The SRS–II multicenter clinical study completed recruitment of 50 patients according to study plan. Patient’s follow up is planned to three years.

Binyamina, Israel, July, 18th , 2017 – Lyra Medical Ltd. a medical device company and a developer of the anchorless trans-vaginal Self-Retaining Support (SRS) Implant, today announces the completion of recruitment in the SRS II clinical study.

The SRS–II clinical study is a multi-center (3 sites in Israel), prospective, non-randomized, single-arm, interventional clinical investigation designed to demonstrate the safety and performance of the SRS device. Study initiation was on March, 2016 enrollment was completed according to plan. The study completion is expected to be on July 2020 when all 50 patients will complete 3 years post procedure follow-up. Study population were women diagnosed with symptomatic anterior POP-Q grade 2 and above (point Ba ≥ -1).

Lyra Medical’s implant is a revolutionary surgical treatment for women suffering from advanced anterior vaginal wall prolapse with or without apical prolapse. The Self-Retaining Support (SRS) technology eliminates the need for complex anchoring techniques delivering a safe and long-term treatment solution.

“Today’s announcement marks another important step in the development of the SRS Implant. We are looking forward to the outcome of the trial expected on Q3 2020. Earlier study indicate the SRS Implant exhibits a safe and efficacy profile compared to other solution. Moreover the fact that recruitment was completed as expected indicate the good user acceptability profile of the SRS Implant. We believe that the SRS Implant has the potential to become a true “next generation” transvaginal option and a great player in the pelvic organ prolapse surgeries.” said Iram Levit, Lyra Medical’s CEO.

About Lyra Medical

Lyra Medical was established in 2011 by a team of seasoned medical device entrepreneurs to develop a new and safer organ support implant for women suffering from pelvic organ prolapse (POP).

The company’s Self-Retaining Support (SRS) technology is presently being applied in the flagship Lyra system for anterior vaginal wall, Apex and uterine prolapse. The support platform may be applicable in other pelvic organ disorder conditions, such as rectocele and urinary incontinence, as well as other clinical areas. In all these areas, there is an acute need for therapeutic solutions that deliver exceptional safety and long-term efficacy.

Booth #320, June 21st-23rd Vancouver Convention Centre – East Building, Vancouver, Canada.

Come visit us at the upcoming IUGA 2017 Annual Meeting, taking place at the Vancouver Convention Centre – East Building, Vancouver, Canada.

We will be located at Booth #320 and looking forward to providing information about our SRS technology and current clinical experience.

About Lyra Medical

Lyra Medical was established in 2011 by a team of seasoned medical device entrepreneurs to develop a new and safer organ support implant for women suffering from pelvic organ prolapse (POP).

The company’s Self-Retaining Support (SRS) technology is presently being applied in the flagship Lyra system for anterior vaginal wall, Apex and uterine prolapse. The support platform may be applicable in other pelvic organ disorder conditions, such as rectocele and urinary incontinence, as well as other clinical areas. In all these areas, there is an acute need for therapeutic solutions that deliver exceptional safety and long-term efficacy.

About IUGA

The International Urogynecological Association (IUGA) is dedicated to global advancement of urogynecological knowledge and patient care through education and the promotion of basic and clinical research on disorders of the female pelvic floor. In addition to holding an annual conference and publishing the International Urogynecology Journal, IUGA activities include conducting education programs around the world, developing consensus terminology in the field, connecting related professionals and producing patient education materials.

IUGA was founded in 1975 and has organized scientific meetings every year in nearly every corner of the world to promote the exchange of urogynecological information to thousands of physicians and healthcare providers.

About IUGA

The International Urogynecological Association (IUGA) is dedicated to global advancement of urogynecological knowledge and patient care through education and the promotion of basic and clinical research on disorders of the female pelvic floor. In addition to holding an annual conference and publishing the International Urogynecology Journal, IUGA activities include conducting education programs around the world, developing consensus terminology in the field, connecting related professionals and producing patient education materials.

IUGA was founded in 1975 and has organized scientific meetings every year in nearly every corner of the world to promote the exchange of urogynecological information to thousands of physicians and healthcare providers.

Kerem-Maharal, Israel, February 11th, 2016 – Lyra Medical, a developer of safe and easy POP trans-vaginal implant procedure, announced today the completion of its First-in-Women study. This international, multi-center study was initiated in September 2014 at three medical centers in Israel and Europe. The SRS was implanted in women who suffered from symptomatic ≥2^nd degree anterior vaginal and apical prolapse. All patients completed their 12-month follow-up. The mean follow-up period (as of February 2016) was 14 months (range: 12-27 months).

Results are excellent and conclusive. All patients had complete anatomical cure with POP-Q measurements of the treated compartments at normal values.

The results suggest that the safety profile and clinical outcome of an anchorless implant is potentially better than that reported for other trans-vaginal surgical meshes or native tissue repair procedures.

Table 1. POP-Q measurements at baseline vs. 12 months follow-up

Lyra Medical’s implant is a revolutionary surgical treatment for women suffering from advanced anterior vaginal wall prolapse with or without apical prolapse. The Self-Retaining Support (SRS) technology eliminates the need for complex anchoring techniques, delivering a safe and long-term treatment solution.

“While carrying out my first procedure I realized that the device can provide an excellent solution for pelvic organ prolapse. The simplicity of the Lyra SRS insertion makes it the most straightforward implant I have ever used. The anatomical and subjective results are very promising in comparison to mesh solutions I have used in the past. I hope that more of my patients will get the chance to benefit from the Lyra SRS solution in the future,” said Dr. Zoltan Fekete, Head of Urogynecology Division, Szeged University Hospital, Szeged, Hungary

“The study results demonstrate that Lyra’s anchorless technique can restore transvaginal implants as a viable, safe and effective treatment. It addresses some of the most common and devastating complications associated with current vaginal meshes,” added Iram Levit, Lyra Medical’s CEO.

For more information about Lyra Medical’s First-in-Women study please refer to the white paper available on Lyra’s website resources page.

About Lyra Medical

Lyra Medical was established in 2011 by a team of seasoned medical device entrepreneurs to develop a new and safer support implant in women suffering from pelvic organ prolapse (POP).

The company’s Self-Retaining Support (SRS) technology is presently being applied in the flagship Lyra system for anterior vaginal wall, Apex and uterine prolapse. The support platform may be applicable in other pelvic organ disorder conditions, such as rectocele and urinary incontinence, as well as other clinical areas. In all these areas, there is an acute need for therapeutic solutions that deliver exceptional safety and long-term efficacy.

Live procedure will be broadcast at the ISPP Congress 2016 meeting on Friday, September 23th at Tel Aviv – Yafo, Israel.

Kerem-Maharal, Israel, July 31th, 2016 – Lyra Medical, a developer of a safe and easy POP trans-vaginal implant procedure, announced today that a live-procedure will be broadcast during the upcoming International Society for Pelviperineology Congress (ISPP) 2016 Annual Meeting which will take place on September 21th – 24th at Tel Aviv – Yafo, Israel

This live-broadcast is a great opportunity to see the SRS technology, for the treatment of anterior vaginal prolapse, with or without apical prolapse at work. Participants will have the chance to present questions and interact with the surgeon throughout the procedure to get a better understanding about this promising trans-vaginal procedure.

“The Lyra SRS implant is very friendly and easy to use. With an overall operating time of 17 minutes from start-to-end, it’s the fastest procedure that I have ever done. Come see it in action,” said Dr. Na’ama Marcus, Head of Urogynecology Unit, Ziv Medical Center, Safed, Israel

“We invite you to participate in this interesting conference, where you’ll have the chance to see our innovative concept during live-case. You are also welcomed to come visit us at the conference exhibition, where our representative can provide further information about our solution,” said Iram Levit, Lyra Medical’s CEO.

About Lyra Medical

Lyra Medical was established in 2011 by a team of seasoned medical device entrepreneurs to develop a new and safer support implant for women suffering from pelvic organ prolapse (POP).

The company’s Self-Retaining Support (SRS) technology is presently being applied in the flagship Lyra system for anterior vaginal wall, Apex and uterine prolapse. The support platform may be applicable in other pelvic organ disorder conditions, such as rectocele and urinary incontinence, as well as other clinical areas. In all these areas, there is an acute need for therapeutic solutions that deliver exceptional safety and long-term efficacy.

About ISPP Congress

ISPP is an international multidisciplinary society with valued contributions from urologists, gynecologists and colorectal surgeons as well as nurses, pelvic therapists, pain therapists and physiotherapists. Tel Aviv – Yafo, a vibrant coastal city is sure to provide a fascinating backdrop for this year’s conference. Our colleagues in Israel are working hard to ensure an inspiring medical and social experience. The Organizing Committee has presented us with a varied and interesting program as well as a series of practical training workshops that will extend our knowledge across disciplines.

Conference website: http://www.pelviperineology.com/conference2016.

Deployable pelvic implant design and several frame-sheet harnessing methods offer an easier and safer implant deployment and surgical procedure

Kerem-Maharal, Israel, March 14th, 2016 – Lyra Medical, a developer of safe and easy POP trans-vaginal implant procedure, filed a new provisional patent to the United States Patent & Trademark Office, covering the company’s Self-Retaining Support technology and recent improvements.

Lyra sees major importance in securing and managing its intellectual property (IP) and protects its IP primarily through patent submission as well as by other means. Two patents titled: “Pelvic implant with anchoring frame” have been approved in the US (Patents No. 7981024, 8920302) and in Europe (Europe Patent No. 1684663). The patents portfolio is managed by “Ehrlich and Partners” an experienced and well respected patent office in Israel.

Lyra evaluates its IP portfolio on an ongoing basis, and additional patent applications are expected to be submitted throughout the development process.

The first issued patent (US 7,981,024) which has been granted by the USPTO on July 19th, 2011, covers the initial pelvic implant with anchoring frame concept, later named after it’s fundamental technology, the SRS (Self-Retaining Support). Lyra Medical has also been granted this patent by the European Patent Office.

Lyra Medical’s implant is a revolutionary surgical treatment for women suffering from advanced anterior vaginal wall prolapse with or without apical prolapse. The Self-Retaining Support (SRS) technology eliminates the need for complex anchoring techniques delivering a safe and long-term treatment solution.

Lyra’s technology mimics the physiologic pubocervical fascia and restores pelvic organs to their anatomical and functional location. This anchorless technique restores transvaginal implants as a viable, safe and effective treatment that far surpasses current mesh kits, sacrocolpopexy and native-tissue repair procedures.

“We believe that the future of Pelvic Organ Prolapse treatment depends on eliminating the need for complex anchoring techniques which has been shown to be the main cause of complications in current trans-vaginal techniques. Lyra’s technology mimics the physiologic pubocervical fascia and restores pelvic organs to their anatomical and functional location. Recent clinical experience with the SRS implant demonstrated that this anchorless technique could restore transvaginal implants as a viable, safe and effective treatment that far surpasses current mesh kits, sacrocolpopexy and native-tissue repair procedures,” said Iram Levit, Lyra Medical’s CEO

For more information about Lyra Medical and its technology please visit www.lyramed.com.

About Lyra Medical

Lyra Medical was established in 2011 by a team of seasoned medical device entrepreneurs to develop a new and safer organ support implant for women suffering from pelvic organ prolapse (POP).

The company’s Self-Retaining Support (SRS) technology is presently being applied in the flagship Lyra system for anterior vaginal wall, Apex and uterine prolapse. The support platform may be applicable in other pelvic organ disorder conditions, such as rectocele and urinary incontinence, as well as other clinical areas. In all these areas, there is an acute need for therapeutic solutions that deliver exceptional safety and long-term efficacy.

The Company Increases Funding to Expand Clinical Studies and Obtain Regulatory Approvals

Kerem-Maharal, Israel, January 26th, 2016 – Lyra Medical, a developer of an innovative trans-vaginal implant, has secured additional funding from a high-profile private investors group in the US. Lyra plans to use this fundraising round to facilitate market adoption of its product, by providing strong clinical evidence and demonstrating the ease-of-use, safety, clinical outcome and economic value of the Self Retaining Support (SRS) technology. This will be obtained by extending Lyra Medical’s clinical studies, i.e. recruiting more patients at more medical centers around the world.

Lyra Medical’s implant is a revolutionary surgical treatment for women suffering from advanced anterior vaginal wall prolapse with or without apical prolapse. The Self-Retaining Support (SRS) technology eliminates the need for complex anchoring techniques delivering a safe and long-term treatment solution.

Lyra’s technology mimics the physiologic pubocervical fascia and restores pelvic organs to their anatomical and functional location. This anchorless technique restores transvaginal implants as a viable, safe and effective treatment that far surpasses current mesh kits and native-tissue repair procedures.

“The continued support from existing shareholders and the trust we have received from our new investors will allow us to significantly extend our clinical studies effort. We intend to use the funds to allow more women at more Medical Centers to participate in our studies. Enhancing our evidence-based data will assist us to obtain regulatory approval and achieve market adoption” said Iram Levit, Lyra Medical’s CEO.

“When you examine a happy patient with optimal anatomy 18 months after SRS implantation, you realize that this unique design provides perfect results even in the most advanced prolapse patients. The Lyra SRS is optimal: short procedure, painless recovery and superior subjective and anatomical results. I’m glad that the completion of this additional fundraising round will allow me and my colleagues to offer the SRS solution to more of our patients” adds Dr. Gil Levy, Lyra Medical’s CMO.

For more information about Lyra Medical and its technology please visit www.lyramed.com.

About Lyra Medical

Lyra Medical was established in 2011 by a team of seasoned medical device entrepreneurs to develop a new and safer support implant for women suffering from pelvic organ prolapse (POP).

The company’s Self-Retaining Support (SRS) technology is presently being applied in the flagship Lyra system for anterior vaginal wall, Apex and uterine prolapse. The support platform may be applicable in other pelvic organ disorder conditions, such as rectocele and urinary incontinence, as well as other clinical areas. In all these areas, there is an acute need for therapeutic solutions that deliver exceptional safety and long-term efficacy.