Preview Newsletter
Ethicon 1/29/2018
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All medical implants need logging on a national register to save patients a lifetime of misery, say campaigners
Jan 26, 2018 | Cambs Times
By Kath Sansom
Mesh injured women have hit out at the Government for failing to check that medical implants used in hospitals across Britain are safe. -
Hernia Mesh Repair Explained Amid Reports Of Pain And 'Life-Changing' Complications
Jan 28, 2018 | HuffPost UK
By Rachel Moss
The vaginal mesh scandal continues to dominate headlines after hundreds of thousands of women around the world experienced life-changing complications, but now, campaigners in the UK want to ensure hernia mesh is part of the debate. -
Woman battling surgical mesh complications swims in Wellington Habour race
Jan 29, 2018 | Stuff
By Miri Schroeter
A Manawatū woman, who experiences debilitating pain from surgical mesh, completed a 3.3-kilometre race in Wellington Harbour. -
Everything That Could Go Wrong for This Drugmaker Did
Jan 26, 2018 | Bloomberg
By Cynthia Koons and Jef Feeley
Opioids. Vaginal mesh. Testosterone. These have become some of the ugliest words in the pharmaceutical industry, telegraphing medical treatments gone awry, in some cases leaving behind disabled customers, epic legal battles, and vast capital destruction. -
Out of the loop
Jan 27, 2018 | Business Times
By Annabeth Leow
A PERMANENT fallopian-tube implant that reportedly caused crippling autoimmune reactions. A plastic vaginal mesh, meant to address pelvic organ prolapse and incontinence, which led to patient complaints of debilitating pain and injury. -
Cesarean Delivery Can Pose Long-Term Risks to Mother and Child
Jan 26, 2018 | New York Times
By Nicholas Bakalar
While a cesarean delivery is sometimes necessary and can be lifesaving, it may have serious long-term disadvantages for both mother and child, researchers report.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Jan 26, 2018 | Cambs Times
By Kath Sansom
Mesh injured women have hit out at the Government for failing to check that medical implants used in hospitals across Britain are safe.
And they warn that a watchdog body, tasked with patient safety, fails to spot problems until years later when thousands have been harmed.
Women have been forced to tell their personal stories to expose 20 years of the pelvic mesh disaster, the biggest women’s health scandal since thalidomide.
They say the MHRA is not fit to properly regulate devices because it suffers from “austerity measures” .
In addition a surgeon database fails to capture problems which means for years the NHS has said the operation is low risk when the long term picture shows the number of women suffering is at least one in ten.
Four years ago, Government watchdog body, the MHRA issued a patient safety alert, admitting nobody was properly reporting medical implant complications.
Promises were made to do better, but in 2018 campaigners say this is still not happening and the MHRA’s database, the Yellow Card, is still little used and largely unheard of.
Jackie Harvey, of Sling the Mesh, said; “Only after thousands of women were maimed from PIP breast implants and hundreds suffered irreversible pain from metal hips did the Government introduce a national register so every person is logged and their breast or hip implants tracked for life.
“This needs to happen for every new medical device launched on the market, it’s the only reliable way to pick up problems immediately.
“We believe it would add £20 per person to their treatment cost. A small price to pay to save a lifetime of unnecessary pain and suffering.”
In 2014, a worrying MHRA patient safety alert said: “Senior managers in NHS organisations are not always aware of important patient safety issues, or the quality of the reporting and learning systems that operate in their organisations.”
The alert flagged up:
• More than eight out of ten doctors were not logging the manufacturer name of a problem implant.
• Two thirds did not record the device name.
• Data was wrongly coded in up to a third of cases or used the word “other”.
• Around 40 per cent did not record outcomes because of wrong codes including death or serious harm.
A spokesman for the MHRA said: “Whilst there is no mandatory requirement, we actively encourage patients and healthcare professionals to report complications associated with implants through the Yellow Card scheme.
“As part of our regulatory role we have assessed the findings of published studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time including adverse events.
“The publication of more data is a natural process, occurring as more experience is gained into the use and complications associated with these procedures and we will continue to review this evidence to ensure the safety of women is protected.”
Campaigners say a doctor database fails to track device performance, a weakness admitted by a spokesman for the Royal College of Obstetrics and Gynaecology (RCOG).
“As an organisation we accept that one of the weaknesses of the database is incomplete reporting which we feel can be addressed through mandating this.
“The British Society of Uro Gynaecologists is keen on this and is liaising with the RCOG to take this forward. This would have to be enforced through Government to become reality as this is outwith our control.”
The MHRA is tasked with regulating a wide range of medical devices including mesh, hips, finger joints, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts and orthopaedic pins.
• This month the MHRA announces it is streamlining its services.
• In America, a loophole was discovered in the FDA system in 2016, allowing medical device makers to hide and report problems years later, allowing a product to continue to be marketed.
• There are 6,000 surgeons working in obstetrics and gynaecology in the UK.
• RCOG has 1,835 members.
• BSUG has 493 members.
• BAUS has 1,924 members.
• There were 1,286 adverse events reported to the MHRA in a decade up to 2016. Of those less than half (533) were reported by healthcare professionals. See statistics from a House of Lords written question here.
http://www.cambstimes.co.uk/news/all-medical-devices-national-register-patient-safety-1-5370952
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Hernia Mesh Repair Explained Amid Reports Of Pain And 'Life-Changing' Complications
Jan 28, 2018 | HuffPost UK
By Rachel Moss
The vaginal mesh scandal continues to dominate headlines after hundreds of thousands of women around the world experienced life-changing complications, but now, campaigners in the UK want to ensure hernia mesh is part of the debate.
Hernia mesh is used in the treatment of hernias, particularly the most common form, inguinal hernia, where a swelling or lump appears in the groin area. Approximately 70,000 surgical inguinal hernia repairs are performed in England each year and a “growing number” of patients are reporting complications.
Hernia mesh patient Jennifer Coles told HuffPost UK the procedure was debilitating, saying she felt like she had “a piece of glass” caught inside her, leaving her unable to work after surgery.
Now, the All Party Parliamentary Group on Surgical Mesh Implants and campaign group Sling the Mesh have told HuffPost UK they want to see a review of official guidelines around hernia mesh and an audit of past patients’ experiences.
So, what do you need to know about hernia mesh and if you’ve already had the procedure, should you be worried?
A hernia occurs when an internal part of the body pushes through a weakness in the tissues that hold muscles together. The condition is more common in men, but can affect anyone.
Andrew de Beaux, president of the British Hernia Society, told HuffPost UK: “Think of a hernia in a sense as a tear in your jeans which has happened from wear and tear. You could sew up the tear, but the tear will soon recur.
“Or you could put a patch of material over the tear - in essence sewing the edge of the patch to less worn fabric - the repair will last longer.”
Hernia mesh is a synthetic material similar to nylon or polyester that’s inserted into the body to “patch” up the weakened area.
Kath Sansom, founder of Sling the Mesh, which was originally set up raise awareness of vaginal mesh complications, said a “growing number of men and women” have been visiting the site looking for advice on hernia mesh.
“It is another case of a quicker, cheaper fix than traditional repairs that take more skill and longer, yet we have men on the page who have lost sex lives, have struggling marriages, lost jobs and are in agonising pain - and none of these risks were explained to them,” she told HuffPost UK.
Jennifer Coles, 33, is just one of the hernia mesh patients now working with Sling the Mesh to raise awareness of complications.
She developed a visible bulge on the left side of her tummy last year and was told a scan revealed a hidden hernia on the right side, too. She was advised to have mesh fitted on both sides of her body.
When she woke up from surgery, Jennifer said it felt as though someone had taken her leg off and “put it back on at a funny angle”.
“I couldn’t seem to straighten it properly. When I got home and I’d healed a little, it felt like I had a tight pair of bikini bottoms under my muscles,” she told HuffPost UK.
The pain didn’t ease over time and in the following months, day-to-day life became a struggle.
“I’d often take my first few steps of the day with no problems and then I’d catch something inside me like a piece of glass. I really dreaded that happening so I’d walk really carefully,” she said.
“Sitting was also really painful. It would start with a dull ache and over the course of about half an hour, it would gradually start to feel like there was barbed wire pressing into me. I tried so hard, but I couldn’t concentrate in meetings, I was always cancelling on my friends.”
Jennifer claimed she was not warned about complications before receiving surgery and after months of suffering, her family paid for her to see a private consultant and have the mesh on her right side removed.
“When I woke up I was in more pain, but the deep, vice-like sensation had gone. The surgeon told me there wasn’t even any sign of a hernia,” she said.
According to Andrew de Beaux, complications directly related to the mesh, such as those reported by Jennifer, “are rare”.
He said the main complication risk after hernia mesh surgery is infection, which has been linked to “less than one in 1,000 mesh implants”.
“Mesh is foreign material, so like any material, be it heart valve, cataract lens or hip replacement, if it gets infected around the time of insertion, treating the infection without removing the material is difficult,” he said.
He added that chronic pain persisting six months after surgery “as a result of involvement of nerves within scar tissue” can happen “after any operation”.
“In some cases, where mesh is inserted close to where the nerves run, the risk of chronic pain as a result of mesh use is higher, but still low,” he said.
However, Jennifer said since sharing her story online, she’s been contacted by nearly 50 strangers who’ve had similar problems. What’s more, MP Own Smith, chair of the All Party Parliamentary Group on Surgical Mesh Implants (APPG), said constituents have also reported problems and the group is investigating.
The conflicting messages around the prevalence of complications could be down to the fact there is no official national register of hernia mesh patients.
According to the Sling the Mesh, NICE (the National Institute for Health and Care Excellence) does not have sufficient guidelines in place around the use of hernia mesh.
“Hernia mesh in the first instance needs NICE guidelines setting up as it has been used extensively in the UK for around 30 years without anything from NICE,” Kath Sansom said.
“It is a permanent device and virtually impossible to remove, yet just like vaginal mesh, there are no national registries and no audit to track how a patient is doing after a hernia mesh operation.”
MP Own Smith also called on NICE to “get on with publishing” guidelines on hernia mesh, adding: “I am also calling on the NHS to undertake a full retrospective audit of all patients who have been treated with mesh – for incontinence, prolapse and hernias – and a prospective registry of new patients, so that we may have some clarity on just how many that treatment has caused life-changing complications.”
As the large scale of the vaginal mesh scandal became clear - with a manufacturer being ordered to pay an American woman $100 million in compensation for complications - NICE updated its guidelines on the procedure in the UK.
It said vaginal mesh repair “should only be used in the context of research” until we know more about complications, adding: “Further research should include details of patient selection, long-term outcomes including complications, type of mesh used and method of fixation, and quality of life.”
But despite reports of complications with hernia mesh, albeit on a smaller scale to date, health bodies do not currently plan to change guidelines.
The Medicines and Healthcare products Regulatory Agency (MHRA), which is part of the Department of Health and is responsible for the regulation of medical devices, claimed it has not had any evidence which would lead it to alter its current stance on surgical mesh for hernia repairs.
An MHRA spokesperson told HuffPost UK: “Patient safety is our highest priority and we recognise some patients do develop complications after surgery.
“We encourage anyone who suspects they have had a complication after having a medical device implanted, to discuss this with their clinician and report to us via the Yellow Card scheme regardless of how long ago the implant was inserted.”
A spokesperson from NICE did not want to provide further comment, but said further information on technology appraisal around hernia mesh could be found here.
Andrew de Beaux said people people who’ve already undergone hernia mesh surgery should not panic in light of recent reports on complications, adding: “If they are currently well, it’s highly likely they will remain well.”
But if you are concerned about your recovery or possible complications following hernia mesh surgery, speak to your GP.
http://www.huffingtonpost.co.uk/entry/hernia-mesh-repair-explained-amid-reports-of-pain-and-life-changing-complications_uk_5a609f18e4b01f3bca58ce90
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Woman battling surgical mesh complications swims in Wellington Habour race
Jan 29, 2018 | Stuff
By Miri Schroeter
A Manawatū woman, who experiences debilitating pain from surgical mesh, completed a 3.3-kilometre race in Wellington Harbour.
Glenys Mahoney struggles to walk, work and or even sit for prolonged periods because she's been battling against vaginal surgical mesh for 11 years.
But, swimming helps reduce the pain and increase movement in her legs, which barley used to move.
In 2006, Mahoney had surgery for a pelvic organ prolapse. She's had 12 operations to attempt to correct it, but there's still mesh in her body that might never be removed.
In mid-2017, two mesh slings were successfully removed, but she has ongoing physio to deal with the last sling in her body.
On Sunday, she took part in the Interislander Capital Classic Ocean Swim, hitting the finish line in one hour and five minutes.
"I was a bit nervous, but once I started swimming it was fine.
"It was challenge, but it means that I can do something."
The hardest part of the race was getting from the ocean to the finish point on land, she said. While most people ran to the finish line, Mahoney struggled to walk.
"I just find it easier in the water than on land."
Swimming reduces pain and swelling in her leg, so she swims daily.
Mahoney can have another operation in an attempt to remove the remaining mesh, but she would risk not being able to walk at all.
"Because of the nerves involved, it's going to be very awkward surgery."
The risk of not being able to walk again wasn't worth it, she said.
In December, Mahoney's surgeon, gynaecologist Dr Hanifa Koya, said in many cases, patients had already had several previous surgeries, which left them with a lot of scarring and made the surgeries high risk.
Surgical mesh used for some gynaecological procedures was removed from New Zealand's supply on January 4, but Mahoney said more needed to be done, such as setting up a registry to monitor how many people were living with surgical mesh.
In New Zealand, ACC has paid out $13 million for 810 claims about injuries because of surgical mesh in the 12 years to June 2017.
Mahoney lives with the daily struggle of not being able to walk and work, but she plans to keep moving as much as possible.
Swimming made it a bit easier, she said.
https://www.stuff.co.nz/manawatu-standard/news/100979202/woman-battling-surgical-mesh-complications-swims-in-wellington-habour-race
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Everything That Could Go Wrong for This Drugmaker Did
Jan 26, 2018 | Bloomberg
By Cynthia Koons and Jef Feeley
Opioids. Vaginal mesh. Testosterone. These have become some of the ugliest words in the pharmaceutical industry, telegraphing medical treatments gone awry, in some cases leaving behind disabled customers, epic legal battles, and vast capital destruction. Some of the industry’s largest companies have been mired in lawsuits and government probes over these issues. But no company has been haunted by the drug industry’s worst nightmares as mercilessly as Endo International Plc.
Just about everything that can go wrong in the world of pharma has gone wrong at Endo, which makes both branded and generic drugs. Through a dealmaking spree largely led by its former chief executive officer, the company amassed debt of more than $8 billion—five times its market capitalization. That might be tolerable for a high-growth company, but Endo faces cratering prices for generic medicines even as it must deal with a slew of litigation involving its products.
The new leadership says the Dublin, Ireland-based company can fix all this; it will just take time. “It’s very important to know that we’re not running or hiding from our challenges,” says CEO Paul Campanelli. “We’re well-equipped to handle these types of issues.”
That includes writing massive checks to get beyond some of Endo’s legal woes. As of November 2017 company officials have agreed to pay more than $3.5 billion in settlements in more than 46,000 suits over its vaginal mesh inserts alone. Endo may have to shell out more to resolve all the mesh cases, according to its U.S. Securities and Exchange Commission filings. Analysts say that should largely contain the problems over the vaginal device, but it will still drain much-needed cash.
“This is not a growth story,” Gabelli & Co. analyst Kevin Kedra says. “There’s significant pressures, mostly stemming from the debt load, and they’re probably not going to be able to make a significant dent in that until 2019.”
Campanelli has been slashing costs to help keep Endo’s finances in check. The company now operates with a staff of around 2,700, down from about 6,000 before he took the job in September 2016. It also stopped marketing its opioid pain drugs at the end of 2016.
Litigation related to Endo’s marketing of opioids remains the biggest wild card. The drugmaker faces at least 125 cases filed by U.S. state attorneys general, counties, and municipalities, alleging its salespeople downplayed the health risks of the extended-release version of its painkiller Opana while overstating its benefits, according to SEC filings. Other opioid makers, such as Johnson & Johnson and Purdue Pharma LP, face identical claims. The companies have denied the allegations.
The states and local governments have hired lawyers who helped negotiate the tobacco industry’s $246 billion master settlement in the late 1990s to handle the opioid suits. There’s no exact figure for the damages sought, and estimates of potential damages vary widely. Bloomberg Intelligence litigation analyst Holly Froum figures the total liability for all opioid makers, including Endo, could be as little as $5 billion or as high as $50 billion. “It’s obviously in a very early stage, and these things typically take years to resolve,” Campanelli says.
The company has shown it can be proactive when the need arises. Its extended version of Opana became the subject of controversy: The drug has been linked to outbreaks of viral infections like HIV as people abusing it spread diseases by sharing needles. U.S. regulators took the unprecedented step last June of asking the company to take the drug off the market. Endo could have appealed that decision, but Campanelli opted to comply—cutting off a drug that racked up around $533 million in sales in a three-year period starting in 2014.
Campanelli is busy putting out fires that were years in the making. In 2013 the drugmaker hired Rajiv De Silva, an ex-Valeant Pharmaceuticals International Inc.executive and former McKinsey & Co. consultant. At the time, Valeant was blazing a new trail for Big Pharma expansion: buying up other companies, cutting research, and jacking up drug prices. With De Silva as CEO, Endo became a prolific dealmaker, acquiring companies and drug rights—from acquisitions in the hundreds of millions of dollars to vying for assets in the $10 billion-plus range against Valeant. De Silva insisted at the time that Endo wasn’t another Valeant, which ran into massive financial and legal troubles, and said he was doing deals to build a company that didn’t need to rely on deals to grow. He declined to comment for this story.
De Silva’s biggest acquisition was the $8.05 billion purchase of Par Pharmaceutical in May 2015, which gave Endo a large foothold in the generics business. Endo, which assumed Par’s debt, financed the deal with borrowings and proceeds from a $2.3 billion equity offering. The Par buyout came at the height of the company’s run: Endo’s stock price peaked around $96 in April 2015. That was more than triple the level when De Silva took over. But concerns over litigation and debt, as well as post-Valeant angst over specialty drugmakers, conspired to drive the stock down over the following year. Ultimately, Campanelli replaced De Silva. “We said from Day One, we’re not fixing this in 12 months,” Campanelli says.
Another hangover from the De Silva era is Endo’s testosterone litigation. The company faces about 1,300 patient suits claiming its testosterone-boosting gels caused fatal heart attacks in some users. How those suits might fare remains uncertain. Two federal court juries in Chicago last year held AbbVie Inc. responsible for injuries suffered by men taking its AndroGel testosterone booster—a product similar to Endo’s—and awarded a total of $290 million in damages. But one of those verdicts was later thrown out by a judge. In November, Endo’s Auxilium unit won the first case to come to trial over its Testim testosterone gel.
Still, Endo’s problems could get worse. The company is likely to face many more Opana suits before any settlement is reached, says Richard Ausness, a University of Kentucky law professor, and Endo may be forced to take extreme measures to pay them out. It could adopt the playbook used by companies sued for selling asbestos-laced products in the 1980s and 1990s by setting up a bankruptcy trust to resolve opioid cases, according to Ausness. That would allow the company to hold down settlement amounts, he says.
“Their debt numbers look terrible. And when you factor in the thousands of opioid suits they may wind up facing, they may have no choice but to ask the bankruptcy courts to help them dispose of those cases,” he says.
Campanelli has heard the B-word before. “The use of the word ‘bankruptcy’—it’s not something that we’re contemplating at this point in time,” he says. “We’re looking to collaborate to deal with the opioid situation. If we ever got to that process, and I’m not saying that we’re thinking of it, it would be years and years before we would be addressing it.”
It’s also possible that any opioid manufacturer settlement could be structured in such a way that Endo doesn’t end up underwater. “There could be some giant master settlement—it would just make life that much more difficult for Endo, but I don’t think these state AGs are going to make Endo go out of business,” says Gabelli’s Kedra.
Despite the financial and legal clouds, Endo officials say they’re concentrating on expanding the business and working on new injectable drugs. The company is also developing one of its key products, Xiaflex, which is used to treat a hand deformity and curvature of the penis, for new uses such as improving the appearance of cellulite. Cosmetic drugs, such as Allergan Plc’s Botox, have turned into powerhouses for pharma companies, and Campanelli has been praising Xiaflex’s prospects. “It fits the model of the new Endo,” he says. Campanelli, however, still has plenty of problems from the old Endo to fix first.
BOTTOM LINE - Generic drugmaker Endo has agreed to pay billions of dollars in settlements for vaginal mesh suits—and possibly faces much more for testosterone and opioid claims.
https://www.bloomberg.com/news/articles/2018-01-26/everything-that-could-go-wrong-for-this-drugmaker-did
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Jan 27, 2018 | Business Times
By Annabeth Leow
A PERMANENT fallopian-tube implant that reportedly caused crippling autoimmune reactions. A plastic vaginal mesh, meant to address pelvic organ prolapse and incontinence, which led to patient complaints of debilitating pain and injury. These horror stories - the first about German giant Bayer's Essure contraceptive device, the second a scandal that has engulfed the British National Health Service - are some that made recent headlines worldwide and rattled the market in medical technology, or medtech.
Bayer eventually pulled sales of Essure from markets outside the United States last September, citing commercial reasons.
Essure had previously been available here. But the Health Sciences Authority said, in reply to media queries, that the device has not been supplied since 2015.
The agency has not received any local adverse event reports for Essure and has not registered any other similar sterilisation devices.
These developments came even as the sector, according to Ernst & Young, yielded over US$360 billion in revenue in 2016, up from around US$300 billion in 2009.
Deloitte, meanwhile, has forecast that medtech industry sales will hit more than US$510 billion in 2020, with the field of in-vitro diagnostics set to get the biggest slice of the pie.
But even with a range of factors at play - from improved gender representation in science, technology and business, to the rise of genomics - industry watchers here say the women's health segment in medtech remains both under-represented and under-served.
'Insane' lack of interest
Medtech can be a tough sell.
David Lai, a venture partner of private investment firm Venturecraft Group, puts key challenges as "finding entrepreneurial talent and funding the long runways to market".
That does not mean a complete dearth of money moving.
Patrick Yeo, head of PwC Singapore's Venture Hub for startups and investors, calls the Republic "clearly a choice location for medtech companies to innovate and test new technology". He points to the infrastructure, skilled workforce, and intellectual property protection.
Mr Yeo also notes that the growing affluence and ageing populace in Asia "will present investment opportunities in areas of obstetrics, gynaecology and dermatology".
But even if women hold up half the sky, Sunil Rai, corporate partner at law firm Dentons Rodyk, tells The Business Times that he has not personally seen early-stage venture entities or investments in medtech that focus on women's health in particular.
"Given a young local medtech ecosystem and lack of institutional investor focus in this sector", Mr Rai finds it likely that big multinational corporations, rather than early-stage entities, are the ones that will have the resources and capabilities to focus on research and development (R&D).
And multinationals, which hold the large purses, seem unwilling to stray from winning formulas.
Larger medical device companies tend to be weighted more heavily towards mature market segments, a McKinsey article said last September. It added that, in the device market, "few high-growth, high-innovation segments remain, although some exist, particularly in cardiovascular".
And that is to say nothing of innovation in therapeutics, which is still in its early days and requires, alongside trial and error, lots of patience. That's in spite of the long list of diseases and conditions that afflict women and women only.
Researcher Nir Arbel, chief executive of Singaporean biotechnology startup Carmentix, has strong feelings about the state of affairs.
His voice rises in excitement when the conversation turns to endometriosis - which a recent study pegged as affecting more than 10 per cent of women in their mid-30s to mid-40s - where womb lining tissue is found in other parts of the pelvic region, with pain and bleeding.
"Why isn't there a solution? Why aren't there diagnostics?" he asks.
Carmentix, which Dr Arbel co-founded in 2015, works on developing biomolecular tools to predict the risk of preterm births in pregnancy.
"It's insane. It's so common. Ten per cent of women have endometriosis and no one has ever thought about how to diagnose it? Think about how much money is invested in cancer and Alzheimer's. It's crazy to me that there's no solution."
He adds: "I think the fact that it is not life-threatening is part of the problem. But the bigger issue is that there are not enough women in key positions driving pharma companies into this space."
Sidney Yee, executive vice-president of Exploit Technologies Pte Ltd (ETPL), does not mince words either when it comes to the need for innovation in women's health.
"Our technology is so advanced now, yet the tools that remain available to us remain decades-old tools," says Dr Yee, from the public-sector Agency for Science, Technology and Research's (A*Star) commercialisation arm.
"That, I think, is not acceptable."
All about the money
Dr Yee, who is also chief executive, Diagnostics Development Hub, which aims to accelerate market adoption of scientific innovations, adds: "We continue to have a bit of a gap in the very early-stage, pre-Series A type of support.
"That's really the area where there's not quite enough for the startup to have something that is able to attract enough investor attention, because it's not a product yet so there's no market validation.
"And it's sort of in no man's land - or no woman's land - where you know that there is a product market fit but there is not quite enough support to get it to a product."
She adds: "As with everything else, unfortunately, things like these are generally driven by the industry seeing whether there's money to be made."
A Deloitte research report from 2017 corroborates this: "Many financially pressured large companies have avoided making risky investments in external innovation."
It adds that "these companies would only consider an external innovation that has been largely or fully 'de-risked'". That is, the technology must have already snagged regulators' green light, on top of demonstrating commercial success.
The gamble of innovating with lesser-studied conditions may be why big companies stick with tried-and-true market segments - such as breast cancer, which made up about one in three cancer diagnoses among women here from 2011 to 2015.
Siemens Healthineers' Singapore-based managing director Siow Ai Li tells BT in an e-mail: "Technology-wise, a lot has happened in the past 10 years in the field of breast care. We have introduced the automated breast volume scanning method which is suitable for patients with very dense breast tissue. In the field of breast MRI (magnetic resonance imaging), we have developed our first dedicated breast MRI scanner, as well as came up with a solution for 3D breast imaging."
National investment
With health and biomedical sciences one of four strategic domains in Singapore's S$19 billion Research, Innovation and Enterprise 2020 master plan, there may be no time like the present to dip a toe in the water.
Mr Rai, of Dentons Rodyk, has seen more scientists join the fray in the past two years, and has received more queries about investment deals involving general medtech.
He anticipates both the volume and quantum of investments to rise in the coming years given the quality of R&D in universities and institutions here, as well as existing capabilities in engineering, manufacturing and biomedical sciences.
"The local ecosystem would, however, need to continue working on attracting institutional investors and corporates to provide guidance on commercialisation of technologies in medtech while developing further capabilities for taking such technologies to market and also patience in seeking significant pay-offs," he adds.
Dr Lai, the Venturecraft venture partner and director of surgical research and development and research at the National University of Singapore (NUS), says: "I have not been involved much in women's health as a sub-segment in medical devices. I have come across some home-grown life science diagnostics tools in women's health, which have commercial potential."
He adds: "I am generally agnostic to the type of device technologies, be it medical diagnostics or therapeutics and will evaluate case-by-case."
Still, when it comes to medtech and women's health, public bodies have traditionally led the charge.
Molecular diagnostic firm Innovations Exchange Pte Ltd (Inex), which focuses on obstetrics, gynaecology, oncology and reproductive health, was founded as a spin-off from NUS. Since being set up in 2006, it has developed non-invasive prenatal testing and a rapid ovarian cancer detection kit - both in partnership with A*Star.
A*Star has also worked with medical imaging startup FITPU Healthcare - a joint spin-off of its Institute of Infocomm Research, and the National Cancer Centre, a public specialist institute.
And it tied up with startup incubator The Biofactory, independently validating genetic screening for potential hereditary disorders, which could help would-be parents in family planning. (Prenatal testing falls under the umbrella of women's health, which is another can of worms.)
Here come the VCs
But venture capital (VC) has been paying attention to medtech, and the women's health segment has not escaped canny investors' eyes.
Besides the screening tool validated by A*Star, home-grown incubator The Biofactory has also backed a drug infusion pump for pain relief during labour, as well as a new placental cord blood collection system.
Carmentix got its cash in hand from Esco Ventures, an evergreen stash funded internally by Singapore's Esco Group. Esco, a family business that supplies life sciences and laboratory equipment for everything from pharmaceuticals to in-vitro fertilisation (IVF), committed S$10 million back in 2014 to be spent on early-stage opportunities in life sciences, medtech and healthcare, with the option of a top-up.
Almost all of that has since been invested, says group president and chief executive Lin Xiangqian, who is also chairman of Carmentix.
According to Mr Lin, the initial focus on pregnancy and women's health - which Dr Arbel calls "completely underserved as a market" - was a business choice to differentiate Esco Ventures from other funds.
Its engagement with reproductive health began with an investment in Lithuania-based IVF device maker AT Medical.
With Carmentix as a flagship, Esco Ventures is also exploring other pregnancy-related conditions such as pre-eclampsia.
Meanwhile, Catalist-listed medical and agricultural investment company Trendlines Group opened a medtech incubator here in 2016.
It already had startups like Escala Medical, which is developing devices to treat pelvic organ prolapse, under its belt back in Israel.
Trendlines Medical Singapore CEO Eric Loh calls the medtech sector here "still fairly nascent", citing a relative lack of success models.
"There's been a lot more focus in terms of wanting to support early-stage companies," he says.
"But I think what needs to go in more, in this case, is not the monetary resources, but really how we provide help to the companies to know what those markets are and how we gear towards those markets from a clinical standpoint, from a regulatory standpoint, and then from a business standpoint."
Its mandate is to explore Asia-Pacific health opportunities, such as eye and kidney conditions. Still, the group partnered the Singapore General Hospital last year to hold clinical trials for a urinary incontinence product for women, under a grant from the bilateral Singapore-Israel Industrial Research and Development Foundation.
Mr Loh adds: "Big companies or healthcare organisations do not always have the in-house expertise to innovate. That's where entrepreneurs can come in and provide value."
Room to grow
Given Esco's history in IVF business, reproductive health startups were a natural progression when Mr Lin launched his life sciences fund.
"I don't want to rule it out, but oncology is very crowded," he says. "And there are so many smart people around the world investing in oncology."
He acknowledges the need for early-detection tests in gynaecological cancers, "but given that the incidence rates are fairly low, this is quite a high bar compared with preterm birth", in terms of the potential market size. About one in 10 babies are born premature, even as the rapid rise in Pap smears and the development of human papillomavirus vaccines has led the rate of cervical cancer to tumble over the years.
A*Star's Dr Yee also argues that "if you think about it, women's health is probably the only healthcare segment where we are actually taking care of the next generation".
She says that research in genomics has shone the spotlight on prenatal health over the past six or seven years. "To me, that sort of brought new light and a new dimension in how people perceive women's health. It's no longer just the women themselves but how it involves the next generation - prenatal, postnatal - as well as menopause, food and nutrition, the whole works."
Yet it also includes the sex-specific ways in which some diseases, such as cardiovascular conditions, are diagnosed and treated.
"More and more, we're becoming more aware that there are gender differences in almost every single disease indication that we're looking at, and a lot of it actually has been enabled by the advent of genomics research and all the technological advances that we have," she notes.
Home-grown Lucence Diagnostics is one life sciences company that found its way into women's health. About 70 per cent to 80 per cent of the biopsy technology developer's laboratory work is from female oncology patients, according to Tan Min-Han, its founder and chief executive - even though women were not the focus when the company opened its doors.
And it's not just for the "Angelina Jolie" genetic test - so named for the Hollywood star who raised the profile of breast and ovarian cancer marker screening after her preventive double mastectomy. The inexplicable rate of terminal lung cancer in non-smoking Asian women - while nowhere as widely discussed as breast or ovarian disease - has also brought more work to Dr Tan's lab.
"These are all real needs of people, and these are all growing," he adds.
The National Cancer Centre of Singapore saw demand for genetic counselling - the process through which individuals at risk of an inherited disorder are advised - nearly triple between 2011 and 2014.
Still, growth in women's medtech will take much mindset change.
Inex's chief operating officer Richie Soong tells BT: "Challenges include achieving the recognition that women's health is a promising sector by itself, as well as the passage of time and education needed to introduce improvements."
Carmentix's Dr Arbel surmises that another reason for the relative novelty of women's health medtech - "probably the main reason", in his words - is that "you don't find many women in top positions at VCs around the world".
"So there's no vested interest in these VCs to actually address the unmet needs in this space," he says. "But it's still 50 per cent of the population."
http://www.businesstimes.com.sg/brunch/out-of-the-loop
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Cesarean Delivery Can Pose Long-Term Risks to Mother and Child
Jan 26, 2018 | New York Times
By Nicholas Bakalar
While a cesarean delivery is sometimes necessary and can be lifesaving, it may have serious long-term disadvantages for both mother and child, researchers report.
The analysis, in PLOS Medicine, pooled data from 80 studies including almost 30 million subjects.
Compared to vaginal delivery, C-sections were associated with a significant reduction in the risk for urinary incontinence and for pelvic organ prolapse, a dangerous weakening of the muscles that hold pelvic organs in place.
But for a pregnancy following a cesarean, there was a 17 percent increased probability of miscarriage and a 27 percent increased probability of stillbirth. The researchers also found nearly triple the probability for placenta accreta, in which the placenta grows too deeply into the uterine wall, and an increased chance of other placental problems.
Children delivered by cesarean had a 21 percent increased probability of asthma by age 12 and a nearly 60 percent increased likelihood of obesity up to age 5.
Still, the absolute risks of delivery-related problems were small. “Both kinds of delivery have very low risks of complications,” said the senior author, Dr. Sarah J. Stock, an obstetrician at the University of Edinburgh. “With placenta accreta, for example, the risk is one in 3,000, and it goes up to three in 3,000 with cesarean. These are rare but serious risks.”
https://www.nytimes.com/2018/01/26/well/family/cesarean-delivery-can-pose-long-term-risks-to-mother-and-child.html
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