Allvision IO, a geospatial analytics company providing insights and asset management to the transportation sector with specific applications for urban mobility, road and rail assets, announced today two new strategic hires. Wade Sheen joins Allvision as Vice President of Sales, and Steve Huber joins as Principal Software Engineer.
Before Allvision, Wade served as the VP of Sales and Business Development for Kaarta, a Pittsburgh sensor manufacturer, where he developed the world-wide channel for product sales, service, and support. His main responsibility for Allvision will be directing his market knowledge and contacts to drive growth for rail and urban verticals.
Prior to Allvision, Steve was the CTO and Director of Engineering at Kaarta, where he led the development of laser and camera based devices that built precise point cloud maps while being carried or driven through spaces. As Allvision Principal Software Engineer, he will be tasked with developing and strengthening technical competence in the development pipeline from capture device into the Allvision platform.
On January 4, 2021, Lightholder Consulting, LLC, a Pittsburgh-based Microsoft Cloud Solutions (MCS) Provider, proudly welcomed Ms. Shelby Prossen to the team as Manager of Business Development.
Ms. Prossen brings expertise in Engineering and SAS in various industries as a top performer in business development. She has spent the last decade at Fortune 500 companies consulting with clients to streamline their needs by leveraging software solutions and integration. She has a passion for helping others that translates to building powerful client partnerships and achieving their goals.
In her new role, she will be focused on building new business relationships, expanding the Lightholder consulting portfolio for future growth, support successful, timely, and strategic implementations of MCS solutions.
Since its launch in 2018, Lightholding Consulting, LLC continues to expand its client base nationally and has outgrown its startup roots. The company’s mission is to provide high-level scalable, affordable, flexible business solutions utilizing various cloud-based Microsoft solutions.
Cook MyoSite, a biotechnology firm based in Pittsburgh, Pennsylvania, today announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Cook MyoSite’s investigational product, Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR), for treatment of women with persistent or recurrent stress urinary incontinence (SUI) following surgical treatment.
Implicit in the RMAT designation is an acknowledgement that SUI meets the FDA's definition of a 'serious condition' in cases where women continue to experience incontinence episodes that have a substantial impact on day-to-day functioning despite having undergone surgical treatment. This acknowledgment represents a major step forward for these patients, many of whom suffer significantly from this life-altering condition with limited treatment options.
“This is a milestone for Cook, for urology, and for regenerative medicine, but most importantly, it’s a victory for the patients who have gotten to the end of the treatment pathway and have no more options,” said Ron Jankowski, Vice President of Scientific Affairs at Cook MyoSite. “This particular group of SUI patients for whom the gold standard of care has failed have a recognized unmet medical need with continued symptoms that substantially impact day-to-day functioning and quality of life.”
Cook MyoSite’s RMAT application was based on retrospective analyses of two open-label clinical studies and two double-blind, randomized, placebo-controlled clinical studies. The combined analyses evaluated the safety and efficacy of AMDC-USR in the subgroup of women enrolled in these studies continuing to experience symptoms despite receiving prior surgical treatment for incontinence. Preliminary evidence of clinically relevant reduction in stress incontinence episode frequency and improvement in quality of life and symptom severity scores, combined with the favorable safety profile, indicates that AMDC-USR has the potential to address unmet medical needs for these women.
To learn more about RMAT, visit https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation.