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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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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Hologic CFO McMahon jumps ship to Agilent | Personnel Moves – August 1, 2018

Hologic (NSDQ:HOLX) said yesterday that its CFO Bob McMahon is leaving to take up a CFO role at Agilent Technologies.

The Marlborough, Mass.-based company said that its current chief accounting officer Karleen Oberton has been lifted to CFO, effective today.

“Bob has made tremendous contributions to Hologic over the last four years, and we wish him all the best in his new role. At the same time, we are excited to promote Karleen to CFO.  She has a deep knowledge of our business and people based on more than 12 years of experience at the company, and has been a great partner to our divisions.  She has been instrumental in our efforts both to drive profitable growth, and to strengthen our balance sheet and cash flows,” chair, prez & CEO Steve MacMillan said in a press release.

Prior to joining Hologic in 2006, Oberton served as senior corporate controller from 2004 to 2006, and acted as Ernst & Young life sceince practice senior audit manager before that.

 BD taps Campion as interventional prez, EVP

Becton Dickinson & Co. (NYSE:BDX) said today it named Simon Campion as its new interventional segment president and exec VP, effective September 4.

Campion came to BD after it acquired C.R. Bard, and has served as the surgery biz worldwide president, the company said. Prior to the acquisition, he led Bard’s surgery business for five years, having joined the company in 2008.

“Simon is a proven leader with deep global experience, a demonstrated focus on results and unique insight and breadth across the BD interventional segment. He is well prepared to drive innovation and cultural initiatives across the peripheral intervention, urology and critical care, and surgery businesses, while continuing to deliver growth as we integrate these businesses into BD,” prez Tom Polen said in a press release.

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 Repro Med lifts Goldberger to board chair, interim prez & CEO

Repro Med Systems (OTC:REPR) said last week it lifted board member Daniel Goldberger to the position of chair and interim prez and CEO

Goldberger joined the board in April, and has previously held positions with companies including Xtant Medical Holdings, Sound Surgical Tech, Xcorporeal and Glucon.

“I look forward to building on the foundation that Andy has laid over thirty years and we appreciate his service. The invention of the Freedom60 has improved the lives of thousands of chronically-ill patients around the globe, and RMS’ portfolio of products has enormous application potential. Andy’s long list of accomplishments has positioned RMS well for strong long-term growth of revenue and shareholder value,” Goldberger said in a press release.

“The prospects for the company are very bright, and we are excited to engage new leadership to embark on our next phase of significant growth,” board member Joseph Manko said in a prepared statement.

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 Philips Canada head Burns to step down, Barnes to step up

Royal Philips (NYSE:PHG) said last week that Jeffrey Barnes is succeeding Iain Burns as Philips Canada prez & CEO, effective immediately.

Barnes serves as a member of Philips NA exec team and is replacing Burns, who retired on July 31. Barnes had previously served as NA commercial leader senior VP.

“Jeff is a proven leader with nearly three decades of experience in working with high-performance, cross-functional teams, and he has worked closely with our North American partners to understand the solutions they need to stay ahead of a rapidly changing industry, helping them to deliver better healthcare for their communities. I am confident that Jeff will build on the exceptional contributions made by Iain Burns to Philips – in Canada, North America and around the globe.  I want to commend Iain for his accomplishments, thank him for his continued commitment to the Canadian business and wish him all the best as he begins to plan for retirement,” Philips NA CEO Vitor Rocha said in a press release.

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 Lineus Medical COO Clement moves to CEO spot

Medtech startup Lineus Medical has appointed former COO Vance Clement as its new chief exec as the comapny looks to move out of the R&D phase and into the product launch phase, according to a recent TalkBusiness report.

Former CEO and founder Spencer Jones, who invented the company’s SafeBreak Vascular product will move to a chief technical officer role, according to the report.

“The board made the move so that Spencer could continue to focus on his strengths such as product development, clinical issues and intellectual property. We moved people to their area of strength to match the company’s current focus,” Clement said, according to TalkBusiness.

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