|Over a week ago|
MiMedx appoints Todd Newton as interim CEO » 07:0809/0609/06/22
MiMedx Group announced…
MiMedx Group announced that K. Todd Newton, a member of the MIMEDX Board of Directors, has been appointed interim CEO. Newton replaces Timothy R. Wright, who served as MIMEDX's CEO since May of 2019. The Board has appointed a special committee to direct the search for a new CEO. The Search Committee comprises M. Kathleen Behrens, James L. Bierman and William A. Hawkins III, and will retain a leading executive search firm to support the process. In connection with today's announcement, Wright is no longer a member of the Board of Directors, and the Board has been reduced to eight members. Newton joined MIMEDX's Board in 2019, and has since served as Chair of the Audit Committee and as a member of the Ethics and Compliance Committee. Mr. Newton previously served as Chief Executive Officer and as a member of the Board of Directors of Apollo Endosurgery (APEN), a medical device company, from July 2014 until March 2021.
|Over a month ago|
Apollo Endosurgery announces ESG procedure featured in IFSO paper » 07:4608/3108/31/22
Apollo Endosurgery announced that the endoscopic sleeve gastroplasty procedure was featured in a 2022 Top 10 Paper at the International Federation for the Surgery of Obesity and Metabolic Disorders 2022 World Congress, held August 23-27 in Miami. Dr. Brandon VanderWel, Bariatric & Metabolic Surgeon at EVIVA in Seattle, Washington, presented the paper entitled "Endoscopic Sleeve Gastroplasty Complements a Bariatric Surgery Practice". The paper is a retrospective review aimed at measuring the impact of integrating the ESG procedure into a bariatric surgery program in a community setting. Procedural volumes from 2020-2021 and clinical outcomes at 12 months were reported. Highlights include: Upon offering the ESG procedure, EVIVA received 469 new patient consults specific to ESG procedure over a two-year period; 197 patients underwent an ESG procedure and 107 patients received a laparoscopic sleeve gastrectomy. In these patients undergoing ESG, the total body weight loss at 12 months was 24% and the excess body weight loss was 75%. The rate of serious adverse events was 1%. In patients with hypertension, 45% were found to be in remission, 20% demonstrated improvement, and 35% demonstrated no change in hypertension at 12 months. In patients with diabetes, 55% were found to be in remission, 33% demonstrated improvement, and 11% demonstrated no change at 12 months.
Apollo Endosurgery announces publication on MERIT study » 07:2307/2907/29/22
Apollo Endosurgery announced the electronic publication of the landmark Multi-center ESG Randomized Interventional Trial Study in The Lancet. The MERIT study is a multi-center, prospective randomized clinical trial evaluating the safety and effectiveness of the Endoscopic Sleeve Gastroplasty procedure, a minimally invasive, endoscopic weight loss procedure performed with Apollo's Endosurgery's OverStitch Endoscopic Suturing System.In the study, patients with Body Mass Index greater than or equal to30 and less than or equal to40 kg/m were randomized to treatment with ESG and lifestyle modification or to a control group which involved lifestyle modification alone. At the conclusion of the primary end point, qualifying patients in the control group were allowed to cross-over to ESG if they met certain conditions. Nine US centers participated in the study, representing both gastroenterology and bariatric surgery practices from academic and community settings. One hundred and fifty-seven subjects completed the study through 52 weeks of follow-up. Seventy-two control patients crossed over to treatment at 52 weeks, and both groups were followed an additional 52 weeks. Key results for patients undergoing ESG include: 49.2% excess body weight loss at 12 months in the treatment group; 16.3% average total body weight loss in the responder group; 68.3% of responders maintained at least 25% EWL at 104 weeks; Improvements in quality of life, eating behaviors, and depression. Three ESG patients experienced a device or procedure related serious adverse event, all of which resolved and did not require intensive care or surgical intervention.
Apollo Endosurgery FDA authorizations a 'significant positive,' says Lake Street » 08:4807/1407/14/22
Lake Street analyst Frank…
Lake Street analyst Frank Takkinen called Apollo Endosurgery receiving FDA de novo marketing authorization for Apollo ESG and Apollo REVISE weight loss specific procedures a "significant positive" and an important element to accelerating Apollo's growth rate to its 20%-plus "mid-term" target. The analyst, who thinks Apollo's growth profile, margin expansion opportunity, and solid balance sheet should justify multiple expansion, reiterates a Buy rating and $14 price target on the shares.
FDA grants De Novo marketing authorization to Apollo ESG, Apollo REVISE systems » 07:3607/1307/13/22
Apollo Endosurgery announced the marketing authorization of the Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx Systems through the U.S. Food and Drug Administration's De Novo Classification process. These are the first and only devices authorized by the FDA for endoscopic sleeve gastroplasty and endoscopic bariatric revision.
Apollo Endosurgery appoints Sharon O'Keefe to board of directors » 07:1507/0607/06/22
Apollo Endosurgery announced that Sharon O'Keefe has joined the company's Board of Directors, effective July 6, 2022. O'Keefe was President of the University of Chicago Medical Center from 2011 to 2020, overseeing a network of physicians and clinics with 10,000 employees and annual operating revenue in excess of $2 billion. Apollo also announced that Rick Anderson has retired from the Apollo Board of Directors, effective immediately. Mr. Anderson, Chairman of Revival Healthcare Capital, has served as a member of the Apollo Board of Directors since 2013.
|Over a quarter ago|
Apollo Endosurgery to highlight products at DDW 2022 » 08:2705/1805/18/22
Apollo Endosurgery announced that Apollo products and procedures that utilize Apollo products will be featured in more than 40 academic posters and videos and over 60 podium presentations and lectures at the upcoming Digestive Disease Week 2022 to be held in San Diego, May 21-24. Highlights include: Full presentation of the MERIT study of the Endoscopic Sleeve Gastroplasty procedure's impact on obesity; 5-year follow-up data for Endoscopic Sleeve Gastroplasty; Endoscopic Sleeve Gastroplasty in Class III Obesity; A systemic review and meta-analysis comparison of ESG and laparoscopic sleeve gastrectomy; Revisional Endoscopic Sleeve Gastroplasty and GLP-1 agonist medications; A multicenter study of the efficacy, feasibility and safety of the X-Tack Endoscopic HeliX Tacking System; Closure of colonic EMR defects using the X-Tack Endoscopic HeliX Tacking System. Included with these presented works will be the full data from the landmark Multi-center ESG Randomized Interventional Trial. ESG is a minimally invasive procedure that uses the OverStitch Endoscopic Suturing System to reduce the volume of a person's stomach. The preliminary MERIT results reported in October at the International Federation for the Surgery of Obesity and Metabolic Disorders revealed that patients who underwent ESG demonstrated an excess body weight loss of 49.2% at 12 months, which was a 45% difference in %EWL compared to patients undergoing moderate intensity lifestyle modification. Presentation of the full MERIT dataset will provide additional information on patient responses to ESG and add to a larger body of evidence of more than 250 publications and abstracts reporting positive outcomes after ESG in over 6,500 patients.
Apollo Endosurgery appoints Jeannette Bankes to board of directors » 07:2904/0404/04/22
Apollo Endosurgery (APEN)…
Apollo Endosurgery (APEN) announced the appointment of Jeannette Bankes to its Board of Directors, bringing the number of board members to eight. Bankes is the President and General Manager of the Global Surgical Franchise at Alcon (ALC).
Apollo Endosurgery price target lowered to $12 from $14 at Piper Sandler » 05:0202/2302/23/22
Piper Sandler analyst…
Piper Sandler analyst Adam Maeder lowered the firm's price target on Apollo Endosurgery to $12 from $14 and keeps an Overweight rating on the shares following the Q4 results. While Q4 revenue came in a touch below estimates, Apollo made a lot of progress transforming the business in 2021 and enters 2022 with momentum in several key areas, Maeder tells investors in a research note.
Apollo Endosurgery management to meet virtually with Lake Street » 04:5501/1101/11/22
Virtual Meeting to be…
Virtual Meeting to be held on January 11 hosted by Lake Street.