MobileODT touts colposcope-based cervical cancer detection AI

MobileODT

MobileODT said last week that it is implementing a new artificial intelligence algorithm in its EVA system Colposcope that it claims can detect cervical cancer more effectively than existing testing.

The new technology, known as Automated Visual Evaluation, has been validated by the National Cancer Institute and the National Library of Medicine, the Israel-based company said, and is able to identify problematic lesions with greater reliability than traditional Pap Cytology testing.

MobileODT said that it is working with the NCI and other researchers to continue validating the AVE algorithm, and that it is launching a large scale pilot looking to validate the clinical application of the AVE algorithm with partners at India’s Genworks Health and Apollo Hospitals.

In the study, researchers will investigate the use of the AI algorithm in detecting cervical cancer in up to 250 women, the company said. It is hopeful that data from the trial will help improve the effectiveness of the AVE tech.

“We are excited by the new AVE algorithm and the promise it holds in fighting cervical cancer. Our team is proud to make available an AVE enabled colposcope to reach more women and save more lives,” CEO Ariel Beery said in a press release.

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Gynesonics touts 1-year pivotal IDE Sonata trial data

Gynesonics

Gynesonics yesterday released 12 month results from the FDA investigational device exemption pivotal trial of its Sonata system intended for diagnostic intrauterine imaging and the transcervical treatment of symptomatic uterine fibroids.

Results from the trial were published in the journal Obstetrics and Gynecology, the Redwood City, Calif.-based company said.

The company’s flagship Sonata System is a uterus preserving, incision-free uterine fibroid treatment designed to treat fibroids transcervically with radiofrequency energy. The system combines both an intrauterine ultrasound system with a proprietary radiofrequency ablation device, Gynesonics added.

“It is exciting to have the final one-year results from the Sonata Pivotal IDE Trial published in Obstetrics and Gynecology. We are appreciative of the investigators and their commitment to advancing options in women’s healthcare by studying the outcomes of our technology for the treatment of symptomatic uterine fibroids in the Sonata Trial. This is an important milestone and it comes on the heels of our recently announced substantial equity financing. We will continue to invest in high quality clinical and health economic outcomes research to help ensure access to the Sonata treatment for women suffering from symptomatic uterine fibroids in the United States and globally,” prez & CEO Christopher Owens said in prepared remarks.

In the 147-patient Sonata trial, investigators explored the use of the Sonata system at 21 outpatient sites in the U.S. and a single site in Mexico.

Data from the trial indicated that 99% of patients in the trial required no surgical reinterventions for heavy menstrual bleeding, with 97% reporting satisfaction with the treatment, the company said. Symptom improvement was reported by 96% of patients, with 95% reporting a reduction in menstrual bleeding. A total of 65% of patients in the trial reported at least a 50% reduction in menstrual bleeding.

The mean length of stay for patients, including procedure time, was reported as 2.5±1.2 hours, with 50% of patients returning to normal activity the next day. No device-related adverse events were reported, Gynesonics said.

“Uterine fibroids are a common problem that reduce the quality of life for women in the United States today. The Sonata pivotal clinical trial outcomes, along with the data from other published clinical outcome studies using the same technology, support offering sonography-guided transcervical uterine fibroid ablation as a treatment option to appropriate patients suffering from symptomatic uterine fibroids. This transcervical, uterine sparing approach avoids some of the risks of other treatment options, with minimal disruption in our patients’ lives,” study lead author Dr. Scott Chudnoff of Stamford Health said in a prepared statement.

“Publication of our pivotal clinical trial results in the prominent journal, Obstetrics and Gynecology, will help us raise awareness among gynecologists, the broader women’s healthcare community, and private insurers about the risk-benefit profile of treating symptomatic uterine fibroids in appropriate patients using the Sonata system. Publication in this excellent journal also supports the quality of the clinical trial design and the robustness of the one-year outcomes. Taken together, our current and future clinical trial publications are designed to strongly support the clinical value of the Sonata system, as we seek insurance coverage and begin commercialization,” board chair Karen Talmadge said in a press release.

Earlier this month, Gynesonics said that it closed a $75 million equity financing round to support its Sonata system.

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QT Ultrasound launches U.S. ultrasound mammography clinic chain

QT Ultrasound

QT Ultrasound said today that it is launching a chain of commercial mammography scanning centers using its radiation and compression-free breast imaging technology.

The Novato, Calif.-based company said the chain will function under the moniker QTbreasthealth, and will provide women a “unique spa-like, patient-centric environment.” The company has already opened locations in Novato, Walnut Creek, Calif. and Grand Rapids, Mich.

“We are thrilled to be on the forefront of this evolution in breast imaging. The QTbreasthealth experience is different than what women are used to. No compression means they get a comfortable experience, no harmful radiation means reduced risk and concern, results delivered and discussed personally with a provider – within just 72 hours – reduces anxiety, and the spa-like facilities and customer-centric philosophy help to define a new generation of breast imaging for women. We are already receiving great feedback from women who have been able to get image clarity delivered with comfort and compassion,” QTbreasthealth chief growth officer Dotty Bollinger said in a prepared statement.

The QT Ultrasound breast scanner has already received FDA 510(k) clearance for breast imaging, though is not intended as a replacement for screening mammography, the company said. The system uses no radiation, compressions or injections, the company added.

“For years we’ve seen the growing trend that consumers want to be involved in decisions about their healthcare. Now, with the QTbreasthealth centers, we’re making it easier for women to put their breast health in their own hands.  This technology is especially effective for women with dense breasts – about half of all women – who may have gotten false positives with mammography or who have been told they need additional screening. The QTscan can see through dense breasts and identify suspicious areas, which mammography may not,” CEO Dr. John Klock said in a press release.

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IZI Medical picks up Cook Medical’s Quick-Core biopsy and breast localization needle assets

Cook Medical, IZI MedicalIZI Medical Products extended its M&A spree today with the acquisition of a set of biopsy and breast localization needles from Cook Medical for an undisclosed amount.

Last September YY-based IZI picked up Benvenue Medical’s vertebral augmentation portfolio, also for an undisclosed amount; in May 2017, the company paid an unspecified price for Cook’s vertebroplasty devices, including the Duro-Ject Osteo-Site, Osteo-Force and Vertefix brands.

The latest deal with Cook includes the Quick-Core biopsy needle, MReye breast localization coil and the Kopans and X-Reidy lesion localization needles, IZI said. The company is owned by Shore Capital.

“This represents IZI’s third add-on acquisition in the last 18 months and significantly adds to our world-class portfolio of minimally invasive diagnostic and therapeutic products for the interventional radiology market,” CEO Greg Groenke said in prepared remarks. “Cook has done a wonderful job over the last several decades establishing these products as leading brands in their space. We are excited to increase the market penetration of these products through significant investment in domestic and international selling resources, select product enhancements, and new product development. These products are complementary to the line of Osteo-Site needles that IZI acquired from Cook in 2017.”

“IZI is strategically focused in diagnostic and therapeutic areas with imaging modalities, which will allow them to have a closer relationship with the diagnostic and interventional physicians that are performing the procedures,” added Cook vascular VP Mark Breedlove. “We were looking for a company that could invest more resources and continue to support these product families, the patients that benefit from them, and the physicians that use them. We have worked with IZI in the past and determined that they would be the ideal partner moving forward, and we are pleased to support the transition as IZI prepares to manufacture these products. This agreement will benefit patients, customers, and hospitals alike.”

“This acquisition continues to expand the breadth of products offered by IZI and is consistent with the strategy we developed when we partnered with Greg Groenke and the management team at IZI less than three years ago,” Shore Capital partner Don Pierce said. “We are building a leading platform to serve the interventional radiology and oncology markets with quality diagnostic and therapeutic medical devices. These product families will further extend IZI’s international sales reach and increase the depth of its portfolio.”

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Atlantic Therapeutics raises $32m Series B for garment-based UI stimulator

Atlantic Therapeutics said yesterday that it raised a Series B round worth $32 million for the garment-based device it makes to treat stress urinary incontinence.

Innovo, an externally worn electrical muscle stimulation device, has CE Mark approval in the European Union and recently won de novo clearance from the FDA, Galway, Ireland-based Atlantic Therapeutics said. Clinical study results released last August showed that 87.2% of the Innovo group and 86.8% of the control group were in the dry or mild SUI categories at 12 weeks, representing an improvement of 32.7% for Innovo and 26.1% for the control group. The Innovo group reported no infections, compared with 7.7% for the control group.

The €28 million round was led by LSP Health Economics Fund 2, Andera Partners and Atlantic Bridge Ventures, joined by existing backers Seroba Life Sciences and Earlybird Venture Capital.

Atlantic said it plans to use the proceeds to enter the U.S. market with Innovo and accelerate sales in other areas. The company said it also plans to develop its existing portfolio and expand into new clinical applications.

“Innovo has already transformed the lives of many thousands of people in Europe,” CEO Steve Atkinson said in prepared remarks. “We are delighted to have completed our Series B financing with such renowned investors and look forward to working together to accelerate the growth and value of Atlantic Therapeutics.”

“Atlantic Therapeutics’ Innovo provides a safe, clinically proven front-line therapy, increasing the options for the treatment of stress urinary incontinence, with the potential to significantly improve quality of life,” added LSP partner Anne Portwich. “We are delighted to offer our financial, clinical and commercial support in helping this exciting company grow around the globe.”

($1 = €0.873150)

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Minerva Surgical raises $9m for endometrial ablation tech

Minerva Surgical updatedMinerva Surgical has raised $9.2 million from 17 investors as part of a $10 million offering, according to a document filed with the SEC this week.

The Redwood City, CA.-based company makes the Minerva endometrial ablation system – a treatment designed to help women manage heavy menstrual bleeding.

Heaving bleeding, which occurs in women between the ages of 30 and 40, is a common diagnosis; the condition affects 1 in 3 women, according to Minerva Surgical.

The company’s technology works by delivering plasma energy to the tissue lining of a woman’s uterus. The doctor dilates the patient’s cervix and inserts a silicone array into the patient’s uterus. There, the silicone array opens and a cervical balloon is inflated to protect the cervix.

The doctor then uses the Minerva System to conduct a series of tests. After the tests are finished, the doctor delivers two minutes of customized plasma energy to treat the patient’s uterine lining, according to Minerva Surgical.

Finally, the cervical balloon is deflated and the silicone array is closed and removed from the patient’s uterus.

Minerva surgical touts that the entire treatment usually takes less than four minutes.

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Gynesonics closes $75m financing round

Gynesonics

Gynesonics said today that it closed a $75 million equity financing round to support its Sonata system intended for diagnostic intrauterine imaging and the transcervical treatment of symptomatic uterine fibroids.

The round was led by Bain Capital Life Sciences and joined by all the Redwood City, Calif.-based company’s existing investors, including Abingworth, Advanced Technology Ventures, Endeavour Vision, HealthCrest, InterWest Partners, HBM Partners, Correlation Ventures and Hercules Technology Growth Capital.

“We are confident that Gynesonics is well-positioned to meet the needs of women who suffer from this debilitating disease. The robust and impressive clinical data will enable the Sonata system to make a significant impact in the multi-billion worldwide market for the treatment of uterine fibroids,” Advanced Technology Ventures general partner & Gynesonics board member Mike Carusi said in prepared remarks.

The company’s flagship Sonata System is a uterus preserving, incision-free uterine fibroid treatment designed to treat fibroids transcervically with radiofrequency energy. The system combines both an intrauterine ultrasound system with a proprietary radiofrequency ablation device, Gynesonics added.

As part of the financing round, Gynesonics said that Bain Capital Life Sciences managing director Jeffrey Schwartz will join the company’s board of directors.

“We are impressed by the quality and promise of the Sonata system and the caliber of the Gynesonics team. We believe there is a strong clinical need for an incision-free option for women who are suffering from symptomatic fibroids. I look forward to joining the board and working closely with the team on this important platform technology as well as other advances in the company pipeline,” Schwartz said in a prepared statement.

Proceeds from the round are slated to support the launch and global commercialization of the company’s Sonata System, which has CE Mark clearance in the European Union and FDA 510(k) clearance. Proceeds will also support further development of the Sonata platform and additional clinical research initiatives.

“On behalf of all of the stakeholders in Gynesonics, I welcome Bain Capital as a new investor and Jeff as a new member of our board. Gynesonics has developed a breakthrough treatment option for symptomatic uterine fibroids that is designed to preserve the uterus. We are proud to offer physicians and the women under their care a new treatment choice for this disease. This financing will provide the capital to successfully commercialize the Sonata System and continue the clinical research essential to our market development objectives,” prez & CEO Christopher Owens said in a press release.

Last January, Gynesonics released results from the pivotal FDA investigational device exemption cleared trial for its Sonata system.

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Report: Despite settlement, patient seeks prosecution for off-label Seri scaffold breast surgery

A patient in Southern California who underwent breast reconstruction surgery using an off-label Seri surgical scaffold is pushing for the state to prosecute the operating plastic surgeon, despite having received $1 million in a settlement, over claims that he altered her medical records, according to a Pasadena Star News report.

The patient, Wendy Knecht, underwent breast reconstruction in 2015 following a cancer-preventive double mastectomy procedure. She was treated by Dr. Max Lehfeldt, who used a Seri surgical scaffold, produced by Allergan (NYSE:AGN) at the time, despite the scaffold having no FDA indications for such a surgery.

Knecht goes on to claim that not only did Lehfeldt use the device off label, they also altered medical documents to conceal the fact that he had not presented safer alternatives to her during an early meeting, according to the report.

Dr. Lehfeldt admitted to making the changes to the documents during deposition last year, the Pasadena Star News reports.

The Seri scaffold was originally developed by Serica Technologies, and won approval for repairing and remodeling damaged connective tissue in 2009. Serica was acquired by Allergan in 2010, which eventually sold the device and its associated IP to Sofregen Medical in 2016.

The FDA warned Allergan in the summer of 2015 about marketing the scaffold for breast surgery indications without appropriate approval, claiming that a review of the Seri website showed it being recommended for use with breast surgery applications.

The device only had indications for “use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome,” according to an FDA posting.

Lehfeldt reportedly had ties to Allergan as a consultant, having received more than $461,000 from the company between 2013 and 2017, according to the report. During the period Lehfeldt worked with Knecht, he was also an investigator in a study exploring the use of the Seri scaffold in breast reconstruction.

“He never told us it was off-label, he never told us he was doing experiments with it at the same time. He just used it on me,” Knecht told the paper in an interview.

Knecht eventually settled with Lehfeldt for $1 million, and settled with Allergan for an undisclosed amount, according to the Pasadena Star News, but the settlement with Dr. Lehfeldt did not include a confidentiality clause.

The California Medical Board has launched a second investigation into Lehfeldt in response to the request from Knecht, after an initial investigation closed shortly after Lehfeldt submitted his records and response to the board, according to the report.

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FDA updates on post-market study revisions, oversight for Bayer’s Essure

Bayer's Essure

The FDA today released steps it is taking to maintain its oversight of Bayer‘s (ETR:BAYN) Essure permanent birth control device following its removal from the U.S. market this summer, including extensions and revisions to a required post-market study of the device.

In an official posting, FDA Commissioner Dr. Scott Gottlieb said the FDA is working with Bayer to “revise and strengthen” its post-market study of Essure, which was ordered by the federal watchdog in 2016.

The trial will now follow patients who received the Essure device for five years rather than the initially requested three years, giving the agency “longer-term information on adverse risks of the device, including issues that may lead women to have the device removed,” Gottlieb wrote in the posting.

The agency said that it will also require additional blood testing for patients on follow-up visits to study levels of inflammatory markers that can indicate increased inflammation, with hopes that it will help evaluate immune reactions to the device and and their associations with reported symptoms.

The FDA said it will also require Bayer to continue to enroll patients who opt to receive the Essure device “in advance of its full discontinuation from the U.S. market” and to submit “more frequent” reports on the study’s progress.

“We believe that this new, revised study plan will help provide more long-term information regarding complications that may be experienced by patients who have Essure, despite reduced enrollment,” Gottlieb wrote in the posting.

The FDA added that in addition to the post-market study, it will “continue its efforts to monitor Essure’s safety and effectiveness since its approval in 2002 by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency.”

“We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them. The FDA will continue to collect and review reports of adverse events associated with device removal and is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device,” Gottlieb wrote in the posting.

In August, a group of Australian women joined others worldwide in a a class action lawsuit against Bayer for medical problems allegedly associated with its Essure device, according to a report from The Guardian.

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Allergan pulls textured breast implants from the European market

Allergan - updated logoAllergan (NYSE: AGN) has removed its textured breast implants from the market in Europe following a recall request from French regulators.

France’s National Agency for the Safety of Medicines and Health Products said that it hasn’t “identified any immediate risk for the health of women carrying the implants,” and that it plans to convene an expert committee to discuss the matter in February next year.

The New York Times reported this week that the implants were linked to an uncommon form of lymphoma that can arise years after the implant is placed.

Allergan’s CE Mark in the E.U. for the implants expired on Sunday and French regulators asked for more data about the devices before it would consider renewing the clearance.

Allergan plans to appeal the agency’s decision, it said in a statement, and that it will continue to push for the renewal of its CE Mark for the textured implants.

The company noted that its smooth breast implants are still on the market.

“Patient safety and product quality are Allergan’s highest priorities. Allergan takes this situation very seriously and is committed to engaging with all stakeholders to ensure they have the most up to date information,” CMO Charles Hugh-Jones said in prepared remarks. “We are committed to strict adherence to all regulatory requirements, to the most rigorous scientific evidence and to the highest industry standards for our products.”

In the U.S. (where the textured implants are still available), the FDA detailed 414 reports in 2018 of the breast implant-associated anaplastic large-cell lymphoma. Of the 414 cases, just 272 specified the implant’s texture and 242 of those featured a textured device. Nine of the 414 cases were fatal, according to the report from the New York Times.

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