access a drug or getting the drug too late or being too poorly by the time the drug becomes available to them. It makes me angry, and it makes me sad.”

O’Donnell, who has been supported by secondary breast cancer charity Make 2nds Count, is frustrated by the gap in care for patients in Scotland.

She said: “These drug are a lifeline to people. It makes all the difference, and it only takes one drug to be your drug that you know can give you six months a year, two years, five years. It’s almost like they’ve given you a bit of good news, but they’ve also put a little bit of a criteria on it that you know they dangle the carrot in front of you.”

David Cameron, professor of oncology at Edinburgh University and chair of trustees for Make 2nds Count, said the system needed improving to better support patients.

He said: “It’s a frustration for many of us in the clinic because for a long time we’ve been saying as we move into an era of medicines, not just cancer medicines, but medicines that are increasingly driven by special tests, we need a system which absolutely locks the two things together.

“There has been progress in that direction, but they’re not locked together. this comes down to the way the NHS is in a sense fragmented internally.”

Health secretary Angela Constance said: “I welcome the acceptance of Elacestrant, known as Korserdu, for treatment of post-menopausal women, and men, with a certain type of advanced breast cancer.

“We work closely with the independent SMC and the NHS in Scotland to improve access to new medicines, helping to expand the range of treatment options available.

“We are aware that a genomic test is needed in order to access this therapy, and we are working in collaboration with the NHS and industry partners to secure access to this as soon as possible.”

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Cancer

New test could cut need for invasive womb cancer checks

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A urine and vaginal fluid test could help rule out womb cancer in women with postmenopausal bleeding, potentially reducing invasive checks.

In a study of 1,864 women with postmenopausal bleeding, the test identified 80 of 99 womb cancers and correctly gave a negative result for 93 per cent of women without the disease.

Researchers said the test was not accurate enough to rule out cancer on its own, but could help fast-track women at the highest risk for urgent investigation while reducing immediate invasive testing for those at lower risk.

Professor Emma Davidson, of the University of Manchester and Manchester University NHS Foundation Trust, said: “Bleeding after the menopause is understandably alarming for women because it can be a sign of cancer, but the vast majority of those investigated will not have the disease.

“At the moment, many women face invasive, uncomfortable tests that can be stressful as well as costly for health services before cancer can be ruled out.

“Our study shows that a simple test using urine and vaginal samples could help identify the women most likely to have cancer while safely reassuring many others much earlier in the diagnostic pathway.

“If further studies confirm these findings in routine practice, this approach has the potential to transform care for thousands of women every year.”

Developed at the University of Manchester and Manchester University NHS Foundation Trust, the test examines cells collected from urine and vaginal fluid samples.

Postmenopausal bleeding currently triggers an urgent cancer referral, although only about 5 to 10 per cent of women who report it have an underlying cancer.

Current investigations include an internal ultrasound scan, a biopsy of the womb lining and hysteroscopy, in which a camera is passed into the womb.

Women taking part in the study attended seven hospitals in north-west England and provided urine and vaginal fluid samples before undergoing their routine tests.

Five per cent of participants, 99 of 1,864 women, were diagnosed with womb cancer through biopsy or surgery.

Cytologists assessed the samples without knowing the women’s diagnoses.

Researchers said the test could be used to triage women suspected of having womb cancer, with lower-risk patients monitored through repeat sampling or given a full assessment if symptoms continued.

They cautioned that the samples were assessed by highly trained specialist cytologists, so it is not yet known whether the same accuracy could be achieved in other settings.

The test has also not been studied in women without symptoms.

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