Endologix touts Japanese collab dev & distro deal, 1st-in-human Ovation Alto trial data

Endologix (NSDQ:ELGX) this week announced a joint R&D and exclusive distribution deal with Japan Lifeline and released case review results from the 1st-in-human use of its Ovation Alto stent graft designed for endovascular aneurysm repair.

The Irvine, Calif.-based company said it inked a deal with Japan Lifeline to jointly invest in development, clinical research and commercialization of novel endovascular stent graft systems for the treatment of thoracic aortic disease.

Japan Lifeline will gain exclusive distribution rights to the systems in Japan, while Endologix said it will commercialize the system through its existing global sales force in other regions.

“JLL is our exclusive distributor in Japan, and it has done an outstanding job supporting physicians and capturing market share in Japan with our AFX device for the treatment of abdominal aortic aneurysms. We are currently working with JLL on a full market release of our AFX2 bifurcated endograft system in Japan after receiving approval for that device earlier this year. We also anticipate Japanese market launches of Ovation and Nellix in the future. These new agreements with JLL will expand our relationship to include thoracic devices and enable us to provide a complete range of endovascular aortic devices to physicians worldwide,” Endologix CEO John McDermott said in a prepared statement.

Endologix also released data from its 1st-in-human experience from the 1st 7 patients treated with the Ovation Alto. The devices were implanted at Auckland, New Zealand’s Auckland City Hospital between Aug. 2017 and Feb. 2017.

Results from the initial cases indicated successful delivery and deployment in all patients with a 100% technical success rate. No type I or type III endoleaks, stent graft migrations, abdominal aortic aneurysm ruptures, abdominal aneurysm-related deaths or secondary interventions were reported.

“Although limited to only 7 patients, early experience with the Ovation Alto was promising and suggests the device may safely expand EVAR indications beyond that of other available devices,” Dr. Sean Lynden, who presented the results at the VIVA 2017 conference wrote in a summary.

Endologix touted that the device features a low-profile 15-F outer diameter delivery system and the ability to seal at the level of the proximal sealing ring, which is 7-mm distal to the top of the fabric.

Last month, Endologix touted results from its Leopard clinical trial, which compared its AFX and AFX2 endografts to other commercially available bifurcated aortic endografts.

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Viveve inks distro deal with InControl Medical, posts Q2 miss

Shares in Viveve (NSDQ:VIVE) have stayed steady today after the company announced a new exclusive distribution deal with InControl Medical and released 2nd quarter earnings that missed expectations on Wall Street.

Under the agreement, Englewood, Colo.-based Viveve said it will be granted exclusive rights to distribute all of InControl Medical’s products to healthcare providers in the US.

“We are pleased with the opportunity to partner with Viveve to enable wider distribution of our clinically proven devices to U.S. medical professionals who can help the millions of patients suffering from pelvic floor and related incontinence conditions. Our hope is that these products will allow more women to have better control and an improved quality of life. Viveve and InControl share a dedicated commitment to advancing solutions for women’s health,” InControl Medical CEO Herschel Peddicord said in prepared remarks.

Viveve said it will be making a $2.5 million equity investment in InControl as part of the distribution agreement, as well.

“Completing an agreement with InControl Medical represents a significant opportunity for Viveve in the U.S. professional healthcare market. The addition of InControl Medical’s FDA cleared medical devices for stress, urge, and mixed incontinence as well as their products to improve pelvic floor strength enhances our portfolio with a range of high quality products that are used by healthcare professionals within Viveve’s currently targeted specialties. In addition to InControl Medical’s innovative devices to treat incontinence, their products aimed at improving patients’ pelvic floor strength and health complement the effectiveness of Viveve’s Geneveve treatment, that currently has regulatory clearance or approval in over 50 countries for the treatment of vaginal laxity and/or the improvement of sexual function. In the United States, the Viveve System is cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis,” Viveve CEO Patricia Scheller said in a prepared statement.

In its earnings report, Viveve posted losses of $10.4 million, or 54¢ per share, on sales of $3.1 million for the 3 months ended June 30, seeing losses grow 96.1% while sales grew 97.7% compared to the same period during the previous year.

Losses per share came in ahead of the 43¢ consensus on Wall Street, where analysts were expecting to see sales of $3.2 million for the quarter.

“During the 2nd quarter, we continued to achieve our commercial objectives and experienced growing demand for our innovative technology in the U.S. We also reached a number of important milestones that support our global commercialization strategy,” CEO Scheller said in a press release.

Shares in Viveve Medical are down 0.9% so far today, at $6.99 as of 10:56 a.m. EDT.

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