Michael Barbella, Managing Editor07.09.22
Pre-holiday news drove much of MPO's website traffic this post-holiday week as cybervisitors sought updates on new products, partnerships, and personnel.
OmniGuide Holdings and MedAlliance received the U.S. Food and Drug Administration's (FDA) blessing for new products, while MedNet and Pancryos entered into new partnerships.
The FDA cleared OmniGuide's RevoLix HTL, a family of pulsed and continuous wave Thulium YAG lasers. The product is used on urology patients undergoing benign prostatic hyperplasia (BPH) and stone management procedures. MedAlliance, meanwhile, nabbed FDA Investigational Device Exemption (IDE) approval for its SELUTION SLR drug-eluting balloon (DEB), making it the first limus DEB to be available to U.S. patients. The SELUTION SLR (Sustained Limus Release) is a sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB granted Breakthrough Device Designation by the FDA on March 4, 2019, and further on Sept. 25, 2019, for below-the-knee (BTK) indications in peripheral artery disease.
Partnerships manifested themselves via distribution and license agreements. MedNet and Foster Corporation are now the official distributors in Europe for high-performance medical polymers, supplying customers with Arkema's Pebax MED, Rilsan MED, Rilsamid MED, Rilsan Clear MED, and Kynar MED products. MedNet is representing Arkema in all countries in Europe, Middle East and Africa. Foster Corporation, already Arkema’s primary polymers distributor in North America and Asia, will also continue to be represented in Europe by MedNet. MedNet will make use of its distribution channels and market position in Europe giving customers the benefit of a single, local point of contact for Foster’s extensive compound portfolio and Arkema’s specialty resins.
Pancryos has executed a global exclusive license with Brigham and Women's Hospital for a convection-enhanced macroencapsulation device (ceMED) it developed with the Harvard Stem Cell Institute (HSCI). ceMED will be the delivery mechanism for the company's stem cell-derived, natural insulin production therapy, PanINSULA, for treating Type 1 diabetes.
Also garnering page views this week was Bigfoot Biomedical's appointment of Matt Rainville as chief commercial officer. He previously served as Insulet Corporation’s vice president and general manager of global Type 2 markets, where he led the company’s Omnipod Type 2 franchise and helped to expand access to insulin pumps for people with diabetes. Prior to Insulet, Rainville spent 13 years with Eli Lilly and Company.
OmniGuide Holdings and MedAlliance received the U.S. Food and Drug Administration's (FDA) blessing for new products, while MedNet and Pancryos entered into new partnerships.
The FDA cleared OmniGuide's RevoLix HTL, a family of pulsed and continuous wave Thulium YAG lasers. The product is used on urology patients undergoing benign prostatic hyperplasia (BPH) and stone management procedures. MedAlliance, meanwhile, nabbed FDA Investigational Device Exemption (IDE) approval for its SELUTION SLR drug-eluting balloon (DEB), making it the first limus DEB to be available to U.S. patients. The SELUTION SLR (Sustained Limus Release) is a sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB granted Breakthrough Device Designation by the FDA on March 4, 2019, and further on Sept. 25, 2019, for below-the-knee (BTK) indications in peripheral artery disease.
Partnerships manifested themselves via distribution and license agreements. MedNet and Foster Corporation are now the official distributors in Europe for high-performance medical polymers, supplying customers with Arkema's Pebax MED, Rilsan MED, Rilsamid MED, Rilsan Clear MED, and Kynar MED products. MedNet is representing Arkema in all countries in Europe, Middle East and Africa. Foster Corporation, already Arkema’s primary polymers distributor in North America and Asia, will also continue to be represented in Europe by MedNet. MedNet will make use of its distribution channels and market position in Europe giving customers the benefit of a single, local point of contact for Foster’s extensive compound portfolio and Arkema’s specialty resins.
Pancryos has executed a global exclusive license with Brigham and Women's Hospital for a convection-enhanced macroencapsulation device (ceMED) it developed with the Harvard Stem Cell Institute (HSCI). ceMED will be the delivery mechanism for the company's stem cell-derived, natural insulin production therapy, PanINSULA, for treating Type 1 diabetes.
Also garnering page views this week was Bigfoot Biomedical's appointment of Matt Rainville as chief commercial officer. He previously served as Insulet Corporation’s vice president and general manager of global Type 2 markets, where he led the company’s Omnipod Type 2 franchise and helped to expand access to insulin pumps for people with diabetes. Prior to Insulet, Rainville spent 13 years with Eli Lilly and Company.