Fractyl Health this week announced encouraging interim feasibility data from its diabetes reversal technology study. Lexington, Massachusetts–based Fractyl’s Revita-T2Di long-term open-label cohort assessed eight patients followed through at least four weeks having been treated. The company’s Revita system resurfaces the upper intestine lining (duodenal mucosa) to treat metabolic disease in patients with insulin-treated type 2 […]
Surgical
Innocoll Biotherapeutics initiates Phase 3 trials for collagen drug-device
Innocoll Biotherapeutics announced today that it initiated two Phase 3 trials to support a label expansion for its collagen drug-device implant. Athlone, Ireland-based Innocoll’s trials are seeking label expansion for the FDA-approved Xaracoll (bupivacaine hydrochloride) implant, according to a news release. INN-CB-024, a Phase 3, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety […]
How Bionaut Labs aims to tackle brain tumors with microrobots
The roboticist Michael Shpigelmacher was one of the founders of PrimeSense, a robotic 3-D vision technology company Apple acquired in 2013. PrimeSense created technology empowering the Microsoft Xbox Kinect and the iPhone’s Face ID feature, allowing users to use facial recognition to unlock their phones. Now Shpigelmacher has set his sights on drug-delivery with Bionaut […]
AmacaThera raises $10.3M in oversubscribed Series A
AmacaThera announced today that it completed an oversubscribed $10.3 million Series A financing round. Lumira Ventures led the Series A funding, with existing investors Viva BioInnovator and Sprout BioVentures contributing as well. New investors BDC Capital Women in Technology Venture Fund, Inveready, MBX Capital, CR Capital Management, StandUp Ventures and MaRS IAF participated, too, according […]
OncoSec announces positive results in metastatic melanoma case study
The International Journal of Surgery Case Reports has published a case study on the use of the humanized antibody Keytruda (pembrolizumab) and tavokinogene telseplasmid (TAVO) from OncoSec (NSDQ:ONCS) for treating metastatic melanoma. The study involved a patient with stage IIB, pT3b melanoma who initially underwent tumor resection but experienced regional recurrence and later disease progression […]
J&J’s Ethicon launches Vistaseal fibrin sealant
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon announced today that it launched its Vistaseal fibrin sealant for managing bleeding during surgery. The sealant system is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard techniques (suture, ligature, cautery) are ineffective or impractical. Vistaseal fibrin sealant consists […]
J&J’s Ethicon wins clearance for devices to deliver Grifols surgical sealant
Johnson & Johnson’s Ethicon has won FDA clearance for airless spray devices to deliver Grifols’ fibrin sealant to stop surgical bleeding, the companies announced today. The Vistaseal fibrin sealant will be the first product Grifols (NSDQ:GRFS) is introducing with Johnson & Johnson (NYSE:JNJ) and Ethicon as part of a global partnership. The 510(k) clearance covers three Vistaseal […]
Researchers question use of antibiotic shunts in hydrocephalus patients
Led by neurosurgeon Dr. Benjamin Warf, a team of researchers from Boston Children’s Hospital published a study this month questioning the benefits of using shunts impregnated with antibiotics to treat hydrocephalus. Hydrocephalus, which affects roughly 400,000 children each year, is characterized by fluid accumulation in the brain. Surgeons use shunts to drain the patient’s excess […]
Intersect ENT touts pooled analysis of steroid-releasing sinus implants
Intersect ENT (NSDQ:XENT) last week touted the publication of a pooled analysis of the company’s Propel Contour and Propel Mini steroid-eluting sinus implants. The company’s devices are designed to prop open the sinus ostia following endoscopic sinus surgery. As the implant dissolves, medicine is delivered directly to the sinus lining. The analysis, published in the International Forum […]
EyePoint nabs CMS reimbursement for Dexycu cataract surgery drug
EyePoint Pharmaceuticals (NSDQ:EYPT) said this week that the Centers for Medicare and Medicaid Services approved transitional pass-through status and reimbursement of its dexamethasone intraocular suspension, Dexycu. The FDA-approved product is designed to treat inflammation following cataract surgery using a single, intraocular dose of long-acting dexamethasone. “The receipt of pass-through status and the assignment of a […]
