Uterine fibroid

Gynesonics Announces $67M Financing to Expand Commercialization of Sonata® Procedure

Retrieved on: 
Thursday, November 2, 2023

The round was led by existing Gynesonics investors Amzak Health, Endeavour Vision, Kaiser Permanente Ventures, Runway Growth Capital, and Bain Capital; with new investments coming from MVM Partners as well as several other healthcare investors excited about Gynesonics’ commercial advances.

Key Points: 
  • The round was led by existing Gynesonics investors Amzak Health, Endeavour Vision, Kaiser Permanente Ventures, Runway Growth Capital, and Bain Capital; with new investments coming from MVM Partners as well as several other healthcare investors excited about Gynesonics’ commercial advances.
  • “Gynesonics continues to lay a strong foundation for success, having achieved a number of important commercial milestones in the most recent quarters,” said Joyce Erony, General Partner, Amzak Health.
  • “The Company is very well positioned to continue the acceleration of its growth going forward.
  • MVM is glad to support Gynesonics in offering a uterus-preserving, incisionless alternative to hysterectomy and myomectomy.”
    “This funding will enable Gynesonics to continue to expand commercial operations and provide millions of patients suffering from symptomatic fibroids a safe and efficacious minimally invasive treatment,” said Skip Baldino, President and CEO of Gynesonics.

Gynesonics Announces $67M Financing to Expand Commercialization of Sonata® Procedure

Retrieved on: 
Thursday, November 2, 2023

The round was led by existing Gynesonics investors Amzak Healthcare, Endeavour Vision, Kaiser Permanente Ventures, Runway Growth Capital, and Bain Capital; with new investments coming from MVM Partners as well as several other healthcare investors excited about Gynesonics’ commercial advances.

Key Points: 
  • The round was led by existing Gynesonics investors Amzak Healthcare, Endeavour Vision, Kaiser Permanente Ventures, Runway Growth Capital, and Bain Capital; with new investments coming from MVM Partners as well as several other healthcare investors excited about Gynesonics’ commercial advances.
  • “Gynesonics continues to lay a strong foundation for success, having achieved a number of important commercial milestones in the most recent quarters,” said Joyce Erony, General Partner, Amzak Ventures.
  • “The Company is very well positioned to continue the acceleration of its growth going forward.
  • MVM is glad to support Gynesonics in offering a uterus-preserving, incisionless alternative to hysterectomy and myomectomy.”
    “This funding will enable Gynesonics to continue to expand commercial operations and provide millions of patients suffering from symptomatic fibroids a safe and efficacious minimally invasive treatment,” said Skip Baldino, President and CEO of Gynesonics.

European Commission Approves the Commercialisation of RYEQO® for the Symptomatic Treatment of Endometriosis

Retrieved on: 
Thursday, November 2, 2023

('Richter') together with Sumitomo Pharma America, Inc. ('SMPA') and Sumitomo Pharma Switzerland, GmbH ('SMPS') today announce that the European Commission ('EC') has granted approval of a Type II Variation application for RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

Key Points: 
  • ('Richter') together with Sumitomo Pharma America, Inc. ('SMPA') and Sumitomo Pharma Switzerland, GmbH ('SMPS') today announce that the European Commission ('EC') has granted approval of a Type II Variation application for RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.
  • RYEQO® was initially approved by the EMA in July 2021 for the treatment of moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age.
  • "We are delighted that this approval has opened the way to offer a viable symptomatic treatment option for many women living with endometriosis" - said Dr. Peter Turek, Global Head of Women's Health at Gedeon Richter.
  • "Approximately 14 million women in the European Union are living with endometriosis, a chronic condition whose painful symptoms can impact a woman's ability to engage in certain daily activities.

Gynesonics’ Incision-Free Sonata Procedure for the Treatment of Uterine Fibroids Reaches Patient Milestones in the U.S. and Globally

Retrieved on: 
Wednesday, October 25, 2023

The Sonata® System is a technology platform that integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids.

Key Points: 
  • The Sonata® System is a technology platform that integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids.
  • The corresponding Sonata Procedure is a breakthrough alternative to hysterectomy and myomectomy, and can treat a wide range of fibroid types, sizes, and locations.
  • Fibroids are treated from inside the uterus, so the Sonata Procedure requires no incisions, no tissue is surgically removed, and the uterus is preserved.
  • 20% to 50% of women with fibroids are symptomatic and each year in the U.S., more than 2 million women undergo treatment for uterine fibroids.

Gynesonics’ Incision-Free Sonata Procedure for the Treatment of Uterine Fibroids Reaches Patient Milestones in the U.S. and Globally

Retrieved on: 
Tuesday, October 17, 2023

The Sonata® System is a technology platform that integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids.

Key Points: 
  • The Sonata® System is a technology platform that integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids.
  • The corresponding Sonata Procedure is a breakthrough alternative to hysterectomy and myomectomy, and can treat a wide range of fibroid types, sizes, and locations.
  • Fibroids are treated from inside the uterus, so the Sonata Procedure requires no incisions, no tissue is surgically removed, and the uterus is preserved.
  • 20% to 50% of women with fibroids are symptomatic and each year in the U.S., more than 2 million women undergo treatment for uterine fibroids.

Hologic Announces Innovative Collaboration with AAGL and Inovus Medical to Optimize OB-GYN Training for Minimally Invasive Surgeries

Retrieved on: 
Tuesday, October 10, 2023

Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, today announced an innovative new partnership with the American Association of Gynecologic Laparoscopists (AAGL) and Inovus Medical.

Key Points: 
  • Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, today announced an innovative new partnership with the American Association of Gynecologic Laparoscopists (AAGL) and Inovus Medical.
  • Hologic becomes the chief provider of hysteroscopes for AAGL’s Essentials in Minimally Invasive Gynecologic Surgery (EMIGS) hands-on hysteroscopy skills training for OB-GYN residents.
  • AAGL contracts with Inovus Medical, an award-winning designer and manufacturer of surgical training technologies, for the manufacturing and delivery of the hands-on training equipment for EMIGS.
  • “Our collaboration with Hologic and Inovus provides the vital infrastructure needed to bring EMIGS to life,” said Linda Michels, AAGL Executive Director.

STARmed America Launches, Pioneering Thermal Ablation Innovations in North America

Retrieved on: 
Thursday, October 5, 2023

STARmed Co., Ltd. has been at the forefront of thermal ablation innovations, offering patient comfort through minimally invasive alternatives.

Key Points: 
  • STARmed Co., Ltd. has been at the forefront of thermal ablation innovations, offering patient comfort through minimally invasive alternatives.
  • Starting its journey focusing on Liver Radiofrequency Ablation (RFA), STARmed has since spearheaded itself in Thyroid Radiofrequency Ablation (RFA) technologies and engineered the first thyroid-specific RF electrodes in 2009.
  • "Establishing STARmed America is an integral step in our journey to bring our cutting-edge thermal ablation solutions readily accessible to providers and patients in North America," remarked Henry Shin, CEO of STARmed.
  • With STARmed America, the parent company aims to further solidify its position as a globally recognized and respected brand in the ablation market.

Arstat Pharmaceuticals Appoints Seasoned Executive Darlene Walley, PhD, as Acting Chief Executive Officer

Retrieved on: 
Tuesday, October 3, 2023

FLEMINGTON, N.J., Oct. 3, 2023 /PRNewswire/ -- Arstat Pharmaceuticals Inc., which addresses, for the first time, critical unmet needs in women's health, announced today that Darlene Walley, PhD has been named the company's Acting Chief Executive Officer.

Key Points: 
  • FLEMINGTON, N.J., Oct. 3, 2023 /PRNewswire/ -- Arstat Pharmaceuticals Inc., which addresses, for the first time, critical unmet needs in women's health, announced today that Darlene Walley, PhD has been named the company's Acting Chief Executive Officer.
  • A seasoned healthcare and life sciences executive, Darlene has led large, global organizations ($100M to $1B) in Procter & Gamble, Oral-B Laboratories/Gillette, and Arm & Hammer.
  • Over the last two decades, Darlene has launched new companies and products, raising capital and enabling multiple successful exits.
  • "We are thrilled that Darlene has joined our team," said Arkady Rubin, PhD, Founder, President, and Chief Scientific Officer of Arstat Pharmaceuticals.

Gynesonics’ Incision-Free Sonata Procedure for the Treatment of Uterine Fibroids is Now Covered by UnitedHealthcare

Retrieved on: 
Tuesday, August 1, 2023

The Sonata® System is a technology platform that integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids.

Key Points: 
  • The Sonata® System is a technology platform that integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids.
  • The corresponding Sonata Procedure is a breakthrough alternative to hysterectomy and myomectomy, and can treat a wide range of fibroid types, sizes, and locations.
  • Fibroids are treated from inside the uterus, so the Sonata Procedure requires no incisions, no tissue is surgically removed, and the uterus is preserved.
  • 20% to 50% of women with fibroids are symptomatic and each year in the U.S., more than 2 million women undergo treatment for uterine fibroids.

EmVenio Research adds principal investigators to research team

Retrieved on: 
Tuesday, August 1, 2023

DURHAM, N.C., Aug. 1, 2023 /PRNewswire/ -- Clinical research organization EmVenio Research recently announced the addition of Dr. Stephen Blank, M.D., and Dr. Suzanne Swan, M.D., to its team, serving as principal investigators. In their roles, they will oversee and conduct objective clinical research to ensure independent, high quality and reproducible results, as well as manage oversight of compliance, financial, personnel and other related aspects of research projects. Coming from varying medical backgrounds, Dr. Blank and Dr. Swan offer a diversity of expertise, expanding EmVenio's ability to conduct a wider range of clinical trials.

Key Points: 
  • DURHAM, N.C., Aug. 1, 2023 /PRNewswire/ -- Clinical research organization EmVenio Research recently announced the addition of Dr. Stephen Blank, M.D., and Dr. Suzanne Swan, M.D., to its team, serving as principal investigators.
  • Stephen Blank and Suzanne Swan to its team of principal investigators.
  • Blank and Swan bring to our team a magnitude of experience and knowledge in the research of new treatments and therapies," said Thad Wolfram, EmVenio president.
  • "With their diverse backgrounds in medicine, they offer a unique level of oversight to the studies EmVenio conducts and provide our organization the depth to conduct a wider range of clinical research studies for pharmaceutical and clinical research organizations."