ODT’s Most-Read Stories This Week—April 23

Personnel, products, and purchasing attracted visitors to ODT’s website this past week.

Leading the charge was LimaCorporate CEO Luigi Ferrari’s decision to step down from his role to pursue new opportunities outside the organization. Ferrari led the company for almost 10 years, and will remain as a senior adviser to the advisory board to assist with the transition to new leadership. Emmanuel Bonhomme, president Europe, Middle East, and Africa, is filling in as interim CEO and a selection process has begun for a new leader. Bonhomme joined LimaCorporate’s management team in June 2018.

Also driving website traffic was the progression AxioMed has made on its FDA application for approval of its viscoelastic lumbar disc replacement. The company has submitted the necessary documents required to complete the last Module III of its FDA application for the product. The company is actively engaged with the FDA to complete responses to all their queries from its previously submitted Module I and II while also completing its final clinical data analyses required for the last Module III submission targeted on or before June 2022. This will allow the company to focus on manufacturing in anticipation of FDA on-sight inspection and for producing inventory to go to market in the United States and internationally.

M&A most always attracts readers, and ARCH Medical’s purchase of Amplify Additive enticed its fair share of visitors. Scarborough, Maine-headquartered Amplify, developer and manufacturer of implants that leverage 3D metal printing, particularly in titanium, now becomes ARCH Additive – Portland under the ARCH Medical Solutions umbrella, expanding the reach of ARCH into additive manufacturing for orthopedics and solidifying the company as a leading, diversified supplier noted for growth, scale and innovative solutions for customers within the medical device contract manufacturing market.

Rounding out product news was Stimwave’s start of its level-1 FREEDOM (FREEDOM – 1) clinical trial series, which will monitor chronic knee pain patients’ response to the company’s Freedom peripheral nerve stimulation (PNS) over time. The primary endpoint is pain reduction equal to or greater than 50 percent based on the visual analog scale. Secondary outcomes include changes in physical knee function while receiving PNS, and overall quality of life improvement.

1. LimaCorporate CEO Luigi Ferrari Steps Down

2. AxioMed Gets Closer to FDA Market Approval for its Lumbar Disc Replacement

3. ARCH Medical Acquires Amplify Additive

4. Higher Readmissions and Medical Complication Rates in TKA Octogenarians

5. Stimwave Begins Freedom PNS Trial for Chronic Knee Pain